2. BACKGROUND
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The practice of medicine, in keeping with its status in society, was always of a paternalistic nature.
Doctors listened to patients’ complaints, examined them, ordered laboratory investigations, diagnosed
the disease, prescribed medication, and prognosticated the course and outcome. Patients were expected
to follow their advice.
The late 20th century saw substantial changes in medicine. Rapid advances in technology and its
application in medicine necessitated subjecting patients to complicated interventions.
Informed consent has been traced, or rather projected into the past, to the Hippocratic Oath.
The process started as a reaction to the numerous human research experiments carried out without
the consent of the patient in the 20th century
Freedom, dignity, telling the truth, keeping promises and justice became central to the patient–
physician relationship. The individual’s ‘right to know’ undergirded the contractual model.
Thus, Informed Consent soon became the standard. It was based on the moral and legal principles
related to the patient’s autonomy and the arguments associated with this. It demanded the disclosure of
information by doctors and intellectual capacity and voluntary decisions on the part of patients.
3. DEFINITION
◈ Informed consent is a process that’s required for most medical procedures. However,
there’s often confusion about what informed consent is, what it means, and when it’s
needed.
◈ In a healthcare setting, informed consent allows you to participate in your own medical
care. It enables you to decide which treatments you do or do not want to receive.
◈ Also, informed consent allows you to make decisions with your healthcare provider.
This collaborative decision-making process is an ethical and legal obligation of
healthcare providers.
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4. The following scenarios require informed consent:
◈ Most surgeries
◈ Blood transfusions
◈ Anesthesia
◈ Radiation
◈ Chemotherapy
◈ Some advanced medical tests, like a biopsy
◈ Most vaccinations
◈ Some blood tests, like HIV testing
4 An informed consent agreement
should include the following
information:
Diagnosis of your condition
Name and purpose of treatment
Benefits, risks, and alternative
procedures
Benefits and risks of each
alternative
PROCEDURES: INCLUDES:
With this information, you can make an educated choice about the procedures you receive.
5. WHY DO YOU NEED TO SIGN A CONSENT FORM?
◈ When your healthcare provider recommends specific medical care, you can agree to all of
it, or only some of it.
◈ Before the procedure, you’ll have to complete and sign a consent form. This form is a
legal document that shows your participation in the decision and your agreement to have
the procedure done.
When you sign the form, it means:
◈ You received all the relevant information about your procedure from your healthcare
provider.
◈ You understand this information.
◈ You use this information to determine whether or not you want the procedure.
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6. CAN OTHERS SIGN A CONSENT FORM ON YOUR
BEHALF?
◈ You aren’t of legal age.
In most states, if you’re younger than 18, a parent or guardian will need to give consent on
your behalf. But some states allow teens who are emancipated, married, parents, or in
the military to provide their own consent.
◈ You want someone else to make the decisions.
If you’d like to let another person make your future medical decisions, you can fill out a
form called an advance directive. This allows someone else to give consent on your
behalf if you’re unable to.
◈ You can’t give consent.
Another person can make your medical decisions if you can’t provide consent. This may
happen if you’re in a coma, or have a condition like advanced Alzheimer’s disease.
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7. CONSENT FORM IN INDIA
In India, informed consent has become a serious issue only in the litigation-prone private
healthcare sector.
Consequently, it is based on legal considerations and not necessarily on ethical practice.
Today, the paternalistic culture which is deeply embedded in our healthcare system,
and which initially employed nondisclosure models of communication, uses full
disclosure models. This has become a form of defensive medical practice.
These are major challenges, which make the implementation of valid informed consent and
shared decision-making difficult in clinical practice. The complete lack of clinical
audits, continuing professional education and re-certification contribute to marked
variations and suboptimal practice.
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8. CONCLUSION
The challenge is to change the prevailing culture within medicine and healthcare.
There is a need for a serious review of the concerns related to informed consent
and shared decision-making. Patients and physicians facing such decisions in
everyday clinical practice also need to have a fair idea of these concerns.
The process of informed consent is necessary, but not necessarily sufficient for ethical
medical practice. Informed consent and shared decision-making will test the
limits of our understanding of biology and culture, and of humanity and life.
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