Health Research Ethics

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An evaluation of ethical concerns raised by a South African research ethics committee using the principles and benchmarks proposed by Emanuel et al. (2004, 2008)
(2022) Magolela, Melda.; Wassenaar, Douglas Richard.
"Mission creep”, “closed doors”, “bureaucracy”, “time delays”, “incompetence” are terms used in some of the arguments advanced by researchers who are not in favour of or are critical of the system of independent ethics review of research by Research Ethics Committees (RECs). “Human subjects’ projection”, “public accountability”, “good research governance” are some of the terms used by researchers who embrace the system of independent ethics review of research. Also known and referred to as institutional review boards (IRBs), ethics review boards (ERBs), ethical review committees (ERCs), human research ethics committees (HRECs) evaluate all human research to ensure that proposed studies comply with international and national ethics principles and guidelines for conducting human research. These committees may either approve, reject, or require modifications to submitted protocols and their decision is binding. A key feature of such committees and their members is their independence. Despite being for or against ethics review, there is a growing body of work attempting to describe and understand the functioning and outcomes of RECs in protecting research participants and promoting ethical research. In this area, there is relatively little work describing the actual issues that RECs look for and subsequently raise when reviewing research protocols. The current study therefore assessed minutes of a South African biomedical REC and identified ethical concerns raised during review of protocols submitted between 2015 - 2016. Ten sets of minutes were retrospectively analysed using Emanuel et al.’s (2004, 2008) framework to code, rank and classify the issues raised by the REC. There were 813 queries raised in the two-year period; 86% (697) of the queries were consistent with the framework. Top four most frequently queries were identified with scientific validity (38%) being the most frequently raised concern, followed by informed consent (33%), ongoing respect for participants (11%) and independent ethics review (9%). Of the 813 queries raised, 14% (116) of queries could not be accommodated by the framework and these pertained to administrative issues. The results of this study support the findings of the primary study by Tsoka-Gwegweni and Wassenaar who were the first to propose and establish that the Emanuel et al. framework is a useful tool to categorize concerns raised by one South African REC. In this study, it was found that 99,7% of 1,043 queries raised for the years 2008 to 2012 were compatible with the Emanuel et al. framework with informed consent emerging as the most frequently raised concern. Equally comparable are the results of a subsequent study by Silaigwana and Wassenaar who also reported that 97,7% of the 1,272 queries raised for the years 2009 to 2014 could be categorised using the Emanuel et al. framework. The Emanuel et al. framework of eight principles and benchmarks proves to be a useful and important tool in evaluating ethical queries raised during EC protocol review meetings. Both the current study and these previous studies support use of this framework.
An exploratory study of vaccinations amongst staff at a South African research institution: personal choice or mandatory?
(2024) Couch, Marilyn Angel.; Toohey, Jacintha Deleane.; Groenewald, Candice Rule.
Controversies related to immunisation have existed since 1840. The focus of much discussion has been on the efficacy of vaccination in protecting public health and safety, as well as the question of vaccine mandates infringing upon individual freedoms. The COVID-19 pandemic, declared by the World Health Organization on March 11, 2020, reignited these debates. In South Africa, under Section 27(2) of the Disaster Management Act No 57 of 2002, the Minister of Employment and Labour is authorised to issue directives linked to the country’s state of disaster. As a result, the COVID-19 Occupational Health and Safety Measures in Workplaces directive (C19 OHS) (Department of Employment and Labour, 2020) was issued by the Minister of Employment and Labour in terms of regulation 10(8) issued by the Minister of Cooperative Governance and Traditional Affairs in terms of Section 27(2) of the Disaster Management Act No 57 of 2002 (Republic of South Africa, 2002). The objective of the directive was to implement occupational health and safety measures in the workplace to stop the spread of the COVID-19 virus and to provide guidance to employers on how to deal with COVID-19 in the workplace. Consequently, this brought to light the need to tackle the dilemma of individual versus collective rights in the context of vaccine mandates in the workplace. The study aimed to explore participants' knowledge and understanding of ethical, human rights, and legal aspects of vaccination. It also sought to understand whether participants believe vaccines should be a personal choice or mandatory, as well as their experiences with COVID-19 vaccination in the workplace. This study used a qualitative methodology approach, conducting 20 semi-structured, in-depth, open-ended individual interviews that took place either face-to-face or virtually. The study sample comprised of staff members from a South African research institution, across three provinces. The interview data were transcribed and then loaded onto Atlas. ti software for coding, using the thematic analysis approach. This social science study employs an interdisciplinary approach that considers the human rights, ethics, and legal aspects in the workplace setting concerning mandatory vaccination policies. The research aimed to provide valuable insights from participants in this study concerning the multifaceted interactions between human rights law, bioethics, and the social dynamics of mandatory vaccination policies. The research also utilises the social constructionist framework as a conceptual model to examine and understand how individuals have shaped their perceptions regarding personal freedoms, the mandatory nature of vaccination, trust in vaccine role players, experiences with COVID-19 in the workplace, and the factors influencing their beliefs. This conceptual approach is used to analyse and interpret participants' viewpoints but does not dictate the entire study. The study indicates that most participants are in favour of personal choice. These findings imply that, for these participants, individual choice in medical freedoms is paramount in healthcare decision-making, including vaccination. Recommendations are made for the South African government, vaccination policymakers, employers, and for future research.
Evaluating ethics approval and informed consent in selected online Nigerian medical journals.
(2021) Alimasunya, Joseph Ethagbe.; Wassenaar, Douglas Richard.
Overview to this study. This was a quantitative, retrospective study which sought to determine the frequency of research ethics approval and informed consent reporting in selected online Nigerian medical journals. The need to regulate research activities involving human subject participation led to the establishment of Institutional Review Boards (IRBs), also known as Research Ethics Committees (RECs) in most research institutions globally. It is a universal requirement that all biomedical research studies involving human subjects be reviewed by an independent REC/IRB (World Medical Association, 2013). One of the fundamentals of research activities involving human participants, including identifiable human materials, data or information, is the provision for ethical protections. The Declaration of Helsinki (WMA, 2013) clearly states the need for researchers to obtain informed consent from study participants as one of the prerequisites that should be met in the study protocol before approval can be granted by an REC or IRB. Similarly, the Council for International Organizations of Medical Sciences (CIOMS, 2016) in its international guidelines has made provision for the ethical protection of participants involved in biomedical research activities. In recent years there has been an increase in social and biomedical research activities throughout the world, with particular emphasis in developing countries where the disease burden is at its highest (Nyika, Kilama, Tangwa et al., 2009). With the increase in biomedical research activities involving human participants in developing countries, Nigeria is no different; there is an increasing need to publish and disseminate research findings in accessible regional and local journals. Studies have been conducted among some western biomedical and health-related journals to examine compliance with adherence to the Declaration of Helsinki (2013). The International Committee of Medical Journal Editors working in conjunction with numerous biomedical journals have developed guidelines which require that “…when reporting experiments on human participants, authors should indicate whether the procedures followed were in accordance with ethical standards of the responsible committee on human experimentation (institutional and national) and with Helsinki Declaration of 1975, as revised in 2000” (Schroter et al., 2006, p. 718–723). Most countries have developed and adhere to their own national framework for human subject research based on these guidelines (Tangwa, 2004). There are no known empirical studies of Nigerian journals which assess the extent to which regional or national biomedical health related journals report adherence to existing research ethics guidelines; in particular regarding whether REC review and informed consent are expressly mentioned in publications reporting research which involves human participants. A study to evaluate the reporting of research ethics approval and informed consent in articles from samples of biomedical Journals in Nigeria may shed light on their reported compliance with national and international ethics guidance. Using a quantitative approach, a consecutive series of articles from five Nigerian online medical and biomedical journals publications were reviewed for reporting of research ethics approval and informed consent. This study attempts to replicate a study by Schroter et al. (2006).

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