B Determining Clinical Trial Compensation

Program	Manual Section
All programs	MA606P

Procedures

Request the “informed consent form” from the clinical trial participant. This form provides most of the information needed to determine whether the income exclusion applies. When the participant does not have the informed consent form, ask him or her to get a copy from the clinical trial administrator.

NOTE An official letter from the administrator of the clinical trial, which provides all the relevant information of the informed consent in a summarized format, can be used in place of the informed consent form.

Follow the steps below when neither the “informed consent form” nor the official letter from the clinical trial administrator are available:

Step	Action
1	Request the following information from the clinical trial participant: The name and location of the clinical trial, The name of disease or condition, and The name, phone number, and address of the clinical trial administrator.
2	Use the information provided to locate the clinical trial in the ClinicalTrials.gov website. This website provides information about clinical trials in the United States, such as purpose and contact information. When the clinical trial appears in the ClinicalTrials.gov website, assume it is an IRB approved the clinical trial. All clinical trials in the United States involving human subjects must meet federal regulations by having an IRB review and approve the research.
3	Obtain the following information from the clinical trial information: Type of clinical trial, which is usually listed under the primary purpose, the title, or stated in the purpose summary; and Name of the condition.
4	Determine when payments are countable or excludable using the instructions below.

If...	Then...
The clinical trial does not involve research and testing of treatments	The income and resource exclusion does not apply.
The clinical trial involves research and testing of treatments	Proceed to verify whether the clinical trial targets a rare disease or condition. Some commonly known rare diseases are amyotrophic lateral sclerosis (Lou Gehrig's disease), Crohn's disease, cystic fibrosis, cystinosis, Duchenne muscular dystrophy, Huntington's disease, and Tourette syndrome. When the condition listed in the summary is not part of this list, and the documentation provided does not state the condition is a rare disease or condition, verify whether the Office of Rare Disease Research’s rare disease database lists the condition named in the informed consent form as a rare disease or condition.
The clinical trial does not target a rare disease or condition	The income exclusion does not apply.
The clinical trial targets a rare disease or condition	The income exclusion applies.