Providence VA Medical Center, Rhode Island

Forms for Each Type of Protocol Submission

Described below are the documents required for IACUC/R&D protocol submissions.
V 1/2/2013

Required Forms for New Proposal Submission - All Studies:

• Request to Review Research Proposal/Project Form
• Animal Component of Research Protocol (ACORP), Version 3
• ACORP Appendix 1, Use of a Non-VA Facility to House Animals Purchased With VA or VA Research and Education Corporation Funds
• ACORP Appendix 2, Antibody Production
• ACORP Appendix 3, Test Substances
• ACORP Appendix 4, Antemortem Specimen Collection
• ACORP Appendix 5, Surgery
• ACORP Appendix 6, Special Husbandry and Procedures
• ACORP Appendix 7, Request to Use Patient Care Procedural Areas for Animal Studies
• ACORP Appendix 8, Request to Use Explosive Agent in the Animal Facility or in Animals
• Scope of Work for Animal-Lab Personnel
• Chief of Service Statement
• BioSafety Form
• RDIS Page 18 for new investigators and Page 18 Codes
• Conflict of Interest Disclosure Form
• CV for New PI and Resume of New Research Staff
• Full Protocol
• Budget
• If the research occurs at another facility, Institutional Safety Committee (or equivalent) approval or exemption for the project.

       __________________________________________          __________________________________
       PI Signature (only)                                                                 Date

Continuing Reviews (conducted annually)

• Institutional Care and Use Committee Continuing Review form

Lapsed Protocol Reinstatement Request

If your protocol expires past the IACUC approval period, the protocol is considered lapsed and automatically falls into a suspended category.  No activity can occur with the study in this category.

Amendment

• Cover memo detailing amendment (specific item (e.g., protocol).
• Modified materials (e.g., pertinent training documentation, protocol).

Responses to Conditionally Approved Items

• Cover memo from PI detailing responses to conditions.
• Copy of memo issued from the Chairperson (either Committee).
• Modified materials (e.g., pertinent training documentation, protocol, etc).

Responses to Tabled/Disapproved Items

• Cover memo from PI detailing responses to the requests/conditions.
• Copy of memo issued from the Chairperson (either Committee).
• Modified materials (e.g., pertinent training documentation, protocol, etc.).

Study Closure

• Institutional Care and Use Committee Study Closure Request form

_________________________________________________     ___________________________
PI Signature (only)                                                                          Date

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