Exploitation of the vulnerable in research: Responses to lessons learnt in history

The Nuremberg Trials raised insightful issues on how and why doctors who were trained in the Hippocratic tradition were able to commit such egregious and heinous medical crimes. The vulnerable were considered to be subhuman, of decreased intelligence, of no moral status and lacking human dignity. The reputation of the medical profession had been undermined, professionalism questioned and the doctor-patient relationship damaged as a result of the Nazi medical experiments. The World Medical Association’s Declaration of Helsinki has been hailed as one of the most successful efforts in rescuing medical research from the darkness of the scandals and tragedies in health research. The first Research Ethics Committee in South Africa was established in 1966 at the University of the Witwatersrand. From the mid-1970s other institutions followed suit. The promulgation of the National Health Act No. 61 of 2003, in 2004, resulted in strong protectionism for research participants in the country

A study of vulnerability in health research

Submitted in fulfilment of the degree of Doctor of Philosophy (PhD) in Bioethics and Health Law, Steve Biko Centre for Bioethics, University of the Witwatersrand. Johannesburg, November 2014Vulnerability, an abstract concept in health research, has concrete effects both on those who are labelled vulnerable and those who are not. It has been used increasingly as an exclusion criterion in research but has been the least examined from an ethical perspective despite being linked in most research ethics guidelines and codes, both international and local, to questions of justice and informed consent. Neither has there been an agreed upon standard for identifying and responding to vulnerability. The guidelines, despite categorizing vulnerable research participants into groups and subpopulations, do not offer a robust and comprehensive definition of vulnerability. The study aimed to analyse the notion of vulnerability in health research with a view to constructing an operational definition of the concept which would assist researchers and RECs to identify and understand vulnerabilities and strategize on maximizing protections for the participants without obstructing essential research. Using normative, metaethical and historical methods of bioethical inquiry, this research has shown that the categorization of people into vulnerable groups is not justified as it could result in obstructing research, and paternalistically excluding participants from necessary research, or inadequately protecting participants enrolled in research. The study has resulted in an appropriate operational definition of vulnerability and a Vulnerability Assessment Scale being developed to assist Research Ethics Committees and researchers identify participants with vulnerabilities and develop focused safeguards for their protections. The concept of vulnerability in health research is no longer nebulous and vague and its definition is therefore no longer an unanswered question

Exploitation of the vulnerable in research: Responses to lessons learnt in history

The Nuremberg Trials raised insightful issues on how and why doctors who were trained in the Hippocratic tradition were able to commit such egregious and heinous medical crimes. The vulnerable were considered to be subhuman, of decreased intelligence, of no moral status and lacking human dignity. The reputation of the medical profession had been undermined, professionalism questioned and the doctor-patient relationship damaged as a result of the Nazi medical experiments. The World Medical Association’s Declaration of Helsinki has been hailed as one of the most successful efforts in rescuing medical research from the darkness of the scandals and tragedies in health research. The first Research Ethics Committee in South Africa was established in 1966 at the University of the Witwatersrand. From the mid-1970s other institutions followed suit. The promulgation of the National Health Act No. 61 of 2003, in 2004, resulted in strong protectionism for research participants in the country

ASSAf consensus study on the ethical, legal and social implications of genetics and genomics in South Africa

CITATION: Pepper, M. S., et al. 2018. ASSAf consensus study on the ethical, legal and social implications of genetics and genomics in South Africa. South African Journal of Science, 114(11/12), Art. #a0302, doi:10.17159/sajs.2018/a0302.The original publication is available at http://sajs.co.zaNo abstract available.https://www.sajs.co.za/article/view/5822Publisher's versio

The evolution of research participant protections in South Africa

South Africa (SA) has played a leading role in health research internationally. Ethical guidelines for the protection of research participants have been published by the Medical Research Council (MRC) as early as 1979. Ironically, the guidelines gave substantial prominence to the oppressive laws of the time. In its 4th edition of the guidelines, the MRC placed emphasis on SA needs, and incorporated the principles of the Bill of Rights of the SA Constitution 1996 into its guidelines. The most significant milestone in the history of participant protections in SA was the inclusion of research and experimentation in the Bill of Rights of the Constitution and the statutory legislation of protections in the National Health Act No. 61 of 2003

An optimistic vision for biosciences in South Africa: reply to Thaldar et al. (2019)

Our reply to Thaldar et al.’s1 response to the ASSAf report2 on human genetics and genomics focuses on two elements of the Report which they highlight, namely ubuntu and sovereignty. The lack of engagement with other issues raised by Thaldar et al. does not acknowledge agreement with those view