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.

Office Administrative Staff:

• Prepares agenda packets to all IRB members scheduled to attend a convened meeting.

  The following items are in included in the agenda packet:

  • Cover letter with Primary Review Team assignment
  • Itemized agenda with protocols for review
  • Other business items for convened review as documented in the cover letter
  • 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 reviews, monitoring reports, non-compliance reports, miscellaneous items (e.g., correspondence from the Institutional Official);
• Distributes a hard copy of all materials listed above to the Primary Review Team for the agenda items they are assigned to review with the following exceptions:
  • Initial review - protocol application without grant; sponsor protocol; and investigator brochure or package insert, if applicable; protocol oversight review form; advertisements; and special populations forms;
  • Continuing review - Investigator’s Progress Report only for closed protocols and Investigator’s Progress Report and clean copy of the Consent Form and, if applicable, the Consent Form with changes highlighted for open protocols;
• Delivers review materials to on campus IRB members 1 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 online, e-mail notification, and 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 2 hours before the meeting.

Courier Service:

• Delivers boxes with review materials to off-campus IRB members 1 week prior to the meeting date.

Approved on November 2, 2009, by:

Sheila Deters Moore, CIP
OIRB Director