(a) The program:
(1) must collaborate with physicians, health care providers, and clinical trial sponsors to notify a prospective subject about the program when:
- (A) the prospective subject consents to a clinical trial; or
- (B) funding is available to provide the program for the clinical trial in which the prospective subject participates;
- (2) must reimburse subjects based on financial need, which may include reimbursement to subjects whose income is at or below 700% of the federal poverty level;
- (3) must provide reimbursement for ancillary costs, including costs described under Section 15, to eliminate the financial barriers to enrollment in a clinical trial;
- (4) may provide reimbursement for reasonable ancillary costs, including costs described under Section 15, to one family member, friend, or other person who attends a clinical trial to support a subject; and
- (5) must comply with applicable federal and State laws.
- (b) The independent third-party organization administering the program shall provide written notice to prospective subjects of the requirements described under subsection (a).
(Source: P.A. 103-227, eff. 6-30-23.)