Research Administration

Human Subject Research (IRB):
Human Subjects Committee Forms

(Save to disk, fill out and print for submission)

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How Do I Submit an IRB Application and Other Guidance?

Research Administration's HIPAA Site

Please be advised that new IRB Application Forms were released on 11/26/07.  As of 2/1/08, Investigators are required to use the new forms.  For assistance, contact Research Review Committee Staff at 444-6246.

Form Name	Current Version Date	Form Specific Instructions
Application Forms
Application Checklist	7/08
Application Form	07/08	Instructions
Appendix 1A: Vulnerable Subjects - Children	07/08	Instructions
Appendix 1B: Vulnerable Subjects - Prisoners	07/08	Instructions
Appendix 1C: Vulnerable Subjects - Pregnant Women & Fetuses	07/08	Instructions
Appendix 1D: Vulnerable Subjects - Decisionally Impaired	07/08	Instructions
Appendix 2: Alterations to the Consent Process	07/08	Instructions
IRB Application for Chart Review (Only)	3/08	Instructions
Personnel List	07/08
Biographical Sketch	01/08
Divider Pages for New Application	7/08
*Nursing Service-Approval to Use Investigational Devices	2/04
*Nursing Service-Approval to Administer Investigational Drugs	2/04
Conflict of Interest	6/07
Research Plan (Instructions)		Instructions
HIPAA Forms
*Consent Form Templates (For all Lifespan Sites)
Informed Consent Checklist
Lifespan Adult (Combined)	07/08	Spanish Version	Portuguese Version
Lifespan Child (Combined)	07/08	Spanish Version	Portuguese Version
*National Cancer Institute Adult Consent Form (Combined)	07/08	Spanish Version	Portuguese Version
*National Cancer Institute Pediatric Consent Form (Combined)	07/08	Spanish Version	Portuguese Version
Adolescent Assent Examples (This material is to view and print only)		Adolescent- Assent  Example 1 Rev. 6/04	Adolescent Assent Example 2 Rev 9/05
Agreement to Participate in Specimen Banking - Anonymous Samples	8/04
Agreement to Participate in Specimen Banking - Identifiable Samples	8/04
Forms for Previously Approved Studies
Request for Revision to Protocol	07/08	Instructions
Continuing Review Report	07/08	Instructions for Continuing Review	FAQs for Continuing Review
Divider Pages for Continuing Review	8/08
Forms for Unanticipated Problems and Adverse Advents (Available in Word and PDF Versions)
Single Unanticipated Problem/Adverse Event Form AE1	1/08		Instructions
Word
PDF
Multiple Unanticipated Problem/Adverse Event Form AE2	1/08
Word
PDF
Fatal Unanticipated Problem/Adverse Event Form AE3	1/08
Word
PDF
Sponsor Required But Otherwise Not Reportable Unanticipated Problem/Adverse Event Form AE4	1/08
Word
PDF
IRB Protocol Deviation/Exception Report	11/07	Instructions

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*Include if appropriate

You will also need to include a research plan or sponsor protocol.

You may substitute pages from an external application that contain the same information requested on the Lifespan forms (e.g. biographical sketches, research plans.)

Full IRB review:  original institutional application plus 25 copies

Expedited/Exempt review:  original institutional application plus 1 copy

For questions concerning submission of applications for committee review, please contact Patricia Houser, Adrienne McParland or Dawn Roux in the Research Review Committee Office.

All documents should be delivered to Aldrich 507.

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