21 CFR Part 56

Question 1

What does 21 CFR Part 56 cover?

Answer 1

Institutional Review Boards

Question 2

Each IRB should have at least how many members?

Answer 2

5

Question 3

Each IRB shall include:

Answer 3

1 member whose primary concerns are in the scientific area and 1 whose primary concerns are in nonscientific areas, and 1 who is not otherwise affiliated with the institution.

Question 4

Criteria for IRB approval

Answer 4

1. Risks to subjects are minimized.
2. Risks to subjects are reasonable in relation to anticipated benefits.
3. Selection of subjects is equitable.
4. informed consent from each subject.
5. informed consent should be documented.
6. research plan makes adequate provision for monitoring the data collected.
7. adequate provisions to protect the privacy of subjects and to maintain confidentiality of subjects.

Question 5

test article

Answer 5

any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 or 354-360F of the public health service act.

Question 6

A research permit under section 505(i) of the act is usually known as

Answer 6

investigational New Drug (IND) application

Question 7

A research permit under section 520(g) of the act is usually known as

Answer 7

investigational device exemption (IDE)

Question 8

When must an IRB register?

Answer 8

Each IRB must submit an initial registration and must renew every 3 years. IRB registration become effective after review and acceptance by HHS.

Question 9

Where can an IRB register?

Answer 9

Either electronically or in writing to the Office of Good Clinical Practice, Office of Special medical programs, Food and drug administration, silver spring, MD.

Question 10

How does an IRB revise its registration information?

Answer 10

must submit changes within 90 days. 30 days if disbanning, otherwise at time of registration renewal.