A scoping review of ethics review processes during public health emergencies in Africa.


Journal

BMC medical ethics
ISSN: 1472-6939
Titre abrégé: BMC Med Ethics
Pays: England
ID NLM: 101088680

Informations de publication

Date de publication:
22 May 2024
Historique:
received: 09 10 2023
accepted: 06 05 2024
medline: 23 5 2024
pubmed: 23 5 2024
entrez: 22 5 2024
Statut: epublish

Résumé

The COVID-19 pandemic forced governments, multilateral public health organisations and research institutions to undertake research quickly to inform their responses to the pandemic. Most COVID-19-related studies required swift approval, creating ethical and practical challenges for regulatory authorities and researchers. In this paper, we examine the landscape of ethics review processes in Africa during public health emergencies (PHEs). We searched four electronic databases (Web of Science, PUBMED, MEDLINE Complete, and CINAHL) to identify articles describing ethics review processes during public health emergencies and/or pandemics. We selected and reviewed those articles that were focused on Africa. We charted the data from the retrieved articles including the authors and year of publication, title, country and disease(s) reference, broad areas of (ethical) consideration, paper type, and approach. Of an initial 4536 records retrieved, we screened the titles and abstracts of 1491 articles, and identified 72 articles for full review. Nine articles were selected for inclusion. Of these nine articles, five referenced West African countries including Liberia, Guinea and Sierra Leone, and experiences linked to the Ebola virus disease. Two articles focused on South Africa and Kenya, while the other two articles discussed more general experiences and pitfalls of ethics review during PHEs in Africa more broadly. We found no articles published on ethics review processes in Africa before the 2014 Ebola outbreak, and only a few before the COVID-19 outbreak. Although guidelines on protocol review and approval processes for PHEs were more frequently discussed after the 2014 Ebola outbreak, these did not focus on Africa specifically. There is a gap in the literature about ethics review processes and preparedness within Africa during PHEs. This paper underscores the importance of these processes to inform practices that facilitate timely, context-relevant research that adequately recognises and reinforces human dignity within the quest to advance scientific knowledge about diseases. This is important to improve fast responses to PHEs, reduce mortality and morbidity, and enhance the quality of care before, during, and after pandemics.

Sections du résumé

BACKGROUND BACKGROUND
The COVID-19 pandemic forced governments, multilateral public health organisations and research institutions to undertake research quickly to inform their responses to the pandemic. Most COVID-19-related studies required swift approval, creating ethical and practical challenges for regulatory authorities and researchers. In this paper, we examine the landscape of ethics review processes in Africa during public health emergencies (PHEs).
METHODS METHODS
We searched four electronic databases (Web of Science, PUBMED, MEDLINE Complete, and CINAHL) to identify articles describing ethics review processes during public health emergencies and/or pandemics. We selected and reviewed those articles that were focused on Africa. We charted the data from the retrieved articles including the authors and year of publication, title, country and disease(s) reference, broad areas of (ethical) consideration, paper type, and approach.
RESULTS RESULTS
Of an initial 4536 records retrieved, we screened the titles and abstracts of 1491 articles, and identified 72 articles for full review. Nine articles were selected for inclusion. Of these nine articles, five referenced West African countries including Liberia, Guinea and Sierra Leone, and experiences linked to the Ebola virus disease. Two articles focused on South Africa and Kenya, while the other two articles discussed more general experiences and pitfalls of ethics review during PHEs in Africa more broadly. We found no articles published on ethics review processes in Africa before the 2014 Ebola outbreak, and only a few before the COVID-19 outbreak. Although guidelines on protocol review and approval processes for PHEs were more frequently discussed after the 2014 Ebola outbreak, these did not focus on Africa specifically.
CONCLUSIONS CONCLUSIONS
There is a gap in the literature about ethics review processes and preparedness within Africa during PHEs. This paper underscores the importance of these processes to inform practices that facilitate timely, context-relevant research that adequately recognises and reinforces human dignity within the quest to advance scientific knowledge about diseases. This is important to improve fast responses to PHEs, reduce mortality and morbidity, and enhance the quality of care before, during, and after pandemics.

Identifiants

pubmed: 38778293
doi: 10.1186/s12910-024-01054-8
pii: 10.1186/s12910-024-01054-8
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

63

Subventions

Organisme : Wellcome Trust
ID : 201433/Z/16/A
Pays : United Kingdom
Organisme : African Academy of Sciences
ID : AAS-CRD01

Informations de copyright

© 2024. The Author(s).

Références

World Health Organization. COVID-19 weekly epidemiological update, edition 115, 26 October 2022. 2022.
Xafis V, Schaefer GO, Labude MK, Zhu YJ, Hsu L. The Perfect Moral Storm: diverse ethical considerations in the COVID-19 pandemic. Asian Bioeth Rev. 2020;12(2):65–83.
doi: 10.1007/s41649-020-00125-3
Aarons D. Research in epidemic and emergency situations: a model for collaboration and expediting ethics review in two Caribbean countries. Dev World Bioeth. 2018;18(4):375–84.
doi: 10.1111/dewb.12157
Aarons D. Addressing the challenge for expedient ethical review of research in disasters and disease outbreaks. Bioethics. 2019;33(3):343–6.
doi: 10.1111/bioe.12543
World Health Organization. Ethical standards for research during public health emergencies: distilling existing guidance to support COVID-19 R&D. Geneva: WHO; 2020.
Tamariz L, Hendler F, Wells J, Anderson A, Bartlett S. A call for Better, not faster, Research Ethics Committee Reviews in the Covid-19 era. Ethics Hum Res. 2021;43(5):42–4.
doi: 10.1002/eahr.500104
Nuffield Council on Bioethics. Research in global health emergencies: ethical issues. London: Nuffield Council on Bioethics; 2020.
Ohaeri C, Thomas DR, Salmon J, Cottrell S, Lyons J, Akbari A et al. Comparative risk of cerebral venous sinus thrombosis (CVST) following COVID-19 vaccination or infection: a national cohort study using linked electronic health records. Hum Vaccines Immunotherapeutics. 2022:2127572.
Rice TW. The historicthical, and legal background of human-subjects research. Respir Care. 2008;53(10).
Kapumba BM, Desmond N, Seeley J. A chronological discourse analysis of ancillary care provision in guidance documents for research conduct in the global south. BMC Med Ethics. 2022;23(1):51.
doi: 10.1186/s12910-022-00789-6
Burgess T, Rennie S, Moodley K. Key ethical issues encountered during COVID-19 research: a thematic analysis of perspectives from South African research ethics committees. BMC Med Ethics. 2023;24(1):11.
doi: 10.1186/s12910-023-00888-y
Voit K, Skuban-Eiseler T, Orzechowski M, Steger F. Informed consent in COVID-19-Research: an ethical analysis of clinical studies performed during the pandemic. 2023;11(12):1793.
Nuffield Councilon Bioethics. Fair and equitable access to COVID-19 treatments and vaccines. Nuffield Council on Bioethics London; 2020.
Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for health-related research involving humans. Fourth Edition ed. Geneva: CIOMS. 2016. 122 p.
World Health Organization. Guidance for managing ethical issues in infectious disease outbreaks. Geneva: WHO; 2016. p. 66.
Ma X, Wang Y, Gao T, He Q, He Y, Yue R, et al. Challenges and strategies to research ethics in conducting COVID-19 research. J evidence-based Med. 2020;13(2):173–7.
doi: 10.1111/jebm.12388
Neumann G, Kawaoka Y. Which Virus Will Cause Next Pandemic? Viruses. 2023;15(1):199.
Hummel P, Adam T, Reis A, Littler K. Taking stock of the availability and functions of National Ethics Committees worldwide. BMC Med Ethics. 2021;22(1):56.
doi: 10.1186/s12910-021-00614-6
Tindana P, De Vries J, Kamuya D. Ethical challenges in community engagement practices in research during the COVID-19 pandemic in Africa [version 1; peer review: 1 approved, 1 approved with reservations]. 2020;3(23).
Fofana MO. Decolonising global health in the time of COVID-19. Glob Public Health. 2021;16(8–9):1155–66.
doi: 10.1080/17441692.2020.1864754
Ndlovu-Gatsheni SJ. Geopolitics of power and knowledge in the COVID-19 pandemic: decolonial reflections on a Global Crisis. 2020;36(4):366–89.
Willows TM, Oliwa J, Onyango O, Mkumbo E, Maiba J, Schell CO et al. COVID-19 and unintended steps towards further equity in global health research. BMJ Global Health. 2023;8(6).
Saxena A, Horby P, Amuasi J, Aagaard N, Kohler J, Gooshki ES et al. Ethics preparedness: facilitating ethics review during outbreaks - recommendations from an expert panel. BMC Med Ethics. 2019;20.
Kieny M-P, Rägo L. Regulatory policy for research and development of vaccines for public health emergencies. Expert Rev Vaccines. 2016;15(9):1075–7.
doi: 10.1080/14760584.2016.1188695
Ijkema R, Janssens M, van der Post JAM, Licht CM. Ethical review of COVID-19 research in the Netherlands; a mixed-method evaluation among medical research ethics committees and investigators. PLoS ONE. 2021;16(7).
Hunt M, Tansey CM, Anderson J, Boulanger RF, Eckenwiler L, Pringle J, et al. The challenge of Timely, Responsive and Rigorous Ethics Review of Disaster Research: views of Research Ethics Committee members. PLoS ONE. 2016;11(6):e0157142.
doi: 10.1371/journal.pone.0157142
Eckenwiler L, Pringle J, Boulanger R, Hunt M. Real-time responsiveness for Ethics Oversight during Disaster Research. Bioethics. 2015;29(9):653–61.
doi: 10.1111/bioe.12193
Packenham JP, Rosselli RT, Ramsey SK, Taylor HA, Fothergill A, Slutsman J, et al. Conducting Science in disasters: recommendations from the NIEHS Working Group for Special IRB Considerations in the review of Disaster Related Research. Environ Health Perspect. 2017;125(9):094503.
doi: 10.1289/EHP2378
Packenham JP, Rosselli R, Fothergill A, Slutsman J, Ramsey S, Hall JE, et al. Institutional Review Board Preparedness for Disaster Research: a practical Approach. Curr Environ Health Rep. 2021;8(2):127–37.
doi: 10.1007/s40572-021-00311-x
Sisa I, Mena B, Teran E. The negative impact of ad hoc committees for ethical evaluation: the case of COVID-19-related research in Ecuador. Dev World Bioeth. 2021;21(1):3–6.
doi: 10.1111/dewb.12307
Lynch H, Lundin D, Meagher E. Ethical Inclusion of Health Care Workers in Covid-19 Research. Ethics Hum Res. 2021;43(2):19–27.
doi: 10.1002/eahr.500082
Beach MC, Lederman HM, Singleton M, Brower RG, Carrese J, Ford DE, et al. Desperate Times: protecting the public from Research without Consent or Oversight during Public Health emergencies. Ann Intern Med. 2020;173(11):926–8.
doi: 10.7326/M20-4631
AHC-MEDIA. COVID-19 pandemic changed informed consent for Biobanking: New Common Rule exception used. IRB Advisor. 2020;20(11):1–2.
van der Graaf R, Hoogerwerf M, de Vries M. The ethics of deferred consent in times of pandemics. Nat Med. 2020;26(9):1328–30.
doi: 10.1038/s41591-020-0999-9
Jamrozik E, Selgelid MJ. Human infection challenge studies in endemic settings and/or low-income and middle-income countries: key points of ethical consensus and controversy. J Med Ethics. 2020;46(9):601–9.
doi: 10.1136/medethics-2019-106001
Jamrozik E, Selgelid M. COVID-19 human challenge studies: ethical issues. Lancet Infect Dis. 2020;20(8):e198–203.
doi: 10.1016/S1473-3099(20)30438-2
Jamrozik E, Littler K, Bull S, Emerson C, Kang G, eep, et al. Key criteria for the ethical acceptability of COVID-19 human challenge studies: report of a WHO Working Group. Vaccine. 2021;39(4):633–40.
doi: 10.1016/j.vaccine.2020.10.075
Hsu NS, Hendriks S, Ramos KM, Grady C. Ethical considerations of COVID-19-related adjustments to clinical research. Nat Med. 2021;27(2):191–3.
doi: 10.1038/s41591-020-01216-2
Hashem H, Abufaraj M, Tbakhi A, Sultan I. Obstacles and considerations related to clinical Trial Research during the COVID-19 pandemic. Front Med. 2020;7.
Dal-Ré R, Bekker L, Gluud C, Holm S, Jha V, Pol, et al. Ongoing and future COVID-19 vaccine clinical trials: challenges and opportunities. The Lancet Infectious diseases; 2021.
Richards AD. Ethical guidelines for deliberately infecting volunteers with COVID-19. J Med Ethics. 2020;46(8):502–4.
doi: 10.1136/medethics-2020-106322
Beauvais M, Knoppers B. Coming out to play: privacy, Data Protection, Children’s Health, and COVID-19 research. Front Genet. 2021;12:659027.
doi: 10.3389/fgene.2021.659027
Lapid MI, Meagher KM, Giunta HC, Clarke BL, Ouellette Y, Armbrust TL, et al. Ethical challenges in COVID-19 Biospecimen Research: perspectives from Institutional Review Board members and bioethicists. Mayo Clin Proc. 2021;96(1):165–73.
Nicol D, Chalmers D, Critchley C, Eckstein L, Nielsen J, Otlowski M. Australian perspectives on the Ethical and Regulatory Considerations for Responsible Data Sharing in response to the COVID-19 pandemic. J Law Med. 2020;27(4):829–38.
Singh S, Cadigan R, Moodley K. Challenges to biobanking in LMICs during COVID-19: time to reconceptualise research ethics guidance for pandemics and public health emergencies? J Med Ethics. 2021.
Agrawal V, Nath C, ishwar, Mishra SK. Ethics committee meeting by video-conferencing during Covid-19. Indian J Med Ethics. 2020:1–2.
Aung MN, Murray V, Kayano R. Research Methods and Ethics in Health Emergency and Disaster Risk Management: the result of the Kobe Expert Meeting. Int J Environ Res Public Health. 2019;16(5).
Bavdekar S. Ethics committees: actions during pandemic and lockdown situations. J Postgrad Med. 2020;66(3):119–22.
doi: 10.4103/jpgm.JPGM_431_20
De Vos E, Ethical PPE. Overseeing Research in the time of COVID-19. Narrative Inq Bioeth. 2021;11(1):69–70.
doi: 10.1353/nib.2021.0025
Faust A, Sierawska A, Krüger K, Wisgalla A, Hasford J, Strech D. Challenges and proposed solutions in making clinical research on COVID-19 ethical: a status quo analysis across German research ethics committees. BMC Med Ethics. 2021;22(1):96.
doi: 10.1186/s12910-021-00666-8
Yagi K, Maeda K, Sakaguchi S, Chuma M, Sato Y, Kane C, et al. Status of Institutional Review Board meetings conducted through web Conference systems in Japanese National University hospitals during the COVID-19 pandemic: Questionnaire Study. J Med Internet Res. 2020;22(11):e22302.
doi: 10.2196/22302
Hinga A, Jeena L, Awuor E, Kahindi J, Munene M, Kinyanjui S, et al. Pandemic preparedness and responsiveness of research review committees: lessons from review of COVID-19 protocols at KEMRI Wellcome Trust Research Programme in Kenya. Wellcome open Res. 2022;7:75.
doi: 10.12688/wellcomeopenres.17533.1
Peters MDJ, Marnie C, Tricco AC, Pollock D, Munn Z, Alexander L, et al. Updated methodological guidance for the conduct of scoping reviews. JBI Evid Synthesis. 2020;18(10):2119–26.
doi: 10.11124/JBIES-20-00167
Arksey H, O’Malley L. Scoping studies: towards a methodological framework. Int J Soc Res Methodol. 2005;8(1):19–32.
doi: 10.1080/1364557032000119616
PRISMA Extension for Scoping Reviews (PRISMA-ScR). Checklist and Explanation. Ann Intern Med. 2018;169(7):467–73.
doi: 10.7326/M18-0850
Alirol E, Kuesel A, Guraiib M, de la Fuente-Núñez V, Saxena A, Gomes M. Ethics review of studies during public health emergencies - the experience of the WHO ethics review committee during the Ebola virus disease epidemic. BMC Med Ethics. 2017;18(1):43.
doi: 10.1186/s12910-017-0201-1
De Crop M, Delamou A, re, Griensven JV, Ravinetto R. Multiple ethical review in North-South collaborative research: the experience of the Ebola-Tx trial in Guinea. Indian J Med Ethics. 2016;1(2):76–82.
de Vries J, Burgess T, Blockman M, Ntusi NAB. Research on COVID-19 in South Africa: guiding principles for informed consent. South Afr Med J. 2020;110(7):635–9.
Schopper D, Ravinetto R, Schwartz L, Kamaara E, Sheel S, Segelid MJ, et al. Research Ethics Governance in Times of Ebola. Public Health Ethics. 2017;10(1):49–61.
Bain LE, Ngwain CG, Nwobegahay J, Sumboh JG, Nditanchou R, Awah PK. Research Ethics Committees (RECs) and epidemic response in low and middle income countries. Pan Afr Med J. 2018;31.
Doe-Anderson J, Baseler B, Driscoll P, Johnson M, Lys J et al. Beating the odds: Successful establishment of a Phase II/III clinical research trial in resource-poor Liberia during the largest-ever Ebola outbreak. Contemporary Clinical Trials Communications. 2016;4:68–73.
Folayan MO, Brown B, Haire B, Babalola CP, Ndembi N. Considerations for stakeholder engagement andCOVID-19 related clinical trials’ conduct in sub-saharan Africa. Dev World Bioeth. 2021;21(1):44–50.
doi: 10.1111/dewb.12283
Emanuel EJ, Wendler D, Killen J, Grady C. What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis. 2004;189(5):930–7.
doi: 10.1086/381709
Mezinska S, Kakuk P, Mijaljica G, Waligóra M, O’Mathúna DP. Research in disaster settings: a systematic qualitative review of ethical guidelines. BMC Med Ethics. 2016;17:62.
doi: 10.1186/s12910-016-0148-7
Watson S. Don’t cross the line, you’re a researcher and not an educator’: incorporating indigenous researchers’ moral perspectives to improve ethical protocols in health research. Soc Sci Med. 2022;315:115503.
doi: 10.1016/j.socscimed.2022.115503
Paleoudis EG, Jacobs LG, Friedman T, Fittizzi C, Sawczuk I, Aschner J. Implementing a review process to facilitate and prioritize COVID-19 research: staying one step ahead of the pandemic. J Empir Res Hum Res Ethics. 2021;16(3):188–92.
doi: 10.1177/15562646211017042
Fernandez Lynch H, Dickert NW, Zettler PJ, Joffe S, Largent EA. Regulatory flexibility for COVID-19 research. J law Biosci. 2020;7(1):lsaa057.
doi: 10.1093/jlb/lsaa057
Sisk BA, DuBois J. Research Ethics during a pandemic: a call for normative and empirical analysis. Am J Bioeth. 2020;20(7):82–4.
doi: 10.1080/15265161.2020.1779868
Barron Ausbrooks CY, Barrett EJ, Martinez-Cosio M. Ethical issues in Disaster Research: lessons from Hurricane Katrina. Popul Res Policy Rev. 2009;28(1):93–106.
doi: 10.1007/s11113-008-9112-7
Falb K, Laird B, Ratnayake R, Rodrigues K, Annan J. The ethical contours of research in crisis settings: five practical considerations for academic institutional review boards and researchers. Disasters. 2019;43(4):711–26.
doi: 10.1111/disa.12398
Schopper D, Upshur R, Matthys F, Singh JA, Bandewar SS, Ahmad A, et al. Research Ethics Review in Humanitarian contexts: the experience of the Independent Ethics Review Board of Médecins Sans Frontières. PLoS Med. 2009;6(7):e1000115.
doi: 10.1371/journal.pmed.1000115
Bavel JJV, Baicker K, Boggio PS, Capraro V, Cichocka A, Cikara M, et al. Using social and behavioural science to support COVID-19 pandemic response. Nat Hum Behav. 2020;4(5):460–71.
doi: 10.1038/s41562-020-0884-z
WHO Technical Advisory Group on Behavioral Insights and Sciences for Health. Behavioural and social sciences are critical for pandemic prevention, preparedness and response: WHO; 2022 [updated 23 February 2022. https://www.who.int/news-room/commentaries/detail/behavioural-and-social-sciences-are-critical-for-pandemic-prevention-preparedness-and-response .
Geissler PW, Kelly A, Imoukhuede B, Pool R, editors. Substantial transactions and an ethics of kinship in recent collaborative malaria vaccine trials in the Gambia. New York: Oxford: Berghahn Books; 2012.
Geissler PW, Kelly A, Imoukhuede B, Pool R. He is now like a brother, I can even give him some blood’ – relational ethics and material exchanges in a malaria vaccine ‘trial community’ in the Gambia. Soc Sci Med. 2008;67(5):696–707.
doi: 10.1016/j.socscimed.2008.02.004
Sulemane N, Armocida B, Valente M, Formenti B, Barigazzi S, Ussai S, et al. Vaccines hesitancy in Africa: how COVID-19 pandemic may affect malaria vaccination campaigns. J Prev Med Hyg. 2022;63(1):E1–3.

Auteurs

Kingsley Orievulu (K)

Africa Health Research Institute, KwaZulu-Natal, Durban, South Africa. Kingsley.orievulu@ahri.org.
School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa. Kingsley.orievulu@ahri.org.
Centre for Africa China Studies, University of Johannesburg, Johannesburg, South Africa. Kingsley.orievulu@ahri.org.

Alex Hinga (A)

KEMRI Wellcome Trust Research Programme, Kilifi, Kenya.

Busisiwe Nkosi (B)

Africa Health Research Institute, KwaZulu-Natal, Durban, South Africa.
University of Toledo, Ohio, Toledo, USA.

Nothando Ngwenya (N)

Africa Health Research Institute, KwaZulu-Natal, Durban, South Africa.
School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.

Janet Seeley (J)

Africa Health Research Institute, KwaZulu-Natal, Durban, South Africa.
School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.
Global Health and Development Department, London School of Hygiene and Tropical Medicine, London, UK.

Anthony Akanlu (A)

West Africa Centre for Cell Biology and Infectious Pathogens, University of Ghana, Accra, Ghana.

Paulina Tindana (P)

Department of Health Policy, Planning and Management, School of Public Health, College of Health Sciences, University of Ghana, Accra, Ghana.

Sassy Molyneux (S)

KEMRI Wellcome Trust Research Programme, Kilifi, Kenya.
Centre for Tropical Medicine and Pandemic Sciences Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.

Samson Kinyanjui (S)

KEMRI Wellcome Trust Research Programme, Kilifi, Kenya.
Centre for Tropical Medicine and Pandemic Sciences Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.

Dorcas Kamuya (D)

KEMRI Wellcome Trust Research Programme, Kilifi, Kenya.
Centre for Tropical Medicine and Pandemic Sciences Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH