In November 2012, FDA issued the new draft guidance document titled “Guidance for IRB’s, Clinical Investigators and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed.”  Per 21 CFR 812.43, the Sponsor is responsible for selecting investigators qualified by training and experience.  However, IRBs play a role in reviewing investigator qualifications as well.  They review the investigational plan and must only approve them if they feel that risks to subjects are minimized or reasonable in relation the proposed benefits of the research being conducted.  In order to do so, they too must review the qualifications of the investigator who will be conducting the research.   An unqualified investigator equals increased risk to subjects.