FDA Issues Guidance For IRBs Feb 2010


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FDA Issues Guidance for IRBs, Clinical Investigators and Sponsors on Conducting Continuing Review

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FDA Issues Guidance For IRBs Feb 2010

  1. 1. NMR News: Volume 3, Issue 2, February 2010 FDA ISSUES GUIDANCE FOR IRBS, CLINICAL INVESTIGATORS AND SPONSORS ON CONDUCTING CONTINUING REVIEW By: Latesha Richards, Marketing Coordinator February 2010 When the Food and Drug Administration (FDA) first issued the institutional review board (IRB) recommendations, back in 1981, sponsors were utilizing a single-investigator site to carry out clinical trial studies. During these studies, the investigators, being well-informed about the events taking place at their particular site, were responsible for the continuing review of the study. Since that time, investigators have been conducting studies across multi-sites, which have made continuing review more challenging because investigators and IRBs may not be privy to the collective body of data coming from all sites. The FDA is concerned at this juncture that the IRB is not fully exercising their regulatory responsibility over these sites to protect the health of human subjects involved in these investigations. In response to this problem, the FDA has issued a draft guidance last month (January 2010) intended to assist IRBs in carrying out their continued review responsibility of these multi- site studies by proposing new recommendations of criteria, process and frequency of review. For example, the FDA recommends that IRBs use either a centralized IRB or a cooperative review agreement to review collective data across multi-sites. The IRB is to review approved research at 1
  2. 2. NMR News: Volume 3, Issue 2, February 2010 least once a year from a general standpoint, but specifically determine which trials should be given more frequent review based on the study’s nature and degree of risk. Under this guidance, the IRB will also be responsible for proactively obtaining information on the study’s progress from the study sponsor. The draft guidance also includes recommendations for expedited review and how continuing review dates should be determined. These new guidelines should ensure the safety and protection of the subjects involved in clinical investigations. The guidance should also help clinical investigators and sponsors better understand their responsibilities in the continuing review process i.e. that sponsors ensure that information on the study’s progress gets reported back to an IRB, in a judicious and timely fashion. Again, the FDA guidance does not legally enforce any responsibility outlined in it. The guidance only represents FDA’s “current thinking” on the topic. This guidance is opened for comments and suggestions through the beginning of March 2010. To access the guidance, please click here. Source: fda.gov About NMR: Nutraceutical Medical Research, LLC is a premiere contract research organization dedicated to substantiating your product or ingredient claims and efficacy with clinical research. We also provide medical writing services which include brochures, literature reviews and journal publication. Our goal is to partner with natural product, cosmeceutical and pharmaceutical companies to help them establish the efficacy and safety of their products using an evidence-based approach. 2