Federal Register /Vol. 82, No. 12/Thursday, January …

1 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 7149. DEPARTMENT OF HOMELAND NATIONAL SCIENCE FOUNDATION III. Definitions for Purposes of this Policy SECURITY ( ). 45 CFR Part 690 IV. Ensuring Compliance with this Policy 6 CFR Part 46 ( ). V. Exempt Research ( ). DEPARTMENT OF TRANSPORTATION VI. Protection of Identifiable Private DEPARTMENT OF AGRICULTURE Information and Identifiable 49 CFR Part 11 Biospecimens 7 CFR Part 1c VII. IRB Membership and Modification to Federal Policy for the Protection of References to Vulnerability DEPARTMENT OF ENERGY Human Subjects ( (a), (a)(3), and (b)). AGENCY: Department of Homeland VIII. IRB Functions and Operations 10 CFR Part 745 Security; Department of Agriculture; ( ). Department of Energy; National IX.

2 IRB Review of Research ( ). NATIONAL AERONAUTICS AND Aeronautics and Space Administration; X. Expedited Review Procedures ( ). SPACE ADMINISTRATION Department of Commerce; Social XI. Criteria for IRB Approval of Research Security Administration; Agency for ( ). 14 CFR Part 1230 International Development; Department XII. Cooperative Research ( ). of Housing and Urban Development; XIII. IRB Records ( ). Department of Labor; Department of XIV. General Requirements for Informed DEPARTMENT OF COMMERCE Consent ( ). Defense; Department of Education;. XV. Documentation of Informed Consent 15 CFR Part 27 Department of Veterans Affairs; ( ). Environmental Protection Agency; XVI. Applications and Proposals Lacking SOCIAL SECURITY ADMINISTRATION Department of Health and Human Definite Plans for Involvement of Human Services; National Science Foundation; Subjects ( ).

3 20 CFR Part 431 and Department of Transportation. XVII. Research Undertaken Without the ACTION: Final rule. Intention of Involving Human Subjects ( ). AGENCY FOR INTERNATIONAL SUMMARY: The departments and agencies XVIII. Conditions ( ). DEVELOPMENT listed in this document announce XIX. Regulatory Impact Analyses revisions to modernize, strengthen, and XX. Environmental Impact 22 CFR Part 225 XXI. Paperwork Reduction Analysis make more effective the Federal Policy XXII. Tribal Consultation Statement for the Protection of Human Subjects Final Regulatory Text DEPARTMENT OF HOUSING AND that was originally promulgated as a URBAN DEVELOPMENT Common Rule in 1991. This final rule Executive Summary is intended to better protect human Purpose of the Regulatory Action 24 CFR Part 60 subjects involved in research, while facilitating valuable research and Individuals who are the subjects of DEPARTMENT OF LABOR reducing burden, delay, and ambiguity research may be asked to contribute for investigators.

4 These revisions are an their time and assume risk to advance 29 CFR Part 21 effort to modernize, simplify, and the research enterprise, which benefits enhance the current system of oversight. society at large. Federal regulations DEPARTMENT OF DEFENSE DATES: This rule is effective on January governing the protection of human 19, 2018. The compliance date for this subjects in research have been in 32 CFR Part 219 rule, except for (b) existence for more than three decades. (cooperative research), is January 19, The Department of Health, Education, 2018. The compliance date for and Welfare first published regulations DEPARTMENT OF EDUCATION. (b) (cooperative research) is for the protection of human subjects in January 20, 2020. 1974, and the Department of Health and 34 CFR Part 97.

5 ADDRESSES: Jerry Menikoff, , , Human Services (HHS) revised them in OHRP, 1101 Wootton Parkway, Suite the early 1980s. During the 1980s, HHS. DEPARTMENT OF VETERANS began a process that eventually led to AFFAIRS 200, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Jerry the adoption of a revised version of the Menikoff, , , Office for Human regulations by 15 Federal 38 CFR Part 16 departments and agencies in 1991. The Research Protections (OHRP), Department of Health and Human purpose of this effort was to promote ENVIRONMENTAL PROTECTION uniformity, understanding, and Services, 1101 Wootton Parkway, Suite AGENCY compliance with human subject 200, Rockville, MD 20852; telephone: 240 453 6900 or 1 866 447 4777; protections as well as to create a 40 CFR Part 26 facsimile: 301 402 2071; email: uniform body of regulations across Federal departments and agencies DEPARTMENT OF HEALTH AND (subpart A of 45 Code of Federal mstockstill on DSK3G9T082 PROD with RULES6.)

6 SUPPLEMENTARY INFORMATION: HUMAN SERVICES Regulations [CFR] part 46), often Preamble referred to as the Common Rule'' or 45 CFR Part 46 Executive Summary Protection of Human Subjects I. The Rationale for Modernizing the Regulations.'' Those regulations were RIN 0937 AA02 Common Rule last amended in 2005, and have II. To What Does This Policy Apply? Scope remained unchanged until the issuance and Applicability of the Regulations of this final rule. VerDate Sep<11>2014 00:33 Jan 19, 2017 Jkt 241001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 E:\FR\FM\ 19 JAR6. 7150 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations Since the Common Rule was Summary of the Major Changes in the conducting the research on promulgated, the volume and landscape Final Rule nonidentified information and of research involving human subjects The final rule differs in important nonidentified biospecimens, having an have changed considerably.

7 Research ways from the NPRM. Most institutional review board (IRB) waive with human subjects has grown in scale significantly, several proposals are not the requirement for informed consent, and become more diverse. Examples of being adopted: or obtaining consent for a specific study. developments include: an expansion in The final rule does not adopt the Establishes new exempt categories the number and types of clinical trials, proposal to require that research of research based on their risk profile. as well as observational studies and involving nonidentified biospecimens Under some of the new categories, cohort studies; a diversification of the be subject to the Common Rule, and that exempt research would be required to types of social and behavioral research consent would need to be obtained in undergo limited IRB review to ensure being used in human subjects research; order to conduct such research.

8 That there are adequate privacy increased use of sophisticated analytic To the extent some of the NPRM safeguards for identifiable private techniques to study human proposals relied on standards that had information and identifiable biospecimens; and the growing use of not yet been proposed, the final rule biospecimens. electronic health data and other digital either does not adopt those proposals or Creates a requirement for includes revisions to eliminate such based institutions engaged in records to enable very large datasets to reliance. cooperative research to use a single IRB. be rapidly analyzed and combined in The final rule does not expand the novel ways. Yet these developments for that portion of the research that takes policy to cover clinical trials that are not place within the United States, with have not been accompanied by major federally funded.

9 Certain exceptions. This requirement change in the human subjects research The final rule does not adopt the becomes effective 3 years after oversight system, which has remained proposed new concept of excluded'' publication of the final rule. largely unaltered over the past two activities. Generally, activities proposed Removes the requirement to decades. to be excluded are now either described conduct continuing review of ongoing On July 26, 2011, the Office of the as not satisfying the definition of what research for studies that undergo Secretary of HHS, in coordination with constitutes research under the expedited review and for studies that the Executive Office of the President's regulations or are classified as exempt. have completed study interventions and Office of Science and Technology Policy The proposed revisions to the are merely analyzing study data or (OSTP), published an advance notice of exemption categories have been involve only observational follow up in modified to better align with the long- proposed rulemaking (ANPRM) to conjunction with standard clinical care.

10 Standing ordering in the final rule. The request comment on how current Other minor changes have been to final rule does not include the proposed regulations for protecting those who improve the rule and for purposes of requirement that exemption participate in research might be determinations need to be made in clarity and accuracy. modernized and revised to be more specified ways. Estimated Costs and Benefits The final rule does not include the On September 8, 2015, HHS and 15 proposed standardized privacy Table 1 summarizes the quantified other Federal departments and agencies safeguards for identifiable private and nonquantified benefits and costs of published a Notice of Proposed information and identifiable all changes to the Common Rule. Over Rulemaking (NPRM) proposing biospecimens.