cost of the drug being tested and very rarely the direct
costs of participation by a patient-subject. There are often
significant expenses associated with enrollment in a clinical
trial that are not covered by the clinical trial site or
sponsor. These include travel expenses to and from the
clinical sites whether by air, car, bus, train, taxi or
public transportation along with the travel costs of parking,
car rental, gas, tolls and lodging.
(8) This disparity threatens one of the most basic
ethical underpinnings of clinical research, the requirement
that the benefits of research be made available equitably
among all eligible individuals.
(9) According to the National Cancer Institute, Cancer
Clinical Trials Resource Guide, some of the barriers
preventing individuals, with cancer or at high risk of
developing cancer, from participating in clinical trials are
direct and indirect financial and personal costs, including
travel.
(10) Some corporations, individuals, public and private
foundations, health care providers and other stakeholders are
hesitant to contribute to or accept funds from programs that
are organized to alleviate financial burdens faced by
patients who wish to participate in clinical trials and their
caregivers due to concerns that the United States Food and
Drug Administration or other Federal regulators would view
the payments made from those funds as prohibited inducements
for patients to receive the health care services provided
during clinical trials.
(b) Intent.--It is the intent of the General Assembly to
enact legislation to define and establish a clear difference
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