VA Research Approval Efficiency Act of 2020

II 116TH CONGRESS 2D SESSION S. 3224 To require the Secretary of Veterans Affairs to allow for the use of commercial institutional review boards for research, and for other purposes. IN THE SENATE OF THE UNITED STATES JANUARY 21, 2020 Mr. CASSIDY (for himself and Mr. TESTER) introduced the following bill; which was read twice and referred to the Committee on Veterans’ Affairs A BILL To require the Secretary of Veterans Affairs to allow for the use of commercial institutional review boards for research, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘VA Research Approval 4 Efficiency Act of 2020’’. 5 SEC. 2. USE BY DEPARTMENT OF VETERANS AFFAIRS OF 6 COMMERCIAL INSTITUTIONAL REVIEW 7 BOARDS IN SPONSORED RESEARCH TRIALS. 8 (a) IN GENERAL.—Not later than 90 days after the 9 date of the enactment of this Act, the Secretary of Vet- 10 VerDate Sep 11 2014 05:58 Jan 22, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3224.IS S3224 kjohnson on DSK79L0C42PROD with BILLS 2 •S 3224 IS erans Affairs shall complete all necessary policy revisions 1 within the directive of the Veterans Health Administration 2 numbered 1200.05 and titled ‘‘Requirements for the Pro- 3 tection of Human Subjects in Research’’, to allow spon- 4 sored clinical research of the Department of Veterans Af- 5 fairs to use accredited commercial institutional review 6 boards to review research proposal protocols of the De- 7 partment. 8 (b) IDENTIFICATION OF REVIEW BOARDS.—Not later 9 than 90 days after the completion of the policy revisions 10 under subsection (a), the Secretary shall— 11 (1) identify accredited commercial institutional 12 review boards for use in connection with sponsored 13 clinical research of the Department; and 14 (2) establish a process to modify existing ap- 15 provals in the event that a commercial institutional 16 review board loses its accreditation during an ongo- 17 ing clinical trial. 18 (c) REPORT.— 19 (1) IN GENERAL.—Not later than 90 days after 20 the completion of the policy revisions under sub- 21 section (a), and annually thereafter, the Secretary 22 shall submit to the Committee on Veterans’ Affairs 23 of the Senate and the Committee on Veterans’ Af- 24 fairs of the House of Representatives a report on all 25 VerDate Sep 11 2014 05:58 Jan 22, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3224.IS S3224 kjohnson on DSK79L0C42PROD with BILLS 3 •S 3224 IS approvals of institutional review boards, including 1 central institutional review boards and commercial 2 institutional review boards. 3 (2) ELEMENTS.—The report required by para- 4 graph (1) shall include, at a minimum, the following: 5 (A) The name of each clinical trial with re- 6 spect to which the use of an institutional review 7 board has been approved. 8 (B) The institutional review board or insti- 9 tutional review boards used in the approval 10 process for each clinical trial. 11 (C) The amount of time between submis- 12 sion and approval. 13 SEC. 3. CREATION OF OFFICE OF RESEARCH REVIEWS 14 WITHIN THE OFFICE OF INFORMATION AND 15 TECHNOLOGY OF THE DEPARTMENT OF VET- 16 ERANS AFFAIRS. 17 (a) IN GENERAL.—Not later than one year after the 18 date of the enactment of this Act, the Secretary of Vet- 19 erans Affairs shall establish within the Office of Informa- 20 tion and Technology of the Department of Veterans Af- 21 fairs an Office of Research Reviews (in this section re- 22 ferred to as the ‘‘Office’’). 23 (b) ELEMENTS.—The Office shall do the following: 24 VerDate Sep 11 2014 05:58 Jan 22, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3224.IS S3224 kjohnson on DSK79L0C42PROD with BILLS 4 •S 3224 IS (1) Perform centralized security reviews and 1 complete security processes for approved research 2 sponsored outside the Department, with a focus on 3 multi-site clinical trials. 4 (2) Develop and maintain a list of commercially 5 available software preferred for use in sponsored 6 clinical trials of the Department and ensure such list 7 is maintained as part of the official approved soft- 8 ware products list of the Department. 9 (3) Develop benchmarks for appropriate 10 timelines for security reviews conducted by the Of- 11 fice. 12 (c) REPORT.— 13 (1) IN GENERAL.—Not later than one year 14 after the establishment of the Office, the Office shall 15 submit to the Committee on Veterans’ Affairs of the 16 Senate and the Committee on Veterans’ Affairs of 17 the House of Representatives a report on the activity 18 of the Office. 19 (2) ELEMENTS.—The report required by para- 20 graph (1) shall include the following: 21 (A) The number of security reviews com- 22 pleted. 23 VerDate Sep 11 2014 05:58 Jan 22, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3224.IS S3224 kjohnson on DSK79L0C42PROD with BILLS 5 •S 3224 IS (B) The number of personnel assigned for 1 performing the functions described in sub- 2 section (b). 3 Æ VerDate Sep 11 2014 05:58 Jan 22, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\S3224.IS S3224 kjohnson on DSK79L0C42PROD with BILLS