The Review ProcessThe IRB may review some or all of the research submitted by using an expedited review procedure, if the research involves no more than minimal risk. The IRB may also use the expedited procedure to review minor changes in previously approved research within one year after initial approval has been authorized. Under an expedited review procedure, the review may be carried out by the IRB chairperson, by one or more experienced IRB reviewers, or by persons with specialized knowledge in a particular discipline who are designated by the chairperson. In reviewing the research, the reviewers may exercise all of the authority of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the full review procedure.
Review Procedure When Full Review is Warranted
- Upon receipt of the Submission of Proposed Research for IRB Approval form, the chairperson of the IRB reviews the materials to ensure that the form was properly completed, that the necessary description of the research is provided, and that the applicant has current training in human subject protection. Copies of the application are then distributed to members of the IRB.
- 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 subjects. Any investigator may ask to appear before the IRB 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. No IRB may have a member participate in the IRB’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.
- to approve the proposal with restrictions or conditions.
- to defer the proposal, pending changes in the application or receipt of additional information from the investigator or consultants to the IRB.
- to disapprove the proposal.
- Minutes will be taken at all IRB meetings.
- The chairperson will inform the principal investigator in writing of the decision of the IRB.
- If the IRB recommends changes, the IRB chairperson or designated member will communicate these in writing to the investigator.
- The IRB chairperson or designee will be responsible for review and approval of the investigator's submitted changes.
- If the investigator deems it necessary to make further changes, these can be submitted to the chairperson or a designee for review and approval.
- If there are changes in the study which the chairperson or designee feels may change the level of risk to human subjects, the investigator will 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 only when the proposal has been revised and/or provides additional information.