2. IRB Records and Minutes

IRB minutes should record
a) Number of members voting for and against the motion
b) Names of members voting for and against the motion
c) Names of members voting for, against and abstaining from the motion
d) Number of members voting for, against and abstaining from the motion

d) Number of members voting for, against and abstaining from the motion

If a regular voting member and his alternate both attend the meeting then
a) Only the voting member can present the study
b) Only the voting member can participate in the motion
c) Only the voting member can count towards the quorum
d) Only the voting member can be shown as attending the meeting in the minutes

c) Only the voting member can count towards the quorum

The Minutes of the IRB meeting should records
a. A detailed account of the discussion for every study
b. the reason for members voting against the moton
c. summary of the discussion of controverted issues
d. an account of the scientific evaluation for each study.

c. summary of the discussion of controverted issues

A controverted issue is one in which:
a. there was a tie vote for the study
b. one or more members abstained form the vote
c. a motion to defer the study was approved
d. any issue that caused a debate among the members

d. any issue that caused a debate among the members

According to DHHS regulations IRB records must include:
a. Scientific evaluations that accompany each proposal
b. reports of injuries to subjectes
c. copies of all correspondence bewteen IRB and investigators
d. all of the above.

d. all of the above.

The minutes of the IRB meeting should include sufficient details to show attendance. In practice, this involves showing:
a. the names of the attendance and their representative roles
b. the earned degrees of the members attending
c. the alternate members and who they are alternates for
d. all of the above

d. all of the above

During a meeting a voting member has a conflict of interest for a study being reviewed the minutes must indicate:
a. the name of the conflicted member
b. the name of the alternate who substituted for the conflicted member if applicable
c. the study of which the conflict was recorded
d. all of the above.

d. all of the above.

The IRB records must be maintained for how long after the completion of the research:
a. one year
b. two years
c. three years
d. five years

c. three years

In the event of a DHHS agency audit, the IRB records
a. may be disclosed only if the IRB deems relevant
b. cannot be copied by the auditors
c. must be made available whenever the agency auditor shows up
d. must be accessible for inspection and copying at reasonable times and in a reasonable manner.

d. must be accessible for inspection and copying at reasonable times and in a reasonable manner.

According to DHHS regulations IRB records must include:
a. research proposal reviewed, approved consent documents, continuing review activities and significant new finding provided to subjects.
b. significant new findings provided to subjects, conflict of interest document, continuing review activities, progress reports submitted by investigators
c. financial disclosure forms, reports of FDA audits of the studies, conflict of interest documents, reports of injuries to subjects
e. significant new findings provided to subjects, conflict of interest documents, scientific evaluations of studies, reports of FDA audits.

a. research proposal reviewed, approved consent documents, continuing review activities and significant new finding provided to subjects.

According to DHHS regulations the IRB staff should maintain
a. complete copies of all IRB activities
b. copies of all external audits of the IRB
c. financial records of IRB changes to sponsors for IRB reviews
d. adequate documentation of IRB activities

d. adequate documentation of IRB activities

The IRB minutes should contain:
a. records of the scientific evaluations of the studies presented
b. reasons behind the votes for abstention
c. reasons behind a tie vote
d. the basis for requiring changes in or disapproving the research.

d. the basis for requiring changes in or disapproving the research.