SynthesisBMC medical ethics2016
National ethics guidance in Sub-Saharan Africa on the collection and use of human biological specimens: a systematic review.
Synthesis in BMC medical ethics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
19 citing papers in PubMed.
- Return of health research findings in Nigeria-perspective of potential research participants.BMC medical ethics · 2026Article
- Adolescent views on participating in HIV biomedical research during pregnancy: a qualitative analysis of motivators and barriers.AIDS care · 2026Article
- Ethical navigation of biobanking establishment in Ukraine: learning from the experience of developing countries.Journal of medical ethics · 2026Article
- Return of health research findings in Nigeria-perspective of potential research participants.Research square · 2025Article
- Can biosampling really be "non-invasive"? An examination of the socially invasive nature of physically non-invasive biosampling in urban and rural Malawi.Global bioethics = Problemi di bioetica · 2024Article
- Beyond translations, perspectives for researchers to consider to enhance comprehension during consent processes for health research in sub-saharan Africa: a scoping review.BMC medical ethics · 2023Article
- Feeding back of individual genetic results in Botswana: mapping opportunities and challenges.BMC medical ethics · 2023Article
- Assent, parental consent and reconsent for health research in Africa: thematic analysis of national guidelines and lessons from the SickleInAfrica registry.BMC medical ethics · 2022Article
- Strengthening ethics committees for health-related research in sub-Saharan Africa: a scoping review.BMJ open · 2022Article
- Strengthening ethics committees for health-related research in sub-Saharan Africa: a scoping review protocol.BMJ open · 2021Article
- African genetic diversity and adaptation inform a precision medicine agenda.Nature reviews. Genetics · 2021Review
- Authorship Patterns in Cancer Genomics Publications Across Africa.JCO global oncology · 2021Article
- A scoping review of genetics and genomics research ethics policies and guidelines for Africa.BMC medical ethics · 2021Article
- Qualitative study of comprehension of heritability in genomics studies among the Yoruba in Nigeria.BMC medical ethics · 2020Article
- Engaging research ethics committees to develop an ethics and governance framework for best practices in genomic research and biobanking in Africa: the H3Africa model.BMC medical ethics · 2019Article
- Environmental Health Research in Africa: Important Progress and Promising Opportunities.Frontiers in genetics · 2019Review
- Integrating environmental health and genomics research in Africa: challenges and opportunities identified during a Human Heredity and Health in Africa (H3Africa) Consortium workshop.AAS open research · 2019Article
- Exploring perspectives of research ethics committee members on the governance of big data in sub-Saharan Africa.South African journal of scienceArticle
- Data sharing governance in sub-Saharan Africa during public health emergencies: Gaps and guidance.South African journal of scienceArticle
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEthical 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.
methodsAn 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.
resultsOf 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.
conclusionsDespite 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.