The Department of Health and Human Service’s (HHS) Office for Human Research Protections on March 15 clarified how to meet the latest requirements, which took effect in January. The new regulations, updated for the first time since 1991, required clinical trials to publicly post the consent forms but didn’t specify how researchers can demonstrate compliance.
The federal standards to protect research volunteers from undue harm, known as the Common Rule, apply to human subjects research at almost 20 federal agencies, including the National Institutes of Health (NIH). Many of the changes to the requirements were to accommodate a transition from single investigators conducting research at one institution to a more global, collaborative approach involving many investigators at multiple institutions.
Institutions that violate the Common Rule could have all federally funded research suspended. But the HHS office rarely takes such extreme measures, reserving it for situations such as Johns Hopkins University in 2001 after Ellen Roche, a 24-year-old healthy volunteer, died in an asthma study.
Selected information in the "Pharmaceutical Science Update" is compiled from summaries and articles from Bloomberg BNA.