The Importance of Proposed Changes in the “Common Rule” for ­Clinical and Translational Researchers

and Human Services (HHS) released an Advanced Notice of Proposed Rule Making (ANPRM) changes in the “Common Rule,” entitled, “Human Subjects Research Protections: enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators.” Th e enhancements were proposed to “...ensure the highest standards of protections for human subjects involved in research, while enhancing eff ectiveness of oversight.” Despite the seeming opacity of the announcement to many, and its arcane target, the procedures for protecting human research subjects, this represents a major event for clinical and translational researchers. Th e Society for Clinical and Translational Science, accordingly, will have weighed in on these changes before the deadline for comment, October 26, 2011. Once the rules have been revised, there will be another chance for comment, and all members of the translational science community should take the opportunity to weigh in on the changes if they have not already done so. We all endorse vigorous protections of research participants. Aft er a history of lack of reliable protections over the past several decades, research regulations and practices have improved signifi cantly. In 1974, HHS human subject protection regulations were fi rst issued based on statutory authority under the Code of Federal Regulations (CFR) as 45 CFR, part 46. In 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research published “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” known as the Belmont Report. It identifi ed the three fundamental ethical principles that are oft en cited as the basis for human subject research: respect for persons, benefi cence, and justice. Th e current HHS regulations include fi ve subparts, of which Subpart A (which specifi es the basic set of protections for all human subjects of research conducted or supported by HHS) and Subpart E, (which requires registration of institutional review boards [IRBs] for human research studies) are most relevant to clinical research. In 1991, 15 federal departments and agencies together issued the “Federal Policy for the Protection of Human Research Subjects,” known as the “Common Rule” based on the HHS 45 CFR part 46 Subpart A, providing identical language in the regulations of those departments and agencies, and technical amendments were made in 2005. The changes now proposed by HHS are designed to strengthen protections for human research subjects. (Th e full ANPRM can be seen at http://www.hhs.gov/ohrp , and additional information can be found at http://www.hhs.gov/ohrp/ humansubjects/anprm2011page.html . Particularly helpful is a table of comparison between the current rules and the changes being considered at http://www.hhs.gov/ohrp/humansubjects/ anprmchangetable.html .) Some of the issues on which comments were invited included: (1) Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk. (2) Using a single IRB review for all domestic sites of multisite studies. (3) Updating the forms and processes used for informed consent. (4) Establishing mandatory data security and information protection standards for all studies involving identifi able or potentially identifi able data. (5) Implementing a systematic approach to the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonize the complicated array of defi nitions and reporting requirements, and to make the collection of data more effi cient. (6) Extending federal regulatory protections to apply to all research conducted at US institutions receiving funding from the Common Rule agencies. (7) Providing uniform guidance on federal regulations.