21 CFR Part 56

Question 1

What does 21 CFR Part 56 Cover?

Answer 1

Institutional Review Boards

Question 2

Each IRB shall have at least how many members?

Answer 2

5

Question 3

An IRB shall include:

Answer 3

1) Men & Women
2) Members of more than one profession
3) At least one member whose primary concerns are in the scientific area
4) At least on member whose primary concerns are in nonscientific areas
5) At least one member who is not otherwise affiliated with the institution

Question 4

In order to review proposed research at a convened IRB meeting, who must be present?

Answer 4

1) A majority of the members

AND

2) At least one member whose primary concerns are in nonscientific areas

Question 5

How often must an IRB conduct a continuing review?

Answer 5

At least once a year, and more frequently if appropriate to the degree of risk

Question 6

How often must an IRB renew it’s registration with the FDA?

Answer 6

Every 3 years

Question 7

What are the timeframes for an IRB to revise their registration information with the FDA?

Answer 7

1) For changes to the IRB contact or chair person info = 90 days
2) If the IRB decides to review new types of FDA-regulated products = 30 days
3) If the IRB decides to disband = within 30 days of permanent cessation

Question 8

In order to approve research what are the 7 criteria that the IRB must determine are satisfied?

Answer 8

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 will be sought
5) Informed consent will be documented
6) Where appropriate, there are adequate plans for monitoring data to ensure subject safety
7) Where appropriate, there are adequate plans to protect the privacy of subjects & confidentiality of data

Question 9

How long do IRB records need to be retained?

Answer 9

For 3 years after the completion of the research. (Same in 45 CFR 46 & ICH GCP)

Question 10

If an IRB is found to be noncompliant with 21 CFR Part 56 the FDA may require the IRB to:

Answer 10

1) Withhold approval of new studies
2) Direct that no new subjects be added to ongoing studies
3) Terminate ongoing subjects if it would not endanger subjects

Question 11

What is published in the FDA’s Federal Register?

Answer 11

A list of categories of research that may be reviewed by an IRB through an expedited review process