Consent, Assent & HIPAA Templates

This page provides a variety of consent, assent, permission forms, and HIPAA authorization forms.

For your convenience, all forms and templates are available in both English and Spanish. For any non-English translated documents, attach the translated document(s) in addition to the Translation Certification Form to Kuali. View the Translation Guidance Document for more information.

We encourage you to review the appropriate forms carefully and customize them according to your specific research protocol. If you have any questions regarding the forms or require additional guidance, please contact the IRB office.

Document

Description

Language Version

INFORMED CONSENT, ASSENT AND PERMISSION LETTER TEMPLATES

G1. Adult Informed Consent Form

Use this template for studies where the research subjects are 18 and older

English

Spanish

G2. Adult Informed Consent Form for federally funded studies

Use this template if the study is receiving funding from NIH or other federal agencies. This template includes NIH-specific required language

English

Spanish

G3. Parent Permission Form

Use this template to obtain parent permission for the participation of minors in research

English

Spanish

G4. Assent Form

Use for children between the ages of 6-12

English

Spanish

G5. Exempt Consent Information Sheet

For research that qualifies for exempt status, this information sheet template may be used for basic research procedures such as surveys, interviews or focus groups. Additional information may need to be added based on individual study details. Template language may be modified as needed; similar language may be used for in-person, email or online consent. Please note that this template does not contain the required elements of consent that are necessary for Expedited or Full Review research studies.

English

Spanish

G6. Information Letter for Online Studies

Use this template for studies involving online survey/questionnaire tools. This template has been approved by the Versiti Blood Center of Wisconsin, Children's Wisconsin, Medical College of Wisconsin/Froedtert Hospital, Milwaukee School of Engineering and University of Wisconsin-Milwaukee.

English

Spanish

HIPAA AUTHORIZATION FORMS & TEMPLATES

H1. HIPAA Authorization Form

Use this form when subjects are giving direct authorization to release and use PHI. Most often used in conjunction with an Informed Consent Form.

English

Spanish

H2. Data Use Agreement for Research

A covered entity may use and disclose a limited data set for research activities conducted by itself, another covered entity, or a researcher who is not a covered entity if the disclosing covered entity and the limited data set recipient enter into a data use agreement.

English

Spanish