ethical consideration in research proposal example pdf

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Addressing ethical issues in your research proposal

This article explores the ethical issues that may arise in your proposed study during your doctoral research degree.

What ethical principles apply when planning and conducting research?

Research ethics are the moral principles that govern how researchers conduct their studies (Wellcome Trust, 2014). As there are elements of uncertainty and risk involved in any study, every researcher has to consider how they can uphold these ethical principles and conduct the research in a way that protects the interests and welfare of participants and other stakeholders (such as organisations).  

You will need to consider the ethical issues that might arise in your proposed study. Consideration of the fundamental ethical principles that underpin all research will help you to identify the key issues and how these could be addressed. As you are probably a practitioner who wants to undertake research within your workplace, consider how your role as an ‘insider’ influences how you will conduct your study. Think about the ethical issues that might arise when you become an insider researcher (for example, relating to trust, confidentiality and anonymity).  

What key ethical principles do you think will be important when planning or conducting your research, particularly as an insider? Principles that come to mind might include autonomy, respect, dignity, privacy, informed consent and confidentiality. You may also have identified principles such as competence, integrity, wellbeing, justice and non-discrimination.  

Key ethical issues that you will address as an insider researcher include:

• Gaining trust
• Avoiding coercion when recruiting colleagues or other participants (such as students or service users)
• Practical challenges relating to ensuring the confidentiality and anonymity of organisations and staff or other participants.

(Heslop et al, 2018)

A fuller discussion of ethical principles is available from the British Psychological Society’s Code of Human Research Ethics (BPS, 2021).

You can also refer to guidance from the British Educational Research Association and the British Association for Applied Linguistics .

Ethical principles are essential for protecting the interests of research participants, including maximising the benefits and minimising any risks associated with taking part in a study. These principles describe ethical conduct which reflects the integrity of the researcher, promotes the wellbeing of participants and ensures high-quality research is conducted (Health Research Authority, 2022).  

Research ethics is therefore not simply about gaining ethical approval for your study to be conducted. Research ethics relates to your moral conduct as a doctoral researcher and will apply throughout your study from design to dissemination (British Psychological Society, 2021). When you apply to undertake a doctorate, you will need to clearly indicate in your proposal that you understand these ethical principles and are committed to upholding them.  

Where can I find ethical guidance and resources? 

Professional bodies, learned societies, health and social care authorities, academic publications, Research Ethics Committees and research organisations provide a range of ethical guidance and resources. International codes such as the Universal Declaration of Human Rights underpin ethical frameworks (United Nations, 1948).  

You may be aware of key legislation in your own country or the country where you plan to undertake the research, including laws relating to consent, data protection and decision-making capacity, for example, the Data Protection Act, 2018 (UK).  If you want to find out more about becoming an ethical researcher, check out this Open University short course: Becoming an ethical researcher: Introduction and guidance: What is a badged course? - OpenLearn - Open University  

You should be able to justify the research decisions you make. Utilising these resources will guide your ethical judgements when writing your proposal and ultimately when designing and conducting your research study. The Ethical Guidelines for Educational Research (British Educational Research Association, 2018) identifies the key responsibilities you will have when you conduct your research, including the range of stakeholders that you will have responsibilities to, as follows:   

• to your participants (e.g. to appropriately inform them, facilitate their participation and support them)
• clients, stakeholders and sponsors
• the community of educational or health and social care researchers
• for publication and dissemination
• your wellbeing and development

The National Institute for Health and Care Research (no date) has emphasised the need to promote equality, diversity and inclusion when undertaking research, particularly to address long-standing social and health inequalities. Research should be informed by the diversity of people’s experiences and insights, so that it will lead to the development of practice that addresses genuine need. A commitment to equality, diversity and inclusion aims to eradicate prejudice and discrimination on the basis of an individual or group of individuals' protected characteristics such as sex (gender), disability, race, sexual orientation, in line with the Equality Act 2010.  

The NIHR has produced guidance for enhancing the inclusion of ‘under-served groups’ when designing a research study (2020). Although the guidance refers to clinical research it is relevant to research more broadly.  

You should consider how you will promote equality and diversity in your planned study, including through aspects such as your research topic or question, the methodology you will use, the participants you plan to recruit and how you will analyse and interpret your data.    

What ethical issues do I need to consider when writing my research proposal?

You might be planning to undertake research in a health, social care, educational or other setting, including observations and interviews. The following prompts should help you to identify key ethical issues that you need to bear in mind when undertaking research in such settings.  

1.     Imagine you are a potential participant. Think about the questions and concerns that you might have:

• How would you feel if a researcher sat in your space and took notes, completed a checklist, or made an audio or film recording?
• What harm might a researcher cause by observing or interviewing you and others?
• What would you want to know about the researcher and ask them about the study before giving consent?
• When imagining you are the participant, how could the researcher make you feel more comfortable to be observed or interviewed? 

2.     Having considered the perspective of your potential participant, how would you take account of concerns such as privacy, consent, wellbeing and power in your research proposal?  

[Adapted from OpenLearn course: Becoming an ethical researcher, Week 2 Activity 3: Becoming an ethical researcher - OpenLearn - Open University ]  

The ethical issues to be considered will vary depending on your organisational context/role, the types of participants you plan to recruit (for example, children, adults with mental health problems), the research methods you will use, and the types of data you will collect. You will need to decide how to recruit your participants so you do not inappropriately exclude anyone.  Consider what methods may be necessary to facilitate their voice and how you can obtain their consent to taking part or ensure that consent is obtained from someone else as necessary, for example, a parent in the case of a child. 

You should also think about how to avoid imposing an unnecessary burden or costs on your participants. For example, by minimising the length of time they will have to commit to the study and by providing travel or other expenses. Identify the measures that you will take to store your participants’ data safely and maintain their confidentiality and anonymity when you report your findings. You could do this by storing interview and video recordings in a secure server and anonymising their names and those of their organisations using pseudonyms.  

Professional codes such as the Code of Human Research Ethics (BPS, 2021) provide guidance on undertaking research with children. Being an ‘insider’ researching within your own organisation has advantages. However, you should also consider how this might impact on your research, such as power dynamics, consent, potential bias and any conflict of interest between your professional and researcher roles (Sapiro and Matthews, 2020).  

How have other researchers addressed any ethical challenges?

The literature provides researchers’ accounts explaining how they addressed ethical challenges when undertaking studies. For example, Turcotte-Tremblay and McSween-Cadieux (2018) discuss strategies for protecting participants’ confidentiality when disseminating findings locally, such as undertaking fieldwork in multiple sites and providing findings in a generalised form. In addition, professional guidance includes case studies illustrating how ethical issues can be addressed, including when researching online forums (British Sociological Association, no date).

Watch the videos below and consider what insights the postgraduate researcher and supervisor provide  regarding issues such as being an ‘insider researcher’, power relations, avoiding intrusion, maintaining participant anonymity and complying with research ethics and professional standards. How might their experiences inform the design and conduct of your own study?

Postgraduate researcher and supervisor talk about ethical considerations

Your thoughtful consideration of the ethical issues that might arise and how you would address these should enable you to propose an ethically informed study and conduct it in a responsible, fair and sensitive manner. 

British Educational Research Association (2018)  Ethical Guidelines for Educational Research.  Available at:  https://www.bera.ac.uk/publication/ethical-guidelines-for-educational-research-2018  (Accessed: 9 June 2023).

British Psychological Society (2021)  Code of Human Research Ethics . Available at:  https://cms.bps.org.uk/sites/default/files/2022-06/BPS%20Code%20of%20Human%20Research%20Ethics%20%281%29.pdf  (Accessed: 9 June 2023).

British Sociological Association (2016)  Researching online forums . Available at:  https://www.britsoc.co.uk/media/24834/j000208_researching_online_forums_-cs1-_v3.pdf  (Accessed: 9 June 2023).

Health Research Authority (2022)  UK Policy Framework for Health and Social Care Research . Available at:  https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/uk-policy-framework-health-and-social-care-research/#chiefinvestigators  (Accessed: 9 June 2023).

Heslop, C., Burns, S., Lobo, R. (2018) ‘Managing qualitative research as insider-research in small rural communities’,  Rural and Remote Health , 18: pp. 4576.

Equality Act 2010, c. 15.  Available at:   https://www.legislation.gov.uk/ukpga/2010/15/introduction   (Accessed: 9 June 2023).

National Institute for Health and Care Research (no date)  Equality, Diversity and Inclusion (EDI) . Available at:  https://arc-kss.nihr.ac.uk/public-and-community-involvement/pcie-guide/how-to-do-pcie/equality-diversity-and-inclusion-edi  (Accessed: 9 June 2023).

National Institute for Health and Care Research (2020)  Improving inclusion of under-served groups in clinical research: Guidance from INCLUDE project.  Available at:   https://www.nihr.ac.uk/documents/improving-inclusion-of-under-served-groups-in-clinical-research-guidance-from-include-project/25435  (Accessed: 9 June 2023).

Sapiro, B. and Matthews, E. (2020) ‘Both Insider and Outsider. On Conducting Social Work Research in Mental Health Settings’,  Advances in Social Work , 20(3). Available at:  https://doi.org/10.18060/23926

Turcotte-Tremblay, A. and McSween-Cadieux, E. (2018) ‘A reflection on the challenge of protecting confidentiality of participants when disseminating research results locally’,  BMC Medical Ethics,  19(supplement 1), no. 45. Available at:   https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-018-0279-0

United Nations General Assembly (1948)  The Universal Declaration of Human Rights . Resolution A/RES/217/A. Available at:  https://www.un.org/en/about-us/universal-declaration-of-human-rights#:~:text=Drafted%20by%20representatives%20with%20different,all%20peoples%20and%20all%20nations . (Accessed: 9 June 2023).

Wellcome Trust (2014)  Ensuring your research is ethical: A guide for Extended Project Qualification students . Available at:  https://wellcome.org/sites/default/files/wtp057673_0.pdf  (Accessed: 9 June 2023).

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Ethical Considerations – Types, Examples and Writing Guide

Table of Contents

Ethical Considerations

Ethical considerations in research refer to the principles and guidelines that researchers must follow to ensure that their studies are conducted in an ethical and responsible manner. These considerations are designed to protect the rights, safety, and well-being of research participants, as well as the integrity and credibility of the research itself

Some of the key ethical considerations in research include:

• Informed consent: Researchers must obtain informed consent from study participants, which means they must inform participants about the study’s purpose, procedures, risks, benefits, and their right to withdraw at any time.
• Privacy and confidentiality : Researchers must ensure that participants’ privacy and confidentiality are protected. This means that personal information should be kept confidential and not shared without the participant’s consent.
• Harm reduction : Researchers must ensure that the study does not harm the participants physically or psychologically. They must take steps to minimize the risks associated with the study.
• Fairness and equity : Researchers must ensure that the study does not discriminate against any particular group or individual. They should treat all participants equally and fairly.
• Use of deception: Researchers must use deception only if it is necessary to achieve the study’s objectives. They must inform participants of the deception as soon as possible.
• Use of vulnerable populations : Researchers must be especially cautious when working with vulnerable populations, such as children, pregnant women, prisoners, and individuals with cognitive or intellectual disabilities.
• Conflict of interest : Researchers must disclose any potential conflicts of interest that may affect the study’s integrity. This includes financial or personal relationships that could influence the study’s results.
• Data manipulation: Researchers must not manipulate data to support a particular hypothesis or agenda. They should report the results of the study objectively, even if the findings are not consistent with their expectations.
• Intellectual property: Researchers must respect intellectual property rights and give credit to previous studies and research.
• Cultural sensitivity : Researchers must be sensitive to the cultural norms and beliefs of the participants. They should avoid imposing their values and beliefs on the participants and should be respectful of their cultural practices.

Types of Ethical Considerations

Types of Ethical Considerations are as follows:

Research Ethics:

This includes ethical principles and guidelines that govern research involving human or animal subjects, ensuring that the research is conducted in an ethical and responsible manner.

Business Ethics :

This refers to ethical principles and standards that guide business practices and decision-making, such as transparency, honesty, fairness, and social responsibility.

Medical Ethics :

This refers to ethical principles and standards that govern the practice of medicine, including the duty to protect patient autonomy, informed consent, confidentiality, and non-maleficence.

Environmental Ethics :

This involves ethical principles and values that guide our interactions with the natural world, including the obligation to protect the environment, minimize harm, and promote sustainability.

Legal Ethics

This involves ethical principles and standards that guide the conduct of legal professionals, including issues such as confidentiality, conflicts of interest, and professional competence.

Social Ethics

This involves ethical principles and values that guide our interactions with other individuals and society as a whole, including issues such as justice, fairness, and human rights.

Information Ethics

This involves ethical principles and values that govern the use and dissemination of information, including issues such as privacy, accuracy, and intellectual property.

Cultural Ethics

This involves ethical principles and values that govern the relationship between different cultures and communities, including issues such as respect for diversity, cultural sensitivity, and inclusivity.

Technological Ethics

This refers to ethical principles and guidelines that govern the development, use, and impact of technology, including issues such as privacy, security, and social responsibility.

Journalism Ethics

This involves ethical principles and standards that guide the practice of journalism, including issues such as accuracy, fairness, and the public interest.

Educational Ethics

This refers to ethical principles and standards that guide the practice of education, including issues such as academic integrity, fairness, and respect for diversity.

Political Ethics

This involves ethical principles and values that guide political decision-making and behavior, including issues such as accountability, transparency, and the protection of civil liberties.

Professional Ethics

This refers to ethical principles and standards that guide the conduct of professionals in various fields, including issues such as honesty, integrity, and competence.

Personal Ethics

This involves ethical principles and values that guide individual behavior and decision-making, including issues such as personal responsibility, honesty, and respect for others.

Global Ethics

This involves ethical principles and values that guide our interactions with other nations and the global community, including issues such as human rights, environmental protection, and social justice.

Applications of Ethical Considerations

Ethical considerations are important in many areas of society, including medicine, business, law, and technology. Here are some specific applications of ethical considerations:

• Medical research : Ethical considerations are crucial in medical research, particularly when human subjects are involved. Researchers must ensure that their studies are conducted in a way that does not harm participants and that participants give informed consent before participating.
• Business practices: Ethical considerations are also important in business, where companies must make decisions that are socially responsible and avoid activities that are harmful to society. For example, companies must ensure that their products are safe for consumers and that they do not engage in exploitative labor practices.
• Environmental protection: Ethical considerations play a crucial role in environmental protection, as companies and governments must weigh the benefits of economic development against the potential harm to the environment. Decisions about land use, resource allocation, and pollution must be made in an ethical manner that takes into account the long-term consequences for the planet and future generations.
• Technology development : As technology continues to advance rapidly, ethical considerations become increasingly important in areas such as artificial intelligence, robotics, and genetic engineering. Developers must ensure that their creations do not harm humans or the environment and that they are developed in a way that is fair and equitable.
• Legal system : The legal system relies on ethical considerations to ensure that justice is served and that individuals are treated fairly. Lawyers and judges must abide by ethical standards to maintain the integrity of the legal system and to protect the rights of all individuals involved.

Examples of Ethical Considerations

Here are a few examples of ethical considerations in different contexts:

• In healthcare : A doctor must ensure that they provide the best possible care to their patients and avoid causing them harm. They must respect the autonomy of their patients, and obtain informed consent before administering any treatment or procedure. They must also ensure that they maintain patient confidentiality and avoid any conflicts of interest.
• In the workplace: An employer must ensure that they treat their employees fairly and with respect, provide them with a safe working environment, and pay them a fair wage. They must also avoid any discrimination based on race, gender, religion, or any other characteristic protected by law.
• In the media : Journalists must ensure that they report the news accurately and without bias. They must respect the privacy of individuals and avoid causing harm or distress. They must also be transparent about their sources and avoid any conflicts of interest.
• In research: Researchers must ensure that they conduct their studies ethically and with integrity. They must obtain informed consent from participants, protect their privacy, and avoid any harm or discomfort. They must also ensure that their findings are reported accurately and without bias.
• In personal relationships : People must ensure that they treat others with respect and kindness, and avoid causing harm or distress. They must respect the autonomy of others and avoid any actions that would be considered unethical, such as lying or cheating. They must also respect the confidentiality of others and maintain their privacy.

How to Write Ethical Considerations

When writing about research involving human subjects or animals, it is essential to include ethical considerations to ensure that the study is conducted in a manner that is morally responsible and in accordance with professional standards. Here are some steps to help you write ethical considerations:

• Describe the ethical principles: Start by explaining the ethical principles that will guide the research. These could include principles such as respect for persons, beneficence, and justice.
• Discuss informed consent : Informed consent is a critical ethical consideration when conducting research. Explain how you will obtain informed consent from participants, including how you will explain the purpose of the study, potential risks and benefits, and how you will protect their privacy.
• Address confidentiality : Describe how you will protect the confidentiality of the participants’ personal information and data, including any measures you will take to ensure that the data is kept secure and confidential.
• Consider potential risks and benefits : Describe any potential risks or harms to participants that could result from the study and how you will minimize those risks. Also, discuss the potential benefits of the study, both to the participants and to society.
• Discuss the use of animals : If the research involves the use of animals, address the ethical considerations related to animal welfare. Explain how you will minimize any potential harm to the animals and ensure that they are treated ethically.
• Mention the ethical approval : Finally, it’s essential to acknowledge that the research has received ethical approval from the relevant institutional review board or ethics committee. State the name of the committee, the date of approval, and any specific conditions or requirements that were imposed.

When to Write Ethical Considerations

Ethical considerations should be written whenever research involves human subjects or has the potential to impact human beings, animals, or the environment in some way. Ethical considerations are also important when research involves sensitive topics, such as mental health, sexuality, or religion.

In general, ethical considerations should be an integral part of any research project, regardless of the field or subject matter. This means that they should be considered at every stage of the research process, from the initial planning and design phase to data collection, analysis, and dissemination.

Ethical considerations should also be written in accordance with the guidelines and standards set by the relevant regulatory bodies and professional associations. These guidelines may vary depending on the discipline, so it is important to be familiar with the specific requirements of your field.

Purpose of Ethical Considerations

Ethical considerations are an essential aspect of many areas of life, including business, healthcare, research, and social interactions. The primary purposes of ethical considerations are:

• Protection of human rights: Ethical considerations help ensure that people’s rights are respected and protected. This includes respecting their autonomy, ensuring their privacy is respected, and ensuring that they are not subjected to harm or exploitation.
• Promoting fairness and justice: Ethical considerations help ensure that people are treated fairly and justly, without discrimination or bias. This includes ensuring that everyone has equal access to resources and opportunities, and that decisions are made based on merit rather than personal biases or prejudices.
• Promoting honesty and transparency : Ethical considerations help ensure that people are truthful and transparent in their actions and decisions. This includes being open and honest about conflicts of interest, disclosing potential risks, and communicating clearly with others.
• Maintaining public trust: Ethical considerations help maintain public trust in institutions and individuals. This is important for building and maintaining relationships with customers, patients, colleagues, and other stakeholders.
• Ensuring responsible conduct: Ethical considerations help ensure that people act responsibly and are accountable for their actions. This includes adhering to professional standards and codes of conduct, following laws and regulations, and avoiding behaviors that could harm others or damage the environment.

Advantages of Ethical Considerations

Here are some of the advantages of ethical considerations:

• Builds Trust : When individuals or organizations follow ethical considerations, it creates a sense of trust among stakeholders, including customers, clients, and employees. This trust can lead to stronger relationships and long-term loyalty.
• Reputation and Brand Image : Ethical considerations are often linked to a company’s brand image and reputation. By following ethical practices, a company can establish a positive image and reputation that can enhance its brand value.
• Avoids Legal Issues: Ethical considerations can help individuals and organizations avoid legal issues and penalties. By adhering to ethical principles, companies can reduce the risk of facing lawsuits, regulatory investigations, and fines.
• Increases Employee Retention and Motivation: Employees tend to be more satisfied and motivated when they work for an organization that values ethics. Companies that prioritize ethical considerations tend to have higher employee retention rates, leading to lower recruitment costs.
• Enhances Decision-making: Ethical considerations help individuals and organizations make better decisions. By considering the ethical implications of their actions, decision-makers can evaluate the potential consequences and choose the best course of action.
• Positive Impact on Society: Ethical considerations have a positive impact on society as a whole. By following ethical practices, companies can contribute to social and environmental causes, leading to a more sustainable and equitable society.

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• Ethical Considerations in Research | Types & Examples

Ethical Considerations in Research | Types & Examples

Published on 7 May 2022 by Pritha Bhandari .

Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.

The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviours, and improving lives in other ways. What you decide to research and how you conduct that research involve key ethical considerations.

These considerations work to:

• Protect the rights of research participants
• Enhance research validity
• Maintain scientific integrity

Table of contents

Why do research ethics matter, getting ethical approval for your study, types of ethical issues, voluntary participation, informed consent, confidentiality, potential for harm, results communication, examples of ethical failures, frequently asked questions about research ethics.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe for research subjects.

You’ll balance pursuing important research aims with using ethical research methods and procedures. It’s always necessary to prevent permanent or excessive harm to participants, whether inadvertent or not.

Defying research ethics will also lower the credibility of your research because it’s hard for others to trust your data if your methods are morally questionable.

Even if a research idea is valuable to society, it doesn’t justify violating the human rights or dignity of your study participants.

Prevent plagiarism, run a free check.

Before you start any study involving data collection with people, you’ll submit your research proposal to an institutional review board (IRB) .

An IRB is a committee that checks whether your research aims and research design are ethically acceptable and follow your institution’s code of conduct. They check that your research materials and procedures are up to code.

If successful, you’ll receive IRB approval, and you can begin collecting data according to the approved procedures. If you want to make any changes to your procedures or materials, you’ll need to submit a modification application to the IRB for approval.

If unsuccessful, you may be asked to re-submit with modifications or your research proposal may receive a rejection. To get IRB approval, it’s important to explicitly note how you’ll tackle each of the ethical issues that may arise in your study.

There are several ethical issues you should always pay attention to in your research design, and these issues can overlap with each other.

You’ll usually outline ways you’ll deal with each issue in your research proposal if you plan to collect data from participants.

Voluntary participation means that all research subjects are free to choose to participate without any pressure or coercion.

All participants are able to withdraw from, or leave, the study at any point without feeling an obligation to continue. Your participants don’t need to provide a reason for leaving the study.

It’s important to make it clear to participants that there are no negative consequences or repercussions to their refusal to participate. After all, they’re taking the time to help you in the research process, so you should respect their decisions without trying to change their minds.

Voluntary participation is an ethical principle protected by international law and many scientific codes of conduct.

Take special care to ensure there’s no pressure on participants when you’re working with vulnerable groups of people who may find it hard to stop the study even when they want to.

Informed consent refers to a situation in which all potential participants receive and understand all the information they need to decide whether they want to participate. This includes information about the study’s benefits, risks, funding, and institutional approval.

• What the study is about
• The risks and benefits of taking part
• How long the study will take
• Your supervisor’s contact information and the institution’s approval number

Usually, you’ll provide participants with a text for them to read and ask them if they have any questions. If they agree to participate, they can sign or initial the consent form. Note that this may not be sufficient for informed consent when you work with particularly vulnerable groups of people.

If you’re collecting data from people with low literacy, make sure to verbally explain the consent form to them before they agree to participate.

For participants with very limited English proficiency, you should always translate the study materials or work with an interpreter so they have all the information in their first language.

In research with children, you’ll often need informed permission for their participation from their parents or guardians. Although children cannot give informed consent, it’s best to also ask for their assent (agreement) to participate, depending on their age and maturity level.

Anonymity means that you don’t know who the participants are and you can’t link any individual participant to their data.

You can only guarantee anonymity by not collecting any personally identifying information – for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, and videos.

In many cases, it may be impossible to truly anonymise data collection. For example, data collected in person or by phone cannot be considered fully anonymous because some personal identifiers (demographic information or phone numbers) are impossible to hide.

You’ll also need to collect some identifying information if you give your participants the option to withdraw their data at a later stage.

Data pseudonymisation is an alternative method where you replace identifying information about participants with pseudonymous, or fake, identifiers. The data can still be linked to participants, but it’s harder to do so because you separate personal information from the study data.

Confidentiality means that you know who the participants are, but you remove all identifying information from your report.

All participants have a right to privacy, so you should protect their personal data for as long as you store or use it. Even when you can’t collect data anonymously, you should secure confidentiality whenever you can.

Some research designs aren’t conducive to confidentiality, but it’s important to make all attempts and inform participants of the risks involved.

As a researcher, you have to consider all possible sources of harm to participants. Harm can come in many different forms.

• Psychological harm: Sensitive questions or tasks may trigger negative emotions such as shame or anxiety.
• Social harm: Participation can involve social risks, public embarrassment, or stigma.
• Physical harm: Pain or injury can result from the study procedures.
• Legal harm: Reporting sensitive data could lead to legal risks or a breach of privacy.

It’s best to consider every possible source of harm in your study, as well as concrete ways to mitigate them. Involve your supervisor to discuss steps for harm reduction.

Make sure to disclose all possible risks of harm to participants before the study to get informed consent. If there is a risk of harm, prepare to provide participants with resources, counselling, or medical services if needed.

Some of these questions may bring up negative emotions, so you inform participants about the sensitive nature of the survey and assure them that their responses will be confidential.

The way you communicate your research results can sometimes involve ethical issues. Good science communication is honest, reliable, and credible. It’s best to make your results as transparent as possible.

Take steps to actively avoid plagiarism and research misconduct wherever possible.

Plagiarism means submitting others’ works as your own. Although it can be unintentional, copying someone else’s work without proper credit amounts to stealing. It’s an ethical problem in research communication because you may benefit by harming other researchers.

Self-plagiarism is when you republish or re-submit parts of your own papers or reports without properly citing your original work.

This is problematic because you may benefit from presenting your ideas as new and original even though they’ve already been published elsewhere in the past. You may also be infringing on your previous publisher’s copyright, violating an ethical code, or wasting time and resources by doing so.

In extreme cases of self-plagiarism, entire datasets or papers are sometimes duplicated. These are major ethical violations because they can skew research findings if taken as original data.

You notice that two published studies have similar characteristics even though they are from different years. Their sample sizes, locations, treatments, and results are highly similar, and the studies share one author in common.

Research misconduct

Research misconduct means making up or falsifying data, manipulating data analyses, or misrepresenting results in research reports. It’s a form of academic fraud.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement about data analyses.

Research misconduct is a serious ethical issue because it can undermine scientific integrity and institutional credibility. It leads to a waste of funding and resources that could have been used for alternative research.

Later investigations revealed that they fabricated and manipulated their data to show a nonexistent link between vaccines and autism. Wakefield also neglected to disclose important conflicts of interest, and his medical license was taken away.

This fraudulent work sparked vaccine hesitancy among parents and caregivers. The rate of MMR vaccinations in children fell sharply, and measles outbreaks became more common due to a lack of herd immunity.

Research scandals with ethical failures are littered throughout history, but some took place not that long ago.

Some scientists in positions of power have historically mistreated or even abused research participants to investigate research problems at any cost. These participants were prisoners, under their care, or otherwise trusted them to treat them with dignity.

To demonstrate the importance of research ethics, we’ll briefly review two research studies that violated human rights in modern history.

These experiments were inhumane and resulted in trauma, permanent disabilities, or death in many cases.

After some Nazi doctors were put on trial for their crimes, the Nuremberg Code of research ethics for human experimentation was developed in 1947 to establish a new standard for human experimentation in medical research.

In reality, the actual goal was to study the effects of the disease when left untreated, and the researchers never informed participants about their diagnoses or the research aims.

Although participants experienced severe health problems, including blindness and other complications, the researchers only pretended to provide medical care.

When treatment became possible in 1943, 11 years after the study began, none of the participants were offered it, despite their health conditions and high risk of death.

Ethical failures like these resulted in severe harm to participants, wasted resources, and lower trust in science and scientists. This is why all research institutions have strict ethical guidelines for performing research.

Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

Scientists and researchers must always adhere to a certain code of conduct when collecting data from others .

These considerations protect the rights of research participants, enhance research validity , and maintain scientific integrity.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe.

Anonymity means you don’t know who the participants are, while confidentiality means you know who they are but remove identifying information from your research report. Both are important ethical considerations .

You can only guarantee anonymity by not collecting any personally identifying information – for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, or videos.

You can keep data confidential by using aggregate information in your research report, so that you only refer to groups of participants rather than individuals.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement but a serious ethical failure.

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Ethical considerations in malaria research proposal review: empirical evidence from 114 proposals submitted to an Ethics Committee in Thailand

Pornpimon adams.

Office of Research Services, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand

Sukanya Prakobtham

Chanthima limphattharacharoen, pitchapa vutikes, srisin khusmith.

Department of Microbiology and Immunology, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand

Krisana Pengsaa

Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand

Polrat Wilairatana

Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand

Jaranit Kaewkungwal

Department of Tropical Hygiene, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand

Malaria research is typically conducted in developing countries in areas of endemic disease. This raises specific ethical issues, including those related to local cultural concepts of health and disease, the educational background of study subjects, and principles of justice at the community and country level. Research Ethics Committees (RECs) are responsible for regulating the ethical conduct of research, but questions have been raised whether RECs facilitate or impede research, and about the quality of REC review itself. This study examines the review process for malaria research proposals submitted to the Ethics Committee of the Faculty of Tropical Medicine at Mahidol University, Thailand.

Proposals for all studies submitted for review from January 2010 to December 2014 were included. Individual REC members’ reviewing forms were evaluated. Ethical issues (e.g., scientific merit, risk–benefit, sample size, or informed-consent) raised in the forms were counted and analysed according to characteristics, including study classification/design, use of specimens, study site, and study population.

All 114 proposals submitted during the study period were analysed, comprising biomedical studies (17 %), drug trials (13 %), laboratory studies (24 %) and epidemiological studies (46 %). They included multi-site (13 %) and international studies (4 %), and those involving minority populations (28 %), children (17 %) and pregnant women (7 %). Drug trials had the highest proportion of questions raised for most ethical issues, while issues concerning privacy and confidentiality tended to be highest for laboratory and epidemiology studies. Clarifications on ethical issues were requested by the ethics committee more for proposals involving new specimen collection. Studies involving stored data and specimens tended to attract more issues around privacy and confidentiality. Proposals involving minority populations were more likely to raise issues than those that did not. Those involving vulnerable populations were more likely to attract concerns related to study rationale and design.

Conclusions

This study stratified ethical issues raised in a broad spectrum of research proposals. The Faculty of Tropical Medicine at Mahidol University is a significant contributor to global malaria research output. The findings shed light on the ethical review process that may be useful for stakeholders, including researchers, RECs and sponsors, conducting malaria research in other endemic settings.

Malaria research is predominantly conducted in developing countries, corresponding to endemic areas of the disease. Over the past few decades, there have been ongoing concerns and arguments on research ethics. These issues are related to the over- or under-protection of human subjects in drug and vaccine clinical trials, as well as non-clinical studies carried out in disease burden areas [ 1 – 6 ]. Concerns raised include the balance between ethics and science, patient risks and benefits, individuals’ educational background and local concepts of health and disease, ethical justice principles at the community and country level, and even arguments around the Hippocratic dictum ‘ primum non nocere’ [ 1 , 2 , 5 ]. Regarding research ethics in developing countries, it is a reasonable notion that regardless of where the research is conducted, not only should the quality be the same, but also that study participants are equally valued and respected [ 7 ]. Despite the generic ethical principles that can be applied to healthcare-related research, there has been debate about the application of such principles in different research settings because socio-cultural and economic contexts vary considerably around the world [ 2 , 7 ].

In attempting to prohibit malpractice of human experiments in the medical community, the “Declaration of Helsinki” was initially adopted in 1964 and has undergone several revisions since. The Declaration introduced the concept of an independent committee; it stated explicitly that the research protocol must be submitted to the concerned research ethics committee for consideration, comment, guidance, and approval before the study begins [ 8 ]. The research ethics committee (REC) must be qualified, independent, and have no conflict of interest when reviewing the research protocol. This evolved into the term “institutional review board” (IRB) used in the US. The IRB concept was established after the U.S. National Research Act (1974), and the Belmont Report (1979), stating its purpose to protect human subjects involved in both clinical and behavioural research [ 9 ]. The IRB Guidebook [ 10 ] was developed by the US Office for Human Research Protections (OHRP) and is one of the resources that ethics committees across the globe adopt for their own operations. It includes issues of IRB administration, regulation and policies, protocol review mechanisms and other ethical principles. Similarly, the European Union Clinical Trials Directive regards the research ethics committee as an independent body with responsibility to protect the rights, safety, and well-being of human subjects involved in a research study [ 11 ]. The terms IRB and REC are often used interchangeably, but arguably have somewhat different meanings; according to the ICH Guideline [ 12 ]: IRB could be a subsection of REC (a review board or a committee, institutional, regional, national, or supranational), but the IRB or REC plays a major role in regulating the ethical conduct of research by reviewing research proposals before the research is carried out. While judging whether the proposal is worthwhile and ethical, part of the committee’s role may also be to provide constructive recommendations to researchers in an attempt to maintain high-quality, ethical research [ 8 , 10 – 12 ].

With its role in ethical review of research proposals, questions have been raised about whether the REC is facilitating or impeding the advancement of scientific research, and there have been comments from researchers regarding the quality of the REC review itself [ 13 ]. Some investigators in international or multicentre studies have complained of substantial inefficiencies in REC review, and have requested that RECs pay more attention to scientific integrity alongside the protection of human subjects involved in the study [ 14 ]. Investigators have also raised concerns that REC review burdens have grown to include studies involving interviews, secondary use of public-use data and similar activities, most of which involve minimal risks [ 9 ]. Criticism has also been raised regarding the REC requirement for paperwork and mechanical monitoring, which may undermine the main goal of the protection of human subjects [ 9 ]. With the emergence of new fields in biomedical research and technology, particularly in genetics and genomics, a range of views exist within and between RECs and the research groups in these evolving fields [ 15 ]. This reflects the complexity and diversity and lack of common ground surrounding many ethical issues related to this type of research [ 15 , 16 ].

In assessing ethical quality in protocol review—particularly the oversight of human subject research—RECs and other stakeholders, including sponsors, regulators and the public, need to have evidence-based information [ 17 , 18 ]. Several proxy indicators of ethical quality assessment have been proposed. Some suggest using measurement parameters and/or quality metrics including objective and subjective quality assessment, which can be used to improve REC review and deliberation processes, and strengthen relationships between the REC and researchers [ 13 , 19 ]. It has been suggested that ethnographic studies on REC meetings and minutes could help identify the critical ethical issues that the REC considers when reviewing proposals, thus determining whether ethical principles have been thoroughly considered [ 14 ].

An analysis of malaria publication data (2010–2014) in the SciVal database, to which Mahidol University subscribes, found that Mahidol University (Thailand) ranked #4 (with 450 papers) for number of research studies. Of these, the Faculty of Tropical Medicine, Mahidol University contributed 87 % (with 391 papers), correlating to a ranking of #6 if counted as an independent institute. To promote the conduct of research at FTM, the Office of Research Services (ORS) provides administrative services to the faculty’s research community. One of its major functions is as the Secretariat to the FTM Ethics Committee (FTM-EC), managing the operations of Ethics Committee meetings. The FTM-EC has been continuously registered with the Federal-wide Assurance (FWA) of the US OHRP since 2002. The FTM-EC comprises one clinical and one non-clinical panel, which convene at monthly meetings.

Given the level of malaria research output and ethics committee activity at the FTM, it is an ideal location to examine the REC review process for malaria research. Therefore, this study attempts to reveal how malaria research studies conducted in Southeast Asia (along the Thai borders) were reviewed by the local REC, the FTM-EC. In particular, the purpose of this study was to identify the ethical considerations for different types of malaria research proposals submitted to the FTM-EC during the period 2010–2014.

Dimensions of ethical consideration

In reviewing research proposals, REC members should base their judgment on international standards of ethical concerns pertaining to moral values including dignity, bodily integrity, autonomy, and privacy. Such ethical concerns are listed in several guidelines for REC review, and although they might be expressed differently in varying circumstances, similar principles are often cited [ 11 , 20 – 24 ]. The World Health Organization (WHO) [ 22 ] states in its standards for ethical review that the approval or disapproval of the protocol should be based on the ethical acceptability of the research while accounting for its social value, scientific validity, and applicable laws. As stated in the guidelines of the Council for International Organizations of Medical Sciences (CIOMS) [ 21 ], all research involving human subjects should be in accordance with the moral weight of the three basic ethical principles: respect for persons, beneficence, and justice. The European guidelines [ 11 ] suggest four main components of a research ethics committee: dignity, bodily integrity, autonomy, and privacy. The European Commission [ 23 ] even suggests that researchers pre-check their proposal to ensure that it follows the principles of human dignity, fair distribution of research benefits and burden, and protection of the values, rights, and interests of the research participants. The UK Health Department [ 24 ] provides guidance in governance arrangements for RECs in reviewing research proposals to act as part of an efficient, accountable, and independent body in protecting the dignity, rights, safety, and well-being of people who take part in research. The US IRB Guideline on basic IRB review [ 25 ] discusses issues of human subject research, in particular for risk–benefit analysis, monitoring and observation, informed consent and additional safeguards, selection of subjects, incentives for participation, and privacy and confidentiality.

Ethics is not about prescribing a specific set of rules or policies, rather it is about providing a framework for evaluating problems and determining an appropriate course of action [ 26 ]. According to the WHO manual for capacity training for RECs [ 26 ], the ethical analysis is to identify a set of governing principles reflecting both internationally accepted norms and locally relevant cultural values, and then apply such principles to evaluate the research. Several frameworks for ethical research conducted in developing countries have been proposed, focusing on collaborative partnerships and sharing responsibilities with researchers, policy-makers and the community [ 2 , 21 , 26 , 27 ]. The framework should be based on the notation set forth in the Declaration of Helsinki so that ethical principles could be effectively identified and applied, particularly in developing countries in regards to each country’s socioeconomic circumstances, laws and regulations, and executive and administrative arrangements [ 21 ]. Proposed basic ethical principles include: (1) considering social value by specifying the beneficiaries of the research, (2) ensuring scientific validity through the scientific design and research objectives, (3) fair study population selection to ensure scientific validity, (4) assessment of the risk–benefit ratio by comparing the net risks of the research project with the potential benefits, (5) ensuring public accountability through independent reviews mandated by laws and regulations, (6) ensuring informed consent while involving the community in establishing recruitment procedures and incentives, and (7) respecting study participants and communities [ 2 , 26 , 27 ].

In particular, ethical issues that should be considered as part of malaria field studies in developing countries have been discussed as lessons learned in a community-based clinical trial of rectal artesunate conducted in a few developing countries [ 28 ]. Issues to consider include the ethical review process, standard of care, incentives and reimbursement, and insurance and indemnity. It has also been suggested that local ethical review should consider the vulnerability of patients with no or poor access to healthcare, specific cultural attitudes, literacy, and both local written and oral languages [ 28 ]. A study on convergent ethical issues in HIV/AIDS, TB, and malaria vaccine trials in Africa revealed that sharing simple and effective consent form templates and procedures across diseases was achievable [ 29 ]. Comprehension testing of subjects prior to and during study participation, to ensure understanding of the important study concepts, has also been proposed [ 28 ]. Moreover, it has been suggested that the REC should also examine the suitability of the investigators and the adequacy of facilities and the methods and documentation to be used in the study [ 11 ].

At the FTM-EC, individual REC members are provided with a review form prior to every convened meeting. The review form outlines certain ethical issues similar to those described above. Each member uses this form as a guide to ethical issues to consider when reading the proposal. They then complete each part that he/she considers relevant and requires explanations from the researchers. The form also has an open-ended component, where the REC can note other ethical considerations. The review form used during the study period (currently the form has been revised) guiding the REC members in reviewing each protocol was composed of 19 check boxes for close-ended items on being a human research subject study: types of study (clinical, epidemiological, social science, or behavioural); reasonable scientific questions/objectives; proper sampling techniques/data collection methods; quality of investigators/facilities; project budget; compensation; justification of the involvement of vulnerable populations; rationale for use of human specimen; adequate toxicological/pharmaceutical information; sufficient provision of information and proper informed consent process and forms; rating on level of risk and benefit of the study; and the overall ethical acceptability of the proposal. The review form also consists of 9 open-ended comment items regarding project summary (to be filled in by two primary reviewers) and other ethical issues (to be filled by all REC members) including major points of concern, levels of risk, comments on the title, proposal content (objectives, research methodology, protection of privacy and confidentiality), participation information sheet, informed consent/assent form, questionnaire/advertisement/case record form, attached document (investigator’s brochure, material transfer, etc.), and other comments/suggestions. For the purpose of this study, the ethical issues were divided into six dimensions, as follows: (1) study rationale and validity; (2) study design; (3) study participants; (4) informed consent process; (5) data collection and analysis; and (6) facility and support. Each dimension thus covers its related ethical considerations in the review form (as presented in the “ Results ” section).

Classification of malaria research studies

Research protocols reviewed by RECs can be categorized according to different schemes [ 22 , 30 , 31 ]. The European Science Foundation [ 31 ] reviews health research classification systems in different countries across continents. The UK Health Research Classification System (HRCS) for classifying and analyzing biomedical and health research funding applies a two-dimensional framework. Codes on health categories are used to classify the type of health or disease being studied, covering 21 categories encompassing all diseases, conditions and areas of health. Research activity codes are used to classify the type of research activity being undertaken (from basic to applied), covering 48 codes of eight subgroups: (1) Underpinning, (2) Aetiology, (3) Prevention, (4) Detection and Diagnosis, (5) Treatment Development, (6) Treatment Evaluation, (7) Disease Management, and (8) Health Services. The Australian and New Zealand research classification scheme has been developed and updated over the years. The three constituent classifications in use are: (1) Type of Activity (ToA)—pure basic research, strategic basic research, applied research and experimental development; (2) Field of Research (FoR)—methodology used in research and development (R&D) fields of the research investigated by institutions and organizations as well as emerging areas of study; and (3) Socio-economic objective (SEO) consisting of discrete economic, social, technological or scientific domains for identifying the principal purposes of R&D.

On the other hand, the WHO [ 22 ] simply classifies different types of research studies to be reviewed by RECs, including, but not limited to, the following: (1) clinical trials, (2) epidemiological research, (3) social science research, (4) research on medical records or other personal information, (5) research on stored samples, (6) health systems research, and (7) implementation research. The US Office for Human Research Protections [ 30 ] categorized research reviewed by IRBs as either biomedical or behavioural studies. Biomedical research covers two types of studies: (1) those designed primarily to generate scientific knowledge about the natural history of the disease and normal or abnormal physiology, and (2) studies designed primarily to evaluate the development of medical products and the efficacy, effectiveness, efficiency and safety of a medical intervention. Behavioural research includes studies of the epidemiology and social science of individual or group behaviour. As part of the biomedical research study, clinical trials, which often originate in the laboratory to develop new therapies or procedures, are tested in animal studies, then subsequently on human subjects [ 32 ]. The US National Institutes of Health (NIH) distinguishes between different types of clinical trials including, for example, natural history studies, prevention, screening, diagnostic, treatment, or quality of life trials [ 32 ]. Biomedical research can be sub-classified as basic/pre-clinical research or clinical research [ 33 ].

Many RECs face challenges in the protocol review of studies in the fields of molecular and genetic or genomic research. Lack of clarity on how researchers should respond to RECs has been reported, particularly concerning issues of informed consent and the use of archived specimens [ 20 , 34 ]. Confusion and debate remains within and across RECs around studies involving the collection and use of non-identifiable stored tissue specimens. There is disharmony among regulatory requirements in different countries and REC bodies within countries, but there is a growing international agreement on the provision and access to research data and bio-specimen collections in order to optimize their long-term value and potential for health discovery and validation [ 35 – 37 ]. The UK Medical Research Council [ 35 ] proposed operational and ethical guidelines for the use of human tissue and biological samples, such that samples of human biological material should be treated as donations, and research involving these should be conducted with respect and transparency. The research study should be planned with respect to the trust of the potential donors with individual, cultural, or religious differences in the meaning and significance attached to samples for use.

With contradictory legal and ethical frameworks across national borders, there has been an attempt to set up an international charter of principles for sharing bio-specimens and data [ 36 ]. The following five principles include major ethical considerations: (1) respect for privacy and autonomy, (2) reciprocity, (3) freedom of scientific enquiry, (4) attribution, and (5) respect for intellectual property. In the US, the Food and Drug Administration has set rules and regulations regarding the use of identifiable and unidentifiable specimens for clinical investigators, sponsors, and RECs. The US Health Insurance Portability and Accountability Act privacy rule has set less restrictive rules for the use of stored specimens and tissue repositories (such as biobanks), when released data have been de-identified [ 20 ]. The UK Medical Research Council [ 35 ] emphasizes custodianship as the responsibility of researchers for safe keeping of samples and control of their use and eventual disposal, defining “anonymized samples or data” where all identifying information is removed, either as linked or unlinked anonymous data and samples; and “coded samples or data” where a code is used in place of identifiers to protect the confidentiality of the individual during routine use. The American Society of Human Genetics distinguishes between retrospective and prospective studies, such that the “retrospective research studies” utilise previously obtained samples collected for a purpose that is different from that of the current proposal and the “prospective research studies” are those in which the collection of the new samples is part of the current study design [ 37 ]. Similarly, four types of sample identification were defined: (1) anonymous, no identifiers and impossible to link with their sources, (2) anonymised, originally with identified information but irreversibly stripped off and are impossible to link to their sources, (3) identifiable, unidentified for the current research purposes, but can be linked to their sources, and (4) identified, with identifiers and are attached and available to the researchers [ 37 ]. In Thailand, however, the use of specimens or medical records, either identifiable or unidentifiable, is considered to be human subject research. Studies involving such material commonly require REC review, either full-board or expedited, and very few receive exemption.

The two panels of the FTM-EC comprise different sets of members. The “clinical panel” reviews clinical research studies involving the application of any clinical interventions in human research subjects, while the “non-clinical panel” reviews other types of biomedical study, including research conducted in clinical settings but where no clinical intervention was applied, epidemiological studies, and studies that use stored specimen or secondary data. Malaria study proposals submitted to the FTM-EC fall into either of the categories and are reviewed by the relevant panel. Because these two broad categories of research might be subject to different constraint levels of ethical consideration, reviewed studies were classified for the purposes of this study in two ways. For classification based on research study design, there are four categories: (1) clinical (drug) trials; (2) biomedical studies; (3) laboratory studies, and (4) epidemiological/social science studies. For classification based on the use and non-use of specimens, there are four categories: (1) new specimen collection; (2) use of archived un-identifiable/un-linked specimens; (3) use of archived/identifiable/linked specimens; and (4) use of medical records and new data collection.

Sources of information and statistical analysis

This study adopts the process of internal audits on quality systems of independent ethics committees in Europe [ 38 ], by conducting documentation reviews. The reviewed documentation included minutes of meetings and agendas, each individual REC member’s reviewing form, and the notifications to researchers informing them of the review outcome for the submitted proposal. This study was conducted by the office managing the submitted proposals and the REC members at the FTM-EC. Information was extracted by personnel authorized to access these documents. To avoid bias, three office employees (non-voting members of the FTM-EC), were assigned to identify the main ethical considerations noted by each REC member on his/her review form, while cross-checking with each other. Ethical considerations raised were counted quantitatively whether the ethical issues (e.g. scientific merit, risk and benefit, sample size, or informed-consent process) were noted/discussed, both in the pre-specified and open-ended items, on each individual REC member’s review form as well as all other documents related to the submitted proposal. It should be noted that for the open-ended items, very little subjective judgment was required by the person extracting the data, because most of the major ethical issues raised by the reviewers could be obviously categorized. All proposals related to malaria research submitted to FTM-EC over a period of 5 years, from January 2010 to December 2014, were reviewed. Analyses of ethical considerations were presented according to study classification, study design and specimen uses; Chi square tests were performed on each ethical issue separately. In addition, analyses were performed according to study location (multi-site, international, approval together with other REC study) and study population (minority or vulnerable population involved). To further investigate the relationship between ethical considerations and different study types, additional statistical analyses were performed using simple crude odds ratios (ORs). Logistic regression was performed for each ethical issue by different type of study separately.

Types of malaria research studies

During the study period, 114 research proposals on different malaria species were submitted to the FTM-EC for review. These comprised 19 (17 %) biomedical studies, 15 (13 %) drug trials, 28 (24 %) laboratory studies and 52 (46 %) epidemiological/social science studies. Drug trials adopted atypical phase classification of the drug development process including 12 studies on investigational new drug ranging from Phase I to Phase III, and 3 Phase IV drug safety studies. No malaria vaccine trial proposals were submitted to the FTM-EC during the study period. Biomedical studies included eight studies comparing different malaria treatments/regimens and/or with different indications in clinical settings, and 11 bioequivalence or pharmacokinetic studies. Laboratory studies covered pure basic science and genetic studies. Epidemiology/social science studies included retrospective study using medical records and social/behavioural research. Approximately one-third of studies required FTM-EC approval together with that of other RECs, within Thailand and/or internationally. Approximately 13 % were multi-site and 4 % were international studies. Most malaria studies were conducted at malaria-endemic areas along the Thai borders; therefore, 28 % involved minority (hill tribe and cross-border) populations. Seventeen percent involved children and 7 % involved pregnant women (Table  1 ).

Table 1

Malaria study proposals submitted to the FTM-EC during the study period

FTM - EC Faculty of Tropical Medicine Ethics Committee and IRB institutional review board

Overall ethical considerations on malaria proposals

Of the 114 proposals, the ethical issues raised by REC members on “study rationale and significance of the study” included 12 % on research questions and 17 % on research objectives. As shown in Fig.  1 , regarding the “study design and methodology” dimension, approximately 30 % were related to study schedule and activities, and 37 % to risk–benefit balance. For the ethical considerations concerning “research study participant”, 52 % were related to inclusion and exclusion criteria, 26 % to sample size, 27 % to recruitment procedures, and 23 % to participant compensation. Higher percentages were shown for the “informed consent process” dimension, with 57 % on the participation information sheet, 50 % on the informed consent form/process, and 24 % on the privacy and confidentiality of the information. Regarding the “data collection and analysis” dimension, approximately 61 % related to the specimen and data collection procedure, 17 % to case record form (CRF) design and use and 13 % to data analysis methods. For “study facility and supporting information”, 4 % were on study site location, 2 % on study budget, and 15 % on supporting documentation (e.g. material transfer agreement, and approval of authorities in the community where the study was taking place).

Overall ethical considerations on malaria research proposals (n = 114)

Comparisons of ethical considerations by proposal type

When comparing ethical considerations according to study design, almost all ethical issues were statistically significantly different across the four study designs. Proposals for drug trials had higher percentages for most ethical issues, followed by proposals of for biomedical/clinical research then laboratory or basic science research (Table  2 ). Proposals for epidemiology studies had fewer ethical issues raised by the FTM-EC. Interestingly, ethical issues for “privacy and confidentiality” specifically showed an opposite but non-statistically significant trend, being higher for laboratory and epidemiology studies than biomedical studies or drug trials. Other non-statistically significant differences among different study designs were for CRFs, data analysis, study budget and supporting documents.

Table 2

Comparisons of ethical considerations by study design

When comparing ethical considerations by different types of specimen/data collection and use, again almost all ethical issues were statistically significantly different across the four types of study proposal. Proposals involving new specimen collection had higher percentages for most ethical issues, followed by proposals using medical records or collecting new data using CRFs or questionnaires (Table  3 ). The proposals involving the use of stored specimens, either linked (identifiable) or unlinked (un-identifiable) had a smaller percentage of ethical issues raised by the FTM-EC. Again, ethical issues for “privacy and confidentiality” showed an opposite but non-statistically significant trend, with the percentage higher for studies involving stored specimens. Other non-statistically significant differences among different study designs were study rationale, data analysis, and study facility and supporting documents.

Table 3

Comparisons of ethical considerations by type of specimen/data use

CRF case record form

Strength of relationship between ethical considerations and different types of malaria proposals

Regarding study location, proposals that required other REC review had higher ORs compared with proposals that required only FTM-EC review for the following ethical issues: study design and methodology; study participants; the informed consent process; and study facility and supporting documents. For comparisons between international vs. local studies, and between multi- vs. single-site studies, higher ORs were found for the dimension study facility and supporting documents (Table  4 ).

Table 4

Comparisons of ethical considerations by different study characteristics

Italics denotes statistically significant values

CI confidence interval, IRB institutional review board, OR odds ratio

Regarding study populations, proposals involving minority populations had higher ORs than proposals that did not involve such populations, for all ethical issues apart from study rationale and significance. In contrast, proposals involving vulnerable populations had higher ORs than proposals that did not, for study rationale/significance and study design/methodology.

When comparing the four study designs using epidemiology studies as a reference group, higher ORs were reported for biomedical/clinical research for all ethical issues except study facility and supporting documents. For drug trials, higher ORs were reported for all ethical issues except study participants and informed consent process. This was because 100 % of drug trial researchers were asked for clarifications on these two ethical issues. For laboratory studies, higher ORs were reported for three ethical issues: study design and methodology, study participants, and the informed consent process.

When comparing the four types of specimen/data use using proposals with medical records/CRFs as the reference group, higher ORs were reported for studies that collected new specimens for all ethical issues except study rationale, data collection and analysis, and research facility and supporting documents. Interestingly, when comparing proposals for studies using medical records/CRFs with those using identifiable or unidentifiable stored specimens, no statistically significant differences were reported.

The roles and responsibilities of an REC are to ensure protection of the safety, well-being and basic rights of potential participants and participants of a research study. The REC should review the protocol and associated documents and provide opinions on three different ethical considerations, i.e. science, ethics, and data quality [ 33 ]. The classical view of research ethics is governed by four ethical principles: respect for persons, beneficence, justice, and respect for communities [ 39 , 40 ]. Ethical foundations to be considered and addressed include issues on research subjects, the informed consent process, study design concept, risk–benefit ratio, vulnerable group protection and research gatekeepers [ 10 , 41 ]. In this study, the ethical issues raised in malaria research proposals fell within these common principles. Approximately half of the proposals required revision and clarification on the informed consent process and study participant protection; and, for those studies that required specimen collection, the process to obtain the specimen from the study participants. Approximately one-third required information about risk–benefit and study schedule-activities. Less than one-fifth required explanation of the research objectives and a few proposals required clarification or revision of research questions and supporting documents.

Although only approximately 12 % of the proposals in the present study needed elaboration or provision of more robust information about the research questions (study rationale and significance), debate remains whether the FTM-EC has gone beyond its designated roles. The highest percentage of ethical issues raised by the FTM-EC regarding the malaria research proposals in the study related to the specimen and data collection schedule and activities. At times, some investigators have also questioned whether the ethics committee should comment on research methodology. These scientific merit and research procedure issues remain controversial internationally. It has been reported that REC members are pressured to review a wide range of issues in research proposals, needing to provide opinions ranging from research design to patient privacy and budgeting matters [ 9 , 33 ]. Some research investigators believe that these are beyond the scope of research protection [ 9 ]. Others have suggested that researchers should have already thought carefully about the nature of how the study results can be generated and how they are aligned with the aims of the research. Heterogeneity of bioethics ought to be welcomed, but those involved should engage meaningfully and explicitly with questions concerning normative justification and the methodological process and about the coherence of components of their study [ 42 ]. The OHRP also notes that REC members very often ask to what degree it is his/her responsibility to review the underlying science of the proposal [ 43 ]. It has long been argued that “if it is not good science, it is not ethical” and the US federal regulations do not clearly call for REC review of the scientific validity of the research design. However, if the underlying science is inadequate, then it follows that the study is unlikely to yield important knowledge [ 43 ]. To mitigate this controversial ethical consideration made by RECs, the ORHP guideline suggests that if the REC lacks expertise in the scientific matter of the particular proposal, the REC should recognise its limits. Although REC members are not required to be experts in scientific methodology or statistics, they should have certain basic knowledge about study design, and they should consult experts if they have concerns about the research rationale and methodology that seem to pose a significant problem [ 43 ]. At the FTM, besides some FTM-EC members who have been working in malaria research over decades, there is a pool of expertise in malaria research, ranging from molecular to field studies, and several of them have been consulted for advice for any unclear or controversial matter before issuing the letter to investigators or making a final decision on the submitted proposals.

The REC has a responsibility to consider the balance between the risks and benefits of the research proposal. International standards clearly state that the REC must safeguard the rights, safety and well-being of all study participants [ 10 , 33 , 44 ]. Based on the classic ethics principle of beneficence, researchers have an obligation not to harm needlessly and to promote the good of the study participants where possible. Regarding justice, researchers have an obligation to ensure that study procedures for the selection of research subjects are equitable [ 44 ]. It is also agreed that researchers neither exploit the vulnerable nor exclude unreasonably those who could be receive benefit from the study. This means that eligibility criteria listed in the proposal must be clearly justified [ 45 ]. Among all 114 malaria proposals submitted for FTM-EC review, about 28 % involved minority populations along the country borders, and 27 % involved other vulnerable groups (pregnant women, children, the elderly or unconscious patients). Thus, the finding that over one-third of proposals required clarification on the risk–benefit balance is not surprising.

As clearly stated in international standards on ethical review of research protocols [ 12 , 23 – 25 , 46 ], the informed consent process is one of the main ethical considerations that must be observed by RECs. Indeed, it could be said that the informed consent process is a legal, ethical, and regulatory requirement for most research and healthcare transactions [ 20 , 47 ]. The informed consent process is based on the classic ethical principle of respect for persons, such that researchers must ensure that potential study participants make their own decisions whether or not to take part [ 44 ]. It should also be noted that, by signing informed consent documents, the study participants have agreed to a controlled breach of their privacy/confidential information for a specific purpose mentioned in the study protocol, and for use over a specific period of time [ 14 ]. It is thus important that participants are clearly informed about the methods of handling and use of their personal data, the justification for requesting or obtaining their data from different sources, and the duration of data use and storage, while maintaining their right to withdraw their consent at any time [ 14 ]. All guidelines suggest that special attention should be paid to studies involving vulnerable participants who may be unable or have limited capacity to make a decision [ 10 , 21 , 48 , 49 ]. In a study on ethical dilemmas in malaria drug and vaccine trials [ 1 ], it was stated that, in most cases, obtaining informed consent was problematic because the studies were usually conducted with patients or surrogates with limited educational attainment levels in developing countries, and thus were not able to fully understand the study protocol. Potential participants may not understand the science underlying the study and therefore be able to make proper informed decisions. The finding in that study suggests the need for a better consent processes. As suggested elsewhere in the literature, a consent process considered valid or truly informed should have the following characteristics: (1) provision of adequate information, (2) capacity to understand that information, (3) decision making voluntarily, (4) understanding of information provided, and (5) agreement to the proposed treatment or procedure [ 50 ]. It has also been suggested that the informed consent forms are usually too long and complex for a layperson to read and comprehend, but there are various methods to simplify such forms [ 51 ]. Researchers are obliged to ensure that they plan their informed consent process with care, even the complicated aspects of research, by having the information explained simply and comprehensibly to the potential study participants. In the present study, over half the malaria research proposals and all malaria drug trial proposals submitted to FTM-EC required revision of the informed consent process to meet such requirements.

When examining different research designs, it was found that proposals on laboratory-based (usually using archived specimens) and epidemiological studies had fewer ethical issues raised by the FTM-EC than clinical research and drug trials. However, “privacy and confidentiality” showed an opposite, albeit non-statistically significant, trend. This concurs with one of the main ethical considerations in all international guidelines, that possible invasions of privacy of individuals and breaches of confidentiality may arise in biomedical and behavioural/social research [ 22 , 24 , 25 , 27 , 46 ]. As suggested in the guideline on ethics of research related to healthcare in developing countries, one of the RECs’ primary tasks is to review the ethical acceptability of research proposals with special attention to the provisions for protecting the security and confidentiality of data about patients [ 7 ]. From a data protection and privacy issues point of view, all study participants must be informed about not only what they have to do in the research, if they decide to participate, but also what and how the research plans to use the data that they provide [ 46 ]. There were reports of potential improper use or misuse of the collected data; even in case studies showing that what seems to be unlinked information can sometimes be taken for use out of context and lead to a personal data breach [ 46 ]. This could be because study procedures in clinical and drug trial proposals tended to be stated clearly by the study investigators in protecting participants’ personal information, whereas proposals of laboratory (predominantly using stored specimens) and epidemiology studies (predominantly using medical records and CRFs in healthcare settings) were generally not as clear. As suggested in the literature about ethical and legal issues of research using human specimens and clinical data, materials should be provided to the investigator with the minimal clinical information needed for the study and specimens should not be individually identifiable where applicable [ 15 , 16 , 20 ].

The malaria proposals that required additional review by other RECs, whether international or local, appeared to raise more ethical issues regarding study design and methodology, study participants, informed consent processes and study facility and supporting documents. This might be because such proposals are likely to be developed by non-local investigators and thus there might be certain local sensitive issues that were overseen by the proposal developers. As suggested in the literature regarding ethical principles in conducting clinical research in developing countries, investigators should consider the principle of collaboration by developing partnerships with local researchers, policy makers and the community [ 2 ]. It is recommended that the study should respect the community’s values, culture, traditions, and social practices. Even regarding scientific validity, the research team should ensure that the scientific design and methodology has recognized social value for the primary beneficiaries of the research, and is feasible within the social, political, and cultural context, or provides sustainable improvements in the local healthcare and physical infrastructure [ 2 ].

Ethical issues that should be considered, as part of field studies of malaria in developing countries, were also discussed in terms of practical problems that arise in the course of research. These include differing circumstances in developing countries, such as standards of care, incentives and reimbursement, insurance and indemnity [ 28 ]. The local REC should ensure that local context is adequately addressed and convey their knowledge of local factors that affect human subject protection [ 52 ]. The issues raised by the FTM-EC for these international studies confirm the notion that local ethical review should consider the vulnerability of study participants, particularly in remote border areas with no or poor access to healthcare services, alongside cultural beliefs and attitudes, literacy and language [ 25 , 28 ]. As has also been suggested by others, the REC should provide public assurance of such protection by ensuring that investigator(s) are suitable to conduct the study, facilities are adequate, and that the methods and materials and informed consent process are appropriate [ 33 ].

Malaria research studies conducted along the Thai borders generally involved minority populations in endemic areas. These populations are considered vulnerable, with poor/limited educational attainment and cross-border/migrant status. Therefore, it is not surprising to observe that all ethical issues (except study rationale) were raised for such proposals by FTM-EC. The principle of fair selection of study population is important to minimize risks while enhancing other critical principles of collaborative partnership and social value when the research study is taking place in local communities [ 2 ]. Balancing risk–benefit considerations, informed consent processes and having respect for recruited participants and study communities, especially among vulnerable populations, remain the major concerns of all RECs [ 2 , 25 ].

There were more ethical considerations in almost all aspects for drug trials and clinical studies compared with proposals for epidemiological studies. Clinical research studies usually directly involve human subjects, either with preventive, therapeutic, or non-therapeutic procedures. In general, the study procedures in such study designs put human subjects at higher risks, thus there are more ethical concerns. The primary ethical considerations of clinical studies are competent medical treatment and care, alongside an acceptable risk–benefit balance [ 40 , 41 , 44 ]. However, many laboratory research studies use stored specimens, with less invasive procedures, and epidemiology studies usually employ data collection through medical records, CRFs or questionnaires. Ethical issues for the latter, therefore, mainly concern confidentiality and privacy of the study participants [ 25 ]. However, it was found that studies that collect new specimens received more comments on ethical issues. There remains debate among RECs about solutions for issues around sample export, storage, and reuse [ 15 , 16 , 34 ]. However, it is recommended that in order to ensure adequate protection of human research subjects participating in scientific research, RECs bear the responsibility of guaranteeing that participants are provided with sufficient detail to be able to provide informed consent as well as to understand the reality of genetic research as it is practiced [ 53 ].

Limitations of the study

The main limitation of this study is that it is based on information from only one institution, the Faculty of Tropical Medicine, Mahidol University. It may, therefore, not be representative of RECs elsewhere in Thailand or around the world where malaria proposals are submitted. However, the top five institutions publishing malaria research papers during 2010–2014 were the London School of Hygiene and Tropical Medicine (882), the University of Oxford (766), the University of Liverpool (485), Mahidol University (450, including 391 from the FTM), and Johns Hopkins University (409). The proposals under the FTM affiliation were all reviewed by the FTM-EC. This study examined all 114 malaria research proposals submitted to an REC in Thailand during a five-year period. Overall, the FTM makes a considerable contribution to malaria research globally. Identifying the ethical issues considered during the protocol review process at the FTM may inform the planning of future malaria research studies in endemic countries in Southeast Asia and/or beyond.

Regardless of study design and setting, the REC focus is on the science, ethics and quality assurance of each study protocol. Several important ethical issues were identified for protocol approval, ranging from study design to supporting documents. Ethical considerations, particularly for clinical research and drug trials appeared to be mainly focused on the risk–benefit balance, vulnerable participants, and informed consent process, whereas the main considerations for laboratory and epidemiology studies were the confidentiality and privacy of data and use of specimens. As with studies subject to review by any REC, generic ethical principles are applied to malaria research, such that research validity and quality must be maintained while respecting study participants within the social, cultural and economic contexts where the research is conducted. Ethics and bioethics represent large domains of their own in balancing both theoretical and practical aspects of human research study conduct. While stakeholders, including researchers, sponsors and RECs, have to consider the practicability of research conduct within malaria-endemic settings, which are commonly populated with those who are poor and vulnerable, they cannot violate the classic ethical principles of autonomy, beneficence, and justice.

Authors’ contributions

All authors discussed and agreed upon the content, contributed to the development and revision of the draft manuscripts. PA, JK drafted the initial version. PW, SK, KP contributed useful criticism and suggestions. CL, SP, PV extracted unlinked study data from the secured documents of the FTM-EC. All authors read and approved the final manuscript.

Acknowledgements

The authors would like to thank the FTM-EC members in both panels for their kind support for this study.

Compliance with ethical guidelines

Competing interests The authors declare that they have no competing interests.

Abbreviations

Contributor information.

Pornpimon Adams, Email: [email protected] .

Sukanya Prakobtham, Email: [email protected] .

Chanthima Limphattharacharoen, Email: [email protected] .

Pitchapa Vutikes, Email: [email protected] .

Srisin Khusmith, Email: [email protected] .

Krisana Pengsaa, Email: [email protected] .

Polrat Wilairatana, Email: [email protected] .

Jaranit Kaewkungwal, Email: [email protected] .

Research Proposal Example/Sample

Detailed Walkthrough + Free Proposal Template

If you’re getting started crafting your research proposal and are looking for a few examples of research proposals , you’ve come to the right place.

In this video, we walk you through two successful (approved) research proposals , one for a Master’s-level project, and one for a PhD-level dissertation. We also start off by unpacking our free research proposal template and discussing the four core sections of a research proposal, so that you have a clear understanding of the basics before diving into the actual proposals.

• Research proposal example/sample – Master’s-level (PDF/Word)
• Research proposal example/sample – PhD-level (PDF/Word)
• Proposal template (Fully editable) 

If you’re working on a research proposal for a dissertation or thesis, you may also find the following useful:

• Research Proposal Bootcamp : Learn how to write a research proposal as efficiently and effectively as possible
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FAQ: Research Proposal Example

Research proposal example: frequently asked questions, are the sample proposals real.

Yes. The proposals are real and were approved by the respective universities.

Can I copy one of these proposals for my own research?

As we discuss in the video, every research proposal will be slightly different, depending on the university’s unique requirements, as well as the nature of the research itself. Therefore, you’ll need to tailor your research proposal to suit your specific context.

You can learn more about the basics of writing a research proposal here .

How do I get the research proposal template?

You can access our free proposal template here .

Is the proposal template really free?

Yes. There is no cost for the proposal template and you are free to use it as a foundation for your research proposal.

Where can I learn more about proposal writing?

For self-directed learners, our Research Proposal Bootcamp is a great starting point.

For students that want hands-on guidance, our private coaching service is recommended.

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