IRB: Ethics & Human Research
Research Ethics Committees in Nigeria: A Survey of Operations, Functions, and Needs
Heightened global commitment to research on diseases such as HIV/AIDS, tuberculosis, and malaria has led to increased research over the past decade in many African countries, including Nigeria. This increase in research has led to debates about the ethics of health research in resource-poor or developing countries and has drawn further attention to existing ethical review processes. This study was undertaken to describe and benchmark the operational and organizational structures as well as functions of research ethics committees (RECs) in Nigeria. The article explores the factors that contribute to REC conformity with the Nigerian National Ethics Code and World Health Organization (WHO) guidelines for RECs. Data were collected using a self-administered, semistructured questionnaire. A descriptive analysis was conducted, and Fisher’s exact tests performed to assess associations between selected REC characteristics and the degree of conformity to applicable national and international requirements. Eighty percent of RECs (20 out of 25) had standard operating procedures, while 68% (17 out of 25) met at least quarterly and provided final review determinations within three months. RECs with committee chairs who had prior bioethics training were more likely to have operations conforming to the WHO and the Nigerian ethics guidelines. Overall, this study suggests that there is variability in the degree to which operations and functions of RECs in Nigeria conform to the Nigerian National Code and WHO guidelines.
Heightened global commitment to research on diseases such as HIV/AIDS, tuberculosis, and malaria has led to increased research over the past decade in many African countries, including Nigeria. This increased investment by the international community is driven by global as well as regional declarations and commitments that reflect a desire to help reduce disease burden while fostering development in these countries.1 This increase in research has led to debates about the ethics of health research in resource-poor or developing countries and has drawn further attention to existing ethical review processes.2 Some of these discussions have focused on the creation and application of both international and local guidelines, on codes of practice or laws on ethics of research, and on the role of national, local, and institutional research ethics committees (RECs) in the protection system for human research participants.3
While the majority of literature on RECs has emerged from high-income contexts,4 a growing literature from and about RECs in developing countries has more recently surfaced. Topics explored in these studies are varied and include descriptive studies on the structure and functions of RECs,5 diversity in REC reviews,6 multicenter ethics review,7 and both descriptive and mode studies on evaluation of RECs.8 Studies examining RECs in developing countries describe structural and operational elements of RECs at national and regional levels. Country-specific studies include those describing REC activities in Egypt, Tanzania, Turkey, Mexico, Sudan, Granada, El Salvador, South Africa, and Uganda.9 For example, Sleem et al. report that RECs in Egypt comprised, on average, 10.3 members, who were mostly physicians; none of the RECs had a formal operating budget; and the absence of national research ethics guidelines and lack of ongoing training in research ethics for REC members were identified as some of the major challenges.10 Ikingura et al. found that RECs in Tanzania had members with various educational backgrounds, with about 52% (n = 66) of members being biomedical scientists.11 Arda discusses new guidelines that mandated establishment of RECs in Turkey. He argues that the guidelines could help foster protection of the rights of research participants through the application of the informed-consent process in research studies,12 and Caniza et al. describe how an iterative and interactive process of capacity building led to the establishment of three institutional RECs and a national REC in El Salvador.13 Studies from Uganda and Nigeria describe processes for developing national research ethics guidelines,14 while other studies have focused on RECs in Latin America, Europe, Southeast Asia, and Africa.15 A recent review of the literature showed that the efficiency of RECs in most African countries is challenged by lack of membership diversity, scarcity of resources, insufficient training of members, inadequate capacity to review and monitor studies, and lack of national ethics guidelines and accreditation.16
Of the available literature on African RECs, there are only a few published studies empirically evaluating RECs’ operations in Nigeria. Falusi et al. describe the process of establishing the REC at the University College Hospital in Ibadan, Nigeria.17 Eyelade et al. retrospectively audited protocols submitted to an REC from 2002 to 2007 to determine the profile of the lead investigators, sources of funding for research, and the duration of review in the same institution.18 And Agunloye et al. describe the structure and operations of three RECs from three different geopolitical zones in Nigeria.19 An unpublished study of eight RECs from Southwest Nigeria, which looked at training and resource needs, is reported to have found that most RECs needed more opportunities for training, especially on risk-benefit assessment and for new committee members.20 Research examining committee structures, functions, and needs is important for regulatory and quality-improvement purposes. Information from such studies within a given country could further help national regulatory bodies better oversee and strengthen the capacity of RECs and could help future researchers and funding institutions better understand the ethical review systems in such countries.
Survey of Nigerian RECs
This study was undertaken with the goal of describing and benchmarking the operational and organizational structures as well as functions of RECs in Nigeria. We intended to identify unaddressed needs, describe structures and operations, and evaluate factors that contribute to higher conformity of RECs in Nigeria with the country’s National Code of Health Research Ethics and the World Health Organization’s (WHO’s) Operational Guidelines for Ethics Committees that Review Biomedical Research.21
RECs in teaching hospitals, medical centers, other private hospitals, and research institutes throughout Nigeria were identified through the database of registered (active or inactive) ethics committees of the U.S. Office for Human Research Protections (OHRP) and the Nigeria National Health Research Ethics Committee (NHREC).22 Unregistered RECs were also identified through the Nigerian Federal Ministry of Health (FMOH) and the Office of the Director of Health Sciences from the Federal Ministry of Science and Technology (FMS&T). RECs or their host institutions were contacted via email, and those that consented to participate were included in this study.
A cross-sectional survey design was adopted using a primarily closed-ended semistructured questionnaire adapted from a similar study.23 The questionnaire had 81 items broadly categorized into five domains to capture information on REC membership, operations, training, resources, and attitudes or perceptions. The questionnaire was pilot tested with two faculty members and two students from the Johns Hopkins Berman Institute of Bioethics as well as members from two RECs in Nigeria. Feedback from this process was used to produce the final questionnaire in English.
The questionnaire was sent by postal mail and email to the chairpersons, secretaries, or administrative officers of the identified RECs. The questionnaire was sent to chief medical directors or chief executive officers of institutions hosting RECs in cases in which contact information of principal REC officers was not available. Data were initially collected over a period of five months (February to July 2010), and thereafter nonresponding RECs received follow-up phone calls or emails at least once a month for five months. All responses were received via the contact email provided in the questionnaire.
Returned questionnaires were manually coded and deidentified. Responses to closed-ended questions were entered into IBM-SPSS and cross-checked for inappropriate entries. Proportions were calculated and Fisher’s exact tests conducted to identify possible associations between selected REC characteristics and the degree to which REC structure and operations conformed to relevant guidelines. Conformity was determined based on response and alignment with 16 criteria (Table 1, available, along with the other tables, via the IRB: Ethics & Human Research web page). These criteria were derived from those that were common to the Nigeria National Code of Health Research Ethics and the WHO guidelines24 with three exceptions: review turn-around time, compliance with other international guidelines, and registration (of the REC) with both the NHREC and OHRP (criterion 13, 15, and 16, respectively, in Table 1). Criterion 13 was specific to the Nigerian guideline, while criteria 15 and 16 were added for the purposes of this study alone. RECs received a score of 1 for each criterion reported to have a corresponding policy. Scores were converted to percentage points, and RECs were categorized as having low conformity (< 40%), moderate conformity (41%-59%), or high conformity (> = 60%).
Of 72 institutions identified from OHRP, the NHREC, FMOH, and FMS&T as likely to have RECs, we confirmed at the outset that six did not have any REC. Questionnaires were sent to the RECs of the remaining 66 institutions. Responses were received from 29 institutions, resulting in a 44% response rate. Of the 29 institutions that responded, 4 further reported that their RECs were not operational; thus, this study reports on responses from 25 operational RECs in Nigeria unless otherwise specified (effective response 25/66 = 38%) (Figure 1, available via the IRB: Ethics & Human Research web page).
REC chairpersons completed 19 (76%) of the questionnaires, while either the secretary or a member of the REC completed each of the rest. Responding RECs were spread across Nigeria’s six geopolitical zones. Most were based at public teaching hospitals; most universities did not have RECs (Table 2). Twenty-three RECs (92%) reported having criteria for membership. Some of the criteria included requirements for including laypersons/community members and for multiprofessional representation, by, for example, lawyers and clergy. Committees had an average of 12 members, with an average gender breakdown of eight males and four females. Fourteen RECs (56%) reported that they had at least one layperson/community member, 16 (64%) a lawyer, and 7 (28%) a bioethicist as members, while only 3 (12%) had both a Muslim and a Christian clergyperson. All RECs reported having at least one physician among their members.
Sixteen RECs (64%) reported that they provided training for their members and had trained, on average, seven members each. This included 10 RECs (out of a total of 14) that required members to receive refresher trainings at least once a year and 6 RECs (out of a total of 9) that had no such requirement. As for the type (mode) of training reported by the 16 RECs, 10 RECs (63%) provided an in-person workshop or seminar only, 1 REC (6%) provided an online course only, and 5 RECs (31%) provided both online and workshop- or seminar-style trainings for members (Table 2).
Twenty RECs (80%) reported having a document on standard operating procedures (SOPs) to guide operations. Seventeen (68%) said the committee met at least quarterly (Table 3). Eighty-eight percent of RECs (n = 24) required a “primary review” (review of protocols by all committee members prior to scheduled meetings), while 18 (78%, n = 23) had policies requiring consultation with external experts to guide determinations when expertise within the REC was insufficient. All 25 RECs reported using at least one international ethics guideline as the basis for their operations; the World Medical Association’s Declaration of Helsinki and the Council for International Organization for Medical Sciences’ (CIOMS’s) International Ethical Guidelines for Biomedical Research Involving Human Subjects were the most commonly used guidelines (Table 3).
As part of the application process, 20 RECs (80%) required that investigators complete application forms and submit full study protocols. Sixteen RECs required submission of protocol summaries or research plans, which are abridged versions of full study protocols used to determine the type of review necessary. Twenty-one RECs (84%) required the submission of other supporting documents, such as consent forms, questionnaires, and interview guides, while only two RECs (8%) required submission of certificates of investigator training in research ethics. At least 14 RECs (56%) considered study design, participant selection, risk versus benefits of the study, and informed-consent processes and forms to be the most important elements during protocol review.
Of the 24 RECs that responded to the question on the validity period for ethics approvals, more than half (58%) gave approvals that lasted the entire length of studies, and only 9 (38%) gave approvals limited to one year (Table 4). Of the 22 RECs that responded to the question on continuing review policy, 15 (68%) reported conducting continuing oversight of approved research studies. This was done through review of progress reports, visits to study sites, or both (Table 4).
All RECs (n = 25) kept records of their operations, and all reported keeping approved research proposals and supporting documents (Table 4). Twenty-four (96%) kept minutes of REC meetings, 15 (60%) kept research progress reports, and 11 (44%) kept records of research completion reports. Records included meeting minutes, approved research protocols, and supporting documents. Twenty-one RECs (84%) reported on the duration for which they kept records; of these, 7 RECs (33%) kept records for 6 to 10 years after the completion of a study, while others kept them for less than this period.
Seventeen RECs (68%) processed applications within three months, and eight RECs (32%) in less than one month (Table 4). The total number of study protocols reviewed in 2008 varied widely, with 13 RECs (54%) reporting reviewing fewer than 30 protocols, 8 RECs (33%) reporting 30 to 70 protocols, and 3 RECs (13%) reporting more than 70 protocols. For 14 RECs (58%), at least 75% of studies reviewed were local studies with no international funding.
Only 11 RECs (44%) reported having a dedicated office space, while a similar percentage had secure storage rooms for record keeping, computers, printers, and Internet access. Of the 24 RECs (96%) that responded to questions concerning availability of staff, all had secretaries, 13 (54%) had administrative officers, and 7 (29%) had clerks. Regarding financial resources, 3 of 22 RECs (14%) had dedicated budget lines from their host institutions for operations; 14 of 24 RECs (58%) charged fees for review, which were differentially priced for internationally and locally funded research projects. Several RECs reported being funded through grants from the Ministry of Health, medical or health research councils, and the European and Developing Countries Clinical Trials Partnership (EDCTP). Only 5 of 21 RECs (24%) remunerated their members (Table 5).
The degree of conformity of RECs in this study to the Nigerian National Code of Health Research Ethics and to the operational guidelines of the WHO’s REC was evaluated based on the selected 16-point criteria in Table 1. Four RECs (16%) satisfied fewer than 6 (< 38%) of the criteria; 9 RECs (36%) met between 7 and 10 of the criteria (44% to 63%), while 12 RECs (48%) met at least 11 of the criteria (> 68%). Table 6 shows the results of our analysis of the relationship of REC characteristics with the degree of conformity of RECs to the Nigerian code and the WHO’s REC guidelines. The results show that RECs with chairs who had prior training in bioethics (p = 0.067) and those committees registered with both OHRP and the NHREC (p = 0.013) were more likely to exhibit a higher degree of conformity to these guidelines. No strong association was found with the other factors assessed.
RECs (72%) reported support from the head of their host institution as a major strength of the ethics committee. Fourteen RECs (56%) also thought that the training and experience of their members in contemporary bioethics issues was an important strength that had helped them function effectively. Nineteen RECs (76%) mentioned inadequate funding as their major weakness. Other weaknesses reported included low motivation of REC members and lack of adequate office space (in both cases, this was reported by 13 RECs, [52%]). Respondents also rated, from most to least important, their preferences for training in nine different areas. At least 14 RECs (56%) agreed on the importance of three training needs: “[e]thical issues in research with vulnerable populations,” “[e]thical issues in research with communities,” and “[e]thical issues in drug/vaccine trial.” RECs preferred that these issues be addressed through workshop or seminar trainings and that these last for less than one week.
This study describing the structures and operations of health RECs in Nigeria provides insight into the RECs’ capacities to promote the protection of human research participants in accordance with the Nigerian National Code of Health Research Ethics and the WHO’s REC guidelines. When published in 2000, the WHO’s guidelines were widely consulted as a reference document for the establishment of RECs and operational benchmarking especially in developing countries. The document provided guidance on constitution of RECs, membership structure, establishment of offices, quorum requirements, record keeping and archiving, consultation with external experts, training of members, meeting requirements, elements of review, and the like.25 The Nigerian ethics code provided further specification on the provisions of the WHO’s guidelines and how they ought to apply to the operations of RECs in Nigeria. The Nigerian code was developed (as were the WHO guidelines) with consideration of provisions from other international sources including CIOMS’s ethics guidelines, the WHO’s Declaration of Helsinki, and the U.S. Common Rule (45 CFR 46.107). Fadare and Proteri provide a more detailed analysis of the Nigerian code, comparing it with international guidelines.26
Overall, there is variability in the degree to which operations and review processes adopted by RECs in this study conformed to the Nigerian code and the WHO’s guidelines. At least 80% of the RECs reported having SOPs, multidisciplinary membership, and a proper record-keeping practice. This agrees with a similar report from Egypt by Sleem et al. and a multicountry study by Nyika et al., which reported that 83% and 71% of RECs, respectively, had SOPs.27 This may be attributable to capacity-building initiatives present in Nigeria since 2006 that included the establishment of the West African Bioethics Training Program (funded by the Fogarty International Center and the National Human Genome Research Institute, both entities of the U.S. National Institutes of Health).28 Other in-country institutions or nongovernmental organizations supporting capacity building for RECs include the New HIV/AIDS and Microbicide Advocacy Society, the Obafemi Awolowo University Institute of Public Health, and the Association for Good Clinical Practice.29
The finding in this study that few laypersons/community members were on the RECs is similar to findings from other studies.30 However, there are practices and recommendations that promote the inclusion of more laypersons on RECs. In the United Kingdom, the U.K. Health Department’s policy on RECs requires laypersons to comprise one-third of RECs, and the law in Denmark requires half plus one of all REC members to be laypersons.31 In the United States, the National Bioethics Advisory Commission recommended that laypersons constitute 25% of REC membership.32 In both the U.K. and Denmark, the requirement for having laypersons on the committee is an attempt to ensure that the perspectives of nonscientists are taken into consideration during REC reviews. Similarly, regulatory requirements in the United States for RECs to include at least one individual who is not otherwise affiliated with the institution and one individual who is a nonscientist, in theory, supports the identification of potential concerns and preferences of those who represent “outside” interests and perspectives. Although there is no specific document that defines who a lay member is in Nigeria, in practice, the term “layperson” is used to apply to members with nonscientific backgrounds who are not affiliated with the REC and who bring perspectives from the lay community from which people will be recruited to participate in research. The interchange in the use of “laypersons/community members” in this article reflects the multiple roles that laypersons are typically meant to serve in the country. In Nigeria, a new approach is further being implemented to improve the role of laypersons/community members on RECs. This approach focuses on the ability of laypersons/community members to engage in the protocol review process and provide constructive feedback. In 2009 and 2010, the New HIV Vaccine and Microbicide Advocacy Society, in collaboration with the NHREC, successfully trained 30 laypersons/community members from more than 10 RECs in Nigeria to review protocols and provide constructive feedback.33 An evaluation of the impact of this new project on the work of RECs would be an important undertaking, especially given our results indicating that priority topics for REC capacity development include ethical issues in research with communities and vulnerable populations.
RECs demonstrated high compliance in terms of the documents that they requested that researchers submit for review, except in the requirement for submission of investigator certificates in ethics training; information about these certificates has not been reported in other studies on RECs in the region. The high number of RECs with record-keeping policies is encouraging, although, in practice, not all of these RECs fully conformed with extant record-keeping guidelines. While the current Nigerian guideline requires RECs to keep all study records for at least 10 years after the completion of a study, only 24% reported keeping records for that long. This finding may be attributable to the limited office space that the RECs had; only 11 RECs had dedicated office spaces in their host institutions.
The RECs that were surveyed reviewed, on average, 36 protocols per year, which were mostly local studies. Review of international collaborative studies constituted at least 25% of the workload of most of the RECs. This shows that the workload of the RECs was modest and similar to what was found in the study on RECs in Egypt, which reviewed an average of 42.3 (n = 9) protocols per year.34
The NHREC requires that all RECs demonstrate that they provide some form of ethics training for their members as part of the requirement for initial and renewal REC registration. Although nine RECs reported not having a policy for refresher training, it was also reported by several of these RECs that some members had received refresher training even though the RECs did not have a formal training policy. This may suggest that even without such a policy, RECs are aware of the importance of training for their members and are making efforts in this regard. Nonetheless, 40% of RECs in this study reported lack of training in bioethics as a major challenge. Furthermore, anecdotal evidence suggests that delays in renewal of REC registrations are largely due to the inability to organize the required refresher training for REC members due to limited funding. Member training prior to committee appointment is also likely to be important. While our results indicate that many chairs of RECs in Nigeria reported having completed some amount of training in research ethics prior to their service, many other members did not. This finding is also similar to that of Sleem et al.,35 indicating an important challenge for similarly situated RECs. Ideally, all members should have prior training in research ethics and continuing training during their service as REC members.
As mentioned above, recently adopted systems for registration of RECs, such as those instated in Nigeria and South Africa, may help bridge the training gap.36 In these countries, individuals who apply or are nominated for REC membership must have a minimum level of training in research ethics. In Nigeria, this is typically satisfied by completion of an NHREC-approved training workshop (which lasts between 3 and 5 days) and/or the Nigerian component of the CITI online training.37 The observed low conformity of RECs to the Nigerian requirement for prior training in research ethics was likely attributable to REC member appointments’ having occurred before formal initiation of the national REC registration process.38 Additional future training activities for REC members should take into account stated preferences for face-to-face interaction, although further studies may be needed to better understand actual training practices and obstacles for REC members in Nigeria and similarly situated countries.
Resources available to RECs were also found to be inadequate to support high-quality administrative processes. The finding that most RECs did not have administrative officers or clerks is similar to findings in previous reports.39 Moreover, poor financing, in general, of RECs in Nigeria and across much of Africa has also been documented previously.40 This poses a major challenge for the development, sustainability, and growth of research ethics systems in the region.
Limited resources, along with nonremuneration of REC members, could also contribute to motivational deficits among REC members and affect the productivity and efficiency of RECs. Indeed, 52% of RECs in this study reported that low motivation was a major weakness. Nyika et al.’s suggestion to study the funding necessary for RECs in Africa to function effectively remains relevant as a first concrete step to inform key stakeholders and support long-term sustainability.41 Furthermore, the Association of Administrators of Research Ethics Committees in Africa, which was established as an outcome of the African Conference for Administrators of Research Ethics Committees in Botswana, may serve as a resource in the work of strengthening REC administrators in the subregion.42 However, this new initiative would also require funding to become fully functional.
It is interesting that conformity with the Nigerian code and the WHO guidelines was positively associated with prior training of REC chairs in bioethics and with the dual registration status of RECs with OHRP and the NHREC. The former association is relevant to the numerous calls in the literature and elsewhere for REC capacity building not only in procedures but also in ethics principles themselves, while the latter suggests that registration of RECs with both OHRP and the NHREC can support (or be a sign of) efforts by RECs to meet both local and global standards. Indeed, it was noteworthy to us that better adherence to international ethics guidance was not found when an REC had registered with only either OHRP or the NHREC but only when an REC had registered with both. Of note, however, all NHREC-registered RECs in the study were also registered with OHRP. The lack of positive association with OHRP registration alone might signal the importance of local oversight of research ethics committees and, perhaps more pointedly, of support that local governing bodies can provide to help committees interpret and apply local and international standards. A close collaboration between OHRP and national ethics committee regulatory authorities, where they exist and are functional, could help in this regard.
RECs generally agreed that a national body (the NHREC) that coordinates and provides guidelines for the operations of RECs adds value to protection systems for human research participants in Nigeria. This finding is consistent with findings from Egypt43 and supports the call by the WHO and UNESCO’s International Bioethics Committee for the establishment of such national structures in developing countries. However, it is important to ensure that national committees are established within existing public health systems if they are to be sustainable and capable of supporting the strengthening of health systems.44 In Nigeria, the NHREC is now legislatively supported by the Nigeria National Health Act, 2014. Its role includes, among other things, setting norms and standards for the conduct of human and animal research (including clinical trials), registering and auditing RECs, adjudicating complaints about REC operations, and advising the government on ethical issues.45
This study’s effort to identify ethics committees according to the degree to which their organization and operations conform to local and international guidelines offers a basic approach for assessing the broad functional quality of RECs. However, while the ways in which RECs are organized and their operations are important, these are only components of functional quality. Assessing the degree to which structural and functional variations in RECs influence the protection of human research participants is beyond the scope of this national review but should be an aim of future in-depth functional quality evaluations.
Finally, there are many research studies being conducted in biomedical and social and behavioral science faculties in the more than 45 universities in Nigeria; however, preliminary evidence suggests that almost none of the universities in Nigeria have RECs. It is nationally and internationally important to determine what systems, if any, exist for research oversight in these institutions and what steps might be taken to move additional institutions toward compliance with international norms.
This study has several limitations. Although the response rate for the study was within the expected range as reported by Cook et al., poor Internet access in the country as well as the length of the questionnaire may have influenced survey completion and the overall rate of response.46 Respondents were also limited to REC chairs or their designees (secretaries, administrative officers, or members), and, thus, there is a risk of response bias. That 41 RECs either did not respond to the survey or were found to be nonoperational may also suggest bias among the 25 that did respond. However, of those that responded, only a slightly higher number of responding RECs (15 RECs) were registered with either OHRP or the NHREC or both; the remaining 10 RECs were unregistered at the time of data collection. Having this diversity in registration statuses may help to offset nonresponse bias; however, it cannot render such bias wholly insignificant. In addition, prior training in research ethics was self-defined, and, therefore, we are not able to determine whether, for example, there is a difference in association with guideline conformity depending on the duration or type of training received. Moreover, due to the study design, we were unable to obtain certain information, such as what the RECs meant by stating that they used the Belmont Report principles more than the U.S. Common Rule to guide their work. Finally, since the surveys were anonymous, we were unable to understand the reasons for omissions by respondents and whether the individuals responding did so unilaterally or with input from other REC members. Given that the lead researcher was also the secretary to the National Ethics Committee, it was centrally important to use an anonymous approach, but it also affected our ability to address the volume of “missing data” values.
To our knowledge, this is the first study documenting the operations, organization, and needs of RECs from across all the geopolitical zones in Nigeria. This study highlights the fact that, though REC operations are generally aligned with many local and international codes and guidelines, there is wide variability among institutions in the degree to which these guidelines are applied. Additionally, in most RECs, the availability of material, human, and financial resources needed for optimal operations is inadequate, and there are limited opportunities for continuous capacity building for REC members. In particular, in order to address the variability observed in this study, we recommend the establishment or strengthening of networks for chairs and administrators of RECs across Nigeria. This would have the potential to foster improved common understanding of national standards and norms of practice. Further capacity building for RECs supported by the NHREC as well as institutionalization of REC audits or other monitoring mechanisms that support REC operations may also be useful in this regard, especially given the limited capacity of OHRP to audit registered RECs around the world. Lastly, with the enactment of the law that now further strengthens the NHREC and other institutional RECs–and taking into consideration the competition for the limited funding available across all sectors of the Nigerian economy and, more specifically, organizations within the health sector, such as the NHREC–there is a need to implement a mechanism to ensure that RECs receive resources necessary for their optimal operations. Though methodologically difficult, resource allocation and priority-setting decisions would be greatly facilitated by future efforts to evaluate the degree to which structural and functional variations in RECs influence the protection of human research participants.
Tables and Figure
All of the tables and the figure for this article are available via the IRB: Ethics & Human Research web page, part of the Hastings Center website.
Aminu A. Yakubu, BSc, MPH, is an assistant chief research officer in the Department of Health Planning, Research & Statistics and a desk officer to the National Health Research Ethics Committee in the Federal Ministry of Health, in Abuja, Nigeria; Adnan A. Hyder, MD, MPH, PhD, is a professor and the codirector of the Johns Hopkins-Fogarty African Bioethics Training Program at the Johns Hopkins Berman Institute of Bioethics and Johns Hopkins Bloomberg School of Public Health at Johns Hopkins University; Joseph Ali, JD, is a research scholar at the Johns Hopkins Berman Institute of Bioethics at Johns Hopkins University; and Nancy Kass, ScD, is a professor and the codirector of the Johns Hopkins-Fogarty African Bioethics Training Program at the Johns Hopkins Berman Institute of Bioethics and Johns Hopkins Bloomberg School of Public Health at Johns Hopkins University.
This study was conducted as the practicum part of the Johns Hopkins Fogarty African Bioethics Fellowship awarded to Aminu A. Yakubu. We are grateful to Prof. Clement Adebamowo for providing local supervision of this study in Nigeria as well as to Mr. Makwin Mabwe and Dr. Olusegun Afolabi for their support with statistical analysis. This work was supported by the National Institutes of Health/Fogarty International Centre Science Education Partnership Award number 2R25TW001604-13.
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- See ref. 9, Sleem et al. 2010.
- See ref. 5, Ikingura et al. 2007.
- See ref. 5, Arda B. 2000.
- See ref. 9, Caniza et al. 2006.
- See ref. 5, Loue and Okello 2000; Yakubu A, Adebamowo CA. Implementing national system of health research ethics regulations: The Nigerian experience. BeOnline: Journal of the West African Bioethics Training Program 2012;1(1):4-15.
- Kirigia JM, Wambebe C, Baba-Moussa A. Status of national research bioethics committees in the WHO African region. BMC Medical Ethics 2005;6:E10; Rivera R, Ezcurra E. Composition and operation of selected research ethics review committees in Latin America. IRB: Ethics & Human Research 2001;23(5):9-12; World Health Organization. Ethics in Health Research: An Overview of Ethical Review Mechanisms in Countries of South-East Asian Regional Office. 27th Session of the WHO South-East Asia Advisory Committee on Health Research. Dhaka, Bangladesh, April 15-18, 2002.
- Silaigwana B, Wassenaar D. Biomedical research ethics committees in sub-Saharan Africa: A collective review of their structure, functioning, and outcomes. Journal of Empirical Research on Human Research Ethics 2015;10(2):169-184.
- Falusi AG, Olopade OI, Olopade CO. Establishment of a standing ethics/institutional review board in a Nigerian university: A blueprint for developing countries. Journal of Empirical Research on Human Research Ethics 2007;2(1):21-30.
- Eyelade OR, Ajuwon AJ, Adebamowo CA. An appraisal of the process of protocol review by an ethics review committee in a tertiary institution in Ibadan. African Journal of Medicine and Medical Sciences 2011;40(2):163-169.
- Agunloye AM, Salami AT, Lawan A. Current role of research ethics committees in health research in three geopolitical zones in Nigeria: A qualitative study. South African Journal of Bioethics and Law 2014;7(1):19-22.
- Oyedeji KS. A study of the needs and resources of health research ethics committees in South Western Nigeria [master’s dissertation]. University of KwaZulu-Natal, Pietermaritzburg, South Africa, 2011. Referenced in: Silaigwana B, Wassenaar D. Biomedical research ethics committees in sub-Saharan Africa: A collective review of their structure, functioning, and outcomes. Journal of Empirical Research on Human Research Ethics 2015;10(2):169-184.
- World Health Organization. Operational Guidelines for ethical committees that review biomedical research. Geneva: World Health Organization, 2000; Federal Ministry of Health. National Code of Health Research Ethics. Abuja, Nigeria: Federal Ministry of Health, 2007.
- Department of Health and Human Services. Office for Human Research Protections (OHRP) Database for Registered IORGs & IRBs, Approved FWAs, and Documents Received in Last 60 Days. https://ohrp.cit.nih.gov/search/irbsearch.aspx?styp=bsc; National Health Research Ethics Committee. Database of Registered Health Research Ethics Committees. https://nhrec.net/nhrec/registered-health-research-ethics-committees-in-nigeria-hrec/.
- Milford C, Wassenaar D, Slack C. Resource and needs of research ethics committees in Africa: Preparations for HIV vaccine trials. IRB: Ethics & Human Research 2006;28(2):1-9.
- See ref. 21, World Health Organization 2000.
- The WHO guidelines were revised in 2011, providing more depth to the 2000 version and an improved structure to enable its use in performance monitoring of RECs; however, the core elements required for REC operations and structures remained the same. This study was conducted prior to the issuance of the 2011 version.
- Fadare JO, Porteri C. Informed consent in human subject research: A comparison of current international and Nigerian guidelines. Journal of Empirical Research on Human Research Ethics 2010;5(1):67-74.
- See ref. 9, Sleem et al. 2010; Nyika A et al. Capacity building of ethics review committees across Africa based on the results of a comprehensive needs assessment survey. Developing World Bioethics 2009;9(3):149-156.Â
- Adebamowo CA. West African bioethics training program: Raison d’etre. African Journal of Medicine and Medical Sciences 2007;36 Suppl:35-38.
- The Institute of Public Health. Obafemi Awolowo University, Ife, Oyo State. https://iphoau.org/structure.php; Association for Good Clinical Practice. https://www.agcpng.com.
- See ref. 5, Ikingura et al. 2007; see ref. 9, Moodley and Myer 2007; see ref. 15, Kirigia et al. 2005; see ref. 16, Silaigwana et al. 2015; Nyika A et al. Composition, training needs and independence of ethics review committees across Africa: Are the gate-keepers rising to the emerging challenges? Journal of Medical Ethics 2009;35(3):189-193.
- Holm S. How many lay members can you have in your IRB?: An overview of the Danish system. IRB: Ethics & Human Research 1992;14(6):8-11; U.K. Departments of Health. Governance Arrangements for Research Ethics Committees: A Harmonised Edition. Department of Health, 2011.
- National Bioethics Advisory Commission. Ethical and Policy Issues in Research Involving Human Participants, vol. I. Rockville, MD: U.S. Government Printing Office, 2001.
- Folayan MO et al. Impact of three years training on operations capacities of research ethics committees in Nigeria. Developing World Bioethics 2014;14(1):1-14.
- See ref. 9, Sleem et al. 2010.
- See ref. 9, Sleem et al. 2010.
- See ref. 9, Moodley and Myer, 2007; Adebamowo CA et al. Developing ethical oversight of research in developing countries: Case study of Nigeria. Harvard Health Policy Review 2007;8(1):96-106.
- Braunschweiger P, Goodman KW. The CITI program: An international online resource for education in human subjects protection and the responsible conduct of research. Academic Medicine 2007;82(9):861-864.
- In Nigeria, the registration system is further used to categorize RECs according to the types, nature, and complexity of research studies they may review and their area(s) of jurisdiction.
- See ref. 30, Nyika et al. 2009.
- See ref. 9, Moodley and Myer 2007, Sleem et al. 2010; see ref. 23, Milford et al. 2006; see ref. 30, Nyika et al. 2009.
- See ref 30, Nyika et al. 2009.
- Brecher B et al. Is it appropriate for research ethics committees to make judgements about the scientific quality of research proposals? Nursing Ethics 2011;18(1):122-125.
- See ref. 9, Sleem et al. 2010.
- Hyder AA et al. Moving from research ethics review to research ethics systems in low-income and middle-income countries. Lancet 2009;373(9666):862-865.
- Federal Republic of Nigeria Official Gazette. National Health Act, 2014.
- Cook C, Heath F, Thompson RL. A Meta-analysis of response rates in web- or Internet-based surveys. Educational and Psychological Measurement 2000;60(6):821-836.