Sec. 2034. REDUCING ADMINISTRATIVE BURDEN FOR RESEARCHERS
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## SEC. 2034 REDUCING ADMINISTRATIVE BURDEN FOR RESEARCHERS **[**[42 U.S.C. 3501 note](/us/usc/t42/s3501)**]** ###
(a)Plan Preparation and Implementation of Measures To Reduce Administrative Burdens ####
(1)In general Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall— #####
(A)lead a review by research funding agencies of all regulations and policies related to the disclosure of financial conflicts of interest, including the minimum threshold for reporting financial conflicts of interest; #####
(B)make revisions, as appropriate, to harmonize existing policies and reduce administrative burden on researchers while maintaining the integrity and credibility of research findings and protections of human participants; and #####
(C)confer with the Office of the Inspector General about the activities of such office related to financial conflicts of interest involving research funding agencies. ####
(2)Considerations In updating policies under paragraph (1)(B), the Secretary shall consider— #####
(A)modifying the timelines for the reporting of financial conflicts of interest to just-in-time information by institutions receiving grant or cooperative agreement funding from the National Institutes of Health; #####
(B)ensuring that financial interest disclosure reporting requirements are appropriate for, and relevant to, awards that will directly fund research, which may include modification of the definition of the term “investigator” for purposes of the regulations and policies described in subparagraphs
(A)and
(B)of paragraph (1); and #####
(C)updating any applicable training modules of the National Institutes of Health related to Federal financial interest disclosure. ###
(b)Monitoring of Subrecipients of Funding From the National Institutes of Health The Director of the National Institutes of Health (referred to in this section as the “Director of National Institutes of Health”) shall implement measures to reduce the administrative burdens related to monitoring of subrecipients of grants by primary awardees of funding from the National Institutes of Health, which may incorporate findings and recommendations from existing and ongoing activities. Such measures may include, as appropriate— ####
(1)an exemption from subrecipient monitoring requirements, upon request from the primary awardees, provided that— #####
(A)the subrecipient is subject to Federal audit requirements pursuant to the Uniform Guidance of the Office of Management and Budget; #####
(B)the primary awardee conducts, pursuant to guidance of the National Institutes of Health, a pre-award evaluation of each subrecipient’s risk of noncompliance with Federal statutes and regulations, the conditions of the subaward, and any recurring audit findings; and #####
(C)such exemption does not absolve the primary awardee of liability for misconduct by subrecipients; and ####
(2)the implementation of alternative grant structures that obviate the need for subrecipient monitoring, which may include collaborative grant models allowing for multiple primary awardees. ###
(c)Reporting of Financial Expenditures The Secretary, in consultation with the Director of National Institutes of Health, shall evaluate financial expenditure reporting procedures and requirements for recipients of funding from the National Institutes of Health and take action, as appropriate, to avoid duplication between department and agency procedures and requirements and minimize burden to funding recipients. ###
(d)Animal Care and Use in Research Not later than 2 years after the date of enactment of this Act, the Director of National Institutes of Health, in collaboration with the Secretary of Agriculture and the Commissioner of Food and Drugs, shall complete a review of applicable regulations and policies for the care and use of laboratory animals and make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. In carrying out this effort, the Director of the National Institutes of Health shall seek the input of experts, as appropriate. The Director of the National Institutes of Health shall— ####
(1)identify ways to ensure such regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative, including with respect to inspection and review requirements by Federal agencies and accrediting associations; ####
(2)take steps to eliminate or reduce identified inconsistencies, overlap, or duplication among such regulations and policies; and ####
(3)take other actions, as appropriate, to improve the coordination of regulations and policies with respect to research with laboratory animals. ###
(e)Documentation of Personnel Expenses The Secretary shall clarify the applicability of the requirements under the Office of Management and Budget Uniform Guidance for management and certification systems adopted by entities receiving Federal research grants through the Department of Health and Human Services regarding documentation of personnel expenses, including clarification of the extent to which any flexibility to such requirements specified in such Uniform Guidance applies to entities receiving grants through the Department of Health and Human Services. ###
(f)Research Policy Board ####
(1)Establishment Not later than 1 year after the date of enactment of this Act, the Director of the Office of Management and Budget shall establish an advisory committee, to be known as the “Research Policy Board” (referred to in this subsection as the “Board”), to provide Federal Government officials with information on the effects of regulations related to Federal research requirements. ####
(2)Membership #####
(A)In general The Board shall include not more than 10 Federal members, including each of the following Federal members or their designees: ######
(i)The Administrator of the Office of Information and Regulatory Affairs of the Office of Management and Budget. ######
(ii)The Director of the Office of Science and Technology Policy. ######
(iii)The Secretary of Health and Human Services. ######
(iv)The Director of the National Science Foundation. ######
(v)The secretaries and directors of other departments and agencies that support or regulate scientific research, as determined by the Director of the Office of Management and Budget. #####
(B)Non-federal members The Board shall be comprised of not less than 9 and not more than 12 representatives of academic research institutions, other private, nonprofit research institutions, or other nonprofit organizations with relevant expertise. Such members shall be appointed by a formal process, to be established by the Director of the Office of Management and Budget, in consultation with the Federal membership, and that incorporates— ######
(i)nomination by members of the nonprofit scientific research community, including academic research institutions; and ######
(ii)procedures to fill membership positions vacated before the end of a member’s term. ####
(3)Purpose and responsibilities The Board shall make recommendations regarding the modification and harmonization of regulations and policies having similar purposes across research funding agencies to ensure that the administrative burden of such research policy and regulation is minimized to the greatest extent possible and consistent with maintaining responsible oversight of federally funded research. Activities of the Board may include— #####
(A)providing thorough and informed analysis of regulations and policies; #####
(B)identifying negative or adverse consequences of existing policies and making actionable recommendations regarding possible improvement of such policies; #####
(C)making recommendations with respect to efforts within the Federal Government to improve coordination of regulation and policy related to research; #####
(D)creating a forum for the discussion of research policy or regulatory gaps, challenges, clarification, or harmonization of such policies or regulation, and best practices; and #####
(E)conducting ongoing assessment and evaluation of regulatory burden, including development of metrics, periodic measurement, and identification of process improvements and policy changes. ####
(4)Expert subcommittees The Board may form temporary expert subcommittees, as appropriate, to develop timely analysis on pressing issues and assist the Board in anticipating future regulatory challenges, including challenges emerging from new scientific advances. ####
(5)Reporting requirements Not later than 2 years after the date of enactment of this Act, and once thereafter, the Board shall submit a report to the Director of the Office of Management and Budget, the Administrator of the Office of Information and Regulatory Affairs of the Office of Management and Budget, the Director of the Office of Science and Technology Policy, the heads of relevant Federal departments and agencies, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives containing formal recommendations on the conceptualization, development, harmonization, and reconsideration of scientific research policy, including the regulatory benefits and burdens. ####
(6)Sunset The Board shall terminate on September 30, 2021. ####
(7)GAO report Not later than 4 years after the date of enactment of this Act, the Comptroller General of the United States shall conduct an independent evaluation of the activities carried out by the Board pursuant to this subsection and submit to the appropriate committees of Congress a report regarding the results of the independent evaluation. Such report shall review and assess the Board’s activities with respect to the responsibilities described in paragraph (3).
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Sec. 2034
REDUCING ADMINISTRATIVE BURDEN FOR RESEARCHERS
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