11.1 Humans as research subjects
- "research conducted with or about people, or their data or tissue."
- More sets of rules than animal research.
- Turning points was the development of the Nuremburg code after the Second World War.
- Direct response to the atrocities committed by some Nazis in the name of medical research, and is the basis of the Helsinki code that was subsequently adopted by medical researchers around the world.
11.2 Do we still need codes for human research?
- Stanley Milgram and Philip Zimbardo
- Both found that given the right set of circumstances, ordinary people will do things that are immoral or unethical, and even cruel.
- Milgram’s experiments are called collectively “studies of obedience and the individual”.
- Zimbardo’s main study is known as “the Stanford Prison experiment” because it was carried out at Stanford University in California.
The participants were not informed
about the experiment, the researchers
(they participated in the experiments, and in Zimbardo’s case were not controlled studies), and that researchers ran experiments in such a way that they harmed the participants.
11.3 Milgram’s 1963 study ‘Obedience and Individual responsibility’
- Asked to administer an electric shock of increasing intensity to a "learner" for each mistake made during the experiment.
- Sixty percent of the "teachers" obeyed orders to punish the learner to the very end of the 450-volt scale! No subject stopped before reaching 300 volts!
11.4 Zimbardo’s 1973 Stanford Prison Experiment
- how good people behaved in bad situations
- constructed a prison
- Volunteers were assigned roles as ‘prisoners’ or ‘guards’
- The guards did whatever they judged necessary to keep the prisoners in order.
- trial was aborted less than half way through its planned duration because of psychological damage to prisoners, such as depression, and sadism on the part of guards.
- no controls
- Zimbardo was not a neutral observer because he superintended the experiment, and that it does not enlighten us about behaviour because the volunteers were role-playing.
- Zimbardo’s work may help to explain events like those at Abu Ghraib, where US soldiers abused prisoners. It helps us to see why victims sometimes fail to take what seem to be obvious actions to improve their situation.
11.5 Drug trials
- We need drug trials.
- The general process for development of drugs involves years of pre-clinical testing with animals.
- Followed by clinical trials with human volunteers to determine safety, dosage, effectiveness, side effects and the consequences of long-term use.
- Cases in which volunteers have subsequently claimed that they were not adequately informed of the risks of a trial.
- Eg. pharmaceutical company Pfizer in Nigeria
- It is claimed that up to 50 of the 200 children treated died and that others suffered some severe side effects.
- One point at issue was whether Pfizer obtained adequate consent for the trial from the children or their representatives.
11.6 Informed consent
- Informed consent means that the subject has not merely had the aims, procedures, funding arrangements, and expected risks and benefits explained to them, but that they have understood those explanations and not been subject to any undue pressure.
- There was a time when prisoners were a popular source of volunteers for medical trials, but this practice came under attack because it was felt that there was undue pressure on prisoners to enlist as a volunteers.
- As a rule the informed consent, must be in written form and be signed by the participant or their legal representative