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Organizing Your Social Sciences Research Paper

• 4. The Introduction
• Purpose of Guide
• Design Flaws to Avoid
• Independent and Dependent Variables
• Glossary of Research Terms
• Reading Research Effectively
• Narrowing a Topic Idea
• Broadening a Topic Idea
• Extending the Timeliness of a Topic Idea
• Academic Writing Style
• Applying Critical Thinking
• Choosing a Title
• Making an Outline
• Paragraph Development
• Research Process Video Series
• Executive Summary
• The C.A.R.S. Model
• Background Information
• The Research Problem/Question
• Theoretical Framework
• Citation Tracking
• Content Alert Services
• Evaluating Sources
• Primary Sources
• Secondary Sources
• Tiertiary Sources
• Scholarly vs. Popular Publications
• Qualitative Methods
• Quantitative Methods
• Insiderness
• Using Non-Textual Elements
• Limitations of the Study
• Common Grammar Mistakes
• Writing Concisely
• Avoiding Plagiarism
• Footnotes or Endnotes?
• Further Readings
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The introduction leads the reader from a general subject area to a particular topic of inquiry. It establishes the scope, context, and significance of the research being conducted by summarizing current understanding and background information about the topic, stating the purpose of the work in the form of the research problem supported by a hypothesis or a set of questions, explaining briefly the methodological approach used to examine the research problem, highlighting the potential outcomes your study can reveal, and outlining the remaining structure and organization of the paper.

Key Elements of the Research Proposal. Prepared under the direction of the Superintendent and by the 2010 Curriculum Design and Writing Team. Baltimore County Public Schools.

Importance of a Good Introduction

Think of the introduction as a mental road map that must answer for the reader these four questions:

• What was I studying?
• Why was this topic important to investigate?
• What did we know about this topic before I did this study?
• How will this study advance new knowledge or new ways of understanding?

According to Reyes, there are three overarching goals of a good introduction: 1) ensure that you summarize prior studies about the topic in a manner that lays a foundation for understanding the research problem; 2) explain how your study specifically addresses gaps in the literature, insufficient consideration of the topic, or other deficiency in the literature; and, 3) note the broader theoretical, empirical, and/or policy contributions and implications of your research.

A well-written introduction is important because, quite simply, you never get a second chance to make a good first impression. The opening paragraphs of your paper will provide your readers with their initial impressions about the logic of your argument, your writing style, the overall quality of your research, and, ultimately, the validity of your findings and conclusions. A vague, disorganized, or error-filled introduction will create a negative impression, whereas, a concise, engaging, and well-written introduction will lead your readers to think highly of your analytical skills, your writing style, and your research approach. All introductions should conclude with a brief paragraph that describes the organization of the rest of the paper.

Hirano, Eliana. “Research Article Introductions in English for Specific Purposes: A Comparison between Brazilian, Portuguese, and English.” English for Specific Purposes 28 (October 2009): 240-250; Samraj, B. “Introductions in Research Articles: Variations Across Disciplines.” English for Specific Purposes 21 (2002): 1–17; Introductions. The Writing Center. University of North Carolina; “Writing Introductions.” In Good Essay Writing: A Social Sciences Guide. Peter Redman. 4th edition. (London: Sage, 2011), pp. 63-70; Reyes, Victoria. Demystifying the Journal Article. Inside Higher Education.

Structure and Writing Style

I.  Structure and Approach

The introduction is the broad beginning of the paper that answers three important questions for the reader:

• What is this?
• Why should I read it?
• What do you want me to think about / consider doing / react to?

Think of the structure of the introduction as an inverted triangle of information that lays a foundation for understanding the research problem. Organize the information so as to present the more general aspects of the topic early in the introduction, then narrow your analysis to more specific topical information that provides context, finally arriving at your research problem and the rationale for studying it [often written as a series of key questions to be addressed or framed as a hypothesis or set of assumptions to be tested] and, whenever possible, a description of the potential outcomes your study can reveal.

These are general phases associated with writing an introduction: 1.  Establish an area to research by:

• Highlighting the importance of the topic, and/or
• Making general statements about the topic, and/or
• Presenting an overview on current research on the subject.

2.  Identify a research niche by:

• Opposing an existing assumption, and/or
• Revealing a gap in existing research, and/or
• Formulating a research question or problem, and/or
• Continuing a disciplinary tradition.

3.  Place your research within the research niche by:

• Stating the intent of your study,
• Outlining the key characteristics of your study,
• Describing important results, and
• Giving a brief overview of the structure of the paper.

NOTE:   It is often useful to review the introduction late in the writing process. This is appropriate because outcomes are unknown until you've completed the study. After you complete writing the body of the paper, go back and review introductory descriptions of the structure of the paper, the method of data gathering, the reporting and analysis of results, and the conclusion. Reviewing and, if necessary, rewriting the introduction ensures that it correctly matches the overall structure of your final paper.

II.  Delimitations of the Study

Delimitations refer to those characteristics that limit the scope and define the conceptual boundaries of your research . This is determined by the conscious exclusionary and inclusionary decisions you make about how to investigate the research problem. In other words, not only should you tell the reader what it is you are studying and why, but you must also acknowledge why you rejected alternative approaches that could have been used to examine the topic.

Obviously, the first limiting step was the choice of research problem itself. However, implicit are other, related problems that could have been chosen but were rejected. These should be noted in the conclusion of your introduction. For example, a delimitating statement could read, "Although many factors can be understood to impact the likelihood young people will vote, this study will focus on socioeconomic factors related to the need to work full-time while in school." The point is not to document every possible delimiting factor, but to highlight why previously researched issues related to the topic were not addressed.

Examples of delimitating choices would be:

• The key aims and objectives of your study,
• The research questions that you address,
• The variables of interest [i.e., the various factors and features of the phenomenon being studied],
• The method(s) of investigation,
• The time period your study covers, and
• Any relevant alternative theoretical frameworks that could have been adopted.

Review each of these decisions. Not only do you clearly establish what you intend to accomplish in your research, but you should also include a declaration of what the study does not intend to cover. In the latter case, your exclusionary decisions should be based upon criteria understood as, "not interesting"; "not directly relevant"; “too problematic because..."; "not feasible," and the like. Make this reasoning explicit!

NOTE:   Delimitations refer to the initial choices made about the broader, overall design of your study and should not be confused with documenting the limitations of your study discovered after the research has been completed.

ANOTHER NOTE : Do not view delimitating statements as admitting to an inherent failing or shortcoming in your research. They are an accepted element of academic writing intended to keep the reader focused on the research problem by explicitly defining the conceptual boundaries and scope of your study. It addresses any critical questions in the reader's mind of, "Why the hell didn't the author examine this?"

III.  The Narrative Flow

Issues to keep in mind that will help the narrative flow in your introduction :

• Your introduction should clearly identify the subject area of interest . A simple strategy to follow is to use key words from your title in the first few sentences of the introduction. This will help focus the introduction on the topic at the appropriate level and ensures that you get to the subject matter quickly without losing focus, or discussing information that is too general.
• Establish context by providing a brief and balanced review of the pertinent published literature that is available on the subject. The key is to summarize for the reader what is known about the specific research problem before you did your analysis. This part of your introduction should not represent a comprehensive literature review--that comes next. It consists of a general review of the important, foundational research literature [with citations] that establishes a foundation for understanding key elements of the research problem. See the drop-down menu under this tab for " Background Information " regarding types of contexts.
• Clearly state the hypothesis that you investigated . When you are first learning to write in this format it is okay, and actually preferable, to use a past statement like, "The purpose of this study was to...." or "We investigated three possible mechanisms to explain the...."
• Why did you choose this kind of research study or design? Provide a clear statement of the rationale for your approach to the problem studied. This will usually follow your statement of purpose in the last paragraph of the introduction.

IV.  Engaging the Reader

A research problem in the social sciences can come across as dry and uninteresting to anyone unfamiliar with the topic . Therefore, one of the goals of your introduction is to make readers want to read your paper. Here are several strategies you can use to grab the reader's attention:

• Open with a compelling story . Almost all research problems in the social sciences, no matter how obscure or esoteric , are really about the lives of people. Telling a story that humanizes an issue can help illuminate the significance of the problem and help the reader empathize with those affected by the condition being studied.
• Include a strong quotation or a vivid, perhaps unexpected, anecdote . During your review of the literature, make note of any quotes or anecdotes that grab your attention because they can used in your introduction to highlight the research problem in a captivating way.
• Pose a provocative or thought-provoking question . Your research problem should be framed by a set of questions to be addressed or hypotheses to be tested. However, a provocative question can be presented in the beginning of your introduction that challenges an existing assumption or compels the reader to consider an alternative viewpoint that helps establish the significance of your study. 
• Describe a puzzling scenario or incongruity . This involves highlighting an interesting quandary concerning the research problem or describing contradictory findings from prior studies about a topic. Posing what is essentially an unresolved intellectual riddle about the problem can engage the reader's interest in the study.
• Cite a stirring example or case study that illustrates why the research problem is important . Draw upon the findings of others to demonstrate the significance of the problem and to describe how your study builds upon or offers alternatives ways of investigating this prior research.

NOTE:   It is important that you choose only one of the suggested strategies for engaging your readers. This avoids giving an impression that your paper is more flash than substance and does not distract from the substance of your study.

Freedman, Leora  and Jerry Plotnick. Introductions and Conclusions. University College Writing Centre. University of Toronto; Introduction. The Structure, Format, Content, and Style of a Journal-Style Scientific Paper. Department of Biology. Bates College; Introductions. The Writing Center. University of North Carolina; Introductions. The Writer’s Handbook. Writing Center. University of Wisconsin, Madison; Introductions, Body Paragraphs, and Conclusions for an Argument Paper. The Writing Lab and The OWL. Purdue University; “Writing Introductions.” In Good Essay Writing: A Social Sciences Guide . Peter Redman. 4th edition. (London: Sage, 2011), pp. 63-70; Resources for Writers: Introduction Strategies. Program in Writing and Humanistic Studies. Massachusetts Institute of Technology; Sharpling, Gerald. Writing an Introduction. Centre for Applied Linguistics, University of Warwick; Samraj, B. “Introductions in Research Articles: Variations Across Disciplines.” English for Specific Purposes 21 (2002): 1–17; Swales, John and Christine B. Feak. Academic Writing for Graduate Students: Essential Skills and Tasks . 2nd edition. Ann Arbor, MI: University of Michigan Press, 2004 ; Writing Your Introduction. Department of English Writing Guide. George Mason University.

Writing Tip

Avoid the "Dictionary" Introduction

Giving the dictionary definition of words related to the research problem may appear appropriate because it is important to define specific terminology that readers may be unfamiliar with. However, anyone can look a word up in the dictionary and a general dictionary is not a particularly authoritative source because it doesn't take into account the context of your topic and doesn't offer particularly detailed information. Also, placed in the context of a particular discipline, a term or concept may have a different meaning than what is found in a general dictionary. If you feel that you must seek out an authoritative definition, use a subject specific dictionary or encyclopedia [e.g., if you are a sociology student, search for dictionaries of sociology]. A good database for obtaining definitive definitions of concepts or terms is Credo Reference .

Saba, Robert. The College Research Paper. Florida International University; Introductions. The Writing Center. University of North Carolina.

Another Writing Tip

When Do I Begin?

A common question asked at the start of any paper is, "Where should I begin?" An equally important question to ask yourself is, "When do I begin?" Research problems in the social sciences rarely rest in isolation from history. Therefore, it is important to lay a foundation for understanding the historical context underpinning the research problem. However, this information should be brief and succinct and begin at a point in time that illustrates the study's overall importance. For example, a study that investigates coffee cultivation and export in West Africa as a key stimulus for local economic growth needs to describe the beginning of exporting coffee in the region and establishing why economic growth is important. You do not need to give a long historical explanation about coffee exports in Africa. If a research problem requires a substantial exploration of the historical context, do this in the literature review section. In your introduction, make note of this as part of the "roadmap" [see below] that you use to describe the organization of your paper.

Introductions. The Writing Center. University of North Carolina; “Writing Introductions.” In Good Essay Writing: A Social Sciences Guide . Peter Redman. 4th edition. (London: Sage, 2011), pp. 63-70.

Yet Another Writing Tip

Always End with a Roadmap

The final paragraph or sentences of your introduction should forecast your main arguments and conclusions and provide a brief description of the rest of the paper [the "roadmap"] that let's the reader know where you are going and what to expect. A roadmap is important because it helps the reader place the research problem within the context of their own perspectives about the topic. In addition, concluding your introduction with an explicit roadmap tells the reader that you have a clear understanding of the structural purpose of your paper. In this way, the roadmap acts as a type of promise to yourself and to your readers that you will follow a consistent and coherent approach to addressing the topic of inquiry. Refer to it often to help keep your writing focused and organized.

Cassuto, Leonard. “On the Dissertation: How to Write the Introduction.” The Chronicle of Higher Education , May 28, 2018; Radich, Michael. A Student's Guide to Writing in East Asian Studies . (Cambridge, MA: Harvard University Writing n. d.), pp. 35-37.

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• Online Guide to Writing

Structuring the Research Paper

Formal research structure.

These are the primary purposes for formal research:

enter the discourse, or conversation, of other writers and scholars in your field

learn how others in your field use primary and secondary resources

find and understand raw data and information

For the formal academic research assignment, consider an organizational pattern typically used for primary academic research.  The pattern includes the following: introduction, methods, results, discussion, and conclusions/recommendations.

Usually, research papers flow from the general to the specific and back to the general in their organization. The introduction uses a general-to-specific movement in its organization, establishing the thesis and setting the context for the conversation. The methods and results sections are more detailed and specific, providing support for the generalizations made in the introduction. The discussion section moves toward an increasingly more general discussion of the subject, leading to the conclusions and recommendations, which then generalize the conversation again.

Sections of a Formal Structure

The introduction section.

Many students will find that writing a structured  introduction  gets them started and gives them the focus needed to significantly improve their entire paper. 

Introductions usually have three parts:

presentation of the problem statement, the topic, or the research inquiry

purpose and focus of your paper

summary or overview of the writer’s position or arguments

In the first part of the introduction—the presentation of the problem or the research inquiry—state the problem or express it so that the question is implied. Then, sketch the background on the problem and review the literature on it to give your readers a context that shows them how your research inquiry fits into the conversation currently ongoing in your subject area. 

In the second part of the introduction, state your purpose and focus. Here, you may even present your actual thesis. Sometimes your purpose statement can take the place of the thesis by letting your reader know your intentions. 

The third part of the introduction, the summary or overview of the paper, briefly leads readers through the discussion, forecasting the main ideas and giving readers a blueprint for the paper. 

The following example provides a blueprint for a well-organized introduction.

Example of an Introduction

Entrepreneurial Marketing: The Critical Difference

In an article in the Harvard Business Review, John A. Welsh and Jerry F. White remind us that “a small business is not a little big business.” An entrepreneur is not a multinational conglomerate but a profit-seeking individual. To survive, he must have a different outlook and must apply different principles to his endeavors than does the president of a large or even medium-sized corporation. Not only does the scale of small and big businesses differ, but small businesses also suffer from what the Harvard Business Review article calls “resource poverty.” This is a problem and opportunity that requires an entirely different approach to marketing. Where large ad budgets are not necessary or feasible, where expensive ad production squanders limited capital, where every marketing dollar must do the work of two dollars, if not five dollars or even ten, where a person’s company, capital, and material well-being are all on the line—that is, where guerrilla marketing can save the day and secure the bottom line (Levinson, 1984, p. 9).

By reviewing the introductions to research articles in the discipline in which you are writing your research paper, you can get an idea of what is considered the norm for that discipline. Study several of these before you begin your paper so that you know what may be expected. If you are unsure of the kind of introduction your paper needs, ask your professor for more information.  The introduction is normally written in present tense.

THE METHODS SECTION

The methods section of your research paper should describe in detail what methodology and special materials if any, you used to think through or perform your research. You should include any materials you used or designed for yourself, such as questionnaires or interview questions, to generate data or information for your research paper. You want to include any methodologies that are specific to your particular field of study, such as lab procedures for a lab experiment or data-gathering instruments for field research. The methods section is usually written in the past tense.

THE RESULTS SECTION

How you present the results of your research depends on what kind of research you did, your subject matter, and your readers’ expectations. 

Quantitative information —data that can be measured—can be presented systematically and economically in tables, charts, and graphs. Quantitative information includes quantities and comparisons of sets of data. 

Qualitative information , which includes brief descriptions, explanations, or instructions, can also be presented in prose tables. This kind of descriptive or explanatory information, however, is often presented in essay-like prose or even lists.

There are specific conventions for creating tables, charts, and graphs and organizing the information they contain. In general, you should use them only when you are sure they will enlighten your readers rather than confuse them. In the accompanying explanation and discussion, always refer to the graphic by number and explain specifically what you are referring to; you can also provide a caption for the graphic. The rule of thumb for presenting a graphic is first to introduce it by name, show it, and then interpret it. The results section is usually written in the past tense.

THE DISCUSSION SECTION

Your discussion section should generalize what you have learned from your research. One way to generalize is to explain the consequences or meaning of your results and then make your points that support and refer back to the statements you made in your introduction. Your discussion should be organized so that it relates directly to your thesis. You want to avoid introducing new ideas here or discussing tangential issues not directly related to the exploration and discovery of your thesis. The discussion section, along with the introduction, is usually written in the present tense.

THE CONCLUSIONS AND RECOMMENDATIONS SECTION

Your conclusion ties your research to your thesis, binding together all the main ideas in your thinking and writing. By presenting the logical outcome of your research and thinking, your conclusion answers your research inquiry for your reader. Your conclusions should relate directly to the ideas presented in your introduction section and should not present any new ideas.

You may be asked to present your recommendations separately in your research assignment. If so, you will want to add some elements to your conclusion section. For example, you may be asked to recommend a course of action, make a prediction, propose a solution to a problem, offer a judgment, or speculate on the implications and consequences of your ideas. The conclusions and recommendations section is usually written in the present tense.

Key Takeaways

• For the formal academic research assignment, consider an organizational pattern typically used for primary academic research. 
•  The pattern includes the following: introduction, methods, results, discussion, and conclusions/recommendations.

Mailing Address: 3501 University Blvd. East, Adelphi, MD 20783 This work is licensed under a  Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License . © 2022 UMGC. All links to external sites were verified at the time of publication. UMGC is not responsible for the validity or integrity of information located at external sites.

Table of Contents: Online Guide to Writing

Chapter 1: College Writing

How Does College Writing Differ from Workplace Writing?

What Is College Writing?

Why So Much Emphasis on Writing?

Chapter 2: The Writing Process

Doing Exploratory Research

Getting from Notes to Your Draft

Introduction

Prewriting - Techniques to Get Started - Mining Your Intuition

Prewriting: Targeting Your Audience

Prewriting: Techniques to Get Started

Prewriting: Understanding Your Assignment

Rewriting: Being Your Own Critic

Rewriting: Creating a Revision Strategy

Rewriting: Getting Feedback

Rewriting: The Final Draft

Techniques to Get Started - Outlining

Techniques to Get Started - Using Systematic Techniques

Thesis Statement and Controlling Idea

Writing: Getting from Notes to Your Draft - Freewriting

Writing: Getting from Notes to Your Draft - Summarizing Your Ideas

Writing: Outlining What You Will Write

Chapter 3: Thinking Strategies

A Word About Style, Voice, and Tone

A Word About Style, Voice, and Tone: Style Through Vocabulary and Diction

Critical Strategies and Writing

Critical Strategies and Writing: Analysis

Critical Strategies and Writing: Evaluation

Critical Strategies and Writing: Persuasion

Critical Strategies and Writing: Synthesis

Developing a Paper Using Strategies

Kinds of Assignments You Will Write

Patterns for Presenting Information

Patterns for Presenting Information: Critiques

Patterns for Presenting Information: Discussing Raw Data

Patterns for Presenting Information: General-to-Specific Pattern

Patterns for Presenting Information: Problem-Cause-Solution Pattern

Patterns for Presenting Information: Specific-to-General Pattern

Patterns for Presenting Information: Summaries and Abstracts

Supporting with Research and Examples

Writing Essay Examinations

Writing Essay Examinations: Make Your Answer Relevant and Complete

Writing Essay Examinations: Organize Thinking Before Writing

Writing Essay Examinations: Read and Understand the Question

Chapter 4: The Research Process

Planning and Writing a Research Paper

Planning and Writing a Research Paper: Ask a Research Question

Planning and Writing a Research Paper: Cite Sources

Planning and Writing a Research Paper: Collect Evidence

Planning and Writing a Research Paper: Decide Your Point of View, or Role, for Your Research

Planning and Writing a Research Paper: Draw Conclusions

Planning and Writing a Research Paper: Find a Topic and Get an Overview

Planning and Writing a Research Paper: Manage Your Resources

Planning and Writing a Research Paper: Outline

Planning and Writing a Research Paper: Survey the Literature

Planning and Writing a Research Paper: Work Your Sources into Your Research Writing

Research Resources: Where Are Research Resources Found? - Human Resources

Research Resources: What Are Research Resources?

Research Resources: Where Are Research Resources Found?

Research Resources: Where Are Research Resources Found? - Electronic Resources

Research Resources: Where Are Research Resources Found? - Print Resources

Structuring the Research Paper: Formal Research Structure

Structuring the Research Paper: Informal Research Structure

The Nature of Research

The Research Assignment: How Should Research Sources Be Evaluated?

The Research Assignment: When Is Research Needed?

The Research Assignment: Why Perform Research?

Chapter 5: Academic Integrity

Academic Integrity

Giving Credit to Sources

Giving Credit to Sources: Copyright Laws

Giving Credit to Sources: Documentation

Giving Credit to Sources: Style Guides

Integrating Sources

Practicing Academic Integrity

Practicing Academic Integrity: Keeping Accurate Records

Practicing Academic Integrity: Managing Source Material

Practicing Academic Integrity: Managing Source Material - Paraphrasing Your Source

Practicing Academic Integrity: Managing Source Material - Quoting Your Source

Practicing Academic Integrity: Managing Source Material - Summarizing Your Sources

Types of Documentation

Types of Documentation: Bibliographies and Source Lists

Types of Documentation: Citing World Wide Web Sources

Types of Documentation: In-Text or Parenthetical Citations

Types of Documentation: In-Text or Parenthetical Citations - APA Style

Types of Documentation: In-Text or Parenthetical Citations - CSE/CBE Style

Types of Documentation: In-Text or Parenthetical Citations - Chicago Style

Types of Documentation: In-Text or Parenthetical Citations - MLA Style

Types of Documentation: Note Citations

Chapter 6: Using Library Resources

Finding Library Resources

Chapter 7: Assessing Your Writing

How Is Writing Graded?

How Is Writing Graded?: A General Assessment Tool

The Draft Stage

The Draft Stage: The First Draft

The Draft Stage: The Revision Process and the Final Draft

The Draft Stage: Using Feedback

The Research Stage

Using Assessment to Improve Your Writing

Chapter 8: Other Frequently Assigned Papers

Reviews and Reaction Papers: Article and Book Reviews

Reviews and Reaction Papers: Reaction Papers

Writing Arguments

Writing Arguments: Adapting the Argument Structure

Writing Arguments: Purposes of Argument

Writing Arguments: References to Consult for Writing Arguments

Writing Arguments: Steps to Writing an Argument - Anticipate Active Opposition

Writing Arguments: Steps to Writing an Argument - Determine Your Organization

Writing Arguments: Steps to Writing an Argument - Develop Your Argument

Writing Arguments: Steps to Writing an Argument - Introduce Your Argument

Writing Arguments: Steps to Writing an Argument - State Your Thesis or Proposition

Writing Arguments: Steps to Writing an Argument - Write Your Conclusion

Writing Arguments: Types of Argument

Appendix A: Books to Help Improve Your Writing

Dictionaries

General Style Manuals

Researching on the Internet

Special Style Manuals

Writing Handbooks

Appendix B: Collaborative Writing and Peer Reviewing

Collaborative Writing: Assignments to Accompany the Group Project

Collaborative Writing: Informal Progress Report

Collaborative Writing: Issues to Resolve

Collaborative Writing: Methodology

Collaborative Writing: Peer Evaluation

Collaborative Writing: Tasks of Collaborative Writing Group Members

Collaborative Writing: Writing Plan

General Introduction

Peer Reviewing

Appendix C: Developing an Improvement Plan

Working with Your Instructor’s Comments and Grades

Appendix D: Writing Plan and Project Schedule

Devising a Writing Project Plan and Schedule

Reviewing Your Plan with Others

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What Is Human Subjects Research?

Department of Philosophy, Dalhousie University

• Published: 15 December 2020
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This chapter provides an overview of the nature, scope, and practice of human subjects research. It begins by tackling the general question, “What is research?” Attempts to answer this question typically define research by its methods and/or goals, and the chapter surveys the limits of these definitions through discussion of tough boundary cases. Along the way, the chapter describes various methods (quantitative, qualitative) and types of human subjects research (clinical, social scientific, etc.). The second section of the chapter investigates who is referred to by the language of “human subjects”: which humans tend to be selected as research participants, where human subjects are located globally, and how these locations are changing. The chapter also raises questions about which subjects are considered human in this context, for instance, whether definitions include embryos, cadavers, or stem cells. Throughout, the chapter highlights the ethical issues raised by the various types of activities and subjects described.

Which of the following is human subjects research?

A clinician conducts a placebo-controlled, double-blind, randomized trial of a new treatment for depression.

A sociologist conducts a series of in-depth interviews with paramedics and firefighters about their experiences of burnout, which are then transcribed and analyzed for common themes.

On the basis of published research indicating a reduction of adverse events, a hospital administrator implements mandatory surgical checklists in one of their operating rooms and tracks the outcomes compared to the hospital’s other operating rooms; the administrator hopes that the expected positive results will help to convince reluctant hospital staff to adopt surgical checklists.

A team of economists selects three cities, sends invitation letters to all low-income citizens in those selected cities, and then partners with local government to provide a basic income to selected individuals for three years, tracking a range of health and life outcomes.

A patient seeks care from a family physician for a rare heart condition; after several unsuccessful treatments, the physician tries an unusual combination of medications, and the patient reports feeling much better.

Same as example 5, but the physician then writes up the case for publication in a peer-reviewed medical journal.

A pediatric oncologist offers patients with an otherwise untreatable form of cancer the option to try promising new treatments that are in the earliest stages of development.

Medical students manipulate human embryos in order to learn how to extract cells for genetic tests.

A geneticist analyzes and sequences the DNA from blood samples collected decades ago from the members of a marginal population.

If you found yourself struggling to decide which of these counts as human subjects research, you are not alone: experts and newcomers to research ethics alike find this task difficult. In fact, even highly respected regulatory bodies and authors of codes of ethics struggle to articulate clear and consistent answers to this question (for examples, see the opening chapters in this handbook). And because an affirmative answer to the question is thought to determine which activities are in need of prospective ethics review, the stakes of this debate are thought to be quite high.

The difficulty of this task persists for many reasons but, in particular, because both key concepts in the question—“research” and “human subjects”—are hard to define and plagued by tough, and ever-evolving, boundary cases. In what follows, I will outline these controversies and investigate whether there might be a clear sorting mechanism for the kinds of cases just outlined. For both concepts (“research” and “human subjects”), I will show that a clear definition is hard, if not impossible, to find. But this may not be as big a problem as it seems. In order to explain why not, I will explore a common underlying assumption about the high stakes of this assessment: the presumed connection between ethics and a particular type of regulatory review in human subjects research. Clarifying this relationship will help to defuse the worry about demarcation criteria for these concepts.

What is research? This is a harder question to answer than one might expect: any answer is in danger of being either underinclusive (for instance, by focusing narrowly on medical research when similar activities are carried out by researchers in other disciplines or professions) or overinclusive (labeling everything vaguely experimental or involving human interaction as research). The Tri-Council Policy Statement (TCPS 2) in Canada begins with a reflection on the broad range of practices and activities that qualify as research, before proposing a definition:

The scope of research is vast. On the purely physical side, it ranges from seeking to understand the origins of the universe down to the fundamental nature of matter. At the analytic level, it covers mathematics, logic and metaphysics. Research involving humans ranges widely, including attempts to understand the broad sweep of history, the workings of the human body and the body politic, the nature of human interactions and the impact of nature on humans—the list is as boundless as the human imagination. For the purposes of this Policy, research is defined as an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation . (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada 2018 , 5, emphasis added)

The ethical guidelines provided by the Council for International Organizations of Medical Sciences (CIOMS) provide a similar (though health-focused) definition and some examples of common research methods:

The term “health-related research” in these Guidelines refers to activities designed to develop or contribute to generalizable health knowledge within the more classic realm of research with humans, such as observational research, clinical trials, biobanking and epidemiological studies. Generalizable health knowledge consists of theories, principles or relationships, or the accumulation of information on which they are based related to health, which can be corroborated by accepted scientific methods of observation and inference . (2016, xii, emphasis added)

Likewise, according to the original Belmont Report in the United States, “the term ‘research’ designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge ” (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978, emphasis added).

Note first that each of these definitions would lead to a slightly different assessment of the cases outlined at the beginning of this chapter, so we can’t simply point to regulations to answer our question for us without engaging in further discussion about which regulations are correct. More to the point here, though, we can see that the following concepts tend to arise in definitions of research: scientific methods (observation, hypothesis testing, and/or inference), systematic and/or disciplined inquiry, generalizability, and contributing to knowledge. Research, it seems, is implicitly scientific research . Research is something that scientists do (as contrasted with journalists or celebrities, for instance). This qualification is supported by landmark ethical guidelines such as the original Nuremberg Code, Article 8 of which states, “The experiment should be conducted only by scientifically qualified persons” (Nuremberg Code 1949 , 182). And scientific research involves certain systematic and disciplined methods , which when used properly provide some assurance about the generalizability of results.

Does a focus on the scientific method help to sort the test cases? This seems a promising route since the scientific method is thought to be what makes results more reliable than unsystematic observation and inference, which connects to the aim of producing knowledge. The difficulty is that there are many different methods used by researchers in a range of disciplines. Each research method aims to answer a different question—some are comparative, while others try to find out why someone holds a position or acts a certain way.

Qualitative research methods involving human subjects range from those involving close contact and communication between researchers and individual subjects, which are often open-ended and dynamic, such as ethnographic studies, oral histories, narrative inquiries, focus groups, and minimally structured interviews, to more structured and less dynamic methods such as large-scale surveys and structured interviews. Qualitative research is excellent at answering “why” and “how” questions and much less focused on reporting numerical results than quantitative research. As such, it plays an important and complementary role to quantitative research: a quantitative study may determine that some percentage of elementary school teachers report feeling burned out, for instance, while a qualitative study can investigate why this occurring and how it is experienced or understood by those who self-report.

Quantitative research methods involving human subjects include case studies, case series, and n -of-1 studies, all of which focus on the description and analysis of individual cases. They include observational methods such as case–control and cohort studies, which track and compare groups of people over time (either prospectively or retrospectively). In these types of studies, subjects are not assigned to different groups but rather self-select or are otherwise independently sorted into groups (for instance, a study might follow cyclists and non-cyclists). And then there are interventional methods such as randomized controlled trials (RCTs), in which participants are assigned to intervention and control groups randomly, and, when double-blind, neither they nor the researchers involved know which group they were assigned to until the study is completed. In many domains, including economics, public policy, and medicine, the RCT design is regarded as the gold standard of quantitative methods because of its rigorous comparative design and perceived objectivity.

Quantitative clinical research, in particular, proceeds on the basis of positive results in earlier animal studies and then is carried out in phases. Phase I clinical research typically enrolls a small number of healthy subjects (20–80) and aims to determine whether a proposed intervention is safe in humans and at what approximate dose or intensity. Phase II clinical research enrolls a somewhat greater number of subjects (100–300)—this time those with the health condition the intervention aims to treat—and aims to assess both safety and efficacy (the effect under near-ideal conditions). Phase III clinical research enrolls large numbers of subjects (1,000+) and aims to determine whether an intervention is effective. This phase of research is typically the basis for national regulatory approval, meaning that the treatment can be prescribed and sold to patients in some jurisdiction once it has the support of (typically at least two) well-designed phase III trials. Phase IV, or post-marketing trials, track outcomes in the general population once a treatment is widely available.

In both qualitative and quantitative domains, there are meta-level research methods designed to amalgamate the results of research. These include literature reviews, systematic reviews, and meta-analyses. In an effort to reach busy audiences, there are also summaries and syntheses which aim to bring together all research on a given topic and provide an overall assessment. Guidelines for practitioners in medicine often draw upon these meta-level studies, as well as expert opinion, in recommending standards of practice. And the range of methods is always expanding: some newer methods, such as cluster RCTs and umbrella trials, are discussed by Hey and Weijer in this handbook.

Generalizable Knowledge

What this wide range of scientific methods, from in-depth interviews to RCTs, have in common is that they involve a systematic or disciplined effort to produce results that contribute not just to knowledge but to generalizable knowledge —a standard interpretation of this term is “the use of information to draw conclusions that apply beyond the specific individuals or groups from whom the information was obtained” (Coleman 2019 , 248). This brings us to the aims of research, which were a common component of the definitions of research offered earlier. Each of the methods described might be thought of as contributing to generalizable knowledge, while something like trial and error in clinical practice might be aimed only at benefiting an individual patient. In order to figure out whether quality improvement efforts—such as instituting a surgical checklist in one operating room and comparing with others—count as generating generalizable knowledge, we would look to their aim. In the case as I described it at the outset, the administrator believed that they already knew the intervention would be successful at reducing rates of adverse events, based on the research evidence. The aim was to convince the healthcare team in the hospital that these results applied locally so that they would adopt the practice. This seems to be a case where the primary aim is changing local behavior rather than adding to general knowledge. This way of separating quality improvement activities from research proper has become quite popular in recent years. Scholars take different positions on whether this way of settling the matter is successful or not. This debate turns on, among other things, different ideas of what is meant by “generalizable knowledge.”

Most interpretations of “generalizable” focus on the applicability of results to people who were not in a study. But this can be tricky. An RCT with strict criteria for who is included, that tests an intervention against placebo, and that strictly controls the context in which treatment is administered (for instance, only by specialists in a highly resourced urban hospital) may produce results indicating that a particular medical treatment is effective. This sort of clean explanatory RCT is thought by many scholars to be the exemplar of a study design yielding generalizable results. But a rural physician in a low-resource area dealing primarily with elderly patients who have multiple health conditions might not regard the results of the study just described as generalizable to their patients. (And they would probably be right about this—the gap between research evidence and individual patient care is a real one, and closing or narrowing that gap is something researchers have been working on for decades. The advance of pragmatic trials is one attempt to solve this problem, for instance.) Through this example, we see some of the challenges inherent in claims made about generalizability, particularly when interpretations focus on applicability. Not all areas of scientific investigation lend themselves to the production of law-like generalizations of the sort (ostensibly) found in physics or chemistry. And very few medical interventions work for all patients, without qualification. To return to the quality improvement case, there is a sense in which knowledge is gained through the investigation—something new is learned about whether surgical checklists work in this specific location—and the knowledge is intended to generalize—for instance, across other operating rooms in that facility. Is this not (at least locally) generalizable knowledge, then? Many people seem to want to say “no” here but struggle to find a clear rationale for their position.

The challenges encountered thus far in our efforts to define research indicate that a new strategy is in order; accordingly, let’s turn back to our original question—“What is human subjects research?”—and ask why we are seeking an answer to this question. Perhaps the question is ill-conceived, or perhaps our aims will help guide us toward one of these imperfect options or even something better. What are the stakes here? Why does it matter what counts as human subjects research? Why would anyone resist having their actions labeled “research”?

The common answer to this question—the one potential researchers themselves would likely be quick to offer—is that it matters because activities that are considered research involving human subjects must undergo review by a research ethics committee (REC) and secure approval before recruiting any participants. 1 In other words, there are regulations in most jurisdictions requiring that certain types of activities are subject to independent oversight. According to the TCPS 2 in Canada, for instance, “A determination that research is the intended purpose of the undertaking is key for differentiating activities that require ethics review by an REB and those that do not” (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada 2018 , 14). 2 A common rationale for this is that the primary aim of research is to gather knowledge to benefit people other than those in the study itself. By contrast, clinical practice, which also involves human subjects, is regulated differently (and with much less direct oversight)—by expectations that professionals will adhere to professional norms and guidelines. Because the aim of practice is benefit for the particular patient, it is thought that fewer or at least different ethical concerns arise. Similarly, other professions, like journalism, have their own sets of norms and rules guiding their activities, tied to their specific aims. The special ethical oversight of research activities is relatively new, in historical terms, since national regulations on human subjects research were enacted in most jurisdictions, in response to the public outcry over publicized cases of abuse of research subjects (for more on this, see the opening chapters of this handbook). When these regulations were proposed, those who drafted the regulations were acutely aware of the need to avoid encroaching on other domains of professional activity—particularly clinical practice (Beauchamp and Saghai 2012 ).

From the earliest attempts to offer a research–practice distinction it was clear that there would be troublesome boundary cases. 3 Phase I (or “first in human”) clinical trials—famously, those in pediatric oncology—tend to enroll patients who have cancer (not healthy subjects), and when there is no other treatment option available for that form of cancer, the research looks pretty much identical to practice (Kass et al. 2013 ). These sorts of activities might be thought of as “therapeutic research,” “innovative therapy,” or “unvalidated practice” depending on one’s orientation to the research–practice distinction. Other boundary cases recognized by early scholarship in this area included what would now be considered a type of comparative effectiveness research, in which two widely available treatments are compared to see which performs better, and quality improvement activities, in which healthcare systems experiment with new rules or guidelines in order to see how well they work in local settings (Beauchamp and Saghai 2012 , 49). Note that it is a necessary, not merely accidental, feature of such activities that they are in some sense both research and practice simultaneously. Phase IV studies are also often ambiguous—depending on how rigorously they are designed, they may also look simply like tracking adverse events in clinical practice. So while research has been defined in terms of its distinctive aim, the distinction is fuzzy and contested; and it continues to be plagued by borderline cases. 4

Note also that the way research was defined for regulatory purposes—against medical practice in particular—meant that the resulting distinction tracked the activities of greatest ethical concern in the medical context specifically. But human subjects research is a much broader category than simply medical research: there are a range of ways in which human subjects may be subjects of studies, including, for instance, in social scientific research. Because this type of research is helpful for understanding the stakes of getting the answer to the title question right, I will outline briefly the social scientific backlash to research ethics oversight, which typically involves delays associated with the prospective review of proposed research and some of the ways that ethics regulation has adjusted to accommodate the range of different types of investigations involving human subjects.

Cases from the social sciences are among the more prominent examples of controversial research in the twentieth century: the Milgram experiment on obedience to authority and Zimbardo’s prison experiment with students assigned to the role of prisoner or guard might come to mind (Haggerty 2004 ). Given that the outcry about the abuse of human subjects in medical research happened around the same time in many jurisdictions (roughly the 1970s), it is no surprise that ethics regulations were developed and applied across all domains of research with human subjects, including social science research. Resistance to these regulations is common, particularly (though not uniformly) in the social sciences, where being lumped in with medical researchers strikes many as bizarre overreach: “What began years ago as a sort of safeguard against doctors injecting cancer cells into research patients without first asking them if that was OK has turned into a serious, ambitious bureaucracy with interests to protect, a mission to promote, and a self-righteous and self-protective ideology to explain why it’s all necessary” (Becker 2004 , 415). Becker is referring here to what he calls “ethics creep,” which involves “a dual process whereby the regulatory system is expanding outward to incorporate a host of new activities and institutions, while at the same time intensifying the regulation of activities deemed to fall within its ambit” (Haggerty 2004 , 391).

A common critique raised by social scientists hinges on the inconsistency between the way different professionals, for instance, journalists and academic social scientists, are treated under current regulatory schemes. The very same activity—interviewing people, for instance—seems to trigger extensive and burdensome oversight when conducted by social scientists even though journalists proceed much more freely. In locating the problem with this arrangement, Haggerty draws attention to precisely the problem identified in this chapter, namely that central concepts like research are poorly defined in documents regarding the ethical regulation of research; they are “empty signifiers, capable of being interpreted in a multitude of ways, and occasionally serving as sites of contestation” (2004, 411). Interpretation is required, and because members of RECs feel responsible for protecting people, they tend to take what he calls a “just in case” approach, in which research is interpreted inclusively (and over-broadly) (2004, 411). This means that social scientists may be subject to extensive oversight.

In 2004, Haggerty articulated his concern as follows: “Over time, I fear that the [REC] structure will follow the pattern of most bureaucracies and continue to expand, formalizing procedures in ways that increasingly complicate, hamper, or censor certain forms of non-traditional, qualitative, or critical social scientific research” (pp. 392–393). This has also been referred to as part of the expansion of neoliberal audit culture and identified as part of the increasing bureaucratization of academia (Taylor and Patterson 2010 ). In response to this perceived ethics creep, some social scientists have called for “creative compliance” or even outright resistance to ethics regulations. One option—reclassifying one’s research as performance art (or some other unregulated activity) is offered with a wink, but behind closed doors researchers will sometimes admit using such tactics (Haggerty 2004 , 408). These efforts have in some cases been met with further regulation: “As some of us have tried new dodges to skirt the requirements, the [RECs] have wised up and closed loopholes” (Becker 2004 , 415).

Yet against these dire predictions and in response to the outcry and backlash generated by social scientists in the wake of early, more heavy-handed and medically oriented regulatory approaches, regulations (and their interpretation) have shifted in the opposite direction in many jurisdictions (for an overview of international regulations, see the chapter by Nelson and Forster in this handbook). In Canada, for instance, the most recent version of the TCPS 2 takes a proportionate approach to the review of research:

Given that research involving humans spans the full spectrum of risk, from minimal to significant, a crucial element of REB review is to ensure that the level of scrutiny of a research project is determined by the level of risk it poses to participants. … A reduced level of scrutiny applied to a research project assessed as minimal risk does not imply a lower level of adherence to the core principles. Rather, the intention is to ensure adequate protection of participants is maintained while reducing unnecessary impediments to, and facilitating the progress of, ethical research. (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada 2018 , 9)

As this statement indicates, while all research is held to the same high ethical standard, research of minimal risk is thought to require a lower degree of oversight. Ethics review in Canada begins with a determination that the activity is in fact research with human subjects; activities described as falling outside of the definition of research include the sorts of quality improvement activities outlined in the hospital administrator case and “creative practice activities” such as those undertaken by artists (p. 19). 5 Next, some activities that meet the definition of human subjects research are automatically exempt from review, including 1) research that relies entirely on legally accessible, publicly available information where the individuals have no reasonable expectation of privacy and 2) exclusively observational qualitative research conducted in public places where there is no reasonable expectation of privacy and individuals are not identified in the written report (pp. 15–18). This will cover much of the research conducted by historians and some observational studies conducted by social scientists, educators, etc.

At this point, if an activity is considered research and not exempt, it may still be afforded an expedited (“delegated”) review if it is low-risk: according to Article 6.12, “In keeping with a proportionate approach to research ethics review, the selection of the level of REB review shall be determined by the level of foreseeable risks to participants: the lower the level of risk, the lower the level of scrutiny (delegated review); the higher the level of risk, the higher the level of scrutiny (full board review)” (p. 79). In delegated review, the committee assigns one member (or some equivalently qualified person) to assess the proposal rather than assessing it all together. A negative assessment at this stage refers the study back to the full committee for review. Because social scientific research is more likely to be minimal-risk than medical research, it is well positioned to benefit from delegated review. Canada is not unique here: similar exclusions and exemptions typically exist in other national regulatory systems. And in some jurisdictions they are even broader: in the United States, for instance, public health surveillance, criminal justice, and intelligence activities are all excluded from the domain of “research” and exemptions (activities requiring only “limited review”) are offered for most interview- and survey-based research, secondary research even when it uses identifiable private information or biospecimens, and “benign behavioral interventions” (Coleman 2019 , 248). This is a more permissive approach, overall, than the one found in Canada, and the trajectory seems to be generally in the more permissive direction over time.

At this point, we have enough background about the relationship between research and regulation to return to our question about the stakes of this discussion: why would someone wish to avoid having their activity labeled research? The answer given by some investigators is that they might resist if they think there are immediate, and burdensome, regulatory implications. A few things can now be said about this. First, it may be the case that there were times and places where the burdens of regulatory oversight were heavy even in the face of minimally risky activities or where the interpretation of regulations was overzealous. But it is unlikely to be true today—most systems have built-in exemptions and expedited processes for these sorts of cases, as the Canadian example makes clear, and discrepancies in interpretation between RECs have had time to resolve. In the face of complaints from researchers, it is good to look closely at the current local regulations and the way they are implemented. Second, in some jurisdictions today there are known inefficiencies in the regulatory oversight system—this occurs for a wide range of reasons but particularly because the process typically relies on volunteer labor and can involve reading hundreds of pages of detailed, technical proposals at a time. As a result, there are sometimes long delays, and researchers are entirely within their rights to complain about this, though they should be careful about selecting an appropriate target of criticism, whether that’s the local REC or the system within which RECs operate. Further, instantaneous processing of files would be unreasonable on the part of researchers, so negotiation will be needed to find a reasonable timeline, given shared goals. 6 Finally, some of the resistance likely arises from a misunderstanding about what ethics is and how it operates in the world. This requires some attention.

For many researchers, regulatory oversight has become synonymous with ethical assessment. You might hear a hint of this when researchers talk about “getting through ethics,” “waiting for ethics,” or claiming to have “completed ethics” once they have received approval from an ethics board for their study. A similar sort of reduction of ethics to a formal process sometimes occurs in contexts where healthcare providers seek informed consent: they may talk about “consenting the patient” in advance of a procedure, for instance, which is typically reduced to having the patient sign a legal document. It is important to appreciate why this position is indefensible—why legal paperwork or regulatory approval isn’t in any meaningful way a substitute for ethics, understood properly.

To begin, consider a study that has received ethics approval and yet which, when it is actually carried out, has risks that are unreasonably high (perhaps most subjects enrolled will die) a flawed design (perhaps it is not possible to achieve statistically significant or otherwise meaningful results), subjects are told they can’t leave the study once enrolled (violating the voluntariness of their ongoing consent), or the particular individuals in the study are easily identifiable in the published final report (violating their privacy). That study is unethical, in spite of having received approval from an ethics committee. Any number of things may have gone wrong here. First, like all human activities, review is fallible, and sometimes committee members will make mistakes. Sometimes the mistake will be in applying the rules, but at other times the mistake might be in the rules themselves. The particular rules applied by any ethics committee are open to debate, discussion, and revisions in light of new developments in scientific or ethical domains. The regular updates to codes of ethics such as the “Declaration of Helsinki,” currently in its seventh revision since 1975, provide some indication of the rate of change in these domains. Second, the researchers may have provided only a general description of certain activities (such as the trial design or informed consent process) in their application to the ethics committee and then, in specifying these matters later on, made poor choices. Third, researchers may simply have deviated from what they promised to do in their application to the ethics board. The research process relies on a certain amount of trust and good will between reviewers and researchers, and this can be violated by unethical or incompetent researchers. Approval by an ethics committee, then, is not all there is to an assessment of whether some activity is actually ethical .

Awareness of this simple fact helps us to see the dangers of thinking that classifying something as research means a particular set of ethical rules applies that wouldn’t otherwise. Codes of ethics aim to identify and articulate ethical principles or rules, and ethics committees do their best to interpret and apply these general principles to particular cases. But whether those committees existed in the middle ground between principles and action or not (and until recently, they didn’t), ethical principles would still apply to certain activities whenever those activities had certain features. Research with human subjects, as noted, aims at generalizable knowledge, and it typically “uses” those subjects to get knowledge. Along the way, the subjects may be made better or worse off, and any interaction where people make others worse off raises ethical concerns about harms such as exploitation and disrespect. Think about the contrast between paradigmatic cases of medical practice and medical research here—in practice, a healthcare provider aims primarily to benefit the patient, while in research, they aim primarily to generate new knowledge. When getting new knowledge requires the use of another person’s body, it seems clear that we’re in risky ethical territory.

Another way of appreciating the scope of ethics as something far bigger than ethics regulations is to think about the fact that regulations won’t specifically state things like “don’t murder your subjects” or “don’t steal the personal belongings of your subjects” because these ethical prohibitions are thought to be covered by existing criminal laws and not in need of restating. There are many ways to be unethical beyond those listed in codes of ethics because those codes are only part of a larger social system.

Further, some of the ethical rules present in codes and guidelines arise because of the place of research within society and not merely because it is a transaction between individuals. Research proceeds only with the cooperation and support of the societies in which it is conducted, which provide funding, regulation, legal protections, social and physical infrastructure, potential subjects, and more. The requirement that research is socially valuable—that it contribute to knowledge on the topic and directly or indirectly benefits society—is one such rule imposed on research with human subjects (you can read more about this requirement elsewhere in this handbook). The requirement that research is scientifically valid—including the expectation that methods are rigorous and results are meaningful—draws on norms of science developed independently by scientists, which prioritize epistemic values such as fruitfulness, scope, and accuracy in theory construction. Scientists are also held to ethical restrictions around activities considered research misconduct, such as plagiarism, fabrication, and falsification, even though these activities aren’t listed explicitly in codes of ethics for research with human subjects.

Professional Ethics

We’ve been discussing, and trying to articulate the problems with, a particular resistance to being labeled research that results from a misunderstanding about how ethics operates in the world. Hopefully the responses to this argument have been convincing thus far. There is, however, a more nuanced version of the position remaining: some investigators might resist the research label because they believe they are governed by codes of ethics developed prior to current codes and articulated within their professions and see the bureaucracy associated with contemporary ethics review as a less nuanced and perhaps even misleading way to go about thinking through the ethical dimensions of their work. They see a perfectly functional self-regulating profession taken over by people with little or no understanding of the nature of their work or the subtle and precise responses to ethical dilemmas they’ve developed over time.

For example, journalists have ethical norms prioritizing the protection of sources—these norms evolved because of social-historical cases where harm arose (in the extreme, people who were killed when they were identified after a story was published) and a recognition of the need to avoid those harms going forward. This ethical rule for journalists is tied to what is valuable about the activity (here: truth) and a recognition of particular harms that could arise in telling the truth (here: people who assisted in exposing the truth could be killed). If you want to proceed with an activity that involves interaction with other people (maybe even in some sense “uses” them to gain knowledge) but in that interaction, or afterward, those people might be harmed, you should probably ask how that harm can be minimized. Responsible professionals in a range of domains have engaged in this thoughtful work for decades and even centuries. Anthropologists, for instance, have been reflecting about the particular ethical duties arising from ethnography since the method was developed, such as the shifting loyalties that result from the close relationships formed during fieldwork, and the desire of state entities to access and direct their research to secure information from enemies during wartime (Fluehr-Lobban 2002 ).

A decisive response to these concerns is unnecessary here: it is sufficient for the purpose of this chapter that we are aware of them. It is a matter of ongoing discussion in a range of human domains whether certain activities should be regulated or not or whether they should be regulated using one set of rules or another. In general, the position taken by liberal democratic states is that professions and industries with a history of serious harm to citizens have forfeited their right to self-regulation. Research on human subjects has a sufficiently sordid history to qualify here. Whether this inappropriately covers social scientists or others will likely be a matter for further debate. For our purposes, what is important is that we recognize that ethical rules apply regardless of which set of regulations is in force (state-imposed external ethics review, professional codes of ethics, or novel alternative oversight mechanisms). So while the stakes of the discussion are high in the sense that they determine this regulatory path, they are not as high as people tend to think because the ethical rules will apply regardless. Being labeled performance art rather than research might mean you avoid filling out some forms, but it won’t on its own change the nature of your ethical obligations since those arise out of the type of activity planned and its aims and consequences.

In sum, the best response we have to the question “What is research?” is probably that research aims to produce generalizable knowledge, but it is important to recognize that this is an imperfect definition and leaves open a range of debates, including those related to the correct interpretation of “generalizability.” It is also important to recognize that answering this question may not be the best way to decide what systems of accountability ought to track the ethical issues that arise in knowledge-gathering activities; it is worth always keeping in mind that a range of regulatory mechanisms are possible. We have also defused some of the anxiety around responses to this question by tracing and responding to some of the reasons for resistance to the label. The ethical principles arising from an activity aren’t invented and dictated by RECs—they apply whether an activity is labeled research or not and whether it is regulated as such or not. There is room for critical engagement here, but at the end of the day there’s just no escaping ethics.

Human Subjects

I have indicated that there is debate over not only what counts as research, as we’ve just seen, but also who is included in our discussions of human subjects. There are two versions of the question “Who are human subjects?,” each of which raises distinct ethical issues. First, we might wonder which humans end up being research subjects. Is there a paradigm or “model human” researchers have in mind? Are there some humans on whom research is forbidden or significantly restricted? Where are human subjects located globally, and how is this changing? Is there a shortage or surplus of human subjects available for research? How many people are research subjects annually? Depending on the answers to these questions, how might we assess the fairness of the burdens and benefits of research participation? This version of the question raises issues about representation in research as well as more general concerns of distributive and social justice.

Second, we might wonder which subjects are included in discussions of human subjects research. Are any of the following included, for instance: fetuses, embryos, brain-dead humans, cadavers, human organs or tissues, reproductive tissues, or stem cells? And, particularly if some of these items are included, why stop at the boundary of the human species? What lies behind the strict demarcation between human and nonhuman animals as subjects of research? Thinking more broadly, what are the implications of various positions on this matter for research on (hypothetical) conscious, sentient robots or aliens? This version of the question raises issues of moral status. I’ll outline both of these sets of issues.

Which Humans?

The human subjects of research have not always been representative of the diversity of humanity or even of the local populations within which research was conducted. The tendency of Western researchers (white men, for the most part), prior to ethics regulations, to seek out vulnerable populations such as prisoners, children at boarding schools, hospital patients, sex workers, citizens of other countries, racial minorities, and impoverished persons (and especially people at the intersection of these categories) for inclusion in research is well documented. The attraction of these groups was precisely their vulnerability—the fact that it was difficult or impossible for them to refuse involvement, for instance. Early responses to this situation focused on protections for variously identified vulnerable populations. While these concerns persist, and took on new life when multinational research became more common in the 1990s, another concern about representation has arisen more recently: the underrepresentation of certain groups in research. While the first set of concerns track disproportionate burdens of research participation, the second set tracks the lost benefits of research participation. The ethical assessment of the former actions—essentially, preying on the vulnerable—is more easily appreciated, so I’ll say a bit about the latter problem. Failing to ensure that subjects are representative of particular groups can lead not only to missed opportunities to benefit those populations but also to direct harm when research is falsely generalized across that group, as when a drug with positive results in one group is dangerous or toxic to another.

Women were underrepresented in clinical research in the United States (and elsewhere) until at least the 1990s. As a result of improved regulations, the United States has shifted toward more equitable inclusion of women in publicly funded clinical trials, though most studies still fail to analyze results by sex/gender in spite of the recognized benefits of doing so (cf. Geller et al. 2018 ). This is a development worth noting, but it is important to keep in mind that this tracks only clinical research, funded publicly, in one country. We shouldn’t assume the underrepresentation of women in human subjects research has been resolved or even that sensible extension to related domains has been made—the selection of exclusively male mice for animal research continued for many years after these changes were made to human subjects regulation and is still the status quo in many countries and contexts (Shansky 2019 ). The attempted justification for these exclusions has been decisively refuted in the literature dozens of times. Addressing one common mistake clearly driven by outdated gender norms, Shansky reminds us, “Women, but not men, are still pejoratively described as hormonal or emotional, which curiously neglects the well-documented fact that men also possess both hormones and emotions” (2019, 825). The resulting imbalance has affected research in many fields that continue to rely on animal studies such as neuroscience, endocrinology, physiology, and pharmacology. As a result of the exclusion of female mice from neuroscience research, and because research in animals provides the foundation for clinical trials, “the current understanding of how to most effectively treat disease in humans is similarly unbalanced” (Shansky 2019 , 825).

Over the past five years, Canadian and American funding bodies have introduced new requirements for researchers to consider sex as a biological variable in animal studies, and similar efforts have been made by the European Commission (Shansky 2019 ). Of course, sex/gender is not the only characteristic that has been unequally distributed in research studies. The same arguments offered in support of ending the exclusion of female animals from animal research and women from clinical research have been marshaled in favor of improving the inclusion of children, pregnant women, and specific ethnic minority groups (for instance, particular indigenous groups in Canada) with limited success. As mentioned, these exclusions have the potential to lead to significant harm to these populations, particularly in clinical practice since interventions never tested on a population may turn out to have more harms than benefits, and the lack of information about effects of treatments in that population might leave clinicians and others uncertain about how best to act even when acting quickly is critical. It may also simply be unjust in its own right to exclude people from research that might benefit them.

In addition to the explicit long-standing exclusion of particular identifiable groups, such as women, researchers have excluded populations indirectly by, for instance, preferring subjects who are healthier, are younger, and have fewer comorbid conditions. One result of these exclusions has been an underrepresentation of elderly people in clinical research. Because underrepresentation in research means the bench-to-bedside knowledge translation gap is bigger, this likely means elderly people are missing out on certain health benefits. And they aren’t the only ones losing out on benefits: clinical research subjects are not generally representative of a large percentage of the patient population for whom the interventions are intended. For instance, Humphreys and colleagues found that “highly cited trials do not enroll an average of 40.1% of identified patients with the disorder being studied, primarily owing to eligibility criteria” (2013, 1030). Other identifiable groups who may be affected by exclusions indirectly are people whose immigration status is uncertain, people who don’t speak the local language, and people who live far from the urban centers where much research occurs. Who is overrepresented in studies, then? People from “Western, Educated, Industrialized, Rich, and Democratic . . . societies” (Henrich, Heine, and Norenzayan 2010 , 61). The 2019 World Health Organization’s World RePORT , drawing on data from 2016, indicates that the recipients of research funding from the top 10 funders globally continue to be mostly institutions and investigators in North America and Europe working on non-communicable diseases (World Health Organization 2019 ).

While this is true today, some things are changing. Though most clinical research (approximately 70 percent) is still conducted in North America and Europe, “significant West-to-East and North-to-South shifts appear to be underway” with researchers looking increasingly to Asia, Africa, South America, and eastern Europe (Sismondo 2018 , 55). One reason this is thought to be happening is that researchers are keen to find countries where the medical system is advanced enough to locate their trials, with access to a large population, but at the lowest cost possible. According to Sismondo, costs per subject in clinical trials are estimated to be 30–50 percent lower in India than in North America or western Europe (2018, 55). Researchers are also interested in finding populations where individuals are not already taking other medications, and countries like India may have a greater proportion of subjects like this (Sismondo 2018 , 54). There are also more altruistic motives: low- and middle-income countries (LMICs) have particular health problems, and some researchers in high-income countries (HICs) may have an interest in helping to alleviate those problems, such as high rates of HIV transmission, epidemics such as the recent Ebola outbreaks, neonatal disorders, and neglected tropical diseases. Research in developmental economics suggests that these motives and effects can also be mixed in quite complicated ways: for instance, aid organizations may seek to alleviate global poverty and design studies to inform this effort but, in doing so, also reinforce the continued existence of their organization, create cycles of dependency, or perpetuate assumptions about the lack of knowledge or expertise in targeted populations.

Another reason for this global shift is that researchers often report difficulty recruiting subjects in HICs. For example, according to McDonald and colleagues ( 2006 , np), for multi-center RCTs funded by two UK funding agencies, “Less than a third (31%) of the trials achieved their original recruitment target and half (53%) were awarded an extension. The proportion achieving targets did not appear to improve over time. The overall start to recruitment was delayed in 47 (41%) trials and early recruitment problems were identified in 77 (63%) trials.” In general, “Recruitment is often slower or more difficult than expected, with many trials failing to reach their planned sample size within the timescale and funding originally envisaged” (McDonald et al. 2006 , np). This shortage of (appropriate) research subjects is of interest to research ethics because it can drive the demographic shifts just described, which raises concerns about potential exploitation of subjects in multinational studies. It also arguably lends further support to the social value requirement of research since a resource shared by all researchers (including industry researchers) is in limited supply: human research subjects. Perhaps this means lower-value research ought not to be conducted, or the bar for what counts as a sufficiently socially valuable study should be raised (Borgerson 2016 ).

The relationship between funders, researchers, and subjects is also of interest to bioethicists. One of the reasons ethical concerns arise in LMICs is that the research is often funded and designed in HICs, and this raises worries about potential exploitation. Another concern arises when the results of the research conducted in LMICs won’t benefit other people in those same populations. One of the reasons given for the increased interest in conducting research in LMICs is that populations are “treatment-naive”—this means in general they don’t have access to healthcare, and they are likely to be unable to afford whatever treatment emerges from the research if it is successful. This feature of multinational research has generated extensive discussion among bioethicists, many of whom now agree that research should be responsive to the health needs of local populations if it is to avoid charges of exploitation. Yet this worrisome overview of the global situation was provided in 2013:

Total global investments in health R&D (both public and private sector) in 2009 reached US$240 billion. Of the US$214 billion invested in high-income countries, 60% of health R&D investments came from the business sector, 30% from the public sector, and about 10% from other sources (including private non-profit organisations). Only about 1% of all health R&D investments were allocated to neglected diseases in 2010. Diseases of relevance to high-income countries were investigated in clinical trials seven-to-eight-times more often than were diseases whose burden lies mainly in low-income and middle-income countries. (Røttingen et al. 2013 , 1286)

Dandona et al. also found that research priorities were misaligned with the health needs of the local population in India specifically: “funding for some of the leading causes of disease burden, including neonatal disorders, cardiovascular disease, chronic respiratory disease, mental health, musculoskeletal disorders and injuries was substantially lower than their contribution to the disease burden” (2017, 309). The gap between funding priorities and disease burden has been of interest to economists, political scientists, and bioethicists alike for many years.

A roughly 70/30 split between industry funding and other sources is common in clinical research. Of the US$1.42 billion spent on health research in India in 2011–2012, “95% of this funding was from Indian sources, including 79% by the Indian pharmaceutical industry” (Dandona et al. 2017 , 309). In the United States, “Principal research sponsors in 2003 were industry (57%) and the National Institutes of Health (28%)” (Moses et al. 2005 , 1333). Even though there seem to be shifts underway toward more industry-sponsored research in the clinical context, practicing physicians are still a vital part of research, often supplying the subjects for research:

Currently, about three-quarters of studies in the United States are conducted in the private sector by non-academic physicians who recruit their own patients or local community members into drug studies. Over 60,000 of these studies take place in the United States each year, accounting for 75 percent of the 80,000 clinical trials conducted worldwide; to execute these studies, more than 50,000 U.S. physicians registered with the Food and Drug Administration (FDA) as principal investigators on one or more clinical trials in 2001. As for the human subjects, 3.62 million Americans participated in pharmaceutical clinical trials in 2003 alone. (Fisher 2009 , 2)

The particular ethical obligations arising from the dual role of physician-investigators, such as the need to balance a commitment to doing what’s best for the patient with an interest in seeking knowledge, have received attention from bioethicists, as have the financial conflicts of interest arising when physicians play not only these two roles but a third role in their relationship to industry sponsors.

Another matter of interest to bioethicists is that there are some people who make a career out of being research subjects. Some of them self-identify as “guinea pigs for hire” and seek participation in phase I studies (on healthy subjects) (Lemmens and Elliott 2001 ). The inclusion of these people in studies raises ethical issues about appropriate compensation (whether wages and benefits or payment), undue inducement (if the payment is thought to be too high), scientific validity (whether people strongly oriented to please researchers so that they may be hired again will be more inclined to deceive researchers, for instance), upper limits of risk for studies under conditions of informed consent, and social justice and fair subject selection (since career research subjects tend to be from particular demographic groups, such as homeless people and students). For more on this issue, see the chapter by Fisher in this handbook.

Finally, a note about the number of research subjects: the research enterprise is massive and enrolls millions of human subjects every year. It is surprisingly difficult to get a clear picture of the enterprise globally (for more on why, see Young et al. 2015 ). Our best estimates come from clinical research: drawing on the 2009 CenterWatch Sourcebook, Sismondo suggests that, while estimates vary widely, there are approximately three to six million subjects involved each year (2018). And these numbers seem to be increasing. If we were able to add in figures from research in the social sciences, these numbers would skyrocket. In fact , you might be a research subject right now : there is ongoing debate over whether the tactics used by social media sites to track and manipulate their users qualify as human subjects research. If they do—and this turns partly on how we settle the issues raised in the first part of this chapter—we might find out that many of us are unwitting research subjects.

Which Subjects?

Who counts as a human subject of research? Codes of research ethics are often inclusive in their definition, for instance: “The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects , including research on identifiable human material and data ” (World Medical Association, 2013 , 2191, emphasis added). Codes that initially had a narrow focus on medical research have expanded over time to cover new areas, for instance, increasing interest in the storage and use of biospecimens in research (biobanking) led CIOMS to merge its ethical guidelines for epidemiological research and biomedical research in 2016 (CIOMS, xi). Guidelines for research on human subjects are likely to be inclusive about who or what counts as a subject because many of the same ethical issues—privacy and informed consent, for instance—arise whether the subject’s body, tissues, or data are manipulated. In jurisdictions like Canada “human subjects” includes embryos and cadavers, though in the United States (ex vivo) embryos and cadavers are excluded from the definition. This doesn’t necessarily mean the use of cadavers, for instance, is unregulated but rather that it may be regulated differently. In all cases, the potential for harm to an identifiable person raises ethical concern.

If a central focus of research ethics is the prevention or minimization of harm, what then are we to make of the differences between the way humans and nonhuman animals are treated by researchers? The latter are not regarded as human subjects, even on inclusive definitions. And yet the “vast majority of biomedical research activity is conducted on animals or their tissues, cells, or even parts of cells” (Levine 2008 , 214). While research on human subjects is guided by ethical principles such as respect for persons, informed consent, fair subject selection, and a favorable risk–benefit ratio, research on nonhuman animals is typically governed by different approaches, such as the 3R framework: reduction (in numbers of animals used), refinement (improving the conditions for the animals), and replacement (using animals with lower capacity for pain or computer models when possible). Clear demarcation criteria, separating humans from other animals, have been very hard to come by, particularly as researchers discover more about the intellectual, emotional, and social capacities of a wide range of animals from crows to chimpanzees to elephants. The issue of which beings “count” morally, then, is unsettled, and as a result these divisions between the ethical principles applied in each domain rest on unsettled foundations.

It is good to keep this in mind because for many areas of research from neuroscience to immunology animal research is the basis for human research. You can’t typically propose a clinical trial on humans without convincing evidence from animal studies that the intervention might be successful. This expectation persists even though animals are never going to be ideal models for human behaviors, diseases, or functions—the ideal model for humans is humans. The reason why research doesn’t just skip over animals and start with humans, then, is ethical: it is thought to be acceptable to subject animals to risks that we find unacceptable for humans. There are deep and important issues here regarding the relative value of different lives. These issues surface in research ethics when trade-offs are proposed between human and animal studies. For instance, if “higher-level” animals like chimpanzees are no longer used in animal research (for ethical reasons), this may mean that the results from studies on the replacement animals (e.g., mice) lead to more uncertainty in the leap from animal to human studies. But this is at odds with a commitment to reduce harms to human research subjects. It will not be straightforward to find the right ethical path through these trade-offs (for one recent attempt, see Johnson and Barnard 2014 ). But if it is concern about harm to the interests of sentient beings that drives us toward research ethics oversight, we can’t proceed without attending to these difficult decisions. In the discussion of human subjects of research in section 2.1, I reviewed concerns about exploitation that arise when one group is harmed for the benefit of another. If the moral status of animals is even somewhat higher than that of inanimate objects, similar issues will arise when humans extract knowledge for our benefit from the bodies of animals.

In the future, we may have to decide how and whether to proceed with research on advanced forms of artificial intelligence or other nonhuman intelligent beings. So these gaps and unsettled foundations might matter to whether our current divisions between humans and other species are defensible in the long run.

In sum, neither “research” nor “human subjects” is easily defined, and efforts to use these concepts to draw black-and-white ethical lines around activities will struggle with a continuous and growing body of boundary cases. This is a productive realization since it helps us to see the gaps in current regulations (ethical concerns extend far beyond those captured in such regulations) and envision and work toward more efficient and nuanced systems of ethical accountability, such as those aspired to in systems aiming for the deep integration of research and practice (for more on these alternatives, see the chapter by Kim in this handbook). But it is also helpful for those of us working within current systems since it reminds us of the need to keep our focus on what we’re worried about, whether that’s exploitation, disrespect, scientific misconduct, power imbalances within relationships, conflicts of interest, violations of privacy, injustice in the selection of research participants, or opportunity costs when healthcare resources are used inefficiently. And our worries need to be responsive to an ever-changing reality: the internationalization of research, in particular, may well create new incentives (or reinforce existing incentives) that push researchers toward activities that breach different ethical principles or breach well-established principles in new ways. We will always need to be ready to provide timely, creative, and well-grounded responses to new ethical violations.

This chapter aimed to accomplish two things: 1) provide an overview of the scope and practice of research with human subjects and 2) highlight some of the philosophical issues raised by any attempt to provide such an overview. Let us return to our opening cases to see if we can apply what we’ve learned. Using the aim of generalizable knowledge as an initial sorting mechanism, it seems all cases except the family physician who “experiments” with different treatments will qualify as research. This is consistent with most regulatory assessments (keeping in mind they will then exclude and exempt some research from review). And all interventions involve human subjects directly or—in the case of blood samples—indirectly and so would likely be included because identifiable individuals raise ethical concerns about consent and privacy. Embryo research is a tough case, and different jurisdictions and different scholars handle it differently; we didn’t attempt to settle the issue here. Note that while most of the cases turn out to be human subjects research on the most common definitions, we are left with lingering worries—for instance, why does the clinical practice case change from practice to research when it is written up for publication—forget about the regulations, what changes here ethically ? Hopefully it is clear that while some things are settled in this domain, there is still much to work out. As is so often the case in philosophy, even the simplest question—"What is human subjects research?”—is harder to answer than it seems.

Beauchamp, Tom L. , and Yashar Saghai . 2012 . “ The Historical Foundations of the Research–Practice Distinction in Bioethics. ” Theoretical Medicine and Bioethics 33: 45–56.

Google Scholar

Becker, Howard S.   2004 . “ Comment on Kevin D. Haggerty, ‘Ethics Creep: Governing Social Science Research in the Name of Ethics. ’” Qualitative Sociology 27, no. 4: 415–416.

Borgerson, Kirstin . 2016 . “ An Argument for Fewer Clinical Trials. ” Hastings Center Report 46: 1–11.

Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada. 2018 . Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans Ottawa, ON, Canada: Secretariat on Responsible Conduct of Research. http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/ .

Google Preview

CBC News. 2019. “Ethics Board Must Rule on Projects within 30 Days: N.L. Supreme Court Judge.” https://www.cbc.ca/news/canada/newfoundland-labrador/sequence-bio-wins-court-application-for-ethics-board-timelines-1.5014596 .

Coleman, Carl H.   2019 . “ Rethinking the Regulatory Triggers for Prospective Ethics Review. ” Journal of Law, Medicine & Ethics 47: 247–253.

Council for International Organizations of Medical Sciences (CIOMS). 2016. “International Ethical Guidelines for Health-related Research Involving Humans.” Fourth Edition. Geneva. https://cioms.ch/publications/product/international-ethical-guidelines-for-health-related-research-involving-humans/

Dandona, Lalit , Rakhi Dandona , G. Anil Kumar , Krycia Cowling , Pritty Titus , Vishwa Mohan Katoch , et al. 2017 . “ Mapping of Health Research Funding in India. ” National Medical Journal of India 30: 309–316.

Fisher, Jill A.   2009 . Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials . New Brunswick, NJ: Rutgers University Press.

Fluehr-Lobban, Carolyn . 2002 . “ A Century of Ethics and Professional Anthropology. ” AAA Anthropology News 43, no. 3: 20.

Geller, Stacie E. , Abigail R. Koch , Pamela Roesch , Amarette Filut , Emily Hallgren , and Molly Carnes . 2018 . “ The More Things Change, the More They Stay the Same: A Study to Evaluate Compliance with Inclusion and Assessment of Women and Minorities in Randomized Clinical Trials. ” Academic Medicine 93, no. 4: 630–635.

Haggerty, Kevin D.   2004 . “ Ethics Creep: Governing Social Science Research in the Name of Ethics. ” Qualitative Sociology 27, no. 4: 391–414.

Henrich, Joseph , S. J. Heine , and A. Norenzayan . 2010 . “ The Weirdest People in the World? ” Behavioural and Brain Sciences 33, no. 2–3: 61–83.

Humphreys, Keith , Natalia C. Maisel , Janet C. Blodgett , Ingrid L. Fuh , and John W. Finney . 2013 . “ Extent and Reporting of Patient Nonenrollment in Influential Randomized Clinical Trials, 2002 to 2010. ” JAMA Internal Medicine 173: 1029–1031.

Johnson, Jane , and Neal D. Barnard . 2014 . “ Chimpanzees as Vulnerable Subjects in Research. ” Theoretical Medicine and Bioethics 35, no. 2: 133–141.

Kass, Nancy E. , Ruth R. Faden , Steven N. Goodman , Peter Pronovost , Sean Tunis , and Tom L. Beauchamp . 2013 . “ The Research–Treatment Distinction: A Problematic Approach for Determining which Activities Should Have Ethical Oversight.” In “Ethical Oversight of Learning Health Care Systems, ” special report, Hastings Center Report 43, no. 1: S4–S15.

Lemmens, Trudo , and Carl Elliott . 2001 . “ Justice for the Professional Guinea Pig. ” American Journal of Bioethics 1, no. 2: 51–53.

Levine, Robert J.   2008 . “The Nature, Scope, and Justification of Clinical Research.” In The Oxford Textbook of Clinical Research Ethics , edited by Ezekiel J. Emanuel , Christine Grady , Robert A. Crouch , Reidar K. Lie , Franklin G. Miller , and David Wendler , 211–221. Oxford: Oxford University Press.

McDonald, Alison M. , Rosemary C. Knight , Marion K. Campbell , Vikki A. Entwistle , Adrian M. Grant , Jonathan A. Cook , et al. 2006 . “What Influences Recruitment to Randomised Controlled Trials ? A Review of Trials Funded by Two UK Funding Agencies.” Trials 7: 9.

Moses, Hamilton , E. Ray Dorsey , David H. M. Matheson , and Samuel O. Thier . 2005 . “ Financial Anatomy of Biomedical Research. ” Journal of the American Medical Association 294, no. 11: 1333–1342.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979 . The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research . https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

Nuremberg Code. 1949 . “Permissible Medical Experiments.” In Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, 181–182. Washington, DC: US Government Printing Office.

Røttingen, John-Arne , Sadie Regmi , Mari Eide , Alison J. Young , Roderik F. Viergever , Christine Årdal , et al. 2013 . “ Mapping of Available Health Research and Development Data: What’s There, What’s Missing, and What Role Is There for a Global Observatory? ” Lancet 382, no. 9900: 1286–1307.

Shansky, Rebecca M.   2019 . “ Are Hormones a ‘Female Problem’ for Animal Research? ” Science 364, no. 6443: 825–826.

Sismondo, Sergio . 2018 . Ghost-Managed Medicine: Big Pharma’s Invisible Hands . Manchester, UK: Mattering Press.

Taylor, Judith , and Matthew Patterson . 2010 . “ Autonomy and Compliance: How Qualitative Sociologists Respond to Institutional Ethical Oversight. ” Qualitative Sociology 33, no. 2: 161–183.

World Health Organization. 2019 . Number of Grants for Biomedical Research by Funder, Type of Grant, Duration and Recipients (World RePORT) . Geneva: World Health Organization. https://www.who.int/research-observatory/monitoring/inputs/world_report/en/ .

World Medical Association. 2013 . “ World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. ” Journal of the American Medical Association 310, no. 20: 2191–2194.

Young, Alison J. , Robert F. Terry , John-Arne Røttingen , and Roderik F. Viergever . 2015 . “ Global Trends in Health Research and Development Expenditures—The Challenge of Making Reliable Estimates for International Comparison. ” Health Research Policy and Systems 13: 7.

I use the generic term “research ethics committee” in this chapter to refer to the committee providing prospective ethical review of research. In some jurisdictions these have other names, such as “research ethics boards” or “institutional review boards.”

The document goes on to say, “In some cases it can be difficult to make this distinction, underscoring the need to have reviewers or ad hoc advisors . . . who can assist with this determination” (p. 14). This highlights a lesson articulated in this section of the chapter: it is not easy to determine which activities are “research.”

I use the term “boundary cases” here to refer to any study designs that can’t be easily classified as “research” or “practice.” As the examples indicate, this includes “hybrid” or “overlap” activities which intentionally blend research and practice, such as those found in proposed models for learning health care systems.

This is one of the (many) reasons why scholars are so interested in the design and pursuit of learning health care systems in which the research–practice distinction is downplayed or eliminated and new mechanisms of accountability are explored. This and related issues are discussed by Kim elsewhere in this handbook.

The TCPS 2 has a very specific scope: it only covers research funded by the three federal funding agencies in Canada. Other parties, such as independent or private researchers and funders in Canada, typically agree to abide by these rules; but only researchers funded through these agencies are strictly bound by them.

A recent court decision in Newfoundland and Labrador, Canada, for instance, sets this “reasonable” window at 30 days (CBC News 2019 ).

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Chapter 2. Research Design

Getting started.

When I teach undergraduates qualitative research methods, the final product of the course is a “research proposal” that incorporates all they have learned and enlists the knowledge they have learned about qualitative research methods in an original design that addresses a particular research question. I highly recommend you think about designing your own research study as you progress through this textbook. Even if you don’t have a study in mind yet, it can be a helpful exercise as you progress through the course. But how to start? How can one design a research study before they even know what research looks like? This chapter will serve as a brief overview of the research design process to orient you to what will be coming in later chapters. Think of it as a “skeleton” of what you will read in more detail in later chapters. Ideally, you will read this chapter both now (in sequence) and later during your reading of the remainder of the text. Do not worry if you have questions the first time you read this chapter. Many things will become clearer as the text advances and as you gain a deeper understanding of all the components of good qualitative research. This is just a preliminary map to get you on the right road.

Research Design Steps

Before you even get started, you will need to have a broad topic of interest in mind. [1] . In my experience, students can confuse this broad topic with the actual research question, so it is important to clearly distinguish the two. And the place to start is the broad topic. It might be, as was the case with me, working-class college students. But what about working-class college students? What’s it like to be one? Why are there so few compared to others? How do colleges assist (or fail to assist) them? What interested me was something I could barely articulate at first and went something like this: “Why was it so difficult and lonely to be me?” And by extension, “Did others share this experience?”

Once you have a general topic, reflect on why this is important to you. Sometimes we connect with a topic and we don’t really know why. Even if you are not willing to share the real underlying reason you are interested in a topic, it is important that you know the deeper reasons that motivate you. Otherwise, it is quite possible that at some point during the research, you will find yourself turned around facing the wrong direction. I have seen it happen many times. The reason is that the research question is not the same thing as the general topic of interest, and if you don’t know the reasons for your interest, you are likely to design a study answering a research question that is beside the point—to you, at least. And this means you will be much less motivated to carry your research to completion.

Researcher Note

Why do you employ qualitative research methods in your area of study? What are the advantages of qualitative research methods for studying mentorship?

Qualitative research methods are a huge opportunity to increase access, equity, inclusion, and social justice. Qualitative research allows us to engage and examine the uniquenesses/nuances within minoritized and dominant identities and our experiences with these identities. Qualitative research allows us to explore a specific topic, and through that exploration, we can link history to experiences and look for patterns or offer up a unique phenomenon. There’s such beauty in being able to tell a particular story, and qualitative research is a great mode for that! For our work, we examined the relationships we typically use the term mentorship for but didn’t feel that was quite the right word. Qualitative research allowed us to pick apart what we did and how we engaged in our relationships, which then allowed us to more accurately describe what was unique about our mentorship relationships, which we ultimately named liberationships ( McAloney and Long 2021) . Qualitative research gave us the means to explore, process, and name our experiences; what a powerful tool!

How do you come up with ideas for what to study (and how to study it)? Where did you get the idea for studying mentorship?

Coming up with ideas for research, for me, is kind of like Googling a question I have, not finding enough information, and then deciding to dig a little deeper to get the answer. The idea to study mentorship actually came up in conversation with my mentorship triad. We were talking in one of our meetings about our relationship—kind of meta, huh? We discussed how we felt that mentorship was not quite the right term for the relationships we had built. One of us asked what was different about our relationships and mentorship. This all happened when I was taking an ethnography course. During the next session of class, we were discussing auto- and duoethnography, and it hit me—let’s explore our version of mentorship, which we later went on to name liberationships ( McAloney and Long 2021 ). The idea and questions came out of being curious and wanting to find an answer. As I continue to research, I see opportunities in questions I have about my work or during conversations that, in our search for answers, end up exposing gaps in the literature. If I can’t find the answer already out there, I can study it.

—Kim McAloney, PhD, College Student Services Administration Ecampus coordinator and instructor

When you have a better idea of why you are interested in what it is that interests you, you may be surprised to learn that the obvious approaches to the topic are not the only ones. For example, let’s say you think you are interested in preserving coastal wildlife. And as a social scientist, you are interested in policies and practices that affect the long-term viability of coastal wildlife, especially around fishing communities. It would be natural then to consider designing a research study around fishing communities and how they manage their ecosystems. But when you really think about it, you realize that what interests you the most is how people whose livelihoods depend on a particular resource act in ways that deplete that resource. Or, even deeper, you contemplate the puzzle, “How do people justify actions that damage their surroundings?” Now, there are many ways to design a study that gets at that broader question, and not all of them are about fishing communities, although that is certainly one way to go. Maybe you could design an interview-based study that includes and compares loggers, fishers, and desert golfers (those who golf in arid lands that require a great deal of wasteful irrigation). Or design a case study around one particular example where resources were completely used up by a community. Without knowing what it is you are really interested in, what motivates your interest in a surface phenomenon, you are unlikely to come up with the appropriate research design.

These first stages of research design are often the most difficult, but have patience . Taking the time to consider why you are going to go through a lot of trouble to get answers will prevent a lot of wasted energy in the future.

There are distinct reasons for pursuing particular research questions, and it is helpful to distinguish between them.  First, you may be personally motivated.  This is probably the most important and the most often overlooked.   What is it about the social world that sparks your curiosity? What bothers you? What answers do you need in order to keep living? For me, I knew I needed to get a handle on what higher education was for before I kept going at it. I needed to understand why I felt so different from my peers and whether this whole “higher education” thing was “for the likes of me” before I could complete my degree. That is the personal motivation question. Your personal motivation might also be political in nature, in that you want to change the world in a particular way. It’s all right to acknowledge this. In fact, it is better to acknowledge it than to hide it.

There are also academic and professional motivations for a particular study.  If you are an absolute beginner, these may be difficult to find. We’ll talk more about this when we discuss reviewing the literature. Simply put, you are probably not the only person in the world to have thought about this question or issue and those related to it. So how does your interest area fit into what others have studied? Perhaps there is a good study out there of fishing communities, but no one has quite asked the “justification” question. You are motivated to address this to “fill the gap” in our collective knowledge. And maybe you are really not at all sure of what interests you, but you do know that [insert your topic] interests a lot of people, so you would like to work in this area too. You want to be involved in the academic conversation. That is a professional motivation and a very important one to articulate.

Practical and strategic motivations are a third kind. Perhaps you want to encourage people to take better care of the natural resources around them. If this is also part of your motivation, you will want to design your research project in a way that might have an impact on how people behave in the future. There are many ways to do this, one of which is using qualitative research methods rather than quantitative research methods, as the findings of qualitative research are often easier to communicate to a broader audience than the results of quantitative research. You might even be able to engage the community you are studying in the collecting and analyzing of data, something taboo in quantitative research but actively embraced and encouraged by qualitative researchers. But there are other practical reasons, such as getting “done” with your research in a certain amount of time or having access (or no access) to certain information. There is nothing wrong with considering constraints and opportunities when designing your study. Or maybe one of the practical or strategic goals is about learning competence in this area so that you can demonstrate the ability to conduct interviews and focus groups with future employers. Keeping that in mind will help shape your study and prevent you from getting sidetracked using a technique that you are less invested in learning about.

STOP HERE for a moment

I recommend you write a paragraph (at least) explaining your aims and goals. Include a sentence about each of the following: personal/political goals, practical or professional/academic goals, and practical/strategic goals. Think through how all of the goals are related and can be achieved by this particular research study . If they can’t, have a rethink. Perhaps this is not the best way to go about it.

You will also want to be clear about the purpose of your study. “Wait, didn’t we just do this?” you might ask. No! Your goals are not the same as the purpose of the study, although they are related. You can think about purpose lying on a continuum from “ theory ” to “action” (figure 2.1). Sometimes you are doing research to discover new knowledge about the world, while other times you are doing a study because you want to measure an impact or make a difference in the world.

Basic research involves research that is done for the sake of “pure” knowledge—that is, knowledge that, at least at this moment in time, may not have any apparent use or application. Often, and this is very important, knowledge of this kind is later found to be extremely helpful in solving problems. So one way of thinking about basic research is that it is knowledge for which no use is yet known but will probably one day prove to be extremely useful. If you are doing basic research, you do not need to argue its usefulness, as the whole point is that we just don’t know yet what this might be.

Researchers engaged in basic research want to understand how the world operates. They are interested in investigating a phenomenon to get at the nature of reality with regard to that phenomenon. The basic researcher’s purpose is to understand and explain ( Patton 2002:215 ).

Basic research is interested in generating and testing hypotheses about how the world works. Grounded Theory is one approach to qualitative research methods that exemplifies basic research (see chapter 4). Most academic journal articles publish basic research findings. If you are working in academia (e.g., writing your dissertation), the default expectation is that you are conducting basic research.

Applied research in the social sciences is research that addresses human and social problems. Unlike basic research, the researcher has expectations that the research will help contribute to resolving a problem, if only by identifying its contours, history, or context. From my experience, most students have this as their baseline assumption about research. Why do a study if not to make things better? But this is a common mistake. Students and their committee members are often working with default assumptions here—the former thinking about applied research as their purpose, the latter thinking about basic research: “The purpose of applied research is to contribute knowledge that will help people to understand the nature of a problem in order to intervene, thereby allowing human beings to more effectively control their environment. While in basic research the source of questions is the tradition within a scholarly discipline, in applied research the source of questions is in the problems and concerns experienced by people and by policymakers” ( Patton 2002:217 ).

Applied research is less geared toward theory in two ways. First, its questions do not derive from previous literature. For this reason, applied research studies have much more limited literature reviews than those found in basic research (although they make up for this by having much more “background” about the problem). Second, it does not generate theory in the same way as basic research does. The findings of an applied research project may not be generalizable beyond the boundaries of this particular problem or context. The findings are more limited. They are useful now but may be less useful later. This is why basic research remains the default “gold standard” of academic research.

Evaluation research is research that is designed to evaluate or test the effectiveness of specific solutions and programs addressing specific social problems. We already know the problems, and someone has already come up with solutions. There might be a program, say, for first-generation college students on your campus. Does this program work? Are first-generation students who participate in the program more likely to graduate than those who do not? These are the types of questions addressed by evaluation research. There are two types of research within this broader frame; however, one more action-oriented than the next. In summative evaluation , an overall judgment about the effectiveness of a program or policy is made. Should we continue our first-gen program? Is it a good model for other campuses? Because the purpose of such summative evaluation is to measure success and to determine whether this success is scalable (capable of being generalized beyond the specific case), quantitative data is more often used than qualitative data. In our example, we might have “outcomes” data for thousands of students, and we might run various tests to determine if the better outcomes of those in the program are statistically significant so that we can generalize the findings and recommend similar programs elsewhere. Qualitative data in the form of focus groups or interviews can then be used for illustrative purposes, providing more depth to the quantitative analyses. In contrast, formative evaluation attempts to improve a program or policy (to help “form” or shape its effectiveness). Formative evaluations rely more heavily on qualitative data—case studies, interviews, focus groups. The findings are meant not to generalize beyond the particular but to improve this program. If you are a student seeking to improve your qualitative research skills and you do not care about generating basic research, formative evaluation studies might be an attractive option for you to pursue, as there are always local programs that need evaluation and suggestions for improvement. Again, be very clear about your purpose when talking through your research proposal with your committee.

Action research takes a further step beyond evaluation, even formative evaluation, to being part of the solution itself. This is about as far from basic research as one could get and definitely falls beyond the scope of “science,” as conventionally defined. The distinction between action and research is blurry, the research methods are often in constant flux, and the only “findings” are specific to the problem or case at hand and often are findings about the process of intervention itself. Rather than evaluate a program as a whole, action research often seeks to change and improve some particular aspect that may not be working—maybe there is not enough diversity in an organization or maybe women’s voices are muted during meetings and the organization wonders why and would like to change this. In a further step, participatory action research , those women would become part of the research team, attempting to amplify their voices in the organization through participation in the action research. As action research employs methods that involve people in the process, focus groups are quite common.

If you are working on a thesis or dissertation, chances are your committee will expect you to be contributing to fundamental knowledge and theory ( basic research ). If your interests lie more toward the action end of the continuum, however, it is helpful to talk to your committee about this before you get started. Knowing your purpose in advance will help avoid misunderstandings during the later stages of the research process!

The Research Question

Once you have written your paragraph and clarified your purpose and truly know that this study is the best study for you to be doing right now , you are ready to write and refine your actual research question. Know that research questions are often moving targets in qualitative research, that they can be refined up to the very end of data collection and analysis. But you do have to have a working research question at all stages. This is your “anchor” when you get lost in the data. What are you addressing? What are you looking at and why? Your research question guides you through the thicket. It is common to have a whole host of questions about a phenomenon or case, both at the outset and throughout the study, but you should be able to pare it down to no more than two or three sentences when asked. These sentences should both clarify the intent of the research and explain why this is an important question to answer. More on refining your research question can be found in chapter 4.

Chances are, you will have already done some prior reading before coming up with your interest and your questions, but you may not have conducted a systematic literature review. This is the next crucial stage to be completed before venturing further. You don’t want to start collecting data and then realize that someone has already beaten you to the punch. A review of the literature that is already out there will let you know (1) if others have already done the study you are envisioning; (2) if others have done similar studies, which can help you out; and (3) what ideas or concepts are out there that can help you frame your study and make sense of your findings. More on literature reviews can be found in chapter 9.

In addition to reviewing the literature for similar studies to what you are proposing, it can be extremely helpful to find a study that inspires you. This may have absolutely nothing to do with the topic you are interested in but is written so beautifully or organized so interestingly or otherwise speaks to you in such a way that you want to post it somewhere to remind you of what you want to be doing. You might not understand this in the early stages—why would you find a study that has nothing to do with the one you are doing helpful? But trust me, when you are deep into analysis and writing, having an inspirational model in view can help you push through. If you are motivated to do something that might change the world, you probably have read something somewhere that inspired you. Go back to that original inspiration and read it carefully and see how they managed to convey the passion that you so appreciate.

At this stage, you are still just getting started. There are a lot of things to do before setting forth to collect data! You’ll want to consider and choose a research tradition and a set of data-collection techniques that both help you answer your research question and match all your aims and goals. For example, if you really want to help migrant workers speak for themselves, you might draw on feminist theory and participatory action research models. Chapters 3 and 4 will provide you with more information on epistemologies and approaches.

Next, you have to clarify your “units of analysis.” What is the level at which you are focusing your study? Often, the unit in qualitative research methods is individual people, or “human subjects.” But your units of analysis could just as well be organizations (colleges, hospitals) or programs or even whole nations. Think about what it is you want to be saying at the end of your study—are the insights you are hoping to make about people or about organizations or about something else entirely? A unit of analysis can even be a historical period! Every unit of analysis will call for a different kind of data collection and analysis and will produce different kinds of “findings” at the conclusion of your study. [2]

Regardless of what unit of analysis you select, you will probably have to consider the “human subjects” involved in your research. [3] Who are they? What interactions will you have with them—that is, what kind of data will you be collecting? Before answering these questions, define your population of interest and your research setting. Use your research question to help guide you.

Let’s use an example from a real study. In Geographies of Campus Inequality , Benson and Lee ( 2020 ) list three related research questions: “(1) What are the different ways that first-generation students organize their social, extracurricular, and academic activities at selective and highly selective colleges? (2) how do first-generation students sort themselves and get sorted into these different types of campus lives; and (3) how do these different patterns of campus engagement prepare first-generation students for their post-college lives?” (3).

Note that we are jumping into this a bit late, after Benson and Lee have described previous studies (the literature review) and what is known about first-generation college students and what is not known. They want to know about differences within this group, and they are interested in ones attending certain kinds of colleges because those colleges will be sites where academic and extracurricular pressures compete. That is the context for their three related research questions. What is the population of interest here? First-generation college students . What is the research setting? Selective and highly selective colleges . But a host of questions remain. Which students in the real world, which colleges? What about gender, race, and other identity markers? Will the students be asked questions? Are the students still in college, or will they be asked about what college was like for them? Will they be observed? Will they be shadowed? Will they be surveyed? Will they be asked to keep diaries of their time in college? How many students? How many colleges? For how long will they be observed?

Recommendation

Take a moment and write down suggestions for Benson and Lee before continuing on to what they actually did.

Have you written down your own suggestions? Good. Now let’s compare those with what they actually did. Benson and Lee drew on two sources of data: in-depth interviews with sixty-four first-generation students and survey data from a preexisting national survey of students at twenty-eight selective colleges. Let’s ignore the survey for our purposes here and focus on those interviews. The interviews were conducted between 2014 and 2016 at a single selective college, “Hilltop” (a pseudonym ). They employed a “purposive” sampling strategy to ensure an equal number of male-identifying and female-identifying students as well as equal numbers of White, Black, and Latinx students. Each student was interviewed once. Hilltop is a selective liberal arts college in the northeast that enrolls about three thousand students.

How did your suggestions match up to those actually used by the researchers in this study? It is possible your suggestions were too ambitious? Beginning qualitative researchers can often make that mistake. You want a research design that is both effective (it matches your question and goals) and doable. You will never be able to collect data from your entire population of interest (unless your research question is really so narrow to be relevant to very few people!), so you will need to come up with a good sample. Define the criteria for this sample, as Benson and Lee did when deciding to interview an equal number of students by gender and race categories. Define the criteria for your sample setting too. Hilltop is typical for selective colleges. That was a research choice made by Benson and Lee. For more on sampling and sampling choices, see chapter 5.

Benson and Lee chose to employ interviews. If you also would like to include interviews, you have to think about what will be asked in them. Most interview-based research involves an interview guide, a set of questions or question areas that will be asked of each participant. The research question helps you create a relevant interview guide. You want to ask questions whose answers will provide insight into your research question. Again, your research question is the anchor you will continually come back to as you plan for and conduct your study. It may be that once you begin interviewing, you find that people are telling you something totally unexpected, and this makes you rethink your research question. That is fine. Then you have a new anchor. But you always have an anchor. More on interviewing can be found in chapter 11.

Let’s imagine Benson and Lee also observed college students as they went about doing the things college students do, both in the classroom and in the clubs and social activities in which they participate. They would have needed a plan for this. Would they sit in on classes? Which ones and how many? Would they attend club meetings and sports events? Which ones and how many? Would they participate themselves? How would they record their observations? More on observation techniques can be found in both chapters 13 and 14.

At this point, the design is almost complete. You know why you are doing this study, you have a clear research question to guide you, you have identified your population of interest and research setting, and you have a reasonable sample of each. You also have put together a plan for data collection, which might include drafting an interview guide or making plans for observations. And so you know exactly what you will be doing for the next several months (or years!). To put the project into action, there are a few more things necessary before actually going into the field.

First, you will need to make sure you have any necessary supplies, including recording technology. These days, many researchers use their phones to record interviews. Second, you will need to draft a few documents for your participants. These include informed consent forms and recruiting materials, such as posters or email texts, that explain what this study is in clear language. Third, you will draft a research protocol to submit to your institutional review board (IRB) ; this research protocol will include the interview guide (if you are using one), the consent form template, and all examples of recruiting material. Depending on your institution and the details of your study design, it may take weeks or even, in some unfortunate cases, months before you secure IRB approval. Make sure you plan on this time in your project timeline. While you wait, you can continue to review the literature and possibly begin drafting a section on the literature review for your eventual presentation/publication. More on IRB procedures can be found in chapter 8 and more general ethical considerations in chapter 7.

Once you have approval, you can begin!

Research Design Checklist

Before data collection begins, do the following:

• Write a paragraph explaining your aims and goals (personal/political, practical/strategic, professional/academic).
• Define your research question; write two to three sentences that clarify the intent of the research and why this is an important question to answer.
• Review the literature for similar studies that address your research question or similar research questions; think laterally about some literature that might be helpful or illuminating but is not exactly about the same topic.
• Find a written study that inspires you—it may or may not be on the research question you have chosen.
• Consider and choose a research tradition and set of data-collection techniques that (1) help answer your research question and (2) match your aims and goals.
• Define your population of interest and your research setting.
• Define the criteria for your sample (How many? Why these? How will you find them, gain access, and acquire consent?).
• If you are conducting interviews, draft an interview guide.
•  If you are making observations, create a plan for observations (sites, times, recording, access).
• Acquire any necessary technology (recording devices/software).
• Draft consent forms that clearly identify the research focus and selection process.
• Create recruiting materials (posters, email, texts).
• Apply for IRB approval (proposal plus consent form plus recruiting materials).
• Block out time for collecting data.
• At the end of the chapter, you will find a " Research Design Checklist " that summarizes the main recommendations made here ↵
• For example, if your focus is society and culture , you might collect data through observation or a case study. If your focus is individual lived experience , you are probably going to be interviewing some people. And if your focus is language and communication , you will probably be analyzing text (written or visual). ( Marshall and Rossman 2016:16 ). ↵
• You may not have any "live" human subjects. There are qualitative research methods that do not require interactions with live human beings - see chapter 16 , "Archival and Historical Sources." But for the most part, you are probably reading this textbook because you are interested in doing research with people. The rest of the chapter will assume this is the case. ↵

One of the primary methodological traditions of inquiry in qualitative research, ethnography is the study of a group or group culture, largely through observational fieldwork supplemented by interviews. It is a form of fieldwork that may include participant-observation data collection. See chapter 14 for a discussion of deep ethnography. 

A methodological tradition of inquiry and research design that focuses on an individual case (e.g., setting, institution, or sometimes an individual) in order to explore its complexity, history, and interactive parts.  As an approach, it is particularly useful for obtaining a deep appreciation of an issue, event, or phenomenon of interest in its particular context.

The controlling force in research; can be understood as lying on a continuum from basic research (knowledge production) to action research (effecting change).

In its most basic sense, a theory is a story we tell about how the world works that can be tested with empirical evidence.  In qualitative research, we use the term in a variety of ways, many of which are different from how they are used by quantitative researchers.  Although some qualitative research can be described as “testing theory,” it is more common to “build theory” from the data using inductive reasoning , as done in Grounded Theory .  There are so-called “grand theories” that seek to integrate a whole series of findings and stories into an overarching paradigm about how the world works, and much smaller theories or concepts about particular processes and relationships.  Theory can even be used to explain particular methodological perspectives or approaches, as in Institutional Ethnography , which is both a way of doing research and a theory about how the world works.

Research that is interested in generating and testing hypotheses about how the world works.

A methodological tradition of inquiry and approach to analyzing qualitative data in which theories emerge from a rigorous and systematic process of induction.  This approach was pioneered by the sociologists Glaser and Strauss (1967).  The elements of theory generated from comparative analysis of data are, first, conceptual categories and their properties and, second, hypotheses or generalized relations among the categories and their properties – “The constant comparing of many groups draws the [researcher’s] attention to their many similarities and differences.  Considering these leads [the researcher] to generate abstract categories and their properties, which, since they emerge from the data, will clearly be important to a theory explaining the kind of behavior under observation.” (36).

An approach to research that is “multimethod in focus, involving an interpretative, naturalistic approach to its subject matter.  This means that qualitative researchers study things in their natural settings, attempting to make sense of, or interpret, phenomena in terms of the meanings people bring to them.  Qualitative research involves the studied use and collection of a variety of empirical materials – case study, personal experience, introspective, life story, interview, observational, historical, interactional, and visual texts – that describe routine and problematic moments and meanings in individuals’ lives." ( Denzin and Lincoln 2005:2 ). Contrast with quantitative research .

Research that contributes knowledge that will help people to understand the nature of a problem in order to intervene, thereby allowing human beings to more effectively control their environment.

Research that is designed to evaluate or test the effectiveness of specific solutions and programs addressing specific social problems.  There are two kinds: summative and formative .

Research in which an overall judgment about the effectiveness of a program or policy is made, often for the purpose of generalizing to other cases or programs.  Generally uses qualitative research as a supplement to primary quantitative data analyses.  Contrast formative evaluation research .

Research designed to improve a program or policy (to help “form” or shape its effectiveness); relies heavily on qualitative research methods.  Contrast summative evaluation research

Research carried out at a particular organizational or community site with the intention of affecting change; often involves research subjects as participants of the study.  See also participatory action research .

Research in which both researchers and participants work together to understand a problematic situation and change it for the better.

The level of the focus of analysis (e.g., individual people, organizations, programs, neighborhoods).

The large group of interest to the researcher.  Although it will likely be impossible to design a study that incorporates or reaches all members of the population of interest, this should be clearly defined at the outset of a study so that a reasonable sample of the population can be taken.  For example, if one is studying working-class college students, the sample may include twenty such students attending a particular college, while the population is “working-class college students.”  In quantitative research, clearly defining the general population of interest is a necessary step in generalizing results from a sample.  In qualitative research, defining the population is conceptually important for clarity.

A fictional name assigned to give anonymity to a person, group, or place.  Pseudonyms are important ways of protecting the identity of research participants while still providing a “human element” in the presentation of qualitative data.  There are ethical considerations to be made in selecting pseudonyms; some researchers allow research participants to choose their own.

A requirement for research involving human participants; the documentation of informed consent.  In some cases, oral consent or assent may be sufficient, but the default standard is a single-page easy-to-understand form that both the researcher and the participant sign and date.   Under federal guidelines, all researchers "shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative.  No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's rights or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence" (21 CFR 50.20).  Your IRB office will be able to provide a template for use in your study .

An administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB is charged with the responsibility of reviewing all research involving human participants. The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy.

Introduction to Qualitative Research Methods Copyright © 2023 by Allison Hurst is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License , except where otherwise noted.

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Overview of Single-Subject Research

Rajiv S. Jhangiani; I-Chant A. Chiang; Carrie Cuttler; and Dana C. Leighton

Learning Objectives

• Explain what single-subject research is, including how it differs from other types of psychological research.
• Explain who uses single-subject research and why.

What Is Single-Subject Research?

Single-subject research  is a type of quantitative research that involves studying in detail the behavior of each of a small number of participants. Note that the term  single-subject  does not mean that only one participant is studied; it is more typical for there to be somewhere between two and 10 participants. (This is why single-subject research designs are sometimes called small- n designs, where  n  is the statistical symbol for the sample size.) Single-subject research can be contrasted with  group research , which typically involves studying large numbers of participants and examining their behavior primarily in terms of group means, standard deviations, and so on. The majority of this textbook is devoted to understanding group research, which is the most common approach in psychology. But single-subject research is an important alternative, and it is the primary approach in some more applied areas of psychology.

Before continuing, it is important to distinguish single-subject research from case studies and other more qualitative approaches that involve studying in detail a small number of participants. As described in Chapter 6, case studies involve an in-depth analysis and description of an individual, which is typically primarily qualitative in nature. More broadly speaking, qualitative research focuses on understanding people’s subjective experience by observing behavior and collecting relatively unstructured data (e.g., detailed interviews) and analyzing those data using narrative rather than quantitative techniques. Single-subject research, in contrast, focuses on understanding objective behavior through experimental manipulation and control, collecting highly structured data, and analyzing those data quantitatively.

Assumptions of Single-Subject Research

Again, single-subject research involves studying a small number of participants and focusing intensively on the behavior of each one. But why take this approach instead of the group approach? There are several important assumptions underlying single-subject research, and it will help to consider them now.

First and foremost is the assumption that it is important to focus intensively on the behavior of individual participants. One reason for this is that group research can hide individual differences and generate results that do not represent the behavior of any individual. For example, a treatment that has a positive effect for half the people exposed to it but a negative effect for the other half would, on average, appear to have no effect at all. Single-subject research, however, would likely reveal these individual differences. A second reason to focus intensively on individuals is that sometimes it is the behavior of a particular individual that is primarily of interest. A school psychologist, for example, might be interested in changing the behavior of a particular disruptive student. Although previous published research (both single-subject and group research) is likely to provide some guidance on how to do this, conducting a study on this student would be more direct and probably more effective.

A second assumption of single-subject research is that it is important to discover causal relationships through the manipulation of an independent variable, the careful measurement of a dependent variable, and the control of extraneous variables. For this reason, single-subject research is often considered a type of experimental research with good internal validity. Recall, for example, that Hall and his colleagues measured their dependent variable (studying) many times—first under a no-treatment control condition, then under a treatment condition (positive teacher attention), and then again under the control condition. Because there was a clear increase in studying when the treatment was introduced, a decrease when it was removed, and an increase when it was reintroduced, there is little doubt that the treatment was the cause of the improvement.

A third assumption of single-subject research is that it is important to study strong and consistent effects that have biological or social importance. Applied researchers, in particular, are interested in treatments that have substantial effects on important behaviors and that can be implemented reliably in the real-world contexts in which they occur. This is sometimes referred to as social validity  (Wolf, 1976) [1] . The study by Hall and his colleagues, for example, had good social validity because it showed strong and consistent effects of positive teacher attention on a behavior that is of obvious importance to teachers, parents, and students. Furthermore, the teachers found the treatment easy to implement, even in their often-chaotic elementary school classrooms.

Who Uses Single-Subject Research?

Single-subject research has been around as long as the field of psychology itself. In the late 1800s, one of psychology’s founders, Wilhelm Wundt, studied sensation and consciousness by focusing intensively on each of a small number of research participants. Herman Ebbinghaus’s research on memory and Ivan Pavlov’s research on classical conditioning are other early examples, both of which are still described in almost every introductory psychology textbook.

In the middle of the 20th century, B. F. Skinner clarified many of the assumptions underlying single-subject research and refined many of its techniques (Skinner, 1938) [2] . He and other researchers then used it to describe how rewards, punishments, and other external factors affect behavior over time. This work was carried out primarily using nonhuman subjects—mostly rats and pigeons. This approach, which Skinner called the experimental analysis of behavior —remains an important subfield of psychology and continues to rely almost exclusively on single-subject research. For excellent examples of this work, look at any issue of the  Journal of the Experimental Analysis of Behavior . By the 1960s, many researchers were interested in using this approach to conduct applied research primarily with humans—a subfield now called  applied behavior analysis  (Baer, Wolf, & Risley, 1968) [3] . Applied behavior analysis plays an especially important role in contemporary research on developmental disabilities, education, organizational behavior, and health, among many other areas. Excellent examples of this work (including the study by Hall and his colleagues) can be found in the  Journal of Applied Behavior Analysis .

Although most contemporary single-subject research is conducted from the behavioral perspective, it can in principle be used to address questions framed in terms of any theoretical perspective. For example, a studying technique based on cognitive principles of learning and memory could be evaluated by testing it on individual high school students using the single-subject approach. The single-subject approach can also be used by clinicians who take any theoretical perspective—behavioral, cognitive, psychodynamic, or humanistic—to study processes of therapeutic change with individual clients and to document their clients’ improvement (Kazdin, 1982) [4] .

• Wolf, M. (1976). Social validity: The case for subjective measurement or how applied behavior analysis is finding its heart.  Journal of Applied Behavior Analysis, 11 , 203–214. ↵
• Skinner, B. F. (1938). T he behavior of organisms: An experimental analysis . New York, NY: Appleton-Century-Crofts. ↵
• Baer, D. M., Wolf, M. M., & Risley, T. R. (1968). Some current dimensions of applied behavior analysis.  Journal of Applied Behavior Analysis, 1 , 91–97. ↵
• Kazdin, A. E. (1982).  Single-case research designs: Methods for clinical and applied settings . New York, NY: Oxford University Press. ↵

A type of quantitative research that involves studying in detail the behavior of each of a small number of participants.

Research that involves studying large numbers of participants and examining their behavior primarily in terms of group means, standard deviations, and so on.

Referred to as treatments that have substantial effects on important behaviors and that can be implemented reliably in the real-world contexts in which they occur.

A subfield of psychology (behaviorism) that focuses exclusively on the effects of rewards, punishments, and other external factors on behavior.

An application of the principles of experimental analysis of behavior that plays an important role in contemporary research on developmental disabilities, education, organizational behavior, and health, among many other applied areas.

Overview of Single-Subject Research Copyright © 2022 by Rajiv S. Jhangiani; I-Chant A. Chiang; Carrie Cuttler; and Dana C. Leighton is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License , except where otherwise noted.

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2024 Theses Doctoral

Ice formation, deformation, and disappearance

Case, Elizabeth

From the moment a snowflake touches down on the surface of a glacier, it begins a process of transformation. Fresh snow, made up of single-grained snowflakes is compacted into glacial ice by the weight of subsequent snowfall and by sintering, grain boundary sliding and diffusion. At first, snow grains accommodate the stress through mechanical failure and by changing their shapes and positions. Fragile, dendritic structures on the edges of snowflakes break off, and grains round into lower free energy configurations. Rounded grains slip into air pockets. As time passes, increasing overburden of a load to bear, and it is, for a single snowflake. But it is precisely this stress that creates a glacier. Stress, in this case, is a catalyst for transformation. But don't worry. I am not going to make an overly forced metaphor for what happens during a doctorate program.} Pressure causes the grains to merge, large grains absorbing small ones. As ice grains squeeze and grow into all the available pore space, grains trap air bubbles and cut them off from the atmosphere, preserving records of climate conditions. Eventually, these processes densify the snow so thoroughly that it metamorphoses into glacial ice, and from a crumbly collection of snowflakes emerges a cohesive crystalline matrix. This process, firn densification, is the subject of my first chapter. From measurements of englacial strain rates by repeat phase-sensitive radar deployments, we show it is possible to extract densification rates that match modeled predictions. The formation of ice is just the beginning of the story of a glacier. As and after ice forms, gravity pulls on the body of the glacier; ice flows under its own weight, becoming a viscous river that meanders from high elevations toward the sea level. Along the way, various other forces act on the ice (e.g., friction at the ice-bed causes ice to shear, narrowing valley walls create compressive stresses, etc.). This history can be written into the ice in the orientation and configuration of its molecular structure. Ice is made of a regular crystal matrix of water molecules. Covalently bonded oxygen and hydrogen molecules assemble into sheets of hexagons, held to each other by hydrogen bonds. The relative orientation of these hexagonal sheets is called the "ice fabric”, and its importance lies in the fact that ice’s asymmetric molecular structure gives rise to asymmetric properties. For example, ice is softer—more deformable—when stress is applied parallel to the hexagonal planes, like playing cards sliding over one another. Over hundreds or thousands of years, this asymmetric response to stress causes the hexagonal planes to rotate so that they lie perpendicular to the direction of compressive stress. This, in turn, changes which relative direction a glacier is the “softest”. In short, the history of the glacier is written into its fabric. Ice remembers the stress it has undergone, and that memory changes its resistance to (or accommodation of) stress in the present and future. In chapter two, I use an autonomous phase-sensitive radar to measure the ice fabric along a central transect of Thwaites Glacier. Thwaites drains ice from West Antarctica and is one of the fastest changing glaciers on the continent. Locked up in Thwaites is at least half a meter of sea level rise, as well as much of the buttressing that holds back WAIS. Measurements of the fabric of Thwaites tell us about the history of stress undergone by the glacier, as well as any change in relative direction of the "softest" ice. As a glaciologist, I have dedicated my life to studying how glaciers form, flow, and disappear. As an artist and writer, I am interested in material memory, with a particular orientation toward ice itself and in the way the language and mathematics used to describe ice mimic processes that happen in body, mind, and society. My fourth chapter is centered on the creative research and art produced during my dissertation, particularly focused on a visual autoethnography of my body I created during my first field season in Antarctica in 2022-2023. In it, I try to grapple with whether/how, even as positivist science demands I remove as much of myself as possible from my scientific research, my body/myself show up in small ways in my data. I consider how ice's response to stress—to soften or harden, to flow or crack—is in many ways, a mirror for how we as humans respond to stress. Other work in Chapter 4 was created in direct response to the beauty of glaciated landscapes and the grief I struggle to manage in response to their rapid change. Biome I is a short zine that uses faux-color satellite imagery overlain with text and meshes of glaciers from Grand Teton National Park (GRTE). In 2021, I spent six months as a Scientists-in-Parks fellow through AmeriCorps, joining the park's physical science team in Wyoming to expand their glacier monitoring program. From this work emerged Chapter 3 a history of glacial change in the park over the last 70 years from in situ and remotely sensed observations. This work, while quite different from my previous scientific output, allowed me to learn and explore other glaciological techniques as well as template methodologies and provide information that is immediately useful for education and action in GRTE and other rapidly deglaciating landscapes. Much of the way I have come to understand glacial geophysics is by considering the ways they connect more broadly to our lived experiences. In the Tetons, this involved understanding how deglaciation affects the park's ecological systems and the evolving safety for visitors given the changing ice conditions. In pursuit of both expanding my own understanding and hoping to share with others the joy and beauty of the study of ice, I have developed numerous education efforts to make the study of glaciers, climate, and the earth physical, tangible, less abstract, emotional, joyful, and intuitive. Chapter 5 concludes the thesis by taking a step back to look at education and teaching, the thread that has carried through my doctorate, from prior to starting graduate school and, I hope, that will continue long after. I discuss the influences of teacher-philosophers like Shannon Mattern, Lynda Barry, and bell hooks, who have all, in their own way, striven to reshape the (idea of the) classroom into forms that better serve the learner. This work has taken place on the seat of a bicycle riding across the country, on an icefield in Juneau, Alaska, and in my own backyard, in classrooms across New York City. To conclude, I hope this thesis is not only a scientific effort, but one that draws the curtain back on the broader work we do as glaciologists. We are also artists and educators, caretakers, archivists, and public figures. Our work can be physically, mentally, and emotionally demanding, and it is as often full of grief as it is of awe.

Geographic Areas

• Wyoming--Grand Teton National Park
• Alaska--Juneau
• New York (State)--New York
• Physical geography
• Glaciers--Climatic factors
• Glaciologists
• Climatic changes
• Environmental sciences--Study and teaching
• AmeriCorps (Program : U.S.)

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Key facts about the abortion debate in America

The U.S. Supreme Court’s June 2022 ruling to overturn Roe v. Wade – the decision that had guaranteed a constitutional right to an abortion for nearly 50 years – has shifted the legal battle over abortion to the states, with some prohibiting the procedure and others moving to safeguard it.

As the nation’s post-Roe chapter begins, here are key facts about Americans’ views on abortion, based on two Pew Research Center polls: one conducted from June 25-July 4 , just after this year’s high court ruling, and one conducted in March , before an earlier leaked draft of the opinion became public.

This analysis primarily draws from two Pew Research Center surveys, one surveying 10,441 U.S. adults conducted March 7-13, 2022, and another surveying 6,174 U.S. adults conducted June 27-July 4, 2022. Here are the questions used for the March survey , along with responses, and the questions used for the survey from June and July , along with responses.

Everyone who took part in these surveys is a member of the Center’s American Trends Panel (ATP), an online survey panel that is recruited through national, random sampling of residential addresses. This way nearly all U.S. adults have a chance of selection. The survey is weighted to be representative of the U.S. adult population by gender, race, ethnicity, partisan affiliation, education and other categories.  Read more about the ATP’s methodology .

A majority of the U.S. public disapproves of the Supreme Court’s decision to overturn Roe. About six-in-ten adults (57%) disapprove of the court’s decision that the U.S. Constitution does not guarantee a right to abortion and that abortion laws can be set by states, including 43% who strongly disapprove, according to the summer survey. About four-in-ten (41%) approve, including 25% who strongly approve.

About eight-in-ten Democrats and Democratic-leaning independents (82%) disapprove of the court’s decision, including nearly two-thirds (66%) who strongly disapprove. Most Republicans and GOP leaners (70%) approve , including 48% who strongly approve.

Most women (62%) disapprove of the decision to end the federal right to an abortion. More than twice as many women strongly disapprove of the court’s decision (47%) as strongly approve of it (21%). Opinion among men is more divided: 52% disapprove (37% strongly), while 47% approve (28% strongly).

About six-in-ten Americans (62%) say abortion should be legal in all or most cases, according to the summer survey – little changed since the March survey conducted just before the ruling. That includes 29% of Americans who say it should be legal in all cases and 33% who say it should be legal in most cases. About a third of U.S. adults (36%) say abortion should be illegal in all (8%) or most (28%) cases.

Generally, Americans’ views of whether abortion should be legal remained relatively unchanged in the past few years , though support fluctuated somewhat in previous decades.

Relatively few Americans take an absolutist view on the legality of abortion – either supporting or opposing it at all times, regardless of circumstances. The March survey found that support or opposition to abortion varies substantially depending on such circumstances as when an abortion takes place during a pregnancy, whether the pregnancy is life-threatening or whether a baby would have severe health problems.

While Republicans’ and Democrats’ views on the legality of abortion have long differed, the 46 percentage point partisan gap today is considerably larger than it was in the recent past, according to the survey conducted after the court’s ruling. The wider gap has been largely driven by Democrats: Today, 84% of Democrats say abortion should be legal in all or most cases, up from 72% in 2016 and 63% in 2007. Republicans’ views have shown far less change over time: Currently, 38% of Republicans say abortion should be legal in all or most cases, nearly identical to the 39% who said this in 2007.

However, the partisan divisions over whether abortion should generally be legal tell only part of the story. According to the March survey, sizable shares of Democrats favor restrictions on abortion under certain circumstances, while majorities of Republicans favor abortion being legal in some situations , such as in cases of rape or when the pregnancy is life-threatening.

There are wide religious divides in views of whether abortion should be legal , the summer survey found. An overwhelming share of religiously unaffiliated adults (83%) say abortion should be legal in all or most cases, as do six-in-ten Catholics. Protestants are divided in their views: 48% say it should be legal in all or most cases, while 50% say it should be illegal in all or most cases. Majorities of Black Protestants (71%) and White non-evangelical Protestants (61%) take the position that abortion should be legal in all or most cases, while about three-quarters of White evangelicals (73%) say it should be illegal in all (20%) or most cases (53%).

In the March survey, 72% of White evangelicals said that the statement “human life begins at conception, so a fetus is a person with rights” reflected their views extremely or very well . That’s much greater than the share of White non-evangelical Protestants (32%), Black Protestants (38%) and Catholics (44%) who said the same. Overall, 38% of Americans said that statement matched their views extremely or very well.

Catholics, meanwhile, are divided along religious and political lines in their attitudes about abortion, according to the same survey. Catholics who attend Mass regularly are among the country’s strongest opponents of abortion being legal, and they are also more likely than those who attend less frequently to believe that life begins at conception and that a fetus has rights. Catholic Republicans, meanwhile, are far more conservative on a range of abortion questions than are Catholic Democrats.

Women (66%) are more likely than men (57%) to say abortion should be legal in most or all cases, according to the survey conducted after the court’s ruling.

More than half of U.S. adults – including 60% of women and 51% of men – said in March that women should have a greater say than men in setting abortion policy . Just 3% of U.S. adults said men should have more influence over abortion policy than women, with the remainder (39%) saying women and men should have equal say.

The March survey also found that by some measures, women report being closer to the abortion issue than men . For example, women were more likely than men to say they had given “a lot” of thought to issues around abortion prior to taking the survey (40% vs. 30%). They were also considerably more likely than men to say they personally knew someone (such as a close friend, family member or themselves) who had had an abortion (66% vs. 51%) – a gender gap that was evident across age groups, political parties and religious groups.

Relatively few Americans view the morality of abortion in stark terms , the March survey found. Overall, just 7% of all U.S. adults say having an abortion is morally acceptable in all cases, and 13% say it is morally wrong in all cases. A third say that having an abortion is morally wrong in most cases, while about a quarter (24%) say it is morally acceptable in most cases. An additional 21% do not consider having an abortion a moral issue.

Among Republicans, most (68%) say that having an abortion is morally wrong either in most (48%) or all cases (20%). Only about three-in-ten Democrats (29%) hold a similar view. Instead, about four-in-ten Democrats say having an abortion is morally  acceptable  in most (32%) or all (11%) cases, while an additional 28% say it is not a moral issue. 

White evangelical Protestants overwhelmingly say having an abortion is morally wrong in most (51%) or all cases (30%). A slim majority of Catholics (53%) also view having an abortion as morally wrong, but many also say it is morally acceptable in most (24%) or all cases (4%), or that it is not a moral issue (17%). Among religiously unaffiliated Americans, about three-quarters see having an abortion as morally acceptable (45%) or not a moral issue (32%).

• Religion & Abortion

What the data says about abortion in the U.S.

Support for legal abortion is widespread in many countries, especially in europe, nearly a year after roe’s demise, americans’ views of abortion access increasingly vary by where they live, by more than two-to-one, americans say medication abortion should be legal in their state, most latinos say democrats care about them and work hard for their vote, far fewer say so of gop, most popular.

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