In January 2017, the U.S. Department of Health and Human Services and 15 other federal agencies published its final revision of the Common Rule to protect the rights of clinical research patient volunteers. The Common Rule is also known as the Federal Policy for the Protection of Human Subjects. It was published in 1991 and was heavily based on the Belmont Report.
The Common Rule was codified into 15 separate regulations (45 CFR part 46), with each agency having Code of Federal Regulations [CFR] section numbers and language identical to the HHS codification at 45 CFR part 46, subpart A. Essentially, 45 CFR part 46 was made up of 4 subparts: subpart A known as the Common Rule; subpart B, which provided additional protections for pregnant women, fetuses, and newborns; subpart C, which provided extra protections for prisoners; and subpart D, which provided supplementary protections for children.
Prior to publishing the revised Final Rule on January 18, 2017, the Department of Health and Human Services and the other federal agencies published a Notice of Proposed Rulemaking (NPRM) in the federal register on September 8, 2015. The NPRM proposed modifying the informed consent process to better reflect its commitment to patient volunteer rights. It also proposed enhancing the efficacy of the IRB (Institutional Review Board) oversight system. The adoption of many NPRM proposals led to the creation of the Final Rule, which will go into effect in 2018. The Final Rule’s most important provisions are:
- The requirement to provide potential research subjects with more informative consent forms that explain the scope of a trial, including its potential risks and benefits. With an enhanced informed consent process, patient volunteers are positioned to make better decisions about their participation in clinical trials.
- The requirement that multi-institutional research trials in the United States use a single institutional review board (IRB). However, in modifications to the NPRM proposals, broad groups of studies will now be removed from this requirement.
- The adoption of a broad consent process, which gives a patient volunteer the right to grant secondary research use of identifiable private information and identifiable biospecimens. Broad consent allows patient volunteers to decide whether their biological specimens can be used for future research purposes and the extent to which they will engage in succeeding clinical trials. The Department of Health and Human Services hopes that this transparent process will mitigate the high level of public distrust regarding clinical research trials. The Final Rule, however, keeps in place the right of research organizations to use non-identified stored data or biospecimens without consent.
- The adoption of limited IRB reviews for lower-risk studies. This new practice will reduce the regulatory burdens on research organizations and allow IRBs to focus on higher-risk studies.
- The discontinuation of research studies that contribute little to the protection of patient volunteers.
- The requirement for specific, federally-funded clinical trial consent forms to be published on public websites.
- The requirement for specific trials to be registered with the federal government and for results to be submitted to ClinicalTrials.gov.
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