AN OPEN LETTER FROM AN AFRICAN WOMEN SCIENTIST TO RESEARCH ETHICS COMMITTEES

Con antecedentes inspiradores, desafíos, experiencias ricas y diversas, las mujeres científicas africanas han demostrado que el género no importa siempre que tengas la voluntad y la pasión. Pero ¿cuántas de estas mujeres son reconocidas en su trabajo diario? Desde la dificultad de evolucionar en un entorno dominado por los hombres hasta los desafíos de adentrarse en un campo nuevo, son muchos los desafíos que las mujeres africanas deben afrontar para encontrar su lugar en la ciencia. Las científicas africanas se enfrentan todos los días a las dificultades de ser científicas, y de ser consideradas el sexo más débil. Sería muy útil fortalecer las redes de mujeres científicas facilitando su acceso a la información y promoviendo que se apoyen entre sí y a las más jóvenes que quieran seguir una carrera científica. Las científicas africanas merecen protección en sus actividades científicas mediante textos aplicables y vinculantes. La autora leyó esta carta a los integrantes del Comité de Ética de la Investigación de Aragón y de los Comités Éticos Nacionales de Benín, Guinea Bissau, Guinea Conakry, Malí y Senegal en la apertura del 2.º International Congress on the Harmonisation of Gender Mainstreaming in West Africa, liderado por la Universidad de Zaragoza.

A Survey to Determine the Capacity Development Needs of Research Ethics Committee Administrators in South Africa

Most capacity development efforts for research ethics committees focus on committee members and little on ethics administrators. Increasing studies mandate the focus on administrators’ capacity development needs to enable adequate and effective committee support. This study investigated current responsibilities, training requirements, and administrator role needs. An online cross-sectional survey was conducted among administrators from 62 National Health Research Ethics Council-registered research ethics committees in South Africa. In total, 36 administrators completed the questionnaire. Results show that, in addition to administration, they perform managerial, review process and guidance-advisory tasks. Nearly 49% indicated only having received informal research ethics-related training, not targeted formal training, with 81% of the informal training being through workshops. Research ethics administrators’ responsibilities have evolved to complex tasks requiring targeted capacity development efforts.

The Challenges of Big Data for Research Ethics Committees: A Qualitative Swiss Study

Big data trends in health research challenge the oversight mechanism of the Research Ethics Committees (RECs). The traditional standards of research quality and the mandate of RECs illuminate deficits in facing the computational complexity, methodological novelty, and limited auditability of these approaches. To better understand the challenges facing RECs, we explored the perspectives and attitudes of the members of the seven Swiss Cantonal RECs via semi-structured qualitative interviews. Our interviews reveal limited experience among REC members with the review of big data research, insufficient expertise in data science, and uncertainty about how to mitigate big data research risks. Nonetheless, RECs could strengthen their oversight by training in data science and big data ethics, complementing their role with external experts and ad hoc boards, and introducing precise shared practices.

Challenges During Review of COVID-19 Research Proposals: Experience of Faculty of Medicine, Ain Shams University Research Ethics Committee, Egypt

The COVID-19 pandemic resulted in an overwhelming increase in research studies submitted to research ethics committees (RECs) presenting many ethical challenges. This article aims to report the challenges encountered during review of COVID-19 research and the experience of the Faculty of Medicine, Ain Shams University Research Ethics Committee (FMASU REC). From April 10, 2020, until October 13, 2020, the FMASU REC reviewed 98 COVID-19 research protocols. This article addressed the question of how to face an overwhelming amount of research submitted to the REC while applying the required ethical principles. Ethical challenges included a new accelerated mode of review, online meetings, balance of risks vs. benefits, measures to mitigate risks, co-enrolment in different studies, protection of a vulnerable COVID-19 population, accelerated decisions, online research, how to handle informed consent during the pandemic, and justification of placebo arm.

“An Official Conscience and Warranting Agency”: Institutional Isomorphism and the Rise of Dutch Ethics Review in the 1970s and 1980s

Why did medical research involving human subjects, a practice that is arguably as old as medicine itself, come to be regulated by research ethics committees in the late twentieth century? In this essay, I answer this question for the Netherlands, by querying the rise of ethics review in the 1970s and 1980s through the lens of “institutional isomorphism”. Drawing on the classic work of Paul Dimaggio and Walter Powell, I argue that extra-national changes to funding and publishing requirements in this period were identifiably more important for the emergence of ethics review in the Netherlands than were ethical concerns for research misconduct – a process that was marked by definitive elements of internationally coercive, and perhaps also of mimetic isomorphism. In addition, I detail how, as a consequence of these developments, those involved in Dutch ethics review came to consider “variation and inconsistency” as one of the system’s biggest problems in the late 1980s. To remedy this, numerous normative isomorphic attempts were undertaken in the late twentieth century to make all Dutch research ethics committees act in the same way. This emphasis on institutional homogeneity has been borne out in the Netherlands, even though it has repeatedly been criticized for hampering democratic and ethical decision-making.

Assessment of the Operational Characteristics of Research Ethics Committees in Ghana

There were eighteen Research Ethics Committees (RECs) operating in Ghana as of December 2019 but no empirical assessment of their operational characteristics had been conducted. We assessed the characteristics of Ghanaian RECs using an existing Self-Assessment Tool for RECs in Developing Countries. We present results from nine RECs that participated in this nation-wide assessment. Our results indicate that the RECs are generally adherent to the recommendations in the Tool including being composed of members with diverse expertise. They also reviewed and approved research protocols as well as had access to some limited funding for their activities. There is no national policy on research human protections or an ethics authority to regulate the activities of the RECs. We recommend the establishment of this authority in Ghana while encouraging institutions to sustain efforts aimed at making their RECs operate independently.

The Role of Research Ethics Committees: Making a Fair Offer

"In this paper, I engage with the on-going debate about the nature of the task that research ethics committees (RECs) have in coming to assess the ethics of research proposals. Some have argued that the role of RECs is to protect participants from harm in the context of researchers who want to benefit future people. Others have argued that the role of RECs is primarily to ensure that potential participants are provided with full information – enough to make an informed choice. On this later view, RECs protect choice rather than restrict it. I argue that both of these orientations are mistaken and that the role of RECs more akin to a societal overseer who ensures that the research is worthwhile and, most importantly, that it presents a fair offer to potential participants. On this view, the REC’s role is to balance potential harms to participants with the potential benefits of the research in the context of presenting the choice about whether to participate to potential participants. "

Whorephobia in Higher Education: a reflexive account of researching cis women’s experiences of stripping while at university

This is a reflexive account of carrying out ‘dirty research’ on cis women’s experiences of working as erotic dancers while at university in the UK. Focusing on the recruitment process, I discuss how universities avoided becoming ‘subjects’ of research by blocking the study and labelling it ‘extremely sensitive’ or ‘inappropriate’. By scrutinising the fieldwork, this revealed the prevalence of whorephobia within Higher Education and the general, rather than idiosyncratic, prioritisation of institutional reputation management at the expense of silencing marginalised voices and experiences. This article adds to scholarship problematising the taken-for-granted, subjective power wielded by research ethics committees which has the potential to curtail academic freedom and the advancement of knowledge and debate within specific fields. By restricting access to potential participants and through delay tactics, this hindered my ability to carry out the initial research design, shaping the type of data gathered and the knowledge I was able to contribute to this already under-researched area of study.

Informed consent in cluster randomised trials: a guide for the perplexed

In a cluster randomised trial (CRT), intact groups—such as communities, clinics or schools—are randomised to the study intervention or control conditions. The issue of informed consent in CRTs has been particularly challenging for researchers and research ethics committees. Some argue that cluster randomisation is a reason not to seek informed consent from research participants. In fact, systematic reviews have found that, relative to individually randomised trials, CRTs are associated with an increased likelihood of inadequate reporting of consent procedures and inappropriate use of waivers of consent. The objective of this paper is to clarify this confusion by providing a practical and useful framework to guide researchers and research ethics committees through consent issues in CRTs. In CRTs, it is the unit of intervention—not the unit of randomisation—that drives informed consent issues. We explicate a three-step framework for thinking through informed consent in CRTs: (1) identify research participants, (2) identify the study element(s) to which research participants are exposed, and (3) determine if a waiver of consent is appropriate for each study element. We then apply our framework to examples of CRTs of cluster-level, professional-level and individual-level interventions, and provide key lessons on informed consent for each type of CRT.