§ 146.348

146.348 Reimbursement in cancer clinical trial programs. (1) In this section:(a) 'Cancer clinical trial' means a research study that tests a new cancer treatment regimen on patients, including chemotherapy and other new treatments.(b) 'Inducement' means paying a person money, including a lump sum or salary payment, to participate in a cancer clinical trial.(c) 'Patient-subject' means a person participating in a cancer clinical trial.(2) All sponsors of cancer clinical trials shall provide potential patient-subjects at the time of the informed consent process the following information:(a) Whether reimbursement for travel and ancillary costs may be available to patient-subjects.(b) That coverage of the travel and ancillary costs is done to eliminate financial barriers to enrollment in order to retain patient-subjects in the cancer clinical trial.(c) Whether family members, friends, or chaperones who attend the cancer clinical trial treatments to support the patient-subject may be eligible for reimbursement of their travel and ancillary costs.(3) (a) Reimbursement of travel, ancillary costs, and other direct patient-incurred expenses related to cancer clinical trial participation

gible for reimbursement of their travel and ancillary costs.(3) (a) Reimbursement of travel, ancillary costs, and other direct patient-incurred expenses related to cancer clinical trial participation will not be considered an undue inducement to participate in a cancer clinical trial.(b) Reimbursement for travel and ancillary costs may not be considered coercive or as exerting undue influence to participate in a cancer clinical trial, but rather shall be considered a means to create parity in cancer clinical trial access and remove a barrier to participation for financially burdened patient-subjects.(c) Government, industry, public charities, private foundations and other nonprofit organizations, associations, corporations and other business entities, individuals, and any other legal or commercial entities may offer financial support to patient-subjects, or the family, friends, or chaperones of patient-subjects, to cover ancillary costs through their support of a reimbursement entity or program.(4) (a) Language informing patient-subjects that reimbursement entities or programs that cover travel, ancillary costs, and other direct patient-incurred expenses may be available must be

or program.(4) (a) Language informing patient-subjects that reimbursement entities or programs that cover travel, ancillary costs, and other direct patient-incurred expenses may be available must be submitted for review to the relevant federally designated institutional review board in conjunction with the review of a proposed cancer clinical trial and included in the informed consent form approved by the institutional review board.(b) A reimbursement entity or program must disclose the nature of the ancillary support and general guidelines on financial eligibility to interested patient-subjects and employ a reimbursement process that conforms to federal law and guidance.History: 2019 a. 150.