INFORMED CONSENT.
Dr. Nick Neave
(Chair of PSS Ethics Committee)
nick.neave@northumbria.ac.uk
Some Background...
• The Hippocratic Oath.
• Hippocrates, often described as the
‘father of medicine’ is famous for the
‘Hippocratic Oath’ – a set of laws for
defining good medical practice and
morals.
• It set out the duty of the doctor to
respect life and to do the best for one’s
patients.
• Most modern medical schools use a
modernised version written by Dr
Louis Lasagna.
• Currently there is no such oath for
scientists!
Hippocrates of Kos
(ca 460 BC–ca 370 BC)
Nazi Human Medical Experiments
• In the concentration camps Nazi
doctors conducted horrific
experiments on inmates for
‘medical science’.
• These included deliberate
exposure to nerve gases and
biological agents .
• Notorious ‘research’ involved
immersing inmates into icy water
wearing flying uniforms to mimic
a crash landing at sea.
• The inmates were forced to stay
in the water until they froze to
death or drowned – the data was
then used to improve Luftwaffe
pilot survival.
A cold water immersion
test at Dachau
The Nuremberg Trials.
• The ‘Nuremberg trials’ were held between 1946-49 in order
to bring to justice Nazi war criminals.
• One of the trials was called ‘The Doctors Trial’ where 20
doctors and 3 Nazi officials were accused of being involved
in human experimentation in the concentration camps, and
in conducting euthanasia programmes in hospitals and
nursing homes.
• In their defence the doctors argued that there was
currently no
international law dealing with medical
experimentation.
• As a result Leo Alexander and Andrew Conway Ivy drafted
the ‘Nuremberg Code’ a 10-point list calling for voluntary
consent, avoidance of unnecessary pain and suffering etc
Tuskegee Syphilis Experiment.
• Between 1932-1972 , the US Public Health Service conducted
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a study on syphilis in African-American males in Tuskegee
Alabama.
They recruited 399 impoverished males who had the disease,
to study the effects of various treatments.
In 1940 a cure for syphilis was found (penicillin) and by 1947
this was the standard treatment.
The researchers continued with the study and withheld
treatment in order to study the effects of the disease.
In 1966 Peter Buxtun, a disease investigator, raised his
concerns as to the ethics and morality of the Tuskegee study,
but the Center for Disease Control successfully argued for the
study to continue until all the ‘volunteer’s had died.
Buxtun went to the press and the scandal broke in 1972,
there were 5 survivors.
‘Declaration of Helsinki’.
• The ‘Declaration of Helsinki’ was adopted in 1964 by the
World Medical Association as a set of ethical principles
covering human experimentation.
• It was the first key attempt by the medical community to
regulate research activities and was based on the
‘Nuremberg code’ established in 1947 in light of Nazi and
Japanese medical experimentation.
• It has undergone several revisions and clarifications, the
most recent revision took place in 2008.
• It is widely regarded as the cornerstone document of
human research ethics.
Key Articles from the ‘Declaration of
Helsinki’.
• The fundamental principles are:
• ‘Respect for the individual’ (Article 8).
• ‘The right to self-determination’ and the right to make
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‘informed decisions’ (Articles 20-22).
The duty of the researcher is towards the patient or the
volunteer (Articles 2,3,10,16,18).
The welfare of the participant must take precedence over
the research (Article 9).
Individuals or groups who are deemed to be ‘vulnerable’
require special vigilance (Article 8).
Even if consent is granted by someone else legally
permitted to give it, the individual must still give their
assent (Article 25).
Protecting Research Participants.
• In General you should:
• Avoid harming participants (psychologically as well as
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physically).
Avoid personal misconduct.
Show due concern for issues of diversity and equal
opportunity.
Ask participants about any factors that might lead to their
harm and inform them of any actions they should take to
minimise this.
Refrain from using financial compensation or other
inducements to risk harm beyond that which they face in
their normal life.
Inform participants of their right to withdraw without
prejudice.
Inform participants that they may decline to answer any
questions.
Privacy and Confidentiality.
• You should at all times maintain standards of
privacy and confidentiality:
• Maintain appropriate records.
• Disclose information appropriately.
• Store confidential information in accordance with
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the Data Protection Act.
Only make audio/video /photographic recordings
or take bodily fluids from participants with their
explicit consent.
The Participant Information Sheet.
• This should provide the individual with all of the information they
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will need to make an informed judgement about whether or not to
take part. Eg:
Clearly state any exclusion criteria.
Describe the process clearly, give an approximate idea of how long
it will take, and whether it will involve any physical or personal
discomfort.
Mention any payments or incentives.
Mention any invasive techniques (e.g. blood samples).
Explain how confidentiality will be maintained.
Explain how the data/information might be used in the future.
Clearly state how the person can withdraw from the project.
Provide contact details (preferably email).
Avoid jargon – ensure that anyone can read and understand it.
See example
So, consent should be:
• 1. VOLUNTARY: The decision to take
part in a research study should be
made by the individual without any
undue coercion or inducement.
• 2. INFORMED: The decision to
participate in a research study should
be made only after sufficient
information has been provided that
would make that decision ‘informed’.
• 3. WRITTEN: Participants should give
their informed consent in writing.
However, if they are unable to do so
then they may give their oral consent
in the presence of an independent
witness.
Informed Consent.
• You should:
• Ensure that participants are given sufficient opportunity to
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understand the nature, purpose, and possible consequences of
their research participation.
Obtain written, informed consent.
Keep adequate records of when, how, and from whom, consent
was obtained.
Ensure that where an individual cannot provide consent, then it
should be obtained from others legally permitted to provide it (e.g.
parents, doctors).
Take particular care when seeking informed consent from
individuals who may be pressured to consent by their environment
(work place, prison, school etc).
Restrict research based on observations to those situations in
which individuals being studied would reasonably expect to be
observed by strangers (unless they have consented).
Avoid intentional deception unless it is necessary to preserve the
integrity of the research.
Debriefing.
• You should:
• Fully debrief participants at the conclusion of their
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participation in order to inform them of the outcomes and
nature of the research, and to provide them with contact
details so that they can subsequently withdraw their data.
Take particular care when discussing outcomes as
seemingly evaluative statements may carry unintended
weight.
Inform participants when evidence is obtained of a
psychological or physical problem of which they are
apparently unaware.
Exercise caution when responding to requests for advice
from participants concerning psychological / physiological
/ emotional issues.
See example