NEW PROTOCOL/PROPOSAL SUBMISSION:

Refer to the categories below to determine if the research meets the requirements for an Exempt or Expedited approval. If the research does not meet those requirements it should be submitted for Full Board approval.

Exemption Categories

Expedited Categories

Save a copy of these forms on your computer's hard drive before filling them in.

Right-click links and select "Save Link As..." or "Save Target As..." to save a copy of the form on your hard drive, then double-click the saved file to launch MS Word and fill in the form.

MS Word macros must be enabled in order to use the automation features of these documents.

Complete one of the following forms depending on the type of review you are requesting: Exempt, Expedited or Full Board.

Medical Exemption Protocol Summary Form REQUIRED for Exempt Medical Research

Medical/Behavioral Protocol Summary Form REQUIRED for all Behavioral Research and Expedited or Full Board Medical Research- See Protocol Summary Form for which Appendix is required, it may be more than one.

• Appendix A - International Research
• Appendix B - Internet Use in Research
• Appendix C - Children as Research Participants
• Appendix D - Cognitively Impaired or Mentally Disabled Research Participants
• Appendix E - Prisoners as Research Participants
• Appendix F - Use of Drugs, Biologic Agents, or Devices
• Appendix G - Imaging/Diagnostic Radiation
• Appendix H - The Use of Biological Specimens

Complete a Consent Form or Permission Template, if required.

• Behavioral Template (Revised 05/08)
• Behavioral Assent Template (Revised 05/08)
• Medical Template (Revised 05/08)
• Parental Permission Template (Revised 05/08)
• Parental School Permission Template (Revised 05/08)
• Parental School Information Sheet (Revised 05/08)
• Humanitarian Use Device Template (Created 07/06)
• Assent Template (Revised 05/08)
• Information Sheet (Revised 05/08)
• Short Form Consents are available in Arabic, Bengali, Chinese, Hindi, French, German, Italian, Polish, Russian, Spanish, and Swahili (Please see the HIC standard operating procedure on Informed Consents Involving Non-English Speaking Participants for guidance if necessary)

Complete a HIPPA Summary Form (and HIPPA Authorization Form found in Consent Templates, if applicable)

HIPPA Summary Form

Additional Forms that may be required for Initial Submissions:

Single Time Emergency Use of a Test Article (Drug, Biologic or Device) Form (Created 11/06)

Coordinating Center Application

Humanitarian Use Device (HUD) Form

Administrative Application

Authorization to Use Another IRB for Protocol Approval Agreement

Authorization to be the IRB of Record for Collaborating Entity

Data Use Agreement

Additional Key Personnel List

AMENDMENT SUBMISSION:

Amendment Submission Form

HIPPA Summary Form

Consent Form

Appendix A-G

UNEXPECTED PROBLEMS/ADVERSE REACTION SUBMISSION:

Unexpected Problem Form

Unexpected Problem Follow-up Form

CONTINUATION/RENEWAL OF PREVIOUSLY APPROVED RESEARCH

Continuation Submission Form

COMPLETION OF ALL RESEARCH RELATED ACTIVITY (INCLUDING FOLLOW-UP)

Closure Form