Research Administration

Human Subject Research (IRB):
Human Subjects Committee Forms

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How Do I Submit an IRB Application and Other Guidance?

Research Administration's HIPAA Site

Form Name	Current Version Date	Form Specific Instructions
*Application Forms*
Application Checklist	07/09
Application Form	03/09	Instructions
Appendix 1A: Vulnerable Subjects - Children	02/09	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	02/09	Instructions
Appendix 2: Alterations to the Consent Process	07/08	Instructions
IRB Application for Chart Review (Only)	03/09	Instructions
Personnel List with Prep to Research	08/09
Biographical Sketch	01/08
Divider Pages for New Application	03/09
*Nursing Service-Approval to Use Investigational Devices	02/04
*Nursing Service-Approval to Administer Investigational Drugs	02/04
Conflict of Interest	01/09

Research Plan (Instructions)		Instructions

HIPAA Forms

*Consent Form Templates (For all Lifespan Sites)
Informed Consent Checklist
Lifespan Adult (Combined)	07/09	Spanish Version	Portuguese Version
Lifespan Child (Combined)	07/09	Spanish Version	Portuguese Version
*National Cancer Institute Adult Consent Form (Combined)	07/09	Spanish Version	Portuguese Version
*National Cancer Institute Pediatric Consent Form (Combined)	07/09	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
Obtaining Consent from Subjects Who do not Speak English (Short Form Consent)	07/09	Instructions/Process (Including Links to Translated Forms)
Specimen Banking - Internal	07/09
Specimen Banking - External	07/09

*Forms for Previously Approved Studies*
Request for Revision to Protocol	04/09	Instructions
Continuing Review Report	02/09	Instructions for Continuing Review	FAQs for Continuing Review
Divider Pages for Continuing Review	03/09
Continuing Review Report for *Chart Reviews*	07/09
Termination Report	07/09
Forms for Unanticipated Problems and Adverse Events (Available in Word and PDF Versions)
Unanticipated Problems and Adverse Events	04/09
IRB Protocol Deviation/Exception Report	08/09	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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Research Administration

Human Subject Research (IRB): Human Subjects Committee Forms

Human Subject Research (IRB):
Human Subjects Committee Forms