Rethinking research ethics committees in low- and medium-income countries

Bain, Luchuo Engelbert; Ebuenyi, Ikenna D.; Ekukwe, Nkoke Clovis; Awah, Paschal Kum

doi:10.1177/1747016117692026

Cited by 6 publications

(10 citation statements)

References 15 publications

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“…The competency of research regulatory agencies in many resource limited is generally weak; with their ability to monitor research and their compliance with ethics guidance more so. This limitation can however be effectively addressed through capacity building and appropriate support (Bain et al, 2018 ).…”

Section: Discussionmentioning

confidence: 99%

HIV prevention clinical trials’ community engagement guidelines: inequality, and ethical conflicts

Foláyan

Peterson

2020

Global Bioethics

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In 2004 and 2005, the first clinical trials were launched to investigate the use of tenofovir for HIV prevention in Cambodia, Cameroon, Nigeria and Thailand. Controversies erupted over the ethical integrity of the research protocol. We reflect on the events that led to the controversies and identified that scientific and ethical concerns raised by members of local communities at each of these sites were erased by trialists, causing crisis that led to premature shut down the early PrEP trials. In the aftermath of these trials, the World Health Organisation, UNAIDS, and AVAC developed ethics guidelines intended to recognize the concerns as authentic, and developed guidelines to improve researchers' engagement of communities in biomedical HIV prevention trial design and implementation. Our findings suggest that the ethics guidelines are limited in its ability to address power inequalities that leads to voice erasures and non-recognition of local competencies. Rather the ethical documents enabled trialists to gain a new sense of authority through the interpretations of ethical research conduct enabling trialists regain power that can further entrench inequality and voice erasures. To address concerns with what seems an intractable problem, we suggested models of engagement for off-shored research may be the option.

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Section: Discussionmentioning

confidence: 99%

HIV prevention clinical trials’ community engagement guidelines: inequality, and ethical conflicts

Foláyan

Peterson

2020

Global Bioethics

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“…This is particularly concerning for RECs in LMIC, which are generally underfunded, have members without formal expertize in research ethics and receive very little support from the respective states. Funding and weak institutional support still characterize most of the RECS in LMICs [9, 11]. The will of the governments of LMICs to make enabling legislation available is the most intriguing situation, as most of them lack or have weak research regulations.…”

Section: Discussionmentioning

confidence: 99%

“…Strengthening and building capacity of REC members in most LMICs remain an urgent imperative. Most of them receive little or no support from respective governments, have members not properly trained in research ethics, and operate on altruistic grounds [11]. This could predispose them to unconsciously underappreciate the ethical appropriateness of research protocols from elsewhere.…”

Section: Discussionmentioning

confidence: 99%

Research Ethics Committees (RECs) and epidemic response in low and middle income countries

Bain¹,

Ngwain²,

Nwobegahay³

et al. 2018

Pan Afr Med J

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The recent Ebola and Zika virus epidemics in some parts of Africa and Asia have showcased the porosity in disaster preparedness and response, not only in the affected countries, but on a global scale. For the Ebola epidemic, scientifically robust research was started late during the course of the epidemic, with waste of resources and lost research opportunities. Research Ethics Committees have a significant role to play with regards to epidemic response for the future. This paper presents key challenges and opportunities for ethics review during emergencies, specifically for low and middle income countries. There is no better moment to test the efficacy and safety of drugs or vaccines for infected, or at risk populations than during the disaster itself. The main mantras that form the back bone of research ethics review (Helsinki Declaration, the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, WHO and the ICH guidelines for Good Clinical Practice) are increasingly showing their limitations. Most protocols are generally from developed countries where the funding originates. Not only is the direct transposition to Low and Middle Income Country (LMIC) settings inappropriate on its own, also, using such guidelines in times of public health disasters might be time consuming, and might also lead to wastage of research opportunities, especially when sociocultural peculiarities, and anthropological research arms are completely excluded or avoided within the care and research packages. Governments should include RECs as key members during the elaboration, and daily functioning of their national public emergency response packages. Developing simple research ethics review guidelines, involvement of health care staff in ethics training, community mobilization, and incorporation of anthropological research during the medical response, research and communication phases, are imperatives in epidemic response.

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“…Researchers could shy away from submitting ethically charged protocols for review, or go for “low quality or less stringent” RECs. Complexities of the protocol review process in terms of money, time and requirements could scare researchers from engaging into the endeavor to obtain ethical approval [ 7 ]. With the already worrisome publish or perish syndrome, low quality ethics review, or complete avoidance and consequent opting for predator journals becomes the way out for these researchers.…”

Section: Editorialmentioning

confidence: 99%

“…It is a subject of discussion to systematically provide references or copies of the ethical approvals to journal editorial boards to be sure these were obtained. NECs have the responsibility to have a data base of smaller RECs, define their scope of competence and ensure capacity building [ 7 ]. Lack of coordination could make ethically charged researchers to go to small inexperienced RECs for more rapid approvals.…”

Section: Editorialmentioning

confidence: 99%

Ethics approval: responsibilities of journal editors, authors and research ethics committees

Bain¹

2017

Pan Afr Med J

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Meaningful progress of medicine depends on research that must ultimately involve human subjects. Obtaining ethical approval therefore, especially in medical sciences, should be a moral reflex for researchers. This unfortunately is not the case, with numerous researchers bypassing the ethics approval procedure, or simply unaware of its importance. Good research involves risks taken by research participants and uses tax payers’ money in the process. These mandates the research endeavor to aim at attaining the highest degree of respect for the sacrifices made by others for science. Most researchers mistake scientific clearance or approval, for ethics approval. For a study to be ethical sound, it must be scientifically sound. This is only one of the activities carried out during protocol review. It is not uncommon for sensitive ethical concerns, especially in the social sciences to be overlooked and considered not to be accompanied by any serious risks for the research participants.The researcher has the responsibility of systematically consulting the competent ethics committee for advice and consequent approvals or ethical waivers. Journal editors and reviewers have the duty to systematically evaluate the ethical soundness of manuscripts submitted for review. Capacity building in research ethics and institutional support for Research Ethics Committees to speed up protocol review could reduce the incentive of carrying out research in human subjects without ethics approvals. It is hypocritical and idle to continue to expect optimal reviews on time and of good quality, from ethics committees functioning purely on altruistic grounds. Capacity building for researchers in research ethics, and institutional reforms and support for Research Ethics Committees appear not to have received the attention they truly deserve.

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Rethinking research ethics committees in low- and medium-income countries

Cited by 6 publications

References 15 publications

HIV prevention clinical trials’ community engagement guidelines: inequality, and ethical conflicts

HIV prevention clinical trials’ community engagement guidelines: inequality, and ethical conflicts

Research Ethics Committees (RECs) and epidemic response in low and middle income countries

Ethics approval: responsibilities of journal editors, authors and research ethics committees

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