Aiming to boost the safety and privacy of patients in clinical trials, cut red tape, and address the evolving nature of medical research, the federal government proposed several modifications to current regulations in July. Known as the Common Rule, the regulations have been in place since 1991.
Back then, studies were usually conducted at one institution. Today, most studies that enroll humans involve multiple centers, each with its own institutional review board (IRB) to approve protocols. Receiving IRB approval can take months, and addressing the suggestions of several—sometimes dozens—of boards can impede scientific discovery, researchers say. One of the proposed changes would allow a single IRB to oversee each study.
Taking that step, says Kenneth C. Anderson, MD, director of the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute, “would streamline approvals and fast-forward the time it takes to open a clinical trial.” Anderson's center alone has 25 to 30 multicenter trials under way at any given time.
Institutions that receive any federal funding would be required to follow the Common Rule for all human research. Currently, if an institution isn't receiving taxpayer dollars for a particular study, such as one underwritten by a foundation, researchers needn't abide by the regulations for that study.
In addition, given the proliferation of genomic studies, study participants would be asked if their biospecimens, such as blood and tumor samples, could be used in future research. Current rules say that archived samples can be analyzed years after collection, assuming they are stripped of information that identifies the donor. But given today's technology, “biospecimens are inherently identifiable,” notes Kathy Hudson, PhD, deputy director for science outreach and policy at the National Institutes of Health.
For details on the proposed changes, log on to www.hhs.gov/ohrp.