Components of IRB Review and Approval

Components of IRB Review and Approval The IRB uses the following criteria during review of research:

1. Risks to subjects are minimized.
2. Risks to subjects are reasonable in relation to the anticipated benefits.
3. Importance of knowledge expected to result.
4. Subject selection process is equitable.
5. Informed consent is sought from each prospective subject unless a waiver is appropriate.
6. Informed consent will be properly documented.
7. There is adequate provision for monitoring the data collected and ensuring subject safety.
8. There are adequate provisions to protect the privacy of subjects.
9. There are adequate provisions to maintain confidentiality of data.
10. Protections for subjects who may be vulnerable to coercion or undue influence.
11. Presence of a conflict of interest.

Applications are reviewed for completion, at which time the IRB Chair and/or Administrator determine which category of review the research is eligible. Where appropriate the IRB Chairman may designate a primary reviewer or consultant to give expert opinion(s) regarding the research and any potential risks to subjects. If there is a question whether additional state or local laws are applicable to the protocol, the IRB may ask a member of Legal Services for assistance in interpreting and applying the appropriate laws.

The protocol is disapproved in instances where the IRB determines that sufficient information has not been provided to adequately review and judge the safety of the study. The IRB will send a letter to the Principal Investigator noting additional requirements or requests needed for re-review and approval. Investigators may appeal IRB decisions, in writing, documenting the reasons for the appeal. These will be addressed to the Chair of the IRB and discussed at a convened meeting. Based on the Investigator's response, the IRB may approve, disapprove, or require additional information or changes to the protocol.

Protocol approval is communicated in writing to the Principal Investigator. Protocols are most often approved for a period of one year. If a study is determined to place subjects at potentially higher risk, the study is audited at intervals determined by the IRB members as contingency of the approval.

No Institutional Official or other Institutional Committee may override the decisions of the IRB to disapprove a study. However, the Institution may prevent the performance of a study approved by the IRB.