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Templates & Required Forms

GENERAL INSTRUCTIONS

For every study submission (e.g., initial study, continuation and/or modification), use RAMP IRB to access to templates and forms unless the template or form is only available below. DO NOT use obsolete forms or reuse forms previously submitted with your other studies. Current templates and forms provide the most recent instructions and guidance to assist with your submission and are responsive to researchers' frequently asked questions about the use of these templates and forms.

When modifying or editing your study in order to provide a revision of a previously submitted form such as a protocol or consent form, use the "Update" feature (the button to the left of a submitted form); do not use "Add" button unless you are submitting an additional form, and do not unless you are replacing a form in its entirety delete the form by using the "x" feature. Revise your form as needed, save the form using the same file name, and after selecting the Update button and in the Edit Attachment window, attach your revised form and add a version number if desired.

By using the Update feature the RAMP IRB system automatically tracks and pinpoints changes between the updated version and the previous submitted version to facilitate IRB review. 

Below are only SELECT, frequently-used templates and forms.

Consent-related Templates

NOTE:  The select consent-related templates below follow new federal legal requirements. If your study's consent form(s) do not contain a required consent element, review of your project will be unnecessarily delayed or approval withheld. Modify the templates to suit your study as necessary, but retain the template headings to comply with the regulations (check template instructions for instructions). The templates are suitable for all human research.

KEY TIPS:

  1. Avoid jargon, technical language or unnecessary abbreviations
  2. Use layperson terms suitable for your sample, not for you, your study team, research colleagues or the IRB
  3. Render information at no more than the 8th grade reading level unless you are certain that ALL of your sample has higher educational attainment
  4. For children as subjects, language must be commensurate with the lowest known educational level of a prospective child subject
  5. Always use readability statistics before submitting your consent form for review
  6. A valuable tool in writing your consent forms is the website http://www.plainlanguage.gov/

TEMPLATES:

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Protocol Templates

NOTE: A formal research protocol document utilizing the RAMP IRB Toolkit templates below are required for all human subjects research projects submitted to the IRB. If your study's protocol does not conform to the template structure or format, include a template section or follow the template instructions, your submission will be returned to you for correction, unnecessarily delaying review of your project; approval may also be withheld. Add content and required attachments to suit your study as necessary.

Some select frequently used or newly-available protocol templates are listed below:

These and all other templates are accessible by logging into RAMP IRB, and navigating to the IRB, Library and Templates tabs. If you are not certain whether a formal research protocol for your research will be required for review, complete and submit for review and within RAMP IRB the HRP-503d - Template Determination Form (to submit a request for determination). For reference only, look over this HRP-503d form outside of RAMP IRB. Upon completion of review you will be informed what if any additional forms or information are required, or informed that no further OHSP or IRB review is required such that your activity may commence.

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

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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.

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Select Worksheets & Other Documents

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. 

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