Individuals tend to participate in research for a variety of
reasons. Often it gives them a chance to access a medicine that is
not available on the market for prescription. In this instance it
is important to remember that the study is being performed to find
out if the drug is safe and effective. Therefore, some information
is unknown about the drug and it is considered experimental. Often
the process of collecting information in the study will allow your
doctor to find out more about your disease and the effects it has
on you. This may allow you to benefit from better treatment upon
completion of a trial. A trial may not be of direct benefit to
you, but the data gathered may be of help to other patients with
the same condition. Many patients derive satisfaction from knowing
that they are part of the effort to potentially reduce the
suffering of other people.
The patient’s rights and safety are protected in two important
ways. First, any physician awarded a research grant by a
pharmaceutical company or the National Institute of Health must
obtain approval to conduct the study from an Institutional Review
Board. The review board, which is usually comprised of physicians
and lay people, is responsible for examining the study’s
protocol
to ensure that the patient’s rights are protected and that the
study does not present an unnecessary risk to the patient. Second,
anyone participating in a clinical trial in the United States is
required to sign an “
informed consent
” form. This form details
the nature of the study, the risks involved, and what may happen
to a
patient in the study. The
informed consent
also informs the
patients that they have a right to leave the study at any time.
Brentwood Research Institute offers individuals the opportunity to
participate in innovative research programs. Once at our facility,
potential research participants are fully informed of the aims,
methods, risks and anticipated benefits of the studies. Full
informed consent
must be received prior to study participation.
All research is conducted under
Food and Drug Administration
guidelines, and the health and welfare of our patients is always
our primary concern.
Potential patients must meet specific eligibility criteria before
being entered into a
clinical trial
. Determination of eligibility
usually involves a physical evaluation, laboratory testing, and
other diagnostic tests, depending on the particular study. The
potential patient’s medical and psychiatric history is also
reviewed. Upon qualification, participants are eligible to receive
investigational treatment that would otherwise be unavailable to
the general public. All medical care and medications related to
the study are provided at no cost. Participants will receive
financial compensation for their time and effort which will vary
depending on the study and the level of participation. All
research is performed at our clinic/hospital on an inpatient or
outpatient basis.
Patients considering participating in clinical research should
discuss it with their physicians. They should also seek to
understand the credentials and experience of the individuals and
the facility involved in conducting the study.
If You Participate in a Clinical
Trial, There is No Cost to You:
You receive study
related medication and care at no-cost.
You receive monetary
compensation, depending on the study and level of participation.
No reports are made to
employers, schools or insurance companies. Our patient
information is
confidential
.
