21 CFR Part 56

Question 1

Define the function of IRB:

Answer 1

Responsible for review, approval, and continuing review of an investigation to assure the protect of the rights and welfare of subjects.

Question 2

3 main conditions of IRB membership:

Answer 2

1) Min of 5 members with appropriate exp/expertise.
2) Equal # of men and women with one member from the scientific area, one nonscientific, and one not affiliated with the institution
3) No conflict of interest. Special counsel cannot vote with IRB

Question 3

IRB registrations must be renewed:

Answer 3

q3years

Question 4

If registration info changes, it must submit those changes within ___

Answer 4

90 days

Question 5

If IRB wishes to terminate and/or alter its oversight on an investigation, it must reported within ___

Answer 5

30 days

Question 6

IRB regulation of record retention:

Answer 6

3 years

Question 7

Investigator responsibility during study start-up for IRB: (2)

Answer 7

1) Receive written approval from IRB
2) Receive written approval for ICF and patient facing material.

Question 8

Investigator responsibility during study implementation: (2)

Answer 8

1) Compliance to reporting timelines for PD, noncompliance, AEs
2) Ensure periodic study reporting (no less than annually)

Question 9

Investigator responsibility during study-close out: (2)

Answer 9

1) Send study close-out docs as specified (this can be delegated to sponsor as well)
2) Comply with safety reporting requirements.

Question 10

IRB shall ___ and have authority to ___, request modifications as need, or ___ all research activities.

Answer 10

Review
Approve
Disapprove

Question 11

Why does IRB request modifications to ICF per their judgement?

Answer 11

To ensure protection of the rights/welfare of subjects

Question 12

If a research is waived of a consent as it presents no more than minimal risk of harm, IRB____

Answer 12

may required subjects are provided with a written statement of the research.

Question 13

Two critical policies per IRB when a study involves children:

Answer 13

1) No greater than minimal risk to children
2) Adequate provisions are made for soliciting the assent of the children and the permission of their parents/guardians.

Question 14

Under 21 CFR 56.114, how must IRBs handle multi-institutional research studies?
A. Each institution must have its own IRB review the research.
B. The research must be submitted to the FDA before IRB approval.
C. Cooperative research studies may rely on the review of a single IRB.
D. Multi-institutional studies are exempt from IRB review.

Answer 14

C

Question 15

Under 21 CFR 56.104, which of the following types of research is exempt from IRB review?
A. Research involving investigational drugs.
B. Research conducted in emergency settings without prior consent.
C. Taste and food quality evaluations and consumer acceptance studies.
D. Research involving vulnerable populations like children or prisoners.

Answer 15

C

Question 16

In accordance with 21 CFR 56.113, what action can an IRB take if a research study is not being conducted in accordance with its requirements or is associated with unexpected serious harm to subjects?
A. The IRB must immediately suspend or terminate approval of the research.
B. The IRB must request that the FDA intervene in the study.
C. The IRB can only recommend changes but cannot suspend or terminate the study.
D. The IRB must file a report with the Department of Health and Human Services (DHHS).

Answer 16

A

Question 17

IRB expedited review process for two types of research:

Answer 17

1. research that is on a pre-approved list and is found to have minimal risk to participants
2. minor changes to research that was already approved, as long as it’s within a year of the original approval

Question 18

Under expedited review procedure, the review may be carried out by who?

Answer 18

1. IRB chairperson
2. or 1+ experienced reviewers designated by the chairperson from among members of the IRB.

In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research.

Question 19

Emergency Use

Answer 19

means the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval

Question 20

What is the reporting timeline to IRB if a emergency use of test article is used

Answer 20

5 working days, and any subsequent use of test article at the institution is subject to IRB review.