Pregnant people are often excluded from research without clear justification, even when there is little harm to the fetus in minimal‐risk research. In this issue of Ethics & Human Research, OB/GYN Amina White and colleagues survey current and former institutional review board personnel to find out their interpretations of “minimal risk” to identify factors that might influence IRB decisions to approve research with those who are pregnant. Also in this issue, an ethics review in the Covid‐19 era; designs for an observational toxicology study involving intoxicated patients; and an essay on making metrics meaningful in human research protection programs.

Articles

IRB Decision-Making about Minimal Risk Research with Pregnant Participants

Amina White, Christine Grady, Margaret Little, Kristen Sullivan, Katie Clark, Monalisa Ngwu, Anne Drapkin Lyerly

Creating a Research Ethics Consultation Service: Issues to Consider

Holly A. Taylor, Kathryn M. Porter, Erin Talati Paquette, Jennifer B. McCormick, Emma Tumilty, Jason F. Arnold, Kayte Spector-Bagdady, Marion Danis, Debra Brandt, Jina Shah, Benjamin S. Wilfond, Lisa M. Lee

Making Metrics Meaningful: How Human Research Protection Programs Can Efficiently and Effectively Use Their Data

Kimberley Serpico

Opt-Out Design for an Observational Toxicology Study Involving Intoxicated Patients at a Dance Music Event

Paul Calle, Peter Blanckaert, Sabine Lemoyne, Robert Rubens

Commentary

A Call for Better, Not Faster, Research Ethics Committee Reviews in the Covid-19 Era

Leonardo Tamariz, Fred J. Hendler, John M. Wells, Annette Anderson, Stephen Bartlett

Table of contents of the September-October 2021 Ethics & Human Research:

https://onlinelibrary.wiley.com/toc/25782363/2021/43/5

For more information, contact:

Susan Gilbert

Director of Communications

The Hastings Center

845-424-4040 x244

gilberts@thehastingscenter.org.