Policies Under Review
The following documents reflect policies that are currenly under review by our QA Managers. Please be sure to check back often for updates; new policies will be posted as they become available.
Policy for the request of an IRB reliance and submission to the WCM IRB.
The Human Research Protections Program policy for reporting adverse events, protocol deviations, and emergent risk information (i.e., Reportable Events).
- Guidance concerning how to obtain an expanded access IND for an individual patient in emergency and non-emergency situations.
- Clarification concerning whether vaccines authorized under the FDA's Emergency Use Authorization should or should not be considered an experimental therapy for the purposes of study entry criteria or study follow-up.
- Clarification from the Assistant Dean for Clinical Research Compliance concerning whether IRB amendments are needed to account for clinical studies utilizing remote monitoring visits.
- What to do if your IRB approval has expired beyond 90 days.
- Explains the steps necessary to initiate collaborative human subjects research between the WCM and Cornell Ithaca campuses.
- Clarification concerning which IRB-approved documents are stamped approved by the IRB.
- Clarification concerning requests for access to the IRB roster or membership information.
- Clarification concerning signatures on IRB approval letters.
- Discusses types of protocol deviations and how to properly report them. A companion to the HRPP Immediate Reporting Policy.
- Information about WCM IRBs, including registration numbers.
Templates and Forms
- Standalone HIPAA Authorization template document, for use with the NCI CIRB Boilerplate ICF Template (version: 01/2021).
- CIRB-approved boilerplate language (version: 09/2020), to be inserted into the CIRB-approved consent form(s) by the Investigator.
- Template to report protocol deviations at the time of IRB Continuing Review.
- Form to document study details when using an existing reliance agreement.
- Form for use of the SMART IRB Master Agreement for federally funded cooperative research.
- Local template reliance document for multisite studies not utilizing federal funding or existing agreements.
- For completion when research will use or disclose the PHI of decedents.
- For use in the event of unexpected enrollment of a non-English speaking subject.
- Informed consent and HIPAA Authorization template document.
- Assent template document for enrolling children ages 7-11 or 12-17.
- Informed consent template document for research involving genetic testing.
- A table for reporting adverse events to the IRB at the time of Continuing Review.