Institution Bulletin vol 4, issue 4
Welcome to our November newsletter! This fall we’ve seen quite a bit of regulatory activity surrounding comparative effectiveness research (CER). More than half the treatments provided in the U.S. lack clear evidence that they are effective, according to the Institute of Medicine, and the government is devoting significant research resources to this area. According to a Robert Wood Johnson Foundation article, congressional stimulus spending in 2009 included $1.1 billion for CER studies, and funding under the Affordable Care Act is estimated to reach $500 million annually by 2015.
Despite these resources, the research community is scrambling to determine the appropriate regulatory parameters for CER studies. Just a few weeks ago, the Office for Human Research Protections (OHRP) released draft guidance on “Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.”
The draft guidance responds to the controversy surrounding the SUPPORT trial and concludes that informed consent must set forth the risks of a particular standard-of-care treatment as “risks of research” only if the study assigns each participant a specific version of the accepted standard-of-care to be used, and/or if a purpose of the research study is to assess a particular harm associated with the standard-of-care. Given this narrow focus, the guidance appears to extend to only a subset of CER studies. Comments on the draft guidance can be submitted by email to firstname.lastname@example.org through December 23, 2014.
Not all CER studies fall within federal jurisdiction. In early October, OHRP released correspondence that helps establish when registry research falls outside the jurisdiction of 45 CFR Part 46. The enclosed newsletter article includes an infographic designed by Quorum to illustrate the factors that determine whether federal regulations apply — I recommend it as a useful illustration for IRB members and staff.
Please contact us if we can be of further assistance. We look forward to the opportunity to work with you!
Tags: 45 CFR Part 46, Affordable Care Act, Cami-Gearhart, CER studies, Clinical Trials, draft guidance, gaming, Office for Human Research Protections, OHRP, Quorum Review IRB, regulatory oversight, SUPPORT Trial