The updated final version of the Common Rule was made available for review Wednesday, January 18, with its publication in the Federal Register slated for Thursday, January 19. The Common Rule, you no doubt recall, is the federal regulation setting the basic requirements for the protection of human subjects in research. A proposal to revise the final rule has been kicking around since 2011, and earlier drafts contained some provisions that would have departed significantly from the way we currently do things. Some of the more contentious proposals do not appear in the Final Rule. However, the revisions will indeed means some changes in the way things are done around here. Most parts of the final rule are slated to take effect in 2018.
We are still reviewing the new Final Rule and figuring out exactly what it all means for us. Some resources to get you started include:
A Department of Health and Human Services press release summarizes some of the highlights and includes a link to the final rule text.
We’ve already found one free webinar describing the changes. You can register even if the time doesn’t work for you; registration will get you access to a recording after the presentation.
We’ll continue to keep you posted regarding changes in how the UAMS IRB does things as a result of this new rule.