45 CFR Part 46 - PART 46—PROTECTION OF HUMAN SUBJECTS

CFR
State Regulations

Subpart A—Basic HHS Policy for Protection of Human Research Subjects (§§ 46.101 - 46.124)
Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research (§§ 46.201 - 46.207)
Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects (§§ 46.301 - 46.306)
Subpart D—Additional Protections for Children Involved as Subjects in Research (§§ 46.401 - 46.409)
Subpart E—Registration of Institutional Review Boards (§§ 46.501 - 46.505)

Authority:

5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v–1(b).

Editorial Note:

The Department of Health and Human Services issued a notice of waiver regarding the requirements set forth in part 46, relating to protection of human subjects, as they pertain to demonstration projects, approved under section 1115 of the Social Security Act, which test the use of cost—sharing, such as deductibles, copayment and coinsurance, in the Medicaid program. For further information see 47 FR 9208, Mar. 4, 1982.

The following state regulations pages link to this page.

Alabama

Ala. Admin. Code r. 482-1-071-.24 - 482-1-071-.24 - Prohibition Against Use Of Genetic Information And Requests For Genetic Testing

Alaska

Alaska Admin. Code Title 3 § 28.508 - 3 AAC 28.508 - Prohibition against use of genetic information and requests for genetic testing

Arizona

Ariz. Admin. Code R9-1-301 - R9-1-301 - Definitions

Ariz. Admin. Code R9-25-1308 - R9-25-1308 - Trauma Center Responsibilities (A.R.S. §§ 36-2202(A)(4), 36-2208(A), 36-2209(A)(2), 36-2221, and 36-2225(A)(4), (5), and (6))

Arkansas

Ark. Admin. Rules 054-027-24 - Section 24 - Prohibition against Use of Genetic Information and Requests for Genetic Testing.

California

8 CCR Sec. 6050 - § 6050 - General.

Colorado

1 CCR 212-3 - 1 CCR 212-3 - COLORADO MARIJUANA RULES

Delaware

18 Del. Admin. Code § 1501 - 1501 - Medicare Supplement Insurance Minimum Standards

Florida

Fla. Admin. Code r. 64E-5.601 - 64E-5.601 - License Required

Georgia

GA Reg. 120-2-8-.24 - Rule 120-2-8-.24 - Prohibition Against Use of Genetic Information and Requests for Genetic Testing

Hawaii

Haw. Code R. §16-12-12.9 - §16-12-12.9 - Prohibition against use of genetic information and requests for genetic testing.

Idaho

Idaho Admin. Code r. 18.04.10.082 - 082 - PROHIBITION AGAINST USE OF GENETIC INFORMATION AND REQUESTS FOR GENETIC TESTING.

Indiana

760 Ind. Admin. Code 3-19.1-1 - 760 IAC 3-19.1-1 - Prohibition against discrimination, use of genetic information, and requests for genetic testing

Iowa

Iowa Admin. Code r. 191-37.34 - 191.37.34 - Prohibitions against use of genetic information and against requests for genetic testing.

Iowa Admin. Code r. 481-58.39 - 481.58.39 - Residents’ rights in general.

Iowa Admin. Code r. 481-65.25 - 481.65.25 - Residents’ rights in general.

Louisiana

La. Admin. Code tit. 37, Part XIII, §4513 - §4513 - Prohibitions on the Use of Medical Information and Genetic Test Results

La. Admin. Code tit. 37, Part XIII, §591 - §591 - Prohibition Against Use of Genetic Information and Requests for Genetic Testing

La. Admin. Code tit. 48, Part I, §2505 - §2505 - Definitions

La. Admin. Code tit. 48, Part I, §2509 - §2509 - Policies and Procedures

Maine

02 031 Me. Code R. Ch. 275 § 24 - Section 24 - Prohibition Against Use of Genetic Information and Requests for Genetic Testing

Maryland

COMAR 10.18.02.03 - 10.18.02.03 - Definitions.

COMAR 10.25.18.02 - 10.25.18.02 - Definitions.

COMAR 10.47.01.07 - 10.47.01.07 - Patient Rights and Grievance Procedures.

COMAR 31.10.06.26 - 31.10.06.26 - Prohibition Against Use of Genetic Information and Requests for Genetic Testing.

Massachusetts

104 Mass. Code Regs. 31.04 - 31.04 - Institutional Review Board (IRB)

105 Mass. Code Regs. 240.006 - 240.006 - Suitable Clinical Trials

105 Mass. Code Regs. 305.004 - 305.004 - Definitions

105 Mass. Code Regs. 305.070 - 305.070 - Application for Access to Confidential Birth Information for Research Purposes

105 Mass. Code Regs. 724.003 - 724.003 - Requirements for the Therapeutic Research Program

105 Mass. Code Regs. 970.004 - 970.004 - Definitions

Mississippi

Miss. Admin. Code. 19-3-10.24 - Rule 10.24 - Prohibition Against use of Genetic Information and Requests for Genetic Testing This Section applies to all policies with policy years beginning on or after May 21, 2009.

Missouri

20 CSR 2220-2.005 - 20 CSR 2220-2.005 - Definitions

Montana

Mont. Admin. R. 2.21.6615 - 2.21.6615 - ACCESS TO EMPLOYEE PERSONNEL RECORDS

Mont. Admin. R. 6.6.527 - 6.6.527 - PROHIBITION AGAINST USE OF GENETIC INFORMATION AND REQUESTS FOR GENETIC TESTING

New Hampshire

N.H. Code Admin. R. Ins 1905.26 - Ins 1905.26 - Prohibition Against Use of Genetic Information and Requests for Genetic Testing

North Carolina

10A NCAC 13B .3302 - 10A NCAC 13B .3302 - MINIMUM PROVISIONS OF PATIENT'S BILL OF RIGHTS

10A NCAC 47C .0102 - 10A NCAC 47C .0102 - DEFINITIONS

North Dakota

N.D. Admin. Code 45-06-01.1-20.1 - 45-06-01.1-20.1 - Prohibition against use of genetic information and requests for genetic testing.

Ohio

Ohio Admin. Code 3341-7-07 - 3341-7-07 - Protection of human subjects.

Ohio Admin. Code 3354:1-30-06 - 3354:1-30-06 - Policy on human subjects research.

Ohio Admin. Code 3361:10-17-10 - 3361:10-17-10 - Conduct and ethics: ethical conduct in research involving human subjects.

Ohio Admin. Code 3701:1-58-04 - 3701:1-58-04 - Provisions for the protection of human research subjects.

Ohio Admin. Code 3701:1-66-17 - 3701:1-66-17 - Medical screening and research.

Oklahoma

Okla Admin. Code § 310:10-1-1 - Section 310:10-1-1 - General purpose

Okla Admin. Code § 310:10-1-3 - Section 310:10-1-3 - Definitions

Okla Admin. Code § 310:10-1-4 - Section 310:10-1-4 - Incorporations by reference

Okla Admin. Code § 310:10-3-3 - Section 310:10-3-3 - Compliance with 45 C.F.R. Part 46

Okla Admin. Code § 310:10-5-3 - Section 310:10-5-3 - Compliance with 45 C.F.R. Part 46

Okla Admin. Code § 310:10-7-1 - Section 310:10-7-1 - Responsibility for research integrity

Okla Admin. Code § 310:2-31-1 - Section 310:2-31-1 - General purpose

Okla Admin. Code § 310:2-31-3 - Section 310:2-31-3 - Definitions

Okla Admin. Code § 310:2-31-4 - Section 310:2-31-4 - Incorporations by reference

Okla Admin. Code § 340:2-39-5 - Section 340:2-39-5 - Purpose, scope, and authority

Okla Admin. Code § 340:2-39-7 - Section 340:2-39-7 - Principle and Policies

Okla Admin. Code § 365:10-5-143 - Section 365:10-5-143 - Prohibition against use of genetic information and requests for genetic testing

Okla Admin. Code § 450:1-1-1.1 - Section 450:1-1-1.1 - Definitions

Okla Admin. Code § 450:1-11-5 - Section 450:1-11-5 - Compliance with 45 C.F.R. Part 46

Oregon

OR Admin. Rule 137-087-0085 - 137-087-0085 - Research Programs

OR Admin. Rule 333-010-0055 - 333-010-0055 - Cancer Reporting Regulations: Research Studies

OR Admin. Rule 333-025-0100 - 333-025-0100 - Definitions

OR Admin. Rule 333-270-0080 - 333-270-0080 - Access to Registry Information by Researchers

OR Admin. Rule 407-014-0000 - 407-014-0000 - Definitions

OR Admin. Rule 407-014-0060 - 407-014-0060 - Uses and Disclosures of Protected Information for Research Purposes

OR Admin. Rule 836-052-0192 - 836-052-0192 - Prohibition Against Use of Genetic Information and Requests for Genetic Testing

OR Admin. Rule 845-025-5350 - 845-025-5350 - Marijuana Research Certificate Privileges; Prohibitions

OR Admin. Rule 943-014-0000 - 943-014-0000 - Definitions

OR Admin. Rule 943-014-0060 - 943-014-0060 - Uses and Disclosures of Protected Information for Research Purposes

Pennsylvania

31 Pa. Code § 89.791 - § 89.791 - Prohibition against use of genetic information and requests for genetic testing.

Rhode Island

216-RICR-40-20-3 - Part 3 - Registration of X-Ray Equipment Facilities and Radiation Physics Services (216-RICR-40-20-3)

216-RICR-40-20-5 - Part 5 - Therapeutic Radiation Machines (216-RICR-40-20-5)

230-RICR-20-30-7 - Part 7 - Medicare Supplement Insurance Minimum Standards

South Carolina

S.C. Code Regs. 69-46 - 69-46 - Medicare Supplement Insurance.

Tennessee

TN Rules and Regs. 0780-01-58-.27 - 0780-01-58-.27 - PROHIBITION AGAINST USE OF GENETIC INFORMATION AND REQUESTS FOR GENETIC TESTING

Utah

Utah Admin. Code R590-146-24 - R590-146-24 - Prohibition Against Use of Genetic Information and Requests for Genetic Testing.

Vermont

Vt. Code R. 21 040 013 - 21 040 013 - MEDICARE SUPPLEMENT INSURANCE MINIMUM STANDARDS REGULATIONS

Virginia

12 Va. Admin. Code § 5-191-120 - 12VAC5-191-120 - Federally required assurances and certifications.

14 Va. Admin. Code § 5-170-215 - 14VAC5-170-215 - Prohibition against use of genetic information and requests for genetic testing.

8 Va. Admin. Code § 20-671-770 - 8VAC20-671-770 - Participation of students in human research.

8 Va. Admin. Code § 35-70-20 - 8VAC35-70-20 - Federal regulations adopted.

8 Va. Admin. Code § 90-80-20 - 8VAC90-80-20 - Federal regulations adopted.

Washington

Wash. Admin. Code § 284-66-071 - 284-66-071 - Prohibition against use of genetic information and requests for genetic testing.

Wash. Admin. Code § 296-20-02850 - 296-20-02850 - When may the department cover controversial, obsolete, investigational or experimental treatment?

Wash. Admin. Code § 296-37-510 - 296-37-510 - Scope and application.

West Virginia

WV Code Reg. 114-24-22 - §114-24-22 - Prohibition Against Use of Genetic Information and Requests for Genetic Testing

WV Code Reg. 64-59-9 - §64-59-9 - Research and Experimental Treatment.

Wisconsin

Wis. Admin. Code DHS Sec. 157.59 - DHS 157.59 - General requirements

Wis. Admin. Code DHS Sec. 75.15 - DHS 75.15 - Narcotic treatment service for opiate addiction

Wyoming

Health, Department of, Health Care Innovation Studies, Ch. 1 § 5 - Section 5 - Award or Denial of Health Care Innovation Account Funding.

Insurance Dept., General Agency, Board or Commission Rules, Ch. 35 § 24 - Section 24 - Prohibition Against Use of Genetic Information and Requests for Genetic Testing.