Ethical Standards

Question 0

History: Nazi War Crimes 1939-1945

Answer 0

Sterilization experiments–using harmful radiation, drugs in food
Vaccination for typhoid fever–wanted to see how typhus was spread.

Question 1

Role of an Institutional Review Board (IRB)

Answer 1

Composed of at least 5 members, male and female, variety of disciplines, one person unaffiliated with institution.

Purpose: Ensure that the rights of research subjects are protected.

Question 2

History: US Public Health Services Syphilis Study at Tuskegee 1932-1972

Answer 2

Wanted to follow natural course of syphilis
400 African American men
No informed consent
“Special free treatment”
Didn’t give penicillin upon its discovery

Question 3

History: Willowbrook Study 1963-1966

Answer 3

School for “mentally defective persons”
Wanted to follow natural course of hepatitis
Children infected with hepatitis virus
Parents coerced to allow participation

Question 4

Jewish Chronic Disease Hospital Study 1963

Answer 4

Gave live cancer cells into patients who believed they were receiving a skin test

Question 5

Regulation: Nuremberg Code of 1947

Answer 5

Response to Nazi war crimes

Informed consent

Question 6

Regulation: Declaration of Helsinki (1964)

Answer 6

12 principles; 1 stated that independent review of research protocols by persons not associated with project is required (like an IRB)

Question 7

Regulation: Belmont Report (1978)

Answer 7

Governs all research funded by US govt.
Guiding principles:
1. Autonomy
2. Beneficence
3. Justice

Question 8

Elements of informed consent (11)

Answer 8

1. Purpose
2. Procedures
3. Risks
4. Benefits
5. Alternatives to participation
6. Confidentiality
7. Request for more information available
8. Refusal or withdrawal without penalty
9. Injury statement
10. Consent statement
11. Signature