IRB Records, Minutes, Membership, Voting, & Decision Making

IRB minutes should record:

# of members voting for, against, & abstaining from the motion

The IRB records must be maintained for how long after completion of the research (years)?

3 years

Controverted issue (Definition)

Any issue that caused a debate among the members.

During a meeting, a voting member has a COI for a study being reviewed. The minutes must indicate:

-The name of the conflicted member
-The name of the alternate who substituted for the conflicted member
-The study for which the conflict was recorded

In the event of a DHHS agency audit, the IRB records must be..

accessible for inspection/copying in a reasonable manner/time

The minutes of the IRB meeting should record a summary of what?

Summary of the discussion of controverted issues.

An IRB member with a COI should:

Both not participate in the initial discussion or vote for the study.

In terms of earning the respect for its advice & counsel from the community, the IRB should consider:

diversity of membership in race, gender, & cultural backgrounds

In reviewing matters of state law, the IRB should:

Follow state law if it provides more stringent protections than federal

Scenario: An IRB meeting has 6 members. 3 members vote for the study, but 3 disapprove. What does the IRB do?

Disapprove since majority is needed to approve

An IRB reviewing an IND study must have at least ___ according to FDA guidelines.

One physician present

IRB Quorum (Definition)

A quorum is the minimum number and type of IRB members that must be present at a convened meeting.
It's not defined in the HHS regulations, but by OHRP as (n/2+1) for an even numbers roster.
If a majority of the IRB membership is not present, or if a nonscientist is not present, then quorum has not been met.

If a regular voting member & his alternate both attend the meeting, then only the voting member can...

count towards the quorum.

Scenario: An IRB roster has 11 members. The quorum must contain how many members at minimum?

6

Scenario: In an IRB with 5 members, 3 are present. The IRB is unable to start the meeting. Who is missing: The psychiatrist, oncologist, accountant, or pharmacist?

The accountant (non-scientific member)

Scenario: An IRB has 15 members. 8 members are present. One has a COI. The IRB has to:

Table the study for future meeting where approve # of members present

IRB Roster (Definition)

# of voting positions on the IRB

IRB Membership (Definition)

# who can be designated into the voting member slots & may include alternate members.

In frequently reviewing studies involving vulnerable subjects, the IRB should consist of:

People who are knowledgeable & experienced in working with them

Deferral (Definition)

The decision (vote) by an Institutional Review Board (IRB) that the IRB is unable to approve the research because the applicable criteria for IRB approval have not (yet) been met. The IRB defers the item for further review at a future date, to occur after changes and/or additional information have been provided by the researcher.

Conditional Approval (Definition)

IRB determination that the applicable criteria for IRB approval on an item have been met based on the assumption that specific conditions will be met by the researcher & subsequently verified.

An IRB recommends a study be approved with conditions. The PI submits the revised study & it's approved by the IRB chair. The approval date would be:

Date of approval by IRB chair

A study has 2 treatment groups: one with adults & one with children. IRB has reservations about adequacy of protocol for child inclusion. IRB can...

Approve the study for adults & defer it for children

IRB reviewing a study requires the PI to specify which procedures are standard of care and which are research related. IRB would do what?

Approve the study with the condition

IRB reviewing a study requires the PI to replace the placebo group with comparator drug. Likely action taken by the IRB would be:

Defer the study

An IRB reviewing a surgical study requires a change made in protocol to ensure ICF is done prior to clinic visit. The IRB would:

Approve the study with the condition

IRB that has radiographic imaging requires PI to confirm contrast agent be confined to the type & dose of reagent specified by IRB, so IRB then..

would approve the study with the condition