Protection of the Vulnerable: Declaration of Helsinki Flashcards
Define the Declaration of Helsinki.
This is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics.
When was the Declaration of Helsinki published?
What was used as a set of rules/an ethic by the medical profession before then?
1964
There was no official ethic/set of rules
What was the Nuremberg trial? What did this lead to?
A trial about the atrocities carried out but Nazi doctors during the second world war.
A draft of an ethic – the Nuremberg code
What is the Nuremberg code?
A set of research ethics principles for human experimentation set as a result of the subsequent Nuremberg trials at the end of the Second World War.
Why was the Nuremberg code not accepted?
Because it was deemed that informed consent was counterproductive for science/medicine (doctors could no longer do what they had been able to do in the past).
How many points does the Nuremberg code have and which is the most important?
10
“Required is the voluntary, well-informed, understanding consent of the human subject in a full legal capacity.” - i.e. informed consent is needed before enrolling patients in trials
Why was the WMA, the first international medical organisation, formed?
What did they create?
The World Medical Association was formed explicitly to correct the damage created to medicine by the Nuremberg code, so they wanted to reach a compromise to benefit the medical community and the public and create boundaries/an ethic for experiments. Also because there was still no formal international medical community.
The DoH
How many times has the DoH been amended?
When was the last time?
10 times
2013
“While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.”
What is the main goal of this?
Why is this problematic/contradictory?
To protect the subjects
Surely then you should never involve anyone in research? Taking part in research is usually not in anyone’s interest.
“In medical practice and in medical research, most interventions involve risks and burdens. Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.”
How could this be manipulated? Why does it contradict point 8 of the DoH?
This could be manipulated as - if it is important enough, there is no risk that is too high and so patients will sometimes be subjected to risk even if there is no benefit to them but there is benefit to future populations. It contradicts the other point which states that the goal of generating new knowledge should not take precedence over the rights of the subjects, and this point 16 will prevail in practice as it benefits science.
“Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation.”
Why is this problematic?
Research that is not scientific may present itself as scientific in order to be considered ethical/gain approval.
“For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative.”
How does this differ from the Nuremberg code?
Who may be considered a legal representative?
Informed consent isn’t an absolute requirement in the DoH unlike the Nuremberg code. You can do research without consent under certain circumstances.
A legal guardian, next of kin (who is not a legal guardian), or even a friend! Anyone who is willing to take responsibility for the choice of enrolling the person in the trial and take that responsibility from the doctor.
What is the problem with emergency research in terms of consent?
How is it solved in practice? (3)
Patients are often unconscious and can’t give consent, plus they are unlikely to be accompanied by a legal representative. You need to start the research immediately.
Potential solutions:
Opt out system
Professional legal representative
Consent waiver
Why are placebo control trials or non-treatment control trials unethical?
How is this remedied?
One group is being denied treatment – unfair/unethical as it causes harm to the control group.
By ‘head-to-head’ trials (best existing treatment is trialled against the experimental treatment).
When do “head-to-head” trials not have to be done? (3)
- Where no proven intervention exists
- Where it is necessary to determine the efficacy or safety of an intervention
- Where the patients will not be subject to additional risks of serious or irreversible harm
