Informed consent & protocol templates
The process of informed consent is critical when undertaking human subject research. Use these templates to create informed consent documents to be used when enrolling adult subjects into research.
Aurora Templates
Advocate Templates
Explaining common medical terms
It can be difficult to define medical terms in everyday language, especially for people unfamiliar with research. Please refer to our medical terminology lay language glossary [PDF] for assistance.
AAH Stand Alone Research Authorization
Specimen banking for research purposes
Many research studies collect blood, tissue or other patient specimens for research purposes. These templates allow you to obtain consent for specimen collection, specimen banking and for possible future research use:
Informed consent from parents & kids
Research studies involving children are subject to federal informed consent regulations. Use these templates to obtain informed consent from parents and children 17 years old and younger (when possible).
- Parental permission template (for pediatric subjects) [DOCX]
- Assent template (children ages 7-10) [DOCX]
- Assent template (children ages 11-14) [DOCX]
- Assent template (children ages 15-17) [DOCX]
Informed consent from caregivers
Caregivers often assist patient participants during the course of research studies, especially if subjects have trouble completing study requirements or activities on their own. This template should be used to obtain informed consent from caregivers.
- Caregiver ICF [DOCX]
- Caregiver information sheet [DOCX]
Please refer to RSPP’s caregiver guidance document [PDF] for more information about when to use the caregiver information sheet and how to obtain informed consent from caregivers.
Updates to informed consent documents
Periodically, our RSPP office approves updates to specific informed consent documents. Please refer to these memos for the latest updates:
Guidance for writing protocols
You must write a protocol for most submissions to our institutional review board (IRB). Your submission application contains instructions and details about whether your study requires a protocol.
If your study requires a protocol and the study sponsor has not provided one, please use the protocol template when creating it:
- Protocol template [DOCX]
Your questions answered
Our RSPP/IRB office aims to answer your human subject research questions in a timely manner. Please call the RSPP Office’s main line at 414-219-7744 or complete the contact/question form on the contact Aurora RSPP/IRB page.
IRB approval of research
Find out the steps you need to take to get IRB approval of research. IRB approval process
Resources
Download templates for IRB application, informed consent and more. IRB forms and templates
Contact us
Get answers for all your research study questions. Get in touch