What is the 45 CFR 46?

Laws set by the U.S. Department of Health and Human Services (DHHS) to protect a person from risks in research studies that any federal agency or department has a part in. Also called 45 Code of Federal Regulations Part 46, human participant protection regulations, and Protection of Human Subjects.

Who does 45 CFR 46 apply to?

In the United States, the Code of Federal Regulations Title 45: Public Welfare, part 46 (45 CFR 46) provides protection for human subjects in research carried out or supported by most federal departments and agencies.

Which groups are protected in the Federal regulations 45 CFR 46?

The HHS regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children.

Does the research involve human subjects as defined by 45 CFR Part 46?

Part 46, Title 45 of the CFR, also known as the Common Rule, applies to all research involving human subjects conducted, supported or otherwise subject to regulation by HHS, including research conducted by federal civilian employees or military personnel, and research conducted, supported, or otherwise subject to …

What did 45 CFR 46 raised to regulatory status?

Issued in 1974, 45 CFR 46 raised to regulatory status: US Public Health Service Policy (45 CFR 46 raised to regulatory status the US Public Health Service policy of 1966 “Clinical research and investigation involving human beings”.)

What does IRB stand for?

Institutional Review Board
Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

What is IRB charged with?

The IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human participants. The IRB is concerned with protecting the welfare, rights, and privacy of human subjects.

Which portions of Code of Federal Regulations 45 CFR 46 specifically addresses vulnerable populations?

When conducting research, some populations of research participants require special considerations. The Code of Federal Regulations (CFR 45 part 46) Protection of Human Subjects includes Subparts B, C and D, that describe special protections and criteria for inclusion of pregnant women, prisoners and children.

What are the four common abuses that historically are described as giving rise to vulnerability?

There are four common abuses that historically are described as giving rise to vulnerability 1) physical control, 2) coercion, 3) undue influence, and 4) manipulation.

Why was the Common Rule made?

[3] The Common Rule was developed in response to recommendations made by the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research in 1981 calling for the adoption by all federal agencies of Department of Health and Human Services regulations then in effect for the …

Why is the Common Rule important?

The Common Rule establishes the core procedures for human research subject protections, which include informed consent and review by an Institutional Review Board (IRB). …

What is part 46 of the 45 CFR?

45 CFR Part 46 – PROTECTION OF HUMAN SUBJECTS. 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,…

What does ” minimal risk ” mean in 45 CFR?

45 CFR 46 (Protection of Human Subjects) (d) “Minimal risk” is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.

Is the OHRP annotated version of the common rule?

In addition, OHRP provides an annotated version of the Common Rule that highlights changes between the pre-2018 and 2018 versions of the Common Rule. In general, research initiated before January 21, 2019 continues to comply with the pre-2018 Common Rule unless the institution chose to transition it to the revised Common Rule.

What is Rule 10.24 of the CFR?

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