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.
Application Materials for Initial Submission
Expedited & Full Board Applications
|Human Research Protocol (DOCX)||For any human subjects study that does not have a specific “protocol” from the sponsor.||07/19/19|
|Biological Specimens/Data Repository Protocol (DOCX)||When the only activity is the collection, storage, and distribution of data or specimens for research.||11/29/18|
|Blood Collection Protocol for Non-Clinical Laboratory Research (DOCX)||When the only activity is blood collection for bench science.||11/29/18|
|Qualitative 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|
|Initial Review of an Administrative Tool or Projects to be Developed (DOCX)||Only used when human subject activities are delayed but an IRB certificate is required from the sponsor.||11/19/18|
Exempt Applications, Not Human Subjects & Not Research
When studies are minimal risk and meet certain criteria for exemption from IRB review.
|Not Human Subject Determination (DOCX)||When studies involve the review of data or specimens when there are no identifiers.||02/26/19|
|Not Research Determination
|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.
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.
Informed Consent Templates
|Adult Behavioral/Social Study Consent (DOCX)||04/25/19|
|Adult Medical Study Consent (DOCX)||04/25/19|
|Child Assent (DOCX)||04/25/19|
|Blood Collection Consent (DOCX)||07/30/19|
|Debriefing Consent (DOC)||10/12/16|
|Information Sheet (DOCX)||06/14/19|
|Media Consent (DOC)||10/06/03|
|Pregnant Partner Consent (DOCX)||06/22/18|
|Repository Consent (DOCX)||04/25/19|
|Short Form for Non-English Speaking (DOCX)||01/01/16|
|Expanded Access Consent (DOCX)||11/20/18|
Consent Process Documentation Examples
|Example 1 (DOCX)||07/26/18|
|Example 2 (DOCX)||03/18/19|
|Legally Authorized Example (DOCX)||04/11/18|
Ongoing Consent Templates
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 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. This form does not require prior IRB review and approval unless you need to modify the template.
Request to Rely
UVMClick Data Entry Instructions