Appealing IRB Decision

 

The review of research protocols follows specific work flow in order to provide adequate and appropriate oversight to ensure participant protection.  Any deferral or disapproval of a protocol is done after a very cautious review by more than qualified personnel to ensure adequate review. Protocols submitted for exemption would be reviewed thoroughly before they are elevated to expedited, the next oversight step.  The compliance personnel will discuss the reasons for the action and additional input from the researchers would be entertained to make changes to the protocol so it may qualify for exemption.  Cases where the protocol cannot be altered as the proposed methods may be necessary for answering the research questions, the protocol will be first sent to the IRB for additional clarification if the it needs an expedited review.  Based on the IRB's advice, the protocol may be elevated, but the IRB nor the Office of Compliance would disapprove the proposed protocol.  

A similar strategy is followed to the protocols being reviewed under the expedited mechanism.  When the reviewers determine that that elevated oversight is necessary in order to award an approval, the researchers will be notified and be allowed to first make changes to the protocol to avoid a full committee review.  But if the study requires the proposed protocol to answer the chosen research questions, then the study will be reviewed by a full committee.  The IRB nor the Office of Compliance would disapprove a protocol at this stage.  

After a full committee review, the IRB may approve the protocol (with or without revisions & modifications) or disapprove the study.  All of the IRB actions are final and cannot be appealed.  In instances where the researchers have continued grievance, they must contact the Chair of the IRB or the Office of Compliance or both to resolve any issues.  The researchers must not contact the University officials and executives once an IRB denial has been made.  The HHS regulations bar the institution's administration to be involved in the IRB process.  The University officials may be notified only if the IRB's proposed action would cause harm to the participants.  The OHRP and HHS provides guidelines and requirements that institutions must follow in order to protect research subjects.  Be aware that these requirements may be the threshold and the IRB has the authority to increase the level of oversight if needed and it cannot be appealed under any circumstances.  

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