Comments on two articles recently published in NEJM

In our last blog we referred to a recent edition of the New England Journal of Medicine (NEJM) in which prominent bioethicists argued that some comparative trials involving approved therapeutic or diagnostic interventions (also known as comparative effectiveness research (CER)) could be conducted without research participants’ consent if conducted within a mature healthcare system with robust ethical policies.

While we understand the importance of improving the quality and value of clinical care, it is highly questionable whether this warrants the full waiver of research participants’ rights to make autonomous decisions for themselves. Research ethics codes of conducts were written under the premise that society’s interest in the advancement of science shall never outweigh individual rights and the interests of research participants.

This issue was raised by another group of authors in the same edition of the NEJM, who proposed instead an “integrated consent” model which would not constitute a waiver of consent but rather an alteration of the informed consent requirements. In our opinion, this proposal would still fail to the normative requirements for alteration or waiver of consent which were summarized in our last blog posting.

In light of these two proposals, it’s appropriate to question whether comparative effectiveness research presents such unique characteristics that would justify a normative reform of consent requirements for research. At first glance, we believe that the current framework allows the conduct of such studies without necessarily representing an unreasonable administrative burden, which is the principal motivation for the authors’ call for change.

Blanket consent, broad consent, or an authorization model as alternatives for Comparative Effectiveness Research?

“While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.”

Declaration of Helsinki, Article 8

Possible alternatives that would meet the normative requirements for free and informed consent have been developed, for example for the collection, use and storage of biological materials for future research. Under this approach, hospital patients could complete an informed consent form at time of admission or registration. This informed consent form would explain the hospital’s status as a learning healthcare system and would present the general types of comparative effectiveness research conducted within the hospital. Patients could then specify in advance the extent of their desired involvement as a research participant, after carefully assessing the potential harms, benefits and inconveniences of their participation. Patients would have the opportunity to make a free and informed decision to become a research participant. Following the completion of this form, an approach similar to the proposed “integrated consent” model discussed in NEJM could be possible every time a comparative effectiveness research project met the level of involvement desired by the patient at the time of admission. It is important to remember that, under our proposal, the research project would have to meet the first four criteria outlined in our previous blog (e.g. minimal risk).

It is likely that these alternatives have already been proposed and studied as they have been successfully implemented in various research projects. The purpose of this blog is to raise awareness and comment on research ethics issues and not formally conduct research on ethical, legal and social issues related to research with humans. Nevertheless, we look forward to reading the new developments in this very interesting debate.

The Veritas IRB Inc. Editorial Board

The Veritas IRB Editorial Board covers questions of research ethics, clinical trial conduct, and human research participant protection primarily for sponsors, CROs and investigators/researchers. // Le blogue de Veritas IRB aborde des questions de l'éthique de la recherche, de la bonne conduite des essais cliniques, et de la protection des participants à la recherche dans une perspective axée sur les promoteurs de la recherche, les organismes de recherche sous contrat (ORCs ou CROs), et les chercheurs.