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Proposed Changes to the Common Rule and Management of Clinical Trials

Posted by Brook White on Tue, Jun 12, 2012 @ 09:35 AM


The Department of Health and Human Services has proposed some changes to the Common Rule.  So, what is the Common Rule, what are they planning to change, and how could that impact the management of clinical trials?

What is the Common Rule?

The Common Rule is a federal policy that was developed to regulate safety and privacy to human subjects involved in research.  There are two central requirements of the Common Rule:

  • That people who participate as subjects in covered research are selected equitably and give their fully informed, fully voluntary written consent
  • That proposed research is reviewed by an independent oversight group referred to as an Institutional Review Board (IRB), and approved only if risks to subjects have been minimized and are reasonable in relation to anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to result.

management of clinical trials
What may change?

The Department of Health and Human Services (DHHS) is proposing a number of changes to the Common Rule.  One proposed change which would significantly impact the management of clinical trials is the imposition of oversight by a single IRB for domestic multi-site clinical trials. Under the proposed changes, a central IRB would have sole regulatory responsibility to comply with the Common Rule.  For more information, go to Advance Notice of Proposed Rulemaking and changes being considered.

How could this impact the management of clinical trials?

Requiring central IRB oversight of domestic multi-site studies is ultimately intended to increase human subject protection. Use of a central IRB could decrease the operational burden associated with multiple IRBs by introducing standard practices to minimize variation in policies and procedures.  Standardized review processes, timelines, and costs could contribute to increased study start-up efficiency, condensed timelines, and reduced costs. 

It is important to note that sub-optimal performance on behalf of a central IRB can jeopardize and erode human subject protection, impacting all of the studies’ sites.  To minimize this risk, and to ensure the fastest path to IRB approval, applicants must make every effort to provide an IRB submission that is free of regulatory deficiencies.

What do you think?  Do the potential benefits of using a single IRB outweigh the risks posed by potential low performance of a central IRB?