What is the Code of Federal Regulations 45 CFR 46?

What is the Code of Federal Regulations 45 CFR 46?

45 CFR 46: Protection of Human Subjects under United States Law (1974) 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.

What is the HHS Common Rule?

The Common Rule generally requires that researchers get informed consent from volunteers who participate in research. This includes giving them information about the study, including risks and benefits.

What federal regulations require the IRB?

21 CFR 56.111(a)(1) requires the IRB to assure that risks to the subjects are minimized. 21 CFR 56.111(a)(2) requires the IRB to assure that the risks to subjects are reasonable in relation to the anticipated benefits.

Is my research human subjects?

Private identifiable specimens, records and data about individuals are considered to be human subjects, even if the researcher has no contact or interaction with the individuals. “Third party” or “secondary” subjects.

What groups are protected under 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.

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

Vulnerable populations include those defined 45 CFR 46 Subparts B (Pregnant Women), Subpart C (Prisoners), andSubpart D (Children), and those mentioned in 45 CFR 46.111(b): mentally disabled persons, or economically or educationally disadvantaged persons.

What is covered in 45 CFR 46 Subpart A or the Common Rule?

Subpart A, also known as the Common Rule, provides a robust set of protections for research subjects; subparts B, C, and D provide additional protections for certain populations in research; and subpart E provides requirements for IRB registration.

What are the three ethical principles that constitute the basis for the HHS Human Subjects regulations 45 CFR 46?

Belmont articulates “three principles, or general prescriptive judgements, that are relevant to research involving human subjects”: Respect for Persons, Beneficence and Justice. The applications to the research enterprise of Respect for Persons and Beneficence are clearly described.

What are the Nine revised Common Rule basic elements of an informed consent?

These include: obtaining informed consent before involving a human subject in a research activity; only seeking informed consent under circumstances that provide the prospective subject sufficient opportunity to discuss and consider whether or not to participate; providing information to potential subjects in a way …

What qualifies as human subjects?

, a human subject is “a living individual about whom an investigator (whether professional or student) conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or.

What is exempt human research?

Human subjects research that is classified as “exempt” means that the research qualifies as no risk or minimal risk to subjects and is exempt from most of the requirements of the Federal Policy for the Protection of Human Subjects, but is still considered research requiring an IRB review for an exemption determination.

What are three ethical principles that constitute the basis for the HHS Human Subjects regulations 45 CFR 46 )?

Belmont articulates “three principles, or general prescriptive judgements, that are relevant to research involving human subjects”: Respect for Persons, Beneficence and Justice.

What are vulnerable and protected populations?

There are some groups who have been identified by the federal regulations as “vulnerable populations”: pregnant women and fetuses, minors, prisoners, persons with diminished mental capacity, and those who are educationally or economically disadvantaged.

What are vulnerable populations?

Vulnerable populations include the economically disadvantaged, racial and ethnic minorities, the uninsured, low-income children, the elderly, the homeless, those with human immunodeficiency virus (HIV), and those with other chronic health conditions, including severe mental illness.

Which are the three key principles for the protection of human research subjects established by the Belmont Report in the 1970s?

Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.