(a) A reimbursement under the program must:
(1) be reviewed and approved by the institutional review board associated with the cancer clinical trial for which the reimbursement is provided; and
(2) comply with applicable federal and state laws.
(b) The independent, third-party organization operating the program is not required to obtain approval from an institutional review board on the financial eligibility of a subject who is medically eligible for the program.
(c) The independent, third-party organization operating the program shall provide written notice to a subject on:
(1) the nature and availability of the ancillary financial support under the program; and
(2) the program's general guidelines on financial eligibility.