IRB Monitoring Of Approved Protocol
The IRB, in order to help ensure the protection of human research participants and comply with federal regulations and local IRB policies, has the authority to observe or appoint a designee to observe the informed consent process and conduct of the IRB approved research process. Although IRB members or other designees could serve as the observers, it would often be more practical to utilize the research compliance staff to aid in evaluating how a research protocol is being conducted. The three potential ways this can be accomplished is covered in IRB Policy 12.2. These include the following types:
 

1. Periodic Review – a systematic examination of an IRB approved research protocol on a regular basis due to safety concerns or prior compliance issues. An
    example would be regular review of an investigator who in the past has had documented problems with protocol deviations or other patterns of compliance that
    warrant close supervision. 

2. Directed Review - conducted in response to identified concerns that require an IRB determination of protocol compliance. This could be done for example
    when it appears that some irregularity has occurred when reviewing a continuing review or update. 

3. Consent Process Observation – the IRB can request that an appropriate representative observe the consenting process for an approved protocol.
 

Most often this would occur based upon some information concerning a problem with an approved protocol. However, it could also be used if the IRB determined that a vulnerable population might be better protected if an observation of the consent process were conducted.



Jennifer Sharp, J.D.
April 20, 2005