Reviewing IRB Institution definition

Reviewing IRB Institution. The Participating Institution whose IRB has become the Reviewing IRB for another Participating Institution for an instance of Research under this Agreement.

Reviewing IRB Institution. The Participating Institution whose IRB has will become the Reviewing IRB for another Participating Institution for an instance of Researcha Relying Institution under thisthe Agreement and/or that will provide determinations of exemption from IRB review for a Relying Institution under this Agreement. Site Investigator(s): AnThe investigator(s) responsible for the conduct of the an instance of Research at his/hertheir Participating Institution.

Examples of Reviewing IRB Institution in a sentence

• The Reviewing IRB and Reviewing IRB Institution make no representation about the compatibility of a waiver or alteration of authorization with a Relying Institution’s privacy practices, implementation of HIPAA or obligations under state law.

• Should a Participating Institution decide to participate as a Reviewing IRB Institution or a Relying Institution with regard to any particular Research, no additional individual authorization or reliance agreements need to be completed to effectuate the Ceded Review.

• No Participating Institution shall be obligated to participate as a Reviewing IRB Institution or a Relying Institution with regard to any particular Research.

• The Relying Institution acknowledges and agrees that its withdrawal of Research from Ceded Review may be subject to other requirements or may affect its continued involvement in the Research pursuant to or as a result of other laws, regulations, funding policies, or agreements, or other external sources apart from this Agreement, and that in no event shall a Reviewing IRB or Reviewing IRB Institution be responsible for such requirements or consequences.

• Without limiting the foregoing, whether the Terminating Institution is a Relying Institution or the Reviewing IRB Institution, the Reviewing IRB will, when possible and appropriate, provide continued oversight for such ongoing Research for the reasonable time necessary to appropriately transfer oversight of the Research to another IRB.

• In addition, this Agreement shall terminate immediately upon termination or withdraw of approval of the Study by the Reviewing IRB Institution or upon the termination or expiration of either party’s Joinder Agreement.

• Following a determination to apply Ceded Review pursuant to Section 3.2, the Participating Institution of the Overall PI will have the opportunity to decide whether it will serve as the Reviewing IRB Institution for the Research (if the Participating Institution has an IRB), unless another Reviewing IRB is required or designated pursuant to applicable regulation, funding policy, or other external requirements.

• Reviewing IRB Institution represents and warrants that, without limitation of its review obligations set forth in Section 5.4 of the SMART Agreement, it will, in its review and oversight of the Study, take into consideration, account for and comply with applicable State and local laws, rules and regulations.

• Reviewing IRB Institution and Relying Institutions are responsible for notifications regarding changes to FWA or accreditation status (also described in the Responsibilities section of this SOP): • A Reviewing IRB Institution will promptly notify all Participating Institutions and SMART IRB Administration: o If its FWA is suspended or restricted, lapses, or changes in scope.

• Reviewing IRB Institution will perform those determinations required by the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (collectively, “HIPAA”) with respect to the use and disclosure of Protected Health Information (“PHI”) for the Study subject to this Agreement, including authorizations and waivers of authorization for the use and disclosure of PHI.