21 CFR Part 56

Question 1

What does 21 CFR part 56 cover?

Answer 1

General standards for composition, operation, and responsibility of an IRB

Question 2

Exemptions from IRB requirement

Answer 2

-Early investigations (before July 27 1981) (under old rules)
-Emergency use of test article (must be reported within 5 days)
-Taste and food quality evaluations

Question 3

What information must an IRB register?

Answer 3

-IRB/IRB chairperson’s/person overseeing’s: names, addresses, phone numbers, facsimile number, email address
-number of active protocols
-description of types of FDA regulated products involved

Question 4

When must an IRB register?

Answer 4

Initial registration before it begins reviewing, and renewed every 3 years

Question 5

Who must IRB approval suspension/termination be reported to?

Answer 5

The investigator, appropriate institutional officials, and the Food and Drug Administration.

Question 6

IRB/IEC should include

Answer 6

(a) At least five members.
(b) At least one member whose primary area of interest is in a nonscientific area.
(c) At least one member who is independent of the institution/trial site.

A list of IRB/IEC members and their qualifications should be maintained.

Question 7

What is the IRB’s criteria for approval of research?

Answer 7

1) Risks to subjects be minimized
2) Reasonable risk to benefits
3) Equitable selection of subjects
4) Informed consent will be sought
5) Informed consent will be properly documented
6) Data should be monitored for subject safety
7) Privacy and confidentiality should be ensured

Question 8

What records should the IRB keep?

Answer 8

1) research proposals and related docs
2) minutes of meetings
3) records of continuing review activities
4) correspondence between IRB and investigators
5) list of IRB members, info, and contributions
6) written procedures
7) statements of significant new findings provided to subjects

Question 9

How long should the IRB keep required records?

Answer 9

3 years after the completion of research

Question 10

What happens if the FDA observes noncompliance during an IRB inspection?

Answer 10

The FDA will send the IRB a letter about the noncompliance and require that the IRB respond in a specified time period and describe corrective actions. The parent institution is responsible for an operation of an IRB.

Question 11

What happens if an IRB does not correct noncompliance?

Answer 11

If repeated or refused and it adversely affects participants, the IRB will be disqualified.

Question 12

Who needs to register under 21 CFR Part 56?

Answer 12

Every IRB that reviews clinical investigations must register at a site maintained by the department of health and human services.

Question 13

Where does an IRB need to register?

Answer 13

A site maintained by the department of health and human services (HHS)

Question 14

How quickly does an IRB need to submit changes to contact or chair person’s information?

Answer 14

90 days

Question 15

How quickly does an IRB need to report its decision to review new types of FDA-regulated products OR discontinue reviewing clinical investigations regulated by the FDA?

Answer 15

30 days

Question 16

How quickly does an IRB need to report its decision to disband?

Answer 16

30 days after permanent cessation of IRB’s review of research

Question 17

Gender and IRB

Answer 17

Reasonable effort should be made to ensure that an IRB does not only have male or female members, but they should not make selections on the basis of gender.

Question 18

Can an IRB have members of only one profession?

Answer 18

No

Question 19

Does an IRB need members who work in scientific areas?

Answer 19

An IRB needs at least one member whose primary concerns are scientific and one whose primary concerns are nonscientific.

Question 20

Who can the IRB invite to review complex issues?

Answer 20

A guest with competence in that special area, but this person cannot vote.

Question 21

Can IRB guests vote?

Answer 21

No

Question 22

When can an IRB review proposed research?

Answer 22

1) Convened meetings
2) Majority of members are present
3) One member present must have nonscientific primary concerns

Question 23

How many people are needed to approve proposed research?

Answer 23

A majority of the IRB members present at the meeting.

Question 24

What does an IRB need to follow written procedures for?

Answer 24

1) initial and continuing review of research and reporting findings and actions to the investigator and the institution
2) determining which projects need review more often than annually
3) ensuring prompt reporting to the IRB of changes in research activity
4) ensuring changes in approved research may not be initiated without IRB approval

Question 25

What needs to be promptly reported to the IRB, institutional officials, and the FDA?

Answer 25

1) unanticipated problems w/ risk to human subjects
2) serious of continuous noncompliance
3) suspension or termination of IRB approval

Question 26

When might an IRB not require documentation of informed consent?

Answer 26

1) no more than minimal risk and no procedures that normally require consent (might require a written statement to be provided to subjects)
2) emergency research

Question 27

When can an IRB expedite review procedures?

Answer 27

1) If it’s on the FDA approval list for expedition
2) If it is a minor change in previously approved research

Question 28

How should risks to subjects be minimized?

Answer 28

1) Using procedures consistent with sound research design
2) Use procedures already being performed when possible

Question 29

What does suspension or termination of IRB approval of research need to include?

Answer 29

1) a statement of reasons
2) should be reported promptly to the investigator, appropriate institutional officials, and the FDA

Question 30

What can institutions involved in multi-institutional studies do?

Answer 30

1) Use joint review
2) Rely on review of another qualified IRB
3) Similar arrangements

This is to avoid duplication of effort

Question 31

What might happen while FDA waits for corrective action to be taken after seeing IRB noncompliance?

Answer 31

Until corrective action is taken the FDA might make the IRB withhold approval of new studies, direct no new subjects may be added, or terminate ongoing studies.

Question 32

Who does the FDA send notice of IRB disqualification to?

Answer 32

IRB and parent institution
possibly sponsors and clinical investigators