Compensation for Participating in Clinical Trials

The first $2,000 per year of compensation received by the client and/or his/her spouse for participating in clinical trials for rare diseases or conditions is exempt as property.

The trial must meet all of the following criteria in order for the exclusion to apply:

  • It must be reviewed and approved by an Institutional Review Board (IRB).
  • It must involve research and testing of medical treatments.
  • It must target a rare disease or condition.

Verification

The Informed Consent Form

The Informed Consent Form is can be used as verification and must be requested from the clinical trial participant. If the participant does not have the informed consent form, instruct him or her to obtain a copy from the clinical trial administrator.

Note: Some clinical trial participants may submit an official letter from the administrator of the clinical trial which provides all the relevant information of the informed consent in a summarized format. This letter can be used in lieu of the informed consent form.

Department of Human and Health Services (HHS) regulations dictate that IRBs must approve all informed consents; therefore, an informed consent form can be accepted as a proof that an IRB reviewed and approved the clinical trial.

If the informed consent form is unavailable, request any of the following information from the clinical trial participant:

  • Name and location of the clinical trial,
  • Name of disease or condition, or
  • Name, phone, and address of the clinical trial administrator.

Use the information provided by the participant to locate the clinical trial in the http://clinicaltrials.gov website, a registry of federally and privately supported clinical trials conducted in the United States and around the world. It provides information about a trial's purpose, who may participate, locations, and phone numbers.

If the clinical trial appears in the website, assume it is IRB approved. All clinical trials in the United States, involving human subjects, must meet federal regulations by having an IRB review and approve the research.

Once it is established that clinical trial is approved by IRB, look for the following details in the clinical trial information to determine if the clinical trial meets the other two exclusion requirements:

Name of the condition, and
Type of clinical trial, which is usually listed under the primary purpose, the title, or stated in the purpose summary.

Follow the instructions in this table:

Clinical Trial Property Rules

If... Then...
The clinical trial does not involve research and testing of treatments,  The property exclusion does not apply.
The clinical trial involves research and testing of treatments,

Verify whether the clinical trial targets a rare disease or condition.

Some commonly known rare diseases are Lou Gehrig’s disease, Crohn’s disease, cystic fibrosis, cystinosis, Duchenne muscular dystrophy, Huntington’s disease and Tourette syndrome. For more comprehensive list visit the Office of Rare Disease Research database at: http://rarediseases.info.nih.gov
The clinical trial does not target a rare disease or condition,  The property exclusion does not apply.
The clinical trial targets a rare disease or condition,  The property exclusion applies.

Related Topics

Property Limits