Full Board Review
The IRB meets once a month to review applications submitted for "full" IRB review. All research that is not exempt and does not meet the criteria for expedited review, is reviewed via this review mechanism at a regularly convened meeting.
Criteria for Approval
In order to approve a protocol, the IRB must have sufficient information to determine that all of the following criteria have been met:
- The research design is scientifically sound and will not expose participants to unnecessary risk.
- Risks to participants are reasonable in relation to anticipated benefits to the participants and to society.
- Risks to participants are minimized and, when appropriate, a plan is in place to monitor data collected to ensure the safety of participants.
- Selection of participants is equitable given the purposes of the research and the setting in which it will be conducted.
- Informed consent will be sought from each prospective participant or the participant’s legally authorized representative and will be appropriately documented.
- Additional safeguards are in place to protect participants who are likely to be vulnerable to undue influence or coercion.
- Adequate procedures are in place to protect the privacy of participants and maintain the confidentiality of data.
Depending on the quality of information presented to the Board and the degree to which the preceding criteria are met, the initial review will result in one of the following outcomes.
Outcomes of Review
Approve: If all of the preceding conditions have been met, then approval is granted to proceed with the project as outlined in the IRB application. The investigator is notified of approval in writing.
Conditionally Approve: If the IRB determines that risks to subjects are minimal but minor changes or clarifications are required that do not alter the conduct of the project, then a conditional approval may be granted. In the case of conditional approval, the conditions that must be met to secure approval are outlined in a letter to the investigator. The investigator must respond in writing to the conditions. This response is reviewed by the IRB Chair and/or other designated members to determine if conditions have been met. The research may not proceed until all conditions have been met and full approval is secured. Once it is determined that conditions have been met, the investigator is sent a letter of approval and the research may then proceed as outlined.
Table: If the IRB lacks sufficient information to assess risks and benefits, changes are required that alter the conduct of the project, or major concerns exist in relation to any of the preceding criteria, then the IRB may table a protocol. The investigator is notified of this in writing and given feedback regarding the reasons for this action. The investigator must respond in writing to the concerns of the Board. Because tabled protocols must be reviewed again by the full IRB, the original signed response plus 12 copies should be submitted to Research Services. The response and original materials are reviewed again by the IRB and the investigator is notified in writing of the outcome of the review.
Disapprove: If the IRB determines that a project does not meet the criteria for approval and there are serious concerns related to one or more criteria, the IRB may disapprove a project. The investigator is informed of this decision in writing and is given feedback regarding the reasons for disapproval.