Appendix G: Statutory Authority for Agency Human Subjects Protection Regulations (Research Involving Human Participants V1)

US Government Departments and Regulations Regarding Human Subjects in Research

Department	Regulation	Subject
Department of Agriculture:	7 CFR 1c	Protection of human subjects
Department of Energy:	10 CFR 745	Protection of human subjects
National Aeronautics and Space Administration:	14 CFR 1230	Protection of human subjects
Department of Commerce:	15 CFR 27	Protection of human subjects
Consumer Product Safety Commission:	16 CFR 1028	Protection of human subjects
Agency for International Development:	22 CFR 225	Protection of human subjects
Department of Housing and Urban Development:	24 CFR 60	Protection of human subjects
Department of Justice:	28 CFR 46	Protection of human subjects
Department of Defense:	32 CFR 219	Protection of human subjects
Department of Education:	34 CFR 97	Protection of human subjects
Department of Veterans Affairs:	38 CFR 16	Protection of human subjects
Environmental Protection Agency:	40 CFR 26	Protection of human subjects
Department of Health and Human Services:	45 CFR 46	Protection of human subjects
National Science Foundation:	45 CFR 690	Protection of human subjects
Department of Transportation:	49 CFR 11	Protection of human subjects

5 USC 301

Departmental regulations.

The head of an Executive department or military department may prescribe regulations for the government of his department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property. This section does not authorize withholding information from the public or limiting the availability of records to the public.

42 USC 300v-1(b)

Duties of Commission.

(b) Recommendations to agencies; subsequent administrative requirements

1. Within 60 days of the date a Federal agency receives a recommendation from the Commission that the agency take any action with respect to its rules, policies, guidelines, or regulations, the agency shall publish such recommendation in the Federal Register and shall provide opportunity for interested persons to submit written data, views, and arguments with respect to adoption of the recommendation.
2. Within the 180-day period beginning on the date of such publication, the agency shall determine whether the action proposed by such recommendation is appropriate, and, to the extent that it determines that - (A) such action is not appropriate, the agency shall, within such time period, provide the Commission with, and publish in the Federal Register, a notice of such determination (including an adequate statement of the reasons for the determination), or (B) such action is appropriate, the agency shall undertake such action as expeditiously as feasible and shall notify the Commission of the determination and the action undertaken.

Additional Statutory Authority Cited for Agency Human Subject Protection Regulations (Common Rule)

Department of Energy 42 USC 7254

Rules and regulations.

The Secretary is authorized to prescribe such procedural and administrative rules and regulations as he may deem necessary or appropriate to administer and manage the functions now or hereafter vested in him.

Department of Housing and Urban Development 42 USC 3535 Administrative provisions.

(d) Delegation of authority; rules and regulations

The Secretary may delegate any of his functions, powers, and duties to such officers and employees of the Department as he may designate, may authorize such successive redelegations of such functions, powers, and duties as he may deem desirable, and may make such rules and regulations as may be necessary to carry out his functions, powers, and duties.

Department of Justice 28 USC 509 Functions of the Attorney General.

All functions of other officers of the Department of Justice and all functions of agencies and employees of the Department of Justice are vested in the Attorney General except the functions

1. vested by subchapter II of chapter 5 of title 5 in administrative law judges employed by the Department of Justice;
2. of the Federal Prison Industries, Inc.; and
3. of the Board of Directors and officers of the Federal Prison Industries, Inc.

28 USC 510 Delegation of authority.

The Attorney General may from time to time make such provisions as he considers appropriate authorizing the performance by any other officer, employee, or agency of the Department of Justice of any function of the Attorney General.

Department of Education 20 USC 1221e-3 General authority of Secretary.

The Secretary, in order to carry out functions otherwise vested in the Secretary by law or by delegation of authority pursuant to law, and subject to limitations as may be otherwise imposed by law, is authorized to make, promulgate, issue, rescind, and amend rules and regulations governing the manner of operation of, and governing the applicable programs administered by, the Department.

20 USC 3474 Rules and regulations.

The Secretary is authorized to prescribe such rules and regulations as the Secretary determines necessary or appropriate to administer and manage the functions of the Secretary or the Department.

Department of Veterans Affairs 38 USC 501 Rules and regulations.

(a) The Secretary has authority to prescribe all rules and regulations which are necessary or appropriate to carry out the laws administered by the Department and are consistent with those laws, including - (1) regulations with respect to the nature and extent of proof and evidence and the method of taking and furnishing them in order to establish the right to benefits under such laws;Ö (c) In applying section 552(a)(1) of title 5 to the Department, the Secretary shall ensure that subparagraphs (C), (D), and (E) of that section are complied with, particularly with respect to opinions and interpretations of the General Counsel.

38 USC 7331 Informed consent.

The Secretary, upon the recommendation of the Under Secretary for Health and pursuant to the provisions of section 7334 of this title, shall prescribe regulations establishing procedures to ensure that all medical and prosthetic research carried out and, to the maximum extent practicable, all patient care furnished under this title shall be carried out only with the full and informed consent of the patient or subject or, in appropriate cases, a representative thereof.

38 USC 7334 Regulations.

1. Regulations prescribed by the Secretary under section 7331 of this title, section 7332 of this title with respect to the confidentiality of alcohol and drug abuse medical records, and section 7333 of this title with respect to alcohol or drug abusers shall, to the maximum extent feasible consistent with other provisions of this title, make applicable the regulations described in subsection (b) to the conduct of research and to the provision of hospital care, nursing home care, domiciliary care, and medical services under this title.
2. The regulations referred to in subsection (a) are
   1. regulations governing human experimentation and informed consent prescribed by the Secretary of Health and Human Services, based on the recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, established by section 201 of the National Research Act (Public Law 93-348; 88 Stat. 348); and
   2. regulations governing (A) the confidentiality of drug and alcohol abuse medical records, and (B) the admission of drug and alcohol abusers to private and public hospitals, prescribed pursuant to the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970 (42 USC 4551 et seq.) and the Drug Abuse Office and Treatment Act of 1972 (21 USC 1101 et seq.).
3. Regulations prescribed by the Secretary under sections 7331, 7332, and 7333 of this title may contain such definitions, and may provide for such safeguards and procedures (including procedures and criteria for the issuance and scope of court orders undersection 7332(b)(2)(C) [1] of this title), as are necessary to prevent circumvention or evasion of such regulations or to facilitate compliance with such regulations.
4. In prescribing and implementing such regulations, the Secretary shall, from time to time, consult with the Secretary of Health and Human Services and, as appropriate, with the President (or the delegate of the President) in order to achieve the maximum possible coordination of the regulations, and the implementation of the regulations, which they and the Secretary prescribe.

Department of Health and Human Services 42 USC 289 Institutional review boards; ethics guidance program.

1. 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.
2. 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.

Related Human Subjects Protection Regulations (Not Common Rule) and Statutory Authority Cited

Department of Justice Bureau of Prisons

• 28 CFR 512 - Research
• 5 USC 301 - Departmental regulations.
• 18 USC 3621 - Imprisonment of a convicted person.
• 18 USC 3622 - Temporary release of a prisoner.
• 18 USC 3624 - Release of a prisoner.
• 18 USC 4001 - Limitation on detention; control of prisons.
• 18 USC 4042 - Duties of Bureau of Prisons.
• 18 USC 4081 - Classification and treatment of prisoners.
• 18 USC 4082 - Commitment to Attorney General; residential treatment centers; extension of limits of confinement; work furlough (repealed in part as to offenses committed on or after November 1, 1987).
• 18 USC 5006 - 5024 Chapter 402 of Part IV Correction of youthful offenders (Repealed October 12, 1984 as to offenses committed after that date).
• 18 USC 5039 - Commitment (of youthful offenders).
• 28 USC 509 - Functions of the Attorney General.
• 28 USC 510 - Delegation of authority.

Department of Education

• 34 CFR 97, Subpart D Additional ED protections for children who are subjects in research
  • 5 USC 301 Departmental regulations.
    • 20 USC 1221e-3 General authority of Secretary.
    • 20 USC 3474 Rules and regulations.
  • 42 USC 300v-1(b) Duties of Commission.
    • 34 CFR 98 - Student rights in research, experimental programs, and testing.
    • 20 USC 1221e-3 - General authority of Secretary.
    • 20 USC 1232h - Protection of pupil rights (a) Inspection of instructional materials by parents or guardians.
    • 20 USC 1232h - Protection of pupil rights (b) Limits on survey, analysis, or evaluations.
    • 20 USC 3474 - Rules and regulations.
    • 34 CFR 99 - Family educational rights and privacy.
    • 20 USC 1232g - Family educational and privacy rights.

Office of Special Education and Rehabilitative Services

• 34 CFR 350.4(c) - What regulations apply?
  • 29 USC 761a - Authorization of appropriations.
  • 29 USC 762 - National Institute on Disability and Rehabilitation Research.
  • 42 USC 300v-1(b) - Duties of Commission.
• 34 CFR 356.3(c) - Disability and rehabilitation research: Research fellowships.
  • 29 USC 761a - Authorization of appropriations.
  • 42 USC 300v-1(b) - Duties of Commission.

Department of Veterans Affairs

• 38 CFR 17.85 - Treatment of research-related injuries to human subjects.
  • 38 USC 501 - Rules and regulations.
  • 38 USC 7303 - Functions of Veterans Health Administration: research programs.

Department of Health and Human Services

• 45 CFR 46 Subpart B - Additional Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women, and Human In Vitro Fertilization.
  • 5 USC 301 - Departmental regulations.
  • 42 USC 289 - Institutional review boards; ethics guidance program.
  • 42 USC 300v-1(b) - Duties of Commission.
• 45 CFR 46 Subpart C - Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
  • 5 USC 301 - Departmental regulations.
  • 42 USC 289 - Institutional review boards; ethics guidance program.
  • 42 USC 300v-1(b) - Duties of Commission.
• 45 CFR 46 Subpart D - Additional protections for children involved as subjects in research
  • 5 USC 301 - Departmental regulations.
  • 42 USC 289 - Institutional review boards; ethics guidance program.
  • 42 USC 300v-1(b) - Duties of Commission.

Food and Drug Administration

• 21 CFR 50 - Protection of human subjects
• 21 USC β 321 - Definitions; generally.
• 21 USC β 346 - Tolerances for poisonous or deleterious substances in food; regulations.
• 21 USC β 346a - Tolerances and exemptions for pesticide chemical residues.
• 21 USC β 348 - Food additives
• 21 USC β 352 - Misbranded drugs and devices
• 21 USC β 353 - Exemptions and consideration for certain drugs, devices, and biological products
• 21 USC β 355 - Registration of producers of drugs or devices
• 21 USC β 360
• 21 USC β 360c - Classification of devices intended for human use.
• 21 USC β 360d - Performance standards.
• 21 USC β 360e - Premarket approval.
• 21 USC β 360f - Banned devices.
• 21 USC β 360h - Notification and other remedies.
• 21 USC β 360i - Records and reports on devices
• 21 USC β 360j - General provisions respecting control of devices intended for human use.
• 21 USC β 371 - Regulations and hearings
• 21 USC β 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics.
• 21 USC β 381 - Imports and exports.
• 42 USC β 216 - Regulations.
• 42 USC β 241 - Research and investigations generally.
• 42 USC β 262 - Regulation of biological products
• 42 USC β 263b - Certification of mammography facilities.
• 21 CFR 56 - Institutional review boards
• 21 USC β 321 - Definitions; generally.
• 21 USC β 346 - Tolerances for poisonous or deleterious substances in food; regulations
• 21 USC β 346a - Tolerances and exemptions for pesticide chemical residues.
• 21 USC β 348 - Food additives
• 21 USC β 351 - Adulterated drugs and devices
• 21 USC β 352 - Misbranded drugs and devices
• 21 USC β 353 - Exemptions and consideration for certain drugs, devices, and biological products
• 21 USC β 355 - New drugs.
• 21 USC β 360 - Registration of producers of drugs or devices
• 21 USC β 360c - Classification of devices intended for human use.
• 21 USC β 360d - Performance standards.
• 21 USC β 360e - Premarket approval.
• 21 USC β 360f - Banned devices.
• 21 USC β 360h - Notification and other remedies.
• 21 USC β 360i - Records and reports on devices.
• 21 USC β 360j - General provisions respecting control of devices intended for human use.
• 21 USC β 371 - Regulations and hearings.
• 21 USC β 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics.
• 21 USC β 381 - Imports and exports.
• 42 USC β 216 - Regulations.
• 42 USC β 241 - Research and investigations generally.
• 42 USC β 262 - Regulation of biological products.
• 42 USC β 263b - Certification of mammography facilities.