Templates
Jun 14, 2021

Standard Informed Consent Template

New IRBMED studies should most often use the latest Standard Informed Consent template available on this webpage. Specialty Consent Templates may be appropriate for low-risk studies with simpler study methodologies.
Templates
May 11, 2020

Humanitarian Use Device (HUD) Informed Consent Template

This template should be used when submitting the Humanitarian Use Device (HUD) informed consent documents. The Food and Drug Administration (FDA) defines a Humanitarian Use Device (HUD) as “a medical device intended to benefit patients in the...
Templates
Jul 20, 2018

Foreign Language Short Forms

Investigators are responsible for understanding and following the IRBMED Guidance for non-English speaking subjects before using the forms below. Please note, the instructions on this page are for filling out the form, NOT the guidance for using a...
Templates
Apr 17, 2018

Survey Research Informed Consent Template

This template should be used when creating a Survey Research informed consent document. This template may be used only for studies that involve a survey and no other procedures pose minimal risk to subjects
Templates
Apr 17, 2018

Eligibility Screening Informed Consent Template

This template should be used when creating an Eligibility Screening Informed Consent document. This template may be used only for eligibility screening and only if screening procedures pose no more than minimal risk to subjects. You may not use this...
Templates
Mar 29, 2017

FDA Expanded Access Informed Consent Template

This template should be used when creating an FDA Expanded Access informed consent document. This template is designed for use in all Expanded Access uses, which include both Compassionate Use and Emergency Use. For more information on specific...
Templates
Jan 13, 2014

Assent Template

(Recommended for ages 10 to 14-years-old as well as 14 to 17-year-olds when the study involves drug or pregnancy testing and/or birth control.) Return to I nformed Consent Templates page.
Templates
Jul 8, 2020

Exempt Consent Template

The expectation for all human subject research—whether exempt or not—is for researchers to inform the subjects regarding the research and seek/secure the consent of subjects. Use this consent template for Exempt studies requiring Limited IRB review...
Tags: Study Teams
Templates
Apr 17, 2018

Biorepository Informed Consent Template

This biorepository informed consent template is designed to be accompanied by the illustrated biorepository informational sheet . Clinical teams engaging with the patients are provided with the Biorepository Consent and Authorization template to...