Amendment #3 to H4888

Increasing Access to Cancer Clinical Trials

Mrs. Kane of Shrewsbury moves to amend the amendment by adding the following section:-

“SECTION XX. Chapter 111 of the General Laws, as appearing in the 2018 Official Edition, is hereby amended by adding the following section:-

Section 238. (a) As used in this section, the following words shall 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) (i) 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.

(ii) The informed consent process should inform potential subjects if:

(A) Reimbursement for travel and ancillary costs is available to subjects based on financial need;

(B) Reimbursement of travel and ancillary costs is provided to eliminate financial barriers to enrollment in order to retain subjects in the clinical trial; and

(C) 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 must be reviewed and approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) 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 must be disclosed to subjects. The reimbursement process must conform to state and federal laws and guidance.”

Additional co-sponsor(s) added to Amendment #3 to H4888

Increasing Access to Cancer Clinical Trials