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Templates & Required Forms

To support the FSU human research community and facilitate their preparation of research-related materials, the IRB and OHSP make available many different templates, including for research protocols and consent-related materials. These templates are designed to standardize the format and organization of content, and help to ensure that the information that is required by applicable federal law for IRB review of research will be included as part of an IRB application.

GENERAL INSTRUCTIONS

When preparing study protocols and consent-related forms, access and use ONLY the FSU approved templates available in RAMP IRB, under the IRB, Library and Templates tabs, as these templates are the most up-to-date and include instructions that are responsive to researchers' questions about the use of these templates and forms. Do not submit for IRB review any materials based upon obsolete templates that you may have used in the past or obtained from colleagues; these may be returned to you for correction. As a guide, below are descriptions about the most frequently used templates and forms.

A formal research protocol document utilizing the RAMP IRB Toolkit templates below is required for all human research projects submitted to the FSU IRB for review. Note that a research protocol is a detailed plan of your study that will include, at a minimum, background, significance, rationale, objectives, design, methodology, statistical considerations, description of risks (and how risks will be minimized) and benefits, consent procedures, organization, setting and other information about your study. A research protocol is not intended to refer to a guide, prompt or a list of questions that will be used in a study.

If your study's protocol does not conform to a template, your submission will be returned to you for correction and resubmission, resulting in needless delay in the review of your project. Required study-related materials, such as consent forms, must also follow the FSU approved templates, and these may be uploaded together with research protocols in the applicable RAMP IRB submission workspace sections.

Some select protocol templates and their intended use are described below:

  • HRP-503 - TEMPLATE PROTOCOL: best for basic, medical and clinical research studies that involve health-related interventions, use of pharmaceutical or controlled drugs, devices, biologics and/or nutritional supplements, as well as collection and use of human biological specimens.
  • HRP-503a - TEMPLATE SBS PROTOCOL: best for social, behavioral and educational studies (SBER) that may include a wide range of methodologies (e.g., interviews, focus groups, surveys, observation, behavioral manipulations and the use of previously collected information such as education, social service, employment, health-related or public data or records).
  • HRP-503r - TEMPLATE REPOSITORY PROTOCOL: required for studies involving only creating and maintaining an on-going compilation of information about individuals (whether or not these individuals participate in or their data are used for a specific study, such as for example individuals who take part in non-research activities, or individuals who request or receive non-research services) that will be developed or added to over time or used by more than one researcher or other researchers for future studies. 
  • HRP-503d - Template Determination Form: use this form (1) if instructed by OHSP to use HRP-503d, including in lieu of other HRP-503 series templates, or (2) if you are not certain whether one of the above research protocols will be required for review of your research, complete and submit for review this form; upon completion of review you will be informed what if any of the other protocol templates above and/or additional forms or information are required, or informed that no further OHSP or IRB review is required such that your activity may commence.
    • for economic decision-making studies, the HRP-503de template should as applicable be used.
    • for quality improvement (QI, including DNP) activities, the HRP-503dqi should as applicable be used.
  • UMBRELLA PROTOCOL TEMPLATES: Templates are available for certain Umbrella projects; refer to this Umbrella Research page for information and instructions.

These and all other templates are accessible by logging into RAMP IRB, and navigating to the IRB, Library and Templates tabs. Instructional videos on how to complete the Protocol Template are available at this link.

Consent-related Templates

A consent-related process is required for all human research projects submitted to the FSU IRB for review. Consent procedures must utilize the RAMP IRB Toolkit templates below. In only rare circumstances and under very strict conditions will the IRB waive the requirement to either use a template or obtain a study participant's signature (including e-signature) on a consent-related document. When complete, consent-related documents must be uploaded together with research protocols in the applicable RAMP IRB submission workspace sections.

NOTE:  The select consent-related templates below follow federal legal requirements for format, organization and structure and substantive content. The templates provide detailed instructions. If your consent-related form does not conform to a template (e.g., fails to follow format or does not include a required consent element or content) your submission and the consent-related form will be returned to you for correction and resubmission, resulting in needless delay in the review of your project. You must modify a template consistent with your study, but retain the template headings.

KEY TIPS:

  1. Choose the most suitable template; these are designed for different research contexts and populations (e.g., biomedical vs. social-behavioral research; adult vs. children as study participants)
  2. Avoid jargon, technical language or unnecessary abbreviations
  3. Use layperson terms suitable for your prospective sample population, not for you, your study team, research colleagues or the IRB
  4. Render information at no more than the 8th grade reading level unless you are certain that ALL of your sample has higher educational attainment (consent-related forms are often returned to researchers for failing to meet this requirement!)
  5. For children as subjects, language must be commensurate with the lowest known educational level of a prospective child subject; for research involving children, generally an assent form for a child AND a separate parental permission are required. Some exceptions to the general requirement for parental permission may apply for research involving children; refer to our Waiver of Parental Permission algorithm.
  6. Always use readability statistics as well as proof your consent-related form before submitting
  7. A valuable tool in writing your consent forms is the website http://www.plainlanguage.gov/

Frequently-used Consent-related Templates* and their intended use are described below:

  • HRP-500 - Template - Broad Consent Document: required for studies involving only creating and maintaining an on-going compilation of information about individuals (whether or not these individuals participate in or their data are used for a specific study, such as for example individuals who take part in non-research activities, or individuals who request or receive non-research services) that will be developed or added to over time or used by more than one researcher or other researchers for future studies (see our Study Volunteer Registries page).
  • HRP-502 - TEMPLATE CONSENT DOCUMENT: intended for basic, medical and clinical research studies that involve health-related interventions, use of pharmaceutical or controlled drugs, devices, biologics and/or nutritional supplements, as well as collection and use of human biological specimens.
  • HRP-502a - TEMPLATE - SBER Consent Document: best for social, behavioral and educational (SBER) studies that may include a wide range of methodologies (e.g., interviews, focus groups, surveys, observation, behavioral manipulations and the use of previously collected information such as education, social service, employment, health-related or public data or records).
  • HRP-502b - SBER (7-13 year-old children) Assent Document: for use with SBER studies involving children ages 7-13 years old; for parents, separately use the HRP-502c template (below) to obtain parental signatures.
  • HRP-502c - SBER (14-17 year-old children) Assent and/or Parental Permission Document: for use with SBER involving children ages 14-17 years old AND their parents; may also be used for parents of children ages 7-13 years old, for which children a separate HRP-502b template must be used.
  • HRP-502i - TEMPLATE - Information Sheet (Exempt Studies Only): 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; must be provided to subjects, but does not require subjects' signatures.
    • for economic decision-making studies, the HRP-502ie template should as applicable be used.
    • for quality improvement (QI, including DNP) activities, the HRP-502qi template should as applicable be used.
  • HRP-502v - TEMPLATE - SBER Verbal Assent Script: for use with SBER involving younger children or individuals unable to read or comprehend the standard written consent-related materials.
  • HRP-507 - Template - Consent Document - Short Form: intended ONLY for use with study participants with limited or no English language proficiency (e.g., educationally disadvantaged, ESL); use of this template requires that study participants be provided with BOTH this Short Form Consent AND a consent-related verbal presentation based upon an adequate summary (of what will be verbally presented) of required information contained in the HRP-502, HRP-502a, and/or HRP-502b consent templates above.

*These and ALL other templates are accessible by logging into RAMP IRB, and navigating to the IRB, Library and Templates tabs. 

Other Templates:

The following select checklists are part of the HRPP Toolkit. These and other checklists are referenced in the protocol templates to encourage researchers to look these checklists over as reference guides when writing their research protocols, since the IRB will complete the applicable checklists as part of their review of research. 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.

The following worksheets and other materials are part of the HRPP Toolkit. The worksheets may be referenced in the protocol templates to encourage researchers to look these worksheets over as reference guides when writing their research protocols, since the OHSP and IRB will use these worksheets as part of their review of research. Other documents are intended for researcher's use.

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. 

IMPORTANT NOTE WHEN MODIFYING YOUR 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, be sure to 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. Otherwise, the IRB must re-review your form in its entirety rather than just your changes, which will add to the time to complete IRB review.

Questions? Click for FAQs!