Forms Library
Materials Required for IRB Review & Relying on an External IRB
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| Form | Use | Version |
|---|---|---|
| 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 |
|---|---|---|
| For any human subjects study that does not have a specific “protocol” from the sponsor. | 6/21/2023 | |
| To be used if the research is purely qualitative. If there are any medical procedures use the Human Research Protocol. | 10/6/2023 | |
| When the only activity is the collection, storage, and distribution of data or specimens for research. | 8/14/2023 | |
| When the only activity is blood collection for bench science. | 12/7/2023 | |
| Supplementary form to be used when submitting an emergency research protocol. | 7/25/2023 | |
| Only use when a human subject activities are delayed but an IRB certificate is required from the sponsor | 6/21/2023 | |
| Supporting Document Templates | ||
| 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 |
|---|---|---|
| Educational Research | 5/9/24 | |
| Surveys and Interviews | 4/18/24 | |
| Behavioral Interventions | 5/9/24 | |
| Secondary Data Uses | 4/4/24 | |
| Demo Projects | 5/9/24 | |
| Food and Taste | 5/9/24 |
Data Management and Security Plan
| Form | Use | Last Updated |
|---|---|---|
| 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 | |
| 09/04/2024 | ||
| 09/04/2024 |
Adding Study Team Members
| Form | Use | Last Updated |
|---|---|---|
| ̽̽ NetID request for research | 9.19.2024 | |
| Adding an individual, not employed by ̽̽, on a ̽̽ 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
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Consent Guidance
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Informed Consent Templates
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| Consent Forms | Updated |
|---|---|
| 09/30/22 | |
| 04/03/23 | |
| 03/24/21 | |
| 11/08/19 | |
| 09/29/22 | |
| 10/06/03 | |
| 10/23/2020 | |
| 06/13/2023 | |
| 04/20/21 | |
| 11/02/2020 |
Short Form
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Consent Process Documentation Examples
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| Documentation Forms | Updated |
|---|---|
| 08/31/23 | |
| 08/31/23 |
Ongoing Consent Templates
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| Form | Use | Version |
|---|---|---|
| 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. | ||
| 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 |
̽̽ 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 ̽̽ Medical Center,
̽̽MC Reviews Preparatory to Research
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Attestation for Decedent Research
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Accounting of Disclosures of Protected Health Information
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Ethics and Compliance Reporting
Call (800) 461-9330, or text 1-802-441-6649, or visit the Ethics and Compliance Reporting Helpline website.
