The current federal regulations governing human subjects research oversight – called the Common Rule – have remained essentially the same for twenty years. Today the Department of Health and Human Services (HHS) announced a proposed rule changing those regulations (H/T ScienceInsider). The announcement also signaled the beginning of a public comment period that will close on September 26, 2011. HHS is encouraging submissions via regulations.gov.
This table from HHS summarizes the changes the proposed new rule would make to the Common Rule. The changes fall into two main categories. Many changes seek to reflect changes in technology over the last twenty years, and the implications of those changes on human subjects research. For instance, individual samples that could be rendered ‘de-identified’ by stripping relevant information back in the 1990s could be used without consent, in part because they could not then be tracked back to the individual donor. Advances in both genomics and information technology make that much harder to do, and as a safeguard, donor consent will be required. Data security requirements would be strengthened as well.
The other major category of changes focuses on streamlining the management and administration of clinical trials (Given its current work on clinical trial practices, I suspect the Bioethics Commission has either weighed in on the proposed changes, or will during the course of this rulemaking.) Large research projects that currently require multiple reporting of adverse events or multiple Institutional Review Board (IRB) approval due to using multiple sites would find these requirement centralized. Consent forms would also be streamlined.
What research would be covered by the proposed rule would change as well. Currently it is limited to studies funded by certain federal agencies or involve devices that would be regulated by the Food and Drug Administration (assuming they fit other requirements as well). The scope would be expanded to all research – independent of funding source – conducted by any U.S. institution that supports any research involving human subjects that is funded by an agency currently subject to the Common Rule.
There’s a lot to digest here, and this first comment period is not the end of the process. HHS will review the comments, and likely issue a revised rule. Outreach to stakeholder groups (including the public) will likely occur as well. The revisions are overdue, but a speedy process to correct prior slowness could lead to less effective changes.