VA Research Technology Act

I 116TH CONGRESS 2D SESSION H. R. 8172 To direct the Secretary of Veterans Affairs to use accredited commercial institutional review boards to review research proposal protocols of the Department, and to establish an Office of Research Reviews in the Department of Veterans Affairs. IN THE HOUSE OF REPRESENTATIVES SEPTEMBER 4, 2020 Mrs. LURIA (for herself and Mr. BANKS) introduced the following bill; which was referred to the Committee on Veterans’ Affairs A BILL To direct the Secretary of Veterans Affairs to use accredited commercial institutional review boards to review research proposal protocols of the Department, and to establish an Office of Research Reviews in the Department of Veterans Affairs. 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 Tech- 4 nology Act’’. 5 VerDate Sep 11 2014 23:49 Sep 05, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H8172.IH H8172 pbinns on DSKJLVW7X2PROD with BILLS 2 •HR 8172 IH SEC. 2. USE BY DEPARTMENT OF VETERANS AFFAIRS OF 1 COMMERCIAL INSTITUTIONAL REVIEW 2 BOARDS IN SPONSORED RESEARCH TRIALS. 3 (a) IN GENERAL.—Not later than 90 days after the 4 date of the enactment of this Act, the Secretary of Vet- 5 erans Affairs shall complete all necessary policy revisions 6 within the directive of the Veterans Health Administration 7 numbered 1200.05 and titled ‘‘Requirements for the Pro- 8 tection of Human Subjects in Research’’, to allow spon- 9 sored clinical research of the Department of Veterans Af- 10 fairs to use accredited commercial institutional review 11 boards to review research proposal protocols of the De- 12 partment. 13 (b) IDENTIFICATION OF REVIEW BOARDS.—Not later 14 than 90 days after the completion of the policy revisions 15 under subsection (a), the Secretary shall— 16 (1) identify accredited commercial institutional 17 review boards for use in connection with sponsored 18 clinical research of the Department; and 19 (2) establish a process to modify existing ap- 20 provals in the event that a commercial institutional 21 review board loses its accreditation during an ongo- 22 ing clinical trial. 23 (c) REPORT.— 24 (1) IN GENERAL.—Not later than 90 days after 25 the completion of the policy revisions under sub- 26 VerDate Sep 11 2014 23:49 Sep 05, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H8172.IH H8172 pbinns on DSKJLVW7X2PROD with BILLS 3 •HR 8172 IH section (a), and annually thereafter, the Secretary 1 shall submit to the Committee on Veterans’ Affairs 2 of the Senate and the Committee on Veterans’ Af- 3 fairs of the House of Representatives a report on all 4 approvals of institutional review boards used by the 5 Department, including central institutional review 6 boards and commercial institutional review boards. 7 (2) ELEMENTS.—The report required by para- 8 graph (1) shall include, at a minimum, the following: 9 (A) The name of each clinical trial with re- 10 spect to which the use of an institutional review 11 board has been approved. 12 (B) The institutional review board or insti- 13 tutional review boards used in the approval 14 process for each clinical trial. 15 (C) The amount of time between submis- 16 sion and approval. 17 SEC. 3. CREATION OF OFFICE OF RESEARCH REVIEWS 18 WITHIN THE OFFICE OF INFORMATION AND 19 TECHNOLOGY OF THE DEPARTMENT OF VET- 20 ERANS AFFAIRS. 21 (a) IN GENERAL.—Not later than one year after the 22 date of the enactment of this Act, the Secretary of Vet- 23 erans Affairs shall establish within the Office of Informa- 24 tion and Technology of the Department of Veterans Af- 25 VerDate Sep 11 2014 23:49 Sep 05, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H8172.IH H8172 pbinns on DSKJLVW7X2PROD with BILLS 4 •HR 8172 IH fairs an Office of Research Reviews (in this section re- 1 ferred to as the ‘‘Office’’). 2 (b) ELEMENTS.—The Office shall do the following: 3 (1) Perform centralized security reviews and 4 complete security processes for approved research 5 sponsored outside the Department, with a focus on 6 multi-site clinical trials. 7 (2) Develop and maintain a list of commercially 8 available software preferred for use in sponsored 9 clinical trials of the Department and ensure such list 10 is maintained as part of the official approved soft- 11 ware products list of the Department. 12 (3) Develop benchmarks for appropriate 13 timelines for security reviews conducted by the Of- 14 fice. 15 (c) REPORT.— 16 (1) IN GENERAL.—Not later than one year 17 after the establishment of the Office, the Office shall 18 submit to the Committee on Veterans’ Affairs of the 19 Senate and the Committee on Veterans’ Affairs of 20 the House of Representatives a report on the activity 21 of the Office. 22 (2) ELEMENTS.—The report required by para- 23 graph (1) shall include the following: 24 VerDate Sep 11 2014 23:49 Sep 05, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H8172.IH H8172 pbinns on DSKJLVW7X2PROD with BILLS 5 •HR 8172 IH (A) The number of security reviews com- 1 pleted. 2 (B) The number of personnel assigned for 3 performing the functions described in sub- 4 section (b). 5 Æ VerDate Sep 11 2014 23:49 Sep 05, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H8172.IH H8172 pbinns on DSKJLVW7X2PROD with BILLS