Informed Consent for Treatment of Mesothelioma Cancer
Informed Consent is the term used to describe the communication
between health providers and patients, particularly in clinical
trials for new treatments. Informed Consent laws vary greatly from
state to state, and also according to the specific case. In many
states, Informed Consent laws may be more stringent in cases that
involve experimental treatment. Additionally, some informed consent
laws require written documents, while others do not.
Most laws require that patients be physically and mentally capable
of understanding their condition and the ramifications of the proposed
treatment. Therefore, in cases where the patient is unable to give
their consent, the legal guardian of the patient makes treatment
decisions for the patient. In the case of minors, parents are involved
in any Informed Consent issues.
The primary purpose of informed consent is for the patient to have
a complete understanding of their treatment, the possible risks
of treatment, and the long term consequences of treatment. The goal
is for the patient to have reasonable expectations of the effectiveness
of treatment, and to understand any possible limitations there may
be. As with nearly all cancer treatments, there are usually significant
side effects that must be discussed and understood, as there may
be instances where patients may find possible side effects too severe
when compared to the potential benefits.
Costs associated with treatment are also a major factor when considering
possible treatments. Some patients may need time to determine the
financial impact. Additionally, the treatment itself may have logistical
issues that the patient might want to consider. Certain treatments
may be too draining for some patients, who may prefer to spend their
time and energy with friends and family.
With Informed Consent, patients are given alternative treatment
options as well, helping to give them a full perspective on their
available options. Although offering alternative options is a part
of Informed Consent, many doctors encourage patients to independently
research and explore all their options.
Informed Consent does not stop after the initial pre-treatment
dialogue. The process of Informed Consent is ongoing, which is essential
because patients may change their feelings about a treatment during
the clinical trial. These trials are highly regulated, including
by the FDA, which has many regulations applicable to trials regardless
of whether they have received federal funding. Additionally, many
hospitals have Institutional Review Boards that monitor and regulate
the clinical trials conducted under their supervision. Clinical
trials may also be subjected to peer reviews prior to patient trials.
All of these measures are part of the Consent process, and help
ensure that the trials run smoothly and safely.
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