Protocol Templates
Researchers are required to submit a completed protocol with their submission in VERA. The protocol templates provide the VU HRPP / VU IRB with the main information about the human research that is being conducted.
- : *New* Use this template for social, behavioral, or educational research involving human participants. The previous template will be accepted for a grace period through April 24, 2026 and for modifications.听
- : *New* Use this template to request an exempt determination. The template describes the exemption categories. This template should also be used if your study involves analyzing existing data or biospecimens without collecting new data from participants. The previous Secondary Analysis of Data and/or Biospecimens template will be accepted for a grace period, through April 24, 2026.听
These templates help ensure your submission meets IRB requirements and facilitates a smoother review process.
Consent/Assent Templates
Researchers must provide consent and assent forms to ensure study participants and their legal guardians are fully informed about the research process. Use the appropriate form templates based on participant age and study requirements:
- : Use this comprehensive, standard form for studies requiring detailed participant information and consent documentation.听 The template is adaptable for different study designs. Researchers may tailor this form to the specifics of their research.
- : Use this streamlined information sheet for studies with simpler consent requirements. This template is often used in minimal risk research (e.g., studies involving online surveys, interviews, research requiring a waiver of documentation of consent).
- : This short form should be used with populations who have limited English proficiency and/or cannot read or are physically unable to talk or write. Please refer to 听and听.听
- : Designed for younger participants, this form ensures they understand the study at an age-appropriate level.
- : This form is tailored for older minors, providing relevant study details in clear, understandable language.
- Informed Consent Addendums: The informed consent addendum documents include template content to be included in the informed consent form when applicable.
- : This is applicable to research that has obtained a Certificate of Confidentiality.
- : This is applicable to research regulated/sponsored by the U.S. Department of Defense.
- : This is applicable to research that involves genetic testing or the collection of genetic information.
- This is applicable to research that involves accessing/obtaining/using/sharing protected health information from a covered entity for research purposes.
- : This is applicable to research that intentionally involves prisoners as a study population.听
These templates help researchers comply with ethical standards while protecting participants鈥� rights and welfare.
Forms
- : Use this form if your sponsor requires an IRB determination to release funds. The VU IRB can certify that certain grants or agreements have been awarded with a human subjects research component, but plans for the involvement of human participants are not yet definite.
- : PhD students must use this form to document their faculty advisor's responsibilities in overseeing the conduct of the study. The completed form must be included with the study materials in VERA.
- : Use this form for research collaborators, such as community partners, not affiliated with an FWA institution, to request reliance agreement(s) prior to conducting human subject research for initial studies, and before adding new external research team members to approved studies.
- Use this form to provide the VU HRPP with sufficient information regarding risks and benefits of the research occurring outside of the United States. The expectation to submit this form varies by review level. It is required for expedited and greater than minimal risk research. For exempt research, the VU HRPP may request the form upon the review of the submission at their discretion.
- :听Use this form to determine if the study drug is exempt from FDA IND requirements. Include the completed form when you submit your study in VERA.听
- : Use this form to determine if your study device is exempt from FDA IDE requirements. Include the completed form when you submit your study in VERA.听