Which FDA regulation covers informed consent?

Which FDA regulation covers informed consent?

regulations on Protection of Human Subjects

What is the common rule in clinical research?

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

Why is it called the Common Rule?

The Common Rule is a short name for “The Federal Policy for the Protection of Human Subjects” and was adopted by a number of federal agencies in 1991. The Common Rule applies to human subjects research conducted, supported or otherwise subject to regulation by the VA.

What is the common rule of 45 CFR 46?

The “Common Rule” is the popular term for the Federal (U.S.) Policy for the Protection of Human Subjects , 45 CFR part 46 , which outlines the criteria and mechanisms for IRB review of human subjects research.

What does 45 CFR mean?

human participant protection regulations

What is covered in 45 CFR 46 Subpart A or 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 revised common rule?

The Revised Common Rule removes the requirement for continuing review for minimal risk research and for greater than minimal risk research that is in long-term follow-up or data analysis only, unless the research is FDA-regulated.

Which type of IRB review does not require an IRB approval?

“Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.

Do I need IRB approval for an interview?

It may not necessary to get IRB approval if interview questions are with experts about a particular policy, agency, program, technology, technique, or best practice. The questions are not about the interviewee themselves, but rather about the external topic.