Templates & Required Forms
For every study submission and/or revision, please check back on this page for updated versions of forms, and be sure to submit a tracked changes version in addition to a clean version of any updated documents with your IRB submission if an updated template is present on this page. If you are unsure and need assistance in creating/modifying your document(s), please contact our office at firstname.lastname@example.org or (850) 644-7900 so that our staff can assist you.
NOTE: The select consent-related templates below follow new federal legal requirements that went into effect in 2019. Newly added templates include those for social, behavioral and educational research (SBER) that involve no biomedical procedures. If your study's consent form(s) do not contain a required consent element, review and approval of your project may be unnecessarily delayed. Templates must be modified to suit your study as necessary, but should retain the template headings to comply with the regulations (check the template instructions for detailed instructions). As the name suggests, the templates are intended to be suitable for all human research (e.g.,human sciences, biomedical, social-behavioral), so your careful modifications are expected.
It is very important to ensure that your consent form and process are prepared in layperson terms appropriate for your intended sample, not for you, your study team, or research colleagues. The general guide for adult consent materials is that they be understandable at the 8th grade reading level; for child assent, language should be commensurate with the lowest known educational level of a prospective child subject. Use readability statistics before submitting your consent form for review. A valuable tool in writing your consent forms is the website http://www.plainlanguage.gov/
- Consent Document--Long Form--Biomedical (generally requires subjects' signatures; includes adult consent, child assent, & parent permission) (revisions forthcoming).
- Consent Document--Short Form--Biomedical (intended primarily for participants with limited English language proficiency, e.g., ESL, educationally disadvantaged). Use of the Short Form requires subjects' and witness signatures as well as preparation of a written summary (can be a version of the Long Form but without the subject's signature block) of what will actually be said to subjects; the summary must be signed by the witness and the person obtaining consent (i.e., study team member).
- Consent Document--Social, Behavioral and Educational Research (SBER) (not for use with biomedical studies)
- SBER Assent of Children Ages 14-17 Years and Parental Permission (for use with SBER involving children ages 14-17 years AND their parents; should also be used for parents of children ages 7-13 years, which children will sign the SBER Assent of Children Ages 7-13 below. Not for use with biomedical studies)
- SBER Assent of Children Ages 7-13 Years (for use with SBER involving children ages 7-13; parents should sign the Parental Permission form above. Not for use with biomedical studies)
- SBER Verbal Assent (for use with SBER involving younger children or individuals unable to read or comprehend the standard written consent-related materials)
- Information Sheet Template (intended primarily for studies or activities determined by OHSP or the IRB to qualify for Exempt review, including most surveys, interviews and focus group activities; does not require subjects' signatures)
- Debriefing Form (sample)
- Psychological Debriefing Form (sample)
- Adult Verbal Script
FSU has transitioned to a new IRB system (RAMP IRB) to modernize the University’s research administration business processes and technologies, as well as improve research compliance and project management. For more information, please visit the RAMP project website. The transition to the RAMP IRB system included a Human Research Protection Program (HRPP) Toolkit to aid with the development and management of IRB protocols and to ensure compliance with the regulations. The following select forms, templates, and documents are part of this Toolkit and their links provided here for quick access; however, all materials may be found in RAMP IRB under the IRB and Library tabs. Researchers are encouraged to utilize these RAMP IRB and HRPP Toolkit documents as necessary when writing their research protocols. The RAMP IRB module went live on June 21st, 2019, therefore use of the provided RAMP IRB protocol, consent and other templates is required for all IRB submissions going forward.
NOTE: Effective June 21st, 2019, a formal research protocol document utilizing the Toolkit template below is required for all human subjects research projects submitted to the IRB.
- Protocol Template for Social/Behavioral Research
- Protocol Template for Biomedical Research
- Protocol Template (without instructions)
Instructional videos on how to complete the Protocol Template are available at this link.
The following select checklists are part of the HRPP Toolkit. Researchers are encouraged to utilize these forms as reference guides when writing their research protocols. NOTE: These checklists are not required or intended for investigators to submit, they are used by IRB members when conducting their reviews.
- Waiver or Alteration1 of Consent Process
- Waiver of Written Documentation of Consent
- Waiver of Written Documentation of Consent (Pre-20182)
- Research involving a HIPAA Waiver of Authorization
- Research involving Pregnant Women
- Research involving Prisoners
- Research involving Children
- Research involving Cognitively Impaired Adults
- Research involving Non-Significant Risk Devices
1Alteration can refer to online/electronic consent.
2Pre-2018: For studies originally approved before January 21st, 2019.
Select Worksheets & Other Documents
- HRP-212 Continuing Review/Study Closure Form (for renewals and/or study closures)
- Human Research Determination (to use as a guide only)
- Official Request for Determination of Not Human Research
- HRP-830 Local Context and Communication Form AKA Communication & Responsibilities (for multi-site/single-IRB studies)
- Reportable New Information (adverse events, unanticipated problems, etc.)
- School Permission to Conduct Research Template Letter