University of Vermont

Initial New Review Process

• Initial Exempt Review - Limited or No Risk

• Initial Expedited Review - No More than Minimal Risk

• Initial Full Review - Greater than Minimal Risk

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Initial Exempt Review Process

If application form and materials ARE complete:

• Please email the appropriate form and materials to irb@uvm.edu

If application form and materials are NOT complete:

• An IRB Administrator will contact you by e-mail or phone to let you know what needs to be done to get your application ready for review by the IRB.
• Note:  All student projects require a faculty sponsor review and sign-off prior to submission.

If application form and materials are complete and the study meets the exempt review category criteria:

• An IRB Administrator will send you an exemption certificate by e-mail.   You may begin your research when you receive this Exemption certification.

If application form and materials are complete but the study does not meet the exempt review category criteria:

• You will be notified to submit the required material for review. 

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Initial Expedited Review

If application materials are NOT complete:

• An IRB Administrator will contact you by e-mail or phone to let you know what needs to be done to get your application ready for review by the IRB.

If application materials are complete and the study meets the expedited review criteria:

• Your application and materials will be sent for IRB Expedited Review.

If application materials are complete but the study does not meet the expedited review criteria:

1. Your study will need to be reviewed by Full Committee Review.

2. You  may be asked to submit additional materials for the review.

3. After receipt of any additional materials, your application will be forwarded to the next available Full Committee Review Meeting.

Possible Outcomes from the review of your research:

1. Approval

• The IRB will e-mail the contact person designated in the protocol the following items as applicable;

• the Protection of Human Subjects Assurance (approval), 

• the informed consent form with an IRB stamp with expiration date, or information sheet

• a HIPAA authorization form with a IRB stamp.

• NOTE:  If applicable, approval release will be held until contract, invoice and UVM Medical Center billing compliance is complete.

2. Approval Withheld Pending Clarifications

• The IRB will mail or e-mail the memorandum of clarification.  This decision is determined when the protocol is recommended for approval by the IRB pending your response to IRB-directed questions and/or revisions.  You must provide a memorandum (preferably point-by-point) responding to the IRB’s recommendations. We ask that you indicate the CHRMS/CHRBSS number on this correspondence and attach a revised protocol (if applicable), revised consent form (if applicable), revised Common Protocol Cover form (if applicable), and a revised HIPAA authorization form (if applicable) and any other requested material.  Provide one copy of the response materials via interoffice mail.

• Your response may be reviewed by IRB staff, IRB Chair or the IRB Committee (if necessary) for a decision. 

1. If your response is satisfactory, your protocol will be approved and the  materials sent to the contact person.

2. If your response is not satisfactory or raises additional questions, you will be contacted via email for additional clarifications. 

• NOTE:  The IRB has a 30, 60, 90 day reminder system for all pending protocol items.  The investigator is reminded that the IRB has requested something from them in regards to a protocol and is awaiting his/her response.  At the 120 day mark the protocol is withdrawn from the Committee’s consideration.  This helps to ensure that changes to protocols are handled in a timely fashion. 

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Initial Full Review Process

If application materials are NOT compelete:

• The IRB will contact you by e-mail or phone to let you know what needs to be done to get your application ready for review by the IRB.

If application materials are complete:

• The protocol will be placed on the next Full Committee Review Meeting.  Meeting dates for both the Medical and Behavioral and Social Science Committees can be found here.

Possible Outcomes from the review of your research:

1. Approval 

• The IRB will e-mail the contact person designated in the protocol the following items as applicable;

• the Protection of Human Subjects Assurance (approval), 

• the informed consent form with an IRB stamp with expiration date, or information sheet

• a HIPAA authorization form with a IRB stamp

• NOTE: If applicable, approval release will be held until contract, invoice and UVM Medical Center billing compliance is complete.

2. Approval Withheld Pending Clarifications

• The IRB will e-mail the memorandum of clarification.  This decision is determined when the protocol is recommended for approval by the IRB pending your response to IRB-directed questions and/or revisions.  You must provide a point-by-point memorandum responding to the IRB’s recommendations. We ask that you indicate the CHRMS/CHRBSS number on this correspondence and attach a revised protocol (if applicable), revised consent form (if applicable), revised Common Protocol Cover form (if applicable), and a revised HIPAA authorization form (if applicable).   Provide one copy of the response materials via interoffice mail.  There is no deadline submission date UNLESS the protocol was tabled. 

• Your response may be reviewed by IRB staff, IRB Chair or the IRB Committee (if necessary) for a decision. 

1. If your response is satisfactory, your protocol will be approved and the materials sent to the contact person.

2. If your response is not satisfactory or raises additional questions, you will be contacted by email with the additional clarifications. 

• NOTE:  The IRB has a 30, 60, 90 day reminder system for all pending protocol items.  The investigator is reminded that the IRB has requested something from them in regards to a protocol and is awaiting his/her response.  At the 120 day mark the protocol is withdrawn from the Committee’s consideration.  This helps to ensure that changes to protocols are handled in a timely fashion.

3. Tabled

• More substantive issues regarding the protocol and/or consent form must be addressed.  Clarifications or requested revisions may have a significant impact on subject safety or understanding.  A memorandum is sent to you requesting that these issues be addressed.  You must provide a point-by-point memorandum responding to the IRB’s recommendations. We ask that you indicate the CHRMS/CHRBSS number on this correspondence and attach a revised protocol (if applicable), revised consent form (if applicable), revised Common Protocol Cover form (if applicable), and a revised HIPAA authorization form (if applicable).   Provide one copy of the response materials via interoffice mail.

• The response must go back to a Full Committee review meeting by the submission deadline.  The meetings are held once a month.

• NOTE:  The IRB has a 30, 60, 90 day reminder system for all pending protocol items.  The investigator is reminded that the IRB has requested something from them in regards to a protocol and is awaiting his/her response.  At the 120 day mark the protocol is withdrawn from the Committee’s consideration.  This helps to ensure that changes to protocols are handled in a timely fashion.

4. Disapproved

• Questions regarding the rights and welfare of the subjects are of such significance that the committee finds approval of the study to be unwarranted. 

• The authority of the Committee on Human Research to disapprove a human research study may not be overridden.  

• You may redevelop a protocol given the Committee’s concerns and submit a new application.

Last modified May 09 2016 04:16 PM