Mission- to protect the rights and welfare of human re-
What is an IRB and what does it do for us
search subjects
Physicians communicate information that reasonable pa-
Informed consent tients need to know to make informed decisions about
their medical care
Yes consent can change- if a person consented to surgery
Can consent change? the day prior and then changed their mind, DO NOT PRE-
FORM SURGERY
Consent Scenario:
If the person is confident and in the right mind and has
An older patient is really sick and refuses care but their
decided to refuse treatment it stands
family wants them to have care what do you do?
- emergency situations
- personal health information
- for treatment, payment, or health care operation activi-
When can HIPPA be broken?
ties
- with the patients' informal permission
- national priority purposes
Professional judgement:
A child comes in needing care, the mother agrees to the The standard of care is to give the patient treatment
treatment but the father does not what do you do?
A persons ability to make a decision, the ability to utilize
information about an illness and proposed treatment op-
Capacity
tions to make a choice that is congruent with ones own
values and preferences
- face-to-face interview using a series of open-ended
questions
How is capacity assesed? - open-ended questions
- the interview is used to asses one of the 4 decision-mak-
1/5
, Medical Ethics Exam Review Questions and Answers Graded A+
ing abilities which include: understanding, expressing a
choice, appreciation, and reasoning
the ability of an individual to participate in legal proceed-
What is competence?
ings
How is competence determined? by a judge in a court of law
1. Purpose of the research
2. procedures to be followed
3. foreseeable risks or discomforts to the subjects
4. benefits to the subject or to others reasonably expected
5. alternative procedures or courses of treatment
6. How will confidentiality of the records identifying the
What are the basic elements of informed consent?
subject be assured
7. Compensation for the subjects time
8. Whom to contact for questions or for related injuries
9. Assurance that participation is voluntary
10. Assurance that the subject may discontinue participa-
tion at any time without a penalty
Nuremberg Code 1947
- Made informed consent a central requirement for ethical
research
- the purpose of biomedical research involving human
subjects must be able to:
Declaration of Helsinki
- improve diagnostic, therapeutic, and prophylactic proce-
dures
- understand the etiology and pathogenesis of disease
Declaration of Helsinki Continued
3 fundamental principles include:
What is the Belmont Report and its function?
- individuals are autonomous
2/5