Upon receipt of the research application packet, the staff of the IRB checks to ensure that all properly completed accompanying forms and attachments, CITI training and electronic signatures are present, and that a thorough description of the research is provided. The materials are electronically shared with the appropriate members of the IRB. If required application pieces are missing, review may be delayed.
Upon request of the IRB, the investigator may be asked to provide additional information or to appear in person before the committee to present a full explanation of risks and protection for the human participants. Any investigator may ask to appear before the Board to describe the proposed research.
In cases where it is deemed necessary by the Board, consultants to the IRB may be asked to comment on a proposed research activity.
A necessary quorum for the IRB to consider a proposal is a majority of the total membership. The IRB may not have a member participate in the Board's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
The IRB will decide by a majority of the members present:
To approve the proposal (Please also see Approval of Research in these policies.)
To approve the proposal after modifications and/or specific conditions have been met
To defer the proposal for review at a future meeting, pending changes in the application or receipt of additional information from the investigator or consultants to the IRB
To disapprove the proposal as written
Minutes will be taken at all IRB meetings. Applications will be retained by the IRB for a period of three years after research completion. See the IRB Retention Schedule.
The IRB staff will send the principal investigator and sponsor a determination letter informing them of the decision of the Board.
If changes are recommended by the Board, IRB staff will communicate these via the letter.
The IRB chairperson, director or designated member(s) will be responsible for review and approval of the investigator's submitted modifications.
If the investigator deems it necessary to make further changes, these can be submitted to the IRB for review and approval.
If there are changes in the study which the chairperson, director or designated board member(s) feels may change the level of risk to human participants, the investigator may be requested in writing to submit the proposal to the full Board for further review.
Adverse decisions may be appealed by re-review of the proposal. Appeals will be heard when the proposal has been modified and/or additional information has been provided.
The IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with IRB requirements or that has been associated with unexpected harm to participants. A list of the reasons for any suspension or termination will be provided to the investigator, all appropriate department heads and deans.
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