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. | 11/24/2024 | |
| 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 | 10.24.2024 |
Reliance on an External IRB
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| Form | Use | Last Updated |
|---|---|---|
| Required for all External IRB studies, to be submitted in ̽̽Click. Work with the External IRB or Lead Site to ensure accuracy of IRB determinations and study information. | 10/21/2024 | |
| 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 | |
| If requested by the External IRB or Lead Site. Provides information about ̽̽/̽̽HN and institutional information. | 10/21/2024 | |
| 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 | |
| If ̽̽ 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 | |
| To be filled out after the local study team meets with the ̽̽ 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 ̽̽Click. | 09/25/2024 |
Consent Guidance
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Informed Consent Templates
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| Consent Forms | Use | Updated |
|---|---|---|
| To be used when submitting non-exempt adult behavioral and social science research or the qualitative protocol | 12/10/24 | |
| To be used when submitting non-exempt protocols with medical procedures or clinical trial research. | 12/10/24 | |
| To be used when obtaining assent from children ages 11-17 | 03/24/21 | |
| When submitting a protocol that involves deception and an alteration of consent, use this template to debrief research participants at the end of participation. | 11/08/19 | |
| This template may only be used when applying for an Exempt Determination | 12/10/24 | |
| 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 | 10/06/03 | |
| 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 | |
| To be used when consenting participates in banking of biological specimens and/or a data repository | 12/10/24 | |
| 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. | 04/20/21 | |
| To be used when screening potential participants for eligibility in a research protocol. | 11/02/2020 |
Short Form
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Languages Available | |||
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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
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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 ̽̽ Medical Center,
Reviews Preparatory to Research
Research Using Decedent Protected Health Information
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.
Updated 10/24/2024