Protection of Human Subjects

<RULE> CORPORATION FOR NATIONAL AND COMMUNITY SERVICE <CFR>45 CFR Part 2584</CFR> <RIN>RIN 3045-AA60</RIN> <SUBJECT>Protection of Human Subjects</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Corporation for National and Community Service. <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Corporation for National and Community Service (operating as AmeriCorps) is finalizing its adoption of the Federal Policy for Protection of Human Subjects (referred to as the Common Rule). The Common Rule outlines the basic ethical principles and procedures that an agency will abide by when conducting or sponsoring research involving human subjects. Among the procedures required by the Common Rule are use of institutional review boards (IRBs), obtaining informed consent of research subjects, and requiring submission of assurances of compliance with the rule. AmeriCorps is making the Common Rule applicable to itself, meaning that all research involving human subjects conducted, supported, or otherwise subject to regulation by AmeriCorps will be subject to the Common Rule's ethical principles and procedures. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective on November 29, 2024. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Mary Hyde, Ph.D., Director, AmeriCorps Office of Research and Evaluation, at (202) 606-6834 or <E T="03">mhyde@americorps.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <EXTRACT> <FP SOURCE="FP-2">I. Background</FP> <FP SOURCE="FP-2">II. This Final Rule</FP> <FP SOURCE="FP-2">III. Comments on and Finalization of the Proposed Rule</FP> <FP SOURCE="FP-2">IV. Regulatory Analyses</FP> <FP SOURCE="FP1-2">A. Executive Orders 12866 and 13563</FP> <FP SOURCE="FP1-2">B. Regulatory Flexibility Act</FP> <FP SOURCE="FP1-2">C. Unfunded Mandates Reform Act of 1995</FP> <FP SOURCE="FP1-2">D. Paperwork Reduction Act</FP> <FP SOURCE="FP1-2">E. Federalism (E.O. 13132)</FP> <FP SOURCE="FP1-2">F. Takings (E.O. 12630)</FP> <FP SOURCE="FP1-2">G. Civil Justice Reform (E.O. 12988)</FP> <FP SOURCE="FP1-2">H. Consultation With Indian Tribes (E.O. 13175)</FP> </EXTRACT> <HD SOURCE="HD1">I. Background</HD> On June 18, 1991, the U.S. Department of Health and Human Services (HHS) issued a rule setting forth the Common Rule requirements for the protection of human subjects. (56 FR 28003). The HHS regulations are codified at 45 CFR part 46. At that time, 15 other agencies joined HHS in adopting a uniform set of rules for the protection of human subjects, identical to subpart A of 45 CFR part 46. The basic provisions of the Common Rule include, among other things, requirements related to the review of human subjects research by an IRB, obtaining and documenting informed consent of human subjects, and submitting written assurance of institutional compliance with the Common Rule. On January 19, 2017 (82 FR 7149), HHS issued a final rule revising the Common Rule, which, among other things, established new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process. At the time the Common Rule was first adopted in 1991, AmeriCorps had just been established as the Corporation for National and Community Service under the National and Community Service Act of 1990. AmeriCorps was not a participating agency in either that 1991 Common Rule rulemaking or in the subsequent amendments to the Common Rule; however, AmeriCorps believes it is important to adopt this standard framework for AmeriCorps research professionals, prospective and participating human subjects, and consistency among Federal agencies, as described above. This final rule provides the incentives of a mandatory procedural framework and provides human research subjects the assurance of protection offered by the Common Rule. <HD SOURCE="HD1">II. Final Rule</HD> AmeriCorps is codifying the text of the revised Common Rule in its regulations at 45 CFR part 2584 (the proposed rule projected its placement at 45 CFR part 2558, but AmeriCorps has since determined that part 2584 is more appropriate given a planned improvement of chapter 25's organization). This rule is substantively identical to the HHS regulations in 45 CFR part 46, subpart A, ensuring consistency across Federal agencies. With this codification, AmeriCorps would be subject to the same ethical principles and procedures that other agencies who have adopted the Common Rule are subject to when conducting or supporting research involving human subjects. The rule applies broadly; most relevant to AmeriCorps, it covers instances when an investigator conducting research obtains information through interaction with the individual and uses, studies, or analyzes the information. The rule also sets out certain research that is exempt from the rule. For any non-exempt research, under this rule AmeriCorps would: • Conduct or support non-exempt research only if the institution engaged in the research has provided an assurance that it will comply with the Common Rule, and • Conduct or support non-exempt research only if (when required by the rule) the institution has certified to AmeriCorps that the research has been reviewed and approved by an IRB. The rule also sets out requirements applicable to the IRBs, including requirements for the IRB membership, IRB functions and operations, IRB review of research and criteria for IRB approval of research, IRB authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or has been associated with unexpected serious harm to subjects, and IRB records. The rule also sets out the requirements for investigators to obtain the legally effective informed consent of the subject before involving the subject in any non-exempt research. For example, the investigator must seek informed consent only under circumstances that provide sufficient opportunity to discuss and consider whether to participate in the research (to minimize the possibility of coercion or undue influence), and the investigator must provide the prospective subject with information a reasonable person would want to have in order to make an informed decision as to whether to participate in the research and provide the information in language understandable to the prospective subject. The rule also sets out the basic elements of what information must be provided to each prospective subject and how informed consent must be documented. AmeriCorps at times undertakes research that would be considered non-exempt research under the Common Rule. The Office of Research and Evaluation (ORE), within AmeriCorps, furthers AmeriCorps' mission by providing accurate and timely research on national service, social innovation, volunteering, and civic engagement. ORE conducts original and sponsored research and evaluations, among other activities, to infuse data into AmeriCorps' programs and contribute to the public's understanding of national service. For example, AmeriCorps surveys members/volunteers to inform recruitment and improve member/volunteer experience. ORE uses the survey responses to identify national service trends, such as trends in program participation, motivations, and outcomes. As another example, AmeriCorps sponsors evaluations of national service interventions ( <E T="03">e.g.,</E> Recovery Coach Programs, Tutoring Programs) that collect information from program participants about their experiences and outcomes. ORE staff consists of professional social scientists and research analysts who abide by their professions' codes of ethics, including but not limited to those relating to integrity, respect for people's rights, dignity, and diversity, non-exploitation, and informed consent. AmeriCorps' research is therefore already guided by these codes of ethics, and the agency typically engages in practices such as ensuring that informed consent of human subjects is properly obtained and, when supporting research is conducted by universities and other research partners, ensuring that the research is reviewed and approved by an IRB. Issuance of this rule will not result in major changes in research conducted and supported by AmeriCorps, but it will provide a more concrete framework for AmeriCorps staff to follow to ensure protection of human research subjects. While AmeriCorps may currently avail itself of the broad range of HHS guidance documents on the Common Rule, adopting the Common Rule itself will ensure that it is interpreting those guidance documents in a manner consistent with the regulatory requirements of the Common Rule. HHS guidance includes decisions charts to guide everything from the analysis of whether an activity is covered by the Common Rule to whether documentation of informed consent can be waived, frequently asked question (FAQ) documents, and various other guidance documents—all of which will assist AmeriCorps in ensuring that its research protects human subjects. AmeriCorps' adoption of the Common Rule also provides assurance to individuals who are prospective and participating human research subjects for AmeriCorps-conducted or supported research that AmeriCorps abides by the same ethical and procedural provisions that HHS and 19 other agencies do. Finally, AmeriCorps' adoption of the Common Rule will ensure consistency across agencies in their approach to protecting human subjects in research. <HD SOURCE="HD1">III. Comments on and Finalization of the Proposed Rule</HD> AmeriCorps proposed adoption of the Common Rule on September 20, 2022, at 87 FR 57435 and invited public comment on the advisability or inadvisability of adopting the Common Rule in whole or in part. In response, AmeriCorps received seven public comments on the proposed rule, all of which expressed support for the rule. Several noted th ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 89k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━