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.

Question 11

What is 21 CFR 56 Subpart D

Answer 11

Records and Reports

Question 12

What is 21 CFR 56 Subpart E

Answer 12

Administrative Actions for NonCompliance

Question 13

What is 21 CFR 56 Subpart B

Answer 13

Organization and personnel

Question 14

What is 21 CFR 56 Subpart C

Answer 14

IRB Functions and Operations

Question 15

What is 21 CFR 56 Subpart B 106

Answer 15

Registration

Question 16

What is 21 CFR 56 Subpart B 107

Answer 16

IRB membership

Question 17

What is 21 CFR 56 Subpart C 108

Answer 17

IRB functions and operations

Question 18

What is 21 CFR 56 Subpart C 109

Answer 18

IRB review of research

Question 19

What is 21 CFR 56 Subpart C 110

Answer 19

Expedited review procedures for certain kinds of research involving no more than minial risk, and for minor changes in approved research

Question 20

What is 21 CFR 56 Subpart C 111

Answer 20

Criteria for IRB approval of research

Question 21

What is 21 CFR 56 Subpart C 112

Answer 21

Review by institution

Question 22

What is 21 CFR 56 Subpart C 113

Answer 22

Suspension or termination of IRB approval of research

Question 23

What is 21 CFR 56 Subpart C 114

Answer 23

Cooperative Research

Question 24

What is 21 CFR 56 Subpart D 115

Answer 24

IRB records

Question 25

What is 21 CFR 56 Subpart E 120

Answer 25

Lesser administrative actions

Question 26

What is 21 CFR 56 Subpart E 121

Answer 26

Disqualification of an IRB or an institution

Question 27

What is 21 CFR 56 Subpart E 122

Answer 27

Public disclosure of information regarding revocation

Question 28

What is 21 CFR 56 Subpart E 123

Answer 28

Reinstatement of an IRB or an institution

Question 29

What is 21 CFR 56 Subpart E 124

Answer 29

Actions alternative or additional disqualification