Washington — The federal Office for Human Research Protections has tightened its registration requirements for campus committees that review research involving human subjects. Under a final rule published in today’s Federal Register, such committees — which are commonly known as institutional review boards, or IRB’s — must register with the U.S. Department of Health and Human Services every three years.
The Office for Human Research Protections has operated a voluntary IRB-registration system since 2000. The new rule makes it mandatory, expands the range of information that must be reported, and harmonizes the registration system with that of the Food and Drug Administration.
Among other things, institutions must now report the name and mailing address of the administrator who supervises the IRB and the approximate number of research protocols that the IRB has reviewed during the previous 12 months.
If an institution fails to keep its registrations current, the Office for Human Research Protections has the authority to restrict or revoke the institution’s permission to receive federal research support.
In an interview today, the office’s director, Jerry A. Menikoff, said that the new rule should not be burdensome. “There will be one Web site, and you can register for both FDA and our system at the same time,” he said. “All of this is really designed to, to the extent possible, make things easy for everyone.”
An official with the Council on Governmental Relations, a university coalition that is often skeptical of new federal regulations, said in an e-mail message today that the rule seems fine to her. “We appreciate the efforts of OHRP and FDA to create a single system,” said Carol Blum, the council’s director of research compliance and administration.
The rule will officially take effect on July 14, and all committees must be registered by September 14. —David Glenn




