Informed Consent Flashcards
What is consent?
A voluntary acceptance of what is planned or done by another
Preserves the autonomy of patients to decide for themselves about their care
What is informed consent?
Consent that is voluntarily given after the patient has been informed of possible benefits, risks, and complications of treatment
It is a process of communication between a patient and physician that results in the patient’s authorization or agreement to undergo a specific medical intervention
Is informed consent more that just simply getting a patient to sign a written consent form?
Yes
We must make sure the patient is informed and understand everything discussed
What are the patient’s rights?
Have rights to know everything relevant to their treatment (we must assume they know nothing, so we have to explain everything)
The patient has the right to accept or refuse treatment (if there is a refusal, we should investigate further in order to discover why there was a refusal)
How much information is enough for informed consent?
There is currently no federal statute regarding informed consent to healthcare professionals
States are not uniform in their views of how much information should be disclosed
Each state has one or more informed consent statutes specific to that state
What are the three approaches to informed consent that states tend to adopt? (choose one)
Reasonable physician standard
Reasonable patient standard
Subjective standard
What is reasonable physician standard?
This approach allows the physician to determine what information is appropriate to disclose
This standard is considered inconsistent with the goals of informed consent as is focuses on the physician and not the patient
What is reasonable patient standard?
This approach considers more what the patient needs to know in order to understand the decision at hand
This approach tends to be the most popular
What is subjective standard?
Considers what this particular patient needs to know in order to make an informed decision
Most challenging approach because it requires tailoring information to each patient
Would probably be the most beneficial approach, but it is the least used
What are the two components of informed consent?
Information (discussion in layperson’s terms, must assess the patient’s comprehension of the information)
Consent (may be implied by patient’s willingness to accept harmless touching or treatment, must be expressed when treatment exposes the patient to harm)
What are common elements that should be included in all consent forms?
The diagnosis (the patient must fully understand their condition)
The nature and purpose of the proposed procedure (why it should be performed and what it involves)
Risks and consequences of the procedure
Assessment of the likelihood that the procedure will accomplish the desired objectives
Any reasonably feasible alternatives for treatment including the risks and benefits
The risks and benefits of not receiving treatment
What are other elements that a consent form should have?
Date and time of signature (documenting that the consent was obtained before the patient was under influence of pre-op meds)
Signature lines for the patient, clinician, and witness
Confirmation that the patient was given an opportunity to ask questions concerning the treatment (the patient should have ample opportunity to ask questions regarding the proposed treatment and have them answered)
Limitations of the treatment (patient may impose limitations based on religious beliefs)
Should the physician inform the patient of any research and/or economic interest unrelated to the patient’s health, where that interest may affect the physician’s medical judgment?
Yes
Example: A patient sought treatment for leukemia and it was recommended that the spleen be removed
The doctor then used the spleen for his research
He failed to disclose his research and economic interest to the patient
This requires informed consent
In this case it can easily be assumed that the doctor’s research interest possibly interfered with his recommendations to remove the spleen
What is the model health-care consent act?
Developed by the National Conference of Commissioners on Uniform State Laws
Goal was to promote uniformity in sate law
It is very narrow in scope and doesn’t provide a complete model to guide providers in how to structure consent forms
It is primarily focused on mechanisms for authorization of consent (who can consent, when are they capable of consenting, etc.)
What is the joint commission on accreditation of healthcare organizations?
Many healthcare organizations voluntarily seek accreditation from a recognized accrediting body such as this
Sets voluntary accreditation standards for healthcare organizations
What are the JCAHO ambulatory care standards?
It required that informed consent be obtained
Requires that the patient and family be given the info about the:
Patient’s condition
The proposed treatments, procedures or research
The potential benefits and drawbacks of proposed treatments
Problems related to recuperation
Alternative treatment or procedures
Physician or other practitioner primarily responsible for the patient’s care
Others authorizing or performing procedures or treatments
Any business relationships among individuals treating the patient or between any other healthcare service or educational institution involved in the patient’s care
What are the JCAHO office based surgery standards?
Very similar to ambulatory care
Patient and family should be given information about:
Patient’s condition
Proposed treatment, procedures or research
Potential benefits and drawbacks of proposed treatments
Post-treatment recuperation
Alternative treatments
Risks of no treatment
When blood components may be used and risks and alternatives
Surgeon responsible
Practitioner’s primarily responsible for sedation and anesthesia
Others authorizing or performing procedures
Any business relationship among individuals treating the patient
What is the american medical associations code of medical ethics?
Reflects the concepts of patient self-determination for treatment, accurate and full disclosure of relevant medical facts, and disclosure of therapeutic alternatives to the treatment being consented to
When is consent not required?
When the patient is unconscious or otherwise incapable of consenting and harm from failure to treat is imminent
When risk-disclosure poses such a serious psychological threat of detriment to the patient as to be medically contra-indicated
Do we have an ethical and legal obligation to inform our patients and obtain their consent?
Yes
What should you do if a mistake takes place?
State that you regret the incident took place
Describe the decisions staff made, including those in which the patient participated
Describe the course of events in nontechnical
language
Explain the nature of the mistake, its consequences, and any corrective action taken, including what you’re doing to prevent future mistakes
Elicit questions or concerns from the patient and
address them
Express personal regret again
