final Flashcards
the consent form establishes a person’s ——–
autonomy
in order for the patient to provide valid consent they must be fully informed about 6 things
- nature of ttt (investigation being proposed)
- why its needed
- how the procedure will be performed
- risks and benefits (SE)
- alternative ttts available
- likely success
when a dr requests consent from a patient, what are the 3 types of consent, and what are their legal substantiations
- written consent (MOST legally substantiated)
- oral consent (LESS legally substantiated) it ensures verbal consent is documented in notes
- implied consent (LEAST legally substantiated) best avoided where possible and may be misinterpreted by doctor.
which type of consent ensures verbal consent is documented in notes
oral consent
WHAT ARE THE CRITERIA TO BE MET FOR A CONSENT TO BE VALID
1- patient is fully informed
2- patient is competent
3- consent is voluntary
what factors determine patient capacity (competence) to provide an informed consent
-patient UNDERSTANDS and RETAINS relevant info
-patient weight PROS and CONS to make decision
-patient can communicate their decision to doc (talking, writing, signing)
what is the defenition of informed consent
- Documents describing a medical treatment or research project,
including proposed procedures, risks, and alternatives, that are to be
signed by an individual, or the individual’s proxy, to indicate his/her
understanding of the document and a willingness to undergo the
treatment or to participate in the research
Contrary to popular belief, informed consent is not required only
for research or experimental procedures
* Informed consent is required for any action that affects a person’s
———-
physiological, psychological, or moral integrity
Consent Form, Why?
- Avoiding malpractice
- Respecting patient’s rights
- Emphasizing patient’s autonomy
- Underlining importance of shareholding of patients in decisions
concerning their lives and health - Eliminating paternalistic culture
—— incorporate patient preferences, issues of QoL, and guesswork
Risks
HCPs usually have to tailor their disclosures on factors like ——-
urgency,
family members, patient’s capacity
Legally; ethical consent emphasis on
- Minimum requirements
- Documentation
- Legal protection for the HCP
A —– informed consent could be perceived by patients as a
‘technicality’
written
- The use of ‘decision aids’ could help close that gap
Spending few minutes to ask about the patient’s life; their
worries; priorities; concerns; and wishes
HCPs MUST not only be technically competent, but also morally
skilled
They must have a covenant relationship with their patients such
that treatments SERVE the patient’s wishes
Concordance in Consent
Concordance= decision‐sharing
* New model for sharing complex information
* A need to do more than what is legally required:
When is consent is an ethical requirement?
when there are major differences between treatment outcomes:
Likely complications are much greater for one treatment than another
Choice of treatment involves trade‐off between near and distant benefits
Apparent difference between outcomes is small, but actual options are quite distinct
Patient is more opposed to certain risks
Patient attaches special importance to certain outcomes
what are the Legal Requirements of a Consent Form
- Information
- Comprehension
- Freedom
Treatments that involves ‘physical trespassing’ requires consent
In healthcare, invading a person’s body without consent can be ground for litigation
Rectal and vaginal examination, procedures while the patient is unconscious require
explicit consent
Patients should be treated for what they consented for EXCEPT IN ——-
EMERGENCY
- In research, certain information might be
withheld from the patient, BUT the patient
must be informed that there will be
information that will be revealed only ——— (when?)
after
the research is done
what is the Most complicated and difficult requirement in ethical consent
If the patient can not understand, a ——- has to be nominated to
act for the patient
3rd party
The patient’s health must be taken in consideration, and the final
decision becomes —— decision
collaborative
The primary role of the physician‐researcher is ——- first
physician
* Participants in research (i.e. subjects) must not be worse off in
research than if using accepted therapy
whats another term for proxy consent
vicarious
statement
- Decision FOR the incompetent person must be made for the good of
the individual not the society at large
Choices that would benefit other people must not be considered
except when the proxy believes that these choices would have been
considered by the incompetent person
for example —-
infant with birth defect
can not be sacrificed by the family because of burden on the family, organ donation after death
what * Other persons can also be consulted with regard to proxy decision making
physicians,
religious individuals,
counselors
The assumptions is that people with close or blood bond (parent,
spouse, relatives) ought to look for the best of the patient. This assumption could be challenged when ——
when a decision that seems
un‐ethical or controversial is taken
-Intervening people are usually physicians and other health providers
* Examples: withdrawing or withholding life support
Exceptions to Requirements for Consent: caution
means?
- Patient waves the consent
Exceptions to Requirements for Consent
- Patient waves the consent: caution
- Patient delegates the consent
- Mental incapacity (requires proxy)
- Emergencies (except if at a previous time, the patient refused the
emergency treatment)
HCPs do not require a consent in case of an emergency except if —–
if at a previous time, the patient refused the
emergency treatment
what is therapeutic treatment
Patient must be made aware that consenting to a treatment may implicitly
involve agreeing to as sequence of other procedures, and what these might be
(also to other effects or situations: waking up on ventilator; sore throat after
intubation; etc)
statement
- The obligation to confer benefits and actively prevent and remove harms from
patients is important in pharmacy ethics. However, EQUALLY important is the obligation to assess or “weigh and balance the possible goods against the possible harms of an action”