Duration and Nature of Ceded Review. When review of Research is ceded under this Agreement, the Research will remain under the oversight authority of the Reviewing IRB determined/selected pursuant to Section 3 hereof for as long as IRB review is required for the particular Research (presuming that participation of the Reviewing IRB and Relying Institution in the Agreement has not terminated pursuant to Section 7), except in the circumstance where a Relying Institution determines in its sole discretion that it must withdraw the Research from Ceded Review (in which case it may do so immediately). 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 cases where the Relying Institution will continue with the Research, the Reviewing IRB and Relying Institution will work together to facilitate the transfer of IRB oversight to another IRB with the goals of ensuring the continued protection of human subjects and of limiting the potential disruption to the Research.
Duration and Nature of Ceded Review. When review of Research is ceded under this Agreement, the Research will remain under the oversight authority of the UM IRB for as long as IRB review is required for the particular Research, presuming that participation of the UM IRB and the Relying Institution in this Agreement has not terminated pursuant to Section VI herein. The Relying Institution acknowledges and agrees that its withdrawal of Research from Ceded Review may be subject to other requirements or affect its continued involvement in the Research pursuant to or as a result of law, regulation, funding policies, or agreements, or other external sources apart from this Agreement, and that in no event shall the UM IRB or UM be responsible for such requirements or consequences. In cases in which the Relying Institution will continue with the Research, the UM IRB and the Relying Institution will work together to facilitate the transfer of IRB oversight to another IRB with the goals of ensuring the continued protection of human subjects and of limiting the potential disruption to the Research.
Duration and Nature of Ceded Review. When review of Research is ceded under this Agreement, the Research will remain under the oversight authority of the Reviewing IRB determined/selected pursuant to Section 3 hereof for as long as IRB review is required for the particular Research (presuming that participation of the Reviewing IRB and Relying Institution in the Agreement has not terminated pursuant to Section 7), except in the circumstance where a Relying Institution determines in its sole discretion that it must withdraw the Research from Ceded Review (in which case it may do so immediately). 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 cases where the Relying Institution will continue with the Research, the Reviewing IRB and Relying Institution will work together to facilitate the transfer of IRB oversight to another IRB with the goals of ensuring the continued protection of human subjects and of limiting the potential disruption to the Research. Collaborative Process for Consideration of Ceded Review Requests and Determination of Reviewing IRB Request Process. The Overall PI (defined in Exhibit A) (or designee) may make the request for Ceded Review of particular Research to the IRB of the Participating Institution where the Overall PI is primarily employed or affiliated. Such Participating Institution will make an initial determination about the appropriateness of Ceded Review for the Research that is the subject of the request. The Participating Institution of the Overall PI may also on its own initiative determine that particular Research may be appropriate for Ceded Review. 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. Review of Requests. If the Participating Institution of the Overall PI (or of the requesting Site Investi...
Duration and Nature of Ceded Review. When review of Research is cededCeded Review of Research occurs under this Agreement, the Research will be and remain under the oversight authority of the Reviewing IRB determined/selected pursuant to Section 3 hereof, as “IRB of record,” for as long as IRB review/oversight is required for the particular Research (presuming that participation of the Reviewing IRB/Reviewing IRB Institution and Relying Institution in the Agreement has not terminated pursuant to Section 7 hereof), except in the circumstances whereset forth in Section 2.5.2.
Duration and Nature of Ceded Review. Withdrawal of Research from Ceded Review or Withdrawal of Reviewing IRB; Effect of Withdrawal.
