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 consent template format is required; if your study's consent form(s) do not fit within the required format, your project will be returned for corrections. This template can be modified as necessary, but should retain the headings to comply with the regulations (unless it states that the heading can be removed). Also ensure that your consent form is written in laymen's terms—the general guide for adult consent documents is that they be understandable at the 8th grade reading level. A valuable tool in writing your consent forms is the website http://www.plainlanguage.gov/
- Consent Document (adult consent, child assent, & parent permission)
- Consent Document – Short Form (intended for participants whose native language is not English)
HRPP Toolkit Resources
FSU has transitioned to a new IRB system (RAMP) 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 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 forms, templates, and documents are part of this Toolkit. Researchers are encouraged to utilize these documents as necessary when writing their research protocols. The RAMP IRB module went live on June 21st, 2019, therefore the Protocol template 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 documents are procedures that are applicable to researchers. These procedures, along with other procedures governing the Office for Human Subjects Protection, can be found at this link.
- Human Research Protection Program (HRPP) Plan
- Informed Consent Process for Research
- Written Documentation of Consent
The following 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.
Worksheets & Other Documents
- Continuing Review Form (to submit a renewal in RAMP)
- Communication & Responsibilities (for multi-site/single-IRB studies)
- Reportable New Information (adverse events, unanticipated problems, etc.)
- School Permission to Conduct Research Template Letter
- Informational Sheet Template for studies determined to qualify for Exempt review March 1, 2019
- Debriefing Form October 1, 2018
- Psychological Debriefing Form October 1, 2018
- Adult Verbal Script October 1, 2018