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
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In response to this problem, the FDA has issued a draft guidance last month (January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
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 The draft guidance also includes recommendations for expedited review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.
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