Informed Consent vs.
Informed Refusal
A) Informed Consent: For treatment
For research
1) voluntary and informed conditions __________________
___________________________
2) proxy consent

Informed Consent vs.
Informed Refusal
B) Informed Refusal
1) voluntary and informed conditions __________________
___________________________
2) proxy consent
3) advance directives: instructions living wills medical directives durable power of attorney for health care

Informed Consent vs.
Informed Refusal
Informed consent and informed refusal presuppose decision making capacity
Advance directives usually apply when there is no decision making capacity
The more serious the procedure, the higher the standards for information
Information standards are relative to the capacities of the patient
Consent vs. Assent

Informed Consent for
Treatment
1) Risks/Benefits
2) Alternatives (if no treatment?)
3) Second opinion
4) Competence of doctor, team, institution
5) Nature of procedure
6) Life after:
Recuperation, bodily, psychological changes

Informed Consent for
Treatment
7) Cost
8) Who is involved in treatment (teaching hospital concerns)
9) Patient's role in procedure, recovery
10)Conflicts of interest

Informed Consent -
Research on Human Subjects
1) Consent
Intentional, the result of deliberation
Free, without coercion
Authentic, from one's own values and desires
2) Conditions for Informed Consent
Information about:
* Nature of the research
* Therapeutic or non-therapeutic
* Risks
* Benefits

Informed Consent -
Research on Human Subjects
2) Conditions for Informed Consent (cont.)
Information about:
* Who's doing it, competence of investigators
* What will be done to subject
* Privacy and confidentiality of information
* Right to withdraw without penalty
* Provisions for adverse circumstances

Informed Consent -
Research on Human Subjects
2) Conditions for Informed Consent (cont.)
Information about:
* Amount and level of information is relative to the subject's ability to understand
* The greater the risk the higher the standards of information
* Are the standards different in therapeutic and non-therapeutic research?

Informed Consent -
Research on Human Subjects
3) Competence/Decision Making Capacity
Informed consent presupposes competence
Competence is determined in relation to the task at hand
Legal competence/moral competence
Conditions for competence:
* some degree of self-knowledge and selfawareness
* able to process information

Informed Consent -
Research on Human Subjects
3) Competence/Decision Making Capacity
(cont.)
Conditions for competence:
* able to comprehend information
* able to restate information in one's own terms
* able to act from stable set of values
* free from: acute anxiety acute depression denial

Informed Consent -
Research on Human Subjects
4) Obstacles to Informed Consent:
* Difference in the knowledge base of the doctor and patient
* Patients are compromised by illness, anxiety, etc.
* Language of probabilities is unfamiliar to lay-persons
* Takes too much time
* Some patients just don't want to know

Informed Consent -
Research on Human Subjects
5) Justification for Informed Consent:
* Respects autonomy/persons autonomy as a value autonomy as a goal
* Respects the right to control what happens to one's body
* Respects the right to control access to the self
* Promotes greater social goods

Informed Consent -
Research on Human Subjects
5) Justification for Informed Consent (cont.):
* Promotes trust between doctor and patient
* Reduces liability and malpractice claims
* Can be justified at least on utilitarian, deontological, and rights grounds, also on virtue ethics grounds