Acceptance of and Cooperation with Central IRB Decisions; Amendments. ABC will accept the decisions and requirements of the Central IRB with respect to the Clinical Studies included in this Agreement. ABC will also ensure that its investigators cooperate in the Central IRB’s continuing review process and cooperate with all other requirements of the Central IRB and of the NeuroNEXT CCC related to this Agreement. The principal investigator at ABC may submit requests to the Central IRB for an amendment or exception to the protocol for a Clinical Study in accordance with the criteria and requirements described in the Reliance SOP. No changes to the research activities shall be initiated by ABC or its investigators without prior approval by the Central IRB unless necessary to eliminate apparent immediate hazards to subjects.
