Research Informed Consent
Informed Consent is a fundamental aspect of human subject protections. The informed consent form and process provides critical information to research participants (subjects). Rush requires that each clinical research study be registered in the Clinical Trial Management System ("CTMS"). Faculty and staff have a responsibility to ensure that all clinical research subjects are known to Rush in order to maintain knowledge of the universe of research subjects and to assess each protocol and subject for potential billing. This is outlined in the Mandatory Subject Enrollment in Clinical Trial Management System (CTMS) Policy.
For more information on subject enrollment in the CTMS, please see the Clinical Research Billing Compliance page.
Informed Consent Training Resources:
RUSH Learning Hub ICF Training Modules: Several modules have been developed to address the Informed Consent process. The following modules are role based, scenario driven in a setting that is commonplace when obtaining informed consent. These short (10-15 minute) modules demonstrate a practical application of human subject protections.
Video Learning Module ICF Regulations and Process
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Video Learning Module Short Form Consent Process
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Video Learning Module Assent of Minors Process
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FDA Guidance: The U.S. Food and Drug Administration (FDA) issued the final guidance, “Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors.” This guidance is intended to assist institutional review boards (IRBs), clinical investigators and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent.
The guidance provides the FDA’s recommendations regarding informed consent and describes regulatory requirements to help assure the protection of the rights and welfare of people participating in clinical trials. This was issued August, 2023.
OHRP Resources: OHRP educational videos were developed by the OHRP Division of Education and Development and are intended to provide information regarding the requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR part 46.
This dramatization starts with a fictional investigator and IRB Chair talking about obtaining legally effective informed consent from potential research subjects. The second scene portrays the investigator obtaining appropriate informed consent from a potential subject. (Aug 24, 2010).
In this session, representatives from the Office for Human Research Protections (OHRP) will discuss what goes into a meaningful informed consent. Practical examples will be used to illustrate how to discern meaningful information for potential participants, and how to present information simply in consent documents and materials to ensure consent processes fulfill their goal of enabling potential participants to make informed decisions about whether to participate in the research. (November 10, 2020).
In this video, OHRP Director, Jerry Menikoff, explains the changes and requirements for informed consent in the revised Common Rule including a brief discussion on broad consent. (July 12, 2018).
This video explains the concept of broad consent as described in the revised Common Rule. It describes what it is, what it is not, and how it is anticipated to be used. (June 22, 2018).