A few remarks on limits of research risks and research payments

Perspectives in Biology and Medicine, 2020

The authors would like to acknowledge Kylie Long for her invaluable research assistance and Jonathan Kimmelman and Frank Miller for their helpful comments on an earlier draft of the manuscript.

2004

The question "When are research risks reasonable in relation to anticipated benefits?" is at the heart of disputes in the ethics of clinical research. Institutional review boards are often criticized for inconsistent decision-making, a problem that is compounded by a number of contemporary controversies, including the ethics of research involving placebo controls, developing countries, incapable adults and emergency rooms. If this pressing ethical question is to be addressed in a principled way, then a systematic approach to the ethics of risk in research is required. Component analysis provides such a systematic approach.

Medical Research Ethics: 21st Century Challenges, ed. D.N. Weisstub, Springer , 2023

One of the unmet challenges for risk-benefit assessment in biomedical research is whether there should be an upper limit of risk in non-beneficial studies involving competent and consenting participants, and if yes, how it should be defined. This paper focuses on this second question. It examines the four dominant regulatory and conceptual approaches to setting a maximal risk threshold in research: no catastrophic harm/risk approach, pure procedural approach, numerical approach, and comparative approach. It then considers the pure procedural approach, which leaves the judgment of risk acceptability to RECs discretion. The approach has significant advantages, but it is not free from certain shortcomings, such as unwarranted diversity and arbitrariness of RECs judgments. The paper concludes by sketching the outlines of what is referred to as the "ELS procedural approach" that provides RECs with procedural recommendations for identifying an ethically, legally and socially acceptable upper limit of risk in non-beneficial research on volunteers. The ELS procedural approach is an improvement over the pure procedural approach. It is more standardized and accountable, but still context-sensitive and flexible.

2006

The question "When are research risks reasonable in relation to anticipated benefits?" is at the heart of disputes in the ethics of clinical research. Institutional review boards are often criticized for inconsistent decision-making, a problem that is compounded by a number of contemporary controversies, including the ethics of research involving placebo controls, developing countries, incapable adults and emergency rooms. If this pressing ethical question is to be addressed in a principled way, then a systematic approach to the ethics of risk in research is required. Component analysis provides such a systematic approach.

University of Toronto Law Journal, 2004

to www.ubcpress.ubc.ca. This article will appear as a chapter in the collection Law and Risk, ed. Law Commission of Canada, forthcoming from UBC Press in spring 2005. Both authors are equally responsible for the conceptual development of the article and contributed substantially to all parts of it. Duff Waring took the lead in drafting the section on regulatory science and integrating reviewers' comments, while Trudo Lemmens took the lead in drafting the section about risks. Both contributed substantially to each part of the article. On 2 June 2003, Duff Waring presented an earlier draft of the paper at the joint annual meeting of the Canadian Association of Law Teachers and the Canadian Law and Society Association during the Congress of the Social Sciences and Humanities in Halifax, Nova Scotia. The authors thank William Leiss, James Till, R. Steven Turner, and an anonymous reviewer from the University of Toronto Law Journal for comments on an earlier draft. They are grateful to the Law Commission of Canada, which provided an award for the development of this article. An earlier version of the article was first accepted for publication as a chapter in a collection of essays, written for the Law Commission of Canada, and to be published by the University of British Columbia Press under the title Law and Risk.

HEC Forum, 2014

Most medical research and a substantial amount of non-medical research, especially that involving human participants, is governed by some kind of Research Ethics Committee (REC) following the recommendations of the Declaration of Helsinki for the protection of human participants . The role of RECs is usually seen as twofold: firstly to make some kind of calculation of the risks and benefits of the proposed research, and, secondly, to ensure that participants give informed consent. The extent to which the role of the REC includes the former is not uncontroversial. Indeed the most prevalent debate on the role of RECs sees liberals and strong paternalists arguing over the importance of informed consent given by competent agents versus the significance of making benevolent decisions on behalf of others. On the one hand, liberals argue for the rights of competent adults to decide for themselves the kinds and extents of risks they wish to expose themselves to. On the other hand, proponents of strong paternalism raise concerns about the likelihood of participants being able to truly understand the complex data involved in research. They support a role for RECs in which they exercise duties of benevolence towards patients and participants by limiting the extent to which they can be exposed to significant, permanent and/or irreversible harms. In this paper we will argue that when it comes to decisions about risk it is neither possible nor desirable for RECs to adopt either role.

The American Journal of Bioethics, 2025

American Journal of Bioethics, 2011

2007