21 CFR part 56

Question 1

what does 21 CFR part 56 cover?

Answer 1

IRB’s

Question 2

how many members should an IRB have?

Answer 2

at least 5

Question 3

each IRB should include:

Answer 3

1) a member whose primary concerns are in the scientific area
2) a member whose primary concerns are in nonscientific areas
3) a member who is not otherwise affiliated with the institution

Question 4

what are the criteria for IRB approval? (7)

Answer 4

1) minimal risk
2) risks are reasonable compared to potential benefits
3) equitable subject selection
4) informed consent
5) documented informed consent
6) adequate data monitoring plan
7) adequate measures to protect privacy and confidentiality of subjects

Question 5

what is a test article?

Answer 5

1) drug for human use
2) biological product for human use
3) medical device for human use
4) food additive
5) color additive
6) electronic product
7) 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

an IND (investigational new drug) application

Question 7

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

Answer 7

an IDE (investigational device exemption)

Question 8

when must an IRB register?

Answer 8

after initial registration, a renewal must be submitted every 3 years. IRB registration becomes 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?

Answer 10

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