21 CFR 56

Question 1

What is 21 CFR Part 56?

Answer 1

A federal regulation that governs the functioning and responsibilities of Institutional Review Boards (IRBs) in the protection of human subjects in clinical research.

Question 2

What is the primary role of an Institutional Review Board (IRB) according to 21 CFR Part 56?

Answer 2

The primary role of an IRB is to review, approve, and monitor research involving human subjects to ensure their rights, safety, and well-being are protected.

Question 3

Who is responsible for establishing and maintaining an IRB according to 21 CFR Part 56?

Answer 3

The institution or organization conducting research is responsible for establishing and maintaining an IRB.

Question 4

What are the membership requirements for an IRB under 21 CFR Part 56?

Answer 4

An IRB must have at least five members, including a chairperson, a scientist, a non-scientist, and a community member.

Question 5

How often must an IRB conduct meetings and reviews according to 21 CFR Part 56?

Answer 5

An IRB must conduct meetings at least once a month and review research protocols and activities at these meetings.

Question 6

What is the purpose of IRB review of research protocols under 21 CFR Part 56?

Answer 6

The IRB’s review ensures that research protocols are scientifically sound, ethically conducted, and prioritize the rights and safety of research subjects.

Question 7

What criteria must an IRB consider when reviewing research protocols according to 21 CFR Part 56?

Answer 7

An IRB must consider criteria such as the risks and benefits to subjects, informed consent processes, subject selection, and data monitoring plans.

Question 8

What is the significance of informed consent in the context of IRB review under 21 CFR Part 56?

Answer 8

Ensuring that subjects are adequately informed about the research and voluntarily agree to participate.

Question 9

What is the purpose of continuing review by an IRB under 21 CFR Part 56?

Answer 9

Continuing review ensures that research activities remain ethical and that subjects’ rights and safety are protected throughout the study.

Question 10

What actions can an IRB take in response to non-compliance with its decisions according to 21 CFR Part 56?

Answer 10

An IRB can suspend or terminate approval of research, require modifications to the study, or report non-compliance to appropriate authorities.

Question 11

Who is responsible for establishing and maintaining an Institutional Review Board (IRB) under 21 CFR Part 56?

Answer 11

The institution or organization conducting the research is responsible for establishing and maintaining an IRB.

Question 12

Describe the criteria an IRB should consider when reviewing research protocols under 21 CFR Part 56.

Answer 12

IRBs should consider scientific merit, ethical standards, and the risks and benefits to subjects when reviewing research protocols.

Question 13

What are the documentation requirements for IRB activities under 21 CFR Part 56?

Answer 13

IRBs must maintain records of their activities, including meeting minutes, correspondence, and a list of members.

Question 14

Explain the term “minimal risk” as it relates to 21 CFR Part 56.

Answer 14

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those encountered in daily life or during routine examinations.

Question 15

How does 21 CFR Part 56 address the disclosure of financial interests of IRB members?

Answer 15

IRB members must disclose any financial interests related to the research, and steps should be taken to manage or eliminate conflicts of interest.

Question 16

Explain the concept of “Suspension” of IRB approval under 21 CFR Part 56.

Answer 16

Suspension of IRB approval means a temporary halt of some or all previously approved research activities pending corrective action.

Question 17

What is the role of the IRB in the review of research involving prisoners under 21 CFR Part 56?

Answer 17

The IRB must include at least one member who is not a prisoner and has no association with the prison involved. There are additional safeguards for the protection of prisoners.

Question 18

Describe the process of “Reconstitution” of an IRB under 21 CFR Part 56.

Answer 18

Reconstitution involves rebuilding an IRB, often after the resignation or removal of members, to meet regulatory requirements.

Question 19

What are the elements of information that must be provided to the IRB for research involving children, as per 21 CFR Part 56?

Answer 19

The IRB must receive and review information on the justification for involving children, the research plan, and the provisions for obtaining assent and parental permission.

Question 20

What is the IRB’s role in the review of multi-center clinical trials under 21 CFR Part 56?

Answer 20

The IRB may rely on the review of another qualified IRB for some or all of the research conducted at its institution, provided certain conditions are met.

Question 21

How does 21 CFR Part 56 address the compensation of IRB members?

Answer 21

IRB members may not receive compensation that is contingent upon the IRB taking a particular action or reaching a particular outcome.

Question 22

Describe the criteria for IRB approval of research involving prisoners under 21 CFR Part 56.

Answer 22

The IRB must find that the research is intended for the benefit of prisoners, that risks are minimized, and that the research could not be conducted with non-prisoners.

Question 23

What are the responsibilities of the IRB chairperson under 21 CFR Part 56?

Answer 23

The IRB chairperson is responsible for leading meetings, ensuring proper review procedures, and representing the IRB to external parties.

Question 24

Describe the circumstances under which an IRB can approve research without a convened meeting, according to 21 CFR Part 56.108(c).

Answer 24

An IRB can use an expedited review procedure for certain research activities that involve no more than minimal risk and meet other specified criteria.

Question 25

What is the IRB’s role in reviewing and approving the compensation provided to subjects for their participation in research, according to 21 CFR Part 56.111?

Answer 25

The IRB must review and approve the amount and method of compensation offered to research subjects, ensuring it is not coercive.

Question 26

Explain the concept of “Prisoner Representative” in the context of IRB review under 21 CFR Part 56.111(a)(5).

Answer 26

A Prisoner Representative is an individual with appropriate background and experience who is appointed to represent the interests of prisoners in the IRB review.

Question 27

What is the significance of “Concurrent Review” by other IRBs for multi-center clinical trials, as per 21 CFR Part 56.114?

Answer 27

Concurrent review allows multiple IRBs to review a multi-center clinical trial simultaneously, facilitating efficient and timely approval.

Question 28

Describe the role of the IRB in reviewing and approving the recruitment methods for research subjects under 21 CFR Part 56.111(a)(8).

Answer 28

The IRB must review and approve the methods used to recruit subjects, ensuring that they are not unduly coercive and that information is presented in a clear and unbiased manner.

Question 29

Explain the concept of “Expedited Review” under 21 CFR Part 56.110.

Answer 29

Expedited Review is a procedure by which certain research activities may be reviewed and approved by the IRB chair or a designated voting member rather than the full board.

Question 30

What is the title of 21 CFR Part 56?

Answer 30

INSTITUTIONAL REVIEW BOARDS

Question 31

What are the subparts/titles of 21 CFR Part 56?

Answer 31

Subpart A—General Provisions
Subpart B—Organization and Personnel
Subpart C—IRB Functions and Operations
Subpart D—Records and Reports
Subpart E—Administrative Actions for Noncompliance