The new FDA draft guidance issued last during the second week of November demonstrates that FDA does not want institutional review boards (IRBs) to lose their critical role in the clinical research process. The new guidance, issued in November 2012 entitled “IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed.” A recent article from OutSourcing Pharma shares that FDA reminds IRBs that is “their responsibility to check investigator qualifications and make sure if sites are up to code.” (MacDonald) Furthermore, IRBs will have to utilize their expertise while working closely with investigators to “conduct and supervise the proposed research.” (MacDonald)
FDA shares in an interview with MacDonald that IRBs play an essential role not only with investigators but site reviews as well. There may be instances in which IRBs need “additional information in order to assess the quality of sites to ensure it can adequately execute the protocol requirements.” (MacDonald) Additionally, FDA shared it is the responsibility of the IRB to determine whether an IND or IDE is required.
To review the draft guidance, click here. To check out the full article from OutSourcing Pharma, click here.
Need help with an upcoming clinical study, an IRB review, or assistance in determining whether your research might trigger an IND or IDE FDA filing? Contact us at info@pearlirb.com.