{"data":{"id":"us-wi/wis.-stat.-146.348","jurisdiction":"us-wi","citation":"Wis. Stat. § 146.348","heading":"Reimbursement in cancer clinical trial programs.","body":"(1) In this section:\n(a) “Cancer clinical trial” means a research study that tests a new cancer treatment regimen on patients, including chemotherapy and other new treatments.\n(b) “Inducement” means paying a person money, including a lump sum or salary payment, to participate in a cancer clinical trial.\n(c) “Patient-subject” means a person participating in a cancer clinical trial.\n(2) All sponsors of cancer clinical trials shall provide potential patient-subjects at the time of the informed consent process the following information:\n(a) Whether reimbursement for travel and ancillary costs may be available to patient-subjects.\n(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.\n(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.\n(3)\n(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.\n(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.\n(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.\n(4)\n(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.\n(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.","path":["Chs. 145-160, Public Health","Chapter 146 Miscellaneous Health Provisions"],"source_url":"https://docs.legis.wisconsin.gov/document/statutes/146.348","current_through":"2023-24 Wisconsin Statutes updated through 2025 Wis. Act 247 (published 9-4-26)","vintage":"","retrieved_at":"2026-09-05T12:00:57Z","sha256":"3970b3b676bd204a862dc0e9f08f6019230debdf52eab105bc2e14ff5593de0e","source_id":"us-wi","stale":false,"prev":"us-wi/wis.-stat.-146.345","next":"us-wi/wis.-stat.-146.35"},"notice":"GroundRules: Original legal text. Not legal advice."}