Committee Information : Committees on Human Research : University of Vermont

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Untitled Document Forms Tutorial Submission Guidelines Research Manual (Manual Updated 08/09!!)

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Committee Meeting Schedules

Forms and Submission Requirements

NOTE: Electronic submission of these forms is NOT accepted at this time.

Initial Submission Materials	Guidance / Requirements
To determine the level of committee review necessary for your submission click here
Full or Expedited Review
Protocol: A protocol may be written by an industry sponsor or a local investigator as long as it contains the elements outlined in Section 8.A of the research manual. The Human Research Protocol Form is the preferred method of submission as it contains all of the required elements and is both easy to complete and easy for committee members to review. Common Protocol Cover Form: The Common Protocol Cover Form (Revised 6/18/07) is utilized by the Committees on Human Research, VCC and GCRC and is necessary for the initial submission of protocols.	Form Instructions Full Initial Review Requirements Expedited Initial Review Requirements
Exempt Research (see notes below)
Protocol Exemption Review and Determination Form	Form Instructions Exempt Review Requirements Exempt Screening Checklist
Research Not Involving Human Subjects (see notes below)
Research Not Involving Human Subjects Review and Determination	Form Instructions Not Human Subjects Review Requirements Not Human Subjects Flowchart
Other Research
Request for Review of Emergency Research with Waiver of Consent
*Notes
If your study involves the use of General Clinical research Center (GCRC) resources, the study is also subject to review by the GCRC's Scientific Advisory Committee. Refer to their webpage for further instructions. If your study involves the study of cancer or is cancer-related (see review criteria to the right), the study is also subject to review by the Vermont Cancer Center's Protocol Review Committee. Refer to their webpage for further instructions.	Cancer Center Review Criteria
Student Research	Guidance / Requirements
Instructor's Assurance Form	Student Research Guidance Faculty Sponsors of Student Research
Informed Consent	Guidance / Requirements
Request for Waiver
Request for Waiver of Informed Consent/Authorization/Documentation	Form Instructions Waiving Consent Guidance Informed Consent Module
Templates
Informed Consent Template with Guidelines - Revised 4/16/07 Informed Consent Template without Guidelines - Revised 4/16/07 Template for Consent Process Documentation Consent Addendum Template Media Consent to Interview Humanitarian Use Device Consent Template	Consent Form Document Guidance Informed Consent Checklist Humanitarian Use Device Guidance
HIPAA	Guidance / Requirements
Authorization
HIPAA Authorization Cover Form HIPAA Authorization Template	Cover Form Instructions Informed Consent / Authorization Guidance Authorization Instructions
Partial Waiver of Authorization
Request for Partial Waiver of Authorization for Recruitment Purposes	Form Instructions Partial Waiver Guidance
FAHC Health Information Forms
FAHC Data Use Agreement (applicable only to "Limited Data Sets") FAHC Data Collection for Reviews Preparatory to Research
Amendments	Guidance / Requirements
Request for Modification / Amendment to Approved Protocol (revised 10/13/07)	Form Instructions Amendment Review Requirements
Continuing Review	Guidance / Requirements
Request for Continuing Review Form (this form is mailed to the researcher)	Form Instructions Continuing Review Requirements
Safety Reporting	Guidance / Requirements

Guidance on Revised Safety Reporting - New 7/07	Revised Safety Policy in Manual

Sponsor Letter Regarding Safety Policy
Local Report for Serious and Non-Serious Adverse Events - New 7/07	Form Instructions Reporting Flowchart

New Safety information Form - New 7/07	Form Instructions Safety Report Reporting Flowchart

Report of Protocol-Related Problems and Deviations - New 7/07	Form Instructions Revised Safety Policy in Manual
Deviations	Guidance / Requirements
(now using the Report of Protocol-Related Problems and Deviations Form above)

Last modified October 17 2007 01:11 PM