Timing of Document Distribution for Meetings- PRO145   

PROCEDURE
 

The UAB OIRB sends materials for review to the members 7 days prior to the convened meeting allowing for sufficient time and adequate review.

OIRB Responsibilities

Administrative Staff:

• Prepares agenda and meeting materials to send to all IRB members scheduled to attend a convened meeting. The agenda includes the Reviewer assignments, an itemized agenda of the protocols and other business for review as well as links to the following::
  • Initial review protocol application forms including a copy of the grant application; sponsor protocol; and investigator brochure or package insert, if applicable;
  • Modifications/amendments
  • Continuing review materials
  • Final reports
  • Reportable problems for determination as unanticipated problems involving risks to subjects or others;
  • Responses to the IRB
  • Reports—lists of approved expedited protocol and exempt determinations that underwent limited IRB reviews, monitoring reports, non-compliance reports, miscellaneous items (e.g., correspondence from the Institutional Official);
• Distributes meeting agenda to IRB members one week prior to the meeting date;
• Distributes supplemental materials for current or add-on agenda items to the IRB members prior to the meeting by posting on-line, e-mail notification, or via courier, when necessary;
• Makes available for review to any IRB member all materials for protocols listed on the agenda beginning one week prior to the meeting. Materials are located in the OIRB during office hours and in the IRB conference room two hours before the meeting.