Informed consent forms for research with human subjects: time to end the charade
Date
2025
Authors
Version
Published version
OA Version
Citation
Glantz LH. Informed Consent Forms for Research with Human Subjects: Time to End the Charade. American Journal of Law & Medicine. 2024;50(3-4):204-221. doi:10.1017/amj.2025.6
Abstract
In 1974, the Center for Law and Health Sciences at the Boston University School of Law provided legal background papers on informed consent to research to the newly created National Commission for the Protection of Human Subjects of Biomedical and Behavioral Sciences. These papers were written by George J. Annas, the Center’s Director, as well as Barbara F. Katz and I, who were staff attorneys at the time. These papers can be found in the appendices to the Commission reports1 and in our book Informed Consent to Human Experimentation: The Subject’s Dilemma,2 in which we present a refined version of those papers. This project introduced me to the world of human research ethics and the complexities of protecting the rights and welfare of research subjects.3 Over the past fifty years, I have sat on Institutional Review Boards (IRBs), been a member of the FDA’s Pediatric Research Advisory Board, and engaged in varying activities related to human subject protection. During this time, I took for granted that consent forms were the best method for ensuring that subjects were thoroughly informed about all aspects of the proposed research. Like many IRB members, I spent considerable time reviewing, editing, and debating with other IRB members about the precise wording of these forms.
Description
License
© 2025 The Author(s). Published by Cambridge University Press on behalf of American Society of Law, Medicine & Ethics and Trustees of Boston University. This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited. This article has been published under a Read & Publish Transformative Open Access (OA) Agreement with CUP.