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Health Care Reform:

Health Insurance & Affordable Care Act

WebMD Health News

Still a Long Way to Go in Patient Research Protections

April 13, 2000 (Washington) -- Even though "promising steps" have been taken to protect individuals involved in medical experiments, "minimal progress" has been made in beefing up local boards that oversee these studies. That's the pessimistic conclusion drawn in a new report from the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services.

"Surprisingly little is known [about] how well [these boards] are doing their job," Laura McBride, MS, an analyst who worked on the report, tells WebMD.

Requested by a Congressional panel, this study follows a 1998 OIG report that also warned of weaknesses among the Institutional Review Boards (IRBs). Numbering between three and 5,000, these committees enforce patient protection standards for hospitals and universities carrying out research in humans. Not all IRBs are affiliated with institutions; some are "free-standing" and work independently with drug companies or other groups.

While all IRBs are regulated, they have a good deal of freedom. However, the OIG report is concerned the boards aren't really accountable for their decisions and that patient safety is a low priority after the study gets its initial OK. No one knows for sure, but it's estimated that perhaps 100,000 people are in experiments controlled by IRBs. Many of these patients have severe or life-threatening illnesses.

Other concerns in the report: no specific training and education for IRB members in spite of the increasing complexity of their task. Too much work and too little staff to handle the job, and no fire wall to prevent conflicts of interests from IRB members who may have a financial stake in the research.

"IRBs can't do it alone ... other pieces in the system really need to take responsibility for protections as well, including sponsors and investigators themselves," says McBride.

In the two years since the original report, a number of federal agencies as well as Congress have been looking into ways of enhancing the safety of those participating in medical experiments. The death of 18-year Jesse Gelsinger last September, the first fatality caused directly by gene therapy, further focused the OIG on the issue.

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