In 1972, Ralph Cobbs suffered a duodenal ulcer. He consulted his family physician who concluded he needed surgery. Dr Grant, a surgeon, was called in, and he agreed with the diagnosis. He gave an overview of the surgery and decided to do it but did not disclose the risks of the intended surgery. Cobbs consented to the operation.
During the operation, Cobbs’ spleen was injured and he needed a second operation to remove it. After, Cobbs developed a gastric ulcer. He needed a third operation in which fifty per cent of his stomach was removed. Cobbs was unaware that the incidence of a spleen injury during surgery to relieve a duodenal ulcer is approximately five per cent, nor was he informed that the development of a new ulcer is an inherent risk of the initial operation.
Cobbs filed a lawsuit against Dr Grant, alleging that he negligently performed the operation and that his failure to disclose the inherent risks of the initial surgery vitiated Cobbs’ consent to the operation.
After several trials and considering many constraints, the Supreme Court of California acknowledged that a “reasonable familiarity with the therapeutic alternatives and their hazards is necessary to enable the patient to make a knowledgeable decision, thereby making reasonable disclosure of the available choices concerning proposed therapy part of the physician’s obligation to the patient.”
‘Cobbs v Grant’ is one of the many popular informed consent cases. Informed consent is one patient’s right that is commonly misunderstood or trivialized. Indeed, consent is often given but is it always informed?
What exactly is Informed Consent?
Informed consent is both an ethical and legal obligation in which healthcare providers educate patients about the risks, benefits, and alternatives of a procedure or intervention. This requires competent patients to voluntarily make educated medical decisions. This consent is obtained after patients/participants have had enough time to review a consent document and have all their concerns addressed.
Informed consent means you are capable of making voluntary and informed medical decisions after fully understanding the intended procedure, its risks, benefits and alternatives. Therefore, physicians must not manipulate, cajole or attempt to persuade patients to give consent under any circumstance.
“Every human being of adult years and sound mind has a right to determine what shall be done with his body, and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages.”
-S.C. Justice Benjamin Cardozo (1914)
How is Informed Consent achieved?
Obtaining informed consent is a process that includes:
1. A Proper Description of the Proposed Procedure or Intervention.
Healthcare providers are obligated to meticulously discuss the patient’s health condition and the intended treatment with the patient.
2. Discussing Risks and Benefits
The process of obtaining informed consent (or an informed consent form) must describe the potential risks to the patients. Fully detailed descriptions of risks that can overwhelm patients may not be given, but information on risks that are severe or almost certain must always be included.
Also, the description of the intended benefits should be clear and based on reliable information. It should be sincere and not overly optimistic.
3. Discussing Alternatives to intended Procedures
Patients should be informed of appropriate alternatives, if any, that might be beneficial to them.
4. Confidentiality and Disclosure
The consent process must describe the extent to which confidentiality of the patient’s records will be maintained and should identify entities who may gain access to the records.
5. Emphasizing the patient’s role in the decision making
After assessing and determining that a patient is capable to make decisions, it is required that they be informed that they may decline the proposed procedure or stop participation at any time.
In essence, consent obtained from a patient by manipulation, under the influence of anything that alters the normal function of the mind or body, from an unstable/insane person, or without disclosure of reasonable information about the treatment proposed, is not acceptable as an informed consent.
When is Informed Consent obtained?
Informed consent is required in the following situations:
- Clinical trials involving human beings
- Most surgeries
- Advanced medical tests
- Most vaccinations
Informed consent is a function of how capable and willing a patient is to make decisions. This implies there are situations where consent may not be directly obtainable.
Does this mean someone else can give consent for a patient?
Yes! There are cases where a patient cannot give consent and it is acceptable for certain qualified persons to make decisions on their behalf. In some instances, the court is called to formally repose such powers in a third party.
Exceptions to Informed Consent
a. Incapacitated Patients
In a situation where a patient is in a coma or has a condition where his cognitive skills are offline, another person can help make medical decisions.
b. Life-threatening Emergencies
In emergencies where patients can not make decisions and there is no surrogate to make a decision, doctors usually proceed with life-saving treatment till consent can be obtained.
c. Voluntary Waived Consent
If a patient wants someone else to make decisions on their behalf, they can fill out a form that allows the third party (durable power of attorney for healthcare or a surrogate) to give consent when necessary.
d. Underaged Patients
Patients that are not of legal age (usually 18) need parents or guardians to give consent on their behalf. However, this does not apply to underaged patients that are married, parents or in the military.
Why is Informed Consent Important?
- It gives patients full details of their proposed treatment and gives them a choice to accept or refuse it.
- It creates trust and understanding between doctors and their patients.
- Once sufficient details about the risks of a procedure are discussed and understood, patients get to make the best choices for them, and healthcare providers face lesser risks of legal action.
It is well within your rights as a patient to be informed and given a choice about your medical decisions. You have a right to accept or refuse specific medical procedures.
If you ever have questions about your treatment as a patient, it is your right to ask and be enlightened. Also, it is your obligation as a healthcare provider to disclose the necessary information about a proposed treatment to your patients. This reduces risks for both parties.
It is important to reiterate that although consent is mostly required, informed consent is crucial. If a patient agrees to a procedure without being informed, warned or advised, the patient’s consent is ineffective.
1. Barry B. Novack “Informed Consent and the P Informed Consent and the Patient’s Right to No: Cobbs v o No: Cobbs v. Grant”
Loyola of Los Angeles Law Review (1973)