Possible Changes to U.S. IRB Research Oversight
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
participants (1)
-
Kevin Guidry