research ethics

Question 1

why was the Tuskegee syphylis study unethical?

Answer 1

Participants did not know they were in a study
• No consent given
• Treatment withheld even when penicillin became available
• Most subjects did not even know they had syphilis

Question 2

what was the nuremberg code of 1947?

Answer 2

laid out 10 principles for human experimentation after the nuremberg trials of ww2

Question 3

what are the 10 points of the nuremberg code?

Answer 3

1. voluntary, well-informed consent of the human subject
2. The experiment should aim at positive results for society that cannot be procured some other way
3. It should be based on previous knowledge that justifies the experiment
4. The experiment should be set up in a way which avoids unnecessary physical or mental suffering or injuries
5. It should not be conducted when there is any reason to believe that it implies a risk of death or disabling injury
6. The risks should be in proportion to (and not exceed) the expected humanitarian benefits
7. Preparation and facilities must be provided to protect subjects against risks
8. Staff conducting experiments must be fully trained and scientifically qualified
9. Human subjects must be free to immediately quit the experiment at any point
10. Staff must stop the experiment at any point when they observe that continuation would be dangerous

Question 4

what ethical violations took place after the nuremberg code 1947?

Answer 4

1. 1955-1970 – Willowbrook Hepatitis experiments on children living in residential care with mental health problems/learning disabilities
2. 1950s -1963 – CIA administers LSD to unwitting human participants

Question 5

what was unethical about the willowwbrook experiments?

Answer 5

• Intentionally infected children with hepatitis and observed progression
• parents and children were not informed of the risks of the study
• a coveted space would be given to children if they participated- so parents didn’t have much choice
• consent form was not rigorous or detailed enough

Question 6

which experiments were approved by new york department of health?

Answer 6

willowbrook hepatitis trials

Question 7

what is the helsinki declaration?

Answer 7

• morally binding basic principles of research that should take precedent over any law of any country
• Created at the World Medical Association 18th General Assembly- 1964- most recent revision 2013

Question 8

what are the basic principles of the Helsinki declaration?

Answer 8

• Respect for the individual, their right to self-determination, and the right to
make informed decisions
• The participant’s welfare must take precedence over the interests of science and society
• Ethical considerations must take precedence over laws and regulations.
• Research should be subject to independent ethical review and oversight by a properly convened committee.

Question 9

which studies require ethical approval?

Answer 9

1. human/animal participants
2. Gathering novel data or information
3. Creating knowledge that can be generalised beyond the participant sample or setting

Question 10

which projects don’t require ethical approval?

Answer 10

1. service evaluations that are carried out to improve that particular service
2. clinical audits that compare service against benchmark

Question 11

where to register audit/ evaluation that involves the NHS?

Answer 11

NHS health research authority

Question 12

where to register audit/ evaluation that does not involve the NHS?

Answer 12

Research Governance and Ethics Committee (RGEC)

Question 13

things to consider when wanting ethical approval for a study?

Answer 13

1. scientific rationale
2. rigorous methods
3. informed consent
4. evaluate vulnerability of participating group
5. data confidentiality
6. researcher safety