• ICF Template
  Combined consent and HIPAA research authorization template for a subject to consent to participate in research.
• Assent Form for Children 7-17 Years Old
• ICF Checklists:
  Investigators and research team members can use these checklists when creating ICFs to make sure all of the necessary information is included:
  • Elements of Informed Consent Worksheet (Main Study ICF)
  • OHRP ICF Checklist
• Consent Information Sheet Template
  • This template should be used for Exempt studies, which do not require an ICF.
• WIRB templates:
  • WIRB ICF Template
  • WIRB ICF Template Key
  • WIRB Minor Assent Template

Every human subjects research study must have a protocol. When a study is sponsored by industry, a protocol is typically provided by the sponsor. If a protocol is not provided by the sponsor, or a study is initiated by the Principal Investigator (PI), the PI must create a detailed protocol for the study. If a protocol does not accompany the submission to the IRB, it will delay the review of the research.

To assist with the creation of a protocol, the IRB office has provided the following protocol templates:

• HRP-503- Template Protocol – You can download either the form or the MS Word document on the Forms page.
• NIH and FDA Clinical e-Protocol Writing Tool – This is an electronic protocol building tool created by the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) for phase 2 and 3 IND/IDE studies.
  • FDA_NIH Study Schema Examples
• HRP-508 - Site-Specific Appendix (SSA) – Required for all new and continuing review submissions if the protocol does not already detail aspects of the study as they will occur specifically at this site (e.g., consent process including who conducts the consent interview, specific location of document storage, operational details of recruitment methods). This form will typically be used for those studies that are multi-center or industry sponsored and the protocol document cannot be tailored to this site. You can download either the form or the MS Word document on the Forms page.
• Form 7 (Request for Exemption) – Required for exempt research studies including medical record/chart/electronic database/specimen review and datasets created for research purposes. When submitting a Form 7, there is no need to submit a separate protocol; the Form 7 will serve as the protocol for these studies. You can download this form on the Forms page.
• Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT) This website provides recommendation of scientific, ethical, and administrative elements that should be addressed in a clinical trial protocol.  Included are a useful checklist (WORD | PDF) and example table of assessments (WORD | PDF).