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. 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. Do not use obsolete forms or reuse forms previously submitted with your other studies.
Below are only SELECT, frequently-used templates and forms.
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.
- Avoid jargon, technical language or unnecessary abbreviations
- Use layperson terms suitable for your sample, not for you, your study team, research colleagues or the IRB
- Render information at no more than the 8th grade reading level unless you are certain that ALL of your sample has higher educational attainment
- For children as subjects, language must be commensurate with the lowest known educational level of a prospective child subject
- Always 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; must be provided to subjects, but does not require subjects' signatures)
- Debriefing Form (sample)
- Psychological Debriefing Form (sample)
- Adult Verbal Script
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:
- Protocol template to use for social, behavioral and educational research
- Protocol template to use for biomedical research
- Protocol template to use to only create or maintain repositories/registries for future studies
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). 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.
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.
- HRP-212 - Continuing Review/Study Closure Form (for renewals and/or study closures)
- HRP-214 - Reportable New Information Form (adverse events, unanticipated problems, etc.)
- HRP-310 - Human Research Determination Worksheet (to use as a guide only)
- HRP-311 - Worksheet: Engagement (to use as a guide only)
- HRP-503d - Template Determination Form (to submit a request for determination)
- HRP-504 - School Permission to Conduct Research Template Letter
- HRP-830 - Local Context and Communication Form AKA Communication & Responsibilities (for multi-site/single-IRB studies)