21 CFR Part 56

Question 1

The minimal interval that an IRB should conduct continuing review of research is:

a) no less than once every 3 months
b) no less than once every 6 months
c) no less than once per year
d) no less than once every 3 years

Answer 1

c) no less than once per year

Question 2

In order for research to be approved by the IRB, it shall receive the approval of all members present at the meeting.

true
false

Answer 2

false

21 CFR Part 56.108: approval of a majority of those members present at the meeting

Question 3

An IRB shall require documentation of informed consent even if the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

true
false

Answer 3

false

Question 4

An institution (or IRB where appropriate), shall maintain required records for how many years following the completion of the research:

a) 3
b) 4
c) 5
d) 10

Answer 4

a) 3

Question 5

Compliance with 21 CFR Part 56 is intended to do what?

a) provide guidance for the operation and responsibility of an IRB
b) govern amendment and continuing review submission to local IRBs
c) protect the rights and welfare of human subjects involved in research
d) mandate who should comprise institutions’ local IRB

Answer 5

c) protect the rights and welfare of human subjects involved in research

Question 6

Exemptions from IRB requirement can include
(choose all that apply):

a) investigations beginning before July 27, 1981, that were not subject to requirements for IRB review under FDA regulations
b) a device that the investigator really believes is better than the currently approved device
c) emergency use of a test article
d) taste and food quality evaluations if wholesome foods without additives are consumed

Answer 6

a) investigations beginning before July 27, 1981, that were not subject to requirements for IRB review under FDA regulations

c) emergency use of a test article
d) taste and food quality evaluations if wholesome foods without additives are consumed

Question 7

IRBs mush register at a site maintained by:

a) FDA
b) HHS
c) EPA
d) MNDOT

Answer 7

b) HHS

Department of Health and Human Services

Question 8

Procedures and agents that are considered research can never be conducted or administered without prior approval by an IRB.

true
false

Answer 8

false

see 56.104 exemptions from IRB requirements

Question 9

The FDA can waive any of the requirements contained in 21 CFR Part 56.

true
false

Answer 9

true

Question 10

The primary purpose of the IRB is to assure the protection of the rights and welfare of the human subjects.

true
false

Answer 10

true

Question 11

The FDA may waive any of the requirements for IRB review, for specific research activities or for classes of research activities.

true
false

Answer 11

true

Question 12

Each IRB must renew its registration how often?

a) annually
b) every 2 years
c) every 3 years
d) every 5 years

Answer 12

c) every 3 years

Question 13

Each IRB shall have members with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. Each IRB shall include at least the following members:

a) 2 members from the scientific area and 1 affiliated with the institution
b) 1 member from industry and 2 not affiliated with the institution
c) 1 member from the scientific area, 1 concerned with nonscientific area, 1 not affiliated with the institution
d) 1 member from the scientific area and 1 affiliated with the institution, 1 concerned with nonscientific area

Answer 13

c) 1 member from the scientific area, 1 concerned with nonscientific area, 1 not affiliated with the institution

Question 14

If an IRBs contact of chair-person information changes, the IRB must revise its registration information by submitting any changes in that information within:

a) 5 days
b) 10 days
c) 30 days
d) 90 days

Answer 14

d) 90 days

Question 15

Human subject means an individual who is or becomes a participant in research.

true
false

Answer 15

true

Question 16

In order to approve research, the IRB shall determine that all of the following requirements are satisfied:

a) risks to subjects are minimized
b) risks to subjects are reasonable in relation to anticipated benefits
c) informed consent will be sought from each subject and consent will be appropriately documented
d) all of the above

Answer 16

d) all of the above

Question 17

Which statement is true regarding the criteria used for IRB approval of research?

a) risks to subjects are reasonable in relation to anticipated benefits
b) selection of subjects is equitable
c) informed consent will be appropriately documented
d) all of the above

Answer 17

d) all of the above

Question 18

The IRB shall keep statements of significant new findings provided to subjects for at least:

a) 1 year
b) 2 years
c) 3 years
d) 5 years

Answer 18

c) 3 years

Question 19

An IRB shall conduct continuing review of research at intervals appropriate to the degree of risk, but not less than:

a) every 90 days
b) once per year
c) every 6 months
d) at the end of the research study

Answer 19

b) once per year

Question 20

21 CFR Part 56 includes the following general statements of an Institutional Review Board:

a) composition
b) membership
c) operation
d) a and c

Answer 20

d) a and c

Question 21

The main concept of 21 CFR Part 56 is:

a) IRB regulations
b) protection of human subjects
c) financial disclosure
d) electronic records

Answer 21

a) IRB regulations

Question 22

The FDA may restrict, suspend, or terminate an institution’s or IRB’s use of the expedited review process when necessary to protect the rights or welfare of subjects.

true
false

Answer 22

true

Question 23

FDA regulations require the following information be submitted for institutions registering an IRB:

a) description of types of FDA regulated products involved in protocols reviewed by the IRB
b) approximate number of active protocols involving FDA regulated products
c) IRB Chairperson’s name
d) all of the above

Answer 23

d) all of the above

Question 24

At the minimum, how often should an IRB conduct continuing review?

a) every 6 months
b) annually
c) every 2 years
d) every 5 years

Answer 24

b) annually

Question 25

An IRB may use the expedited review procedure to review: a) minor changes in previously approved research during the period (of one year or less) for which approval is authorized b) some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk c) neither of the above d) either or both of the above

Answer 25

d) either or both of the above

Question 26

Which of the following are not criteria for IRB approval of research (select all that apply)? a) risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result b) selection of subjects is equitable c) risks to subjects are eliminated d) informed consent will be sought from each prospective subject or the subject's legally authorized representative e) informed consent will be appropriately documented f) when appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects g) when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data h) when some or all of the subjects are likely to be vulnerable to coercion or undue influence, they should not be included in the study

Answer 26

c) risks to subjects are eliminated h) when some or all of the subjects are likely to be vulnerable to coercion or undue influence, they should not be included in the study

Question 27

An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB. true false

Answer 27

true

Question 28

In complying with 21 CFR Part 56, institutions involved in multi-institutional studies may use joint review, reliance upon the view of another qualified IRB, or similar arrangements aimed at avoidance of duplication of effort. true false

Answer 28

true

Question 29

In an expedited IRB review, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not _________ the research. a) suspend b) disapprove c) modify d) terminate

Answer 29

b) disapprove see 21 CFR Part 56.110

Question 30

The purpose of the IRB is to: a) Inform study participants of their rights. b) Ensure that each study follows FDA regulations. c) Confirm that risks to participants are minimized through sound study design. d) Protect the rights and welfare of human subjects. e) Ensure that only unique drugs are studied.

Answer 30

d) Protect the rights and welfare of human subjects.