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
1 whose primary concerns are in nonscientific areas,
1 who is not otherwise affiliated with the institution.

Question 4

Criteria for IRB approval of clinical trial

Answer 4

Risks to subjects are minimized.
Risks to subjects are reasonable in relation to anticipated benefits.
Selection of subjects is equitable.
informed consent from each subject.
informed consent should be documented.
research plan makes adequate provision for monitoring the data collected.
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

Question 6

When must an IRB register/when does registration become effective?

Answer 6

Each IRB must submit an initial registration and must renew every 3 years. IRB registration become effective after review and acceptance by FDA.

Question 7

Where can an IRB register?

Answer 7

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 8

How often does an IRB need to revise its registration information? (if changes are made)

Answer 8

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

Question 9

Does an IRB need to register with the FDA before it approves studies?

Answer 9

Yes

Question 10

What is the purpose of the IRB review of the informed consent?

Answer 10

To protect the rights, safety and welfare of the subject.

Question 11

Does an IRB or institution have to compensate subjects if injury occurs as a result of participation in a research study?

Answer 11

Institutional policy, not FDA regulation, determines whether compensation and medical treatment(s) will be offered and the conditions that might be placed on subject eligibility for compensation or treatment(s). Any research involving more than minimal risk must inform the subject of any compensation and medical treatment available if injury occurs.

Question 12

May a clinical investigator be an IRB member?

Answer 12

Yes except they can not participate in initial or continuing review of a study in which they have a conflicted interest.

Question 13

The IRB regulations require an IRB to have a diverse membership. May one member satisfy more than one membership category?

Answer 13

Yes.

Question 14

When IRB members cannot attend a convened meeting, may they send someone from their department to vote for them?

Answer 14

No. Alternates are formally appointed and listed in the membership roster.

Question 15

May the IRB use alternate members?

Answer 15

Yes, if they are formally appointed, listed on the IRB roster and proper IRB procedures are in place that describe their appointment and function.

Question 16

Does a non-affiliated member need to attend every IRB meeting?

Answer 16

No.

Question 17

What are examples of IRB members considered to be non-scientists?

Answer 17

FDA believes the intent of the requirement for diversity of disciplines was to include members who had little or no scientific or medical training or experience. In the past, lawyers, clergy and ethicists have been cited as examples of persons whose primary concerns would be in non-scientific areas.

Question 18

The FDA regulations [21 CFR 56.104(c)] exempt an emergency use of a test article from prospective IRB review, however, “… any subsequent use of the test article at the institution is subject to IRB review.” What does the phrase “subsequent use” mean?

Answer 18

“Subsequent use” would be a second use with that subject or the use with another subject. FDA regulations allow for one emergency use of a test article in an institution without prospective IRB review, provided that such emergency use is reported to the IRB within five working days after such use.

Question 19

What is IRB expedited review?

Answer 19

Procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. The IRB may also use the expedited review procedure to review minor changes in previously approved research.

Question 20

If an IRB disapproves a study submitted to it, and it is subsequently sent to another IRB for review, should the second IRB be told of the disapproval?

Answer 20

Yes. When an IRB disapproves a study, it must provide a written statement of the reasons for its decision to the investigator and the institution and should be included in the subsequent submission to the second IRB.

Question 21

May informed consent be obtained by telephone from a legally authorized representative? (non-emergency)

Answer 21

No, A verbal approval does not satisfy the 21 CFR 56.109(c) requirement for a signed consent document. However, a consent form can be sent to the LAR and discussion can be conducted over the phone with the LAR signing the form and sending it back.

Question 22

What records are an IRB required (at minimum) to retain?

Answer 22

1) Copies of all research proposals reviewed and associated documents
2) Minutes of IRB meetings in sufficient detail to show attendence, actions taken, votes, and written summary
3) Records of continuing review activites
4) Copies of correspondence with investigators
5) List of IRB members with their information
6) Written procedures for IRB
7) Statements of significant new findings provided to subjects

Question 23

How long does an IRB retain its records? (And what happens when an IRB refuses to allow an inspection of records)

Answer 23

3 years

FDA may refuse to consider a clinical investigation in support of an application for a research/marketing permit if the institution or IRB that reviewed the investigation refuses inspection

Question 24

What happens when an IRB is observed to be noncompliant with 21CFRPart56? (Including additional steps the Agency may take)

Answer 24

1) The FDA inspector presents an oral or written summary of observations to an appropriate rep of the IRB
2) FDA may send subsequent letter describing noncompliance to IRB and parent institution
3) FDA requires response within a time specified and describe corrective actions
4) Additionally, agency may:
I) Withold approval of new studies
II) Direct that no subjects be added to ongoing studies
III) Terminate ongoing studies - if it would not endanger subjects
IV) notifiy relevant State and Federal agencies

Question 25

What happens when an IRB has failed to take steps to correct noncompliance?

Answer 25

1) Commissioner institutes preceedings in accordance with requirements for a regulatory hearing
2) Disqualifies IRB if the IRB has refused or repeatedly failed to comply with regulations and noncompliance adversely affects rights or welfare of the human subjects in a clinical investigation
3) If disqualification is appropriate, commissioner issues order regarding ongoing investigations, sends notice to IRB/institution, investigators, sponsors, and may publish notice in Federal Register
4) FDA will not approve application for a research permit for clinical investigation under review of a disqualified IRB or institution

Question 26

Before when, are investigations commenced not subject to IRB approval? (Date)

Answer 26

before 27Jul1981

Question 27

Are taste and food quality evaluations and consumer acceptance studies subject to IRB approval?

Answer 27

No, so long as wholesome foods without additives are consumed, or if a food is consumed that contains an ingredient at or below a level considered safe

Question 28

Active Protocol

Answer 28

any protocol for which an IRB conducted an initial review or a continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months

Question 29

If an IRB changes information that is not contact/chair person or cessation of research, how long does it have to report such information?

Answer 29

Whenever the IRB renews it’s registration

Question 30

What is an IRB Responsible for?

Answer 30

1) Conducting initial and continuing review
2) Determining which projects require greater than annual review
3) ensuring prompt reporting to IRB of changes in research activity
4) ensuring that changes in approved research may not be initiated without IRB review (except in emergency)

Question 31

What is reported by/to IRB?

Answer 31

1) Any anticipated problems involving risks to human subjects
2) any instance of serious or continuing noncompliance with regulations or requirements/determinations of IRB
3) any suspension or termination of IRB approval