Research Microscope Lab

Medical College of Wisconsin HRPP and IRB Forms

IRB Forms including agreement and IND exemption request forms.

IRB 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.  

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.

ICH-GCP E.6 Checklist for Investigators (DOCX)
An attestation to confirm Investigators will follow ICH-GCP E.6 requirements for project.

Letter of Support Template (DOCX)
This Letter of Support Template can be used for projects where research activities are occurring outside of MCW/FH at locations/organizations which may not have a formal ethics review board or IRB.


IND Exemption Forms

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