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RESEARCH STUDIES SUBMITTED
AFTER APRIL 14, 2003 &
HIPAA PRIVACY REQUIREMENTS

Investigators who intend to use Protected Health Information in proposed research studies must include either a "Research Participation Authorization Form" or an "Application for Waiver Form" in addition to the standard UMCIRB submission forms.

All forms required for submission of new research studies are available at: http://www.ecu.edu/irb.

Guidance on what data or information may be considered Protected Health Information may be found at http://www.ecu.edu/compliance/hipaa.htm.

Forms & Documents

GENERAL INFORMATION:

• Not sure which forms to complete? Go to our simple questionnaire below.
• ALL member of the research team must complete the Mandatory IRB Training before the Institutional Review Board office will accept your submission.
• Be sure to FOLLOW INSTRUCTIONS and include ALL necessary attachments.
• It's important to record your IRB number and expiration date.
• If your study is completed, you must fill out a Continuous Review and Closure Form and submit to the UMCIRB.

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Answer the following questions:

Does your study involve:

A biomedical procedure performed on a human?
Yes No

A medical therapeutic intervention performed on a human?
Yes No

A drug administered to a human?
Yes No

An investigational device used on a human?
Yes No

If you answered Yes to any of the above questions, then you will need to use the Biomedical Forms. Otherwise, you will use the Behavioral & Social Science Forms.

If your study does not seem to fit either category, please call the UMCIRB at (252) 744-2914.

		University and Medical Center Institutional Review Board East Carolina University 600 Moye Boulevard Brody School of Medicine, Room 1L-09 Mail stop # 682 Greenville, NC 27834 Telephone: 252-744-2914 Fax: 252-744-2284 umcirb@ecu.edu