Common use of Informed Consent Form Clause in Contracts

Informed Consent Form. The Designated IRB will review informed consent forms for each research study included under this Agreement. The forms will be consistent among sites except for site-specific language included by the Relying Institution. The Designated IRB will provide approved informed consent forms for each site to the Principal Investigator or the Coordinating Center to distribute to Investigators for use at their sites. HIPAA Authorization. The Designated IRB will perform the initial determinations required by the Health Insurance Portability and Accountability Act of 1996, the Health Information Technology for Economic and Clinical Health Act of 2009, and their implementing regulations (collectively, “HIPAA”) with respect to the mechanisms for permitting the use and disclosure of Protected Health Information (“PHI”) for the Research reviewed under this Agreement, namely authorization and waivers of authorization for use and disclosure of PHI as applicable. Other than the initial determinations regarding mechanisms for use and disclosure of PHI referenced above, each party shall be independently responsible for its own HIPAA compliance and obligations (for example, minimum necessary requirements, or accounting of disclosures of PHI made pursuant to a waiver of authorization) in connection with the Research subject to this Agreement.