OHRP Proposes New IRB Rule

ORHP has issued an Advanced Notice of Proposed Rule Making to enable OHRP to hold institutional review boards (IRB) and the institutions or organizations operating the IRBs directly accountable for meeting certain regulatory requirements of the DHHS regulations for the protection of human subjects. (http://edocket.access.gpo.gov/2009/E9-4628.htm) Comments on this proposal are due by June 3, 2009.

If adopted, this proposal could change the relationship between research institutions and external IRBs. Is this a good thing or not? Although I think that external IRBs should be held accountable for compliance, I am concerned that this will make some of the problems concerning external IRBs worse. One problem with external IRBs is what was illustrated with the GAO sting. Research organizations just pick an IRB without making sure that they meet appropriate standards. If the organizations are no longer responsible for IRB compliance, this will increase the likelihood that organizations will just pick an IRB that is fast and easy. Second, organizations that use an external IRB often do not realize that they need to have an HRPP and oversee the research. They think they have IRB approval so that's all they need to do. This new rule could increase that tendency.

So, I think that holding external IRBs accountable is fine, but OHRP should continue to hold the research organizations accountable for IRB compliance as well.