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.

 Establishing a Single IRB (sIRB) Reliance and sIRB Submission Process

 HRPP Immediate Reporting Policy

• Investigator Checklist to Obtain Expanded Access IND for Treatment of Individual Patient
  Guidance concerning how to obtain an expanded access IND for an individual patient in emergency and non-emergency situations.
•  SARS-CoV-2 Vaccination Considerations for Clinical Research Studies
  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.
•  Remote Monitoring for Clinical Studies
  Clarification from the Assistant Dean for Clinical Research Compliance concerning whether IRB amendments are needed to account for clinical studies utilizing remote monitoring visits.
•  IRB Guidance on Lapses in IRB Approval (Continuing Reviews and PAM-ARs)
  What to do if your IRB approval has expired beyond 90 days.
•  Human Subjects Research Inter-Campus Collaborations
  Explains the steps necessary to initiate collaborative human subjects research between the WCM and Cornell Ithaca campuses.
•  Approval Stamps for IRB-Approved Documents
• Clarification concerning which IRB-approved documents are stamped approved by the IRB.
•  Requests for IRB Roster/Membership Information
  Clarification concerning requests for access to the IRB roster or membership information.
•  IRB Signatures on Approval Letters
  Clarification concerning signatures on IRB approval letters.
•  IRB Protocol Deviations Guidance
  Discusses types of protocol deviations and how to properly report them. A companion to the HRPP Immediate Reporting Policy.
•  Information about the Weill Cornell IRBs
  Information about WCM IRBs, including registration numbers.

•  NCI CIRB Standalone HIPAA Authorization Form
  Standalone HIPAA Authorization template document, for use with the NCI CIRB Boilerplate ICF Template (version: 01/2021).
•  NCI CIRB Boilerplate ICF Template
  CIRB-approved boilerplate language (version: 09/2020), to be inserted into the CIRB-approved consent form(s) by the Investigator.
•  Protocol Deviation Log Template
  Template to report protocol deviations at the time of IRB Continuing Review.
•  WCM IRB Reliance Memo
  Form to document study details when using an existing reliance agreement.
•  SMART IRB Acknowledgement Memo
  Form for use of the SMART IRB Master Agreement for federally funded cooperative research.
•  WCM Single Scope Reliance
  Local template reliance document for multisite studies not utilizing federal funding or existing agreements.
•  HIPAA Form: Investigator Representation for Research on Protected Health Information of Decedents
  For completion when research will use or disclose the PHI of decedents.
•  English Short Forms & Translated Versions
  For use in the event of unexpected enrollment of a non-English speaking subject.
•  Informed Consent and HIPAA Authorization for Research
  Informed consent and HIPAA Authorization template document.
•  Assent Form for Minors for Clinical Investigation
  Assent template document for enrolling children ages 7-11 or 12-17.
•  Informed Consent for Research Involving Genetic Testing
  Informed consent template document for research involving genetic testing.
•  AE & IND Safety Report Cumulative Table
  A table for reporting adverse events to the IRB at the time of Continuing Review.