b. Documentation of Meeting Minutes and Board Determinations

IRB Full Board staff write minutes that contain the following information: 

1. which IRB (IRB-01, IRB-02, or IRB-03) reviewed the project; 
2. attendance at each meeting including those members or alternate members who participated through videoconference or teleconference,
3. documentation that those members not physically present received all pertinent materials prior to the meeting and were able to participate in all discussions. 
4. indication by name when members absent themselves from the meeting due to a conflicting interest on individual agenda items and the reason for absenting themselves, or indication by name that a member was not present for discussion and voting on individual agenda items;
5. the vote on actions taken by the IRB including the number, for, against and abstaining;
6. Separate deliberations for each action, where applicable;
7. actions taken by the board including determinations as required by federal regulations and protocol-specific findings justifying those determinations for waiver or alteration of the consent process, research involving pregnant women, human fetuses, and neonates, research involving prisoners, and research involving children;
8. justification of any deletion or substantive modification of information concerning risks or alternative procedures contained in the Department of Health and Human Services-approved sample informed consent document;
9. the basis for requiring changes in or disapproving research;
10. the length of time of an approval;
11. a written summary of the discussion of controverted issues and their resolution;
12. specific comments relevant to inclusion of certain populations;
13. whenever a significant risk/non-significant risk determination is made, the rationale for significant risk/non-significant risk device determinations.
14. where appropriate, information regarding expedited approvals, modifications, terminations, emergency/single patient use, unanticipated problems involving risks to subjects or others, and any other business appropriate for board meetings.

For IRB-03, if the convened IRB approves research contingent on specific minor conditions and the IRB Chair, or another IRB member designated by the Chair, approves the modifications, the approval by the Chair or designee is documented in the minutes of the first IRB meeting that is convened after the date of approval.  After approval by the IRB, the minutes cannot be altered by anyone including a higher authority.