IRB - Institutional Review Board Forms

PRISM Title Waiver

As of 09/08/16 full protocol titles will be included within the Research Flag of the electronic medical record (PRISM).  To request a waiver of this requirement please use the form below. 

Behavioral or Social Science (CHRBSS) Committee Review (Full & Expedited)

Full or Expedited Review

As of July 1st, all submissions are required to be submitted through InfoEd. You must have proper security access to create electronic submissions. For more information on electronic submissions, visit our Electronic Submission Guide (InfoEd) page.

To choose the appropriate forms to submit you must first determine if what you are proposing is solely qualitative research or a combination of both qualitative and quantitative research. Qualitative research is the gathering of data primarily through the methods of participant observation, face-to-face interviews, or open-ended surveys or questionnaires, often for the purpose of addressing questions pertaining to social and/or cultural issues. Quantitative research generates numerical data or information that can be converted into numbers.

New Behavioral or Social Science Committee Protocols
Protocol Materials Notes

File Qualitative Research Protocol (DOCX)

If the research is purely qualitative complete the
Qualitative Research Protocol

AND (if applicable) Operations Center Activities Supplement

04/29/16

Microsoft Office document icon Operations Center Activities Supplement (DOC)

06/27/11


File Common Protocol Cover Form (DOCX)

If the research is qualitative and quantitative complete the

Common Protocol Cover Form AND Human Research Protocol

OR the Data Repository Protocol

08/07/17

File Human Research Protocol (DOCX) 07/01/15
File Data Repository Protocol (DOCX) 05/02/17
Consent Form or Waiver Request (if applicable) include in any of the applications above
Awarded Grant, Contract or Agreement with Sponsor, Collaborative Agreements
with Other Institutions, Recruitment Materials, Any documents provided
to the subject (e.g. questionnaires/diaries/educational materials),
Verbal Consent Script, Information Sheet in lieu of Signed Consent
(if applicable) include in any of the applications above
Microsoft Office document icon Request for UVM NetID for Required Training (DOC) NA

 

Medical (CHRMS) Committee Review (Full & Expedited)

Full or Expedited Review

As of July 1st, all submissions are required to be submitted through InfoEd. You must have proper security access to create electronic submissions. For more information on electronic submissions, visit our Electronic Submission Guide (InfoEd) page.

Typically, the same protocol materials are required for Full vs Expedited Review.  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.

New Medical Committee Review
Protocol Materials Notes

File Common Protocol Cover Form (DOCX)

AND (if applicable) Operations Center Activities Supplement

AND Human Research Protocol  (industry written is acceptable)

08/07/17

Microsoft Office document icon Operations Center Activities Supplement (DOC) 06/27/11
File Human Research Protocol (DOCX)

(industry written is acceptable)

07/01/15

File Blood Collection Protocol for Non-Clinical Laboratory Research (DOCX) This form is to be used when the only procedure involving human subjects is blood collection.  If any other procedures are being included STOP and complete the Common Protocol Cover form.

07/13/16

File Biological Specimens/Data Repository Protocol (DOCX)

This form is to be used when the only procedure involving human subjects is their specimens and/or data, and use of a repository. 

05/02/17

File Initial Review of an Administrative Tool (DOCX)

This form is used only as a compilation of research being conducted under a specific grant. It does not constitute a review of the risk/benefit ratio of protocols to be conducted under it.  Those protocols (including informed consent documents) must be submitted for IRB review and approval separate from this request.

07/13/16

File Health Records Review Protocol (DOCX)

This form is to be used when the only procedure involving human subjects is review of identifiable Protected Health Information (PHI) from a covered entity.

01/13/17

Consent Form or Waiver Request (if applicable) include in any of the applications above
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
(if applicable) include in any of the applications above
Microsoft Office document icon Request for UVM NetID for Required Training (DOC) NA

 

Consent & HIPAA Guidance

The Committee has developed multiple templates for use.  Please refer to our PDF icon Consent Form Guidance (PDF) and our PDF icon Consent Form Checklist (PDF) for additional guidance. The File HIPAA and Research FAQs (DOCX) document is also available for reference.

As of 09/01/16 the HIPAA authorization language will be included within the consent form.  All  new consent submissions received on or after this date must include the HIPAA language.  Any protocols that are currently active must update the consent form either at time of next amendment or continuing review whichever comes first.  Please refer to the "Consent for Medical Study" template found below to develop or modify the study consent form.

Consent and HIPAA Guidance
Initial Informed Consent Notes
Microsoft Office document icon Assent for Children (DOC)

For use when the assent is a separate document from the parental consent. (behavioral/social study)

10/12/16

Microsoft Office document icon Consent for Behavioral/Social Study (DOC) 11/04/16
Microsoft Office document icon Debriefing Consent (DOC) To be used to inform and obtain continued consent to use subject's data when deception was used.
File Consent for Medical Study (DOCX)  11/11/16
PDF icon Consent Template WITH guidance (PDF) 08/22/16
File Information Sheet (DOCX)

To be used when protocols are minimal risk and meet the criteria for a waiver of documentation.

11/07/16

Microsoft Office document icon Documentation of Consent Process Template (DOCX) Good Clinical Practice (GCP) for medical  research recommends that you have documentation of the consent process for each participant.  This template can be used for this purpose.
File Short Form Consent Template (DOCX)

To be used for non-English speaking individuals.  Refer to Section 8.B.3. of Research Manual.

-PDF icon UVMMC Interpreter Tips (PDF)

01/01/16

Microsoft Office document icon Blood Drawing Consent Template (DOC)

To be used for blood collection protocols only.

11/04/16

File Repository Protocol Consent Template (DOCX)

To be used for specimen or data collection protocols with the intention of banking for future research.

07/14/16

Microsoft Office document icon Expanded Access Consent Template (DOC)
 

(Emergency) This would only be used when the investigational products are to be used for serious or life-threatening conditions when there is no satisfactory alternative. Contact the office for assistance in these situations.

 

Microsoft Office document icon Media Consent to Interview (DOC) To be used anytime a subject is willing to share his/her experiences with the media in any format.  The IRB does not need to review, but it should be executed and kept with the subject's research file.
Consent and HIPAA Guidance Continued
HIPAA Forms and Guidance Notes
File PHI from UVMMC Template (DOCX)

To be used as a replacement for the HIPAA authorization when you intend to review patient's PHI from UVMMC.

11/11/16

File PHI from LUSE UVM Template (DOCX) 

To be used as a replacement for the HIPAA authorization when you intend to review patient's PHI from LUSE UVM.

05/22/17

Microsoft Office document icon Request for Partial Waiver of Authorization for Recruitment Purposes (DOC)

Submit this form to the IRB when you intend to review patient's PHI for recruitment purposes when you have no existing clinical relationship with the patient.

02/5/15

Microsoft Office document icon UVM Medical Center Data Use Agreement (DOC) ("Limited Data Sets") If the research includes use of a limited data set from the hospital you must enter into this agreement with the hospital.
File UVM Medical Center Reviews Preparatory to Research (DOCX)

If you wish to review records (not taking any protected health information) to design a research study or to assess the feasibility of conducting a study, you must complete this form and forward to UVM Medical Center Privacy Officer Dept for approval.

10/12/17

Consent and HIPAA Guidance Continued
Ongoing Consent Notes
File Continued Participation after Reaching Age of Majority (DOCX) To be completed once a child subject has turned 18 years of age. This document was developed by the IRB, therefore an IRB approval stamp is not required.  However, if you wish to change the content (other than inserting the names and numbers) it requires an amendment prior to use.  See Research Manual 8.B.1.b.
Microsoft Office document icon Consent Addendum (DOC) To be used anytime you have some additional information for subjects that may affect their willingness to continue participation

 

Waiver or Alteration of Consent & HIPAA

Waiver of Documentation of Consent/HIPAA:  In some research, verbal or implied consent of the subject is sufficient and a signed consent form is not necessary.  A typical example would be a mailed survey with a cover letter explaining the research.  The receipt of a completed survey implies that the subject wanted to participate.

Alteration of Consent/HIPAA:  In some research, an alteration of the individual’s informed consent or elements of the process may be waived.  An example of an alteration of consent would be when research requires deception.  In these cases, some of the elements of informed consent are met but not all.  Information typically held would be the basis for the research and subjects are debriefed after the research is complete. Studies that involve more than mild deception (e.g., fake interaction partners, false feedback, fabricated interpersonal acceptance or rejection) should include a post-experimental interview, an interactive debriefing, and a written debriefing.

Waiver of Consent/HIPAA:  In some research, written or verbal consent is not possible.   A typical example would be retrospective record or pathology reviews.  Consent is not possible because the subjects are not available to sign a consent form.

The request form has been combined to address the three different types of requests above.  

Waiver or Alteration of Consent and HIPAA
Waiver Materials Notes
Microsoft Office document icon Request for Waiver of Informed Consent/Authorization/Documentation (DOC) 5/2/17
Microsoft Office document icon Request for Partial Waiver of Authorization for Recruitment Purposes (DOC) 4/6/17

 

Submissions Not Requiring Committee Review (Exempt, NHS, Not Research & Instructor Assurance)

Exempt Review

DHHS Guidelines (45 CFR Part 46.101(b) and (c)) define research as exempt from further IRB review when the research involves no risk to the subject. Research that is considered exempt from Committee review must still be filed with the IRB and certified as exempt.

You may also reference the Research Manual "Section 7.C. Exempt Review Categories of Research" to help you decide which exemption category might apply to your research.

Note: PI and Faculty Sponsors (if applicable) ARE required to complete the Human Subjects tutorial training. If you do not have a UVM Net ID to complete the training, please submit the "Request for UVM Net ID for Required Training" form.

Exempt Review
Exempt Review Materials Notes
File Protocol Exemption Review and Determination (DOCX) 08/07/17
File Information Sheet (DOCX)

Include if applicable in the application. To be used when protocols are minimal risk and meet the criteria for a waiver of documentation.

11/07/16

Microsoft Office document icon Request for UVM Net ID required for Training (DOC) NA

 

Determinations of Not Human Subjects and Engagement (If your research uses decedent protected health information)

Not Human Subjects and Engagement
Not Human Subjects Review Materials Notes

File Research Not Involving Human Subjects Review and Determination (DOCX)

08/07/17

File Engagement Determination (DOCX)

04/06/17

File Attestation Form for Decedent Research (DOCX)

If your research uses decedent UVMMC PHI, fill this form out and send to Lianne.Cleary@uvmhealth.org.

09/22/15

 

Determinations of Not Research and Engagement (Quality Assurance and Improvement, Program/Curriculum Evaluation and Public Health Practice projects)

Not Research and Engagement
Not Research Review Materials Notes

File Not Research Review and Determination (DOCX)

The projects are conducted to assess a process, program or system with the intent to improve that same process, program or system or primary intent to identify/control a health problem.  Many of these projects also may contain elements of research.  Information usually will be shared beyond those involved in or overseeing the program/process/system.  Intent to publish is an insufficient criterion alone for determining if a project is research.  There are other purposes for publishing descriptions of non-research activities, e.g., QI projects are often disseminated outside the institution for the purpose of sharing the process (the QA/QI methodology) not the health care outcomes or implications.

08/07/17

File Engagement Determination (DOCX) 4/16/15

 

Instructor Assurance for Student Research

Instructors must provide exemption determinations prior to classroom research activities beginning. 

Classroom Research
Classroom Research Materials Notes
Microsoft Office document icon Instructor's Assurance Form (DOC)

For a new class

08/07/17

Microsoft Office document icon Instructor's Assurance Annual Update Form (DOC)

For ongoing classes - reminders are sent

6/27/11

 

UVM Medical Center Research Subject Registrations

As of January 1, 2014 researchers and research staff will need to complete a registration form for any UVM Medical Center patients executing a new consent form to participate in a research study.  For more information please see PDF icon annoucement from UVM Medical Center (PDF).

Completed forms must be submitted to “Registration – Research Studies” Outlook Mailbox (registrationresearchstudies@uvmhealth.org) or FAX to 847-4179.

Maintaining Approval (Continuing Approval, PI or Key Personnel & Amendments)

Amendment Review Materials

Changes to the protocol require review and prior approval.

Maintaining Approval - Amendments
Amendment Review Materials Notes

File Request for Modification/Amendment to Approved Protocol (DOCX)

Amendments for Exempt and Not Human Subjects protocols only need to be submitted if the amendment will potentially change the review category. If you are unsure, please contact the RPO office for assistance.

09/20/17

Materials from sponsor justifying changes, Revised consent or information sheets, Revised recruitment materials, Any revised documents provided to subjects (questionnaires/diaries/educational materials)

Include if applicable

 

 

Change in Principal Investigator or Key Personnel

Changes to either the PI or key personnel require review.

Maintaining Approval - Principal Investigator or Key Personnel
Key Personnel Review Materials Notes

File Request for Change in Principal Investigator (PI) (DOCX)

08/03/17
File Request for Change in Key Personnel (KP) (DOCX) 06/01/17
Revised consent when the PI has changed

Include if applicable

Microsoft Office document icon Request for UVM NetID for Required Training (DOC) To be used when the key personnel does not have a UVM NetID
 

Continuing Review Materials

Every protocol (except exempt) must submit a progress report at least every 12 months. You will recieve a reminder notice beginning three months prior to expiration of approval.

Note: If you wish to close the protocol, you must complete the appropriate continuing review form below and submit for review and final closure. 

Maintaining Approval - Continuing Review
Continuing Review Forms Notes
File Standard Protocol - Request for Continuing Review Form (DOCX) 10/09/17
Microsoft Office document icon Operations Center Activities Supplement - Continuing Review (DOC)

(if applicable)

11/12/14

File Blood Collection Protocol for Non-Clinical Laboratory Research - Continuing Review (DOCX)

10/12/17

File Biological Specimens/Data Repository Protocol - Continuing Review (DOCX)

10/09/17
File Administrative Tool - Continuing Review (DOCX) 08/07/17
File Health Records Review - Continuing Review (DOCX) 10/09/17
Copy of last signed consent – subject name covered (if enrolling within the last year), Data Safety and Monitoring Report, Sponsor Monitoring Report Include as applicable in the application

 

Safety & Deviation Reporting (UAP & New Safety Information)

Safety and Protocol Deviation Review Materials

The IRB must review all unanticipated problems that potentially affect risk to subjects or others.  Section 9.B of Research Manual has further information.  We will also acknowledge any new information not affecting risk. 

Maintaining Approval - Safety and Protocol Deviation Review
Safety and Protocol Deviation Review Materials Notes
Microsoft Office document icon Unanticipated Problem or Noncompliance Potentially Involving Risk to Subjects or Others (DOC) 09/20/17
Microsoft Office document icon New Safety Information Not Affecting Risk to Subjects or Others (DOC) 08/07/17
Interim findings from sponsor potentially affecting risk, Copy of DSMB meetings/minutes, Corrective action plans when there are protocol deviations, For adverse events attach pertinent medical information with subject name obscured, UVM Medical Center Safe Report, FDA Medwatch Form, If HIPAA deviation, copy of correspondence to UVM Medical Center HIPAA Privacy Officer Include if applicable

 

 

IACUC - Institutional Animal Care and Use Committee Forms

Initial Submission

Initials - Full, Designated, or Identical

Veterinarian Review Requirements

  • All new protocols must be reviewed and signed off on by the UVM Veterinarian prior to submission to the IACUC Office. 
  • Investigators should contact the UVM Veterinarian prior to the deadline to allow enough time for the vet review and revisions prior to submission. 
  • New protocols will not be considered for IACUC review until this has been completed and the Veterinarian signed off on the protocol.
IACUC Forms Library
Initial Submission Forms Notes

 Microsoft Office document icon Animal Use Protocol Form (DOC)

The University Veterinarian must review and sign off on the form prior to submission.  Make sure that all key personnel have completed their required training and are up-to-date with their occupational health participation requirement prior to submission.

10/12/17

Commercial Farm (DOC)

(if applicable)

04/02/15

File Teaching Protocol (DOCX)

(Animal Science teaching projects)

08/07/17

Maintaining Approval (Continuing Approval, PI or Key Personnel, Amendments & Protocol Deviations)

Occupational Health & Safety

Occupational Health and Safety Program for Employees Working with Animals

IACUC Forms Library Continued
Occupational Health Forms Notes
Microsoft Office document icon Baseline (DOC) 09/15
Microsoft Office document icon Annual (DOC) 09/15

IBC - Institutional Biosafety Committee Forms

Initial Submission

Initials - Full, Simultaneous, Exempt, Designated or Identical

Biological Review Requirements

  • All new protocols must be reviewed and signed off by the UVM Biological Safety Officer (BSO) prior to submission to the IBC Office. 
  • Investigators must contact the BSO prior to the deadline to allow enough time for a meeting and possible site visit to the lab. 
  • Send protocol to BSO, Jeff.Labossiere@uvm.edu, in word format so that he may track suggested changes.
  • Once reviewed and signed off by the BSO, protocols and any supplemental materials must be converted to pdf format and emailed to the IBC by 4:30 on day of deadline.
  • New protocols will not be considered for IBC review until this has been completed and the BSO has signed off on the protocol.
IBC Forms Library
Initial Submission Notes

File Protocol Form (DOCX)

The Biological Safety Officer must complete and sign the risk assessment section of the form prior to submission.

10/17

Standard Operating Procedure

Standard Operating Procedures for work with biohazardous agents or toxins

IBC Forms Library
Initial Submission Notes

Microsoft Office document icon Standard Operating Procedure (DOC)

(if applicable) A Standard Operating Procedure must be submitted for each biohazardous agent listed in sections 2.2 and/or 3.2 in the protocol.

2/16

Maintaining Approval (Continuing Approval, PI or Key Personnel, Amendments & Incidents)

Ongoing Submissions

IBC Forms Library Continued
Continuing Review Notes

Continuing Review Form 

(Online through InfoEd)

The Research Protections Office has recently made changes to the IBC continuing review process.  Effective with the February 2nd notices, we will be forwarding to you (and/or your contact) through the InfoEd system, a continuing review form that will now include the currently approved protocol information.  You will open the form attached in that email, and then complete the current status, update the funding and research materials, and apprise us of any problems during the last review period on this pre-populated document.

This change has been made to reduce researcher burden and to support increased compliance. 

1/15

IBC Forms Library Continued
Amendments Notes

Microsoft Office document icon Amendment Form (DOC)

If you only have key personnel changes, you must use the "Request for Change to Key Personnel" found below.

5/16

Microsoft Office document icon Request to Change PI or Key Personnel Form (DOC)

Any persons working on a BSL2 protocol must complete UVM mandatory safety on-line, and  BSL2, in-class training.

10/17

IBC Forms Library Continued
Incidents Notes

Microsoft Office document icon Incident Report Form (DOC)

Use this form to report to the IBC any incidents (E.g. accidental exposure, spills that may be environmentally dangerous, events requiring any type of medical attention) or any noncompliance with NIH guidelines.

6/17