Organization Policy on HSPP Assurance of Compliance with DHHS Policy (Policy 103.1) 
May 2005

The Organization will provide written assurance documents to the OHRP to comply with the requirement of 45 CFR 46.103.  Assurance documents will be maintained and renewed in accordance with regulations.

The Organization may rely on other organizations to provide IRB review.  Such reliance shall be documented in written IRB review agreements, and the terms of the agreements shall be reflected in the Organization’s assurance documents, as applicable.

JHM IRBs, and any IRB delegated by JHM to review research, have the authority to:

1. Approve, require modifications to secure approval, or disapprove, all human subjects research activities overseen and conducted by the organization.
    
2. Suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to participants.
    
3. Observe, or have a third party observe, the consent process.
    
4. Observe, or have a third party observe, the conduct of the research.   

Officials of the Organization may not approve research if it has not been approved by the IRB.  Officials of the Organization may disapprove research that has been approved by the IRB.