What does the Common Rule specifically identify?

What does the Common Rule specifically identify?

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 the Common Rule in clinical research?

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 are the Common Rule elements of informed consent for a research study?

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 …

Which of the following is one of the three basic protections provided by the Common Rule?

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

Which groups have special protections under the Common Rule?

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.

What is the Common Rule NIH?

As many in the research community know, the “Common Rule” refers to current regulations to protect individuals who participate in research as human subjects. The regulations, which have been in place since 1991, are followed by 18 federal agencies that support research – hence the name.

What is the Common Rule of 1991?

A single, general set of regulatory provisions governing human subjects protections was adopted by sixteen federal departments and agencies[2] in 1991; the Common Rule specifies how research that involves human subjects is to be conducted and reviewed, including specific rules for obtaining informed consent.

Which of the following activities constitutes engagement in research?

Which of the following activities constitutes engagement in research? Obtaining informed consent and conducting research interviews.