Continued Concern: Human Subject Protection, the Irb, and Continuing Review

Abstract

On September 17, 1999, Jesse Gelsinger, an eighteen-year-old man with a rare metabolic disease, died while undergoing experimental genetic therapy administered in a clinical trial at the University of Pennsylvania. Jesse Gelsinger's death focused public attention on the problem of effective monitoring of clinical trials, otherwise known as continuing review.

In recent years several major government reports have been highly critical of contemporary research oversight. In addition, the Department of Health and Human Services' Office for Human Research Protection has found it necessary to suspend research at a growing number of institutions due to regulatory violations, including failure to conduct appropriate continuing reviews.

Providing adequate protection to all research participants through effective continuing review of clinical trials is a challenging and onerous task, but also an extremely important one. Many believe that limited resources, inadequate personnel, and significant time constraints currently prevent IRBs from performing thorough and effective continuing reviews. Thus far, however, there has been minimal evaluation of mechanisms by which IRB functioning in the area of continuing reviews could be improved.

This article provides a rigorous analysis of the problem of continuing review and suggests a variety of means by which to enhance the review process. The article describes the current oversight system for clinical research under the federal regulations and assesses its deficiencies. It further discusses the importance of the continuing review process in light of relevant ethical principles, economic incentives, and liability concerns. Finally, the author offers a series of recommendations relating to the staffing of IRBs, funding for IRBs, the content of continuing reviews, and other aspects of IRB monitoring operations.

Keywords: Clinical research, Institutional Review Board, continuing review of clinical studies, FDA, HHS, research regulation

JEL Classification: I18