Cooperative Research and the New Common Rule

By LaVonneDowney, Ph.D.

So, what does the new common rule say about cooperative research? First of all, let’s define cooperative research which is research “involving more than one institution”. Previously, both institution’s IRB would review the research which extended and often duplicated the review process for all involved, especially researchers. The new Common Rule wants to avoid having to duplicate IRB reviews and make the process more cooperative. This can be done by having an IRB Authorization / Reliance Agreement. The simplicity of the solution a cooperative /authorizing agreement belies the potential complexity involved. This is in part, due to issues involving whose IRBis doing oversight. Each institution is still responsible for safeguarding the rights and welfare of human subjects and for complying with applicable laws and regulations. Thus, certain steps have to be outlined in any agreement.

These include the following :

• Determining when other IRBs are involved, and whose guidelines are followed
• Determining which IRB has the expertise to be the led for example a medical institution might have more experience and structures in place to oversee medical patient-based research than a non-medicine patient-based research university.
• Determining the time frame of the agreements defining their respective responsibilities in connection with the research; such as where data is stored
• Communicating as appropriate with the other involved IRBsNotifying investigators of any special expectations with regard to the conduct of multi-site research.
• The University IRB should determine prior to the initiation of research how it will solicit and review reports of unanticipated problems involving risks to subjects or others thus, certain steps have to be outlined in any agreement.

Again, the good news is this can all be done through cooperative agreements, intra-institutional, reliance, and authorizing agreements. You can find the current IRB Reliance Agreement here under “Sample Consent Forms“.  The neutral news is that this process is often like negotiating a contract, often between two entities with differing layers of requirements and procedures. Thus, the process of creating and moving towards an agreement should start as soon as possible with the understanding that it might take time for both parties( IRB ) to agree on all the details. The helpful news is that the research office can help you with the process. Please use these resources so both sites are working together with their respective strengths to ensure ethical research is being done.