18. Ethical issues in research

Question 1

Tuskegee Syphilis study (1932-72)

Answer 1

effects of untreated syphilis in 400 African American men who:
didnt know they were in a study
did not give consent
Mostly didnt know they had syphilis
didn’t get treatment even when penicillin became available

Question 2

1939-45 Second world war experiments

Answer 2

Intense period of research on topics such as eugenics, effects of radiation etc
Germany and US carried out research involving human participants w/o information or consent

Question 3

Nuremberg Code 1947

Answer 3

1. Voluntary well-informed consent of human subject
2. Experiment has to have positive results for society that can’t be gotten another way
3. Should be based on previous knowledge to justify experiment
4. Avoid unnecessary physical or mental suffering/injuries
5. can not imply risk of death or disabling injury
6. risks should be proportional and not more than expected humanitarian benefits
7. preparation and facilities must be provided to protect subjects against risks
8. Staff conducting experiments have to be fully trained and qualified
9. Human subjects must be free to quit immediately at any point
10. Staff have to stop experiment when they think continuing might be dangerous

Question 4

Willowbrook Hepatitis experiments 1955-1970

Answer 4

experiments on children living in residential care with mental health problems/learning disabilities

intentionally infected w hepatitis and observed progression

approved by New York Department of Health

Question 5

CIA LSD experiments

Answer 5

1950s-1960 CIA administered LSD to unwitting human participants

Question 6

1964 Helsinki declaration

Answer 6

ethical principles for research involving human participants (revised in 2013)

basic principles:
respect for individual, their right to self-determination and make informed decisions
participant’s welfare takes precedence over interests of science and society
ethical considerations have to take precedence over laws and regulations

Research should be subject to independent ethical review and oversight by a properly convened committee

Question 7

What studies require ethical approvals?

Answer 7

Studies involving human/animal participants
Gathering novel data or info
creating knowledge that can be generalised beyond the patient sample or setting