Author: Jon Merz
Date: 01-19-06 09:22
Source: Chronicle of higher ed
URL: http://chronicle.com/temp/email2.php?id=tXPkjNwksprFkGzyQjk23YcfSc6tGGcY
Date published: January 18th 2006
Federal Agency Decides Not to Regulate 'IRB Shopping,' Saying the Research Dodge Appears to Be Uncommon
By JEFFREY BRAINARD
Washington
The Food and Drug Administration announced on Tuesday that it would not regulate "IRB shopping," a practice in which sponsors of clinical trials choose to submit proposed research to institutional review boards that they believe will approve it. The FDA said it had concluded that such choosiness either does not occur or is not a significant problem.
Many large universities and higher-education groups had criticized the idea of new rules, saying they would bog down institutional review boards in paperwork without providing additional protection for research subjects. But advocates for those volunteers say the practice, even if it cannot be quantitatively documented, is real and worrisome because it could allow ethically suspect studies to avoid adequate oversight.
The FDA had requested comment in 2002 on whether new rules were needed to control the practice. In particular, the agency was mulling over the idea of requiring sponsors of studies regulated by the agency, and academic scientists who performed them, to inform institutional review boards about any prior decisions by other review panels.
Federal rules make the review boards, known as IRB's, responsible for protecting the safety and welfare of volunteers in biomedical and behavioral research regulated by the FDA or financed by the U.S. Department of Health and Human Services.
In 1998 the inspector general of the department, which is the FDA's parent agency, recommended just such a rule. In a report, that office said it had "heard of a few situations where sponsors and/or research investigators who were unhappy with one IRB's reviews switched to another without the new IRB being aware of the other's prior involvement."
On Tuesday, in an announcement in the /Federal Register,/ the FDA said that most of the 55 comments it had received -- which came from pharmaceutical companies, colleges, and other organizations -- contended that IRB shopping was not a big problem. Some commenters noted that there was no systematic evidence of IRB shopping. Others suggested that the new rule would tend to force IRB's to examine the details and circumstances of decisions by other IRB's. That would be especially burdensome for the increasing number of clinical trials that involve dozens of separate sites.
Universities already can control IRB shopping by their faculty members, who are required to use their own institutions' IRB's unless the IRB's give explicit permission otherwise. Some experts believe IRB shopping is a more serious issue among pharmaceutical companies that hire independent, for-profit IRB's to review their work.
For universities, then, the question was whether a new FDA rule should or could prevent sponsors of clinical trials from choosing a particular college to participate. In one comment submitted to the FDA, Alastair J.J. Wood of Vanderbilt University said: "We have found that sponsors tend to first choose investigators and institutions for reasons such as the reputation of the investigator or institution, unique characteristics of the local population, and resources available for the research at that particular site. Then they are required to use the IRB with which the investigators are affiliated."
Several commenters said that IRB's should simply ask clinical-trial sponsors whether their proposals had previously been rejected by another review board.
Other commenters who wanted the FDA to take action suggested that the logistics could be simplified if the information about IRB rejections were placed in a Web-based, federally sponsored registry for all clinical trials. The federal government has set up such a registry, called ClinicalTrials.gov, but it does not require IRB rejections to be listed.
Other commenters suggested that clinical-trial sponsors intent on IRB shopping could get around the registry by simply giving a rejected research proposal a new title and details to make it appear novel.
Had the FDA done its own investigation about the extent of IRB shopping, rather than taking the word of others, it would have found that the practice is common and worth tracking, said Adil E. Shamoo, a professor of biochemistry at the University of Maryland's School of Medicine and co-founder of an advocacy group for research volunteers, Citizens for Responsible Care in Research. "There are certain things, once you are in the trenches" of human-subjects research, "that you smell, you see, you experience, and they become obvious," he said.
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