OHRP & the Requirement for IRB Review of Registries

The Office for Human Research Protections (OHRP) recently posted correspondence with the National Health Registry in two letters dated August 11, 2011 and December 29, 2011 in hopes that the responses would be useful to sponsors, institutions, and IRBs. The correspondence relates primarily to the issue of whether various activities related to the registry require IRB review. The links below provide the full text of the letters: - See more at: http://www.quorumreview.com/ohrp-irb-review-registries/#sthash.UpYuS69f.dpufLire moins