HRPP and IRB Forms
IRB Forms including agreement and IND exemption request forms.
Agreement of Investigator Responsibilities (DOC)
This must be submitted whenever there is a change in Principal Investigator
Attestation for Ceded Reviews & Projects (DOCX)
This attestation should be completed by the investigator in the process of requesting a ceded review or in the establishment of a reliance agreement of IRB review.
Back-Translator Declaration Form (DOCX)
Required documents when Investigators submit translated & back-translated documents to the IRB for review
De-identified Data Agreement (DOC)
Model letter to include in IRB submissions when receiving or providing de-identified samples to/from other institutions
Electronic Copy Certification for paper Informed Consents (DOCX)
For projects which seek to archive paper informed consents electronically in accordance IRB SOP: Research Consent Storage: Electronic Copies of Paper Informed Consent Forms.
- How to bookmark and password protect scanned documents (PDF)
Additional guidance on how to bookmark and password protect electronic copies of paper ICF file has been developed
IRB Reliance Request Form (DOCX)
Use this form to request MCW to serve as the IRB of record or defer IRB oversight when a project may involve 2 or more institutions.
- Please use Request for Single or Central IRB Services from MCW IRB (DOCX) if you would like MCW to serve as the central IRB including for NIH-funded projects
ICH-GCP E.6 Checklist for Investigators (DOCX)
An attestation to confirm Investigators will follow ICH-GCP E.6 requirements for project.
IND Exemption Forms
- IND Exemption Form for Marketed Products (DOCX)
This exemption form should be used for drugs or biologics which already have FDA approval
- IND Exemption Form for Products with Isotopes (DOCX)
This exemption form should be used for drugs or biologics which contain either a radioactive or cold isotope component
- IND Exemption Form for GRAS Products or being used in a Challenge (DOCX) - This exemption form should be used for products which have been deemed generally regarded as safe (GRAS) or if the FDA approved product is being used to induce a physiological challenge
In-vitro Diagnostic (IVD) Device Research Attestation (DOCX)
An attestation to confirm that the proposed research involving an IVD device meets the criteria as outlined in 2006 FDA guidance for Approval without the Requirements of Informed Consent.
Protocol Deviation Summary Report Template (DOC)
A template for study teams to use when reporting protocol deviations at the time of continuing progress report
Public Data Set Nomination Checklist (DOCX)
An application to nominate new data sets to be determined as publicly available by the MCW HRPP office
Translator Declaration Form (DOCX)
Required documents when Investigators submit translated documents to the IRB for review