Protocol Review

1. Full board review.

All applications for full board review turned in at least one week before the scheduled board meeting will be included in the month’s agenda. The Secretariat will send the meeting notification and agenda to the board members or external reviewers (if needed) through email at least five working days before the scheduled meeting. Panel members are expected to confirm their attendance at least three days before the meeting. If lack of quorum is anticipated, the alternate members will be invited to attend.

During the meeting, primary reviewers shall present their evaluations (FM-URC-025 and FMURC-027) to the board. After further discussion, the Chair calls on the members to vote for any of the following actions:

Approve. The study is given ethical clearance.

Major modifications. For research protocols requiring major modifications, the board enumerates recommendations to make the research more compliant to ethical standards. Researchers will be required to resubmit a modified protocol, which will be deliberated on at the next full board meeting.

Minor modifications. For research protocols requiring minor modifications, the board enumerates recommendations to make the research more compliant to ethical standards. Researchers will be required to resubmit a modified protocol, which will only require an expedited review by the Chair.

Disapprove. The research may not commence due to major ethical violations; the researcher will be encouraged to change his or her research topic.

The action will be decided based on the majority vote.

2. Expedited review.

All applications for expedited review do not need to go through the board review process. The primary reviewers assigned to the expedited protocol must submit their evaluation (FM-URC-025 and FM-URC-027) to the Chair within 5 working days from initial receipt.

The primary reviewers will indicate one of the following actions on the form: approve, major modification, minor modification, disapprove.