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.
- Standard Protocol (HRP-503): Use this template for studies involving social, behavioral, or educational research involving human participants.If you anticipate that your study will be reviewed as exempt research, only complete the purple colored questions.
- Secondary Analysis of Data and/or Biospecimens Only Protocol (HRP-503a): Use this template if your study involves analyzing existing data or biospecimens without collecting new data from participants.
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:
- Informed Consent Form Template: Use this comprehensive, standard form for studies requiring detailed participant information and consent documentation. The template is adaptable for different study designs. Researchers may tailor this form to the specifics of their research.
- Research Information Sheet Template: 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).
- Short Form Informed Consent Template: 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 HRP-090 – SOP – Informed Consent Process for Research and HRP-091 – SOP – Written Documentation of Consent.
- Assent Form (Ages 7-12): Designed for younger participants, this form ensures they understand the study at an age-appropriate level.
- Assent Form (Ages 13-17): 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.
- Certificate of Confidentiality (CoC): This is applicable to research that has obtained a Certificate of Confidentiality.
- U.S. Department of Defense (DoD) Regulated/Sponsored Research: This is applicable to research regulated/sponsored by the U.S. Department of Defense.
- Genetic Information Nondiscrimination Act (GINA): This is applicable to research that involves genetic testing or the collection of genetic information.
- Health Insurance Portability and Accountability Act (HIPAA) Authorization: This is applicable to research that involves accessing/obtaining/using/sharing protected health information from a covered entity for research purposes.
- Research Involving Prisoners: This is applicable to research that intentionally involves prisoners as a study population.
These templates help researchers comply with ethical standards while protecting participants’ rights and welfare.
Forms
- 118 Determination Request Form: 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.
- Faculty Advisor Responsibilities Form: 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.
- International Research Consultant Form: 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.
- Investigational New Drug (IND) Exempt Form: 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.
- Investigational Device Exemption (IDE) Exempt Form: 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.