The Common Rule as Regulation

Issue

Since the 1970’s most US research involving humans has been subject to a growing body of federal regulations (“the Common Rule”) that is intended to prevent harm and promote ethical research behavior. As a regulatory system, the Common Rule exhibits weaknesses in design and implementation. It:

  1. was adopted without a systematic effort to empirically assess the problem of harm to human research subjects;
  2. applies to multiple research disciplines without accounting for differences in the purposes, methods and risks of the research;
  3. deploys regulatory tools whose actual effectiveness in preventing human subject harm and abuse is unknown; and
  4. was implemented without new funding, and imposed largely unknown costs in money, lost research opportunities, researcher morale, and research efficacy.
Purpose of Project

Our purpose is to redefine the issue of human subject protection as one of effective and efficient regulation. Without questioning the goal of safe and ethical research practices, we will focus policy and research attention on the question of how the current system works, and what alternative approaches might work better. We will pose three questions:

  1. What do we know about the problem of harm and abuse in research?
  2. What do we know about how institutional review boards operate, how the protective tools they use actually work, and the costs and benefits the system provides?
  3. What are the alternatives to our current approach?

Publications

Published products of the study to date include

  • Burris, S., Buehler, J., & Lazzarini, Z. (2003). Applying the Common Rule to Public Health Agencies: Questions and Tentative Answers about a Public Health Exemption. Journal of Law, Medicine & Ethics, 31, 638-653.
  • Burris, S., Gable, L., Stone, L., & Lazzarini, Z. (2003). The Role of State Law in Protecting Human Subjects of Public Health Research and Practice. Journal of Law, Medicine & Ethics, 31, 654-662.
  • Burris, S., & Moss, K. (2006). U.S. Health Researchers Review Their Ethics Review Boards: A Qualitative Study. Journal of Empirical Research on Human Research Ethics, in press. A methodological appendix for this article is available here.

Published papers are available for download at http://papers.ssrn.com/sol3/cf_dev/AbsByAuth.cfm?per_id=139924