University of Massachusetts Medical School Faculty Publications


What the ANPRM missed: additional needs for IRB reform

UMMS Affiliation

Department of Psychiatry

Publication Date


Document Type



Bioethics and Medical Ethics


Institutional Review Boards are mandated to carry out the requirements of the Common Rule, and it is widely agreed that they are appropriate and necessary mechanisms to ensure the ethical conduct of human research. In this paper, we suggest that the changes proposed in ANPRM, although generally helpful, fail to take into consideration how IRBs actually review applications and therefore do not adequately address some of the problems that may be leading to ineffective human subject protection.


IRB, Institutional Review Board

DOI of Published Version



Lidz, C. W. and Garverich, S. (2013), What the ANPRM Missed: Additional Needs for IRB Reform. The Journal of Law, Medicine & Ethics, 41: 390–396. doi: 10.1111/jlme.12050. Link to article on publisher's site

Related Resources

Link to Article in PubMed

Journal/Book/Conference Title

The Journal of law, medicine and ethics : a journal of the American Society of Law, Medicine and Ethics

PubMed ID