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42 U.S. Code § 282. Director of National Institutes of Health
(a) Appointment
The National Institutes of Health shall be headed by the Director of NIH who shall be appointed by the President by and with the advice and consent of the Senate. The Director of NIH shall perform functions as provided under subsection (b) and as the Secretary may otherwise prescribe.
(b) Duties and authorityIn carrying out the purposes of section 241 of this title, the Secretary, acting through the Director of NIH—
(1)
shall carry out this subchapter, including being responsible for the overall direction of the National Institutes of Health and for the establishment and implementation of general policies respecting the management and operation of programs and activities within the National Institutes of Health;
(2)
shall coordinate and oversee the operation of the national research institutes, national centers, and administrative entities within the National Institutes of Health;
(3)
shall, in consultation with the heads of the national research institutes and national centers, be responsible for program coordination across the national research institutes and national centers, including conducting priority-setting reviews, to ensure that the research portfolio of the National Institutes of Health is balanced and free of unnecessary duplication, and takes advantage of collaborative, cross-cutting research;
(4) shall assemble accurate data to be used to assess research priorities, including—
(A)
information to better evaluate scientific opportunity, public health burdens, and progress in reducing health disparities; and
(B) data on study populations of clinical research, funded by or conducted at each national research institute and national center, which—
(i) specifies the inclusion of—
(I)
women;
(II)
members of minority groups;
(III)
relevant age categories, including pediatric subgroups; and
(IV)
other demographic variables as the Director of the National Institutes of Health determines appropriate;
(ii)
is disaggregated by research area, condition, and disease categories; and
(iii)
is to be made publicly available on the Internet website of the National Institutes of Health;
(5)
shall ensure that scientifically based strategic planning is implemented in support of research priorities as determined by the agencies of the National Institutes of Health, and through the development, implementation, and updating of the strategic plan developed under subsection (m);
(6)
shall ensure that the resources of the National Institutes of Health are sufficiently allocated for research projects identified in strategic plans;
(7)
(A) shall, through the Division of Program Coordination, Planning, and Strategic Initiatives—
(i)
identify research that represents important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that deserve special emphasis and would benefit from conducting or supporting additional research that involves collaboration between 2 or more national research institutes or national centers, or would otherwise benefit from strategic coordination and planning;
(ii)
include information on such research in reports under section 283 of this title; and
(iii) in the case of such research supported with funds referred to in subparagraph (B)—
(I)
require as appropriate that proposals include milestones and goals for the research;
(II)
require that the proposals include timeframes for funding of the research; and
(III)
ensure appropriate consideration of proposals for which the principal investigator is an individual who has not previously served as the principal investigator of research conducted or supported by the National Institutes of Health;
(B)
(i)
may, with respect to funds reserved under section 282a(c)(1) of this title for the Common Fund, allocate such funds to the national research institutes and national centers for conducting and supporting research that is identified under subparagraph (A); and
(ii)
shall, with respect to funds appropriated to the Common Fund pursuant to section 282a(a)(2) of this title, allocate such funds to the national research institutes and national centers for making grants for pediatric research that is identified under subparagraph (A); and
(C)
may assign additional functions to the Division in support of responsibilities identified in subparagraph (A), as determined appropriate by the Director;
(8) shall, in coordination with the heads of the national research institutes and national centers, ensure that such institutes and centers—
(A)
preserve an emphasis on investigator-initiated research project grants, including with respect to research involving collaboration between 2 or more such institutes or centers;
(B)
when appropriate, maximize investigator-initiated research project grants in their annual research portfolios;
(C) foster collaboration between clinical research projects funded by the respective national research institutes and national centers that—
(i)
conduct research involving human subjects; and
(ii)
collect similar data; and
(D) encourage the collaboration described in subparagraph (C) to—
(i)
allow for an increase in the number of subjects studied; and
(ii)
utilize diverse study populations, with special consideration to biological, social, and other determinants of health that contribute to health disparities;
(9)
shall ensure that research conducted or supported by the National Institutes of Health is subject to review in accordance with section 289a of this title and that, after such review, the research is reviewed in accordance with section 289a–1(a)(2) of this title by the appropriate advisory council under section 284a of this title before the research proposals are approved for funding;
(10)
shall have authority to review and approve the establishment of all centers of excellence recommended by the national research institutes;
(11)
(A)
shall oversee research training for all of the national research institutes and National Research Service Awards in accordance with section 288 of this title; and
(B) may conduct and support research training—
(i)
for which fellowship support is not provided under section 288 of this title; and
(ii)
that does not consist of residency training of physicians or other health professionals;
(12)
may, from funds appropriated under section 282a(b) of this title, reserve funds to provide for research on matters that have not received significant funding relative to other matters, to respond to new issues and scientific emergencies, and to act on research opportunities of high priority;
(13)
may, subject to appropriations Acts, collect and retain registration fees obtained from third parties to defray expenses for scientific, educational, and research-related conferences;
(14) for the national research institutes and administrative entities within the National Institutes of Health—
(A)
may acquire, construct, improve, repair, operate, and maintain, at the site of such institutes and entities, laboratories, and other research facilities, other facilities, equipment, and other real or personal property, and
(B)
may acquire, without regard to section 8141 of title 40, by lease or otherwise through the Administrator of General Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of Columbia for use for a period not to exceed ten years;
(15)
may secure resources for research conducted by or through the National Institutes of Health;
(16)
may, without regard to the provisions of title 5 governing appointments in the competitive service, and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, establish such technical and scientific peer review groups and scientific program advisory committees as are needed to carry out the requirements of this subchapter and appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups;
(17)
may secure for the National Institutes of Health consultation services and advice of persons from the United States or abroad;
(18)
may use, with their consent, the services, equipment, personnel, information, and facilities of other Federal, State, or local public agencies, with or without reimbursement therefor;
(19)
may, for purposes of study, admit and treat at facilities of the National Institutes of Health individuals not otherwise eligible for such treatment;
(20)
may accept voluntary and uncompensated services;
(21)
may perform such other administrative functions as the Secretary determines are needed to effectively carry out this subchapter;
(22)
may appoint physicians, dentists, and other health care professionals, subject to the provisions of title 5 relating to appointments and classifications in the competitive service, and may compensate such professionals subject to the provisions of chapter 74 of title 38;
(23)
shall designate a contact point or office to help innovators and physicians identify sources of funding available for pediatric medical device development;
(24)
implement the Cures Acceleration Network described in section 287a of this title;
(25) may require recipients of National Institutes of Health awards to share scientific data, to the extent feasible, generated from such National Institutes of Health awards in a manner that is consistent with all applicable Federal laws and regulations, including such laws and regulations for the protection of—
(A)
human research participants, including with respect to privacy, security, informed consent, and protected health information; and
(B)
proprietary interests, confidential commercial information, and the intellectual property rights of the funding recipient;
(26)
shall consult with the Assistant Secretary for Preparedness and Response, the Director of the Biomedical Advanced Research and Development Authority, the Director of the Centers for Disease Control and Prevention, and the heads of other Federal agencies and offices, as appropriate, regarding research needs to advance medical countermeasures to diagnose, mitigate, prevent, or treat harm from any biological agent or toxin, including emerging infectious diseases, chemical, radiological, or nuclear agent that may cause a public health emergency or other research needs related to emerging public health threats;
(27)
shall consult with the Director of the Office of National Security within the Department of Health and Human Services, the Assistant Secretary for Preparedness and Response, the Director of National Intelligence, the Director of the Federal Bureau of Investigation, and the heads of other appropriate agencies on a regular basis, regarding biomedical research conducted or supported by the National Institutes of Health that may affect or be affected by matters of national security;
(28)
shall ensure that recipients of awards from the National Institutes of Health, and, as appropriate and practicable, entities collaborating with such recipients, have in place and are adhering to appropriate technology practices and policies for the security of identifiable, sensitive information, including information collected, stored, managed, or analyzed by domestic and non-domestic entities; and
(29)
shall ensure that recipients of awards from the National Institutes of Health are in compliance with the terms and conditions of such award, which may include activities to support awareness of, and compliance with, such terms and conditions by any subrecipients of the award.
Chapter 10 of title 5 shall not apply to the duration of a peer review group appointed under paragraph (16). The members of such a group shall be individuals who by virtue of their training or experience are eminently qualified to perform the review functions of such group. Not more than one-fourth of the members of any such group shall be officers or employees of the United States.