[Air-L] Possible Changes to U.S. IRB Research Oversight

Kevin Guidry krguidry at gmail.com
Tue Jul 26 08:52:19 PDT 2011


All,

Since many of us in the U.S. tend to be critical of our institution's
Institutional Review Boards (IRBs) and their impact on our research,
it may be of interest to note that the federal government is beginning
to propose significant changes to the research oversight system.  The
New York Times has coverage here:
http://www.nytimes.com/2011/07/25/health/research/25research.html.
The full details, including the full Advanced Notice of Proposed
Rulemaking and instructions for submitting comments, can be found
here: http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html.

A quick glance at the proposed changes indicate that they might have
an impact on the work that many of us do.  For example, there is a
proposal to make exempt from IRB review "certain types of behavioral
and social science research that goes beyond using only survey
methodology, but nonetheless involves only specified minimal risk
procedures, so long as the subjects are competent adults" (p. 18).
There are also proposals related to data security, privacy, and
identifiability, with definitions derived from HIPAA.  And there
appears to be a proposal to extend IRB oversight to include all
studies at participating colleges and universities regardless of the
funding source(s) of the particular studies.

Since this process is just beginning and there are opportunities for
input, I hope that AoiR and other organizations that represent and
advise researchers are keeping abreast of these changes and offering
appropriate advice and input (ethics committee, I'm looking at you!).
And, of course, I hope that those individuals who may be impacted are
also keeping abreast of these developments and speaking up when
appropriate.


Kevin


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