Bioethics & Research Regulation

The Problem: 

Since the 1970’s, most U.S. 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.
Our Work: 

Our purpose was 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 addressed 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?

Learn more by visiting our project site.