The watchdog website FDAAA TrialsTracker names and shames human studies that breach the FDA’s requirements for reporting results.
Both higher education and industry associations were advocating for a later implementation date for the Common Rule, which governs human studies.
January 23, 2018|
Last week, the US Department of Health and Human Services and 15 government agencies issued a six-month delay to proposed changes to the Common Rule—a federal policy regulating the use of human research subjects—that were set to go live last Friday (January 19). This delay, the agencies write in a statement, would provide additional time for “interested stakeholders” to provide feedback and for research institutions to prepare for the proposed changes. The new effective date for the changes is July 19.
The proposed revisions include stricter rules for informed consent, such as requirements to post brief, comprehensive study summaries at the tops of consent forms and to obtain permission to use stored, unlabeled biospecimens leftover after clinical use. They also include changes to the institutional review board (IRB) process—some studies requiring IRB review will be exempt, and work carried out at multiple institutions will require only one IRB, rather than one at each research site.
According to STAT News, the new rule would also remove pregnant women from its list of examples of “vulnerable populations,” something advocates had hoped would make research more inclusive. “Research with pregnant women is the ethical thing to do. Not doing the research is unethical,” Anne Lyerly, a physician and bioethicist at the University of North Carolina, Chapel Hill, told STAT News last December.
Both higher education and industry groups, such as the Association of American Medical Colleges and the American Medical Informatics Association (AMIA), have been pushing for a delay in order to allow institutions to prepare for the new provisions.
“The six-month compliance delay is a necessary step towards getting this critical research rule back on track after languishing for a full year,” AMIA tells FierceHealthcare in an emailed statement. “While the additional time will allow federal officials and the clinical research community to develop a coordinated implementation strategy and much-needed guidance, it will be important that Common Rule provisions meant to improve the availability of data for secondary research, while strengthening protections for research participants, proceed in a timely fashion.”