AB 542

This bill provides that reimbursement of certain patient-incurred expenses

related to participation in a cancer clinical trial will not be considered undue

inducement to participate in a cancer clinical trial. Under the bill, 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, and 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 as a means to create parity in cancer clinical trial

access and remove a barrier to participation. The bill requires all sponsors of cancer

clinical trials to provide, during the informed consent process, potential participants

with information relating to the possible availability of reimbursement for certain

expenses. Under the bill, 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. The reimbursement entity or program

must also 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.