Ethics in Research Flashcards
1
Q
Nazi War Crimes
A
Sterilization experiments, vaccination for typhoid fever
2
Q
US Public Health Services Syphilis Study (1932-1972)
A
- Purpose: follow natural course of syphilis
- No informed consent, false pretenses
- Penicillin available, not given
3
Q
Willowbrook Study (1963-1966)
A
- State school in NY for “mentally defective persons”
- Purpose - to follow natural course for hepatitis
- Children infected, coerced to allow participation
4
Q
Jewish Chronic Desease Hospital Study (1963)
A
- Injected live cancer cells, told it was a skin test
- Wanted to understand immune response to cancer
5
Q
Nuremberg Code of 1947
A
- First formal guidelines for conduct in research
- human subjects must voluntarily give consent to participate
6
Q
Declaration of Helsinki (1964)
A
- International code of ethics for biomedical research
- independent review of research protocols by committee of persons not associated with project
7
Q
Belmont report (1978)
A
- governs all research funded by US govt.
- 3 basic principles - respect for persons, beneficience, justice
respect for persons - autonomous agents understand risks and benefits to provide consent
beneficience - do no harm; minimize harm, maximize benefits
justice - fair and equitable treatment (equipoise)
8
Q
Institutional Review Board
A
- Purpose is to protect subjects, evaluate risks and benefits
- 5 people: both genders, one non-scientist, one non-employee
9
Q
Informed Consent Document
A
- Purpose of Project
- Procedures
- Risks
- Benefits
- Alternatives to Participation
- Confidentiality
- Request for More Information
- Refusal or Withdrawal
- Injury Statement
- Consent Statement
- Signatures
