Preventing ethics dumping: the challenges for Kenyan research ethics committees

Chatfield, Kate; Schroeder, Doris; Guantai, Anastasia Nkatha; Km, Bhatt; Bukusi, Elizabeth A.; Odhiambo, Joyce A.; Cook, Julie; Kimani, Joshua

doi:10.1177/1747016120925064

Cited by 15 publications

(14 citation statements)

References 43 publications

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“…To be framed in health and social justice terms, global health research (31) should generate knowledge that improves the health and well-being of disadvantaged and marginalised individuals and communities (28,32). Those who lack access to Covid-19 vaccination because of unequal allocation between countries should be seen as disadvantaged, and research involving them should be based on health and social justice, rather than building on structural injustice.…”

Section: Resultsmentioning

confidence: 99%

“…First, an ethical strategy cannot be built on an unethical premise, which is, in this case, the inequitable allocation of vaccines between countries. Second, this strategy could even be seen as "ethics dumping", that is the practice of undertaking research in a lowor middle-income setting which would not, for different reasons, be permitted in a high-income setting (28). Third, it would de facto reverse the principle of benefit sharing in global research (29,30), as the burden of research would be only for the most vulnerable communities, while the benefit of research would be available to communities in more affluent countries.…”

Section: The Best Standard: For Whom and Where?mentioning

confidence: 99%

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Problematic Covid-19 vaccine trials in times of vaccine nationalism

Ravinetto¹

2021

IJME

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Thanks to an impressive R&D effort, three vaccines for COVID19 have been conditionally approved by stringent regulators as of February 2021, and sixteen have entered the WHO evaluation process. However, they all need to keep on being evaluated in clinical trials. The WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine suggested that countries with limited or no access to an effective vaccine could ethically permit placebo-controlled trials, even if effective vaccines were already being marketed elsewhere. Here, I argue that inclusion in a placebo-controlled trial is ethically sound for those who would be in any case ineligible for vaccination outside the trial, and as long as the access to the vaccine outside the trial depends on a transparent and just allocation framework. Conversely, carrying out placebo-controlled studies in countries where vaccines are not (or are insufficiently) available because of unequal global allocation, would be unethical, as an ethical strategy cannot be built on an unethical premise.

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Section: Resultsmentioning

confidence: 99%

Section: The Best Standard: For Whom and Where?mentioning

confidence: 99%

Problematic Covid-19 vaccine trials in times of vaccine nationalism

Ravinetto¹

2021

IJME

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“…Moreover, the declaration of certain participants indicating they have never submitted a protocol to the CNERS (while only one of the surveyed research institutions had its own IRB) suggests that research is being carried out in Benin without prior ethics approval. One could also think of "ethical dumping" which consists of undertaking in a low-or middle-income settings, research that would not be permitted, or would be severely limited, in a high-income country [5].…”

Section: Discussionmentioning

confidence: 99%

“…To prevent this ethical dumping, the CNERS, like other RECs, must take up the eleven challenges proposed by Kate Chat eld and collaborators in the Kenyan context [5]. These challenges, which are also valid in the Beninese context, are namely: variations in governance standards; resistance to double ethics review; resource constraints; unresolved issues in the management of biological samples; unresolved issues in the management of primary data; unsuitable informed consent procedures; cultural insensitivity; differing standards of care; reluctance to provide feedback to research communities; power differentials which facilitate the exploitation of local researchers; lack of local relevance and/or affordability of the resulting products.…”

Section: Discussionmentioning

confidence: 99%

Knowledge, Opinions and Experiences of Researchers Regarding Ethical Regulation of Biomedical Research in Benin: A Cross-Sectional Study

Gangbo

QUENUM

GUEDOU

et al. 2022

Preprint

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Background: Ethics in biomedical research is still a fairly new concept in Africa. This work aims to assess the knowledge, attitude and experiences of Beninese researchers in regard to the national ethical regulatory framework of biomedical research in Benin.Methods: This was a cross-sectional, prospective and descriptive study, involving all the researchers fulfilling the inclusion criteria. Data were collected through a face-to-face interview using a questionnaire and analysed. Proportions and means were calculated with their confidence intervals and standard deviations, respectively.Results: Of the 110 participants included in the study, 40.9% were medical lecturers and 71.1% had been involved in more than 10 biomedical research as researcher. Less than three quarters (69.1%) were able to correctly quote the basic principles from Belmont report. The quarter (25.45%) of them knew the attributions of the National Ethics Committee for Health Research (CNERS in French) and 38.2%, the content of the legislation on health research ethics in Benin. The common ethical rules were known by 69.1% of the participants. A quarter (25.5%) of participants said they always present the study’s briefing note to their study participants and 62.7% said they systematically request informed consent. For those who do not present the briefing note to participants, the main reasons provided were the researchers' difficulties in writing the note in plain language and the participants ' limitation in understanding it.Conclusions: The foundations of a good ethical framework for health research exist in Benin. However, the deployment and use of the various legal texts deserve to be improved.

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“…For researchers, the institutions they represent, and IRBs, the spirit of equity should extend to supporting research topics that have not enjoyed as much scholarly attention and making the landscape more hospitable for early-career, student, and independent researchers. To paraphrase Chatfield et al [ 33 ], making this possible includes ensuring that IRBs are staffed with the right kind of ‘qualified experts’—given that there are “no absolute standards upon which IRBs can rely [in evaluating protocols]” and ethics boards must therefore bank on “a fair exercise of intelligence and discretion on the part of [their] members” [ 21 ] (p. 562)—and lessening the bureaucratic roadblocks that make even getting ethics approval already a laborious process. To recapitulate a point made earlier, a change in research culture requires not taking time away from the actual conduct of the study—from data gathering, analysis, and paper writing.…”

Section: Discussionmentioning

confidence: 99%

How ethics committees and requirements are structuring health research in the Philippines: a qualitative study

Lasco

Palileo-Villanueva

2021

BMC Med Ethics

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Background The last few decades have seen the rising global acknowledgment of the importance of ethics in the conduct of health research. But research ethics committees or institutional review boards (IRBs) have also been criticized for being barriers to research. This article examines the case of the Philippines, where little has been done to interrogate the health research and IRB culture, and whose circumstances can serve as reflection points for other low- and middle-income countries. Methods Semi-structured interviews were conducted from July to October 2020 to elicit health researchers’ perspectives and experiences regarding IRBs and the ethics approval process in the country, as well as counterpoint narratives from researchers who have also worked for IRBs. Results Across the fields of clinical, public health, and social science research, the issue of ethics review revealed itself to be foremost an issue of inequity. IRB processes serve as a barrier for those outside the academe; those belonging to institutions, cities, or entire regions without their own accredited IRBs; and researchers working independently, without ample budget, or on highly specialized topics—more so for non-clinical researchers who must grapple with the primarily biomedical framework of most IRBs. Consequently, the research landscape invariably favors those with the resources to do research, and researches that tend to attract funding. Conclusion The broader challenge of equity in health research will entail more fundamental reforms, but proximal interventions can be done to make the ethics approval process more equitable, such as enhancing institutional oversight, regulating IRB fees, and enabling a more supportive and welcoming environment for early-career, student, independent, and non-clinical health researchers. This article ends by reflecting on the implications of our findings toward the larger research culture.

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Preventing ethics dumping: the challenges for Kenyan research ethics committees

Cited by 15 publications

References 43 publications

Problematic Covid-19 vaccine trials in times of vaccine nationalism

Problematic Covid-19 vaccine trials in times of vaccine nationalism

Knowledge, Opinions and Experiences of Researchers Regarding Ethical Regulation of Biomedical Research in Benin: A Cross-Sectional Study

How ethics committees and requirements are structuring health research in the Philippines: a qualitative study

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