This section contains all forms and consent templates that researchers and study staff need to submit for site approval or IRB review. The IRB recommends the use of the consent templates to help researchers meet the requirements for informed consent.

Forms

  • Coverage Analysis Worksheet
    Complete this worksheet to delineate standard of care versus research procedures involved with the study.
  • Translator’s Declaration
    If the translator or translation service you have used to translate study documents does not provide a certificate of translation, you can use this form to have the translator certify the translation. This is not required to use if you are provided with a certificate of translation.

Templates

  • Research Proposal Template
    This is a template containing an outline of topics to address in a research proposal. This will help you to describe your research when submitting to the IRB.
  • Informed Consent Form Template
    The Informed Consent Template is intended for use in clinical trials but can be revised to fit many types of research studies; additional instructions for the template can be found on the first page of the document.
  • Brief Informed Consent Template
    The Brief Informed Consent Form can be used for studies that are no more than minimal risk and have few or simple study procedures, which do not require extensive explanation (for example: survey studies, focus groups, etc.).
  • Pediatric Informed Consent Form Template
    The Pediatric Informed Consent Form is intended for use in clinical trials involving pediatric participants but can be revised to fit many types of research studies; additional instructions for the template can be found on the first page of the document.
  • Pediatric Assent Form Template
  • The Pediatric Assent Form Template is intended for use in clinical trials involving pediatric subjects. Language in the assent form should suit the intended population(s). SIRB requires assent for subjects ages 7-17.
  • Adult Informed Consent Form Bill of Rights (Spanish)
    The Bill of Rights (found at the end of the Adult Informed Consent Form) is provided here in Spanish for your convenience. Feel free to use this and include it at the end of your Spanish-translated informed consent form.
  • Pediatric Informed Consent Form Bill of Rights (Spanish)
    The Bill of Rights (found at the end of the Pediatric Informed Consent Form) is provided here in Spanish for your convenience. Feel free to use this and include it at the end of your Spanish-translated pediatric informed consent form.
  • Model Language for Informed Consent Clauses on Reproductive Risks
    See attached for template language regarding reproductive risks in clinical trials that aligns with the Catholic health care ethical religious directives.
  • Informed Consent Checklist Template
    The Informed Consent Checklist can be used to assess participants’ understanding of the information provided during the consent process.
  • HIPAA Authorization for Research (English/Spanish)
    If applicable to the study, use this template as the framework for creating the HIPAA Authorization Form for Research. The template is provided in both English and Spanish for your convenience. About the HIPAA Authorization Form
  • HIPAA Authorization for Future Research (English/Spanish)
    If applicable to the study, use this template as the framework for creating the HIPAA Authorization Form for Future  The template is provided in both English and Spanish for your convenience.
  • Translator’s Certification for HIPAA Authorization Forms and Bill of Rights for Reference Only
    The translator’s certification for the HIPAA Authorization Forms and Bill of Rights is provided here for your reference.