When should you obtain informed consent?
Before all medical interventions that have potential harm including diagnostic and therapeutic procedures.
elements of informed consent
-Why are you doing the procedure?
-Other options available.
-Potential complications
-Consequences of not having the procedure
process of informed consent
-establish responsibility
-define the problem with the patient
-set goals for treatment (is a cure reasonable?)
-select a treatment approach
-sign the consent form
requirements for informed consent
-patient must be competent to make an informed decision
-patient must be given sufficient information about the treatment and alternatives
-patient must voluntarily give consent
patient capacity
assessing the patient's ability to understand the nature of the condition and various treatment options/outcomes and communicate an understanding of their decision
adult competence
deemed competent until legally declared otherwise
minor competence
deemed incompetent until legally declared otherwise
(exception: STDs and pregnancy)
PARQ
Procedure
Alternatives (to the procedure)
Risks (of the procedure)
Questions (about the procedure)
adequate information for consent
diagnosis, nature of procedure, risks/consequences/benefits
(PARQ)
reasonable physician standard of disclosure
Responsibility is limited to the disclosures that a health professional practicing in your community would make under the same/similar circumstances
reasonable person standard of disclosure
Disclosure of all facts, risks, and alternatives that a reasonable patient would consider important in deciding to have or not have a recommended procedure
subjective standard of disclosure
Addresses what "this particular patient" needs to know and understand in order to make an informed decision (most challenging to use)
voluntary choice
A "good faith" effort was made to avoid manipulation or coercion on the part of the provider.
*
recommendations are not considered coercion
*
implied consent
used when immediate action is required (ex: emergency department, blood work)
general consent
used as a "blanket" consent; does not list specific procedure, risk, benefits, or alternatives (ex: upon hospital admission)
special consent
used for specific high risk procedures and medical treatments
written consent
holds up better in court, preferred method, legally binding, may require a witness
verbal consent
difficult to prove, may require a witness, legally binding
components of a consent form
name, date/time, procedure (risks, indications, alternatives), indicates an opportunity for patient ask questions, witness signature
What do you do if a patient refuses treatment?
document and encourage signature of witness
emergency situation
informed consent not required if treatment is needed immediately to prevent serious/irreversible harm or death
incompetent patient
if the patient is unable to give consent, a surrogate/legal guardian must provide consent
waiver of consent
patient chooses to relinquish the right to informed consent to the health care provider or surrogate
public health requirements
informed consent not required if intervention has a potential benefit to community and patient
therapeutic privilege
informed consent not required if there is sufficient evidence that the patient is not psychiatrically or emotionally stable enough to handle information and may post serious/immediate harm to the patient