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Posted by Shawn Kennedy on Mon, Nov 06, 2017

New Draft Guidance Released: Informed Consent Information Sheet!

It should come as no surprise that FDA has released a new draft guidance regarding informed consent.  Every year, FDAs Bioresearch Monitoring Program (BIMO) releases summative information on the results of the inspections they have conducted on their website.  The results of the inspections conducted are a yearly focus of IMARC as we try to make sense of what the FDA is most concerned with regarding the conduct of research involving human subjects.  Almost inevitably, the most frequent citation from an FDA inspection at a clinical investigation site pertains to improper or inadequate informed consent.  Given that informed consent is one of the most important parts of the research process, it makes sense in that FDA is sharing yet again their “current views” on the concept.

Topics: New Draft Guidance, Informed Consent Information Sheet, FDA

Posted by John Lehmann on Wed, Mar 04, 2015

New FDA Draft Guidance Concerning IRB Responsibilities

In November 2012, FDA issued the new draft guidance document titled “Guidance for IRB’s, Clinical Investigators and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of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.

Topics: IRB Responsibilities, New Draft Guidance, 21 CFR 812.43, 21 CFR 812.20, FDA

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