Examples of Reviewing IRB Institution in a sentence
A potential Reviewing IRB Institution should provide any publicly- available information related to investigations or inspections of the IRB that may be relevant to or influence another institution’s decision whether to rely upon that IRB.
No Participating Institution shall be obligated to participate as a Reviewing IRB Institution or a Relying Institution with regard to any particular Research.
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.
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.
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.
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.
This section describes other events that may occur that require reporting to the Reviewing IRB Institution and/or Relying Institutions.
Changes in FWA, IRB Registration, or Accreditation Status 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.
Although, all information about “local considerations” as defined in Section 6.4 of the “Agreement” will be considered by the Reviewing IRB for purposes of assessing federal human subjects protection requirements, the Reviewing IRB and Reviewing IRB Institution make no representation about the compliance or compatibility of its review with a Relying Institution’s obligations under other applicable federal and state law and local policy requirements.
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.