38 U.S.C. § 7306 — Office of the Under Secretary for Health

Page 1162 TITLE 38—VETERANS’ BENEFITS § 7304 ‘‘(2) establish a process to modify existing approv- als in the event that a commercial institutional re- view board loses its accreditation during an ongoing clinical trial. ‘‘(c) REPORT.— ‘‘(1) IN GENERAL.—Not later than 90 days after the completion of the policy revisions under subsection (a), and annually thereafter, the Secretary shall sub- mit to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives a report on all approvals of institutional review boards used by the Department, including central institutional review boards and commercial institutional review boards. ‘‘(2) ELEMENTS.—The report required by paragraph (1) shall include, at a minimum, the following: ‘‘(A) The name of each clinical trial with respect to which the use of an institutional review board has been approved. ‘‘(B) The institutional review board or institu- tional review boards used in the approval process for each clinical trial. ‘‘(C) The amount of time between submission and approval.’’ APPLICABILITY TO FISCAL YEAR 2002 Pub. L. 107–135, title II, § 205(b), Jan. 23, 2002, 115 Stat. 2460, related to transfer of appropriations for fiscal year 2002 to carry out subsec. (e) of this section for that fis- cal year. POST-TRAUMATIC STRESS DISORDER RESEARCH Pub. L. 102–405, title I, § 122(a), Oct. 9, 1992, 106 Stat. 1981, provided that: ‘‘In carrying out research and awarding grants under chapter 73 of title 38, United States Code, the Secretary shall assign a high priority to the conduct of research on mental illness, including research regarding (1) post-traumatic stress disorder, (2) post-traumatic stress disorder in association with substance abuse, and (3) the treatment of those dis- orders.’’ RESEARCH RELATING TO WOMEN VETERANS’ HEALTH Pub. L. 102–585, title I, § 109, Nov. 4, 1992, 106 Stat. 4948, provided for initiation and expansion of research relating to health of women veterans and authorization of appropriations for fiscal years 1993 through 1995 to carry out such studies, prior to repeal by Pub. L. 103–452, title I, § 102(b)(2), Nov. 2, 1994, 108 Stat. 4786. § 7304. Regulations (a) Unless specifically otherwise provided, the Under Secretary for Health shall prescribe all regulations necessary to the administration of the Veterans Health Administration, including regulations relating to— (1) travel, transportation of household goods and effects, and deductions from pay for quar- ters and subsistence; and (2) the custody, use, and preservation of the records, papers, and property of the Adminis- tration. (b) Regulations prescribed by the Under Sec- retary for Health are subject to the approval of the Secretary. (Added Pub. L. 102–40, title IV, § 401(a)(3), May 7, 1991, 105 Stat. 212; amended Pub. L. 102–405, title III, § 302(c)(1), Oct. 9, 1992, 106 Stat. 1984.) Editorial Notes AMENDMENTS 1992—Pub. L. 102–405 substituted ‘‘Under Secretary for Health’’ for ‘‘Chief Medical Director’’ in subsecs. (a) and (b). § 7305. Divisions of Veterans Health Administra- tion The Veterans Health Administration shall in- clude the following: (1) The Office of the Under Secretary for Health. (2) A Medical Service. (3) A Dental Service. (4) A Podiatric Service. (5) An Optometric Service. (6) A Nursing Service. (7) A Readjustment Counseling Service. (8) Such other professional and auxiliary services as the Secretary may find to be nec- essary to carry out the functions of the Ad- ministration. (Added Pub. L. 102–40, title IV, § 401(a)(3), May 7, 1991, 105 Stat. 212; amended Pub. L. 102–405, title III, § 302(c)(1), Oct. 9, 1992, 106 Stat. 1984; Pub. L. 112–239, div. A, title VII, § 728(c), Jan. 2, 2013, 126 Stat. 1813.) Editorial Notes AMENDMENTS 2013—Pars. (7), (8). Pub. L. 112–239 added par. (7) and redesignated former par. (7) as (8). 1992—Par. (1). Pub. L. 102–405 substituted ‘‘Under Sec- retary for Health’’ for ‘‘Chief Medical Director’’. § 7306. Office of the Under Secretary for Health (a) The Office of the Under Secretary for Health shall consist of the following: (1) The Deputy Under Secretary for Health, who shall be the principal assistant of the Under Secretary for Health and who shall be a qualified doctor of medicine. (2) The Associate Deputy Under Secretary for Health, who shall be an assistant to the Under Secretary for Health and the Deputy Under Secretary for Health and who shall be a qualified doctor of medicine. (3) Not to exceed eight Assistant Under Sec- retaries for Health. (4) Such Medical Directors as may be ap- pointed to suit the needs of the Department, who shall be either a qualified doctor of medi- cine or a qualified doctor of dental surgery or dental medicine. (5) A Director of Nursing Service, who shall be a qualified registered nurse and who shall be responsible to, and report directly to, the Under Secretary for Health for the operation of the Nursing Service. (6) A Director of Pharmacy Service, a Direc- tor of Dietetic Service, and a Director of Opto- metric Service, who shall be responsible to the Under Secretary for Health for the operation of their respective Services. (7) Such directors of such other professional or auxiliary services as may be appointed to suit the needs of the Department, who shall be responsible to the Under Secretary for Health for the operation of their respective services. (8) The Director of the National Center for Preventive Health, who shall be responsible to the Under Secretary for Health for the oper- ation of the Center. (9) The Director of Physician Assistant Serv- ices, who shall— Page 1163 TITLE 38—VETERANS’ BENEFITS § 7306 (A) serve in a full-time capacity at the Central Office of the Department; (B) be a qualified physician assistant; and (C) be responsible and report directly to the Chief Patient Care Services Officer of the Veterans Health Administration on all matters relating to the education and train- ing, employment, appropriate use, and opti- mal participation of physician assistants within the programs and initiatives of the Administration. (10) A Podiatric Medical Director, who shall be a qualified doctor of podiatric medicine and who shall be responsible to the Under Sec- retary for Health for the operation of the Podiatric Service. (11) The Chief Officer of Women’s Health. (12) Such other personnel as may be author- ized by this chapter. (b) Appointments under subsection (a) shall be made by the Secretary. In the case of appoint- ments under paragraphs (1), (2), (3), (4), (8), and (10) of that subsection, such appointments shall be made upon the recommendation of the Under Secretary for Health. (c) Except as provided in subsection (d)— (1) any appointment under this section shall be for a period of four years, with reappoint- ment permissible for successive like periods, (2) any such appointment or reappointment may be extended by the Secretary for a period not in excess of three years, and (3) any person so appointed or reappointed or whose appointment or reappointment is ex- tended shall be subject to removal by the Sec- retary for cause. (d)(1) The Secretary may designate a member of the Chaplain Service of the Department as Di- rector, Chaplain Service, for a period of two years, subject to removal by the Secretary for cause. Redesignation under this subsection may be made for successive like periods or for any period not exceeding two years. (2) A person designated as Director, Chaplain Service, shall at the end of such person’s period of service as Director revert to the position, grade, and status which such person held imme- diately before being designated Director, Chap- lain Service, and all service as Director, Chap- lain Service, shall be creditable as service in the former position. (e) In organizing the Office and appointing per- sons to positions in the Office, the Under Sec- retary shall ensure that— (1) the Office is staffed so as to provide the Under Secretary, through a designated clini- cian in the appropriate discipline in each in- stance, with expertise and direct policy guid- ance on— (A) unique programs operated by the Ad- ministration to provide for the specialized treatment and rehabilitation of disabled vet- erans (including blind rehabilitation, care of spinal cord dysfunction, mental illness, and long-term care); and (B) the programs established under section 1712A of this title; and (2) with respect to the programs established under section 1712A of this title, a clinician with appropriate expertise in those programs is responsible to the Under Secretary for the management of those programs. (f) For purposes of applying any provision of chapter 74 of this title, including sections 7404, 7410, and 7421, or any other provision of law, the Secretary may treat any appointment for a posi- tion under this chapter to be an appointment under this section. (Added Pub. L. 102–40, title IV, § 401(a)(3), May 7, 1991, 105 Stat. 212; amended Pub. L. 102–405, title II, § 205, title III, § 302(c)(1), Oct. 9, 1992, 106 Stat. 1983, 1984; Pub. L. 102–585, title V, § 511(b), Nov. 4, 1992, 106 Stat. 4956; Pub. L. 103–446, title XII, § 1201(c)(3), Nov. 2, 1994, 108 Stat. 4683; Pub. L. 104–262, title III, § 344, Oct. 9, 1996, 110 Stat. 3207; Pub. L. 106–419, title II, § 206, Nov. 1, 2000, 114 Stat. 1842; Pub. L. 107–135, title I, § 131, Jan. 23, 2002, 115 Stat. 2454; Pub. L. 111–163, title V, § 514(a), May 5, 2010, 124 Stat. 1165; Pub. L. 116–315, title V, § 5101(a), Jan. 5, 2021, 134 Stat. 5022; Pub. L. 117–96, § 1(a), Mar. 14, 2022, 136 Stat. 34; Pub. L. 117–168, title IX, § 906(d), Aug. 10, 2022, 136 Stat. 1813; Pub. L. 118–210, title I, § 141, Jan. 2, 2025, 138 Stat. 2744.) Editorial Notes AMENDMENTS 2025—Pub. L. 118–210 redesignated subsecs. (c) to (g) as (b) to (f), respectively, substituted ‘‘subsection (d)’’ for ‘‘subsection (e)’’ in introductory provisions of sub- sec. (c), and struck out former subsec. (b) which related to the Assistant Under Secretaries for Health ap- pointed under subsec. (a)(3). 2022—Subsec. (a)(6). Pub. L. 117–96, § 1(a)(1)(A), struck out ‘‘a Director of Podiatric Service,’’ after ‘‘a Director of Dietetic Service,’’. Subsec. (a)(10), (11). Pub. L. 117–96, § 1(a)(1)(B), (C), added par. (10) and redesignated former par. (10), relat- ing to Chief Officer of Women’s Health, as (11). Another par. (11), relating to such other personnel as may be au- thorized by this chapter, subsequently redesignated (12). Subsec. (a)(12). Pub. L. 117–168, § 906(d)(1), redesig- nated par. (11) relating to such other personnel as may be authorized by this chapter as (12). Subsec. (b)(1). Pub. L. 117–96, § 1(a)(2), inserted ‘‘podiatric medicine,’’ after ‘‘doctors of medicine,’’. Subsec. (c). Pub. L. 117–96, § 1(a)(3), substituted ‘‘(8), and (10)’’ for ‘‘and (8)’’. Subsec. (g). Pub. L. 117–168, § 906(d)(2), added subsec. (g). 2021—Subsec. (a)(10), (11). Pub. L. 116–315 added par. (10) and redesignated former par. (10) as (11). 2010—Subsec. (a)(9). Pub. L. 111–163 added par. (9) and struck out former par. (9) which read as follows: ‘‘The Advisor on Physician Assistants, who shall be a physi- cian assistant with appropriate experience and who shall advise the Under Secretary for Health on all mat- ters relating to the utilization and employment of phy- sician assistants in the Administration.’’ 2002—Subsec. (a)(5). Pub. L. 107–135 inserted ‘‘, and re- port directly to,’’ after ‘‘responsible to’’. 2000—Subsec. (a)(9), (10). Pub. L. 106–419 added par. (9) and redesignated former par. (9) as (10). 1996—Subsec. (f). Pub. L. 104–262 added subsec. (f). 1994—Subsec. (a)(3). Pub. L. 103–446, § 1201(c)(3)(A)(i), substituted ‘‘Assistant Under Secretaries for Health’’ for ‘‘Assistant Chief Medical Directors’’. Pars. (7) to (9). Pub. L. 103–446, § 1201(c)(3)(A)(ii)–(iv), redesignated par. (8), relating to such directors, as (7), par. (7) as (8), and par. (8), relating to such other per- sonnel, as (9), and in par. (8), as so redesignated, sub- stituted ‘‘Under Secretary for Health’’ for ‘‘Chief Med- ical Director’’. Page 1164 TITLE 38—VETERANS’ BENEFITS § 7307 Subsec. (b). Pub. L. 103–446, § 1201(c)(3)(B), substituted ‘‘Assistant Under Secretaries for Health’’ for ‘‘Assist- ant Chief Medical Directors’’. Subsec. (c). Pub. L. 103–446, § 1201(c)(3)(C), substituted ‘‘and (8)’’ for ‘‘and (7)’’. 1992—Pub. L. 102–405, § 302(c)(1), substituted ‘‘Under Secretary for Health’’ for ‘‘Chief Medical Director’’ in section catchline. Subsec. (a). Pub. L. 102–405, § 302(c)(1), substituted ‘‘Under Secretary for Health’’ for ‘‘Chief Medical Direc- tor’’ wherever appearing. Subsec. (a)(7). Pub. L. 102–585, § 511(b)(1)(B), added par. (7). Former par. (7), relating to such directors, redesig- nated (8). Pub. L. 102–405, § 205(2), added par. (7). Former par. (7), relating to such other personnel, redesignated (8). Subsec. (a)(8). Pub. L. 102–585, § 511(b)(1)(A), redesig- nated par. (7), relating to such directors, as (8). Pub. L. 102–405, § 205(1), redesignated par. (7), relating to such other personnel, as (8). Subsec. (b)(2), (3). Pub. L. 102–405, § 302(c)(1), sub- stituted ‘‘Under Secretary for Health’’ for ‘‘Chief Med- ical Director’’ wherever appearing. Subsec. (c). Pub. L. 102–585, § 511(b)(2), substituted ‘‘(4), and (7)’’ for ‘‘and (4)’’. Pub. L. 102–405, § 302(c)(1), substituted ‘‘Under Sec- retary for Health’’ for ‘‘Chief Medical Director’’. Statutory Notes and Related Subsidiaries DEADLINE FOR IMPLEMENTATION OF 2010 AMENDMENT Pub. L. 111–163, title V, § 514(b), May 5, 2010, 124 Stat. 1165, provided that: ‘‘The Secretary of Veterans Affairs shall ensure that an individual is serving as the Direc- tor of Physician Assistant Services under paragraph (9) of section 7306(a) of title 38, United States Code, as amended by subsection (a), by not later than 120 days after the date of the enactment of this Act [May 5, 2010].’’ § 7307. Office of Research Oversight (a) REQUIREMENT FOR OFFICE.—(1) There is in the Veterans Health Administration an Office of Research Oversight (hereinafter in this section referred to as the ‘‘Office’’). The Office shall ad- vise the Under Secretary for Health on matters of compliance and assurance in human subjects protections, research safety, and research im- propriety and misconduct. The Office shall func- tion independently of entities within the Vet- erans Health Administration with responsibility for the conduct of medical research programs. (2) The Office shall— (A) monitor, review, and investigate matters of medical research compliance and assurance in the Department with respect to human sub- jects protections; and (B) monitor, review, and investigate matters relating to the protection and safety of human subjects and Department employees partici- pating in medical research in Department pro- grams. (b) DIRECTOR.—(1) The head of the Office shall be a Director, who shall report directly to the Under Secretary for Health (without delega- tion). (2) Any person appointed as Director shall be— (A) an established expert in the field of med- ical research, administration of medical re- search programs, or similar fields; and (B) qualified to carry out the duties of the Office based on demonstrated experience and expertise. (c) FUNCTIONS.—(1) The Director shall report to the Under Secretary for Health on matters re- lating to protections of human subjects in med- ical research projects of the Department under any applicable Federal law and regulation, the safety of employees involved in Department medical research programs, and suspected mis- conduct and impropriety in such programs. In carrying out the preceding sentence, the Direc- tor shall consult with employees of the Veterans Health Administration who are responsible for the management and conduct of Department medical research programs. (2) The matters to be reported by the Director to the Under Secretary under paragraph (1) shall include allegations of research impropriety and misconduct by employees engaged in medical re- search programs of the Department. (3)(A) When the Director determines that such a recommendation is warranted, the Director may recommend to the Under Secretary that a Department research activity be terminated, suspended, or restricted, in whole or in part. (B) In a case in which the Director reasonably believes that activities of a medical research project of the Department place human subjects’ lives or health at imminent risk, the Director shall direct that activities under that project be immediately suspended or, as appropriate and specified by the Director, be limited. (d) GENERAL FUNCTIONS.—(1) The Director shall conduct periodic inspections and reviews, as the Director determines appropriate, of med- ical research programs of the Department. Such inspections and reviews shall include review of required documented assurances. (2) The Director shall observe external accred- itation activities conducted for accreditation of medical research programs conducted in facili- ties of the Department. (3) The Director shall investigate allegations of research impropriety and misconduct in med- ical research projects of the Department. (4) The Director shall submit to the Under Secretary for Health, the Secretary, and the Committees on Veterans’ Affairs of the Senate and House of Representatives a report on any suspected lapse, from whatever cause or causes, in protecting safety of human subjects and oth- ers, including employees, in medical research programs of the Department. (5) The Director shall carry out such other du- ties as the Under Secretary for Health may re- quire. (e) SOURCE OF FUNDS.—Amounts for the activi- ties of the Office, including its regional offices, shall be derived from amounts appropriated for the Veterans Health Administration for Medical Care. (f) ANNUAL REPORT.—Not later than March 15 each year, the Director shall submit to the Com- mittees on Veterans’ Affairs of the Senate and House of Representatives a report on the activi- ties of the Office during the preceding calendar year. Each such report shall include, with re- spect to that year, the following: (1) A summary of reviews of individual med- ical research programs of the Department completed by the Office. (2) Directives and other communications issued by the Office to field activities of the Department. (3) Results of any investigations undertaken by the Office during the reporting period con- sonant with the purposes of this section.