Decision Making

In making decisions on applications for the ethical review biomedical research, KNH-/UON-ERRC should take the following into consideration:

1.                   A member should withdraw from the meeting during discussions and decision making procedures, concerning an application where arises a conflict of interest; the conflict of interest should be indicated to the chairperson prior to the review of the application and recorded in the minutes.

2.                   A decision may only be taken when sufficient time has been allowed for review and discussion of an application in the absence of non-members (e.g. the investigator, representatives of the sponsor, independent consultants) from the meeting, with the exception of KNH/UON-ERRC staff.

3.                   Decisions should only be made at meetings where a quorum (as stipulated in the KNH/UON-ERRC’s written operating procedures) is present.

4.                   The documents required for a full review of the application should be complete and the relevant elements mentioned about should be considered before a decision is made.

5.                   Only members who participate in the review should participate in the decision.

6.                   There should be a predefined method for arriving at a decision (e.g. by consensus, by vote); it is recommended that decisions be arrived at through consensus, where possible; when a consensus appears unlikely; it is recommended that the KNH/UON-ERRC vote;