Informed Consent

Plan
Informed consent: the action of an autonomous, informed person agreeing to
submit to medical treatment or experimentation
o Conditions
o Exceptions
Two senses of informed consent
Key questions:
1) What is informed consent?
2) How can we ensure that informed consent is given?

Conditions
Informed consent has been given if and only if:
o The patient is competent to decide
Not a minor, not developmentally disabled, not mentally ill (i.e.
competent, autonomous more or less)
o She receives adequate disclosure of information
Physician-based standard (ie what the medical community thinks
is adequate)
Patient-based standard (reasonable person standard isnt
clear who counts as an average reasonable person and what
information he/she needs to know. We are all different have a
wide array of background information. It is difficult to judge)
Subjective standard (varies by a particular person by allowing
patient to ask whatever questions they want. Flaw: patient must
have background info in order to ask the appropriate follow up
questions. Especially when there is a sudden flow of info.

It is difficult to know how much information needs to be

disclosed? What kinds of information need to be disclosed? These
depend on:
Nature of the procedure
Risks involved
Expected benefits of treatment
Alternatives (including no treatment)

Informed consent has been given if and only if:

o The patient is competent to decide
o She receives adequate disclosure of information
o She understands the information
o She decides voluntarily (cant be manipulated by physician for example or
by being decived (emphasing risks and deemphasizing the benefits of
other treatments)
o She consents to the treatment (patient actively authorizes the treatment
and whatever that happens as a consequence I xx
 Exceptions
Obtaining informed consent not required:
o In emergencies (because time is of essence, person might be unconscious/
incompetent to decide. Patient cant get all of the information and consent
to the treatment so that it can be effective (most of the top critiera are not
met))
o In cases of waiver, the patients giving up right to informed consent (
o In cases of therapeutic privilege, withholding some information when
disclosure likely to cause harm (since it counteracts the concept of
informed consent unless its a sever kind of harm e.g. irrational fear of
antibiotics but they will die if they dont take it its okay to do this
otherwise its not)

What is informed consent?

Faden and Beauchamp distinguish two senses of informed consent:
o Sense1: genuine informed consent
A kind of action that may be performed by patients or subjects
o An autonomous authorization
o Sense2: effective informed consent
What needs to happen to meet social and legal requirements for
informed consent
o Varies between jurisdictions

You can have one without the other!

Plan
Sense1: genuine informed consent
Sense2: effective informed consent
1) What is (sense1) informed consent?
o Faden and Beauchamp: autonomous authorization
o Katz: joint decisionmaking
Which one is a better model?
2) How can we ensure that (sense1) informed consent is given?
o Katz: barriers to informed consent
o Brody: define (sense1) informed consent in a way that is easily translated into
legal (sense2) informed consent

What is (sense1) informed consent?

Faden and Beauchamp: informed consent is autonomous authorization
an informed consent in sense1 is given if a patient or subject with (1)
substantial understanding and (2) in substantial absence of control by others (3)
intentionally (4) authorizes a professional (to do an intervention) (p. 191)
(4) differentiates informed consent from others

o Authorization involves the transfer of ones own right to control ones body to
someone else
 So authorizer assumes some responsibility for whatever happens
as a consequence (this is a critical point ***)

Katz: informed consent as joint decisionmaking

o Physician and patient enter into a dialogue: physician reveals crucial
information, patient asks questions (brings biases- from physician)

o Faden and Beauchamp criticize this model

Katz wrongly equates informed consent with joint
decisionmaking they believe that you can have one without the
other and thus are not synonymous
His model not appropriate in research contexts informed consent is
necessary when someone agrees to be part of a research study and
informed consent criteria dont apply here (since the physian and
patient its blunt truth) while in a research its just whether or not
you want to be apart of a study more emphasis on the patients
decision really.)
Although the patient and physician may reach a decision together,
they need not. It is the essence of informed consent in sense1 only
that the patient authorizes autonomously; it is a matter of
indifference where or how the proposal being authorized
originates (pp. 191-92) i.e. it doesnt have to arise in a
conversation