Written consent for the treatment
According to medical regulation in some countries, a written consent has to be
signed by the patient before the start of the first treatment. This consent has to
contain the following points:
a. Clear capacity (or ability) to make the decision.
b. The medical provider must disclose information on the treatment,
test, or procedure in questions, including the expected benefits
and risks, and the likelihood (or probability) that the benefits and
risks will occur.
c. The patient must comprehend the relevant information.
d. The patient must voluntarily grant consent, without coercion or
duress.
Doctors must give information to the patients about a particular treatment or test
so that the patient can decide whether or not they wish to undergo the
treatment or the test. This process of understanding the risks and benefits of
treatment is known as informed consent. It is based on the moral and legal
premise of patient autonomy: Patients have the right to make decisions about
their own health and medical conditions.
• The patient must give their voluntary, informed consent for the
treatment and for most medical tests and procedures. The legal term for
failing to obtain informed consent before performing a test or
procedure on a patient is called battery (a form of assault).
• For many types of interactions (for example, a physical exam with your
doctor), the implied consent is assumed.
• For more invasive tests or for those tests or treatments with significant
risks or alternatives, you will be asked to give explicit (written) consent.
• Under certain circumstances, there are exceptions to the informed
consent rule. The most common exceptions are these:
I. An emergency in which medical care is needed
immediately to prevent serious or irreversible harm.
II. Legal incompetence in which someone is unable to
give permission (or to refuse permission) for testing or treatment.
For clear orientation the FDA (USA) and MHRA (UK) guidelines for written consent
are attached in Appendix 7.
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