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12/10/12

Summary:

  • The first $2,000 received in a calendar year by an individual for participating in a clinical trial involving testing of treatments for a rare disease or condition is exempt as income when determining eligibility for medical benefits.
  • Verify that the clinical trial meets the requirements to exempt the income.

Advances in the treatment of disease depend on clinical trial research conducted at public and private research institutions. The challenges associated with enrolling willing and able participants in research studies are especially difficult for studies that evaluate treatment for rare diseases and conditions. For this reason, the "Improving Access to Clinical Trials Act" (Public Law 111-215) was signed into law on October 5, 2010. This law exempts the first $2,000 received in a calendar year by an individual for participating in a clinical trial when determining eligibility for Medical benefits.

Clinical Trial Requirements

The person participating in the clinical trial must be at least 19 years old. For the income to be exempt the clinical trial must:

  • be reviewed and approved by an Institutional Review Board (IRB), and
  • involve research and testing of treatment that targets a rare disease or condition.

When a person reports that income is received as compensation for participating in a clinical trial involving a rare disease or condition, request documentation that the clinical trial meets the requirements listed above.  

Clinical Trial is Approved by an IRB

Informed Consent Form

An "informed consent form" is a document that describes the rights of the clinical trial participant, includes details about the study (such as, purpose, duration, required procedures, risks, expected benefits and contact information), and is signed by the participant. Federal regulations require that IRBs must approve all informed consent forms; therefore, a copy of the informed consent form is acceptable proof that an IRB reviewed and approved the clinical trial.

Informed Consent Form Not Available

If an informed consent form is not available, accept an official letter from the administrator of the clinical trial. The letter must contain the name and location of the clinical trial, name of the disease or condition, and the name and contact information of the administrator. Use the information provided to locate the clinical trial in the ClinicalTrials.gov website. If the clinical trial appears on this website you may assume an IRB approved the study.

Clinical Trial Involves a Rare Disease or Condition

Review the documentation to determine if the study involves a rare disease or condition. Some commonly known rare diseases are Lou Gehrig's disease (amyotrophic lateral sclerosis), Crohn's disease, cystic fibrosis, cystinosis, Duchenne muscular dystrophy, Huntington's disease, and Tourette syndrome. The clinical trial meets the requirement if the documentation lists one of these diseases, or indicates that the study involves a rare disease or condition as defined in the "Orphan Drug Act".

MANUAL REVISIONS

[signed copy on file]

Michelle R.B. Saddler

Secretary, Illinois Department of Human Services 

Julie Hamos

Director, Illinois Department of HealthCare and Family Services