Right to Decline to Be IRB of Record Sample Clauses

Right to Decline to Be IRB of Record. A campus HRPP may decline, on a case-by case basis, to be the reviewing IRB for research conducted at another UC location. If this occurs, the HRPP of the IRB being asked to review will notify all relevant parties, i.e., the PI at the campus of the reviewing IRB, the HRPP and PI at the campus seeking to rely, and ORGS at UCOP.
Sample 1
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Right to Decline to Be IRB of Record. A Reviewing IRB may decline, on a case-by case basis, to act as the Reviewing IRB for research conducted at other Participating Institutions. I. Right to Terminate Serving as the IRB of Record. After initial approval of a study, the Reviewing IRB may terminate serving as the IRB record for a study with at least six months advance written notice to the Principal Investigator (Pl) and the Relying Institutions, in order to provide time for the protocol to be transferred to another IRB. A. The Relying Institution bears responsibility for the conduct of all human subject research in which it is engaged. This includes the following: 1. Maintain a Federalwide Assurance (or equivalent federal assurance) and human research protection program if engaged in federally funded or support research. 2. Ensure that the relying institution’s investigators and other research personnel are appropriately qualified and meet the relying institution’s standards for eligibility to conduct research. This includes, but is not limited to, having the required professional staff appointments, credentialing, insurance coverage, and background checks for their assigned role in the research. 3. Promptly report to the Reviewing IRB any proposed changes in the research and ensure that the researchers will not initiate changes in the research (including changes in the consent form) without prior review and approval by the Reviewing IRB, except where necessary to eliminate apparent immediate hazards to the subjects. 4. Ensure that the researchers will not enroll individuals in research prior to review and approval by the Reviewing IRB. 5. Ensure that the researchers when responsible for enrolling participants will obtain, document and maintain records of consent for the each subject as stipulated by the Reviewing IRB. 6. Ensure that the researchers will provide to the Reviewing IRB any data safety monitoring board reports they receive at continuing review or upon request by the Reviewing IRB. B. The Relying Institution grants the reviewing IRB the authority to: 1. Approve, require modifications to secure approval, and disapprove the research. The Relying Institution shall not approve specifically related research that has not been approved by the Reviewing IRB. 2. Suspend or terminate approval of the research when not being conducted in accordance with the Reviewing IRB's requirements or that has been associated with unexpected serious harm to subjects. 3. Observe, or have a third party obser...
Sample 1

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