Conflict of interest statement: No conflicts declared
Impact of Three Years Training on Operations Capacities of Research Ethics Committees in Nigeria
Article first published online: 24 SEP 2012
© 2012 John Wiley & Sons Ltd
Developing World Bioethics
Volume 14, Issue 1, pages 1–14, April 2014
How to Cite
Folayan, M. O., Adaranijo, A., Durueke, F., Ajuwon, A., Adejumo, A., Ezechi, O., Oyedeji, K. and Akanni, O. (2014), Impact of Three Years Training on Operations Capacities of Research Ethics Committees in Nigeria. Developing World Bioethics, 14: 1–14. doi: 10.1111/j.1471-8847.2012.00340.x
- Issue published online: 13 MAR 2014
- Article first published online: 24 SEP 2012
- Sidaction. Grant Numbers: NG-04-08-01, NG-04-09-01
- “European & Developing Countries Clinical Trials Partnership” (EDCTP). Grant Number: CB.2008.41302.013
- AVAC Global Advocacy
- developing world;
- research ethics;
- sub-Saharan Africa
- Top of page
This paper describes a three-year project designed to build the capacity of members of research ethics committes to perform their roles and responsibilities efficiently and effectively. The project participants were made up of a cross-section of the membership of 13 Research Ethics Committees (RECs) functioning in Nigeria. They received training to develop their capacity to evaluate research protocols, monitor trial implementation, provide constructive input to trial staff, and assess the trial's success in promoting community engagement in the research.
Following the training, technical assistance was provided to participants on an ongoing basis and the project's impacts were assessed quantitatively and qualitatively. Results indicate that sustained investment in capacity building efforts (including training, ongoing technical assistance, and the provision of multiple tools) improved the participants’ knowledge of both the ethical principles relevant to biomedical research and how effective REC should function. Such investment was also shown to have a positive impact on the knowledge levels of other RECs members (those who did not receive training) and the overall operations of the RECs to which the participants belonged. Building the capacity of REC members to fulfill their roles effectively requires sustained effort and investment and pays off by enabling RECs to fulfill their essential mission of ensuring that trials are conducted safely and ethically.
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Multiple guidelines and regulations have been developed to govern, define and describe the ethical conduct of biomedical research. The existence of these and other documents, however, has not entirely stopped violation of the rights of research participants in both higher and lower income countries. Research participants in developing countries, especially African study participants and communities, are particularly vulnerable to exploitation due to the high levels of poverty, low literacy rates, severely limited access to basic health care, and weak infrastructure for the regulation of biomedical research. Opportunities for exploitation are wide spread and the potential for it exists in HIV research (as it does in all areas of biomedical research), despite the field's dedication to developing new HIV prevention tools, better and more user-friendly treatments, and finding a cure for the infection. Global HIV/AIDS statistics illustrate the urgent need for such research to continue as HIV continues to spread and renewed epidemics occur in regions of the world where the virus was thought to be under control.
Current HIV treatment, prevention tools (such as male and female condoms, circumcision, and prevention of vertical transmission to babies), as well as behavioral intervention efforts, have slowed the spread of HIV but have not stopped it. Although great strides have been made in the availability and affordability of antiretroviral treatment (ART) for people living with HIV, problems of adherence to treatment regimens, drug resistance, side effects, poor medical infrastructures, and the associated high costs of drugs in some areas continue to make ART access difficult for many. Moreover, the most comprehensive ART available does not cure HIV infection. At best, it merely slows down the rate of disease progression.
Research to develop new HIV prevention technologies (including microbicides, Pre-exposure Prophylaxis or PrEP, vaccines, etc.) continues specifically because of the limitations faced by countries struggling to cope with HIV/AIDS. The field is also witnessing a new and urgent desire on the part of community-based stakeholders (those who are the potential end-users of these new tools) to be actively engaged in shaping these research efforts.
The field of HIV/AIDS related research is growing rapidly, both in terms of the number of new trial sites being established and the types of research being undertaken. Unfortunately, this expansion has not been accompanied by commensurate efforts to develop the capacity of local community stake-holders to participate knowledgeably in the field. They need basic background training in the science and ethics of clinical trials in order to make informed contributions regarding research activities.
Building a trusting relationship with the communities hosting clinical trials is critical to the conduct of successful research. The active participation in trial oversight and monitoring by respected community members gives host communities a ‘voice at the table’ and assurance that their interests are represented in the research process. Thus, it is an essential component of community trust building.
Authentic representation, however, cannot be accomplished simply by appointing community members to Research Ethics Committees (RECs) and Advisory Boards without also providing them with the training they need ot participate effectively. Incomplete or inadequate investment in community representation (such as appointing community representatives without equipping them to fill the role effectively), poor research literacy in the community overall (due to lack of outreach and community engagement), lack of consensus on ethical issues, and differing definitions of what constitutes adequate care for trial participants are all problems that can undermine community trust in the research enterprise. Experience over the last decade with the premature closure of HIV prevention trials have demonstrated this. To date, three HIV prevention trials were shut down due to poor community engagement processes, controversies fuelled by the media and lack of consensus on ethical issues.
One strategy for preventing such costly and counter-productive outcomes is the provision of initial and continuing education in the ethics and science of biomedical and behavioral research to community-based stakeholders engaged in research or interested in becoming so engaged. Lay members (non-scientists) of RECs are among those to whom the provision of such education is particularly critical. A REC can be described as “an independent body made up of medical, scientific, and non-scientific members whose responsibility is to protect the rights, safety, and well-being of human participants involved in a clinical trial. Research ethics committees review and approve the initial protocol, review materials to be used in recruiting and consenting trial participants, and provide continuing review of a trial protocol and any amendments.
With adequate and continued education, community stakeholders can bring unique perspective, knowledge of the community, and sensitivity to the REC's discussion of new and emerging ethical concerns in the conduct of research. They can also offer new skills and strategies for dealing with ethical dilemmas as they emerge during protocol review. Finally, they can build the capacity of their colleagues on the REC to contribute further to the ever increasing international debates on ethical issues by presenting the scientific and medical REC members with new perspectives on how such issues are viewed by the host community. As one particiant noted in a study of sex workers’ perspectives on research participation, ‘[r]espect requires ongoing education and awareness by the researchers of their own privilege, and power, as well as societal oppressions at work’.
Nigeria, like many other developing countries, has limited access to training in research ethics due to weak social, economic, and health infrastructures. This paper describes the first three years of a five year project to build the capacity of REC members to perform their roles and responsibilities efficiently and effectively. The project participants were a cross-section of the membership of 13 RECs functioning in Nigeria. They received training to develop their capacity to evaluate research protocols, monitor trial implementation, provide constructive input to trial staff, and assess the trial's success in promoting community engagement in the research.
In all, this project conducted two five-day training workshops for laypersons serving on RECs, one 3-day training workshop specifically on monitoring research ethics during trial implementation also for laypersons and nurses on ethics committees, and one short (1.5 day) training workshop on community engagement in research for chairpersons of ethics committees. The ethics committees targeted were the 13 ethics committees adopted for the 5 years project.
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The New HIV Vaccine and Microbicide Advcacy Society (NHVMAS) was established in 2003 by Nigerian activists to ensure proactive and early involvement by the Nigerian Government and its citizens in the research and development of new HIV prevention technologies. A non-governmental organisation, it works to combat the spread of HIV by promoting a supportive environment for research to test and develop these new technologies and bring them to market. One key strategy NHVMAS uses to accomplish this is to build the capacity of communities likely to encounter HIV prevention research in a way that enables them to actively and constructively engage with the research process.
In 2005, NHVMAS identified the members of Nigeria's RECs as critical stakeholders in the sucessful conduct of research, including HIV prevention research. It identified the laypersons serving on RECs as a particularly important constituency within REC memberships because they serve as community gatekeepers and shape community attitudes toward research. In 2007, NHVMAS embarked on a five-year project to address the specific educational and capacity-buiding needs of this group of stakeholders.
The first three years of the project have been devoted to (i) needs assessment activities (ii) capacity-building through trainings, provision of technical support, and follow-up contacts and (iii) evaluation of the impact of the project on participants’ capacity to review research protocols and provide constructive feedback, as well as on the efficiency of the REC's operation overall.
The following summarizes the activities and results of years 1–3. The evaluative material derived from these activities will inform the design of the last two years of the project.
Recruitment and needs assessment
The project started with a desk review followed by recruitment of eligible participants. Once recruited, these participants were surveyed to assess their training needs. These data then informed the development of the training curricula.
Desk review: A desk review conducted in 2007 showed that four national training workshops on ethics had been conducted in the country between 2004 and 2007. Intended to meet the needs of researchers and REC members, these training workshops exposed participants to existing research ethics guidelines and regulations and sought to increase their knowledge of how ethical principles governing research are applied, as well as the roles and responsibilities of RECs. Only one of these training workshops focused on the application of ethical principles governing biomedical HIV prevention research. None of the training was designed to build the capacity of laypersons on RECs to engage actively in research protocol review processes.
This information prompted a decision to conduct a specific assessment of the training needs of laypersons serving on RECs. To define this population, NHVMAS used criteria articulated on page 13 Section Df of the National Code for Health Research Ethics. Namely, a layperson must not be a staff of the institution in which the HREC [Health Research Ethics Committee] is hosted and must not be related to any member of staff in that institution.
The National Health Research Ethics Committee (NHREC) certifies and registers RECs in Nigeria. Inclusion of at least one lay member on an REC is one requirement in their certification criteria. Outreach for this project, therefore, was initiated by contacting all of the NHREC-certified RECs in the country. It is notable that only eight of the 26 RECs ultimately identified and contacted were certified by NHREC in 2008.
A public advertisement was also placed in a daily national newspaper inviting laypersons serving on RECs to apply for project participation and letters regarding this opportunity were sent to the heads of 23 medical training insitutions in Nigeria. Of the 42 applications received through this outreach, 10 met the project criteria.
Finally, NHVMAS made contacts with organisers of past ethics training in the country to identify existing RECs not yet registered with NHREC. Through outreach to these entities, 12 more participants were identified. Seven advocates who work within research communities in close proximity to the 23 medical training institutions were also identified as participants for the training.
In all, 30 qualified applicants were identified for the first national training organised for laypersons serving on RECs. Twenty seven applicants confirmed availability for training held in August 2008, and 21 ultimately participated in it. A second national training for lay REC members was held in April 2010 with 26 participants in attendance. Altogether, 52 laypersons and seven community advocates were trained through the first and second laypersons workshops. Of these, only 7 (17.5%) had attended previous ethics training.
At the conclusion of the first training workshop, the needs assessment was repeated. Participants said their highest priority was further development of their capacity to monitor objectively the research studies conducted and approved by their institutions.
In response to this, NHVMAS designed and conducted a three-day training workshop to build capacity among laypersons and nurses on clinical trial ethics, with the goal of improving their ability to monitor activities on the field and serve as community watchdogs for unethical research practices. This training, conducted in November 2009, had 17 participants. Of these, eight participants had attended the national training on protocol review organised in August 2008, and one participant had attended a prior bioethics training workshop. None of the 17 participants had previously received training in monitoring research ethics.
At the conclusion of the second five-day training session in April 2010, participants requested training of other members of their RECs, as well as the Administrative Officers who manage the office affairs of the committee. In response to this, NHVMAS conducted a one and a half day training workshop on community engagement in research. It was designed specifically for the Chairpersons of the 13 RECs participating in the project. A total of 12 participants attended this training. The Administrative Secretaries and REC Chairpersons recruited for the training were identified by participants in the laypersons REC members’ trainings.
Once identified and recruited, participants in the laypersons training were asked to answer a semi-structured questionnaire to assess their competency to review protocols, their current levels of engagement in protocol review processes, and the specific types of training they needed to serve effectively on an REC. Their responses were anonymous.
Analysis of the 20 responses received showed that participants’ length of REC service varied from less than one year to 10 years. Only 20% (4 participants) of respondents had any previous training in biomedical ethics, and only 25% (5 participants) had ever reviewed a research protocol.
Four of the five participants who had reviewed a research protocol indicated that scientific terminologies was a challenge for them and expressed difficulty engaging with the protocol review process because they did not fully understand the protocol language. Three of the five respondents felt that some of the protocol structures were not clear or explicit enough to review adequately. All five respondents felt that informed consent issues were not well addressed in most research protocols, and that community engagement in research was often overlooked.
All 20 of the needs assessment respondents noted that their active contributions to the discussions during protocol review meetings were limited. Forty percent (8 participants) reported that they had either never or only occasionally attended REC meetings.
Trainings developed and delivered
The overall objectives of all four of the workshops were to expose participants to existing international guidelines and regulations on research involving human participants, increase their knowledge and application of the principles of research ethics, deepen understanding of the ethical principles that govern HIV prevention and treatment research, and equip participants with knowledge and skills to deal with the ethical challenges arising in the course of research protocol review and monitoring. The workshops also created a platform for sharing experiences, learning from the field experiences of others, and networking.
The curriculum for each workshops was certified by the National Health Research Ethics Committee (NHREC), the entity responsible for regulating and coordinating the affairs of all RECs in the country. The content of these workshops is summarized in Table 1.
|Content||Brief description of content of each plenary session||How to review a research protocol and provide constructive feedback||Research monitoring||Community engagement in research|
|1||History of Research Ethics||Discuss the history of research of research participant abuse, the evolution of the principles of ethics and ethical guidelines, and the Trovan case study in Nigeria||X||–||–|
|2||Basics of Research and Clinical Trials||Define research, describe the various steps in conducting research, emphasis the place and importance of community engagement in research design and implementation, described the different types of research, discuss what ethics committee members should be concerned with when reviewing these research proposals and emphasised the place and role of laypersons in basic research implementation||X||x||–|
|3||Principles of research ethics||Describe ethics and bioethics, discuss the four ethical principles of research, discuss a few additional principles elicited by other authors of research papers in the field, discuss who should safeguard ethical standard with reference to the national Health research ethics code||X||x||X|
|4||Ethical Review of Research Protocols||Discuss when and how a researcher apply for ethics review, components of an ethical review application, how to settle grievances that could arise from an ethics committee's review decision, described how ethics committee should operate based on a review of the NHREC guidelines, discussed the role of the laypersons on ethics committee and the possible challenges to engaging community in research||X||–||–|
|5||Informed Consent||Reiterate the principles of respect for persons, emphasis on the principle of autonomy and what this means for the research participants, highlight how the research design addresses this principle, discuss the eight minimal content of an informed consent document, discuss the processes for ensuring and assessing informed consent, discuss the challenges involved with obtaining informed consent in different socio-cultural settings, highlight what the National Health Ethics Code say about obtaining informed consent and discuss the role of laypersons in ensuring the informed consent process is an active rather than a passive process||X||–||–|
|6||Risks, Benefits and Inducement||Define the terms risks, emphasis the need to minimize risk in research, discuss the importance of risk analysis and the concept of minimal risk, define the term benefit, define the term inducement, discuss the challenges with balancing undue inducement and exploitation, discuss how to make inducement ethical, discuss about compensation for research related injuries, discuss the role of laypersons in addressing these issues while reviewing a protocol||X||–||–|
|7||Vulnerable Populations in Research||Identify the vulnerable populations there are in research, define adolescents and the peculiar challenges in enrolling them in trials, define PLHIV and the peculiar challenges in enrolling them in trials, define sex workers, MSMs, drug users, women, prisoners and the peculiar challenges in enrolling them in trials, discuss these peculiarities vis a vis enrolment of these populations in HIV research, discuss the ‘how’ and ‘why’ vulnerable populations may be involved in clinical research, discuss the role of laypersons in promoting the interest of vulnerable populations||X||–||–|
|8||Standard of Care and Prevention||Explain what standard of care means, define standard of care for trial participants, discuss the standard of care for research participants defined in the National consensus document, discuss community involvement in defining standards of care. Refer to the GPP document. Identify the section of the research protocol that addresses standard of care, discuss what should be highlighted in the research protocol when defining the standard of care for research participants, discuss how laypersons should address the standard of care for research participants especially in a multisite research involving developed and developing countries||X||–||–|
|9||The Research Protocol||Describe the minimum component of a research protocol, describe the five stages of protocol development, emphasis the need for consultation with the potential research community in the protocol development stage, discuss the importance of community involvement in research protocol development, discuss the importance of a protocol and brainstorm with participants what constitutes an ethically acceptable research. Note responses on a flip chart and discuss these.||X||–||–|
|10||Research Protocol Review Process||Discuss the protocol review process, highlight how records must be kept for all protocol reviewed by the ethics committee, highlight documentation procedures for ethics committee, highlight communication mechanism between committee and researcher, highlight the need and importance of an ethical clearance certificate, discuss the roles and responsibilities of the ethics committee to the researcher and the research participants for all approved research protocol, discuss the national and international guidelines on the review process, discuss international guidelines on review process, discuss the role of laypersons in the protocol review process, ask participants to share their experiences with review of research protocols in their ethics committees||X||–||–|
|11||Providing Constructive Feedback||Discuss the need for constructive feedbacks when recommending protocol amendments, the characteristics of constructive feedback, ways to make feedback constructive, ways to give constructive feedback and highlight the role of laypersons in facilitating the process||X||–||–|
|12||Monitoring of Research||Explain why it is important to monitor research, emphasis the objective of research monitoring, emphasis that research monitoring starts from the protocol review stage prior to implementation, identify elements of the research to be monitored pre, intra and post trial conduct, identify the legal structures that support ethics committee monitoring function, discuss the principles of good clinical and laboratory practice documents, discuss the six principles of good community engagement listed in the GPP, discuss the National food and drug regulatory agency regulations, discuss the National Research Ethic code, define the role and composition of the DSMB in monitoring international multisite research, discuss the importance of local ethics committee following up DSMB reports about trials conducted in their centre, define the place for community oversight and monitoring of research, elicit from participants how they can provide oversight for research conducted within hospital settings and discuss how they can provide constructive feedback on observations made during research monitoring||X||–||–|
|13||HIV Treatment Research||Discuss how HIV can be contracted, discuss HIV management including opportunistic infection treatment, nutritional support, infection prevention and psychological support, briefly discuss HIV treatment – when to commence, resistance, possibilities for switches, discuss national treatment guidelines, highlight the importance of continued treatment research, discuss the need for treatment success monitoring, emphasis that HIV treatment is for life, highlight that treatment interruption is not successful and such researches should not be encouraged, discuss the ‘why’ and ‘how’ of treatment monitoring, discuss the role of laypersons in ensuring the proper design and conduct of HIV treatment||X||–||–|
|14||HIV Prevention Research||Discuss the need to expand HIV prevention options, discuss the limitation of existing tools, highlight the importance of continued HIV prevention research, discuss additional tools for HIV prevention identified by recent research, discuss ongoing HIV prevention research, discuss lessons learnt from past, ongoing and future HIV prevention research, discuss ARV access in HIV prevention trials, discuss the role of laypersons in ensuring the proper design and conduct of HIV prevention research in Nigeria||X||–||–|
|15||Community Engagement in Research||Define community, identify features of a community, discuss the four ethical principles of community engagement, discuss the approaches to community engagement, discuss the various sections in ethical documents that highlights the need for community engagement in research, discuss the goals of community engagement, discuss the challenges to community partnership, discuss the various context for community engagement||x||–||X|
|16||Community Advisory Mechanism||Define community advisory mechanism, discuss the history of community advisory mechanism engagement in research, discuss the composition of the CAB, define their role and functions, discuss how to ensure their autonomy, discuss the use of multiple community engagement mechanisms in the community in addition to CABs, identify the role of laypersons in facilitating community input in research through its life cycle||X||–||X|
|17||Civil Society Engagement in Research||Define civil society, share lessons on constructive civil society engagement, share lessons on destructive civil society engagement, discuss the pros and cons of engaging civil society in research, define ways to facilitate civil society engagement in research and protocol development||X||–||X|
|18||The Good Participatory Practice Guidelines||Discuss the history, objectives and components of the GPP, discuss how the GPP can facilitate the work of laypersons on ethics committees||X||x||X|
|19||Research and research monitoring: NHREC and HREC roles||Describe the role of Health Research Ethics Committees in research, discuss the need for research monitoring, discuss NHREC Expectations from HRECs, introduce the National Code for Health Research Ethics (NCHRE) discuss the sections that describes the monitoring responsibilities of HRECs||–||x||–|
|20||Research and research monitoring: NAFDAC roles||Discuss the role of NAFDAC in providing ethical oversight for research, discuss the guidelines for application, approval and registration of products and devices, discuss the guidelines 34 and 39 issued by NAFDAC , discuss the Expectations of NAFDAC from NHREC and HRECs, discuss the obligations of NHREC and HREC to NAFDAC, discuss the NAFDAC monitoring procedures, discuss obligations of Research Ethics Committees to NAFDAC||–||x||–|
|21||Good Clinical Practice (GCP)||Give a background to the development of the GCP, define what the GCP is, discuss the 13 principles of GCPand conclude by describing the stakeholders in clinical research||–||x||–|
|22||Good Laboratory Practice (GLP)||Define GLP, distinguish between GLP and standards of laboratory safety, identify the rationale for GLP, discuss the objectives of GLP, discuss the history of GLP and discuss the GLP principles||–||x||–|
|23||Roles and Responsibilities of a Monitor||Define clinical research monitoring, identify the various reasons to monitor clinical research, discuss the four monitoring objectives, discuss the roles and responsibilities of a monitor||–||x||–|
|24||Monitoring Obligations and Methods||Discuss the types of research monitoring that can be done, discuss the categories of research monitoring there are, describe in details the indications for each category of monitoring there are, and discuss the emerging issues on role of community oversight for research||–||x||–|
|25||Monitoring Clinical Trials||Describe the roles and responsibilities of a trial monitor, discuss preparations that need to be made when planning a monitoring visit, discuss the variability of research monitoring intensity, the criteria for selecting monitors for a research and the frequency of clinical trial monitoring visits||–||x||–|
|26||Monitoring qualitative research||Describe the features of qualitative research, describe who, where and how qualitative research is conducted, discuss the need for and how qualitative researches can be monitored, discuss ethical issues that may crop up when monitoring qualitative research||–||x||–|
|27||Monitoring Community Engagement Efforts||Review the elements of Good Community Practices as listed by the GPP, identify the stages of community involvement and engagement in research, discuss the timing and tools of monitoring for community involvement in processes, describe how to monitor the adherence of researchers to best practices in the field||–||x||x|
|28||History and Forms of Community Engagement in Research||Define community engagement, discuss the history of community engagement in research, identify the ethical dilemma that could arise with community engagement efforts, discuss the benefits and limitations of community engagement in research, discuss the Nigeria situation and the importance of IRBs providing an oversight to prevent community expoitation by research||–||–||X|
|29||Key elements of ensuring community engagement in research||Discuss the need for formative research and how to engage the community, discuss about community engagement during protocol development and how to seek for evidence during protocol review, discuss about community engagement through representation on the IRBs, discuss community Advisory mechanisms and the role of the community in developing the informed consent form, negotiating for access to care and standard of preventions in HIV research, developing the community education plan and being engaged with the research result dissemination plan||–||–||X|
The two five-days training workshops held in August 2008 and April 2010 focused specifically on the knowledge and skills required for providing constructive feedback during the REC protocol reviews.
The three-day training workshop on research monitoring was held in November 2009. The training focused on building skills to conduct monitoring of the various types of researches approved by ethics committees (clinical trials, social science studies and basic science research) and by what means laypersons can assess community engagement efforts on the field. None had formal training on research monitoring.
The 1.5 day training workshop focused on communtiy engagement in research, particularly with regard to how this can be assessed during protocol review and research monitoring. None of the participants had previously participated in formal training on community engagement in research.
The workshops, facilitated by seven resource persons with experience in both training and research ethics, were conducted in English, the official language in Nigeria. The participatory approaches utilised in each of the workshops included:
- group work sessions to enable participants to brainstorm and share ideas;
- plenary discussion sessions that addressed HIV/AIDS research ethical guidelines;
- multiple case studies accompanied by question and answer sessions;
- experience sharing sessions;
- mock research ethics committee sessions; and
- round table discussions on existing policy and guideline documents relevant to HIV/AIDS research and service provision in Nigeria.
Participants were divided into small groups to discuss cases and complete group assignments. When they reconvened in a plenary session, the groups shared their outcomes with all workshop participants. Reference materials and lecture notes were made available to all participants on the first day of the workshop. Certificates of course completion were distributed at the end of the training.
REC lay members training on research protocol review
The training included 19 plenary sessions designed to build understanding of the workings of the REC (composition and function), the importance of a research protocol, the relevance of its various components, and how to assess and ensure standard of care in clinical trials are addressed, the safety of vulnerable populations are ensured, and community engaged in research are respected and protected.
Working in groups, participants reviewed case studies, used checklists to critique sample informed consent forms, considered which sections of protocol most needed a layperson's review and feedback, practiced techniques for changing non-constructive feedback into constructive feedback, and held mock REC meetings. Quiz sessions and games were also held each morning to reinforce understanding of research terminologies and to help review the previous day's work.
Research monitoring training
The training in research monitoring was three days in length and included nine plenary sessions and several interactive sessions. It summarized best clinical practices, best laboratory practices and best community engagement practices, and the parameters for assessing compliance with each of these using existing sets of guidelines. The importance of, and methods for, monitoring clinical trials and social science research were also taught (see Table 1). Emphasis was placed on building the capacity of trainees to look for evidence of community engagement during research protocol reviews and field visits.
Quiz sessions and games were again conducted each morning to reinforce participants’ familiarity with research terminologies and review the previous day's work. Guided by a checklist, participants in small groups reviewed research protocols, looking for evidence of whether or not they addressed community concerns and interest. A roundtable discussion was held on the research monitoring requirements of the National Health Research Ethics Committee (NHREC) and the National Agency for Food and, Drug and Administration and Control (NAFDAC). Mock HREC sessions were also held, as well as two mock monitoring field visits.
Community engagement training
The 1.5 day long training workshop for REC staff and Chairpersons focused on community engagement in research. Its six plenary sessions explored by what means communities can be constructively engaged in research and how to evaluate such engagement during protocol review and research monitoring. The sessions generated intensive discussions about the challenges that ethics committees face and how these could be resolved. Using the checklist guide, participants reviewed sample research protocols for evidence of whether or not they addressed community concerns and interest.
After each workshop, NHVMAS staff followed up with trainees one-on-one through emails and phone calls to provide technical support and address the challenges participants encountered while using the new information and skills they acquired. Trainees generally reported that the learning they received was tremendously useful. Several, however, said that the feedback they offered in REC meetings was met with resistance and challenges from other REC members who were not conversant with community involvement issues. Some, having learned in the workshop to request copies of research protocols under review, reported that these copies were sometimes not provided upon request. A few trainees (14%) reported difficulties in obtaining protocol copies. It was this kind of experience that generated the request by lay REC members that NHVMAS organize trainings for other REC members, including the Administrative Officers who manage the office affairs of each committee.
The training facilitators followed up with trainees by phone calls and text messages every six months to discuss challenges and strategies for addressing them where feasible. This follow-up included provision of logistic support to three Adminstrative Secretaries to facilitate their NHREC certification renewals. Staff also addressed an ethical dilemma encountered by one lay REC members during a research protocol review process.
All trainees gave permission to have their e-mail addresses added to a NHVMAS listserv specifically created for REC members. Using this listserv, staff sent regular updates on new findings and ethical issues in the field of HIV prevention and treatment. A 12-week online training course on the ethical principle of ‘respect for persons’ was also organized and conducted using this technology.
Following other trainee suggestions, the project developed a 52-weeks self-training ethics manual by adapting the content of a course on ‘Protecting Human Research Participants’ developed by the U.S. National Institutes of Health Office of Extramural Research. This manual is now used as a basis for facilitating monthly discussions among REC members via the shared listserv.
Monitoring and evaluation
Pre and post-tests
All workshop participants completed a pre-test before the opening session of their workshop. The results of these were compared to the scores obtained by taking the same test (post-test) at the end of the workshop. The tests contained close-ended questions that assessed knowledge of international guidelines, research ethics and their application, and operations of the REC. Responses were anonymous and each participant chose an identification code used to link his or her pre- and post-test scores. Using an open-ended questionnaire, trainees were also asked to assess the impact of the training on their skills and knowledge on the last day of each training workshop.
Between June 2009 and November 2010, monitoring interviews were conducted with all past trainees using a structured monitoring guide. All trainees were contacted for these interviews within 6–7 months of attending a training workshop. The interviews monitored the trainee's use of the knowledge and skills acquired in the training workshop, focusing specifically on the trainees’ self-described competence to review research protocols, level of engagement in REC meetings, and engagement with research monitoring activities. The interviews also elicited the trainee's perspectives on changes (if any) that had occurred in his/her REC's structures following the training and the degree to which he/she perceived evidence of community engagement in the research protocols reviewed.
Focus group discussions
In November 2010, four focus group discussions (FGD) were conducted with members of Nigerian RECs. Three of these FGDs were held with members of RECs that had participated in the project. These comprised the study arm. The fourth FGD was held with members of a REC that had not participated in the project. As none of its members had attended any of the training workshops, this group constituted the control arm.
This model facilitated comparison of the impact of training a few members of a REC on the functioning of the REC overall, including its efficiency and effectiveness, as well as the individual and collective knowledge level of its members.
Only 3 of 13 RECs participating in the project could be visited for FGDs due to limited funding. The 3 RECs selected for this activity were chosen based on the following criteria:
- Three or more members of the committee must have been trained through this project. Nine RECS met this criterion.
- Selected RECs must represent the geographical regions (North, South and West) where large numbers of RECs are functioning in Nigeria. The nine that met criterion (i) were clustered in these three regions so one from each region was selected randomly.
All members of the four RECs selected for FGD participation were invited to participate in the discussion, whether or not they had attended any of the training workshops. In all, 28 people were involved in the FGDs.
An FGD discussion guide was developed and sessions were conducted in appropriate meeting rooms conducive to the number of participants present. Each group facilitator began by distributing copies of the discussion guide, explaining that the session would be tape recorded and transcribed for analysis, and reviewed the ground rules for conduct (i.e. no interruptions, no phone calls, confidentiality guaranteed). The facilitator then conducted the session following the FGD guide, while also pursuing opportunities for probing and exploring spontaneously generated themes. In discussions held at first three RECs (those containing members who has participated in training workshops), the members present who had not participated in NHVMAS training workshops were asked to comment on how the observed performance of the trainees had changed following training. This way, the project was able to obtain feedback on performance impacts from the trainees’ colleagues.
An assigned note-taker took notes during the session (as a back-up to the tape recording) and documented participants’ non-verbal cues. Immediately after each FGD, the facilitator and note-takers completed a debriefing form describing the session's duration, mood of the group, number of participants, people present, etc. They also wrote a summary of each FGD that included impressions of key issues and the main outcome of the discussion. Each debriefing report represented a summary and extraction of the full data.
Knowledge retention assessment
Following the FGDs, each REC member who had participated in any of the NHVMAS training workshops was asked to take the training post-test again. They were requested to use their past workshop codes. This score was then compared to the score received when he/she took the post-test immediately following the training attended. In this way, NHVMAS was able to assess the level of knowledge retained between the time of the training and the time of the FGD.
Difference in knowledge between trained and untrained committee members
The post tests were also administered following each FGD to REC members who did not attend the training workshops. The difference in the scores obtained by research ethics committee members trained and those not trained through this project were then compared.
Difference in knowledge between RECs with trained members and those without trained members
Members of the REC that served as the control arm for this study also had 11 of its members take the tests readministered to members of the 3 RECs that served as the study arm for this monitoring analysis. The difference in the cumulative scores of the study arm and that of the control arm was assessed.
Once the pre-test and post-test questionnaire scores were collated and compared, and the open-ended questionnaire responses were coded and analysed, it was possible to analyze the significance of scores obtained. To assess knowledge retention, the difference in the immediate post workshop scores and the scores of readministered post tests was done using the paired t test to compare mean score values. To assess impact of the training of selected members of the RECs on other REC members, the test scores of those who had attended the workshops was compared with the scores of those who had not attened the workshop using the t test. To establish the true impact of the workshops on knowledge of REC members who did not attend the workshop, the mean test score of those REC members who were members of ethics committees with trained members was compared with the mean scores of the control REC (REC of which none of its members had attended any of the NHVMAS trainings discussed in this project). Statistical analysis was completed using Intercooled STATA (release 9) for Windows. Statistical significance was taken as P < 0.05.
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Comparison of pre- and post-test scores of trainees
The results of the pre- and post- test scores revealed statistically significant increases in the post- test scores following training on research protocol review and providing constructive feedback. A paired t-test comparison of scores showed a highly significant difference between the pre- and post- test scores in the first laypersons training (70.7 vs 82.1; p = 0.0003) and the second laypersons training (51.1 vs 64.1; p = 0.002). A similar significant result was also obtained with the training on research monitoring (44.6 vs 72.9; p = 0.0002). The training on community engagement for REC staff and Chairpersons yielded a paired t-test comparison of scores that indicated a difference that was not statistically significant (64.3% vs 70.8%; p = 0.06).
Seven trainees were contacted during this evaluation exercise and, of these, six (87.5%) returned completed post- test questionnaires. The mean post- test score generated immediate after the workshop for these respondents was 73.3% ± 9.8. Their mean post- test scores when they repeated the test for this knowledge retention exercise was 61.7% ± 12.9. There was no significant difference between the two scores (p = 0.11). The paired t test analysis also showed no significant difference between the two scores (p = 0.052).
Time appeared to have impacted knowledge retention. Those who were trained 6 to 12 months prior to this evaluation had a 0% to 33% drop in the post- test scores when compared to their scores immediately after the training. The single trainee who was evaluated 27 months post-training had a 50% drop in their post- test score when compared to the post-test score obtained immediately after the training.
Impact of training on capacity to review research protocols and operations of the research ethics committees
The telephone interviews and the FGD discussion results allowed for assessment of the impact these training workshops. Thirteen trained laypersons, eight trained REC Chairs and 32 other REC members who had not been trained through this project contributed information through FGDs and telephone interviews.
Evidence of engagement with protocol review
The responses collected indicate that all the trained laypersons became more engaged with research protocol review after the training. These responses included reports of laypersons receiving and reviewing entire research protocols and making comments that are considered insightful.
Evidence of protocol evaluation for community engagement
The workshops also demonstrably increased trainee interest in the evaluation of protocols for evidence of community engagement and attention to specific community concerns, including those of vulnerable populations. Several specific examples were provided of trainees’ efforts in this direction during protocol review processes.
‘The lay person specifically contributed to the protocol on engaging MSM. He asked questions about the police and discussed the issue of confidentially of the participants and the need to clarify this before protocol approval’.
Evidence of improved monitoring function by research ethics committees
This continues to be a challenge for most of the committees. Of the 13 RECs whose members received training, only two reported development of a mechanism for on-site research monitoring. Members of three other RECs had asked researchers to submit updates on their progress as a means of monitoring the research. In the other eight RECs, there were reports that trainees had raised the issue of the need for research monitoring. A few cited financial constraints as a limiting factor preventing such monitoring from occurring.
Evidence of improved function of the research ethics committees
The training of a few members of the committees was, indeed, shown to be sufficient to bring about significant changes in REC operations. This resulted in part because the training improved the confidence and assertiveness of the trainees.
‘Prior to the training we had poor review process. After the training, protocol review has been made more regular and now holds on a monthly basis’.
Comparative difference in knowledge of trained and untrained  REC members
Seven trainees and 20 untrained REC members were contacted during this evaluation exercise. Of these, six trainees and seven untrained REC members returned their completed post-test questionnaires – a response rate of 85.7% (6/7) for trainees and 35% for non trainees. The mean test score for the past trainees was 61.7% ± 12.9. The mean test score for the untrained members of the research ethics committee was 67.1% ± 19.3. The difference between the two scores was not statistically significant (p = 0.57).
Research ethics committee members not trained by this project commented that training did have an impact on the performance of the trainees.
‘They have enhanced detailed analysis of the ethical implications of research with respect to subjects and the general population’.
Comparative difference in knowledge of untrained members of research ethics committee with trained members and those members of research ethics committee with no members trained
Seven untrained REC members of the RECs contacted through this project returned their questionnaires. The mean score was 67.1% ± 19.3. The mean score of the 13 respondents from the control group – the REC which had none of its members trained – was 38.5% + 14.8. The difference between the two scores was statistically significant (p = 0.002).
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RECs play vital roles in protecting research participants. They are charged with reviewing initial research protocols to make certain that they provide research participants with adequate opportunity to give fully informed consent and that the research does not expose participants to unreasonable risks. Protocols must also protect the rights and integrity of study participants, and where applicable, must ensure that communities hosting the research are not exposed to undue risk but, rather, that such communities benefit from hosting research that is conducted in a way that responds to local health conditions to some extent. Once a research protocol is approved, the RECs have an ongoing responsibility to review its implementation periodically to ensure that research participants’ remain protected through the trial's rigorous adherence to the approved protocol.
As shown here, many REC members need capacity-building training in order to fulfil their roles adequately. The need for investment in such capacity development in Africa, Nigeria inclusive, is underscored by the fact that many professionals in African countries still have limited access to formal training in research ethics. Simultaneously, more and more African scientists are involved in research, and increasing numbers of biomedical clinical trials are being carried out in developing countries.
This situation sharply highlights the need to invest in developing the capacity of those vested with the task of providing high quality ethical oversight for these studies. .The training project described in this paper was developed to contribute to this goal.
Not only did 82.5% of the laypersons reached through this project receive their first formal training in research ethics, but all the trainees received focused training designed to enable them to perform their oversight functions better. The training demonstrably improved the ability of laypersons to review research protocols effectively, provide constructive feedback, monitor research protocols, and evaluate the adequacy of community engagement efforts throughout protocol review and research monitoring.
This project is unique in that it is designed to provide sustained support for trainees over a five year period through multiple mechanisms, including face-to-face training, email communication, listserv forums, and text messages. This provides trainees with ongoing assistance in addressing technical challenges and offers them opportunities for continuing education in research ethics. Together, these supports enable trainees to continue to develop the capacity to understand and work through current and future emerging issues, thus positioning them to perform their functions better.
Project evaluation displayed post-training improvements in participants’ capacity to engage with research protocol review. It also indicated that the training workshops had an impact on the operations of the RECs as a whole – resulting in (among other effects) changes to the REC's composition, improvement in the level of objectivity displayed in protocol reviews, improvement in the regularity of committee meetings, and the knowledge level of trained members in attendance. This improvement is similar to findings in previous studies.
Analysis of the participants’ pre- and post- test scores shows significant improvement in the trainees’ knowledge levels, though correct quiz answers may or may not predict how trainees apply these principles to their own work. The results of the follow up interviews and FGDs confirm that the training workshops meaningfully enhanced members’ capacity to perform their roles on the RECs, as well as triggering systems and structural changes in the RECs that resulted in improved performances.
Overall, trainees retained much of the knowledge acquired from the workshop. This is indicated by the fact that there was no statistically significant difference in the test scores obtained immediately after the workshops and those obtained during the evaluation conducted 6 months, 12 months and 27 months after the training. This may imply that trainees were able to apply, or otherwise internalize the knowledge acquired.
Time appears to have an eroding effect on knowledge retention given the high knowledge attrition rate at 27 months. A trend or pattern in rate of attrition in knowledge could, however, not be established from this result. This possibly points to the need for continued training not only to build new skills and provide new information, but also to help retention of old knowledge. Knowledge attrition varied between 0% and 33% over a 12 month period. In view of this finding, it may be important to recommend that REC members attend update courses at least once a year.
The insignificant difference in the scores of trained members and untrained members of RECs reached by this project, and the significant difference between the scores of untrained members of RECs reached by this project and REC members not reached by this project tells a compelling story. The training of a few members of a REC can have significant impact on the knowledge and skills of other members not directly trained on a project. Choosing to train a few members of a REC could have significant impact on the knowledge of the entire REC membership.
Human capacity-building is a process. For the impact to be long lasting and result in systemmic and structural changes, the process needs to be sustained over a period of time. This report describes the outcome of a three-year sustained effort at building the capacity of 13 RECs in Nigeria. The project went beyond a once-only effort by providing sustained post-training communication and technical support to trainees addressing challenges. It continues to provide online information and updates on a monthly basis, and to assist efforts to address observed challenges to REC efficiency.
This sustained commitment resulted in slow but significant changes seen not only in the capacity of trained individuals to perform their functions better, but also in increased willingess to bring about changes in systems and structures to ameliorate barriers to efficiency.
Obstacles apparently remain, including RECs limited access to the funding needed to undertake other aspects of their core functions such as on-site monitoring of approved research protocols. This project, however, demonstates that sustained investment in capacity building can generate gradual but potentially significant changes capable of supporting improved research conduct and outcomes.
Evaluation of this project was impeded by various limitations. The high non -response rate of untrained REC members introduces some bias to the result. It may be that only members who felt confident about responding to the post-test questions actually completed and returned the questionnaire. The overall sample size for the quantitative assessment of the 3-year project impact was also small. This was due primarily to funding limitations for this phase of the project. Increasing the sample size would have meant increasing the number of monitoring site visits. Email response rates are also often poor because many trainees could not access their email messages on a regular basis. This ruled out the possibility of conducting a web-based evaluation.
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Capacity development in research ethics for members of a Research Ethics Committee does not guarantee the safety for research participants. It is, however, an important component of the array of interventions that can contribute to that goal. The capacity of stakeholders to participate knowledgeably in providing oversight for research conducted in their communities is important in any environment. It is vital in resource-constrained settings where the risk of exploitation may be higher. The training project discussed in this article was developed to help fulfill this goal.
The training workshops and ongoing support provided through this project addressed a previously unaddressed need among REC members for skills-building and knowledge development in research ethics. In doing so, it not only expanded participants’ understanding of ethics principles relevant to biomedical research, but also impacted on the knowledge of other untrained members of the RECs and improved the operations of the RECs to which they belonged. This was possible through sustained investment in capacity-building efforts using multiple tools over an extended period of time.
The results of this study suggest that such training is not only an important starting point for REC members but also that annual refresher courses on ethics should be undertaken to maximize knowledge retention and competency.
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Funding for these trainings and evaluation were obtained from Sidaction grants NG-04-08-01 and NG-04-09-01, “European & Developing Countries Clinical Trials Partnership” (EDCTP) [CB.2008.41302.013] and two training grants from AVAC Global Advocacy for HIV Prevention. Funding to support the publication of this manuscript was provided by AVAC.
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- 4Research Triangle Institute Road map for success in international research: strategies for protecting human research subjects globally. Report of workshop. 2005.
- 6UNAIDS. UNAIDS Report on the Global AIDS Epidemic. 2010. Geneva: UN Joint Programme on HIV/AIDS.
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- 9Research Rashomon, Lessons From the Cameroon pre-Exposure Prophylaxis Trial Site. Global Campaign for Microbicides, 2009. Available at: http://www.global-campaign.org/clientfiles/Cameroon.pdf [Accessed 18 July 2012]; & . Preventing Prevention Trial Failures, A Case Study and Lessons for Future Trials From the 2004 Tenofovir Trial in Cambodia. Global Campaign for Microbicides, 2009. Available at: http://www.global-campaign.org/clientfiles/Cambodia.pdf [Accessed 18 July 2012]., & .
- 11Oral Tenofovir Controversy II: Voices From the Field, a Series of Reports of the Oral Tenofovir Trials From the Perspectives of Active Community Voices Engaged on the Field in Cambodia, Cameroon, Nigeria, Thailand and Malawi. New HIV Vaccine and Microbicide Advocacy Society (NHVMAS), 2009. Available at: http://www.nhvmas-ng.org/publication/TDF2.pdf [Accessed 18 July 2012].& .
- 12National Bioethics Advisory Commission, 2001, USA; Council for International Organization for Medical Sciences International Ethics Guidelines for Biomedical Research Involving Human Subjects. Geneva, Switzerland; 2002.
- 13UNAIDS/AVAC. Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials, 2nd edn . 2011 Geneva: UNAIDS.
- 14Ibid: note 2., op. cit.
- 16Outcome of a research ethics training workshop among clinicians and scientists in a Nigerian university. BMC Med Ethics 2008: 24;9: 1. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2246144/?tool=pubmed [Accessed 18 July 2012].& .
- 17Federal Ministry of Health. The National Code for Health Research Ethics. Version 6.0. Available at: www.nhrec.net [Accessed 18 July 2012].
- 18“untrained” here refers to REC members who did not participate in a NHVMAS training.
- 19Institutional review Boards: their role in reviewing approved research. June 2008. Available at: http://oig.hhs.gov/oei/reports/oei-01-97-00190.pdf [Accessed 18 July 2012];Ibid: and , op. cit. note 13..
- 20Ibid: 1.
- 21Human capital is key to research ethics. 2002. Available at; http://www.scidev.net/en/opinions/human-capital-is-key-to-research-ethics.html [Accessed 18 July 2012].& .
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