ies. The committee recommends that, if legally and logistically feasible, private entities that anticipate submitting the results of intentional dosing studies to EPA for regulatory purposes also should be required to submit protocols to the board before beginning a study. The submission should include the proposed protocol and sufficient background information to establish the scientific value of the experiment and provide assurance of participant safety. The proposed board supplements but does not replace review by an IRB.
The post-experiment review function of the board is distinct from the kind of review that EPA undertakes for the purpose of incorporating results from particular experiments into the regulatory process. It would not replace or modify the structures and procedures for existing EPA review. Instead, it would offer nonbinding advice to the relevant EPA units about the scientific and ethical acceptability of the submitted and completed research. The proposed review board, its functions, and its record should be assessed after five years.
Institute of Medicine (IOM). 2003. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, D.C.: The National Academies Press.