Illinois Amends MHDDCA
Effective January 1, 2025, the State of Illinois has amended the Illinois Mental Health and Developmental Disabilities Confidentiality Act (MHDDCA) through Illinois Senate Bill 3288 (Illinois General Assembly, 2024). The changes will reduce administrative burdens for researchers while maintaining protections for participants in research studies.
These amendments to the Illinois MHDDCA eliminate the requirement for specific provisions in the consent process when the research accesses, uses, or discloses for research purposes mental health information, development disability services, or genetic counseling. Researchers using this information are not required to include a calendar expiration date on consent forms, a statement about the right to inspect records, or obtain the signature of a witness who can attest to the identity of the person signing. These elements are no longer mandatory under the amended law.
The Northwestern University Institutional Review Board (IRB) Office revised the Biomedical Consent Document (HRP-592) and the Social Behavioral Consent Document with HIPAA authorization (HRP-1721) to reflect these changes. Effective March 6th, 2025, researchers will use the updated templates for all new study submissions to ensure alignment with the amended MHDDCA provisions.
It’s important to note that currently approved consent forms, which follow the previous template, remain in compliance with the law and do not need to be modified unless the researcher opts to update them in line with the new requirements. NOTE: Any informed consent form that includes the requirements from before the change in the regulation must continue to comply with the older MHDDCA provisions.
The amended MHDDCA still ensures that participants’ rights are well-protected. The core principles of informed consent—such as ensuring participants understand the nature of the research, its risks, and their rights—remain intact. The amended law maintains these protections while eliminating procedural requirements to reduce the administrative burden.
The IRB Office advises researchers to review the updated consent templates carefully and ensure that all new submissions reflect the revised MHDDCA requirements. Access the revised informed consent form templates on the IRB Office website, Biomedical & Social Behavioral Consent Templates Page. Additionally, the IRB Office has updated our Human Research Policies & Guidance Page to remove the guidance on Research that Involves the Use of Protected Mental Health and/or Developmental Disabilities Information to align with the amendment.
Contact irb@northwestern.edu with any questions.