Forms Library
Materials Required for IRB Review & Relying on an External IRB
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| Form | Use | Version |
|---|---|---|
| Guidance Materials Required for UVMClick Submissions (PDF) | Outlines the materials investigators should assemble and include with their applications for IRB review or Determination of Exemption. | 5/2/2024 |
Initial Submission
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Expedited and Full Board Applications
| Form | Use | Version |
|---|---|---|
| Human Research Protocol (DOCX) | For any human subjects study that does not have a specific “protocol” from the sponsor. | 6/21/2023 |
| Qualitative Research Protocol (DOCX) | To be used if the research is purely qualitative. If there are any medical procedures use the Human Research Protocol. | 10/6/2023 |
| Biological Specimens/Data Repository Protocol (DOCX) | When the only activity is the collection, storage, and distribution of data or specimens for research. | 8/14/2023 |
| Blood Collection Protocol for Non-Clinical Laboratory Research (DOCX) | When the only activity is blood collection for bench science. | 12/7/2023 |
| Exception From Consent For Emergency Research (DOCX) | Supplementary form to be used when submitting an emergency research protocol. | 7/25/2023 |
| Grant Proposals Lacking Definite Plan for Involvement of Human Subjects (DOC) | Only use when a human subject activities are delayed but an IRB certificate is required from the sponsor | 6/21/2023 |
| Supporting Document Templates | ||
| Institutional Support Letter (DOC) | This template can be used to obtain signatures from an executive director, chief executive officer, board president, or other individual with authority to commit the institution's resources, acknowledge the proposed research activity, and grant permission for the engagement of their employee and facilities in that activity. | 2/13/2023 |
Exempt Applications
| Determination Forms | Use | Version |
|---|---|---|
| Exemption 1 (DOCX) | Educational Research | 5/9/24 |
| Exemption 2 (DOCX) | Surveys and Interviews | 3/24/25 |
| Exemption 3 (DOCX) | Behavioral Interventions | 5/9/24 |
| Exemption 4 (DOCX) | Secondary Data Uses | 4/4/24 |
| Exemption 5 (DOCX) | Demo Projects | 5/9/24 |
| Exemption 6 (DOCX) | Food and Taste | 5/9/24 |
Data Management and Security Plan
| Form | Use | Last Updated |
|---|---|---|
| Research Data Management and Security Plan (DOCX) | The DMSP is required to be completed as part of an expedited, full board, exempt 2(iii), 3(i)(C), 4(iii) and all Single IRB submissions. | 11/24/2024 |
| Guidance Document for Medical Researchers (PDF) | 09/04/2024 | |
| Guidance Document for Behavioral Researchers (PDF) | 09/04/2024 |
Adding Study Team Members
| Form | Use | Last Updated |
|---|---|---|
| Request for University of Vermont (UVM) Net ID for Access to UVMClick or UVM Required CITI Training | UVM NetID request for research | 9.19.2024 |
| External Study Team Member Information | Adding an individual, not employed by UVM, on a UVM research protocol | 10.24.2024 |
Reliance on an External IRB
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| Form | Use | Last Updated |
|---|---|---|
| Request to Rely on External IRB | Required for all External IRB studies, to be submitted in UVMClick. Work with the External IRB or Lead Site to ensure accuracy of IRB determinations and study information. | 10/21/2024 |
| Consent/HIPAA Checklist for Required Language | Required local context template language for all External IRB consent/HIPAA forms. When applicable to the study, these sections must be inserted in the External IRB-approved consent/HIPAA template (may need to replace their template language). | 03/24/2021 |
| UVM Institutional Profile | If requested by the External IRB or Lead Site. Provides information about UVM/UVMHN and institutional information. | 10/21/2024 |
| Documentation of External IRB Waiver or Alteration of HIPAA Authorization | May be required if the External IRB issues waiver or alteration of HIPAA Authorization, to document the regulatory criteria have been met. | 10/21/2024 |
| UVM/UVMHN HIPAA Authorization Template | If UVM is acting as the HIPAA Privacy Board, per terms of the Reliance Agreement, this template should be used to obtain local HIPAA Authorization. To be used as a separate document from the consent form, which should not contain any HIPAA language. | 10/21/2024 |
| Study Team Meeting Checklist | To be filled out after the local study team meets with the UVM IRB Reliance Administrator to review External IRB process and responsibilities, prior to release of local approval to begin research activities. Should not be included with initial submission in UVMClick. | 09/25/2024 |
Consent Guidance
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Informed Consent Templates
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| Consent Forms | Use | Updated |
|---|---|---|
| Behavioral & Social Science Consent (DOCX) | To be used when submitting non-exempt adult behavioral and social science research or the qualitative protocol | 12/10/24 |
| Medical Study Consent (DOCX) | To be used when submitting non-exempt protocols with medical procedures or clinical trial research. | 12/10/24 |
| Child Assent (DOCX) | To be used when obtaining assent from children ages 11-17 | 02/04/25 |
| Child or Adult Assent Template with Guidance (DOCX) | Designed for children 11 to 17 years of age or may be used when an adult lacks the capacity to consent but can assent along with a legally authorized representative. | 02/18/2025 |
| Debriefing Consent (DOC) | When submitting a protocol that involves deception and an alteration of consent, use this template to debrief research participants at the end of participation. | 03/04/25 |
| Information Sheet (DOCX) | This template may only be used when applying for an Exempt Determination | 12/10/24 |
| Media Consent (DOC) | Consent to be Interviewed, Videotaped, and/or Photographed, this is not an IRB approved consent for research, a template for researchers to document their participants have agreed to forgo the confidentiality originally consented to | 03/04/25 |
| Pregnant Partner Consent (DOCX) | To be used when data is being requested for research purposes from the pregnant partner of a research participant, informed consent is required from the pregnant partner | 12/10/24 |
| Repository Consent Template | To be used when consenting participates in banking of biological specimens and/or a data repository | 12/10/24 |
| Expanded Access Consent (DOCX) | To be used when consenting a patient with an immediately life-threatening condition or serious disease to gain access to an investigational medical product (drug, biologic, or medical device) for treatment when no comparable or satisfactory alternative therapy options are available. | 03/04/25 |
| Screening Consent Script Template (DOCX) | To be used when screening potential participants for eligibility in a research protocol. | 03/04/25 |
Short Form
Consent Process Documentation Examples
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| Documentation Forms | Updated |
|---|---|
| Example 1 (DOCX) | 08/31/23 |
| Legally Authorized Example (DOCX) | 08/31/23 |
Ongoing Consent Templates
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| Form | Use | Version |
|---|---|---|
| Consent Addendum (DOC) | To be used anytime you have some additional information for subjects that may affect their willingness to continue participation. Prior IRB review and approval is required. | |
| Continued Participation after Reaching Age of Majority (DOCX) | To be completed with the child who has now turned of age. You must review the originally signed consent with the now adult child and obtain consent to continue their participation. | 1/15/20 |
UVM Health Network Documents and Resources
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Data Use Agreement
Where faculty are receiving or sharing human subject data as part of a research collaboration, they will need to ensure that an appropriate Data Use Agreement or other form of research collaboration or confidentiality agreement is in place.
Contact spa@uvm.edu for more information.
Limited Data Sets
If the research includes use of a limited data set from the UVM Medical Center, you must enter into a Data Use Agreement with the hospital.
Reviews Preparatory to Research
Reviews Preparatory to Research (PDF)
Research Using Decedent Protected Health Information
Research Using Decedent Protected Health Information (PDF)
Accounting of Disclosures of Protected Health Information
Accounting of Disclosures of Protected Health Information (PDF)
Ethics and Compliance Reporting
Call (800) 461-9330, or text 1-802-441-6649, or visit the Ethics and Compliance Reporting Helpline website.
Ethics and Compliance Reporting and HelpLineUpdated 10/24/2024