Examples of Ceded Review in a sentence
If the institutions are not able to identify a mutually agreeable approach, the Research will be withdrawn from Ceded Review (without an IRB approval or disapproval) with respect to that Relying Institution.
If any Participating Institution disagrees that the Research is appropriate for Ceded Review and declines to participate in the Ceded Review, the Research shall remain eligible for Ceded Review with respect to the other Participating Institutions that have agreed, if any.
The Participating Institution of the Overall PI may also on its own initiative determine that particular Research may be appropriate for Ceded Review.
Such Participating Institution will make an initial determination about the appropriateness of Ceded Review for the Research that is the subject of the request.
Unless otherwise agreed, the Reviewing IRB(s) (or designee(s)) shall generally be the one(s) to notify the Overall PI and the Site Investigator(s) and the applicable Participating Institutions (i) whether the request for Ceded Review of the Research has been accepted or declined under this Agreement; and (ii) if accepted, which IRB(s) shall be the Reviewing IRB(s).
The institution must inform all Participating Institutions involved in Research (defined below) of the applicability of its FWA to the Research prior to such institution’s participation in any determination of the acceptability of a Ceded Review for the Research pursuant to Section 3 hereof.
If the Overall PI and the Overall PI’s Participating Institution are not seeking but do not object to Ceded Review, other Participating Institutions may still participate in a Ceded Review; in that case, a Site Investigator (defined in Exhibit A) may make a request for Ceded Review of the Research to the IRB of the Participating Institution where the Site Investigator is primarily employed or affiliated.
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.
Alternatively, any Participating Institutions agreeing to participate in a Ceded Review may agree with respect to themselves to waive the requirement of this section to maintain insurance coverage with respect to the Research that is the subject of the Ceded Review.
If no such requirements apply and if the Participating Institution of the Overall PI does not wish to serve as Reviewing IRB, then the determination of the appropriate Reviewing IRB(s) will be made by and among the Participating Institutions involved in the Ceded Review.