All protocols that are not determined to qualify as Expedited or Exempt will be reviewed by the full board. New submissions and “Greater than Minimal” risk protocol renewals will be individually presented, discussed, and voted on at a convened meeting.
Proposals requiring Full Board Review must be submitted by the first of the month to be considered for that month.
Full Board review of protocols will take place only when a majority (one more than 50% of the full committee) of the Committee members are present, including at least one member whose primary concerns are in nonscientific areas.No official actions will be taken at a meeting where a majority of the members, including a non-scientist, are not present.
IRB meetings will take place with all participating members physically present unless circumstances warrant conducting an IRB meeting via telephone conference call or using speakerphone.
- a. Telephone conference call:Official actions may be taken at a meeting in which members participate via telephone when each participating IRB member (i) has received all pertinent material prior to the meeting, and (ii) can actively and equally participate in the discussion of all protocols (e.g. each member can hear and be heard by all other participating members).Satisfaction of these two conditions in addition to the standard regulatory requirements will be documented in the meeting minutes.
- b. Speakerphone:If a member is not able to be physically present during a convened meeting but is available by telephone, the meeting can be convened using speakerphone.The member who is not physically present will be connected to the rest of the members via speakerphone so that all members will be able to discuss the protocol.Members participating by speakerphone may vote provided they have had an opportunity to review all of the materials the other members have reviewed.
All Committee members' votes will be deemed equal and no proxy votes (written or by telephone) will be considered.
The IRB will review all new and continuing protocols to determine the appropriateness of the research in the local research context.Review and approval will be based on detailed applicable information provided in the IRB submission forms (e.g. participant population, participant selection, benefits to participants, mechanisms for protecting privacy, method for minimizing the possibility of coercion, etc.).
Approval of a protocol at Full Board requires the approval of a majority of those members who are present at the meeting.
The Committee’s decision regarding approvability of new research and continuation of ongoing research is based on satisfaction of the regulatory criteria outlined by HHS in 45 CFR 46.111(a)(1-7).