Forms

The IRB-03 requires submission of three basic items for a new project:

1. The IRB Application (also referred to as the IRB Introductory Questionnaire)
2. A Protocol
3. A Proposed Informed Consent document (unless you are requesting a waiver of consent)

*If you would like assistance making changes to your proposal after an IRB reviewer has looked at it, please also submit an electronic or diskette copy of your submission.

AND, if applicable:

• A copy of the DHHS grant proposal for any DHHS-sponsored protocol
• An Investigator’s Brochure or Drug Package Inserts/Product information for drug or device studies
• Flyers, advertisements, surveys, questionnaires, data collection forms, recruitment letters, etc.

Requirements for Submitting Paperwork to the IRB

1. Always download and use the most current submission forms. Check back frequently.
2. All paperwork must be legible/typed.
3. All submissions must be signed by the principal investigator.
4. Attach a copy of all supporting documentation (protocol, advertisements, patient/subject questionnaires/surveys, data collection forms).
5. The submission must be complete, correct, proofed carefully for format, spelling and grammar at time of submission.
6. Attach a separate cover letter if you need to provide additional information. The more information you can give the IRB, the easier it is to evaluate your study.
7. Informed consents must be written on an eighth-grade reading level!
8. Some types of submissions do not have a required form available. If you need to submit information and a form is not available, please provide a cover letter detailing the content of your submission.
9. Sometimes a question on a form may not be appropriate for your study or the available answers don't seem to fit. In either case, please provide a cover letter that indicates which questions/answer is not appropriate and provides an adequate explanation or information to the general intent of the question.

Forms for Existing Studies

Have you renewed your HIPAA for researchers training? Initial training is only good for two years - see information above!

• Adverse Events
• Adverse Event Reporting Guide
• SAE Reporting Form
• AE Nonreportable Form
• AE Summary Table
• Continuing Review Report/Completion of Study Report
• Deviation Reporting Form
• "Disclosures" Tracking Form
• Waiver of HIPAA Privacy Authorization for Research

Forms for New Studies

Have you renewed your HIPAA for researchers training? Initial training is only good for two years - see information above!

• "Disclosures" Tracking Form
• Emergency Use OF Investigational or Unapproved Item Form
• Humanitarian Device Exemption Form (new)
• Humanitarian Device Exemption Closure Form (previously approved)
• Introductory Questionnaire for Full Board and Expedited Studies
• Introductory Questionnaire for Exempt Studies (the "short" form)
• Informed Consent Template (includes HIPAA-required elements)
• Informed Consent Template Without HIPAA Language (for studies that do not collect, use or disclose PHI)
• Protocol Guide
• Training Certification for Obtaining Consent
• Web Site Submission Form (to post an ALREADY APPROVED study to the HSCJ Research Website)

Other IRB Forms

• Certificate for Preparatory Research
• Certificate for Research with Decedents Info
• Radiation Safety Letter
• WIRB - IBC Cover Letter
• Emergency Use Report

Updated: 03/01/2007