Research Methodology 1: Ethics

Question 1

Outline some key history events in terms of research ethics.

Answer 1

• 1932-1972 Tuskegee Syphilis Study – effects of untreated syphilis in 400
African-American men
• 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
• 1939-1945 Second World War
• Intense period of research on topics e.g. eugenics, effects of radiation
• Germany and US carried out research involving human participants without
information or consent
• 1947 The Nuremberg Code for research on Human subjects. Used in
Nuremburg Trials following 2WW

Question 2

outline some key points of the nuremberg code 1947

Answer 2

Required is the voluntary, well-informed consent of the human subject
It should be based on previous knowledge that justifies the experiment
The risks should be in proportion to (and not exceed) the expected humanitarian benefits

Question 3

outline some events that still happened despite nurember

Answer 3

• 1955-1970 – Willowbrook Hepatitis experiments on children living
in residential care with mental health problems/learning disabilities
• Intentionally infected children with hepatitis and observed progression
• Experiments approved by New York Department of Health
• 1950s -1963 – CIA administers LSD to unwitting human participants
• 1964 – Helsinki Declaration: Ethical Principles for research involving
human participants (most recent revision 2013)

Question 4

What is the basic principle of the declaration of helsinki? (3)

Answer 4

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.

Question 5

which studies require ethical approval?

Answer 5

• Studies involving human/animal participants
• Gathering novel data or information
• Creating knowledge that can be generalised beyond the participant
sample or setting

Question 6

what 6 factors should you consider when applying to the ethics committee?

Answer 6

1. Scientific rationale
2. methodology
3. Data protection
4. Safety and wellbeing
5. Vulnerability of group
6. Informed consent

Question 7

why do you need rigorous methodology?

Answer 7

• It is unethical to take up participants’ time with a study which will
not produce valuable results
• You must show you are adhering to an established methodology

Question 8

what does informed part mean in informed consent?

Answer 8

You will need a participant information sheet and a
method for allowing participants to ask questions and consider the
information

Question 9

what does consenting require

Answer 9

You will (typically) need a consent form to collect clear
written evidence of consent

Question 10

what should you consider for a vulnerable group?

Answer 10

If so, what will you do to reduce risks to these participants?
• Could the study induce psychological stress or anxiety, or produce humiliation, or
cause harm or negative consequences beyond the risks encountered in normal life?
• If so, what measures will you put in place to reduce the risk and support participant
safety and wellbeing?