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42 U.S.C. § 289 — Institutional review boards; ethics guidance program

Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 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.

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Source file: Laws/federal/codes/united-states-code/title-42/section-289-institutional-review-boards-ethics-guidance-program--97ef6f7594.md
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Source location: Title 42, Chapter 6A, § 289; chapter-6a-public-health-service.md

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 201 — Funding

Beginning with fiscal year 2010, the Secretary shall transfer from the Public Health and Social Services Emergency Fund such sums as may be necessary to carry out this part.

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 202 — Definitions

When used in this chapter— **(a)** The term “Service” means the Public Health Service; **(b)** The term “Surgeon General” means the Surgeon General of the Public Health Service; **(c)** Unless the context otherwise requires, the term “Secretary” means the Secretary of Health and Human Services. **(d)** The term “regulations”, except when otherwise specified, means rules and regulations made by the Surgeon General with the approval of the Secretary; **(e)** The term “executive department” means any executive department, agency, or independent establishment of the United States or any corporation wholly owned by the United States; **(f)** Except as provided in sections 246(g)(4)(B),11 See References in Text note below. 247c(c)(1),1 254d(h)(3),1 263c(5),1 264(d), 292a(9),1 300a(c), 300f(13), and 300n(1) 1 of this title, the term “State” includes, in addition to the several States, only the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, American Samoa, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau. **(g)** The term “possession” includes, among other possessions, Puerto Rico and the Virgin Islands; **(h)** Repealed. Pub. L. 97–35, title IX, § 986(a), Aug. 13, 1981, 95 Stat. 603. **(i)** The term “vessel” includes every description of watercraft or other artificial contrivance used, or capable of being used, as a means of transportation on water, exclusive of aircraft and amphibious contrivances; **(j)** The term “habit-forming narcotic drug” or “narcotic” means opium and coca leaves and the several alkaloids derived therefrom, the best known of these alkaloids being morphia, heroin, and codeine, obtained from opium, and cocaine derived from the coca

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 218a — National Advisory Councils on Migrant Health

**(a) Appointment; duties** Within 120 days of July 29, 1975, the Secretary shall appoint and organize a National Advisory Council on Migrant Health (hereinafter in this subsection referred to as the “Council”) which shall advise, consult with, and make recommendations to, the Secretary on matters concerning the organization, operation, selection, and funding of migrant health centers and other entities under grants and contracts under section 254b 11 See References in Text note below. of this title. **(b) Membership** The Council shall consist of fifteen members, at least twelve of whom shall be members of the governing boards of migrant health centers or other entities assisted under section 254b 1 of this title. Of such twelve members who are members of such governing boards, at least nine shall be chosen from among those members of such governing boards who are being served by such centers or grantees and who are familiar with the delivery of health care to migratory agricultural workers and seasonal agricultural workers. The remaining three Council members shall be individuals qualified by training and experience in the medical sciences or in the administration of health programs. **(c) Terms of office** Each member of the Council shall hold office for a term of four years, except that (1) any member appointed to fill a vacancy occurring prior to the expiration of the term for which his predecessor was appointed shall be appointed for the remainder of such term; and (2) the terms of the members first taking office after July 29, 1975, shall expire as follows: four shall expire four years after such date, four shall expire three years after such date, four shall expire two years after such date, and three shall expire one year after such date, as designated by the

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 289 — Institutional review boards; ethics guid-

Page 796 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 289 PART H—GENERAL PROVISIONS Editorial Notes CODIFICATION Pub. L. 103–43, title I, § 141(a)(2), June 10, 1993, 107 Stat. 136, redesignated part G ‘‘General Provisions’’ as H. Former part H ‘‘National Foundation for Biomedical Research’’ redesignated I. § 289. Institutional review boards; ethics guid- ance program (a) The Secretary shall by regulation require that each entity which applies for a grant, con- tract, or cooperative agreement under this chap- ter 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 coopera- tive agreement assurances satisfactory to the Secretary that it has established (in accordance with regulations which the Secretary shall pre- scribe) a board (to be known as an ‘‘Institutional Review Board’’) to review biomedical and behav- ioral research involving human subjects con- ducted 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 behav- ioral research involving human subjects are re- sponded to promptly and appropriately. (2) The Secretary shall establish a process for the prompt and appropriate response to informa- tion 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 re- ports of such informatio

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