1. U.S. Code
  2. title 42
  3. chapter 6A
  4. subchapter III
  5. part H
  6. § 289g-5

Collapse to view only § 289g-5. Precision medicine initiative

§ 289. Institutional review boards; ethics guidance program
(a) The Secretary shall by regulation require that each entity which applies for a grant, contract, or cooperative agreement under this chapter for any project or program which involves the conduct of biomedical or behavioral research involving human subjects submit in or with its application for such grant, contract, or cooperative agreement assurances satisfactory to the Secretary that it has established (in accordance with regulations which the Secretary shall prescribe) a board (to be known as an “Institutional Review Board”) to review biomedical and behavioral research involving human subjects conducted at or supported by such entity in order to protect the rights of the human subjects of such research.
(b)
(1) The Secretary shall establish a program within the Department of Health and Human Services under which requests for clarification and guidance with respect to ethical issues raised in connection with biomedical or behavioral research involving human subjects are responded to promptly and appropriately.
(2) The Secretary shall establish a process for the prompt and appropriate response to information provided to the Director of NIH respecting incidences of violations of the rights of human subjects of research for which funds have been made available under this chapter. The process shall include procedures for the receiving of reports of such information from recipients of funds under this chapter and taking appropriate action with respect to such violations.
(July 1, 1944, ch. 373, title IV, § 491, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 873.)

CITE AS: 42 USC 289

§ 289a. Peer review requirements
(a) Applications for biomedical and behavioral research grants, cooperative agreements, and contracts; regulations
(1) The Secretary, acting through the Director of NIH, shall by regulation require appropriate technical and scientific peer review of—
(A) applications made for grants and cooperative agreements under this chapter for biomedical and behavioral research; and
(B) applications made for biomedical and behavioral research and development contracts to be administered through the National Institutes of Health.
(2) Regulations promulgated under paragraph (1) shall require that the review of applications made for grants, contracts, and cooperative agreements required by the regulations be conducted—
(A) to the extent practical, in a manner consistent with the system for technical and scientific peer review applicable on November 20, 1985, to grants under this chapter for biomedical and behavioral research, and
(B) to the extent practical, by technical and scientific peer review groups performing such review on or before November 20, 1985,
and shall authorize such review to be conducted by groups appointed under sections 282(b)(16) and 284(c)(3) of this title.
(b) Periodic review of research at National Institutes of HealthThe Director of NIH shall establish procedures for periodic technical and scientific peer review of research at the National Institutes of Health. Such procedures shall require that—
(1) the reviewing entity be provided a written description of the research to be reviewed, and
(2) the reviewing entity provide the advisory council of the national research institute involved with such description and the results of the review by the entity,
and shall authorize such review to be conducted by groups appointed under sections 282(b)(6) 1
1 See References in Text note below.
and 284(c)(3) of this title.
(c) Compliance with requirements for inclusion of women and minorities in clinical research
(1) In technical and scientific peer review under this section of proposals for clinical research, the consideration of any such proposal (including the initial consideration) shall, except as provided in paragraph (2), include an evaluation of the technical and scientific merit of the proposal regarding compliance with section 289a–2 of this title.
(2) Paragraph (1) shall not apply to any proposal for clinical research that, pursuant to subsection (b) of section 289a–2 of this title, is not subject to the requirement of subsection (a) of such section regarding the inclusion of women and members of minority groups as subjects in clinical research.
(July 1, 1944, ch. 373, title IV, § 492, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 874; amended Pub. L. 103–43, title I, § 132, June 10, 1993, 107 Stat. 135; Pub. L. 109–482, title I, § 102(f)(1)(B), Jan. 15, 2007, 120 Stat. 3685.)

CITE AS: 42 USC 289a

§ 289a–1. Certain provisions regarding review and approval of proposals for research
(a) Review as precondition to research
(1) Protection of human research subjects
(A) In the case of any application submitted to the Secretary for financial assistance to conduct research, the Secretary may not approve or fund any application that is subject to review under section 289(a) of this title by an Institutional Review Board unless the application has undergone review in accordance with such section and has been recommended for approval by a majority of the members of the Board conducting such review.
(B) In the case of research that is subject to review under procedures established by the Secretary for the protection of human subjects in clinical research conducted by the National Institutes of Health, the Secretary may not authorize the conduct of the research unless the research has, pursuant to such procedures, been recommended for approval.
(2) Peer review
(b) Ethical review of research
(1) Procedures regarding withholding of fundsIf research has been recommended for approval for purposes of subsection (a), the Secretary may not withhold funds for the research because of ethical considerations unless—
(A) the Secretary convenes an advisory board in accordance with paragraph (5) to study such considerations; and
(B)
(i) the majority of the advisory board recommends that, because of such considerations, the Secretary withhold funds for the research; or
(ii) the majority of such board recommends that the Secretary not withhold funds for the research because of such considerations, but the Secretary finds, on the basis of the report submitted under paragraph (5)(B)(ii), that the recommendation is arbitrary and capricious.
(2) Rules of constructionParagraph (1) may not be construed as prohibiting the Secretary from withholding funds for research on the basis of—
(A) the inadequacy of the qualifications of the entities that would be involved with the conduct of the research (including the entity that would directly receive the funds from the Secretary), subject to the condition that, with respect to the process of review through which the research was recommended for approval for purposes of subsection (a), all findings regarding such qualifications made in such process are conclusive; or
(B) the priorities established by the Secretary for the allocation of funds among projects of research that have been so recommended.
(3) Applicability
(4) Preliminary matters regarding use of procedures
(A) If the Secretary makes a determination that an advisory board should be convened for purposes of paragraph (1), the Secretary shall, through a statement published in the Federal Register, announce the intention of the Secretary to convene such a board.
(B) A statement issued under subparagraph (A) shall include a request that interested individuals submit to the Secretary recommendations specifying the particular individuals who should be appointed to the advisory board involved. The Secretary shall consider such recommendations in making appointments to the board.
(C) The Secretary may not make appointments to an advisory board under paragraph (1) until the expiration of the 30-day period beginning on the date on which the statement required in subparagraph (A) is made with respect to the board.
(5) Ethics advisory boards
(A) Any advisory board convened for purposes of paragraph (1) shall be known as an ethics advisory board (in this paragraph referred to as an “ethics board”).
(B)
(i) An ethics board shall advise, consult with, and make recommendations to the Secretary regarding the ethics of the project of biomedical or behavioral research with respect to which the board has been convened.
(ii) Not later than 180 days after the date on which the statement required in paragraph (4)(A) is made with respect to an ethics board, the board shall submit to the Secretary, and to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate, a report describing the findings of the board regarding the project of research involved and making a recommendation under clause (i) of whether the Secretary should or should not withhold funds for the project. The report shall include the information considered in making the findings.
(C) An ethics board shall be composed of no fewer than 14, and no more than 20, individuals who are not officers or employees of the United States. The Secretary shall make appointments to the board from among individuals with special qualifications and competence to provide advice and recommendations regarding ethical matters in biomedical and behavioral research. Of the members of the board—
(i) no fewer than 1 shall be an attorney;
(ii) no fewer than 1 shall be an ethicist;
(iii) no fewer than 1 shall be a practicing physician;
(iv) no fewer than 1 shall be a theologian; and
(v) no fewer than one-third, and no more than one-half, shall be scientists with substantial accomplishments in biomedical or behavioral research.
(D) The term of service as a member of an ethics board shall be for the life of the board. If such a member does not serve the full term of such service, the individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.
(E) A member of an ethics board shall be subject to removal from the board by the Secretary for neglect of duty or malfeasance or for other good cause shown.
(F) The Secretary shall designate an individual from among the members of an ethics board to serve as the chair of the board.
(G) In carrying out subparagraph (B)(i) with respect to a project of research, an ethics board shall conduct inquiries and hold public hearings.
(H) In carrying out subparagraph (B)(i) with respect to a project of research, an ethics board shall have access to all relevant information possessed by the Department of Health and Human Services, or available to the Secretary from other agencies.
(I) Members of an ethics board shall receive compensation for each day engaged in carrying out the duties of the board, including time engaged in traveling for purposes of such duties. Such compensation may not be provided in an amount in excess of the maximum rate of basic pay payable for GS–18 of the General Schedule.
(J) The Secretary, acting through the Director of the National Institutes of Health, shall provide to each ethics board reasonable staff and assistance to carry out the duties of the board.
(K) An ethics board shall terminate 30 days after the date on which the report required in subparagraph (B)(ii) is submitted to the Secretary and the congressional committees specified in such subparagraph.
(6) “Ethical considerations” defined
(July 1, 1944, ch. 373, title IV, § 492A, as added Pub. L. 103–43, title I, § 101, June 10, 1993, 107 Stat. 126; amended Pub. L. 109–482, title I, § 102(e), Jan. 15, 2007, 120 Stat. 3684.)

CITE AS: 42 USC 289a-1

§ 289a–2. Inclusion of women and minorities in clinical research
(a) Requirement of inclusion
(1) In generalIn conducting or supporting clinical research for purposes of this subchapter, the Director of NIH shall, subject to subsection (b), ensure that—
(A) women are included as subjects in each project of such research; and
(B) members of minority groups are included as subjects in such research.
(2) Outreach regarding participation as subjects
(3) Strategic planning
(A) In general
(B) Strategic plans
(b) Inapplicability of requirementThe requirement established in subsection (a) regarding women and members of minority groups shall not apply to a project of clinical research if the inclusion, as subjects in the project, of women and members of minority groups, respectively—
(1) is inappropriate with respect to the health of the subjects;
(2) is inappropriate with respect to the purpose of the research; or
(3) is inappropriate under such other circumstances as the Director of NIH may designate.
(c) Design of clinical trials
(1) In general
(2) Reporting requirementsFor any new and competing project of clinical research subject to the requirements under this section that receives a grant award 1 year after December 13, 2016, or any date thereafter, for which a valid analysis is provided under paragraph (1)—
(A) and which is an applicable clinical trial as defined in section 282(j) of this title, the entity conducting such clinical research shall submit the results of such valid analysis to the clinical trial registry data bank expanded under section 282(j)(3) of this title, and the Director of the National Institutes of Health shall, as appropriate, consider whether such entity has complied with the reporting requirement described in this subparagraph in awarding any future grant to such entity, including pursuant to section 282(j)(5)(A)(ii) of this title when applicable; and
(B) the Director of the National Institutes of Health shall encourage the reporting of the results of such valid analysis described in paragraph (1) through any additional means determined appropriate by the Director.
(d) Guidelines
(1) In generalSubject to paragraph (2), the Director of NIH, in consultation with the Director of the Office of Research on Women’s Health and the Director of the Office of Research on Minority Health, shall establish guidelines regarding the requirements of this section. The guidelines shall include guidelines regarding—
(A) the circumstances under which the inclusion of women and minorities as subjects in projects of clinical research is inappropriate for purposes of subsection (b);
(B) the manner in which clinical trials are required to be designed and carried out for purposes of subsection (c); and
(C) the operation of outreach programs under subsection (a).
(2) Certain provisionsWith respect to the circumstances under which the inclusion of women or members of minority groups (as the case may be) as subjects in a project of clinical research is inappropriate for purposes of subsection (b), the following applies to guidelines under paragraph (1):
(A)
(i) In the case of a clinical trial, the guidelines shall provide that the costs of such inclusion in the trial is not a permissible consideration in determining whether such inclusion is inappropriate.
(ii) In the case of other projects of clinical research, the guidelines shall provide that the costs of such inclusion in the project is not a permissible consideration in determining whether such inclusion is inappropriate unless the data regarding women or members of minority groups, respectively, that would be obtained in such project (in the event that such inclusion were required) have been or are being obtained through other means that provide data of comparable quality.
(B) In the case of a clinical trial, the guidelines may provide that such inclusion in the trial is not required if there is substantial scientific data demonstrating that there is no significant difference between—
(i) the effects that the variables to be studied in the trial have on women or members of minority groups, respectively; and
(ii) the effects that the variables have on the individuals who would serve as subjects in the trial in the event that such inclusion were not required.
(e) Date certain for guidelines; applicability
(1) Date certain
(2) Applicability
(f) Reports by advisory councils
(1) In general
(2) ContentsEach triennial report prepared by an advisory council of each national research institute as described in paragraph (1) shall include each of the following:
(A) The number of women included as subjects, and the proportion of subjects that are women, in any project of clinical research conducted during the applicable reporting period, disaggregated by categories of research area, condition, or disease, and accounting for single-sex studies.
(B) The number of members of minority groups included as subjects, and the proportion of subjects that are members of minority groups, in any project of clinical research conducted during the applicable reporting period, disaggregated by categories of research area, condition, or disease and accounting for single-race and single-ethnicity studies.
(C) For the applicable reporting period, the number of projects of clinical research that include women and members of minority groups and that—
(i) have been completed during such reporting period; and
(ii) are being carried out during such reporting period and have not been completed.
(D) The number of studies completed during the applicable reporting period for which reporting has been submitted in accordance with subsection (c)(2)(A).
(g) DefinitionsFor purposes of this section:
(1) The term “project of clinical research” includes a clinical trial.
(2) The term “minority group” includes subpopulations of minority groups. The Director of NIH shall, through the guidelines established under subsection (d), define the terms “minority group” and “subpopulation” for purposes of the preceding sentence.
(July 1, 1944, ch. 373, title IV, § 492B, as added Pub. L. 103–43, title I, § 131, June 10, 1993, 107 Stat. 133; amended Pub. L. 114–255, div. A, title II, §§ 2031(c), 2038(b), 2053, Dec. 13, 2016, 130 Stat. 1056, 1065, 1076.)

CITE AS: 42 USC 289a-2

§ 289b. Office of Research Integrity
(a) In general
(1) Establishment of Office
(2) Appointment of Director
(3) Definitions
(A) The Secretary shall by regulation establish a definition for the term “research misconduct” for purposes of this section.
(B) For purposes of this section, the term “financial assistance” means a grant, contract, or cooperative agreement.
(b) Existence of administrative processes as condition of funding for research
The Secretary shall by regulation require that each entity that applies for financial assistance under this chapter for any project or program that involves the conduct of biomedical or behavioral research submit in or with its application for such assistance—
(1) assurances satisfactory to the Secretary that such entity has established and has in effect (in accordance with regulations which the Secretary shall prescribe) an administrative process to review reports of research misconduct in connection with biomedical and behavioral research conducted at or sponsored by such entity;
(2) an agreement that the entity will report to the Director any investigation of alleged research misconduct in connection with projects for which funds have been made available under this chapter that appears substantial; and
(3) an agreement that the entity will comply with regulations issued under this section.
(c) Process for response of Director
The Secretary shall by regulation establish a process to be followed by the Director for the prompt and appropriate—
(1) response to information provided to the Director respecting research misconduct in connection with projects for which funds have been made available under this chapter;
(2) receipt of reports by the Director of such information from recipients of funds under this chapter;
(3) conduct of investigations, when appropriate; and
(4) taking of other actions, including appropriate remedies, with respect to such misconduct.
(d) Monitoring by Director
(e) Protection of whistleblowers
(1) In general
In the case of any entity required to establish administrative processes under subsection (b), the Secretary shall by regulation establish standards for preventing, and for responding to the occurrence of retaliation by such entity, its officials or agents, against an employee in the terms and conditions of employment in response to the employee having in good faith—
(A) made an allegation that the entity, its officials or agents, has engaged in or failed to adequately respond to an allegation of research misconduct; or
(B) cooperated with an investigation of such an allegation.
(2) Monitoring by Secretary
(3) Noncompliance
(July 1, 1944, ch. 373, title IV, § 493, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 874; amended Pub. L. 103–43, title I, §§ 161, 163, June 10, 1993, 107 Stat. 140, 142.)

CITE AS: 42 USC 289b

§ 289b–1. Protection against financial conflicts of interest in certain projects of research
(a) Issuance of regulations
(b) Relevant projects
(c) Identifying and reporting to Secretary
The Secretary shall by regulation require that each entity described in subsection (a) that applies for assistance under this chapter for any project described in subsection (b) submit in or with its application for such assistance—
(1) assurances satisfactory to the Secretary that such entity has established and has in effect an administrative process under subsection (a) to identify financial interests (as defined under subsection (a)) that exist regarding the project; and
(2) an agreement that the entity will report to the Secretary such interests identified by the entity and how any such interests identified by the entity will be managed or eliminated in order that the project in question will be protected from bias that may stem from such interests; and
(3) an agreement that the entity will comply with regulations issued under this section.
(d) Monitoring of process
(e) Response
In any case in which the Secretary determines that an entity has failed to comply with subsection (c) regarding a project of research described in subsection (b), the Secretary—
(1) shall require that, as a condition of receiving assistance, the entity disclose the existence of a financial interest (as defined under subsection (a)) in each public presentation of the results of such project; and
(2) may take such other actions as the Secretary determines to be appropriate.
(f) Definitions
For purposes of this section:
(1) The term “financial interest” includes the receipt of consulting fees or honoraria and the ownership of stock or equity.
(2) The term “assistance”, with respect to conducting a project of research, means a grant, contract, or cooperative agreement.
(July 1, 1944, ch. 373, title IV, § 493A, as added Pub. L. 103–43, title I, § 164, June 10, 1993, 107 Stat. 142.)

CITE AS: 42 USC 289b-1

§ 289c. Research on public health emergencies
If the Secretary determines, after consultation with the Director of NIH, the Commissioner of the Food and Drug Administration, or the Director of the Centers for Disease Control and Prevention, that a disease or disorder constitutes a public health emergency, the Secretary, acting through the Director of NIH—
(1) shall expedite the review by advisory councils under section 284a of this title and by peer review groups under section 289a of this title of applications for grants for research on such disease or disorder or proposals for contracts for such research;
(2) shall exercise the authority in section 6101 of title 41 respecting public exigencies to waive the advertising requirements of such section in the case of proposals for contracts for such research;
(3) may provide administrative supplemental increases in existing grants and contracts to support new research relevant to such disease or disorder; and
(4) shall disseminate, to health professionals and the public, information on the cause, prevention, and treatment of such disease or disorder that has been developed in research assisted under this section.
The amount of an increase in a grant or contract provided under paragraph (3) may not exceed one-half the original amount of the grant or contract.
(July 1, 1944, ch. 373, title IV, § 494, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 875; amended Pub. L. 102–531, title III, § 312(d)(9), Oct. 27, 1992, 106 Stat. 3504; Pub. L. 109–482, title I, § 104(b)(1)(P), Jan. 15, 2007, 120 Stat. 3693.)

CITE AS: 42 USC 289c

§ 289c–1. Collaborative use of certain health services research funds

The Secretary shall ensure that amounts made available under subparts 14, 15 and 16 of part C for health services research relating to alcohol abuse and alcoholism, drug abuse and mental health be used collaboratively, as appropriate, and in consultation with the Agency for Healthcare Research and Quality.

(July 1, 1944, ch. 373, title IV, § 494A, as added Pub. L. 102–321, title I, § 125, July 10, 1992, 106 Stat. 366; amended Pub. L. 103–43, title XX, § 2016(c), June 10, 1993, 107 Stat. 218; Pub. L. 104–66, title I, § 1062(b), Dec. 21, 1995, 109 Stat. 720; Pub. L. 105–362, title VI, § 601(a)(1)(F), Nov. 10, 1998, 112 Stat. 3285; Pub. L. 106–129, § 2(b)(2), Dec. 6, 1999, 113 Stat. 1670.)

CITE AS: 42 USC 289c-1

§ 289d. Animals in research
(a) Establishment of guidelinesThe Secretary, acting through the Director of NIH, shall establish guidelines for the following:
(1) The proper care of animals to be used in biomedical and behavioral research.
(2) The proper treatment of animals while being used in such research. Guidelines under this paragraph shall require—
(A) the appropriate use of tranquilizers, analgesics, anesthetics, paralytics, and euthanasia for animals in such research; and
(B) appropriate pre-surgical and post-surgical veterinary medical and nursing care for animals in such research.
Such guidelines shall not be construed to prescribe methods of research.
(3) The organization and operation of animal care committees in accordance with subsection (b).
(b) Animal care committees; establishment; membership; functions
(1) Guidelines of the Secretary under subsection (a)(3) shall require animal care committees at each entity which conducts biomedical and behavioral research with funds provided under this chapter (including the National Institutes of Health and the national research institutes) to assure compliance with the guidelines established under subsection (a).
(2) Each animal care committee shall be appointed by the chief executive officer of the entity for which the committee is established, shall be composed of not fewer than three members, and shall include at least one individual who has no association with such entity and at least one doctor of veterinary medicine.
(3) Each animal care committee of a research entity shall—
(A) review the care and treatment of animals in all animal study areas and facilities of the research entity at least semi-annually to evaluate compliance with applicable guidelines established under subsection (a) for appropriate animal care and treatment;
(B) keep appropriate records of reviews conducted under subparagraph (A); and
(C) for each review conducted under subparagraph (A), file with the Director of NIH at least annually (i) a certification that the review has been conducted, and (ii) reports of any violations of guidelines established under subsection (a) or assurances required under paragraph (1) which were observed in such review and which have continued after notice by the committee to the research entity involved of the violations.
Reports filed under subparagraph (C) shall include any minority views filed by members of the committee.
(c) Assurances required in application or contract proposal; reasons for use of animals; notice and comment requirements for promulgation of regulationsThe Director of NIH shall require each applicant for a grant, contract, or cooperative agreement involving research on animals which is administered by the National Institutes of Health or any national research institute to include in its application or contract proposal, submitted after the expiration of the twelve-month period beginning on November 20, 1985—
(1) assurances satisfactory to the Director of NIH that—
(A) the applicant meets the requirements of the guidelines established under paragraphs (1) and (2) of subsection (a) and has an animal care committee which meets the requirements of subsection (b); and
(B) scientists, animal technicians, and other personnel involved with animal care, treatment, and use by the applicant have available to them instruction or training in the humane practice of animal maintenance and experimentation, and the concept, availability, and use of research or testing methods that limit the use of animals or limit animal distress; and
(2) a statement of the reasons for the use of animals in the research to be conducted with funds provided under such grant or contract.
Notwithstanding subsection (a)(2) of section 553 of title 5, regulations under this subsection shall be promulgated in accordance with the notice and comment requirements of such section.
(d) Failure to meet guidelines; suspension or revocation of grant or contractIf the Director of NIH determines that—
(1) the conditions of animal care, treatment, or use in an entity which is receiving a grant, contract, or cooperative agreement involving research on animals under this subchapter do not meet applicable guidelines established under subsection (a);
(2) the entity has been notified by the Director of NIH of such determination and has been given a reasonable opportunity to take corrective action; and
(3) no action has been taken by the entity to correct such conditions;
the Director of NIH shall suspend or revoke such grant or contract under such conditions as the Director determines appropriate.
(e) Disclosure of trade secrets or privileged or confidential information
(July 1, 1944, ch. 373, title IV, § 495, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 875.)

CITE AS: 42 USC 289d

§ 289e. Use of appropriations
(a) Appropriations to carry out the purposes of this subchapter, unless otherwise expressly provided, may be expended in the District of Columbia for—
(1) personal services;
(2) stenographic recording and translating services;
(3) travel expenses (including the expenses of attendance at meetings when specifically authorized by the Secretary);
(4) rental;
(5) supplies and equipment;
(6) purchase and exchange of medical books, books of reference, directories, periodicals, newspapers, and press clippings;
(7) purchase, operation, and maintenance of passenger motor vehicles;
(8) printing and binding (in addition to that otherwise provided by law); and
(9) all other necessary expenses in carrying out this subchapter.
Such appropriations may be expended by contract if deemed necessary, without regard to section 6101 of title 41.
(b)
(1) None of the amounts appropriated under this chapter for the purposes of this subchapter may be obligated for the construction of facilities (including the acquisition of land) unless a provision of this subchapter establishes express authority for such purpose and unless the Act making appropriations under such provision specifies that the amounts appropriated are available for such purpose.
(2) Any grants, cooperative agreements, or contracts authorized in this subchapter for the construction of facilities may be awarded only on a competitive basis.
(July 1, 1944, ch. 373, title IV, § 496, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 877; amended Pub. L. 101–190, § 8, Nov. 29, 1989, 103 Stat. 1695; Pub. L. 103–43, title XX, § 2008(b)(15), June 10, 1993, 107 Stat. 211.)

CITE AS: 42 USC 289e

§ 289f. Gifts and donations; memorials

The Secretary may, in accordance with section 238 of this title, accept conditional gifts for the National Institutes of Health or a national research institute or for the acquisition of grounds or for the erection, equipment, or maintenance of facilities for the National Institutes of Health or a national research institute. Donations of $50,000 or over for the National Institutes of Health or a national research institute for carrying out the purposes of this subchapter may be acknowledged by the establishment within the National Institutes of Health or a national research institute of suitable memorials to the donors.

(July 1, 1944, ch. 373, title IV, § 497, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 877; amended Pub. L. 99–660, title III, § 311(b)(1), Nov. 14, 1986, 100 Stat. 3779; Pub. L. 100–607, title II, § 204(3), Nov. 4, 1988, 102 Stat. 3079; Pub. L. 100–690, title II, § 2620(b)(2), Nov. 18, 1988, 102 Stat. 4244; Pub. L. 101–381, title I, § 102(5), Aug. 18, 1990, 104 Stat. 586; Pub. L. 103–43, title XX, § 2010(b)(6), June 10, 1993, 107 Stat. 214.)

CITE AS: 42 USC 289f

§ 289g. Fetal research
(a) Conduct or support by Secretary; restrictions
The Secretary may not conduct or support any research or experimentation, in the United States or in any other country, on a nonviable living human fetus ex utero or a living human fetus ex utero for whom viability has not been ascertained unless the research or experimentation—
(1) may enhance the well-being or meet the health needs of the fetus or enhance the probability of its survival to viability; or
(2) will pose no added risk of suffering, injury, or death to the fetus and the purpose of the research or experimentation is the development of important biomedical knowledge which cannot be obtained by other means.
(b) Risk standard for fetuses intended to be aborted and fetuses intended to be carried to term to be same
In administering the regulations for the protection of human research subjects which—
(1) apply to research conducted or supported by the Secretary;
(2) involve living human fetuses in utero; and
(3) are published in section 46.208 of part 46 of title 45 of the Code of Federal Regulations;
or any successor to such regulations, the Secretary shall require that the risk standard (published in section 46.102(g) of such part 46 or any successor to such regulations) be the same for fetuses which are intended to be aborted and fetuses which are intended to be carried to term.
(July 1, 1944, ch. 373, title IV, § 498, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 877; amended Pub. L. 100–607, title I, §§ 156, 157(b), Nov. 4, 1988, 102 Stat. 3059; Pub. L. 103–43, title I, § 121(b)(1), June 10, 1993, 107 Stat. 133.)

CITE AS: 42 USC 289g

§ 289g–1. Research on transplantation of fetal tissue
(a) Establishment of program
(1) In general
(2) Source of tissue
(b) Informed consent of donor
(1) In generalIn research carried out under subsection (a), human fetal tissue may be used only if the woman providing the tissue makes a statement, made in writing and signed by the woman, declaring that—
(A) the woman donates the fetal tissue for use in research described in subsection (a);
(B) the donation is made without any restriction regarding the identity of individuals who may be the recipients of transplantations of the tissue; and
(C) the woman has not been informed of the identity of any such individuals.
(2) Additional statementIn research carried out under subsection (a), human fetal tissue may be used only if the attending physician with respect to obtaining the tissue from the woman involved makes a statement, made in writing and signed by the physician, declaring that—
(A) in the case of tissue obtained pursuant to an induced abortion—
(i) the consent of the woman for the abortion was obtained prior to requesting or obtaining consent for a donation of the tissue for use in such research;
(ii) no alteration of the timing, method, or procedures used to terminate the pregnancy was made solely for the purposes of obtaining the tissue; and
(iii) the abortion was performed in accordance with applicable State law;
(B) the tissue has been donated by the woman in accordance with paragraph (1); and
(C) full disclosure has been provided to the woman with regard to—
(i) such physician’s interest, if any, in the research to be conducted with the tissue; and
(ii) any known medical risks to the woman or risks to her privacy that might be associated with the donation of the tissue and that are in addition to risks of such type that are associated with the woman’s medical care.
(c) Informed consent of researcher and doneeIn research carried out under subsection (a), human fetal tissue may be used only if the individual with the principal responsibility for conducting the research involved makes a statement, made in writing and signed by the individual, declaring that the individual—
(1) is aware that—
(A) the tissue is human fetal tissue;
(B) the tissue may have been obtained pursuant to a spontaneous or induced abortion or pursuant to a stillbirth; and
(C) the tissue was donated for research purposes;
(2) has provided such information to other individuals with responsibilities regarding the research;
(3) will require, prior to obtaining the consent of an individual to be a recipient of a transplantation of the tissue, written acknowledgment of receipt of such information by such recipient; and
(4) has had no part in any decisions as to the timing, method, or procedures used to terminate the pregnancy made solely for the purposes of the research.
(d) Availability of statements for audit
(1) In general
(2) Confidentiality of auditAny audit conducted by the Secretary pursuant to paragraph (1) shall be conducted in a confidential manner to protect the privacy rights of the individuals and entities involved in such research, including such individuals and entities involved in the donation, transfer, receipt, or transplantation of human fetal tissue. With respect to any material or information obtained pursuant to such audit, the Secretary shall—
(A) use such material or information only for the purposes of verifying compliance with the requirements of this section;
(B) not disclose or publish such material or information, except where required by Federal law, in which case such material or information shall be coded in a manner such that the identities of such individuals and entities are protected; and
(C) not maintain such material or information after completion of such audit, except where necessary for the purposes of such audit.
(e) Applicability of State and local law
(1) Research conducted by recipients of assistance
(2) Research conducted by Secretary
(f) Report
(g) “Human fetal tissue” defined
(July 1, 1944, ch. 373, title IV, § 498A, as added Pub. L. 103–43, title I, § 111, June 10, 1993, 107 Stat. 129.)

CITE AS: 42 USC 289g-1

§ 289g–2. Prohibitions regarding human fetal tissue
(a) Purchase of tissue
(b) Solicitation or acceptance of tissue as directed donation for use in transplantation
It shall be unlawful for any person to solicit or knowingly acquire, receive, or accept a donation of human fetal tissue for the purpose of transplantation of such tissue into another person if the donation affects interstate commerce, the tissue will be or is obtained pursuant to an induced abortion, and—
(1) the donation will be or is made pursuant to a promise to the donating individual that the donated tissue will be transplanted into a recipient specified by such individual;
(2) the donated tissue will be transplanted into a relative of the donating individual; or
(3) the person who solicits or knowingly acquires, receives, or accepts the donation has provided valuable consideration for the costs associated with such abortion.
(c) Solicitation or acceptance of tissue from fetuses gestated for research purposes
It shall be unlawful for any person or entity involved or engaged in interstate commerce to—
(1) solicit or knowingly acquire, receive, or accept a donation of human fetal tissue knowing that a human pregnancy was deliberately initiated to provide such tissue; or
(2) knowingly acquire, receive, or accept tissue or cells obtained from a human embryo or fetus that was gestated in the uterus of a nonhuman animal.
(d) Criminal penalties for violations
(1) In general
(2) Penalties applicable to persons receiving consideration
(e) Definitions
For purposes of this section:
(1) The term “human fetal tissue” has the meaning given such term in section 289g–1(g) of this title.
(2) The term “interstate commerce” has the meaning given such term in section 321(b) of title 21.
(3) The term “valuable consideration” does not include reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue.
(July 1, 1944, ch. 373, title IV, § 498B, as added Pub. L. 103–43, title I, § 112, June 10, 1993, 107 Stat. 131; amended Pub. L. 109–242, § 2, July 19, 2006, 120 Stat. 570.)

CITE AS: 42 USC 289g-2

§ 289g–3. Breast implant research
(a) In general
The Director of NIH may conduct or support research to examine the long-term health implications of silicone breast implants, both gel and saline filled. Such research studies may include the following:
(1) Developing and examining techniques to measure concentrations of silicone in body fluids and tissues.
(2) Surveillance of recipients of silicone breast implants, including long-term outcomes and local complications.
(b) Definition
(July 1, 1944, ch. 373, title IV, § 498C, as added Pub. L. 107–250, title II, § 215(b), Oct. 26, 2002, 116 Stat. 1615.)

CITE AS: 42 USC 289g-3

§ 289g–4. Support for emergency medicine research
(a) Emergency medical research
The Secretary shall support Federal programs administered by the National Institutes of Health, the Agency for Healthcare Research and Quality, the Health Resources and Services Administration, the Centers for Disease Control and Prevention, and other agencies involved in improving the emergency care system to expand and accelerate research in emergency medical care systems and emergency medicine, including—
(1) the basic science of emergency medicine;
(2) the model of service delivery and the components of such models that contribute to enhanced patient health outcomes;
(3) the translation of basic scientific research into improved practice; and
(4) the development of timely and efficient delivery of health services.
(b) Pediatric emergency medical research
The Secretary shall support Federal programs administered by the National Institutes of Health, the Agency for Healthcare Research and Quality, the Health Resources and Services Administration, the Centers for Disease Control and Prevention, and other agencies to coordinate and expand research in pediatric emergency medical care systems and pediatric emergency medicine, including—
(1) an examination of the gaps and opportunities in pediatric emergency care research and a strategy for the optimal organization and funding of such research;
(2) the role of pediatric emergency services as an integrated component of the overall health system;
(3) system-wide pediatric emergency care planning, preparedness, coordination, and funding;
(4) pediatric training in professional education; and
(5) research in pediatric emergency care, specifically on the efficacy, safety, and health outcomes of medications used for infants, children, and adolescents in emergency care settings in order to improve patient safety.
(c) Impact research
(d) Authorization of appropriations
(July 1, 1944, ch. 373, title IV, § 498D, as added Pub. L. 111–148, title III, § 3504(b), Mar. 23, 2010, 124 Stat. 521.)

CITE AS: 42 USC 289g-4

§ 289g–5. Precision medicine initiative
(a) In general
(b) Components
The Initiative described under subsection (a) may include—
(1) developing a network of scientists to assist in carrying out the purposes of the Initiative;
(2) developing new approaches for addressing scientific, medical, public health, and regulatory science issues;
(3) applying genomic technologies, such as whole genomic sequencing, to provide data on the molecular basis of disease;
(4) collecting information voluntarily provided by a diverse cohort of individuals that can be used to better understand health and disease; and
(5) other activities to advance the goals of the Initiative, as the Secretary determines appropriate.
(c) Authority of the Secretary
In carrying out this section, the Secretary may—
(1) coordinate with the Secretary of Energy, private industry, and others, as the Secretary determines appropriate, to identify and address the advanced supercomputing and other advanced technology needs for the Initiative;
(2) develop and utilize public-private partnerships; and
(3) leverage existing data sources.
(d) Requirements
In the implementation of the Initiative under subsection (a), the Secretary shall—
(1) ensure the collaboration of the National Institutes of Health, the Food and Drug Administration, the Office of the National Coordinator for Health Information Technology, and the Office for Civil Rights of the Department of Health and Human Services;
(2) comply with existing laws and regulations for the protection of human subjects involved in research, including the protection of participant privacy;
(3) implement policies and mechanisms for appropriate secure data sharing across systems that include protections for privacy and security of data;
(4) consider the diversity of the cohort to ensure inclusion of a broad range of participants, including consideration of biological, social, and other determinants of health that contribute to health disparities;
(5) ensure that only authorized individuals may access controlled or sensitive, identifiable biological material and associated information collected or stored in connection with the Initiative; and
(6) on the appropriate Internet website of the Department of Health and Human Services, identify any entities with access to such information and provide information with respect to the purpose of such access, a summary of the research project for which such access is granted, as applicable, and a description of the biological material and associated information to which the entity has access.
(e) Report
(July 1, 1944, ch. 373, title IV, § 498E, as added Pub. L. 114–255, div. A, title II, § 2011, Dec. 13, 2016, 130 Stat. 1047.)

CITE AS: 42 USC 289g-5

§ 289h. Repealed. Pub. L. 103–43, title I, § 121(b)(2), June 10, 1993, 107 Stat. 133

CITE AS: 42 USC 289h

§ 290. National Institutes of Health Management Fund; establishment; advancements; availability; final adjustments of advances

For the purpose of facilitating the economical and efficient conduct of operations in the National Institutes of Health which are financed by two or more appropriations where the costs of operation are not readily susceptible of distribution as charges to such appropriations, there is established the National Institutes of Health Management Fund. Such amounts as the Director of the National Institutes of Health may determine to represent a reasonable distribution of estimated costs among the various appropriations involved may be advanced each year to this fund and shall be available for expenditure for such costs under such regulations as may be prescribed by said Director, including the operation of facilities for the sale of meals to employees and others at rates to be determined by said Director to be sufficient to cover the reasonable value of the meals served and the proceeds thereof shall be deposited to the credit of this fund: Provided, That funds advanced to this fund shall be available only in the fiscal year in which they are advanced: Provided further, That final adjustments of advances in accordance with actual costs shall be effected wherever practicable with the appropriations from which such funds are advanced.

(Pub. L. 85–67, title II, § 201, June 29, 1957, 71 Stat. 220; Pub. L. 87–290, title II, § 201, Sept. 22, 1961, 75 Stat. 603.)

CITE AS: 42 USC 290

§ 290a. Victims of fire
(a) Research on burns, burn injuries, and rehabilitation
The Secretary of Health and Human Services shall establish, within the National Institutes of Health and in cooperation with the Administrator of FEMA, an expanded program of research on burns, treatment of burn injuries, and rehabilitation of victims of fires. The National Institutes of Health shall—
(1) sponsor and encourage the establishment throughout the Nation of twenty-five additional burn centers, which shall comprise separate hospital facilities providing specialized burn treatment and including research and teaching programs and twenty-five additional burn units, which shall comprise specialized facilities in general hospitals used only for burn victims;
(2) provide training and continuing support of specialists to staff the new burn centers and burn units;
(3) sponsor and encourage the establishment of ninety burn programs in general hospitals which comprise staffs of burn injury specialists;
(4) provide special training in emergency care for burn victims;
(5) augment sponsorship of research on burns and burn treatment;
(6) administer and support a systematic program of research concerning smoke inhalation injuries; and
(7) sponsor and support other research and training programs in the treatment and rehabilitation of burn injury victims.
(b) Authorization of appropriations
(Pub. L. 93–498, § 19, Oct. 29, 1974, 88 Stat. 1547; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 106–503, title I, § 110(a)(2)(B)(vii), Nov. 13, 2000, 114 Stat. 2302; Pub. L. 112–239, div. A, title XVIII, § 1802(b)(1), Jan. 2, 2013, 126 Stat. 2100.)

CITE AS: 42 USC 290a