Question: Who does the Common Rule protect?

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.

Who does the Common Rule apply to?

The Common Rule applies to human subjects research conducted, supported or otherwise subject to regulation by the VA. If VA investigators receive support from DHHS (NIH, CDC, etc.), additional subparts of 45 CFR Part 46 may apply.

What does the Common Rule Cover?

The Common Rule is the baseline standard of ethics by which any government-funded research in the US is held; nearly all academic institutions hold their researchers to these statements of rights regardless of funding.

What is a Common Rule department or agency?

o One original signatory (Department of Justice) intends to become an official signatory to the revised Common Rule • The Food and Drug Administration (FDA) is an HHS agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices.

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Why is the Common Rule called the Common Rule?

The Federal Policy for the Protection of Human Subjects is known as the “Common Rule” because it has been adopted by a number of federal departments and agencies.

What is 45 CFR 46 Subpart A?

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. The Common Rule, subpart A, was revised in recent years.

How does the Common Rule define a human subject?

Common Rule Definition of Human Subject:

through intervention or interaction with the individual, and uses, studies or analyzes the information or. obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

What is FDA Common Rule?

The purposes of the Common Rule are to promote uniformity, understanding, and compliance with human subject protections and to create a uniform body of regulations across the federal departments and agencies.

What is human subject protection?

“Human Subjects Protections” is a collective term for the federal, state, and university policies, procedures, and ethical considerations that protect the rights and welfare of human beings who participate in research as the subjects of that research.

What is the new Common Rule?

The new Common Rule broadens the types of research that may be determined to be exempt from IRB review. For example, starting January 19, benign behavioral interventions conducted with adults may be determined to be exempt.

What are the three fundamental principles of informed consent?

The principle of respect for persons is interpreted to mean that researchers should, if possible, receive informed consent from participants, and the Belmont Report identifies three elements of informed consent: information, comprehension, and voluntariness.

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What expedited review?

[1] An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.