You will need to initiate a new protocol through the UVMClick – IRB module. This will require that you complete a General SMARTForm and attach completed consent forms/documents as applicable.

Initial Submission

Expedited & Full Board Applications

Protocol Forms
Protocol FormsUseUpdated
Human Research Protocol (DOCX)For any human subjects study that does not have a specific “protocol” from the sponsor.07/19/19
Exception From Consent For Emergency Research (DOCX)Supplementary form to be used when submitting an emergency research protocolNew 10/07/20
FileBiological Specimens/Data Repository Protocol (DOCX)When the only activity is the collection, storage, and distribution of data or specimens for research.11/29/18
FileBlood Collection Protocol for Non-Clinical Laboratory Research (DOCX)When the only activity is blood collection for bench science.11/29/18
FileQualitative Research Protocol (DOCX)To be used if the research is purely qualitative. If there are any medical procedures use the Human Research Protocol.11/29/18
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 sponsor9/24/20
                                                                                      Supporting Document Templates
Institutional Support LetterThis 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. 7/22/20

 

Exempt Applications, Not Human Subjects & Not Research

Determination Forms
Determination FormsUseUpdated

FileExemption 1 (Educational Research) (DOCX)

Exemption 2 (Surveys and Interviews) (DOCX)


Exemption 3 (Behavioral Intervention) (DOCX)

Exemption 4 (Secondary Data Uses) (DOCX)


FileExemption 5 (Demo Projects) (DOCX)

FileExemption 6 (Food and Taste) (DOCX)

When studies are minimal risk and meet certain criteria for exemption from IRB review.

Common Rule 2018 Exemption Changes (PDF) 

10/07/20
FileNot Human Subject Determination (DOCX)When studies involve the review of data or specimens when there are no identifiers.02/26/19
Requiring IRB Review Determination
(self-determination tool)
When projects are quality improvement or assessment and do not meet the criteria as research.11/19/18

 

Data Management & Security Plan

The Research Data Management and Security Plan form is required to be submitted along with all new expedited and full level protocols as well as any protocols where the IRB requires a clearer plan for the protection of data.

FileResearch Data Management and Security Plan (DOCX)

FileResearch Data Management and Security Plan Guidance (DOCX)

Request to Rely on Single-External IRB (Updated 10/25/19)

Request to Rely

    Consent Information

    2018 Common Rule Guidance

    A concise summary of study activities, risks, and benefits presented to research participant in advance of the body of the consent form is now required as part of the 2018 Common Rule change for any new protocol or active protocol where subjects are still being enrolled. The IRB will not require re-consent for subjects already enrolled.

    Additionally, there are new elements of informed consent that are required as applicable.  These can be found in the UVM sample consent template document in BLUE text.

    FileExamples of the new concise key information section (DOCX)

    View the HIPAA and Research FAQ (opens in a new window)
    Search for a term in the Medical Dictionary (opens in a new window)

    Informed Consent Templates

    Consent Process Documentation Examples

    Documentation Forms
    Documentation FormsUpdated
    FileExample 1 (DOCX)07/26/18
    Microsoft Office document iconExample 2 (DOCX)03/18/19
    FileLegally Authorized Example (DOCX)04/11/18

     

    Ongoing Consent Templates

    Consent Addendum

    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.

    FileConsent Addendum (DOC)

    Continued Participation After Child Reaches 18 years of age

    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. 

    Continued Participation after Reaching Age of Majority (DOCX)

     

    Updated 10/07/20

    Related Documents & Resources

    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
    (opens in a new window)
    .

    UVMMC Reviews Preparatory to Research

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

    UVM Medical Center Reviews Preparatory to Research (DOCX)

    Attestation for Decedent Research

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

    FileAttestation Form for Decedent Research (DOCX)

     

    Follow-on Submissions
    (SMARTForm Only)

    Modifications

    This category applies to all protocol changes including safety updates that do not affect risk to subjects, and key personnel changes.

    Instructions for Initiating a Modification can be found under "User Guides" on the UVMClick – IRB (opens in a new window) module web page.

    Continuing Reviews

    You will need to Initiate a Continuing Review through the UVMClick – IRB module. This will require that you complete a Continuing Review SMARTForm.

    Instructions for Initiating a Continuing Review can be found under "User Guides" on the UVMClick – IRB (opens in a new window) module web page.

    Safety - Reportable New Information (RNI)

    This category applies to adverse events, unanticipated problems or noncompliance that may affect risk to subjects. Please do not submit Investigator Drug Brochure (IDB) updates or safety updates from the sponsor that do not affect risk, these are modifications.

    Instructions for Initiating a Reportable New Information (RNI) can be found under "User Guides" on the UVMClick – IRB (opens in a new window) module web page.

    Study Closures

    Instructions for Initiating a Study Closure can be found under "User Guides" on the UVMClick – IRB (opens in a new window) module web page.