Thursday, March 29, 2012

Central Independent Review Boards and Community Attitudes

The Food and Drug Administration (FDA) requires an Independent Review Board (IRB) to consider "community attitudes" during its review of research.  So what is the FDA's definition of "community attitude" and how can a central IRB have knowledge of a location's attitudes towards research when it reviews submissions from other cities, states or countries? 

The FDA addresses community attitudes in the Non-Local IRB Review section of the FDA Information Sheets.  "The non-local IRB should have adequate knowledge of community attitudes, information on conditions surrounding the conduct of the research, and the continuing status of the research to assure fulfilling the requirements of 21 CFR 56.107, 56.111(a)(3), (a)(7) and (b) for each study site.  The non-local IRB needs to ensure these requirements are met for each location for which it has assumed IRB oversight responsibility.  IRBs need to be knowledgeable about the community from which the participants are drawn to ensure that subject rights will be protected and that the consent process is appropriate for the subject population involved.  The IRB should be sensitive to community laws because state and local laws, as well as community attitudes pertaining to research, may be more restrictive than federal regulations or the prevailing standards of the community where the IRB is located.

No comments:

Post a Comment