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RequirementsFor UCB to rely on another IRB, please affirm that the following are true: ? The reviewing institution holds an active Federalwide Assurance (FWA). See FWA Lookup.? A human subjects protocol has been submitted for IRB review at the reviewing institution.? The study does not use a UCB subject pool (e.g., RPP, SONA, etc).Reviewing IRBReviewing Institution:Click or tap here to enter text.FWA#:Click or tap here to enter text.ProjectProject Title:Click or tap here to enter text.Reviewing IRB Protocol Number:Click or tap here to enter text.Funding Source (Insert or attach additional)UCB Recipient StatusSPO Award#Click or tap here to enter text.? Prime ? Sub ? NoneClick or tap here to enter text.Click or tap here to enter text.? Prime ? Sub ? NoneClick or tap here to enter text.Click or tap here to enter text.? Prime ? Sub ? NoneClick or tap here to enter text.Click or tap here to enter text.? Prime ? Sub ? NoneClick or tap here to enter text.Is UCB the prime recipient of a federal award in which all human subjects activities will be carried out by employees or agents of another institution?? Yes? NoLevel of review conducted (or to be conducted) by the Reviewing IRB:? Exempt? Expedited? Full BoardUCB Investigators (insert or attach additional)Principal Investigator:Click or tap here to enter text.Email:Click or tap here to enter text.Co-/Student Investigator (if applicable):Click or tap here to enter text.Email: Click or tap here to enter text.Investigator (if applicable):Click or tap here to enter text.Email:Click or tap here to enter text.Potential Conflict of Interest (COI)Do UCB investigators have a potential Conflict of Interest (COI) associated with the research? ? Yes ? NoIf YES, please explain: Click or tap here to enter text.TrainingPlease affirm that UCB investigators have completed the following training. See UCB Education and Training Webpage.CITI Human Subjects training (social-behavioral or biomedical, as applicable). Note that the biomedical version is required for all staff involved in FDA-regulated research.? I affirmGood Clinical Practice (GCP) training (e.g., NIH Clinical Trials) ? I affirm? N/AHIPAA training (projects involving protected health information (PHI) ONLY) ? I affirm? N/AUCB Research ActivityBriefly describe activities to be conducted by UCB investigators (such as research design, recruitment, obtaining consent, administering interventions, or analyzing identifiable data) and where these activities will take place:Click or tap here to enter text.Ancillary ReviewsIf any of the following ancillary reviews apply to research conducted on UCB campus, please mark the associated checkbox and provide approval numbers. For ancillary reviews that do not apply, mark “N/A.”? N/A ? Biological Use Authorization (BUA) Number:Click or tap here to enter text.? N/A ? Laser Use Registration (LUR) Number:Click or tap here to enter text.? N/A ? Magnetic Inventory Number (MIN):Click or tap here to enter text.Attachments (please attach)? Most Recent Reviewing IRB Approval Letter ? Reviewing IRB Inter-Institutional Agreement Form or SMART Letter of Acknowledgment (if available now)? CPHS Checklist for Financial Conflict of InterestAgreement by UCB Principal InvestigatorThe UCB Principal Investigator agrees to comply with all requirements and expectations described in UCB’s IRB Reliance Policy, and UCB Guidance on Reliance Agreements for Non-UC Collaborations or MOU Implementation Procedures for UC Collaborations.Click or tap here to enter text.Principal Investigator’s SignatureDate ................
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