University of Vermont

Human Subjects Research - Institutional Review Boards - IRBs

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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.


Protocol Materials

Copies for Full

Copies for Expedited

Last Updated

Common Protocol Cover Form, AND

25 copies

1 copy 6/14
1 copy NA 6/27/11
AND

Human Research Protocol  (industry written is acceptable)

3 copies

1 copy 6/27/11

OR
Blood Drawing Protocol for Non-Clinical Laboratory Research NA 1 copy 11/4/11
OR
Biological Specimens/Data Repository Protocol NA 1 copy 11/4/11
OR
Initial Administrative Review of an Umbrella Grant NA 1 copy 11/4/11

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

Consent Form or Waiver Request

25 copies  

1 copy
NA

HIPAA Authorization

1 copy

1 copy NA
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 25 2014 09:39 AM

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