IRB Membership and Voting

Question 1

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

Answer 1

C.) Not participate in the initial discussion or vote for the study

Question 2

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 for such studies

Answer 2

A.) Ensure protective measures relevant to the population

Question 3

The IRB should
A.) Have a physician as the IRB chair
B.) Have at least one member who is an attorney
C.) Have specialists in the areas which it might review
D.) Be sufficiently qualified through the experience and expertise of its members

Answer 3

D.) Be sufficiently qualified through the experience and expertise of its members

Question 4

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

Answer 4

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

Question 5

In frequently reviewing studies involving vulnerable subjects the IRB should consist of
A.) Community members sympathetic to these groups
B.) Attorneys who specialise in legal issues that pertain to these groups
C.) Individuals who are knowledgeable and experienced in working with these groups
D.) Subjects advocates for each vulnerable group

Answer 5

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

Question 6

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

Answer 6

C.) Invite competent consultants but not have them vote

Question 7

In reviewing matters of state and law the IRB should
A.) Appoint a lawyer certified to practice in the state as a member
B.) Get advice from OHRP on state law matters
C.) Follow the federal guidelines regardless
D.) Follow state law if it provides more stringent protections than federal law

Answer 7

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

Question 8

The IRB has a non-specific 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 approved matching alternates for this member
D.) Write institutional policy for disciplining unruly IRB members

Answer 8

C.) Appoint approved matching alternates for this member

Question 9

An IRB reviewing an IND study must according to FDA guidelines 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

Answer 9

A.) One physician present

Question 10

An IRB must maintain written procedures for
A.) Conducting initial and continuing review
B.) Determining which projects require review more often than annually
C.) Ensuring prompt reporting of proposed changes in research
D.) All of the above

Answer 10

A.) Conducting initial and continuing review
B.) Determining which projects require review more often than annually
C.) Ensuring prompt reporting of proposed changes in research