Informed Consent

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

7) Cost

8) Who is involved in treatment (teaching hospital concerns)

9) Patient's role in procedure, recovery

10)Conflicts of interest

Informed Consent for Treatment

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 self-awareness

* 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

Informed Consent - Research on Human Subjects