International Journal of Medical Sciences

Impact factor

14 November 2018

ISSN 1449-1907 News feeds of published articles

Manuscript login | Account

open access Global reach, higher impact

Journal of Genomics in PubMed Central. Submit manuscript now...


Journal of Cancer

International Journal of Biological Sciences

Journal of Genomics

Journal of Bone and Joint Infection (JBJI)


Journal of Biomedicine


PubMed Central Indexed in Journal Impact Factor

Int J Med Sci 2008; 5(2):68-72. doi:10.7150/ijms.5.68

Short Research Communication

Principal Investigator Views of the IRB System

Simon N. Whitney1, Kirsten Alcser2, Carl E. Schneider3, Laurence B. McCullough4, Amy L. McGuire4, Robert J. Volk5

1. Department of Family and Community Medicine, Houston Center for Education and Research on Therapeutics, Baylor College of Medicine, Houston, TX 77098-3926, USA
2. Survey Research Center, Institute for Social Research, University of Michigan, Ann Arbor, MI, USA
3. University of Michigan Law School, Ann Arbor, MI 48109-1215, USA
4. Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas 77030, USA
5. Department of Family and Community Medicine, Houston Center for Education and Research on Therapeutics, Baylor College of Medicine, Houston, TX 77098-3926, USA


We undertook a qualitative e-mail survey of federally-funded principal investigators of their views of the US human subjects protection system, intended to identify the range of investigator attitudes. This was an exploratory study with a 14% response rate. Twenty-eight principal investigators responded; their comments were analyzed to show underlying themes, which are here presented along with supporting quotations.

There was consensus that it is important to protect human subjects from research abuse, but disagreement over how well the IRB system is functioning. Some researchers felt that the system is effective and serves its purpose well. Of those who support the system, some endorse its methods, purpose, and daily functioning, as they experience it, without reservation. Others, while expressing some frustration, feel that the purpose is important and their local IRB does its best to make a difficult system work well.

Those investigators who were more harshly critical commented on multiple flaws in the system, including (1) consent forms that are inappropriate and incomprehensible, (2) an emphasis on minutiae, and (3) concern with protecting the institution more than research subjects. Respondents told us that the IRB system is a particular burden for research in neurology, emergency medical conditions, repositories, and social sciences in general; a more comprehensive study might identify other problematic areas. Significant concern was expressed about the cost, inefficiency, and irrationality of IRB review. The IRB system works well for some researchers, but our results indicate that other investigators feel the costs outweigh the benefits.

Keywords: Ethics Committees, Research, Questionnaires, Attitude

This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY-NC) License. See for full terms and conditions.
How to cite this article:
Whitney SN, Alcser K, Schneider CE, McCullough LB, McGuire AL, Volk RJ. Principal Investigator Views of the IRB System. Int J Med Sci 2008; 5(2):68-72. doi:10.7150/ijms.5.68. Available from