Research Ethics Flashcards
What constitutes medical research?
Research vs audit vs experiments for teaching and learning
why is research a particularly worthy activity?
what are the virtues and qualities of a good researcher? how do these relate to ethical standards in science?
the dark past of research
ancient Egyptian prisoners may have been vivisection by Herophilus and Erasistratus
1916 chemical weapons testing on 25,000 servicemen at Porton Down
Tuskegee study in Alabama 1932-72
Nazi Germany
Nuremberg trials
harmful/lethal experiments on human captives
german doctors argued that others had conducted harmful research before, the greater food of the state during the war and that there were no agreed standards for human research
legislative journey to todays research standards
1949 Nuremberg code (consent, justification, design, avoiding harm, qualified scientists, end experiment is harm is caused or consent is withdrawn)
National research act public law of 1974 (IRBs in the USA)
1964 and 2008 WMA declaration of helsinki revised
1968 informal RECs established in the UK
1984 and 1990 - principal guidelines covering research int he UK issued by the Royal College of Physicians: require ethical review prior to research being carried out
1991 statutory provisions for LRECs (local REC) and MREC (multi-centre)
2009 IRAS - all human research in a public health and social care setting. UK wide system which is provided by the HRA on behalf of the IRAS partners. partners include: UK health departments, HFEA, NIHCRN
broad principles of research ethics
equipoise a clear purpose principle of benefit/least harm consent confidentiality justice
is research always required in order to be ethical?
would you do an RCT to determine how effective the Heimlich manoeuvre is?
why not? what would make an ethics committee allow an RCT? if a new treatment was developed which had the potential to be more effective/easier to use
are there double standards of consent in a research scenario?
Dr A sees patient B i the outpatient department. B is suffering from depression of a type likely to be helped by antidepressants. there are several slightly different antidepressants available. Dr A advises B to take a particular antidepressant (Drug X), based on her knowledge of B’s condition and other risk factors. she is however quite pressured for time and does not go into the risks and benefits of the alternatives. Drug X is also the cheapest drug of its class and therefore Dr A is encouraged to prescribe this as a first line medication by the hospital.
VS
an RCT is underway to compare to antidepressants, drug X and drug Y. although Dr A tends to prescribe drug X, on reflection she does not think there is good evidence to prefer X to Y. it could be important to establish their relative effectiveness. Dr A therefore agrees to ask suitable patients whether they would be prepared to take part in the trial. Dr A sees patient B in the outpatient department/ in order to conform to the RECs standards, Dr A must obtain valid consent for B to enter the trial. she just inform B about the trial and tis purpose. she must also inform B about both drugs and tell B that a random process will be sued to choose which will be prescribed.
People vulnerable to coercion
children those lacking liberty the foetus students the poor people in developing countries
on what grounds can published work be criticised?
fraud gift/ghost authorship plagiarism multiple submissions conflicts of interest
which guidelines should you choose in research?
official advice is that you should choose the more restrictive
Professor Steven Pinker
believes that the goal for today’s bioethics should be to restive the use of bioethics as much as possible.
he believes that biomedical research can offer vast increases in life, health and flourishing.
he believes that these principles outweigh the need for ‘dignity’ and ‘social justice’ etc in bioethics
how can RECs act more ethically?
JAMA 1992 - “advice on some life-saving therapies has bene delayed for more than a decade, while other treatments have been recommended long after controlled research has shown them to be harmful”
Chalmers suggested the following duties be imposed upon researches by RECs. Requiring researches to do a systematic review prior to commencement of their research, requiring researchers to publish their data, committee should seek advice on appropriate design of the proposed research
