(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 patientsubject 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 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 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.
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