Sec. 10. Definitions.
297 words·~1 min read·
/il/chapter-410/act-416/10A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Sec. 10. Definitions. In this Act:
"Clinical trial" means
(i)a research study that subjects an individual to a new cancer treatment, including a medication, chemotherapy, adult stem cell therapy, or other treatment or
(ii)a voluntary research study conducted on people and designed to answer specific questions about the safety or effectiveness of a drug, vaccine, therapy, medical device, medical diagnostic, or new way of using an existing treatment to treat or diagnose a condition.
"Clinical trial sponsor" means a person, physician, professor, or researcher who initiates a clinical trial; a government entity or agency that initiates a clinical trial; or an industry, including, but not limited to, a pharmaceutical, biotechnology, or medical device company, that initiates a clinical trial.
"Condition" means a disease, disorder, syndrome, illness, or injury, including, but not limited to, cancer, cardiovascular disease, circulatory disease, infectious disease, digestive disease, musculoskeletal disease, nervous system disease, endocrinological disease, metabolic disease, mental health and behavioral disorder, blood disease, and rare diseases.
"Independent third-party organization" means an entity or organization, whether public or private, that is not a sponsor or host of a clinical trial, or that is not in any way directly affiliated with a sponsor or host of a clinical trial, and has experience in patient advocacy and direct patient reimbursement of clinical trial participation costs.
"Inducement" means providing a person something of value, including money, as part of participation in a clinical trial.
"Program" means the clinical trial participation program established under this Act.
"Subject" means an individual who participates in the program.
"Undue inducement" means the value of something received by a potential clinical trial research subject, which value is so large that it may reasonably cause the research subject to take risks that are not in his or her best interests.