Still a Long Way to Go in Patient Research Protections

From the WebMD Archives

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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"We need to be certain that the safety and dignity of patients who volunteer to help advance medicine are fully protected by the law," Rep. Henry Waxman, D-Calif., tells WebMD. Waxman agrees with the OIG report and says he plans to introduce legislation addressing the issue.

Nonetheless, one of the country's leading gene therapists takes issue with the report. W. French Anderson, MD, of the University of Southern California, says overall, patients in research studies are very well protected. "It's not appropriate when you're already doing an excellent job, but you can see that there's room for improvement to say, 'Oh, it's a grim situation. We've all these problems,'" Anderson tells WebMD. Anderson points out that of thousands of gene therapy patients, Gelsinger's death was the only major adverse event.

The government investigators did praise the FDA, as well as the NIH, for efforts to follow up on safety and enforcement questions as well as offering education and training services. In the last three years, the NIH and its Office for Protection from Research Risks have significantly increased their on-site investigations, as has the FDA, according to the report.

Finally, the report points out the need to streamline the so-called Common Rule that governs treatment of human subjects over 17 federal agencies. While the Rule provides consistency, says the OIG, it makes it difficult to change things quickly.

Well-placed sources tell WebMD that within six months the Clinton administration will propose major changes in the IRB structure aimed at improving patient protection.

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