University of Vermont

Human Subjects Research - Institutional Review Boards - IRBs


New Medical Committee Review

Typically, the same protocol materials are required for Full vs Expedited Review, however the number of copies required differs.  Additionally, you will note below that certain types of expedited protocols do not require the Common Protocol Cover form.

For Expedited protocols that ONLY involve secondary data analysis of identifiable Protected Health Information (PHI) from health records/pathology slides/radiographic images (no subject intervention or follow-up), complete only the “Health Records Review Protocol” form.

Protocol Materials

Copies for Full

Copies for Expedited

Last Updated

Common Protocol Cover Form, AND

1 copy

1 copy 06/01/17
1 copy NA 06/27/11

Human Research Protocol  (industry written is acceptable)

1 copy

1 copy 07/01/15

Blood Collection Protocol for Non-Clinical Laboratory Research NA 1 copy 07/13/16
Biological Specimens/Data Repository Protocol NA 1 copy 05/02/17
Initial Review of an Administrative Tool NA 1 copy 07/13/16
Health Records Review Protocol (new April 2016)NA1 copy01/13/17

Also include the following as applicable in the any of the applications above:

Consent Form or Waiver Request

1 copy  

1 copy
One copy as applicable:
Investigational Drug/Device Brochure
Awarded Grant
Contract or Agreement with Sponsor
Collaborative Agreements with Other Insitutitons
Recruitment Materials
Any documents provided to the subject (e.g. questionnaires/diaries/educational materials)
Verbal Consent Script
Information Sheet in lieu of Signed Consent
1 copy 1 copy NA
Request for UVM NetID for Required Training 1 copy 1 copy NA

Last modified June 23 2017 04:14 PM

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