Thousands of Human Experimental Subjects at Risk

June 11, 1998

Thousands of Human Experimental Subjects at Risk

Institutional Review Boards Fail to Protect Subjects

WASHINGTON, D.C. — The health and safety of thousands of human experimental subjects is in jeopardy, said Public Citizen?s Health Research Group today in comments included in the HHS Inspector General Reports on Institutional Review Boards: An Institution in Jeopardy, Observations and Recommendations OEI-01-97-00191-93, released at a Congressional hearing this morning.

“Although the reports conclude there are not ?widespread abuses of human research subjects,? the increasingly large number of violations concerning informed consent documents, the dangerous lack of on-site inspections for government-funded experiments, and the rise of for-profit institutional review boards (IRBs) strongly suggest otherwise,” said Dr. Sidney Wolfe, Director of Public Citizen?s Health Research Group.

Public Citizen?s comments are included in the report released today and are a response to it (see comments). The most alarming findings of today?s report include the number of informed consent violations, the misleading advertisements used to recruit patients to join experiments, and the conflict of interest problems raised by for-profit IRBs.

“People are lured into experiments by emphasizing treatment instead of research,” says Public Citizen. The report found that “the mention of research is either placed at the end of a long list of benefits or is embedded in language so enticing that the inevitable risks of research are easily overlooked…. The danger of these advertisements is that subjects may come to a research study with misconceptions…. They may be motivated by the promise of free treatment, free screening or extra money.”

The Inspector General?s Reports reveal an enormous amount about the inadequacies of the IRBs, but the reports failed to interview subjects of human experiments and failed to assess the differences between review boards based on standardized protocols or to collect data on differences in IRBs on rejection rates, said Public Citizen?s Health Research Group. “No systematic search for abuses was conducted nor were known abuses examined,” said Dr. Wolfe.