REQUESTS FOR USE OF CENTRAL IRBs

We are seeing a growing number of requests for the use of a central IRB (cIRB) - often the result of mandates (or strong suggestions) by funding sources/sponsors.

Of note there are different types of cIRBs; including for example:

• The commercial or independent IRB – see here (http://healthcare.partners.org/phsirb/independentIRB.html) for information on the use of commercial IRBs at MGH/BWH for industry-sponsored, industry initiated Phase III/IV studies.
• A cIRB based at an Academic Medical Center
• A cIRB based at NIH or the VA

If your research includes relying on a cIRB at another institution, please contact Maria Sundquist at msundquist@partners.org. Requests for relying on an IRB at another institution must be reviewed and if approved, require negotiation of a formal reliance agreement between PHS and the other institution.

If your research includes other institutions relying on Partners IRB as the cIRB, please read the Points to Consider document and complete and submit the cIRB request form. 

• Points to Consider
• cIRB Request Form
  

Setting up and maintaining a cIRB requires significant effort that is well beyond that required for routine IRB review.   The amount of work varies by the number of sites; the number of protocols and the type of research.   For PHRC to serve as the cIRB we must identify the resources required to set up the cIRB as well as to support the ongoing reviews and develop a budget.  The cost of the cIRB can then be included in your research budget.  

Any questions re: cIRBs can be directed to:  Maria Sundquist at msundquist@partners.org.