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 | 4/18/24 |
| 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. | 09/04/2024 |
| 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 | 6.5.2024 |
Projects Not Requiring IRB Review
Use the self determination tool to see if your project requires IRB review and submission to the Research Protections Office.
Request to Rely on Single-External IRB
Consent Guidance
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Informed Consent Templates
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| Consent Forms | Updated |
|---|---|
| Adult Behavioral/Social Study Consent (DOCX) | 09/30/22 |
| Medical Study Consent (DOCX) | 04/03/23 |
| Child Assent (DOCX) | 03/24/21 |
| Debriefing Consent (DOC) | 11/08/19 |
| Information Sheet (DOCX) | 09/29/22 |
| Media Consent (DOC) | 10/06/03 |
| Pregnant Partner Consent (DOCX) | 10/23/2020 |
| Repository Consent Template | 06/13/2023 |
| Expanded Access Consent (DOCX) | 04/20/21 |
| Screening Consent Script Template (DOCX) | 11/02/2020 |
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
Data Use Agreement
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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
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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.
UVMMC Reviews Preparatory to Research
Attestation for Decedent Research
Accounting of Disclosures of Protected Health Information
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 8/23/2024