California Pacific Medical Center Institutional Review Board (IRB)
California Pacific Medical Center (CPMC) Institutional Review Board (IRB) Important Information about Your IRB Approval
Information and all IRB forms are available on the CPMC IRB web site at http://www.cpmc.org/professionals/research/irb/forms/index.html
IRB approval does not necessarily constitute approval to begin your new study. “Conditional approval” from the IRB “subject to” specified items means that the pending items must be submitted to and approved by the IRB before research activities can begin. In addition, other (non-IRB) approvals may be needed (e.g., conflict of interest committee).
Study Compliance: IRB approval is contingent upon the CPMC PI's continued compliance with all IRB conditions and requirements. Noncompliance can result in suspension or termination of your research project. It is the CPMC PI's responsibility to understand and comply with the requirements of the IRB and to assure that all co- and sub-investigators and research staff understand and comply with these requirements. The IRB is required to notify federal regulators when a study is suspended or terminated.
Study-Related Documents: All study-related documents, including consent forms, survey instruments, recruitment flyers or letters, and telephone scripts must be approved by the IRB before they are used in a research study.
Informed Consent: Unless specifically waived by the IRB and documented in writing, all CPMC PIs must assure documentation of informed consent using a consent form approved by the CPMC IRB and bearing the CPMC IRB’s approval stamp. You will receive the approved consent form (either by mail or via e-mail in an Acrobat PDF file) for you to copy and use. The “Experimental Subject’s Bill of Rights” is the first page of the consent form document. You may not re-type the consent form or change it in any way. If the consent form requires any revision, that revision must be submitted to the IRB for approval before use. The IRB will send the revised IRB-approved and stamped consent form to you for subsequent use.
Modifications: If any IRB-approved study, study design or study-related document or procedure, requires revision during the course of the study, it must be approved by the IRB prior to implementation. Please complete the Protocol Amendments/Modifications form with relevant support documents attached. Modifications may be made prior to IRB approval only when necessary to protect the safety, rights, or welfare of research participants. These changes must be reported to the IRB within five days of learning of the event. Any other changes in research activity not approved by the IRB are reported as a protocol violation.
Adverse Events (AE): Unanticipated serious adverse events experienced by CPMC study participants must be promptly reported to the IRB within 5 days of learning of the event.
Continuing Review: All IRB-approved research must be reviewed and reapproved at an interval determined by the IRB that is no longer than one year. CPMC PIs are required to submit progress reports written to meet IRB guidelines to enable continuing review and reapproval. It is the PI's responsibility to track the study expiration date and submit a progress or final report in time for reapproval or study closure before it expires. If your IRB approval expires by even one day, study-related activities must stop until the IRB reapproves the research unless subject safety is at risk. If enrollment occurred during the report period, a copy of all consent/assent forms currently in use must accompany the progress/final report. The consents/assents submitted should be that of the last person enrolled with the subject’s name blacked out.
Version 1.0 (November 19, 2009)
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