Continuing Review Intervals – When Might It Need To Be More Often Than Annually?
The IRB must determine which protocols require continuing review more often than annually, as appropriate to the degree of risk and as necessary to ensure the continued protection of the rights and welfare of research subjects.  Studies with a high risk and low probability for benefit may require approval periods of greater than just once a year.  The following are examples of studies that may need additional review: 

   a.   Involvement of vulnerable populations;
b.   Research conducted internationally;
c.   The involvement of recombinant DNA or other types of gene transfer protocols;
d. The use of waiver of informed consent procedures, e.g. surrogate consent;
e.   Classified research;
f.    Research for which there is a disproportionate number or severity of SAEs;
g.   Previous suspension of the researcher due to compliance, record-keeping or other
      concerns;
h.   Recommendations from other institutional committees;
i.    Studies where there is concern that it would be difficult to protect the participants'
      privacy or the confidentiality of their information or the study results.    

Jennifer Sharp, J.D.
June 1, 2005