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�պ�����Click is a paperless, electronic method to submit new protocols, modifications, continuing reviews and reportable new information.

Investigators should visit our Forms Library and the "User Guides" to prepare a submission.

Forms Library

�պ�����Click "Users Guides"

An Assurance is the documentation of institutional commitment to comply with Federal regulations and maintain adequate programs and procedures for the protection of human participants. This is the principal mechanism for compliance oversight by the . �պ����� Institutional Review Boards (IRBs) which serve �պ����� and �պ����� Medical Center are organized and operate in compliance with the US Department of Health and Human Services and the Food and Drug Administration regulations.

Federalwide Assurance Information

• University of Vermont & State Agricultural College FWA Number FWA00000723
• �պ����� Medical Center Inc. FWA Number FWA00000727
• The expiration date for these assurances changes frequently. If you need the expiration date, , and click "Search".
• The are available under "A. Terms of the Federalwide Assurance for Institutions Within the United States"

The IRBs that serve the two institutions are registered to �պ����� and State Agricultural College (IORG 0000289) with the Department of Health & Human Services. Registration numbers for the IRBs are:

• IRB00000485 (IRB #1 - Biomedical I IRB - OHRP/FDA)
• IRB00000486 (IRB #2 - Behavioral IRB - OHRP)
• IRB00000487 (IRB #3 - Biomedical II IRB - OHRP/FDA)

“Human Gene Transfer” or “HGT” is used to describe research involving the transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA, into human subjects. It is also sometimes referred to as “Gene Therapy.”

Effective April 27, 2016, �պ����� Institutional Biosafety Committee will determine whether investigator-initiated research requires RAC review based on specific criteria. If the project is sponsored, the sponsor is responsible for determining if RAC review is required.

Review and approval of a gene transfer protocol can be complex, therefore we have developed a step-by-step guide for submission of a human gene transfer protocol at �պ�����/�պ�����MC.

Other Resources

�պ����� Medical Center Research Subject Registrations

Researchers and research staff are required to associate any �պ����� Health Network patients executing a new consent form to participate in a research study to the research study in Epic.   For more information please see and

Credentialing Process for University of Vermont Clinical Research Personnel

It is mandatory for University of Vermont (�պ�����) employees involved in clinical research activities at �պ����� Medical Center (�պ�����MC) to complete and submit the credentialing documents to the Office of Clinical Trials Research (OCTR).  This includes working on projects involving direct patient interaction, retrieving blood, tissue, or health record data review.

Guidelines for Registering a Clinical Trial on

The Common Rule is the set of regulations governing the conduct of human subjects research conducted or sponsored by the federal departments and agencies that subscribe.

More about the Revised Common Rule.

When projects are quality improvement or assessment and do not meet the criteria as research.