Institutional Review Board Forms and Templates
All forms and templates are downloadable word documents unless noted below.
Templates for New Protocol Submissions
These templates have been created to provide guidance for researchers in developing their protocol. All new study submissions must be submitted to the Office of Research Services for administrative assessment prior to submission through the IRB Compliance Management System (iMedRIS). Please note that the Exempt Review Protocol Template is suitable for retrospective chart review and survey-based projects. The Clinical Research Protocol Template is intended for prospective studies including registries and studies involving an intervention (drug, device, behavioral).
Instructions for iMedRIS access are contained in the HRPP handbook posted on our Standard Guidance and Education page.
Consent Templates and Guidance
A consent template and guidance has been created to assist researchers in developing a participant consent form for your research study. The template is the Saint Luke's Health System standard document to be used for all activities/projects. The guidance is a manual to help researchers and may be subject to change.
Consent Templates:
- Consent Template
- Assent Template
- HUD Consent Template
- Expanded Access Consent Template
- Short Form Consent (English)
- Short Form Consent (Spanish)
Guidance and Other Forms:
- Instructions for Informed Consent
- Consent Guidance
- Alternate Wording (Consent) Guidance (PDF)
- Participation Information Sheet Template
- Letter to Participants
- Opt-Out Consent Template
Additional Forms and Guidance
If there are any additional forms or submission guidance needs, please contact us at irb@saint-lukes.org and we will be happy to assist with your requests.