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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Compensation for research-related harm: The implications of Venter v Roche Products (Pty) Limited and Others for research ethics committees (Papers: Ann Strode & Priya P. Singh | 2014)0

Posted by Admin in on September 13, 2018

The issue of what type of compensation a research participant would be entitled to in a clinical trial when they have signed an informed consent document excluding certain forms of compensation recently came before our courts in the matter of Venter v Roche Products (Pty) Limited and Others (Case No. 12285/08). In this case, the court had to consider whether the plaintiff, Mr Venter, was entitled to claim for non-medical costs such as pain and suffering, loss of income and general damages, even though the informed-consent document expressly excluded such claims.

To set out the facts, issues and judgment in the case, concluding with a discussion of the implications of the judgment for research ethics committees (RECs).

Critical review of a judgment of the Western Cape High Court.

The court concluded that Mr Venter’s application for damages should be dismissed because he had voluntarily agreed to the limited compensation as set out in the informed consent form that had been approved by both the local RECs and the Medicines Control Council.

The Venter case has shown that delictual claims for research-related injuries will not be successful if plaintiffs have agreed to limit their own rights through signing an informed-consent form that limits compensation. This places an important obligation on RECs to ensure that they carefully review compensation clauses in informed-consent documents and that these are made clear to potential research participants.

Strode, A., & Singh, P. (2014). Compensation for research-related harm: The implications of Venter v Roche Products (Pty) Limited and Others for research ethics committees. South African Medical Journal, 104(11), 759-761. doi:10.7196/SAMJ.8596

The perils of fieldwork in authoritarian states – University World News (Yojana Sharma | September 2018)0

Posted by Admin in on September 11, 2018

Doctoral students and researchers in the social and political sciences need more training to deal with the perils of fieldwork in authoritarian states in Southeast Asia, according to two experts on the region.

Before early career researchers (including overseas HDR candidates visiting their ‘home’ country) travel to an authoritarian state to conduct research, is there sufficient attention to professional development/capacity building with regard to the perils? This is a question for heads of area, mentors and supervisors, but could be usefully reconfirmed by research ethics review bodies. We have included links to trove of related items.

They note that existing “one size fits all” recommendations on field research “presume the setting to be liberal democratic regimes” rather than the less accessible or less secure and transparent authoritarian regimes prevalent in the region.
“The discipline of political science is poorly positioned to guide its own scholars on the best way to perform field research in countries lacking guarantees for norms of speech, movement and scholarship,” say Meredith Weiss, associate professor of political science at the State University of New York at Albany in the United States, and Lee Morgenbesser, a lecturer in comparative politics at Griffith University in Australia, in a just-published paper that draws on their own and other academics’ experiences of working in such countries.
“The implications of this lacuna are acute in Southeast Asia,” where nine out of 11 countries are classified as having authoritarian regimes, they say in their paper published in the Asian Studies Review entitled “Survive and Thrive: Field research in authoritarian Southeast Asia”.

Read the rest of this discussion piece

Research ethics in the Kalahari: issues, contradictions and concerns (Papers: Keyan Tomaselli | 2017)0

Posted by Admin in on September 6, 2018

The effects of ethical clearance or institutional review board practices are discussed in relation to the experiences of academic field researchers on the one hand and indigenous research participants and/or co-generators of knowledge on the other. Ethical procedures such as protection (do no harm), control (micromanaging methods) and exploitation (taking ownership) are discussed in relation to researcher experiences in southern Africa. Researcher–researched relations, researcher and subject alienation, ethics creep and the clash of ontologies are examined. Some tentative solutions are proposed.

Keywords: ethics, gatekeepers, indigenous rights, institutional review board, Kalahari, ≠Khomani Bushmen

Tomaselli, K.G. (2017): Ethical Procedures? A Critical Intervention: The sacred, the profane, and the planet. The Ethnographic Edge, [S.l.], v. 1, n. 1, p. 3-16.

Research with, not about, communities – Ethical guidance towards empowerment in collaborative research, a report for the TRUST project – TRUST (Kate Chatfield, et al | July 2018)0

Posted by Admin in on August 28, 2018

Executive Summary and Introduction
Community engagement is an ethical imperative (a ‘must’) for researchers operating globally. Research participants, their local communities and research partners in international locations should be equal stakeholders1 in the pursuit of research-related gains.2,3

Great TRUST paper about a more respectful approach to research with communities. We have included links to a treasure trove of papers, reports, blog posts and news items on matters around the topics discussed in this paper.

In the 1990s, community engagement became prominent as the new guiding light of public health efforts. Involving communities in research and health-improvement programs led to better results than government-led programs alone.4 At the same time, the emerging need to protect indigenous communities in genetic research led Canadian Charles Weijer to demand a fifth principle in bioethics5,6: protection for communities.7 The individualistic nature of existing research ethics principles, stemming from US origins with its traditional emphasis upon individual autonomy was thus questioned. Asian and African ethicists added their voices to highlight the importance of respect for communities, as well as individuals.8,9
This report provides guidance on community engagement in research from the perspective of the four TRUST values: fairness, respect, care and honesty.
These values were identified by a global group of experts as the cornerstones of equitable research partnerships between high-income country (HIC) and low- and middle-income country (LMIC) research partners in any discipline10. The group included representatives from two vulnerable populations that carry a high burden of research: Kenyan sex workers and San indigenous peoples of Southern Africa. The guidance is suitable for all who support vulnerable populations involved in research projects, including civil society organisations, whether or not they are carrying out the research projects themselves.

Chatfield, K. et al. (2018) Research with, not about, communities – Ethical guidance towards empowerment in collaborative research, a report for the TRUST project.