Consent, Assent & HIPAA Templates


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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.

G2 Adult Informed Consent Form for NIH funded studies Use this template if the study is receiving funding from NIH. This template includes NIH-specific required language.

G3 Parent Permission Form Use this template to obtain parent permission for the participation of minors in research.

G4 Assent Form Use for children between the ages of 6-12.

G5 Exempt 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.

G6 Informational 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.

HIPAA AUTHORIZATION FORMS & TEMPLATES

H1 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.

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.