Section 240: Reimbursement for travel and ancillary costs for cancer clinical trials
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/ma/part-i/title-xvi/chapter-111/240·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 240.
(a)As used in this section, the following words shall, unless the context clearly requires otherwise, have the following meanings:
''Cancer clinical trials'', research studies that test new cancer treatments on people, including, but not limited to, medications, chemotherapies, stem cell therapies and other treatments.
''Inducement'', paying a person money, including a lump sum or salary payment, to participate in a cancer clinical trial.
''Subject'', a person who participates in a cancer clinical trial.
''Travel and ancillary costs'', any reasonable costs incurred by a person in connection with their participation in a cancer clinical trial, including, but not limited to, travel and lodging expenses.
(b)(1) Reimbursement of a subject's travel and ancillary costs shall not be deemed an inducement or as exerting undue influence to participate in a cancer clinical trial.
(2)The informed consent process shall inform potential subjects if:
(i)reimbursement for travel and ancillary costs is available to subjects based on financial need;
(ii)reimbursement of travel and ancillary costs is provided to eliminate financial barriers to enrollment in order to retain subjects in the clinical trial; and
(iii)family, friends or chaperones that attend the cancer clinical trial treatments to support the subject are eligible for reimbursement of their reasonable travel and ancillary expenses.
(c)Governmental entities, study sponsors, public and private foundations, corporations and individuals may offer financial support to cover travel and ancillary costs through their support of third-party nonprofit corporations and public charities that seek to increase enrollment, retention and minority participation in cancer clinical trials.
(d)Reimbursement plans to cover travel and ancillary costs shall be reviewed and approved by a duly appointed institutional review board or independent ethics committee reviewing on behalf of a health care facility in conjunction with the review of the proposed cancer clinical trial. The nature of the support for travel and ancillary costs and general guidelines on financial eligibility shall be disclosed to subjects. The reimbursement process shall conform to state and federal laws and guidance.