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It's Not a Problem
Continuing from last time...
One suggestion was to require clinical trial sponsors to report to the IRB information about prior disapprovals. In this way, it was argued, the IRB considering a protocol would be put on notice that there might be issues requiring special attention. Another suggestion involved requiring sponsors to post information about prior disapprovals on a public web site.
As it turns out, the FDA decided not to regulate IRB shopping in any way - at least for now. Its decision, posted this month (January 17 Federal Register), noted that, according to those who submitted comments on the 2002 FDA notice, IRB shopping did not present "a significant problem." Further, many of those who commented expressed logistical concerns, especially for clinical trials conducted at multiple sites, each with its own IRB. Finally, it was argued that the added burden to IRBs and delays would "not provide any additional human subject protection."
Its conclusion was that "IRB shopping either does not occur or does not present a problem to an extent that would warrant rulemaking at this time."
My opinion is that the administrative and business disincentives for pharmaceutical firms and research institutions were perceived to be much greater than the benefits to the research process or the research participants. At the same time, research participant advocates did not effectively present a case for greater regulation in this area.
So, for now at least, the status quo stands.
-Joe
One suggestion was to require clinical trial sponsors to report to the IRB information about prior disapprovals. In this way, it was argued, the IRB considering a protocol would be put on notice that there might be issues requiring special attention. Another suggestion involved requiring sponsors to post information about prior disapprovals on a public web site.
As it turns out, the FDA decided not to regulate IRB shopping in any way - at least for now. Its decision, posted this month (January 17 Federal Register), noted that, according to those who submitted comments on the 2002 FDA notice, IRB shopping did not present "a significant problem." Further, many of those who commented expressed logistical concerns, especially for clinical trials conducted at multiple sites, each with its own IRB. Finally, it was argued that the added burden to IRBs and delays would "not provide any additional human subject protection."
Its conclusion was that "IRB shopping either does not occur or does not present a problem to an extent that would warrant rulemaking at this time."
My opinion is that the administrative and business disincentives for pharmaceutical firms and research institutions were perceived to be much greater than the benefits to the research process or the research participants. At the same time, research participant advocates did not effectively present a case for greater regulation in this area.
So, for now at least, the status quo stands.
-Joe
