Informed Consent and HIPAA Authorization Templates

Important Updates (Effective January 21, 2019)

New Informed Consent Form Templates:  Investigators are required to use the latest versions of the Informed Consent Form Templates, which have been updated to comply with the 2019 Revised Common Rule changes.

Posting of Consent Forms for Clinical Trials For each federally funded clinical trial, one IRB-approved informed consent form used to enroll subjects must be posted to ClinicalTrials.gov or to a docket folder on Regulations.gov (docket ID: HHS-OPHS-2018-0021). The informed consent form must be posted after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.  View further guidance.

Investigators are required to use the FIU Informed Consent templates provided below to ensure compliance with the Informed Consent Requirements. In some circumstances, researchers may still be permitted to use an external Informed Consent form when the research is conducted off-site in collaboration with another institution’s IRB. Such situations are handled by the IRB on a case-by-case basis.

Investigators that will be conducting research involving protected health information (PHI) are required to use the HIPAA Authorization templates.

The templates are revised frequently, so please visit this page prior to submitting any protocols to verify that you are using the latest template. The first page of each form provides guidelines on completing the Informed Consent templates. Remember that your research population and proposed research may require special considerations. Use the templates below to prepare your documents.

FIU IRB Informed Consent Templates:

Adult Written Informed Consent For the acquisition of an adult’s written consent to participate in research
Parental Written Informed Consent For the acquisition of a parent’s written consent to allow a child to participate
Child Written Assent Form For the acquisition of a child’s written assent to participate
Adult Verbal Informed Consent For the acquisition of verbal consent where a waiver of written consent has been requested
Adult Online Informed Consent For the acquisition of online consent where a waiver of written consent has been requested
Adult Information Letter For providing the participant with information about the study (for Exempt research)

FIU IRB MRI Informed Consent Templates:

Adult MRI Written Informed Consent For the acquisition of an adult’s written consent to participate in MRI research
Parental MRI Written Informed Consent For the acquisition of a parent’s written consent to allow a child to participate in MRI research
Child MRI Written Assent Form For the acquisition of a child’s assent to participate in MRI Research

FIU IRB HIPAA Authorization Templates:

Adult HIPAA Authorization Form For the acquisition of an adult’s protected health information (PHI). This is required when accessing medical records for research purposes.
Adult Written Informed Consent and HIPAA Authorization Form (Combined) For the acquisition of an adult’s written consent to participate in research and authorization for PHI (combined Consent/Authorization)
Parental HIPAA Authorization Form For the acquisition of a child’s protected health information (PHI). This is required when accessing medical records for research purposes.
Parental Written Informed Consent and HIPAA Authorization Form (Combined) For the acquisition of a parent’s written consent to participate in research and authorization for PHI (combined Consent/Authorization)

Western IRB (WIRB) Consent & HIPAA Authorization Templates:

All clinical trial protocols being submitted to WIRB are required to use the following templates:
WIRB Informed Consent Form For the acquisition of an adult’s written consent to participate in research
WIRB HIPAA Authorization Form For the acquisition of protected health information (PHI). This is required when accessing medical records for research purposes.
WIRB Informed Consent and HIPAA Authorization Form (Combined) For the acquisition of an adult’s written consent to participate in research and authorization for PHI (combined Consent/Authorization)