IRB Records And Minutes Flashcards
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
IRB minutes should record
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
If a regular voting member and his alternate both attend the meeting then
c) Only the voting member can count towards the quorum
The minutes of the IRB meeting should record
a) A detailed account of the discussion for every study
b) The reasons for members voting against the motion
c) Summary of the discussion of controverted issues
d) An account of the scientific evaluations for each study
The minutes of the IRB meeting should record
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 from the vote
c) A motion to defer the study was approved
d) Any issue that caused a debate among the members
A controverted issue is one in which
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 subjects
c) Copies of all correspondence between the IRB and investigators
d) All of the above
According to DHHS regulations IRB records must include
d) All of the above
a) Scientific evaluations that accompany each proposal
b) Reports of injuries to subjects
c) Copies of all correspondence between the IRB and investigators
The minutes of the IRB meeting should include sufficient detail to show attendance. In practice this involves showing
a) The names of the attendees and their representative roles
b) The earned degrees of the members attending
c) The alternate members and who they are the alternates for
d) All of the above
The minutes of the IRB meeting should include sufficient detail to show attendance. In practice this involves showing
d) All of the above
a) The names of the attendees and their representative roles
b) The earned degrees of the members attending
c) The alternate members and who they are the alternates for
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 for which the conflict was recorded
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
d) All of the above
a) The name of the conflicted member
b) The name of the alternate who substituted for the conflicted member if applicable
c) The study for which the conflict was recorded
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
The IRB records must be maintained for how long after the completion of the research
c) Three years
IRB records must include
a) Research proposals reviewed, approved consent documents, continuing review activities and significant new findings provided to subjects
b) Significant new findings provided to subjects, conflict of interest documents, 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
d) Significant new findings provided to subjects, conflict of interest documents, scientific evaluations of studies, reports of FDA audits
IRB records must include
a) Research proposals reviewed, approved consent documents, continuing review activities and significant new findings provided to subjects
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 charges to sponsors for IRB reviews
d) Adequate documentation of IRB activities
The IRB staff should maintain
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
The IRB minutes should contain
d) The basis for requiring changes in or disapproving the research
