Chapter 3. IRB Membership and Voting

According to DHHS and FDA regulations the IRB roster should consist of:
a. A scientific member
b. A non scientific member
c. A non - affiliated member
d. all of the above

d. all of the above

An IRB member with a conflict of interest should
a) Not participate in the discussion of the study in question
b) Not participate in vote for the study in question
c) Not participate in the initial discussion or vote for the study
d) May be present if the IRB chair overrules the conflict of interest consideration

c) Not participate in the initial discussion or vote for the study

When reviewing studies involving a vulnerable population the IRB should:
a. Ensure protective measures relevant to the population
b. appoint a subject advocate for the vulnerable group
c. require continuing reviews more frequently than annually
d. mandate post approval monitoring of such studies.

a. Ensure protective measures relevant to the population

The DHHS regulations mention the following as a vulnerable category of subject:
a. children
b. prisoners
c. pregnant women
d. handicapped or mentally disabled persons
e. all of the above

e. all of the above

DHHS regulations provide specific and detailed guidelines for the following groups of vulnerable subjects:
a. pregnant women, fetuses, neonates, prisoners, children
b. mentally disabled persons, handicapped individuals, prisoners
c. Elderly, mentally disabled persons, fetuses adn neonates
d. pregnant women, adolescents, the elderly

a. pregnant women, fetuses, neonates, prisoners, children

The IRB should:
a. have a physician as the IRB chair
b. have at least one member who is an attorney
c. have a specialists in the areas which it might review
d. be sufficient qualified through the experiences and expertise of its memebers

d. be sufficient qualified through the experiences and expertise of its memebers

In terms of earning the respect for its advice and counsel from the community the IRB should
a) Consider a highly educated membership
b) Consider only those individuals who are members of professional societies
c) Consider the inclusion of one or more attorneys
d) Consider a diversity of membership in race, gender, cultural backgrounds

d) Consider a diversity of membership in race, gender, cultural backgrounds

In frequently reviewing studies involving vulnerable subjects the IRB should consist of
a) Community members sympathetic to these groups
b) Attorneys who specialize in legal issues that pertain to these groups
c) Individuals who are knowledgeable and experienced in working with these groups
d) Subject advocates for each vulnerable group

c) Individuals who are knowledgeable and experienced in working with these groups

When reviewing studies in specialized areas the IRB should:
a. consider written review only from outside consultants
b. rely on the expertise of its voting members and need not use consultants
c. invite competent consultants but not have them vote
d. invite consultants and include them in the vote.

c. invite competent consultants but not have them vote

In an IRB with five members three are present but the IRB is unable to start the meeting. The group is missing:
a. the accountant
b. the psychiatrist
c. the oncologist
d the pharmacist

a. the accountant

In reviewing matters of state law the IRB should
a) Appoint a lawyer certified to practice in the state as a member
b) Get advice form OHRP on state law matters
c) Follow the federal guidelines regardless
d) Follow state law if it provides more stringent protections than federal law.

d) Follow state law if it provides more stringent protections than federal law.

The IRB has a non scientific member whose attendance at meetings is erratic and leads to loss of quorum. the IRB may address this situation by:
a. firing the non-scientific member
b. meet without the member
c. appoint OHRP approved matching alternates for this member
d. write institutional policy for disciplining unruly IRB members

c. appoint OHRP approved matching alternates for this member

With regard to a quorum at an IRB meeting the DHS regulations:
a. are silent on the definition of a quorum
b. define a quorum and how to calculate it
c. indicate only that a majority of members including one non-scientific member be present
d. specify that a community member be present

c. indicate only that a majority of members including one non-scientific member be present

A quorum for an IRB meeting must contain:
a. a scientific member
b. a non scientific member
c. a community member
d. an attorney

b. a non scientific member

An IRB reviewing an IND study must according to FDA guidelines have at least
a. one physician present
b. a specialist in the study topic present
c. a community member present
d. only the nonscientific member present'

a. one physician present

An IRB roster contains ten members. The quorum for the meeting must contain:
a. 4 members
b. 5 members
c. 6 members
d. three members

c. 6 members

An IRB roster contains 11 members the quorum must contain:
a. 3 members
b. 4 members
c. 5 members
d. 6 members

d. 6 members

An IRB has 15 members and 8 members are present. One of the members has a conflict of interest. the IRB has to:
a. proceed without the conflicted member
b. include the conflicted member to preserve quorum
c. exclude the conflicted member from the discussion but have them vote.
d. Tale the study for a vote at a future meeting where the appropriate numbers of members are present.

d. Tale the study for a vote at a future meeting where the appropriate numbers of members are present.

According to OHRP guidelines for alternative members
a. An alternate member should not vote if the regular member is also present
b. an alternate member may substitute for member rescuing themselves for a conflict of interest if the alternate was OHRP approved
c. an alternate member at large approved by OHRP may substitute for any member that is missing
D. all of the above

D. all of the above

An IRB meeting has six members adn three members vote for the study and three vote to disapprove the IRB:
a. may approve the study
b. let the IRB chair decide on the approval
c. must disapprove the study becasue majority is needed to approve
d. discount the vote of one of the dissenting members as this member always dissents.

c. must disapprove the study becasue majority is needed to approve

An IRB must maintain written procedures for:
a. conducting initial and continuing review
b. determining which projects require review more often than annually
c. ensurign prompt reporting of proposed changes in research
d. all of the above.

d. all of the above.