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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 humansubjects@fsu.edu or (850) 644-7900 so that our staff can assist you. 

Consent-related Templates

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/

Toolkit Resources

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.

Protocol Template

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.

Instructional videos on how to complete the Protocol Template are available at this link.

Checklists

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. 

1Alteration can refer to online/electronic consent.

2Pre-2018: For studies originally approved before January 21st, 2019.

Select Worksheets & Other Documents