Templates

The following are the forms to be used for the submission of protocol information for IRB review. Use the template that most closely fits the research you plan to conduct. You may use the following research acronyms.

NOTE: Investigators may use sponsor-provided ICFs. However, these must be submitted to the IRB as a Microsoft Word document and must incorporate the JHSFooter Template , UHealth Footer Template, or UM/JHS Combined Footer as applicable. Please refer to FAQs regarding footer requirements.

See below for templates for Biomedical, HIPAA, Social & Behavioral, Recording, HIV, Genetic, Pregnant Partner & Short forms.

Biomedical Templates

HIPAA Research Authorization Consent Templates

The language below should be added to the consent forms; the full biomedical consent template with the language included is found above (see HRP- 502a above)

HIPAA section (English)

HIPAA section (Spanish)

HIPAA section (German)

HIPAA section (Portugese)

HIPAA section (Chinese)

HIPAA section (French)

HIPAA section (Creole)

HIPAA section (Russian)

The Certificate of Translation for the above forms may be downloaded by clicking this link.

Social and Behavioral Sciences (SBS)

Recording or Photographing Subjects

The following standalone consent forms may be used or pertinent language may be included in the main Informed Consent Form(s). If the standalone form is used, study teams must ensure that the appropriate footer(s), signature lines, etc. are incorporated into the final versions.

Genetics Consent Templates & Guidelines

The following standalone consent form may be used or pertinent language may be included in the main Informed Consent Form(s). If the standalone form is used, study teams must ensure that the appropriate footer(s), signature lines, etc. are incorporated into the final versions. For more information concerning genetics consent and guidelines, please visit the UM Ethics Programs web site.

HIV Testing as part of Screening Procedures

The following standalone consent forms may be used or pertinent language may be included in the main Informed Consent Form(s). If the standalone form is used, study teams must ensure that the appropriate footer(s), signature lines, etc. are incorporated into the final versions.

Observation of Pregnant Partners of Subjects for Outcome Data

You do not need to submit a consent document for pregnant partner unless one of the subject’s partners becomes pregnant

Short Forms without HIPAA

The Certificate of Translation for the above forms may be downloaded by clicking this link.

Please review our on consent to contact page to review the steps you should take to obtain IRB approval.

Phone Script for Consent to Contact

Phone Script for Consent to Contact (Creole)

Phone Script for Consent to Contact (Spanish) 

Sensitive Populations 

Phone Script for Consent to Contact (Sensitive)

Brief Study Description for Consent to Contact (Sensitive)

The Certificate of Translation for the above forms may be downloaded by clicking the following links: 

Certification of translation - Phone Script for Consent to Contact (Creole)

Certification of translation - Phone Script for Consent to Contact (Spanish) 

Telephone Screening Script

This document is to screen potential participants over the phone.

If you are using the Consent to Contact initiative by CTSI please instead click on 'Phone Script for Consent to Contact' above to find the script to be used for that process.