Ethics & Human Research, March–April 2023 Issue

Articles

Disclosing Conflicts of Interest to Potential Research Participants: Good for Nothing?

Inmaculada de Melo-Martín

The growing commercialization of science has raised concerns about financial conflicts of interest. Evidence suggests that such conflicts threaten the integrity of research and the well-being of research participants. Trying to minimize these negative effects, federal agencies, academic institutions, and publishers have developed conflict-of-interest policies. Among such policies, recommendations or requirements to disclose financial COIs to potential research participants and patients have become commonplace. Here, I argue that disclosing conflicts of interest to potential research participants fails to achieve the weighty moral goals that presumably ground such policies. This is so either because disclosure is simply a wrong means for achieving some of the goals in question or because, although disclosure could be an appropriate means for some of those goals, the way in which it is implemented prevents fulfillment of the desirable moral aim.

Legally Effective but Ethically Inadequate: Institutional Review Board Policies for Consent from Legally Authorized Representatives

Robert R. Harrison

The prevailing approach to enrolling decisionally impaired adults in clinical research is to rely on permission from a default surrogate, one identified by law rather than by the prospective research participant. Reliance on a surrogate transfers the focus of ethical protection from a researcher-participant relationship to a researcher-surrogate relationship; the selection and role of the surrogate are therefore important. The Common Rule defers to state law governing default surrogate consent to research, but most states have no such law; for those states, the Common Rule defers to institutional policy. I reviewed 25 of the study sites with the highest National Institutes of Health funding levels to elaborate the content of institutional review board policies and compare those to a suggested paradigm for ethically defensible policies. My findings suggest that IRB policies provide inadequate protection because they recognize surrogates who lack knowledge of the subject’s current values and preferences without imposing adequate additional safeguards.

Research Ethics during Pandemics: How IRBs Can Prepare

Jacob M. Appel, Ilene Wilets

Remnant Blood Quantification: Informing the Definition of Minimal Risk in Clinical Research

Adam L. Gottula, Sara Constand, Sandra Cabrera, Uwe Stolz, Ann Salvator, Michael Goodman, Jason McMullan

An Uncommonly Good Foundation for Research Ethics

Nancy M. P. King

For more information, contact:

Susan Gilbert

Director of Communications

The Hastings Center

845-424-4040 x244

gilberts@thehastingscenter.org.