We’ll be so glad when the revised Common Rule is finally published…
…because then all the brouahaha about the revisions will finally settle down.
Ha. We are such kidders.
You may recall mention in this blog of the Notice of Proposed Rulemaking (NPRM), which the Office for Human Research Protections released to announce that it is considering revising the Common Rule. Proposed changes include requiring broad consent for future use of stored specimens, and changing some of the review categories for low-risk research projects.
It’s unknown when a final rule will be released, or what form the final rule will take. Meanwhile, the discussion about it continues unabated. The New England Journal of Medicine recently published a commentary taking the proposed rule to task. We encourage you to read it to get an idea of concerns raised about the proposed rule. The authors are well-known in the fields of bioethics and research compliance.