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National ethics guidance in Sub-Saharan Africa on the collection and use of human biological specimens: a systematic review



Ethical and regulatory guidance on the collection and use of human biospecimens (HBS) for research forms an essential component of national health systems in Sub-Saharan Africa (SSA), where rapid advances in genetic- and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks.


An extensive multi-level search for publicly available ethics regulatory guidance was conducted for each SSA country. A second review documented active trials listed in the WHO International Clinical Trials Registry Platform as of January 2015 in which HBS collection was specified in the protocol. Findings were combined to determine the extent to which countries that are study sites for HBS-related research are supported by regulatory guidance language on the collection, use, ownership and storage of biospecimens.


Of the 49 SSA countries, 29 had some form of national ethics guidance, yet only 17 provided language relating to HBS-related research, with specific guidance on consent (14), ownership (6), reuse (10), storage (9), and export/import/transfer (13). Ten countries accounted for 84 % of the active clinical trials involving the collection of HBS in SSA. All except one of these countries were found to have some national guidance in the form of regulations, codes of ethics, and/or standard operating procedures; however, only seven of the ten offered any language specific to HBS.


Despite the fact that the bulk of registered clinical trials in SSA involving HBS, as well as existing and proposed sites for biorepositories under the H3Africa Initiative, are currently situated in countries with the most complete ethics and regulatory guidance, variability in the regulations themselves may create challenges for planned and future pan-African collaborations and may require legislative action at the national level to revise. Countries in SSA that still lack regulatory guidance on HBS will require extensive health system strengthening in ethics governance before they can be full participants in the modern research enterprise.

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Exponential growth in the fields of pharmacogenetics and genomics research over the past decade is fueling worldwide interest in the establishment of biorepositories of human biological specimens. Biorepositories already exist in three SSA countries—The Gambia, South Africa, Zimbabwe [13]. Major expansion in this domain is occurring in Sub-Saharan Africa, largely driven by the Human Heredity and Health in Africa Initiative (H3Africa), a joint effort of the National Institutes of Health (NIH), the Wellcome Trust, and the African Society for Human Genetics [4]. The ‘hub and spoke’ model adopted by this initiative calls for the development of four pilot regional biobanks – two in South Africa and one each in Nigeria and Uganda – which will serve as multi-country repositories of specimens collected under sponsored research activities taking place throughout the region [5]. The H3Africa Initiative reflects significant efforts by the international community of researchers, funding agencies, and African academic institutions to build a foundation for sophisticated, state-of-the-art genomic research on burdensome diseases in Africa; the ultimate goal of the initiative is to improve the health of the African peoples.

From its inception, the initiative has sought broad consensus on topics relating to ethics and governance A Joint NIH and Wellcome Trust Policy document sets forth high-level principles on ethics, governance, and resource sharing with which research networks and programs funded by the initiative are expected to comply [6]. A standing working group on ethics and regulatory issues comprising ethicists and other members of the scientific community meets periodically to discuss and develop recommendations on a wide range of topics including community engagement strategies, cultural issues, informed consent, participant safety, return of results, intellectual property, material transfer agreements, and other regulatory issues. While such guidance has the potential to serve as a model framework for all countries in Africa to consider as they develop their own national guidelines, the current focus of the initiative is on those entities that it supports. Applied more broadly, the pan-continental approach espoused by H3Africa and similar initiatives may require a level of ethical guidance at the country level explicitly addressing the collection and use of HBS which is currently not to be found in most national ethics regulatory guidance. In many African countries, such systems are in their infancy; policies that address emerging technologies such as whole genome sequencing and association studies are absent [7, 8].

The International Declaration on Human Genetic Data, promulgated by UNESCO in 2003, recognized the importance of national policies to guide the collection, processing, use, and storage of human genetic data, as well as the review by local and institutional ethics committees of protocols involving such data [9]. In Africa specifically, a growing body of literature has focused on the need to have ethical and legal governance structures in place to oversee research involving HBS and the operation of biobanks [10, 11].

If the H3Africa vision of a pan-continental genomic enterprise is to be fully realized, ethics guidelines at the national level must align in ways that support interoperability among African countries. In cases where no guidelines presently exist, investment in institutional capacity-building by such entities as H3Africa and others may be needed to support their development. In cases where national guidelines do exist, some may require the addition of new language specific to research involving HBS; such revisions may require legislative approval. There may be instances where national values simply will not support the transnational transfer of genetic information, broad data sharing within research communities (however relevant to their populations), or the delegation of decision-making on future use to an outside authority. The lack of interoperability among African nations in their ethics guidance as well as differences in interpretation of meaning in instances where international recommendations have been adopted has the potential to slow, even derail, the realization of benefit from new advances and approaches in biomedical research [10, 12].

Although a number of scholars have examined the ethical, legal, and social issues associated with the collection and use of biospecimens in research, there has been far less focus on the existence and nature of regulatory guidance on HBS at the national level in Sub-Saharan Africa [8, 1117]. Of particular importance is the identification of national ‘gaps’ in ethics guidance, as well as inconsistencies and national differences among those countries where guidance does exist.


This study involved two systematic reviews designed to determine the availability of publicly accessible regulatory HBS guidance at the national level in SSA countries and to assess the extent to which it addressed ethical and regulatory issues relating to consent, ownership, reuse, storage, and export/import/transfer. Two reviews were conducted as part of this project. The first involved a multi-level search to identify publicly available national research ethics guidance on the collection and use of HBS in countries in Sub-Saharan Africa. This process, detailed in Table 1, involved keyword searches, on-line reviews of international ethics databases and regional and national government websites, and, in those instances where on-line efforts yielded no results, direct contact via email with national ethics committees and scans of ethics review statements included in previously published journal. National ethics guidance was operationalized to include enabling legislation for the creation and constitutions of national research institutes and national research ethics committees, codes of ethics, national ethics guidelines, and standard operating procedures. We excluded those documents that only provided instructions to researchers on how to submit their protocols, instruction on writing consent documents, and organizational information from research ethics committees that were not identified as being national in jurisdiction. Materials Transfer Agreements (MTA) and Specimen Transfer Agreements (STA) for specific countries were included in our search but were only used as a source of guidance if we could find a specific reference to “human” biological specimens. We limited our results to those national documents that we could access publicly on-line or secure through contact with the national regulatory body, reasoning that guidelines that were inaccessible via such mechanisms would be of limited utility to the research community.

Table 1 Search strategy and selection criteria

A second review was conducted using the WHO International Clinical Trials Registry Platform (ICTRP) to identify registered clinical trials taking place in Sub-Saharan Africa as of January 1, 2015, and, of these, the number of clinical trials in each country that called for the collection of HBS as part of the study protocol [18]. The ICTRP is a web-based, publicly accessible compilation of studies that have been registered in any of the following databases: Australian New Zealand Clinical Trials Registry (ANZCTR); Chinese Clinical Trial Registry (ChiCTR);; EU Clinical Trials Register (EU-CTR); ISRCTN; The Netherlands National Trial Register (NTR); Brazilian Clinical Trials Registry (ReBec); Clinical Trials Registry – India (CTRI); Clinical Research Information Service - Republic of Korea (CRiS); Cuban Public Registry of Clinical Trials (RPCEC); German Clinical Trials Register (DRKS); Iranian Registry of Clinical Trials (IRCT); Japan Primary Registries Network (JPRN); Pan African Clinical Trial Registry (PACTR); Sri Lanka Clinical Trials Registry (SLCTR); and Thai Clinical Trials Register (TCTR). Included in the count of active clinical trials were those trials listed in the database as active/not recruiting; recruiting; not yet recruiting; authorized-recruitment/may be ongoing or finished; and pending. Studies were excluded if identified as not recruiting; complete; terminated; closed/follow-up continuing; closed to recruitment/follow-up complete; temporary halt or suspension; other; not applicable; or withdrawn. The process used to identify active trials calling for HBS collection is illustrated in Fig. 1.

Fig. 1
figure 1

Research process for identifying active clinical trials in SSA involving HBS collection (Source: WHO-ICTRP as of January 1, 2015)


Table 2 summarizes the availability of national ethics guidance irrespective of content as well as guidance language specific to HBS in each of the 49 countries included in the WHO region constituting Sub-Saharan Africa. Detailed information on the specific content of any HBS-related language is provided in Table 3. Twenty-nine (60 %) of the countries in the region had some national ethics guidance, either in the form of laws, regulations, codes, guidelines, or standard operating procedures. Of these 29 countries, however, twelve did not have regulations that addressed specific guiding principles or rules for ethics research or review. Six (Congo DRC, Equatorial Guinea, Republic of Guinea, Lesotho, Madagascar, and Mali) had regulatory language that was limited to establishing or defining the functions and constitution of research ethics committees. One (Mauritius) had drafted a code of research ethics that was distributed for public comment in 2003, but no documentation could be found that it had been operationalized. Three countries (Cameroon, Mozambique, Rwanda) offered limited language specific to guiding principles or ethical conduct of research, but link their review processes to the ethical guidance contained in the Declaration of Helsinki, CIOMS, or the ICH-GCP [1921]. No national guidelines for general ethical conduct of research could be found for The Gambia, but the Medical Research Council – The Gambia had published very detailed guidelines for the collection and use of biospecimens stored in the National DNA Bank of The Gambia which we have included in our analysis [22]. In addition, two countries (Chadand Gabon) had been working with UNESCO on the establishment of national ethics committees but no regulatory documentation could be found [23, 24].

Table 2 SSA countries with HBS-related information in legislative/regulatory/guidance ethics documents
Table 3 National regulatory guidance language on collection and use of HBS by country*

More than one half (59 %) of the countries whose guidelines articulated ethical principles or guidelines for ethical review include some language to guide the collection and use of HBS for biomedical research. Fourteen of these offered some language with respect to informed consent; 10 addressed the subject of reuse; and 12 contained specific language relating to export/import/transfer. Only six countries offered language with respect to HBS ownership and nine contained language regarding storage. Thirteen required that a Materials or Specimens Transfer Agreement be executed. Table 4 reports the findings with respect to registered, active clinical trials in Sub-Saharan Africa that called for the collection of HBS. Of the 5319 studies identified in the WHO International Clinical Trials Registry Platform, 1802 of were currently active as of January 1, 2015. Three hundred sixty-six (366) of these involved the collection of a biosample from research subjects. The distribution of these trials across the region are illustrated in Fig. 2.

Table 4 Clinical trials in SSA involving HBS collection (Source: WHO-ICTRP as of January 1, 2015)
Fig. 2
figure 2

Distribution of active clinical trials in SSA involving HBS collection (Trial information Source: WHO-ICTRP as of January 1, 2015; Map source: Wikimedia Commons)

Table 5 reports on the ethics system guidance on HBS found in the countries where the largest number of studies involving HBS are currently taking place in Sub-Saharan Africa. These 10 countries account for nearly 82 % of the active clinical trials involving the collection of HBS in the region that were registered in the WHO International Clinical Trials Registry Platform as of January 1, 2015. They included the five countries that either have existing biorepositories (The Gambia, South Africa and Zimbabwe) or planned to establish regional biorepositories in the near future as part of the H3Africa Initiative (Nigeria, South Africa and Uganda). All ten of these countries had some form of ethics system guidance in the form of regulations, codes of ethics, standard operating procedures, or guidelines, and, with the exception of Mali, provided some regulatory language at the national level as to the collection and use of HBS. Notably only four of these countries (The Gambia, Kenya, Uganda, and Zambia) included language in their national ethics documents on the ownership of HBS. Mali, where at the time of our study there were currently 10 registered active trials requiring a biosample, had no guidance language on HBS in its national ethics documents. Although most of the countries in which large biorepositories existed or are planned as part of H3-Africa contain fairly detailed HBS language in their guidelines, only two (The Gambia and Uganda) spoke to issues of ownership. After Mali, Zimbabwe offered the least guidance within this group of countries, with no language on HBS-specific consent, ownership, or reuse.

Table 5 National ethics guidance on 10 countries host to the most registered clinical trials


This study examined the availability of national ethics and regulatory guidance on biomedical research in Sub-Saharan African countries and identified the extent to which national regulatory systems provided ethics guidance on specific aspects of HBS collection and use to inform research design and ethics review. Ethical principles and regulatory guidance regarding HBS consent, ownership, reuse, storage, and export/import/transfer are foundational elements in national health systems as research activities calling for the collection and use of biospecimens in Africa expand and ethics committees are increasingly called on to review and respond to rapidly advancing innovation in research and research technologies.

Our research found that despite efforts at the international, regional, and national levels, 20 of the countries in Sub-Saharan Africa (41 %) at the time of our study still lacked articulated national ethical principles and regulatory guidance for policy-making, review, and monitoring of research. Among those countries where ethical and regulatory guidance existed, specific language with respect to HBS collection and use was often lacking or incomplete. While in 17 of the countries in Sub-Saharan Africa (59 %), some form of national regulatory guidance relating to HBS did exist, a number of these lacked explicit guidance on HBS-related issues such as consent (3), ownership (11), reuse (7), storage (8), and export/import/transfer (5).

Gaps in national ethical and regulatory guidance in the region on the collection and use of HBS for research may result in inconsistent reviews within ethics committees and pose challenges for full participation by African countries in genomic research. In the absence of guiding principles and regulatory direction, ethics committees may delay or deny HBS-related research of potential benefit to their communities, or they may approve such research without due exploration of its implications for its citizenry or its cultural values.

Differences in ethical and regulatory requirements among African countries where guidance does exist also appear to raise impediments to the interoperable pan-African approach to genomic research espoused by H3Africa. Despite the fact that the bulk of registered clinical trials involving HBS in Sub-Saharan Africa, as well as existing sites and those sites proposed for future biorepositories, are currently situated in countries with the most complete ethics and regulatory guidance on HBS, variability in the regulations themselves may create challenges for pan-African collaborations that rely on transnational sharing of specimens and data or that delegate decision-making responsibility with respect to future use to repository-centric ethics or scientific review committees. Malawi, for example, contained language in its guidelines that all forms of studies and testing aimed at collecting and storing HBS for future unspecified genetic research/analysis is ‘non-permissible’ [25]. Tanzania required that a new consent be secured for each new research protocol in which a sample will be reused [26]. Uganda, where one of the H3Africa repositories is intended to be located, required that all requests for transfers of HBS be made by a legal resident of Uganda who was affiliated with a locally registered and recognized Ugandan organization [27].

While these and other potential sources of regulatory tension may be resolved in the future, for now they represent potential constraints on research that calls for a more ‘regional’ perspective of specimen and data sharing, and are likely to require legislative action at the national level to revise. At the same time, gaps in HBS-related guidance within countries that are already research-intensive sites may give rise to lengthy or inconsistent review decisions by local ethics committees left to make their own policy decisions in the absence of clearly stated regulations or principles at the national level.

Future growth in the fields of pharmacogenetics and genomic research is likely to generate demand for HBS from a more representative pool of the African peoples and to prompt researchers to look for new communities in countries where research is currently not active. The transnational movements of diseases themselves, as seen in the 2014 Ebola outbreak in Western Africa, may identify new target populations for study beyond those of interest at present. Such expansion will require system-wide capacity-building in these settings and will need to be guided by clearly articulated national regulatory guidance to ensure ethical and thoughtful research governance.

Resources to assist national governments in developing ethics capacity may be available through such programs as UNESCO’s Assisting Bioethics Committees (ABC) program, which aims to build and strengthen bioethics infrastructure within its member states and which is already working to build capacity in Chad, Gabon, and Madagascar [23, 24, 28]. H3Africa’s working group on ethics and regulatory issues and its work to date in articulating broad principles and regulatory guidance regarding HBS collection and use [6] would, were its focus to extend beyond its own funded research networks and programs, be a valuable starting point for countries as they begin to build national consensus on the value of genomics research for their communities and the region as a whole.

Limitations of this study

Data used in this study were largely derived from publicly accessible sources. Despite an extensive search, some of the countries in Sub-Saharan Africa that we report as lacking national ethics regulatory guidelines may, in fact, have them. Given the central role that national policies play in shaping the research landscape in the region, it is important that researchers and ethics committees have ready access to country-level guidance on the collection and use of HBS as the scope of genomics research in Sub-Saharan Africa expands. In addition, the mapping of active clinical trials that involve HBS in Sub-Saharan Africa relied on publicly accessible international registries. It therefore did not take into account those studies which are not required to register, and serves more as an illustration of a potential regulatory ‘gap’ between research and national governance than as a comprehensive source of data on HBS-related research in the region.


Despite substantial capacity-building efforts, many countries still lack regulatory guidance on the collection and use of human biological specimens in research. Although the African countries currently most in demand as HBS-related clinical research sites number among those offering the most guidance, extensive health system strengthening will be needed to ensure that regulatory language is available to guide the ethical extension of HBS-related research into other countries in the region. Efforts to create interoperability across national policies to meet international and regional research goals of Pan-African research collaboration must be on-going, recognizing that some differences may be value-based choices by representative governments while others, although malleable to change, will require legislative action to amend.


  1. Sirugo G, van der Loeff S, Sam O, Nyan O, Pinder M, Hill AV, et al. A national DNA bank in The Gambia, West Africa, and genomic research in developing countries. Nat Genet. 2004;36:785–6. doi:10.1038/ng0804-785.

    Article  Google Scholar 

  2. Matimba A, Oluka MN, Ebeshi BU, Sayi J, Bolaji OO, Guantai AI, et al. Establishment of a biobank and pharmacogenetics database of African populations. Eur J Hum Genet. 2008;16:780–3. doi:10.1038/ejhg.2008.49.

    Article  Google Scholar 

  3. University of Kwazulu-Natal African Center for Health and Populations Studies

  4. Human Heredity and Health in Africa (H3Africa) Accessed 10 Oct 2015.

  5. Bruinenberg M, Frey M, Napier M, Summers A. Comparing the hub-and-spoke model practices of the LifeLines study in the Netherlands and the H3Africa Initiative. Biopreserv Biobank. 2014;12:13–6. doi:10.1089/bio.2013.0057.

    Article  Google Scholar 

  6. H3Africa. Terms of reference for the Ethics and Regulatory Issues Working Group. Accessed 10 Oct 2015.

  7. Nyika A, Kilama W, Chilengi R, Tangwa G, Tindana P, Ndebele P, Ikingura J. Composition, training needs and independence of ethics review committees across Africa: are the gate-keepers rising to the merging challenges? J Med Ethics. 2009;35:189–93. doi:10.1136/jme.2008.025189.

    Article  Google Scholar 

  8. Wright GEB, Koornhof PGB, Adeyemo AA, Tiffin N. Ethical and legal implications of whole genome and whole exome sequencing in African populations. BMC Med Ethics. 2013;14:21.

    Article  Google Scholar 

  9. UNESCO. International declaration on human genetic data. 2003.

    Google Scholar 

  10. Barchi F, Matlhagela K, Jones N, Kebaabetswe PM, Merz JF. “The keeping is the problem”: a qualitative study of IRB-member perspectives in Botswana on the collection, use, and storage of human biological samples for research. BMC Med Ethics. 2015;16:54. doi:10.1186/s12910-015-0047-3.

    Article  Google Scholar 

  11. Staunton C, Moodley K. Challenges in biobank governance in Sub-Saharan Africa. BMC Med Ethics. 2013;14:35.

    Article  Google Scholar 

  12. Dove ES, Tasse A-M, Knoppers BM. What are some of the ELSI challenges of international collaborations involving biobanks, global sample collection, and genomic data sharing and how should they be addressed? Biopreserve Biobank. 2014;12(6):363–4. doi:10.1089/bio.2014.1263.

    Article  Google Scholar 

  13. Akintola SA. Ethical and legal issues in biobanking for genomic research in Nigeria. BEOnline. 2013;1(1):16–25.

    Google Scholar 

  14. Andana PA. Human tissue-related inventions: ownership and intellectual property rights in international collaborative research in developing countries. J Med Ethics. 2008;34(3):171–9. doi:10.1136/jme.2006.019612.

    Article  Google Scholar 

  15. Muula AS, Mfutso-Bengo JM. Responsibilities and obligations of using human research specimens transported across national boundaries. J Med Ethics. 2007;33:35–8.

    Article  Google Scholar 

  16. Sathar MA, Dhai A. Laws, regulations and guidelines of developed countries, developing countries in Africa, and BRICS regions pertaining to the use of human biological material (HBM) in research. S Afr J BL. 2012;5:51–4.

    Google Scholar 

  17. Sathar MA, Dhai A, van de Linde S. Collaborative international research: ethical and regulatory issues pertaining to human biological materials at a South African institutional research ethics review committee. Dev World Bioethics. 2014;14(3):150–7.

    Article  Google Scholar 

  18. World Health Organization. International Clinical Trials Registry Platform. Accessed 10 Oct 2015.

  19. World Medical Association. Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects [64th WMA General Assembly, October 2013]. Accessed 10 Oct 2015.

  20. Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects 2002.

  21. The International Conference on Harmonization of Technical Requirements (ICH). E6 Good Clinical Practice: Consolidated Guidance. 1996.

  22. Medical Research Council (MRC) –The Gambia. Guidelines of the National DNA Bank, The Gambia. Fajara, The Gambia: Medical Research Council, 2001.

  23. UNESCO: Meeting to discuss the establishment of the National Bioethics Committee, N'Djamena, Chad, 29 July - 2 August, 2008. [SHS/EST/ABC/REP/10].

  24. UNESCO: 1st Preparatory Meeting on the Establishment of a National Ethics Committee in Gabon [SHS/EST/ABC/REP/09/Rev1]. 2007.

  25. Malawi, National Health Sciences Research Committee. Policy Requirements Procedures and Guidelines for the Conduct and Review of Human Genetic Research in Malawi. 2012. Section 3.4.1

  26. Tanzania National Health Research Forum. Guidelines of Ethics for Health Research in Tanzania, 2nd Ed. [published by National Health Research Ethics Committee]. 2009; Section 8.8

  27. Republic of Uganda, Uganda National Council for Science and Technology. National Guidelines for Research involving Humans as Research Participants. July 2014.

  28. UNESCO: Meeting with the Malgasch National Commission for the Ethics of Science and Technology (CMEST), Antananarivo, Madagascar, 20–25 June, 2007.

  29. République du Benin. Loi No. 2005–31 du 05 Avril 2006: Portant prevention, prise en charge et contrôle du VIH SIDA en République du Benin. 2006.

  30. République du Benin. Loi No. 2010–40 du 08 Decembre 2010: Portant code d’éthique et de déontologie pour la recherché en santé en République du Benin. 2010.

    Google Scholar 

  31. Republic of Botswana. The Anthropological Research Act. 1967.

  32. Republic of Botswana. Drugs and related substances [Act No. 18 of 1992]. Gaborone: Government Printer; 1992.

    Google Scholar 

  33. Republic of Botswana, Drug Advisory Board. Guidelines on drug registration applications in Botswana. 4th ed. 2014.

    Google Scholar 

  34. Republic of Botswana, Ministry of Health. Standard operating procedures for review of biomedical and bio-behavioral research. 2011.

    Google Scholar 

  35. Burkina Faso: Loi No. 23/94/ADP of 19 May 1994 in the Code of Public Health, 1994.

  36. Burkina Faso: Decret No. 2002-536/Portant creation d’un Comité d’éthique pour la recherché en santé au Burkina Faso, 2002.

  37. Burkina Faso: Arrêté conjoint 2004/147/MS/MESSRS. Portant organization et functionnement du Comité d’éthique pour la recherche en santé au Burkina Faso (CERS), 2004.

  38. Republic of Cameroon, Ministry of Public Health. Arrêté No. 079/A/MSP/DS du Octobre 1987. Pourtant création et organization d’un comité d’éthique sur la recherché impliquant les êtres humains. 1987.

    Google Scholar 

  39. Republic of Cameroon, Ministry of Public Health. Décision No. 0674/D/MSP/CIRCB du 13 Octobre 2006. 2006.

    Google Scholar 

  40. Democratic Republic of Congo, Ministry of Health. Politique nationale de recherché sur les systems de santé en République Democratique du Congo. 2004.

    Google Scholar 

  41. Committee of Equatorial New Guinea (CENGE). 2014. Accessed 10 Oct 2015.

  42. Republic of Equatorial Guinea. Decree No. 125/2014 to constitute and name the inaugural members of the CENGE. 2014.

  43. Ethiopia (FDRE), Ministry of Science and Technology. National Research Ethics Guideline. 5th ed. 2014.

    Google Scholar 

  44. The Gambia, Department of State for Health & Social Welfare. National Health Research Policy: Research to protect and improve health, 2010–2014 [Revised draft for discussion 29/12/09].

  45. The Gambia, Department of State for Health & Social Welfare. National health Research Strategic Plan: Research to protect and improve health, 2010–2014 [Final draft: 15 January 2010]

  46. Food and Drugs Authority (FDA). Guidelines for good clinical practice in Ghana. FDA/SMC/CTD/GL-GCP/2013/2. 27 January 2016.

  47. Republic of Guinea: Decree No. D/218/PRG/SGG. On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS). 1998.

  48. Republic of Kenya. Acts 2013: Special Issue. Republic of Kenya: Kenya Gazette Supplement No. 43 (Acts. No. 28) 25 Jan 2013.

  49. Kenya, National Council for Science and Technology. Guidelines for ethical conduct of biomedical research involving human subjects in Kenya (NCST No. 45). 2004.

  50. Kenya Medical Research Institute (KEMRI). National Ethics Review Committee Guidelines and Standard Operating Procedures (SOPs). 2004.

    Google Scholar 

  51. Republic of Kenya, Ministry of Health. Kenya National Guidelines for Research and Development of HIV/AIDS Vaccines. Republic of Kenya: Ministry of Health March; 2005.

    Google Scholar 

  52. Republic of Kenya, Pharmacy and Poisons Board. Guidelines for applications to conduct clinical trials in Kenya. 2011.

    Google Scholar 

  53. Kingdom of Lesotho. National Health and Social Welfare Research Policy (NHSWRP), Lesotho. 2007.

    Google Scholar 

  54. Liberia Institute of Biomedical Research. Liberia Institute of Biomedical Research/National Health Science Research Ethics Committee Guidelines: procedures for researchers. 2011.

    Google Scholar 

  55. University of Liberia-Pacific Institute for Research and Evaluation. Institutional Review Board (IRB) policies and procedures handbook. 2008.

    Google Scholar 

  56. Republic of Liberia, Liberia Medicines and Health Products Regulatory Authority. Guideline for application to conduct clinical trials in Liberia. 1st ed. 2014.

    Google Scholar 

  57. Committee MNHSR. General guidelines on health research. 2007.

    Google Scholar 

  58. Malawi: National Commission for Science and Technology. National policy measures and requirements for the improvement of health research co-ordination in Malawi [Sections 18 & 48 of the Science and Technology Act of 2003]. Malawi: NCST; 2012. Revised.

    Google Scholar 

  59. Republic of Mali. Creation of a National Ethics Committee for Health and Life Sciences, No. 02-496/P-RM. 2002.

    Google Scholar 

  60. Republic of Mali. Minister of Health – Internal ruling: operation and functions of Committee for Health and Life Sciences. 2004.

    Google Scholar 

  61. Republic of Mali. Fundamental principles of scientific and technological research, Loi 86–11 N RM. 1986.

    Google Scholar 

  62. Republic of Mali. Organization and functions of the National Institute of Public Health Research, 06–301 P-RM. 2006.

    Google Scholar 

  63. Republic of Mauritius. The clinical trials bill (No. XIX of 2010). 2010.

    Google Scholar 

  64. Republic of Mozambique, Ministry of Health. Order of Minister of Health establishing the Comité national de bioética para saude. 2002.

    Google Scholar 

  65. World Health Organization (WHO). African Health Observatory (AFRO): Namibia- Research.,_research,_evidence_and_knowledge. Accessed 10 Oct 2015.

  66. Nigeria, Federal Ministry of Health, National Health Research Ethics Committee of Nigeria (NHREC). National code of health research ethics. 2006.

    Google Scholar 

  67. Nigeria, Federal National Health Research Ethics Committee of Nigeria. Policy statement on storage of human samples in biobanks and biorepositories in Nigeria (PS1.02013). 2013.

    Google Scholar 

  68. Republic of Rwanda, Ministry of Health, National Ethics Committee. Standard operating procedures. 2009.

    Google Scholar 

  69. Republic of Rwanda, Ministry of Health. Guidelines for researchers intending to do health research in Rwanda. 2012.

    Google Scholar 

  70. Republic of Senegal. Arrêté ministerial No. 3224 MSP-DERF-DER [March 17, 2004].

  71. Republic of Senegal. Loi No. 2009–17, Code of Ethics for Health Research [March 9, 2009].

  72. Republic of Senegal. Règlement Intérieur du Conseil National de la Recherche en Santé (Standard Operating Procedures) [March 7, 2006].

  73. Republic of Sierra Leone, Ministry of Health and Sanitation, Pharmacy Board of Sierra Leone. Guidelines for conducting clinical trials of medicines, food supplements, vaccines, and medical devices in Sierra Leone (Version 02) (G-SLClinTrial). 2014.

    Google Scholar 

  74. Republic of Sierra Leone, Ministry of Health and Sanitation, Pharmacy Board of Sierra Leone. Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs). 2014.

    Google Scholar 

  75. Republic of Sierra Leone, Ministry of Health & Sanitation, Office of the Sierra Leone Ethics and Scientific Review Committee. Sierra Leone Ethics and Scientific Review Committee –Guidelines. n.d.

  76. Republic of South Africa. Act 61 of 2003 National Health Act, September 2003. [Current version in force].

  77. Republic of South Africa. Regulations relating to the use of human biological material [Government Notice R177 in Government Gazette 35099]. March 2, 2012.

  78. Republic of the Sudan, National Ministry of Health. National guidelines for ethical conduct of research involving human subjects. 2008.

    Google Scholar 

  79. United Republic of Tanzania. National Institute for Medical Research Act, No. 23 of 801979. 1979.

    Google Scholar 

  80. United Republic of Tanzania. The Human DNA Regulation Act. 2009.,_2009_(Act_No_sw.pdf.

    Google Scholar 

  81. United Republic of Tanzania, National Institute of Medical Research. Standard Operating Procedures for the National Health Research Ethics Review Committee. 2007.

    Google Scholar 

  82. Republic of Uganda, Ministry of Health. National health policy. 1999.

    Google Scholar 

  83. Government of Zambia. National Health Research Act, No. 2 of 2013. 2013.

    Google Scholar 

  84. Republic of Zimbabwe. Research Act, Chap 10:22. 1986.

    Google Scholar 

  85. Republic of Zimbabwe, Medical Research Council of Zimbabwe. Ethics Guidelines for Health Research involving Human Participants in Zimbabwe, Version 1.4. [September 30, 2011]

  86. Republic of Zimbabwe, Medicines Control Authority of Zimbabwe. Guidelines for good clinical trial practice in Zimbabwe. 2012.

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Three undergraduate research assistants were made available for this project through the Rutgers University Aresty Research Assistant Program: Madison Little (co-author), Ogechukwu Erechukwu, and Ankita Tripathi. Each of them had an important contribution to make during the data collection phase of this project.


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Availability of data and materials

All data relevant to the analysis of regulatory information is accessible using the links provided in the references for this manuscript. All data used in the analysis of current clinical trials in Africa registered on are available through that web site.

Authors’ contributions

FB conceptualized the project on which this manuscript is based, designed the methodology, participated in data collection, analyzed the findings, and drafted the original manuscript. MTL had the lead in data collection, assisted in the organization of findings, and read and commented on draft versions of the manuscript. Both authors read and approved the final version of the manuscript.

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The authors declare that they have no competing interests.

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Correspondence to Francis Barchi.

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Barchi, F., Little, M.T. National ethics guidance in Sub-Saharan Africa on the collection and use of human biological specimens: a systematic review. BMC Med Ethics 17, 64 (2016).

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