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Research Ethics Committees: Basic Concepts for Capacity-Building

This report from the World Health Organization (WHO) covers concepts for capacity-building. This manual contains six chapters on general topics: the role of research ethics committees, ethical analysis, training programs, evaluation of risks and benefits, confidentiality and informed consent, with annexes covering financial conflicts of interest in medical research and international guidelines and regulations.

Research Ethics Committees: Basic Concepts for Capacity-Building. World Health Organizations 2009.  https://www.who.int/publications/i/item/9789241598002 .

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research ethics committees basic concepts for capacity building

  • Ana Borovecki 2  

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Research ethics committees have become a permanent fixture when it comes to ethics of research. They are essential part of quality control of research protocol, and their existence and work are thoroughly described in all important international documents dealing with research ethics issues. In this contribution history, development and different types of research ethics committees are discussed. The functions, structure, and locale of research ethics committees are also addressed. The global dimension of the work of research ethics committees is also discussed.

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Borovecki, A., ten Have, H., & Oreskovic, S. (2009). Ethics committees in Croatia: Studies in bioethics . Saarbrücken: VDM Verlag Dr. Müller.

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Huriet, C. (2009). Article 19: ethics committees. In H. A. M. J. ten Have & S. J. Michele (Eds.), The UNESCO universal declaration on bioethics and human rights background principles and application (pp. 265–270). Paris: UNESCO.

Jonsen, A. R., Veatch, R. M., & le Roy, W. (1998). Source book in bioethics. A documentary history . Washington, DC: Georgetown University Press.

Levine, R. J. (2004). Research ethics committees. In W. T. Reich (Ed.), Encyclopaedia of bioethics (Vol. IV, pp. 2311–2316). New York, NY: Macmillan Simon and Schuster.

ten Have, H. (2005). Establishing bioethics committees guide No. 1 (pp. 40–52). Paris: UNESCO.

Further Readings

Amdur, R., & Bankert, E. A. (2011). Institutional review board: Member handbook (3rd ed.). Sudbury, MA: Jones and Bartlett Publishers.

Emanuel, E. J., et al. (Eds.). (2008). The Oxford textbook of clinical research ethics (pp. 541–588). Oxford/New York: Oxford University Press.

Schrag, Z. M. (2010). Ethical imperialism. Institutional Review Boards and the Social Sciences, 1965–2009 . Baltimore: The Johns Hopkins University Press.

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Andrija Stampar School of Public Health, School of Medicine, University of Zagreb, Zagreb, Croatia

Ana Borovecki

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Borovecki, A. (2016). Committees: Research Ethics Committees. In: ten Have, H. (eds) Encyclopedia of Global Bioethics. Springer, Cham. https://doi.org/10.1007/978-3-319-09483-0_104

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Research Ethics Capacity Building in Sub-Saharan Africa: A Review of NIH Fogarty-Funded Programs 2000–2012

Paul ndebele.

Medical Research Council of Zimbabwe (Zimbabwe)

Douglas Wassenaar

University of KwaZulu-Natal (South Africa)

Solomon Benatar

University of Cape Town (South Africa)

Theodore Fleischer

Mariana kruger.

Stellenbosch University (South Africa)

Clement Adebamowo

University of Ibadan (Nigeria)

Johns Hopkins Bloomberg School of Public Health (USA)

Adnan A. Hyder

Eric m. meslin.

Indiana University School of Medicine (USA)

The last fifteen years have witnessed a significant increase in investment in research ethics capacity development throughout the world. We examine nine research ethics training programs that are focused on Sub-Saharan Africa and supported by the US National Institutes of Health. We collected data from grants awards’ documents and annual reports supplemented by questionnaires completed by the training program directors. Together, these programs provided long-term training in research ethics to 275 African professionals, strengthened research ethics committees in 19 countries in Sub-Saharan Africa, and created research ethics curricula at many institutions and bioethics centers within Africa. Trainees’ leadership resulted in new national systems and policies on research ethics, human tissue storage and export, and methods of monitoring compliance with research ethics guidelines. Training programs adapted to challenges that arose due to varied trainees’ background knowledge in ethics, duration of time available for training, spoken and written English language skills, administrative obstacles, and the need to sustain post-training research ethics activities. Our report showcases the development of awareness of research ethics and building/strengthening of basic research ethics infrastructure in Sub-Saharan Africa. Nevertheless, the increasing amount and complexity of health research being conducted in Sub-Saharan Africa suggests the need for continued investment in research ethics capacity development in this region. This paper is part of a collection of papers analyzing the Fogarty International Center’s International Research Ethics Education and Curriculum Development program.

In November 1999, the African Malaria Vaccine Testing Network (AMANET) sponsored a seminar on health research ethics in Africa in Arusha, Tanzania, to identify the needs, priorities, structures, and processes for research ethics review and monitoring of research in Sub-Saharan Africa (SSA). Reports by country representatives revealed several problems with the review and monitoring of research including inadequately functioning research ethics committees (RECs), lack of resources, limited or outdated legislation, overworked research ethics committee members, low levels of awareness of research ethics guidelines, and lack of personnel trained in bioethics and research ethics ( Rugemalila & Kilama, 2001 ). These realities were confirmed by other authors who also reported the nonexistence of RECs in some countries and institutions, under resourcing of RECs, and lack of formal research ethics training among REC members as well as the fact that only a handful of trained bioethicists worked in the region ( Milford, Wassenaar, & Slack, 2006 ; Nyika et al., 2009 ).

This lack of adequate resources for research ethics, coupled with the increasing volume of health research in Sub-Saharan Africa, was thought to be contributing to increased vulnerability to exploitative research ( Angell, 1997 ; Benatar, 2002; Isaakidis et al., 2002 ; Rugemalila & Kilama, 2001 ; Singer & Benatar, 2001 ). Investments in research in Africa were disproportionate to the almost complete absence of investment in research ethics. Despite the increasing demand for research ethics expertise, no Sub-Saharan African institution had developed and implemented graduate-level training in research ethics.

At the same time, the US National Bioethics Advisory Commission (NBAC) completed its study of ethical issues in international research ( NBAC, 2001 ), which included two specific recommendations directed at US research sponsors: (1) develop and implement strategies that assist in building local capacity for designing, reviewing, and conducting clinical trials in developing countries; and (2) build the capacity of RECs in developing countries to conduct scientific and ethical review of international collaborative research.

The global research ethics landscape has expanded considerably since the NBAC study conducted in 1999. Between 2000 and 2012, the Fogarty International Center (FIC) invested approximately US$33 million in research ethics capacity development worldwide. Of this amount, approximately 40% (US$13 million) specifically supported capacity building in Sub-Saharan Africa (personal communication, Barbara Sina, Fogarty International Center, National Institutes of Health). Other FIC training programs (e.g., the AIDS International Training and Research Program [AITRP] and the Medical Education Partnership [MEPI]) also supported research ethics training, which suggests that this figure underestimates FIC spending on research ethics capacity in Africa.

The Wellcome Trust, a UK charity, has spent an estimated UK£2million (US$3.1 million) since 2007 (with numerous additional grants prior to 2007) to support bioethics research, research ethics training, and workshops in developing countries. Approximately UK£1.2 million was focused on ethics projects in SSA (personal communication, Katherine Littler, Wellcome Trust). Between 2005 and 2011 the European Developing Countries Clinical Trials Partnership (EDCTP) invested over €3.2 million (US$4 million) in 54 research ethics projects in Africa (personal communication, Nuraan Fakier, EDCTP). Several other institutions and agencies (e.g., World Health Organization, UNAIDS, African AIDS Vaccine Programme, Family Health International, US Department of Health and Human Services Office for Human Research Protections [OHRP], US NIH Department of Bioethics) also conducted or sponsored mostly short-term research ethics training activities in SSA during this period.

We review research ethics capacity building efforts by FIC-sponsored programs in Sub-Saharan Africa between 2000 and 2012. We reflect on the achievements in order to have insight into successes and failures, and identify current needs and gaps as well as future requirements.

We focus on nine FIC funded programs that had at least one long-term trainee from Sub-Saharan Africa (WHO/ AFRO region) and existed for at least one four-year funding cycle between 2000 and 2012. FIC defines a long-term trainee as someone trained for three months or more working toward an academic certificate, diploma, master’s, or doctoral degree. Qualitative and quantitative data were collected from a review of grants award documents and programs’ annual reports. In addition, a 17-item questionnaire was administered by face-to-face discussions and e-mail to the program directors to obtain information on the structure, approach, content, and mentoring aspects of their training programs. In addition, information was collected on the achievements and challenges that the programs have faced (see Appendix A ). A separate paper assesses the achievements and challenges of individual trainees from these Africa-focused training programs ( Ali, Hyder, & Kass, 2012 ).

The programs that recruited long-term trainees from SSA are presented in greater detail. The section also highlights the achievements and challenges faced by the nine programs.

PROGRAMS THAT FOCUSED ON SUB-SAHARAN AFRICA

During the first year of the program (2000–2001), FIC awarded two planning grants to two institutions from Sub-Saharan Africa and five ethics training grants that focused on training scholars from Sub-Saharan Africa. The five training grants were awarded to Johns Hopkins University, University of Toronto, Case Western University, University of Cape Town, and the Universities of Pretoria and KwaZulu-Natal. In 2004, three additional awards were made to support SSA trainees at University of North Carolina at Chapel Hill, University of Ibadan, Nigeria, and both Michigan State University and University of Malawi. In 2008, a new award was made to Indiana University in partnership with Moi University, Kenya ( Meslin, Were, & Ayuku, 2013 ). Six of these nine programs remain funded beyond 2012. This review excludes awards for North Africa or the Middle East region, which are covered in a separate paper ( Silverman et al., 2013 ). We present key information on the nine programs in Table 1 .

FIC Bioethics Programs Accepting Trainees from Sub-Saharan Africa.

The majority of countries from which trainees have been drawn are characterized by low levels of socioeconomic development as evidenced by low GDP per capita and limited expenditure on health. The countries range from 13 to 65 on the Corruption Perceptions Index (CPI), which provides an estimate of perceived corruption in the public sector (a scale of zero represents the highest level of corruption while a score of 100 represents the least corrupt). Table 2 summarizes the social and economic indices for the countries. All the countries except for Namibia had clinical trials that were registered in www.clinicaltrials.gov .

Socio-economic Indices for Bioethics Trainee Home Countries.

DESCRIPTIONS OF THE PROGRAMS

From 2001, the Johns Hopkins Fogarty African Bioethics Training Program (FABTP, 2000–2017) selected three trainees per year from any African country for one year of bioethics and research ethics training ( Hyder et al., 2007 ; Ali et al., 2012 ). Training activities focused on four core concentration areas: theories and principles of ethics, teaching of research ethics, empirical research in research ethics, and research ethics committees. The trainees first spent six months at Johns Hopkins University in Baltimore, Maryland, for training in research methodology, observation of medical and public health institutional review boards (IRBs), completion of graduate school–level academic and intensive bioethics courses, and intensive mentoring. Trainees then returned to their home countries for a funded, mentored six-month practicum. Starting in 2010, FABTP changed its model to focus on developing African institutional ethics capacity instead of individuals, with the aim of building sustainable ethics centers. FABTP competitively selected one African institution with existing strengths in bioethics each year to help the institution deepen its research ethics capacity.

The International Research Ethics Training Program (IRETP 2000–2016) based at Case Western Reserve University in Cleveland, Ohio, provided long- and short-term training in research ethics for participants from Nigeria and Uganda, as well as the post-Communist countries of Romania, the Russian Federation, and Tajikistan. The program supported: (1) a master’s degree program for trainees from each of the countries; (2) a short course in research ethics in each country; (3) faculty from each of the collaborating countries visited Case Western Reserve University to facilitate mid- and senior-level faculty development in research ethics; (4) in-country consultation; (5) an electronic ethics training repository for information, protocols, and projects; (6) a semi-annual electronic newsletter; and (7) web-based activities to facilitate ongoing education in research ethics and continuation of a trainee network. This program no longer includes an African focus.

The University of Toronto developed a Master of Health Science—Bioethics International Stream (UTMBIS 2000–2012), which selected trainees with the potential to make an impact in research ethics in their home countries. The program trained individuals from West Africa and South Asia. According to the grant proposal and annual reports, the trainees completed the program in two components over 24 months. During the University of Toronto component, trainees completed eight courses and a research practicum in general bioethics or international research bioethics to earn a master’s degree in bioethics. During the home country component, trainees conducted mentored projects to integrate newly acquired skills into leadership, research, and teaching at their home institutions.

The International Research Ethics Network of Southern Africa (IRENSA 2000–2011) provided a one-year graduate diploma program at the University of Cape Town, South Africa, consisting of three two-week intensive modules (Research Ethics: Philosophical, Professional, and Legal Perspectives; Research on Human Subjects in a Cross-Cultural Context; Global Health, Public Health Ethics, and Public Health Research Ethics). According to the grant proposal and annual reports, the program was open to candidates from all over Africa and trained 97 mid-career professionals with diverse professional backgrounds from South Africa and eight other African countries, where they were involved in the conduct, monitoring, oversight, funding, or regulation of research or expressed specialized interest in research ethics. This program closed in 2011, but was replaced by ARESA (Advancing Research Ethics Training in Southern Africa) at Stellenbosch University.

The South African Research Ethics Training Initiative (SARETI 2000–2017) is a multidisciplinary program leading to a master’s degree in Health Research Ethics, originally based on a collaboration between the Universities of Pretoria and KwaZulu-Natal, with input from Johns Hopkins University. According to the grant proposal and annual reports, SARETI sponsored four master’s degree candidates each year from 17 African countries as well as 18 nondegree long-term trainees. The core curriculum consisted of: (1) 10 months of modular coursework at the partner institutions; (2) practical work with research ethics committees (RECs); (3) attendance at two intensive US-based bioethics courses at Johns Hopkins Berman Institute of Bioethics and Georgetown University; and (4) a research-based dissertation on a topic of relevance to strengthening health research ethics at the trainee’s home institution, leading to submission of a paper to a peer-reviewed journal.

The West African Bioethics Training Program (WABTP 2004–2016) takes advantage of resources at the University of Ibadan and the Dominican Institute, Nigeria, to offers a master’s degree program, six-week diploma courses, on-site and off-site short certificates, and refresher courses in both English and French to researchers, REC members, and administrators primarily from Nigeria and some from other West African countries. In addition, WABTP offers modules in scientific integrity, good clinical practices, good laboratory practices, grant writing, and pedagogy, and organizes public lectures and symposia to increase awareness of bioethics in West Africa.

The Strengthening Bioethics Capacity and Justice in Health (SBCJH 2004–2012) is a collaborative partnership between the University of North Carolina (USA) and University of Kinshasa in the Democratic Republic of the Congo (DRC). Four fellowships for six-months of mentored ethics research, social science methodology, IRB training, and curriculum development at University of North Carolina were offered to trainees. The program trained a core group of African health professionals who were subsequently supported and mentored to conduct in-country workshops, teach, provide consultation, create curriculum, publish studies, enhance REC capacity, and develop national ethics guidelines.

The Training for Scholarships in Research Ethics program (TSRE 2004–2009) was a collaborative arrangement between Michigan State University and the College of Medicine at the University of Malawi. The program recruited six scholars from Malawi, Tanzania, and Zimbabwe for 18 months of intensive training in research ethics and related social science disciplines, designed to produce independent scholarship in research ethics. Scholars spent six months at Michigan State University taking formal courses and creating a research proposal. After six months, the scholars moved to the College of Medicine, University of Malawi, to take courses for a certificate or master’s in Public Health with a specialty in Bioethics. All scholars were expected to submit a manuscript to a peer-reviewed journal.

The Indiana University–Moi University Academic Research Ethics Partnership (IU–Moi AREP 2008–2017) is a curriculum development and training initiative built on a two-decades-long partnership between the two universities ( Tierney et al., 2013 ). IU–Moi AREP has developed two master’s degree programs: a new concentration in International Research Ethics within the MA in Philosophy at Indiana University in Indianapolis and a MHSc. in International Health Research Ethics in the Department of Behavioural Sciences at Moi University in Eldoret, Kenya. While both master’s programs enroll students independently, they share key curricular components, use joint advisory committees, engage common bioethics-trained faculty as mentors, use similar dissemination plans, and utilize harmonized evaluation strategies. For example, both programs have a year-long required practicum that includes a minimum of six weeks of coursework, lectures, and hands-on experiences at the counterpart university. In addition, topic-based short courses and an annual Teaching Skills in International Research Ethics (TaSkR) workshop rotate between the two universities to provide short-term training opportunities to other interested students and faculty.

Training Program Attributes

To allow for comparison of the key attributes of the nine programs, Table 3 provides a summary of the training program attributes.

Summary of Training Program Attributes.

TRAINING PROGRAM FORMATS

All nine programs aimed to build research ethics capacity, but differed with regard to content, pedagogy, program requirements, mentoring strategy, and format (see Table 3 ). Six programs were multi-institutional collaborations that included training components conducted at another institution, such as workshops, practicum experiences, or summer schools, while three were single institution programs. Six programs offered certificate-level training, two offered diploma-level training, and seven offered master’s degree–level training. While Fogarty grants did not directly support PhD training, two programs (SARETI and SBCJH) managed to secure additional support and graduated four trainees with PhDs. Seven programs offered short duration workshops that reached over 300 individuals. Six programs reported that they introduced major changes to their programs, based on initial experience, including revision of program requirements, such as additional modules or reading materials, development of new outcomes (e.g., MPH degree), amendment of admission criteria, strategies to address gender disparities, and revised partnerships/ consortia arrangements.

LANGUAGE OF INSTRUCTION

All nine programs used English for instruction. Two of these programs, which operated at least in part in French-speaking countries, used both English and French.

TRAINING COMPONENTS

All nine programs reported focusing primarily on research ethics. Seven programs reported including bioethics and public health; and four reported including some focus on clinical/medical ethics. Seven programs included background philosophy (also covering African philosophy) as a core element; all nine programs included research ethics as a core element. Some programs reported covering specialized topics such as the ethics of HIV vaccine trials, community engagement, and professional ethics. All programs reported that they had included instruction in various aspects of Responsible Conduct of Research, consistent with NIH requirements,

All programs reported involving face-to-face interaction; one program reported including an online learning component. Four of the programs reported that they required trainees to submit a dissertation, and a similar number reported that they required trainees to submit or publish a paper in a peer-reviewed journal. Two programs reported that they provided reentry grants to all their trainees, and one program reported that it provided reentry grants to only a subset of trainees. Some of the reentry grants were used for conducting empirical studies, while some used them for establishing or strengthening existing research ethics committees in their institutions.

Eight programs provided a structured system of mentoring. For these programs, mentoring expectations were defined without regard to timing and reporting. Five of nine programs reported that they relied on unstructured mentoring. For the eight programs that had structured mentoring, trainees were assigned to mentors, and mentors engaged in continued contact with their trainees throughout the period of learning and afterwards. In one program, resources were provided for mentors to visit trainees at their home institutions. During such visits, the mentors could facilitate workshops, present seminars, and engage in teaching or other activities aimed at enriching the trainee’s home institution. Another program (IU–Moi AREP) uses a paired-mentor approach in which students have a mentor at their home institution and a practicum mentor at the counterpart institution to provide regular interaction and assistance in completing site-specific portions of the students’ research program.

TRAINING IN CULTURAL ASPECTS OF BIOETHICS

All nine programs included training components on cultural values, for example by having a course, required readings, or seminars dedicated to cultural issues in research or other forms of orientation including visits to communities or cultural sites. Multiple activities taught trainees the importance of culture and cultural differences and their relevance to research and research ethics. For example, one program had a community engagement component during which trainees were expected to spend a week with community members learning about their culture. Some programs also invited community representatives to give talks to students on cultural issues. In one program, students were expected to write an essay on a research experience involving an ethical dilemma around a cultural issue. They were to describe their views at the time they experienced the dilemma and their views after having gone through some training modules. Some concepts and ideas that were considered to be potentially helpful in making progress toward resolving cross-cultural dilemmas in international research ethics were developed into a formal text that was used to explore such issues with participants in the IRENSA and JCB programs ( Benatar, 2004 ).

Long-term Trainees

During the period 2000–2012, the nine programs trained 275 long-term trainees from 19 Sub-Saharan African countries (of the 49 countries in the region) ( Table 4 ). Fourteen of the 19 trainee countries now have five or more returned trainees, nine countries are home to 10 or more trainees, and three of the most populous countries in Sub-Saharan Africa—Kenya, Nigeria, and South Africa—have even larger numbers. The highest number of scholars came from South Africa (76) and Nigeria (72). The two countries were host to training programs.

Trainees by Country from Research Ethics Programs in Sub-Saharan Africa.

Across the nine programs, long-term trainees received different types of training and for different durations: 23% were trained at a certificate level; 42% at a postgraduate diploma level (professional qualification that is below master’s degree level); 34% at the master’s level; and 2% at the doctoral level ( Table 5 ). Seven programs reported having a duration of one year, while one reported having a duration of six months and another reported a duration of 18 months. All programs recruited individuals who had at least a first-level university degree and were involved in work that was relevant to research ethics. Overall, 42% of trainees were female. Only the IRENSA program recruited more female trainees than male (58% or 56 out of 97 trainees).

Trainees from Programs Focusing on Sub-Saharan Africa by Level of Training Acquired and Gender.

Achievements of FIC African Programs

The achievements identified from the training programs were classified using the framework for research ethics system evaluation proposed by Hyder et al. (2009) .

National and Regional Strategies

The programs identified various impacts that they believed their trainees had made on national and regional research ethics policies. Graduates helped craft national research ethics guidelines, developed some of the first policies for storage and export of tissue samples in Africa, provided input to revise national laws guiding the conduct of research, and implemented methods to monitor clinical research. Some trainees took positions of national leadership or were appointed to national bodies ( Kass, Hyder, & Ali, 2013 ). One received a presidential award for contributions to research ethics ( SARETI, 2004 ). At the regional level, substantial networking among program graduates was identified. For example, FIC trainees spearheaded the creation of the African Association of Research Ethics Committee Administrators ( AAREC, 2011 ), where all the executive committee members and the majority of members were former FIC trainees. This network keeps research ethics administrators in Africa updated on best practices in running an REC. Other programs also directly support networking; for example, at the end of each of the two four-year funding cycles, SARETI arranged open Africa Health Research Ethics Symposia for trainees to share scholarly work and ethics review experiences. Two FIC graduates serve as coordinators of the Mapping African Research Ethics Committees project (MARC; IJsselmuiden et al., 2012 ). This project also has an FIC/SARETI-funded social networking component to facilitate consultation and debate among research ethics stakeholders in Africa. Several Fogarty trainees participated in the writing of a research ethics guidebook for African members, a project known as SAREN and funded by EDCTP. This book will be freely available on the Web in pdf format in 2014.

Research Ethics Review

Since 2000, Sub-Saharan Africa has witnessed a dramatic increase in professionals who have received NIH/FIC-supported long-term training in research ethics ( Table 4 ). Many former trainees serve on institutional and national RECs, frequently as chairs, deputies, or secretaries; some entered programs with this experience as well. For example, graduates from the IRENSA program serve on more than 40 RECs in Southern Africa, although many of them were serving on RECs previously. Several programs organized regional REC capacity building workshops. Some trainees developed institutional guidelines and policies for research ethics committees, which are often the first relevant documents to guide the conduct of the REC.

African Publications in Research Ethics

Many programs reported that their trainees have published work in refereed journals; more detail of this is provided elsewhere ( Kass, Hyder, & Ali, 2013 ; Fix et al., 2013 ). Some programs have also published papers that describe their specific accomplishments and challenges ( Ali et al., 2012 ; Hyder et al., 2007 ; Upshur, 2008 ; Meslin, Were, & Ayuku, 2013 ). Faculty and trainees from one program published a paper on research ethics committees in Africa that has been widely cited ( Kass et al., 2007 ).

Institutional Commitment

Several trainees are building new bioethics centers or are heads of existing centers. For example, in Zimbabwe, the secretariat for the national REC is led and staffed by Fogarty trainees from two programs, while at University of Botswana, University of Zambia, and Makerere University, Fogarty program trained individuals are spearheading the establishment of Centers of Bioethics. In one instance (IU–Moi AREP) trainees and the site PI received institutional support to establish a Center for Bioethics and resource library at the university.

Based on the credibility granted to them by their programs, trainees carved out niches that have allowed them to play an active role in building research ethics capacity and, in some cases, to make bioethics a vital part of their careers. For example, some trainees hold academic positions in which they lead research ethics courses and training, or serve in influential positions in government organizations that conduct, regulate, or monitor research. In response to their new skills, new positions have been created in some institutions to accommodate the newly trained graduates. For example, IRB Administrator and Regulator positions were created in Botswana and Zimbabwe respectively. Programs have thus led to the development of research ethics career paths and furthered the institutionalization of research ethics careers in many African institutions for at least some of the trainees. Not all trainees were able to find positions in research ethics and many resumed their previous positions. There were a few trainees who went back to their old positions and engaged in a very minimal amount of research ethics work.

Researchers’ Conduct

Some programs have taken the lead in educating undergraduates and graduates, contributing to a cohort of future researchers with more background in research ethics. The programs have developed curricula, trained researchers and REC members, conducted seminars and workshops, developed institutional and national research ethics guidelines, developed or contributed to online training modules (including African Malaria Network Trust [AMANET] and Training and Resources in Research Ethics Evaluation [TRREE]) for REC members and researchers, and contributed faculty to existing programs. Several FIC program graduates serve as trainers in research ethics, thereby producing a ripple effect.

We believe that these are transformative contributions that could have been made only by programs and trainees with high levels of skills and knowledge. Collectively these nine programs have effected a dramatic change in the research ethics landscape in Sub-Saharan Africa universities. Other trainees are using their skills outside of academia, in the medical insurance industry, the military, nongovernmental organizations, and at research centers ( Kass, Hyder, & Ali, 2013 ).

Discussions with program directors and analysis of questionnaires revealed a number of common and some unique obstacles.

Trainee Preparedness

Programs identified several factors that potentially limited trainee performance including: wide disparities in trainee academic skills and background knowledge (some lacked any exposure to the topics covered, others lacked sufficient skills in using laptop computers or performing online literature searching); time constraints, such as difficulties in obtaining sufficient time off work to fully engage in the training; and difficulty with language, especially when English was the trainee’s second language. Four of the nine programs reported that some of their trainees experienced language-related challenges; such trainees were mainly from Francophone countries and other non-English-speaking African countries. These four programs found ways of assisting such trainees so that they could fulfill program requirements. As a result of this challenge some programs introduced informal tests for fluency in spoken and written English. In at least two programs, the inability of some students to conduct online literature searching led to the establishment of formal training sessions by a university librarian, which has now been adopted for all trainees.

Administrative Problems

Administrative problems included: increased costs in the face of decreasing or constant budgets; exchange rate fluctuations; delayed access to funding occasioned by local administrative incapacity; difficulties in coordinating between collaborating institutions; problems in arranging international travel and visas; and irregular or inadequate Internet connections that hindered communications and research. Most of these administrative challenges were resolved as the programs matured. Through networking, Program Directors were able to rely on their colleagues, both within the Fogarty network and outside of the network among colleagues with other global training program experience, for assistance in resolving some challenges.

Obstacles to Training at Some African Institutions

Some of the programs, particularly those located in politically unstable countries, faced unique challenges such as: social unrest necessitating schedule changes and preventing trainees from finishing their programs within the stipulated time frame; bureaucratic challenges (e.g., obtaining the correct visa for visiting a US-based institution, scheduling a visa interview in the host country); and changes in institutional and national leadership. Some programs disbursed individual research grants in tranches only upon receipt of progress reports. Some programs reported trainees who did not complete their training (especially the research component).

Post-training Issue

Some former trainees encountered problems after returning home due to: limited opportunities to apply their new knowledge and skills at their home institutions; political tensions around status, especially where RECs were traditionally headed by senior professors who were not suitably trained; and pressure of daily work at their home institution causing delays in progress with post-training ethics assignments. New trainees were sensitized to these issues to prepare them for better reentry to their home institutions. Programs reported difficulties in tracking some trainees after they returned home. Due to limited availability of funds and other resources in home institutions, some former trainees also faced the challenge of sustaining research ethics–related activities. However, some trainees acquired small grants from EDCTP and other funders to support post-training activities. Some programs changed recruitment criteria in order to address these challenges. For example, many required a letter of institutional commitment.

Program Critique

There has been some criticism that these training programs have served US purposes by colonizing the minds of Africans with Western notions of research ethics ( Schüklenk, 2000 ). It should be noted, however, that cross-cultural dimensions were prominent aspects of teaching in all of the programs. Several programs highlight relevant aspects of African indigenous value systems in ways that enrich research ethics, maximize local sensitivity and relevance, and, less importantly, offset the allegation that the FIC programs uncritically export the US IRB model to Africa ( Chadwick & Schüklenk, 2006 ).

Gender Balance

Achieving gender balance in programs was not easy: all but two programs failed to achieve the goal of equal numbers of male and female trainees ( Table 5 ), though one of them has since achieved this balance in its incoming cohorts.

Despite these challenges, no program was prematurely ended or required major revision as a result of the problems encountered. Program activities continued even in cases where external forces, such as social instability, seriously disrupted training. Program directors adapted to changing and often unwelcome circumstances. Annual network meetings for program directors as well as the support provided by FIC were essential in facilitating adaptation. Most programs have been able to renew their funding after their initial 4–5 years and made changes to improve training and mitigate problems encountered.

The experiences of the nine programs over a decade represent a substantial and successful investment of human and financial resources to benefit research ethics capacity in Africa. In general, it is clear that research ethics capacity has increased, that measurable outputs can be identified, and that the ethics landscape has changed positively. It is important to highlight that both quantitative and qualitative data are available to document the difference created by these programs. One paper in this journal specifically deals with the papers published by FIC trainees as well as the achievements of individual trainees ( Fix et al., 2013 ). There is evidence (see NIH CareerTrac) to suggest that many FIC graduates assumed positions of relevance to research ethics at both institutional and national levels.

Regarding gender balance, it is possible that the majority of programs could not achieve gender balance because mid-career women in Africa are often not able to take substantial amounts of time (minimum six months) away from home due to family commitments to attend a training program. This could also be explained by the mere fact that male-dominated institutions may be less likely to nominate women. The program that trained more women than men likely did so because on-campus attendance was limited to three two-week periods throughout the academic year.

Regarding the observation concerning the differences in the number of trainees by country, the high demand for training in South Africa and Nigeria may be a result of changes in the legal systems in these two countries, which now require such training ( Nigeria Federal Ministry of Health, 2007 ; South African Department of Health, 2004 ; South African Parliament, 2003 ). In South Africa, for example, the new Health Act makes it mandatory for all research with human participants to be reviewed by a registered REC and all REC members are required to receive initial and ongoing training. Countries with the fewest trainees included Burkina Faso, Mali, Namibia, and Togo, which have relatively small populations. Most of the remaining Anglophone African countries with no FIC trainees appear to conduct little clinical research (see ClinicalTrials.gov).

To address the challenge of a small number of trainees who fail to complete their program requirements on time, better methods of selecting quality trainees are needed, with more objective selection criteria and priority given to candidates who already hold positions of relevance in their home institutions, for example, REC administrators and REC members, and better post-training networking and support.

Sustainability is a concern for all capacity development programs. A sustainable program is one that is capable of creating local demand and operating without FIC funding. The bioethics programs have been sensitive to this issue from the beginning and many have incorporated activities to assist with sustainability from inception. Vital to this has been a common approach of “institutionalizing” the programs and their outputs within universities and institutes in Africa. Strategies range from programs run out of African institutions, to working with specific institutions to enhance their bioethics capacity, to encouraging institutions to use the “products” of these programs, for example, as consultants or members of RECs. It is important that the process of institutionalization continues since it is only when strong research ethics capacity exists within the major research institutions of the continent that sustainability will be achieved. The strengthening of African institutions’ capacity does not mean that there would be no role for colleagues from outside Africa; rather the nature and type of assistance should evolve from basic to advanced training and mentoring, with outsiders serving as consultants and peer reviewers.

It is of concern that to date there is little evidence of indigenous African investment in research ethics capacity development, for example, through grants and university support. It is therefore pertinent to ask whether Africa values this field, acknowledges the need for research ethics capacity, and when it will invest in it. This is a critical question not only for policy support and integration with current priorities but also for sustainability. African governments, academia, development organizations, and even the private sector need to explore this area and make it one of their priorities. The implicit measure of such priority setting is investment. This does not mean that all the needed investments for bioethics and research ethics capacity should come from within Africa; but it does mean that some African funds should flow into capacity development for bioethics. This is also important to ensure that such training processes remain relevant to the ethics issues in Africa ( Tangwa, 2002 ).

Although not directly supported by the data presented in this paper, it is also important to note that more African countries have developed legal frameworks that formalize ethics review requirements, following, for example, the direction provided by Nigeria and South Africa, where ethics review is now a legal requirement for all health research. The absence of legal support for research ethics requirements in many countries limits the rights of research participants ( Andanda et al., 2011 ) and the impact that training research ethicists can make.

Study Limitations

The following limitations with respect to this study are worth highlighting:

  • Self-reported data from program directors, much of which was in their grant proposals or annual progress reports, which may have overplayed success and underplayed challenges.
  • No direct data from trainees.
  • Self-reported data from program directors, even if completely accurate and unbiased, was based on what they thought was important to report. If one PI mentioned something and another one did not, it does not necessarily mean that the second one did not experience the same success or challenge but it simply was not mentioned.
  • Potential recall bias.

Best Practices

Externally funded research ethics training programs should remain an important part of the ethics training landscape in Africa as the number of clinical trials being conducted in Africa rises steadily. There is a clear need for continued investment in Africa-based research ethics leadership and curriculum development to sustain and grow the significant cohort of long-term trainees that FIC-funded programs in Africa have graduated. Training programs must become embedded into local institutions and funding should progressively be sought from local sources. Curricula should in part be sensitive to local issues and value systems and should be published for wider scrutiny and debate to identify effective models and practices and to share resources. African-based programs could better work together to facilitate coordination, referrals, and sharing of resources. Exchanges of students and resource persons between training programs would promote development generally and improve cross-cultural awareness.

Research Agenda

Ongoing and detailed follow-up of trainees and their career paths is required to inform current and future training programs, In addition, all trainees in externally funded training programs should be required to publish work on issues relevant to their training and research ethics practices or environment, to continue the building of Africa-based research ethics knowledge and scholarship that the nine FIC programs described in this paper have significantly accelerated (see Fix et al., 2013 ). Attention also needs to be paid to identifying, developing, and describing possible career paths for research ethics graduates because research ethics remains a “part-time” commitment in many African settings.

Educational Implications

It is clear that these initiatives need to continue. It is also clear that because of the activities described in this paper, Africa now has a growing base of skilled graduates to offer undergraduate research ethics training and short courses that were previously only offered by visiting experts from developed countries. While specialist advisers and consultants from developed countries will always be required, they should no longer be required for basic and introductory research ethics training, which is increasingly being offered by FIC-sponsored graduates. The cohort of FIC-funded research ethics graduates described in this paper has generated a new demand for PhD-level education, to further build African capacity for leadership, skills, and scholarship in this field.

The FIC-funded programs have contributed significantly to research ethics capacity in Africa. The programs are a storehouse of resources for syllabi and teaching methods that could be adapted for use in other programs. Yet gaps still exist. For example, some countries have no or very few people trained in research ethics, and some RECs are still working with untrained administrators. With the growing demand for persons trained in research ethics, there is a need to continue with capacity development so as to meet this demand. In the medium term, a goal worth considering would be to have a Fogarty graduate in each of the over 161 African RECs identified by MARC to date ( IJsselmuiden et al., 2012 ). There also needs to be an increased focus on building institutional capacity, for example, including bioethics in undergraduate and postgraduate courses, and creating and officially recognizing bioethics or research ethics units. The ultimate goal should be to ensure self-sustainability of current programs so that they can continue beyond Fogarty funding by becoming embedded in local institutions and attracting sufficient self-supported applicants to support the program. In order to reach this point, more advanced training is needed at the master’s level. The fact that several individuals have acquired PhDs in research ethics–related areas after completing FIC-funded training is evidence of the need for research ethics training at higher levels. Doctoral training programs and postdoctoral opportunities need to be created so as to address the emerging demand. The few individuals who have been trained at the doctoral level have assumed positions of leadership in Sub-Saharan Africa. Doctoral and postdoctoral training will contribute to the much-needed leadership in research ethics on the African continent.

Acknowledgments

We are very grateful to the Program Directors of all nine Fogarty programs described in this paper who responded to our questionnaire in a timely manner. We also extend our gratitude to program support staff in the nine programs for coordinating the collation of data and Fogarty NIH staff for coordinating data collection and other logistics. We are also grateful to Drs. Barbara Sina and Joe Millum for helpful comments on our manuscript. We thank the Fogarty International Center of the National Institutes of Health for supporting the Research Ethics capacity building grants described above.

Biographies

Paul Ndebele currently serves as Director of the Medical Research Council of Zimbabwe. His research interests include research ethics, health research regulation, and professional integrity. He coordinated the writing of this paper from inception, study tool development, data collection and analysis, and writing and approval of final version.

Douglas Wassenaar is Professor of Psychology in the School of Applied Human Sciences at the University of KwaZulu-Natal. He is the Director of the South African Research Ethics Training Initiative (SARETI). His main interests are in research ethics. He contributed in various ways in the work reported in this paper including; development of the framework, writing and approval of final version.

Solomon Benatar is Emeritus Professor of Medicine at University of Cape Town. His research interests include healthcare systems, research ethics, professional integrity, global health, and global health ethics. He contributed data about the IRENSA program (as PI) and worked on all drafts leading to this final submission.

Theodore Fleischer serves as Deputy Director of the University of Cape Town Bioethics Centre and Senior Lecturer in Bioethics in the Medical Faculty and Senior Lecturer in Law in the Faculty of Law at UCT. He has research interests in bioethics, law, and research ethics. He contributed in various ways to this publication, including development of the framework, data analysis, and writing and approval of the final submission.

Mariana Kruger is the co-director of SARETI and her main interest is the institutionalizing of ethics review committees and children as research participants. Her role in this issue was to assist in designing the questionnaire to collect the data, as well as providing the SARETI data.

Clement Adebamowo is Director of the West African Bioethics Training Program and Chairman of the Nigerian National Health Research Ethics Committee. His research interests are ethics of genomics research, noncommunicable diseases epidemiology, and surgical oncology. He contributed to drafting the manuscript and approved the final content.

Nancy Kass is an Associate Director of the Johns Hopkins Berman Institute of Bioethics. She is Co-Director of the Fogarty Africa Bioethics Training Program. She participated in development of the paper framework, first draft of the paper, and the review of subsequent drafts.

Eric M. Meslin is a professor at Indiana University School of Medicine. He also serves as Director of the Indiana University Center for Bioethics. He participated in the development of the paper framework, the first draft and review of subsequent drafts, and approved the final version.

Adnan A. Hyder is a Professor of International Health and Director of Health Systems in the Department of International Health at Johns Hopkins Bloomberg School of Public Health; and Associate Director of Global Bioethics at the Johns Hopkins Berman Institute of Bioethics. He is Co-Director of the Fogarty Africa Bioethics Training Program and helped develop the first draft of the paper and reviewed subsequent drafts.

Appendix 1. SUB-SAHARAN AFRICA WRITING PROJECT

Questionnaire for PIs for describing program and content

NOTE: Majority of questions require Yes/No answers. The questions highlighted in BOLD require brief descriptions.

Contributor Information

Paul Ndebele, Medical Research Council of Zimbabwe (Zimbabwe)

Douglas Wassenaar, University of KwaZulu-Natal (South Africa)

Solomon Benatar, University of Cape Town (South Africa)

Theodore Fleischer, University of Cape Town (South Africa)

Mariana Kruger, Stellenbosch University (South Africa)

Clement Adebamowo, University of Ibadan (Nigeria)

Nancy Kass, Johns Hopkins Bloomberg School of Public Health (USA)

Adnan A. Hyder, Johns Hopkins Bloomberg School of Public Health (USA)

Eric M. Meslin, Indiana University School of Medicine (USA)

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Research ethics committees Basic concepts

For capacity-building.

www.who.int/ethics/publications/en/

WHO Library Cataloguing-in-Publication Data

Research ethics committees : basic concepts for capacity-building.

1. Ethics, Research - education. 2. Ethics committees, Research - organization and administration.

3. Research support as topic. 4. Manuals. I. World Health Organization.

ISBN 978 92 4 159800 2 (NLM classification : W 20.5)

© World Health Organization 2009

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Acknowledgements ... 4

Glossary ... 5

Introduction ... 9

Research ethics committees ... 11

Ethical analysis ... 19

Organizing a training programme ... 25

Evaluation of risks and benefits ... 29

Confidentiality ... 37

Informed-consent process ... 43

Annex 1 Financial conflicts of interest in medical research ... 51

Annex 2 Guidelines and regulations ... 63

Acknowledgements

This document was prepared by Carl Coleman, Trudo Lemmens, Tarun Mehra and Aissatou Toure, under the coordination of Marie-Charlotte Bouësseau, Ethics and Health Unit, Department of Ethics, Equity, Trade and Human Rights, WHO. We gratefully acknowledge the technical and financial assistance of the PATH Malaria Vaccine Initiative and the inputs of Mylène Botbol Baum, Marc Guerrier, Reva Gutnick and Laurence Lwoff.

A variation on consent where a person who does not possess full com- petence to give informed consent gives affirmative agreement to partic- ipate in research. For instance, a child or person with dementia should give assent before being enrolled in research. However, it is important to note that assent does not eliminate the need for obtaining the per- mission of a parent or other legally authorized decision-maker.

Bioethics :

A field of ethical enquiry that examines ethical issues and dilemmas arising from health, health care and research involving humans.

Competence :

Refers to a potential or enrolled participant’s mental capacity to provide informed consent.

Consent form :

An easily understandable written document that documents a potential participant’s consent to be involved in research and describes the rights of an enrolled research participant. This form should communicate the following in a clear and respectful manner : research timeframe ; title of research ; researchers involved ; purpose of research ; description of research ; potential harms and benefits ; treatment alternatives ; state- ment of confidentiality ; information and data to be collected ; how long the data will be kept, how it will be stored and who can access it ; any conflicts of interest ; a statement of the participant’s right to withdraw from participation at any point ; declarative statement of understanding that the potential participant agrees to and signs. The consent form should be in a language the potential participant understands. For potential participants with limited literacy, the verbal communication of the consent-document details should be provided along with proper documentation of consent, if it is given.

De-identification and data linkage :

The process of de-identification (anonymization) and linking of collected research trial data and identifiable private information. This process ensures that items of data are not individually identifiable, but provides a mechanism for appropriate access to identifiable information.

Ethical guidelines :

Guidance documents which assist with decisions relating to the responsi- bility to adhere to established and relevant standards of ethical principles and practice.

Personal data :

Data that relate to a living person and contain personally identifying information.

Principal investigator (PI) :

The main researcher overseeing or conducting the research process.

Researcher :

A person who engages in the methodical and systematic investigation of hypotheses with the goal of contributing to new knowledge.

Research ethics committee (also known as ethical review board (ERB), ethical review committee (ERC), human research ethics committee (HREC), institutional review board (IRB)) :

Group of individuals who undertake the ethical review of research proto- cols involving humans, applying agreed ethical principles.

Research involving human participants :

Any social science, biomedical, behavioural or epidemiological activity that entails systematic collection or analysis of data with the intent to generate new knowledge ; in which human beings :

1) are exposed to manipulation, intervention, observation or other interaction with investigators, either directly or through alteration of their environment ; or

2) become individually identifiable through investigators’ collec- tion, preparation or use of biological material or medical or other records.

Research protocol :

A document written by the investigator(s), which should contain a project summary ; general information ; background rationale ; references and literature review ; study goals and objectives ; study design ; meth- odology ; safety considerations ; follow-up ; data management considera- tions and statistical analysis ; quality assurance ; expected outcomes of the study ; dissemination of results and publication policy ; duration of the project ; problems anticipated ; project management ; ethical consid- erations ; informed-consent documents ; budget ; funding organizations ; collaborations ; curriculum vitae of each investigator ; list of all current projects ; duration and percentage of time spent on this project ; any financing or insurance.

Requirement by the research ethics committee to alter the protocol in some way prior to approval or additional review by the committee.

Introduction

This manual and CD-ROM grew out of a training workshop organized by WHO in Ouagadougou, Burkina Faso in July 2007, with participants from seven Francophone African countries (members of research ethics committees and researchers). The workshop was prepared with a group of facilitators from Africa, Europe and North America and focused on the discussion of case-studies. Its main objective was to introduce basic ethical concepts useful for the ethics review of research protocols involving human participants.

The manual and CD-ROM are intended to help research ethics com- mittees in low-income and middle-income countries to design train- ing programmes for ethics committee members, researchers, national regulatory authorities, medical school faculty and other interested stakeholders from health care and research. The manual contains six introductory chapters on general topics : the role of research ethics committees, ethical analysis, training programmes, evaluation of risks and benefi ts, confi dentiality and informed consent, with annexes covering fi nancial confl icts of interest in medical research and inter- national guidelines and regulations. The CD-ROM reproduces the printed manual and also provides an extensive bibliography, case- studies designed for use in training programmes and links to addi- tional resources.

These materials are presented as a starting-point for a basic research ethics training programme. They are designed to draw attention to critical issues, without necessarily resolving them. They are not intended to be an exhaustive summary of all issues in research ethics.

Moreover, they should not be viewed as “guidelines” that committees must follow in reviewing research protocols.

Research ethics committees review proposed studies with human partici- pants to ensure that they conform to internationally and locally accepted ethical guidelines, monitor studies once they have begun and, where rel- evant, take part in follow-up action and surveillance after the end of the research. Committees have the authority to approve, reject or stop studies or require modifi cations to research protocols. They may also perform other functions, such as setting policies or off ering opinions on ongoing ethical issues in research.

Review by a research ethics committee is required by international ethical standards governing research involving human participants, as well as by local law in many jurisdictions. In international cooperative research, review may be required by the laws of the country in which the research is being sponsored, even if it is not required by the host country’s own laws. Review is also essential if the researchers intend to publish the results of their inves- tigation, as most medical journals will not publish the results of research that has not received the approval of a research ethics committee.

The main responsibility of a research ethics committee is to protect potential participants in the research, but it must also take into account potential risks and benefi ts for the community in which the research will be carried out. Its ultimate goal is to promote high ethical standards in research for health.

Structure and functions of research ethics committees

Some research ethics committees operate within research institutions (where they may be known by diff erent names, including “institutional

ethics committees

review board” (IRB)), while others operate on a regional or national basis. The advantage of research ethics committees that operate within research institutions is that they are familiar with the local conditions and can engage in closer monitoring of ongoing studies. The disadvantage is that the committee may feel inhibited from rejecting or requesting significant changes to studies, given the institution’s financial interest in attracting externally funded research projects. Regional and national committees are further removed from the site where the research is conducted, but they may provide greater consistency and have greater legitimacy in the eyes of the research community and the public. In coun- tries with multiple committees, it is important to develop mechanisms to promote consistency and avoid unnecessary duplication of work.

The functions of research ethics committees include identifying and weighing up the risks and potential benefits of research ; evaluating the process and materials (printed documents and other tools) that will be used for seeking participants’ informed consent ; assessing the recruit- ment process and any incentives that will be given to participants ; evaluating risks to participants’ confidentiality (and the related risk of discrimination) and the adequacy of confidentiality protections ; and examining any other issues that may affect the ethical acceptability of the research. In international research, the committee represents the interests of the local population. Thus, it should ensure that the partici- pants and their communities will receive fair benefits from the arrange- ment. In studies involving medical interventions, research ethics com- mittees must determine that adequate care and treatment will be provided for participants (see e.g. Guidance Point 14 in the UNAIDS/

WHO publication Ethical considerations in biomedical HIV prevention trials 1 ). This can be a significant issue in studies involving placebo controls (see Declaration of Helsinki, Section 32 2 ). Committees should consider what will happen to participants who need medical attention

1 http ://data.unaids.org/pub/Report/2007/jc1399-ethicalconsiderations_en.pdf, accessed 18 January 2009.

2 http ://www.wma.net/e/policy/b3.htm, accessed 17 January 2009.

during or after the study, either because they suffer injuries as a result of participation or because of the natural progression of a pre-existing illness. Sponsors’ obligations to provide care in such circumstances should be clearly established before a study begins and made clear to potential participants during the informed-consent process.

In the light of their role in identifying and evaluating the risks and benefits of research, research ethics committees must include indi- viduals with scientific and medical expertise. Without such expertise (supplemented, when necessary, by consultants in particular special- ties), they will not be in a position to understand the procedures to be used in the study and their potential consequences for participants.

In addition, committees must be able to assess the scientific validity of the study design to ensure that it is capable of producing reliable information. A badly designed study that will not result in usable data cannot support any level of risk. In some research oversight systems, the primary responsibility for scientific review rests with separate

“scientific review committees”, but even when this is the case, it is important for the members of the research ethics committee to have a basic level of scientific literacy.

Research ethics committees should not, however, be made up exclu- sively of scientific experts. Some types of risks and benefits may be more easily identified by non scientific members, particularly those related to social, legal or cultural considerations. In addition, once risks and benefits have been identified, determining whether the relationship between them is reasonable requires value judgements as well as scientific analysis. A diversity of backgrounds and quali- fications (in medicine as well as law, social sciences, etc.) can help ensure that these judgements are not inappropriately dominated by a single perspective. Social diversity and gender balance should also be reflected in the committee’s composition.

Research ethics committees

Committees also need broad community representation to identify rel- evant local attitudes or practices about which the researchers should be sensitive. For example, in some communities, it may be considered inappropriate to approach individuals about research participation before consulting community leaders. Input from community mem- bers will also enable the committee to assess the understandability of the information that will be provided to prospective participants as part of the informed-consent process.

The membership should be designed to minimize the potential impact of conflicts of interest on the decision-making process. For example, it is important for institutional research ethics committees to have members who are not affiliated with the institution and for Government-sponsored committees to have members who are not employed by the Govern- ment. In addition, members who have a conflict of interest with respect to a particular study should not participate in the review of that study.

Support and oversight

Research ethics committees need staff and funding to support their operations. It is not inappropriate to charge research sponsors a fee for review by the committee, but the fees should be based on the actual costs of review. Funding mechanisms should be designed to ensure that committees and their members have no financial incentive to approve or reject particular studies.

Members should receive training in the international and local ethi- cal and legal standards governing research, as well as in the process the committee uses to review and approve protocols. Non scientific members should be given an understanding of medical terminology and research methodology sufficient to enable them to participate intelligently in the committee’s discussions. A good knowledge of the social and cultural context is also important. Training should not be a single occurrence, but instead should be an ongoing process in which all committee members participate.

Committees should be subject to ongoing oversight, both to ensure that they are following applicable standards and procedures and to determine whether their actions are actually improving the ethical quality of research. Some committees may choose to undergo a formal accreditation process with national or international organizations.

Other oversight mechanisms include regional or national meetings for the purpose of exchanging information about best practices, or partnerships between committees from different countries. Commit- tees can also undertake initiatives to assess the impact of the review process on research participants – for example, by soliciting feedback through suggestion boxes or at community meetings, or by sending representatives to study sites to see if the committee’s guidance to investigators is actually being followed.

Ethics does not prescribe a specific set of rules or policies. Instead, it provides a framework for evaluating problems and determining an appropriate course of action. Ethical analysis should reflect both inter- nationally accepted norms and locally relevant cultural values.

One approach to ethical analysis is to identify a set of governing prin- ciples and then apply those principles to evaluate the appropriateness of particular behaviour. In bioethics, the most commonly identified principles are :

1) individual autonomy (the ability to make decisions for oneself) ; 2) beneficence (the obligation to “do good” for others) ;

3) nonmaleficence (the obligation to avoid causing harm to others) ; and

4) justice (the value of distributing benefits and burdens fairly).

These principles provide a general framework for analysis, which can then be applied to the facts of a particular ethical dilemma to reach a resolution.

For example, consider a study in which researchers propose to assign individuals randomly to an experimental HIV vaccine or a placebo. The principle of autonomy suggests that, as long as the individuals are ade- quately informed of the risks and benefits, they should be free to decide for themselves whether to participate or not. However, the principle of beneficence might lead a research ethics committee to require that the researchers offer participants counselling about risk-reduction meth- ods and possibly care for individuals who become infected during the study. Based on the principle of nonmaleficence, the committee would have to consider whether participating in the study might harm indi- viduals by leading them to think that they are protected from infection

Ethical analysis

and therefore do not need to use risk-reduction measures. Finally, the principle of justice would require consideration whether the burdens of the study fall disproportionately on particular populations.

The principle-based approach to ethical analysis has been criticized as overly vague. This vagueness is due not only to the open-ended nature of each of the principles, but also to the fact that, in many situations, some of the principles may point in different or even obviously con- flicting directions. In the example above, a research ethics committee might be inclined to approve the proposal based on the principle of individual autonomy, but the other principles might suggest that the methodology should be modified or the target population altered.

Some people also assert that the principle-based approach to ethics inappropriately prioritizes the cultural values of Western societies, particularly the principle of individual autonomy.

An alternative to principle-driven ethical analysis is a process known as “casuistic” reasoning. Instead of starting with abstract principles, the casuistic decision-maker begins by evaluating illustrative prior cases. Through the process of inductive reasoning, a judgement is made about the implications of these cases for resolving the particu- lar issue at hand. For example, in evaluating the HIV vaccine trial, a research ethics committee might start by looking at other studies in analogous areas, such as vaccine trials related to other diseases, HIV studies not related to vaccines, or placebo-controlled studies involv- ing preventive interventions. It would then seek to identify ways in which these other studies are both similar and different from the vac- cine study under consideration.

It is not necessary to choose between principle-based and casuis- tic ethical analysis. In fact, most research ethics committees rely on a combination of both methods. Thus, they may consider not only whether a proposed study is consistent with abstract principles like autonomy and justice, but also how it compares with other studies the committee has reviewed in the past.

Ethical analysis in the context of vulnerable populations

Some individuals or communities face a greater-than-usual risk of being enrolled in research in violation of basic ethical standards. These risks can arise from a variety of sources. For example, some individu- als face limitations in their ability to provide informed consent to research because of factors like immaturity or cognitive impairment.

Vulnerability can also stem from individuals’ relationships with others, such as when an employee is asked to participate in research being conducted by a supervisor, or when a student is asked to participate in a study being conducted by an instructor or mentor. Social factors, such as poverty and lack of access to health care, can also make indi- viduals vulnerable to coercion, exploitation or other risks.

International regulations and guidance documents on research require additional protections in studies involving vulnerable par- ticipants. For example, the CIOMS guidelines 1 provide that “special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are selected, the means of protecting their rights and welfare must be strictly applied”. “Special justifica- tion” exists when :

1) the research could not be carried out as well with less vulnerable subjects ;

2) the research is intended to obtain knowledge that will lead to improved diagnosis, prevention or treatment of diseases unique to the vulnerable class ;

3) subjects will be assured reasonable access to any diagnostic, preventive or therapeutic products that will become available as a consequence of the research ;

4) the risks will not exceed those associated with routine medical examination of such persons ; and

1 Council for International Organizations of Medical Sciences/World Health Organization.

International ethical guidelines for biomedical research involving human subjects.

Geneva, World Health Organization, 2002.

5) when prospective subjects are either incompetent or otherwise unable to give informed consent, their agreement will be sup- plemented by the permission of their legal guardians or other appropriate representatives.

The process of ethical deliberation

In ethics, the process by which a decision is made is as important as the outcome. For a decision to be ethically legitimate, it must be made in an open and inclusive process that takes into account the views of all stakeholders. Thus, research ethics committees should be encouraged to include individuals from diverse professional and social backgrounds and, where appropriate, to solicit input proactively from the community.

Most committees make decisions through a process of consensus.

This means that, instead of taking a vote and following the decision of the majority, they strive to make decisions that most people in the committee feel comfortable accepting. While there may be situations in which a few members disagree with the committee’s judgement, it should avoid making decisions to which a significant number of members strongly object.

The first step in organizing a training programme on research ethics is to decide on the intended participants. One option is to have a pro- gramme designed solely for committee members. Such a programme could focus on general ethical principles, the roles and responsibilities of members and the process of protocol review. Another option would be to expand the audience to include other stakeholders, including researchers, national regulatory authorities, patient organizations, community representatives or academics. If the audience is expanded, the content of the programme should be modified accordingly. For example, a programme that includes regulatory authorities could include sessions on the role of legislation and regulation in research ethics oversight, as well as sessions on general ethical issues and the process of protocol review.

Whether the group is confined to members of a single committee or brings together interested stakeholders from a variety of organiza- tions, it is a good idea to ensure that the participants represent a diversity of backgrounds and perspectives. Thus, even if the pro- gramme is limited to committee members, it should include individu- als with both medical and nonmedical backgrounds, persons who are affiliated with research institutions and those who are not, and persons who represent a variety of cultural perspectives. Having a diverse audience will help ensure that all points of view are included in the discussion.

While it would be possible to create a comprehensive training pro- gramme lasting several days that addresses all of the issues discussed in these materials, it can also be valuable to offer shorter sessions limited to one or a few issues. For example, a short programme could

Organizing a training

be devoted solely to informed consent or confidentiality. Committees that meet on a regular schedule could consider holding short training programmes on selected topics at the beginning of each meeting.

Training methodologies

Training programmes are most effective when they rely on a combina- tion of lecture and discussion. For the lecture portion, it can be useful to have more than one speaker presenting on each issue, so that the participants can hear different perspectives. For example, in a session on informed consent, an academic ethicist could discuss general ethi- cal principles, a researcher could talk about the process of communi- cating medical information to prospective research participants and a community representative could talk about cultural issues relevant to the informed-consent process.

For the discussion portion of the programme, one effective method is to break the audience up into smaller groups (ideally, no more than eight people per group) to discuss a case-study. The case-studies can be taken from the CD-ROM or adapted from other sources. If you use a real protocol to create a case-study, make sure you eliminate any references to confidential information. Case-studies should be rela- tively short, so that the participants can read them quickly, and they should focus on issues that have no obviously right or wrong answer.

Before groups begin discussing the case-studies, they should select rapporteurs who will take notes on the discussion.

After the small-group discussions, the large group should reconvene so the rapporteurs from each group can give brief presentations of each group’s observations and conclusions. The purpose of this proc- ess is not to determine which group has come up with the “correct”

response, but to highlight areas of consensus and disagreement. The programme moderator can use the areas of disagreement as a spring- board for further discussion.

Organizing a training programme

Typology of research risks

For subjects

• Risks to physical integrity, including those associated with experi- mental drugs and treatments and with other interventions that will

Evaluation of risks and benefits

• The complexity of the notion of risk, as well as the uncertainty of the potential benefi ts of research, make the process of risk/benefi t assessment a signifi cant challenge for research ethics committees.

• Risk/benefi t assessment does not stop at the individual;

it must also take into account communities and health systems.

• The risks of research are not limited to potential physical harms, but can also include psychological, social, legal and economic ramifi cations.

• Evaluation of the benefi ts of research must distinguish between direct benefi ts for the individuals who participate in the study, expected benefi ts for the community in which the study will take place and potential benefi ts to science and the world at large.

• Identifying and evaluating risks and benefi ts is not a purely scientifi c endeavour. It requires the involvement of all stakeholders in research, including investigators, community and civil society representatives, lawyers, health authorities, etc.

be used in the study (e.g. procedures used to monitor research participants, such as blood sampling, X-rays or lumbar punc- tures).

• Psychological risks : for example, a questionnaire may represent a risk if it concerns traumatic events or events that are especially stressful.

• Social, legal and economic risks : for example, if confidential infor- mation collected during a study is inadvertently released, partici- pants may face a risk of discrimination and stigmatization.

For the community

• Certain ethnic or population groups may suffer from discrimination or stigmatization as a result of research, particularly if members of those groups are identified as having a greater-than-usual risk of having a particular disease.

• The research may have an impact on the existing health system : for example, human and financial resources devoted to research may divert attention from other pressing health care needs in the community.

What are the different phases of risk/benefit assessment ?

Identifying risks

This is first and foremost a task for the investigator, who must specify the nature, characteristics and scale of the risks in the research proto- col submitted to the research ethics committee. The committee should carefully consider the description of risks contained in the protocol, but it should not assume that this description is necessarily accurate or complete. This is particularly true with respect to social risks, which may stem from local conditions or attitudes of which the investigators and sponsors may not be aware.

Identification of the expected benefits

Medical research involves diff erent types of interventions.

• Interventions that hold out the prospect of a direct diagnostic, thera- peutic or preventive benefi t for the individual participants. Some ethical guidance documents state that these types of interventions should not be provided in the context of research unless there is a reasonable basis for expecting that they will be “at least as advan- tageous to the individual subject ... as any available alternative”

(CIOMS Guideline 8).

• Interventions that do not hold out the prospect of direct benefi t for the subject, but are expected to produce scientifi c information that may benefi t society in the future. The risks presented by such inter- ventions must be “reasonable in relation to the importance of the knowledge to be gained” (CIOMS Guideline 8).

After having given their consent, participants in a study about treatments for HIV/AIDS are treated for a specifi c period during which they are required to attend a hospital regularly for monitoring purposes.

The protocol stipulates that if the participants fail to attend for their appointment, they are to be contacted by phone and if necessary a member of the research team will go to their home. The informed-consent materials failed to mention this procedure. In the small town concerned, where everyone knows everyone else, a visit by health workers who are known to work in services treating persons with AIDS gives rise to suspicion. The participants may fi nd themselves victims of exclusion by their family or workmates. In this example, the research ethics committee should have suggested to the investigators alternative measures for monitoring that would not subject participants to a risk of stigmatization.

Evaluation of risks and benefi ts

These two types of benefi ts must be clearly distinguished from ben- efi ts (“perks”) participants may receive in exchange for their partici- pation, such as payments for time spent participating in the study.

While study participants may value these perks, the research ethics committees should not consider them “benefi ts” of the study for the purposes of the risk/benefi t assessment.

Evaluation of the risk/benefit ratio

Any type of research must be preceded by a scrupulous evaluation of the relationship between the risks and the potential benefi ts for the participants and/or their communities. This evaluation requires a thorough and up-to-date knowledge of the scientifi c literature.

Comparison of the risks and benefi ts of research must avoid two pitfalls :

• underestimating the risks and/or overestimating the potential benefi ts, either of which can result in exposing participants to unjustifi ed harm

• overestimating the risks and/or underestimating the potential ben- efi ts, thereby holding back potentially benefi cial research.

For research ethics committees, evaluation of the risk/benefi t ratio is a complex task resulting in a decision which, even when based on precise data, cannot completely exclude uncertainty. In addition, diff erences

Risk evaluation for a study of a vaccine against rotavirus infections

According to the epidemiological data, in the United States rotavirus infections are responsible for 500 000 consultations, 50 000 hospital admissions and 20 deaths each year whereas, in developing countries, they account for 25 million consultations, 2 million admissions to hospital and 400 000- 500 000 deaths.

The potential benefi ts of the study are greater in countries where the need for the vaccine is higher.

deriving from the different social and cultural environments in which the research is carried out have to be taken into account, further com- plicating this evaluation.

In order for the committee to perform an adequate risk/benefit assess- ment, the level and type of risks to which participants may be exposed must be described in detail in the protocol. Committee members should not, however, base their assessment solely on the information in the protocol, but should also actively seek out additional informa- tion, consulting experts and exchanging information with other com- mittees when appropriate.

Quantitative and qualitative evaluation of the risks and benefits for par- ticipants and their community presupposes that the members of the committee are properly trained and well-acquainted with the social, cul- tural and economic context. A multidisciplinary approach is essential to the quality of the evaluation, and the composition of the committee must ensure that the required skills are represented. Continuing education for committees, together with sharing and critical analysis of experiences with other committees, help considerably in enhancing their skills.

In the field of research, there is no such thing as zero risk ; however, ethical review of research must contribute to a practical solution in order to minimize risks and maximize benefits, while ensuring respect for persons and providing the best possible response to the health needs of populations.

Confi dentiality in medical ethics

The ethical principle of confi dentiality, already mentioned in the Hippocratic Oath, forms a cornerstone of the relationship between the patient and his or her physician. While the relationship between researchers and research subjects is diff erent from the traditional physician/patient relationship, protecting confi dentiality remains an important goal.

Confi dentiality is emphasized in medical ethics to build up trust, allow- ing individuals to reveal all information necessary to treat their medi- cal condition, no matter how sensitive it may be, without having to fear public disclosure. This trust is paramount not only in guaranteeing appropriate medical treatment, but also in protecting public health, as untreated conditions may pose a signifi cant threat to other persons. The obligation of nondisclosure is protected by law in many countries.

Confidentiality

• Confi dentiality is a fundamental principle in health-care ethics.

It applies not only to medical treatment, but also to medical research with human participants.

• It is necessary to safeguard all personal information from unauthorized disclosure.

• Research ethics committees must ensure that basic standards of information protection are guaranteed.

• Confi dentiality issues must be taken into account in the informed-consent process.

Participation in research may lead to information disclosure that could have a negative impact on the participant and/or his or her family and community. Therefore, all personal information must be safeguarded, whether or not the researcher and participant are in a formal physician/

patient relationship. This applies even to personal information that the researchers would not consider particularly “sensitive”.

In limited circumstances, physicians and/or researchers may be permit- ted, or even required, to reveal confidential information. Generally, these involve situations in which an individual poses an immediate danger to third parties, such as when mentally ill patients make credible threats of violence against specific individuals.

What information is safeguarded ?

All personal information must be safeguarded. Personal information includes all information “relating to an identified or identifiable natural person (‘data subject’) ; an identifiable person is one who can be identi- fied, directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his physical, physiologi- cal, mental, economic, cultural or social identity” (Chapter 1, Article 2a of European Parliament and Council Directive 95/46/EC 1 ).

This includes all information by which an individual can be identified, includ- ing but not limited to the following : name, social security number, address, phone number, etc. identifying features, information that reveals that an individual is a member of a small group of people, such as the fact that a person works in a particular office or lives in a particular apartment build- ing, a combination of information, such as physical appearance, date of birth and place of work, that together can reveal the individual’s identity.

1 Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (http://europa.eu/scadplus/leg/en/lvb/l14012.htm, accessed 18 January 2009.

All information related to an identified or identifiable person must be safeguarded, but particular care should be taken with respect to sensi- tive information such as the following :

Medical information : medical history, current diagnoses and treat- ments (especially for potentially stigmatizing conditions), mental status, substance abuse, genetic characteristics.

Social status : level of education, family status, employment status, financial information, such as income level.

Other information : sexual orientation and practices, religious beliefs, political affiliation, risky behaviours.

Confidentiality issues that ethics review committees must consider

Ethics review committees must look closely at how information obtained during the trial will be protected from disclosure and ensure that the risk that patients will suffer negative consequences due to information disclosure is reduced to a minimum.

This includes information related to an individual’s participation in a certain trial (e.g. an HIV vaccine trial), information uncovered during the research (e.g. HIV test results) or information uncovered after the research (e.g. when researchers use participants’ identifiable tissue samples in subsequent research projects).

Ways to minimize confidentiality risks

• Only collect data that can lead to the identification of research par- ticipants if this information is necessary for the successful comple- tion of the research project. In some cases, confidentiality risks can

be avoided by not collecting any identifiable information.

• When identifiable information must be collected, consider replac- ing individuals’ names with code numbers and storing the key to the code in a secure location accessible only to a limited number of persons. Destroy the key code when it is no longer necessary to link data with identities for the purpose of research. If linkable informa- tion (that is, potentially identifiable data) is held, the purpose of this storage, its duration and the persons who will be granted access to it must be made explicit.

• Increase researchers’ awareness of confidentiality issues by provid- ing guidance and training.

• Ensure that information is secured by limiting access, using safe storage methods (e.g. locked drawers and password-protected com- puter access) and using protected means of communication (e.g.

encrypted electronic messages).

• Destroy information as soon as it is no longer needed.

Confidentiality and informed consent

The duty to safeguard participants’ information has consequences for the way the process of informed consent is handled.

Firstly, participants should be informed about any personal informa- tion that will be collected, who will have access to that information, the confidentiality protections that will be implemented and the risks that could arise if the information is improperly disclosed.

Secondly, in some circumstances, it may be impossible to guarantee full confidentiality protection. For example, in a study of a serious communicable disease, researchers may be required to report individ- uals who test positive for the disease to the public health authorities.

Absolute confidentiality should not be promised if it cannot be guar- anteed, and full transparency about data-sharing must be the rule.

The process of informed consent : its meaning and origins

Informed consent to participate in research is related to fundamental ethical principles : respect for the persons, their dignity and autonomy.

This process is set forth in the fi rst provision of the Nuremberg Code, which was developed in response to the atrocities committed under the guise of medical research in Nazi Germany :

Informed-consent process

• Consent is both a dynamic and an interactive process.

• Informed consent is the process whereby a person decides, free from any form of coercion or undue infl uence, to participate in research after having been apprised of information relevant to the decision.

• Individuals cannot provide informed consent to research unless they are legally capable. Individuals who do not have the legal capacity to provide consent, such as children or cognitively impaired adults, should not be enrolled in research without the consent of a parent or other surrogate decision-maker.

• The social and cultural context must be taken into account in designing and implementing the informed- consent process.

What elements are required in order for the consent process to be valid ?

In order to be valid, the consent process must :

• precede any intervention

• be based on adequate information that the subject is capable of understanding

• be freely given, i.e. not the result of coercion or undue infl uence

• be clearly given and recorded.

1 Available online at : http ://ohsr.od.nih.gov/guidelines/nuremberg.html, accessed 17 January 2009.

The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching [deception], or other ulterior form of constraint or coercion;

and should have suffi cient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.

This latter element requires that before the acceptance of an affi rmative decision by the experimental subject there should be made known to him the nature, duration and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the eff ects upon his health or person which may possibly come from his participation in the experiment.

The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity 1 .

What information must be given to prospective participants as part of the informed-consent process ?

Before consenting to participate in research, individuals should be informed of the following :

• that it is a research activity designed to produce scientific knowl- edge and the ways in which participating in research differs from receiving medical treatment in the context of an individualized phy- sician/patient relationship

• the duration of the study and the procedures to be employed

• the risks and inconveniences associated with participating in the study

• the potential benefits for the participants and/or the community ; if there are no potential direct benefits to participants, that fact should be made clear

• alternative treatments that exist, if applicable

• measures taken to protect the confidentiality of personal information

• the voluntary and reversible nature of consent, i.e. of their right to withdraw at any time from the study without any penalty

• what they should do in case they experience adverse effects from the research

• whether they will be compensated in the event they experience harm from the research

• whether they will be able to continue receiving the interventions provided in the research after the study ends.

Consent and risk

Even if the potential participant is likely to give consent in any case, disproportionate risk-taking is not justified. Investigators must ensure that reasonable measures are taken to minimize the risks involved in the research and to enhance its benefits.

What are the key points for evaluating informed-consent procedures ?

• Identification of all the information that must be provided to poten- tial participants.

• Verification that all the necessary information is included in the information document and the information aids used.

• Assessment of the comprehensibility of the information, taking into account the persons for whom it is intended.

• Evaluation of the methods/procedures that will be employed to convey the information.

• Evaluation of any constraints that might influence consent.

• Evaluation of the specific social and cultural circumstances and of how they affect the validity of consent.

Compliance with the process of informed consent within the frame- work of multicentre trials poses new challenges for investigators and research ethics committees. Special attention needs to be given to those factors that might undermine the validity of the process :

• the social and economic context : illiteracy, inadequate access to care

• the cultural environment : the role of the community and family and of different sets of values

• the asymmetrical nature of the knowledge of the investigators and that of the participants, which puts the latter in a subordinate rela- tionship

• the tendency of individuals to confuse being a participant in research with receiving individualized medical care (the “therapeutic miscon- ception”).

The tenofovir trial in Cameroon

This placebo-controlled trial involving a group of seronegative illiterate prostitutes in Douala in Cameroon was designed to demonstrate the preventive capacity of the molecule in tenofovir.

Despite its importance, the trial generated considerable debate regarding its ethical legitimacy. The consent process was potentially jeopardized by the vulnerability of the participants and their diffi culty in understanding the notion of a placebo.

This trial has shown that certain situations of vulnerability require special eff orts to convey information.

Trudo Lemmens, Associate Professor, Faculties of Law and Medicine, University of Toronto, Canada 1

A conflict of interest (COI) in research exists when researchers or institu- tions in which the research takes place have specific interests which might affect the primary obligations associated with research. It is not necessary to prove that the conflict will inevitably influence a person’s behaviour.

Conflict-of-interest strategies are preventive : they aim at avoiding situa- tions that could have a negative influence on researchers’ most important duties, or that could reasonably be perceived as having such an influence.

The following questions have to be asked in the context of research : what are the primary professional obligations of researchers ? What secondary interests can affect these obligations ? What is the appropriate measure to deal with a conflict of interest, in the light of its potential impact ?

Identification of conflicts of interest in medical re- search

Professional obligations of researchers

In research involving human subjects, the protection of the rights and well-being of the research subjects remains the most important concern

1 Specially commissioned for this document ; not discussed at the workshop.

Financial conflicts of interest

In medical research.

(Declaration of Helsinki, principle 6). Researchers also have a primary obligation to conduct good research. Sometimes, patients do better when enrolled in a clinical trial than in ordinary clinical care. Yet partici- pation in research also involves risks. When there is a tension between the obligation to conduct good research and the protection of research subjects, the obligation to protect the subjects takes priority.

Types of financial conflict of interest in medical research

In clinical research, per capita payments are often used as a financial incentive to stimulate or speed up subject recruitment. Researchers are often paid for time spent with research subjects, for filling out question- naires and research forms, for blood and tissue collection and for admin- istrative procedures. Payments given for the sole purpose of recruiting patients are termed “finder’s fees”, and they often form a hidden part of general payments for services provided. Researchers are sometimes paid more generally per project. They are sometimes paid per annum as consultants to a sponsor. Researchers may receive expensive research equipment, books or payment for speaking at conferences. Many researchers are members of speakers’ bureaux or sit on advisory boards of pharmaceutical sponsors, and are paid for these services. Indirect benefits can also result from research participation, such as paid par- ticipation at conferences. Additional benefits of such participation are air-miles which can then be used for personal travel. Researchers may own shares in the company that produces the product they are studying, or may receive stock options for their participation in research.

Potential impact of conflicts of interest

Financial interests may have a negative impact on the protection of the rights and well-being of the research subjects. Financial interests may push researchers to disrespect inclusion criteria, to disrespect informed-consent procedures, to pressure research subjects to remain in a trial, or to continue a trial which should be stopped.

Money can influence behaviour in medical research, as in other walks of life. There is rarely, if ever, clear proof of such influence. It may be subtle

and is often unconscious. It seems impossible to measure concretely how much impact financial interests have on someone’s actions.

Financial interests may threaten the integrity of the research process.

They may influence the design of the study, the way it is conducted, the interpretation of research data and the presentation of the final results.

Empirical studies have established a statistically significant link between source of funding and research outcome. Industry-sponsored research is more likely than non-commercially-sponsored research to lead to a conclusion that a new therapy is better than the standard therapy. There is systematic evidence of under-reporting of negative studies. There is also evidence of conscious manipulation of research questions and dissemination of results. Unfortunately, financial interests have also led academic researchers to put their name on publications written by spe- cialist agencies working directly for the sponsor of the study.

The availability of strong financial incentives in industry-sponsored research may make it harder for non-industry-sponsored trials (e.g.

on neglected diseases) to find sufficient researchers or research sub- jects, or to obtain institutional support for a study, thus distorting the research agenda.

Remedies for financial conflicts of interest

Regulatory remedies

Academic institutions, funding agencies, professional organizations and regulatory agencies should adopt conflict-of-interest policies and procedures.

Researchers should disclose any financial interest in the subject of their research to the research ethics committee. The committee should con- sider whether these interests should be disclosed to prospective par- ticipants as part of the informed-consent process. Researchers should

ensure that all conflicts of interest are disclosed in publications and pres- entations related to the research. The disclosure should contain com- plete information on the nature and extent of the conflict of interest.

Review procedures

Financial interests should be evaluated by a sufficiently independent and publicly accountable research ethics committee or by a specialized con- flict-of-interest committee (COIC). The committee should have access to the research budget and receive information about all other relevant finan- cial interests of investigators and of the institution. If a conflict-of-interest committee reviews the financial interests, it should report any conflicts to the research ethics committee for final evaluation. The research ethics committee should determine how to inform research subjects of these interests and whether other conflict-of-interest measures are needed.

Within academic institutions, review of all research contracts is neces- sary, to avoid that researchers enter into contracts with sponsors that limit their academic freedom or that may create contractual obliga- tions that can affect the protection of research participants. Academic institutions should not allow researchers to enter into contracts that give a sponsor a right of veto over publication.

Ensuring independent oversight of the research process

Research ethics committees may impose some or all of the following con- ditions on research in order to deal with identified conflicts of interest :

• Appointment of an independent consent monitor,

• Appointment of an independent investigator to monitor the research process,

• Appointment of an independent data-monitoring committee, par- ticularly in research that involves patients and may expose patients to significant risks. The data-monitoring committee should review all adverse events and can recommend to the research ethics com- mittee that the research should be stopped. It should also review the proposed statistical methodology, the analysis, the presentation of findings and the final publication of results.

The conditions selected should be proportionate to the risk that the conflict of interest may affect the research or the protection of human subjects.

Prohibitions

A financial conflict of interest may be deemed so significant that an individual or institution should be prohibited from participating in a study. There should be a rebuttable presumption that researchers with significant financial interests ought not to be involved in the research and institutions with significant conflicts of interest ought not to have research take place in that institution. What constitutes a “significant” conflict of interest obviously depends on the social and economic context in which the research takes place, for exam- ple on the salary or consultation payments that health-care work- ers receive in their daily professional practice. National or regional regulatory agencies, funding agencies or professional organizations should provide guidance on this by means of regulations or guide- lines, to ensure that this concept is not misused and avoid too many different interpretations at the local level.

In addition, some types of conflict of interest may be the subject of specific prohibitions. For example, research ethics committees may conclude that the payment of finder’s fees, i.e. payment for the mere recruitment or referral of subjects, should not be allowed. Aca- demic institutions, which have a clear public mandate, should also be strict with respect to potential financial interests among their researchers. An institution may, for example, prohibit researchers who receive full-time salaries from receiving additional payments for recruiting participants for research projects that are related to the researcher’s salaried job.

Registration of clinical trials and results reporting

Mandatory registration of all clinical research and mandatory report- ing of all research results are important to ensure the integrity of medi- cal research. The Declaration of Helsinki now explicitly requires that

all clinical trials must be registered in a publicly accessible database before recruitment of the first subject (DOH principle 19) ; and that authors have a duty to make the results of research publicly available and to report accurately (DOH principle 30). Research ethics commit- tees should impose trial registration as a condition for final approval of the research protocol. They also should ensure that there are no contractual clauses preventing appropriate results reporting and that all research results will be reported at the end of the research.

Bibliography

Association of American Medical Colleges Task Force on Financial Conflicts of Interest in Clinical Research. Protecting patients, preserving integrity, advancing health : accelerating the implementation of COI policies in human subjects research. A report of the AAMC-AAU Advisory Committee on Financial Conflicts of Interest in Human Subjects Research, 2008 (http ://www.aau.edu/WorkArea/showcontent.aspx ?id=6822, accessed 18 January 2009).

Bekelman JE et al. Scope and impact of financial conflicts of interest in biomedical research. Journal of the American Medical Association, 2003, 289 :462-463.

Hampson LA, Bekelman JE, Gross CP. Empirical data on conflicts of interest. In : Emanuel EJ et al. Oxford textbook of clinical research ethics.

Oxford, Oxford University Press, 2008 :767-779.

Lemmens T. Leopards in the temple : Restoring scientific integrity to the commercialized research scene. Journal of Law, Medicine & Ethics, 2004, 32 :641-657.

Lemmens T, Luther L. Conflicts of interest of clinician-researchers. In : Singer PS, Viens A, eds. Cambridge textbook of bioethics. Cambridge, Cambridge University Press, 2008 :222-230.

Lemmens T, Warring DR, eds. Law and ethics in biomedical research : regulation, conflict of interest and liability. Toronto, University of Toronto Press, 2006.

Lexchin J et al. Pharmaceutical sponsorship and research outcome and quality : systemic review. British Medical Journal, 2003, 326 :1167-77.

Thompson DF. Understanding financial conflicts of interest. New England Journal of Medicine, 1993, 8 :573-576.

Guidelines and codes of best practice

Nuremberg Code 1

Established in 1947 in the aftermath of the Second World War to avert future atrocities in the name of science, the Nuremberg Code is a 10-point declaration framing key principles that have become the backbone of research ethics, including the following :

• voluntary, informed consent

• absence of coercion

• opt-out possibility at any time during the experiment

• scientifi c justifi cation and necessity of the experiments

• protection of the research subject against grievous bodily harm

• proportionality of risk.

Declaration of Helsinki 2

The declaration was fi rst adopted in 1964 by the World Medical Asso- ciation, an international organization of physicians. There have since been six revisions, the last in the year 2008. Some of these revisions have been controversial, particularly with respect to the issues of pla- cebo use in clinical trials and access to post-trial care. In addition to reiterating the principle of respect for research subjects, the Declaration of Helsinki underlines the importance of protecting vulnerable popula- tions not capable of giving voluntary consent. Moreover, it stresses the obligation to off er the best proven care to trial participants after the end of the research project. Unlike the Nuremberg Code, the Declaration

2 Declaration of Helsinki, 6th revision (http ://www.wma.net/e/policy/pdf/17c.pdf, accessed 17 January 2009).

Guidelines and regulations

allows surrogates to consent to research on behalf of individuals who lack decision-making capacity.

Belmont Report 1

Outcry over the United States Public Health Service’s study of untreated syphilis among African-American men in Tuskegee, Alabama led to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, whose findings were published in the Commission’s 1979 report “Ethical Principles and Guidelines for the Protection of Human Subjects of Research”, also known as the Belmont Report.

The report identified three major ethical principles that must be observed when conducting research with human beings.

I. Respect for the research participant : Protecting individual autonomy was identified as a central value of research ethics.

As a consequence, informed consent must be obtained before the study may be started. Persons not capable of autonomous decisions must be given special protection.

II. Beneficence : This concept refers to the obligation to secure the participant’s well-being by maximizing possible benefits while minimizing risks. This requires an adequate assessment of risks and benefits.

III. Justice : Ensuring that the benefits and burdens of research are fairly distributed throughout society.

CIOMS : International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002) 2

1 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report : ethical principles and guidelines for the protection of human subjects of research. Washington, DC, Department of Health, Education and Welfare, 1979.

2 Council for International Organizations of Medical Sciences/World Health Organization.

International ethical guidelines for biomedical research involving human subjects. Geneva, World Health Organization, 2002.

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  1. Research ethics committees: Basic concepts for capacity-building

    This casebook has been developed as a teaching tool for instructors and workshop leaders. It contains 64 case studies, each of which raises an important and difficult ethical issue connected with planning, reviewing, or conducting health-related research. Other languages. Arabic pdf, 4.5Mb. French pdf, 4.16Mb.

  2. Research ethics committees: Basic concepts for capacity-building

    Research ethics committees: basic concepts for capacity-building. 1.Ethics, Research - education. 2. Ethics committees, Research - organization and administration. 3.Research support as topic. 4.Manuals. I.World Health Organization. ISBN 978 92 4 159800 2 (NLM classification: W 20.5)

  3. Research ethics committees. Basic concepts for capacity-building

    This manual introduces basic ethical concepts useful for the ethics review of research protocols involving human participants. It intends to help research ethics committees in low-income and middle-income countries to design training programmes for ethics committee members, researchers, national regulatory authorities, medical school faculty and other interested stakeholders from health care ...

  4. Research Ethics Committees: Basic Concepts for Capacity-Building

    This report from the World Health Organization (WHO) covers concepts for capacity-building. This manual contains six chapters on general topics: the role of research ethics committees, ethical analysis, training programs, evaluation of risks and benefits, confidentiality and informed consent, with annexes covering financial conflicts of interest in medical research and international guidelines ...

  5. Research ethics committees: Basic concepts for capacity-building

    Research ethics committees: Basic concepts for capacity-building. Casebook. 29 September 2009 ... or conducting health-related research. Other languages. Arabic pdf, 4.5Mb; French pdf, 4.16Mb . More publications on Global health ethics. More about Global health ethics. WHO Team. Health Ethics & Governance. Number of pages. 71. Reference numbers ...

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  9. Committees: Research Ethics Committees

    Research ethics committees monitor the research in progress and are mandated by law in almost all national legislation around the world dealing with research on human subjects or animals. However, their existence is not something that came about with the advent of human research. ... Basic concepts for capacity building. Geneva: WHO. Google ...

  10. Ethics in human research

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    (2009). Research ethics committees: basic concepts for capacity-building. Retrieved January 21, 2022, ... & L. Horn (Eds.), Research ethics in Africa: A resource for research ethics committees. Sun Media Stellenbosch. In addition, REC secretariats are understaffed and burdened with administrative work leaving less time on the main review ...

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    FINANCIAL RESOURCES FOR RESEARCH ETHICS CAPACITY BUILDING. The global research ethics landscape has expanded considerably since the NBAC study conducted in 1999. Between 2000 and 2012, the Fogarty International Center (FIC) invested approximately US$33 million in research ethics capacity development worldwide.

  17. Research ethics committees basic concepts for capacity- building.pdf

    Introduction This manual and CD-ROM grew out of a training workshop organized by WHO in Ouagadougou, Burkina Faso in July 2007, with participants from seven Francophone African countries (members of research ethics committees and researchers). The workshop was prepared with a group of facilitators from Africa, Europe and North America and focused on the discussion of case-studies.

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  19. REC Ethics Basic Concepts

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