HIC Forms, Submission Requirements, Review Categories
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. THE MOST CURRENT VERSIONS OF THE FORMS/TEMPLATES ARE LISTED IN PARENTHESIS AFTER THE FORM, i.e. (7/08).
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 (7/08) REQUIRED for Exempt Medical Research
Medical/Behavioral Protocol Summary Form (04/08/09) 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 (7/08)
- Appendix B - Internet Use in Research (3/08)
- Appendix C - Children as Research Participants (5/20/08)
- Appendix D - Cognitively Impaired or Mentally Disabled Research Participants (12/06)
- Appendix E - Prisoners as Research Participants (3/17/08)
- Appendix F - Use of Drugs, Biologic Agents, or Devices (8/27/08)
- Appendix G - Imaging/Diagnostic Radiation (3/17/08)
- Appendix H - The Use of Biological Specimens (3/17/08)
HELPFUL HINT: Refer to the following link to review the IRB Reviewer Form for committee expectations during the review process.
IRB Reviewer Form- Intial Submission
Complete a Consent Form or Permission Template, if required.
- Behavioral Template (Revised 01/09)
- Behavioral Assent Template (Revised 05/08)
- Medical Template (Revised 01/09)
- Parental Permission Template (Revised 02/09)
- Parental School Permission Template (Revised 02/09)
- Parental School Information Sheet (Revised 01/09)
- 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, French, German, Hindi, 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)
- Oral Short Form English Translation
Complete a HIPPA Summary Form (and HIPPA Authorization Form found in Consent Templates, if applicable)
- HIPPA Summary Form (3/17/08)
Additional Forms that may be required for Initial Submissions:
- Single Time Emergency Use of a Test Article (Drug, Biologic or Device) Form (11/06)
- Coordinating Center Application (9/3/08)
- Humanitarian Use Device (HUD) Form (7/08)
- Administrative Application (9/3/08)
- Authorization to Use Another IRB for Protocol Approval Agreement (5/18/04)
- Authorization to be the IRB of Record for Collaborating Entity (4/10/08)
- Data Use Agreement
- Additional Key Personnel List (07/08)
- Amendment Submission Form (11/24/08 [revised:5/12/09 instructions only])
- HIPPA Summary Form (3/17/08)
- Consent Form (see above)
- Appendix A-G (see above)
UNEXPECTED PROBLEMS/ADVERSE REACTION SUBMISSION:
- Unexpected Problem Form (02/02/09)
- Unexpected Problem Follow-up Form (02/02/09)
- Adverse Event Algorithm
- Determining which Adverse Events are Unexpected
- Unexpected Problem Checklist for PI's
CONTINUATION/RENEWAL OF PREVIOUSLY APPROVED RESEARCH
- Continuation Submission Form (3/13/09) NEW
COMPLETION OF ALL RESEARCH RELATED ACTIVITY (INCLUDING FOLLOW-UP)
- Closure Form (12/06)