by Craig Klugman, Ph.D.
Yesterday, the Department of Health & Human Services released the long-awaited, and debated, new Common Rule. Many of the proposals that were released in earlier versions for public comment did not make their way into the rule. All IRB members will also need to undergo training to incorporate the new rules into their reviews. Most of the changes have a deadline of 1 year (January 2018) for enactment.
Though many experts in research ethics will be writing on this in great detail, I offer a brief synopsis of the changes here. However, keep in mind that the incoming administration has suggested they may rollback all executive orders made by the Obama administration in its last few months, if not during the entire Obama presidency. Thus, it is possible that these rule changes are rolled back very quickly.
Who is covered?
The new rules maintain that only federally funded clinical trials must be reviewed by an IRB.
For the first time, the rules adopt a definition of Clinical Trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.” The new rules also offer separate definitions of “identifiable biospecimen” and “identifiable private information,” whereas previously, both were defined together.
Some definitions were tweaked (e.g. “private information”) and others remain unchanged (e.g. “human subject”).
Biobanking specimens and information
One of the most controversial proposed changes was that of having to gain subject consent for use of banked specimens.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.