Tips of the Week
Did you know...
...that protocol deviations and violations are to be reported to the Data and Safety Monitor or Data Safety Monitoring Board? [IRB Policy II.F]
Did you know...
...that the Investigator must submit Data and Safety Monitoring reports to the IRB as soon as possible upon receipt, but no later than 10 working days after the Investigator first learns of the report? [IRB Policy II.F]
Did you know...
...that IRB Committee members must have an understanding of basic ethical principles, the regulatory requirements, and the mechanics of serving on the IRB? [IRB Policy III.A]
Did you know....
...that IRB committee members conduct initial and continuing review of proposed research activities according to DHHS regulations 45 CFR 46, 21 CFR 50 and 56, and 38 CFR 16 and 17? [IRB Policy III.A]
Did you know...
...that IRB Committee members identify any conflicts of interest prior to the review of research activities and bring this to the attention of the staff member for reassignment? [IRB Policy III.A]
Did you know...
...that Committee members obtain guidance or additional information in order to conduct an adequate study evaluation. This may include the request of an additional reviewer or consultant with expertise in the area of research under review?
Did you know...
...that Consultants and ad hoc reviewers can provide guidance and/or additional information in order to allow the Committee to make an adequate evaluation of the research? [IRB Policy III.A]
Did you know...
...that a consultant to the IRB may not be able to attend the meeting, but is expected to provide a written review of the research? This could be a narrative or could be captured on the reviewer's comment form. [IRB Policy III.A]
Did you know...
...that a consultant to the IRB may attend the meeting to participate in the review and discussion, however; the consultant may not count toward quorum or vote? [IRB Policy III.A]
Did you know...
...That a Committee member or HSPP staff member may request a written review from an expert consultant and may also request they attend the meeting for participation in the discussion? [IRB Policy III.A]
Did you know...
...that each IRB Committee must include at least one member whose primary interests are in a scientific area, one member whose primary interests are in a non-scientific area, and one member who is not affiliated with the University of Arizona? [IRB Policy III.C]
Did you know...
...that administrative personnel [who attend IRB meetings] do not have voting privileges? [IRB Policy III.C]