(a) A reimbursement under the program at a trial site that conducts clinical trials must: (1) be reviewed and approved by the institutional review board associated with the 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 with respect to the financial eligibility of a subject who is medically eligible for a clinical trial. (c) The independent third-party organization operating the program shall provide written notice to a subject on: (1) the nature, availability, and scope of the ancillary financial support under the program; and (2) the program's general guidelines on financial eligibility. review board associated with the clinical trial for which the reimbursement is provided; and ancillary financial support under the program; and eligibility.
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