Informed Consent Quality Improvement Plan

DHHS OHRP Training ResourcesInformed Consent is a fundamental aspect of human subject protections.  To ensure the protection of autonomy is upheld, a new initiative related to informed consent began in FY19 and will continue in FY22.  This includes the Informed Consent Form (ICF), the Consent Process, and Consent Documentation.  The initiative creates many opportunities for research personnel to advance their knowledge and ensure compliance with Rush policy, Federal regulations and Good Clinical Practices (GCP). 

Standard Operating Procedure (SOP):  Monitoring Informed Consent, HIPAA & Consent Documentation

The Monitoring Informed Consent, HIPAA & Consent Documentation SOP established a review process to assess gaps related to obtaining Informed Consent and Process Documentation.  When gaps are detected individuals will be referred for training.  The training is multifaceted and individuals will be directed to the following learning opportunities. 

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 common place when obtaining informed consent.  These short (10-15 minute) modules demonstrate a practical application of  human subject protections.   

Informed Consent Training Resources:

Recent Updates: 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.

General Informed Consent Requirements: 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). General Informed Consent RequirementsWatch Here 

Simplifying Informed Consent: 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). Watch Here

Whats New in Informed Consent: Revisions to the Common Rule: 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). Revised common rule videoWatch Here

Broad Consent in the Revised Common Rule: 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). revised common rule video 5Watch Here