45 U.S. Code of Federal Regulations (CFR)

Question 1

What does 45 CFR Part 46 cover?

Answer 1

Regulations for the protection of human subjects in research funded by the U.S. Department of Health and Human Services (HHS).

Question 2

What is the main purpose of 45 CFR Part 46?

Answer 2

To protect the rights and welfare of research participants, especially those in federally funded studies.

Question 3

What are the four subparts of 45 CFR Part 46?

Answer 3

• Subpart A: Basic protections for human subjects (The Common Rule).
• Subpart B: Additional protections for pregnant women, fetuses, and neonates.
• Subpart C: Additional protections for prisoners.
• Subpart D: Additional protections for children.

Question 4

What is ‘The Common Rule’?

Answer 4

A set of ethical guidelines that apply to all federally funded research involving human subjects.

• It requires informed consent.
• IRB review and approval are mandatory.
• Participants must be protected from unnecessary risks.

Question 5

What special protections apply to pregnant women, fetuses, and neonates?

Answer 5

• Research must minimize risk to these groups.
• Informed consent from the mother (and sometimes the father) is required.
• Research must not interfere with the health of the fetus unless directly intended to benefit it.

Question 6

What special protections apply to prisoners?

Answer 6

• Research must relate to issues specifically affecting prisoners.
• Participation must not affect parole or legal status.
• A prisoner advocate must be included on the IRB.

Question 7

What special protections apply to children?

Answer 7

• Parental permission and child assent are required.
• Research must minimize risks and focus on potential benefits.
• Certain high-risk research requires additional review.

Question 8

What is the role of IRBs under 45 CFR Part 46?

Answer 8

• IRBs must review and approve research protocols to ensure ethical conduct.
• IRBs must ensure informed consent is obtained.
• IRBs must conduct continuing review of approved studies.

Question 9

What is informed consent under 45 CFR Part 46?

Answer 9

Participants must be fully informed about the study’s purpose, risks, benefits, and their rights before agreeing to participate.

• Consent must be voluntary and documented.
• Participants must have time to ask questions and make an informed decision.

Question 10

What types of research are exempt from 45 CFR Part 46?

Answer 10

• Certain educational tests, surveys, or public behavior studies with minimal risk.
• Research involving public data without identifiable information.
• Some studies involving public officials or service programs.