1. (a) A reimbursement under the program at a trial site that conducts clinical trials must:

   1. (1) be reviewed and approved by the institutional review board associated with the clinical trial for which the reimbursement is provided; and
   2. (2) comply with applicable federal and State laws.
2. (b) The independent third-party organization operating the program is not required to obtain approval from an institutional review board with respect to the financial eligibility of a subject who is medically eligible for a clinical trial.

3. (c) The independent third-party organization operating the program shall provide written notice to a subject on:

   1. (1) the nature, availability, and scope of the ancillary financial support under the program; and
   2. (2) the program's general guidelines on financial eligibility.

(Source: P.A. 103-227, eff. 6-30-23.)