If the “informed consent form” is unavailable as evidence, request any of the following
information from the clinical trial participant:
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name and location of the clinical trial,
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name of disease or condition, or
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•
name, phone, and address of the clinical trial administrator.
Clinical Trials.gov provides key information about clinical trials in the United States, such as purpose
and contact information. Use the information provided to locate the clinical trial
in the Clinical Trials.gov website.
If the clinical trial appears in the Clinical Trials.gov website, assume 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.
To determine if the clinical trial meets the other two exclusion requirements, look
for the following details in the clinical trial information:
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•
type of clinical trial, which is usually listed under the primary purpose, the title,
or stated in the purpose summary; and
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Follow the instructions in this table:
IF:
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THEN:
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The clinical trial does not involve research and testing of treatments.
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•
The income exclusion does not apply.
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•
Proceed to document the clinical trial compensation using regular income counting
rules.
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The clinical trial involves research and testing of treatments.
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•
Proceed to verify whether the clinical targets a rare disease or condition.
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•
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.
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•
If 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.
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The disease or condition is not rare.
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•
The income exclusion does not apply.
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•
Proceed to document the clinical trial compensation using regular income counting
rules.
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The disease or condition is rare.
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•
The income exclusion applies.
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•
Proceed to document the clinical trial information, see instructions in SI 00830.735D.3. (in this section) for guidance.
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