Forms & Templates
The forms and templates found below are intended to be useful tools for you as you prepare for and implement your research project.
Consent Templates (Updated August 2023)
Starting October 1, 2023, the use of locked templates is mandatory for all non-exempt initial research submissions. For existing research that remains open to enrollment at renewal, investigators will be expected to submit a modification to adopt the new templates prior to the next renewal.
- Comprehensive (Full Board) - Locked: This template is required for studies with greater than minimal risk, vulnerable populations, and/or does not fit into any of the federally defined expedited categories. The VU IRB convenes monthly during the academic year. See the for submission deadlines.
- Comprehensive (Full Board) Parent/Guardian - Locked: This template should be used for full board studies involving children and their parents or guardians.
- Comprehensive (Full Board) Spanish - Locked: This template is required for studies including Spanish speaking participants and with greater than minimal risk, vulnerable populations, and/or does not fit into any of the federally defined expedited categories. The VU IRB convenes monthly during the academic year. See the for submission deadlines.
- Abbreviated (Expedited) - Locked: This template should be used if your study will likely involve no more than minimal risk (i.e., risks encountered in everyday life) and fits into one of the federally defined expedited review categories. Many social-behavioral studies fall into this category.
- Abbreviated (Expedited) Parent/Guardian - Locked: This template should be used for expedited studies involving children and their parents or guardians.
- Exempt: This template is allowable only for research which meets federal criteria for exemption
Please note that you may use a consent template for a review level more stringent than you expect for your study, but not less. For example, if you anticipate expedited review, you may use the comprehensive template or the abbreviated template, but not the exempt template.
Assent Templates
If you are including minors or adults unable to provide legal consent on their own behalf as participants in your study, you will need to provide a consent form for parents/legal guardians (one of the options from the consent template list above) as well as an appropriate assent form for the minors/adults with impaired decisional ability.
Assent templates are provided for convenience only. The IRB will always consider the PI's expertise with the population at hand when reviewing assent and researchers should adjust the template language as they feel is appropriate for the population.
For adults unable to consent on their own, please choose the assent document appropriate for the equivalent cognitive capacity.
- 5-8 years old: This template provides the basic elements required for young children or adults with limited decisional capacity to provide assent.
- 9-12 years old: This template provides the basic elements required for younger minors to provide assent and could also be used as a model for higher functioning individuals with diminished decisional capacity.
- 13-17 years old: This template provides the basic elements required for older minors to provide assent and could also be used as a model for higher functioning individuals with diminished decisional capacity.
Other documents you provide participants may range from recruitment materials to debriefing forms offered post-participation. Everything that you intend to provide a participant should be presented to the IRB as part of your protocol application via .
Reliance Forms
These forms are for researchers that are working with individuals or institutions outside of ÄÌÌÇÖ±²¥. All researchers working with outside investigators must submit an independent investigator agreement with their Cayuse application.
Questions about reliance agreements can be directed to IRB@villanova.edu
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Questions
If you are uncertain whether your activity meets the regulatory definition of human subjects research, submit a "Help me determine if my project meets the regulatory definition of human subjects research and requires IRB review" application by selecting that option in question A.1 of the general information section. This abbreviated application path allows ORP and the IRB to make a determination about whether the project requires review.
If your project does not meet the regulatory definition of human subjects research, the IRB will not review or validate your plan to consent any of your participants. However, consent is a best practice for any activities involving human participants, and all templates and training resources are still available. Please remove reference to IRB review and approval from the documents if you adapt them for non human subjects research projects.
Choose the template that matches the level of review you are applying for (Exempt, Expedited, or Full Board). Descriptions of the different exemption and expedited review categories can be found within the Cayuse application in the "General Information" section - question A.1. ORP staff are also available for a consultation to discuss your study and help you determine the appropriate review category.
Use of a ÄÌÌÇÖ±²¥ IRB-approved consent template is required for all human subjects research.
Any adverse events or protocol deviations should be submitted to the IRB as an "incident" submission through .
Still have questions about how to determine which template fits your study? Review your application and/or contact the IRB.
For more information about the consent process generally, review modules or view our ÄÌÌÇÖ±²¥ training resource.