Research Ethics - Medical Ethics

Research Ethics

·        Codes:

o  Nuremberg code:

§  Informed consent of subjects, and liberty to withdraw

§  Benefits to society (can‟t be got by other means)

§  Avoid unnecessary suffering and injury

§  Degree of risk not greater than potential benefit of problem to be solved

§  Only conducted by scientifically qualified persons 

o  Declaration of Helsinki: 1964, revised 1975. Main difference: required to be supervised by medically qualified person 

·        Experiments on people that won‟t benefit current patients 

o  If study not sound then won‟t answer questions Þ risk not worth it and waste of resources

o  Informed consent by participants 

o  Ensure study remains ethical in progress Þ „stop‟ criteria and monitoring of interim results 

o  „Therapeutic Research‟ a misnomer (although used in Declaration of Helsinki). In research, if the patient happens to benefit that‟s coincidental. Research subject gives up normal expectation of tailored treatment.

·        Placebos: 

o   „Equipoise‟: randomisation only ethical if there is justifiable uncertainty of merit between intervention and control – but reasonable possibility that the new treatment is better than placebo

o   Must be significant knowledge to be gained from a placebo trial

·        Implications of randomisation

o   Severs normal connection between patient and individually tailored treatment

o   Must be able to break the code if things don‟t go as expected

·        Investigator requirements:

o   Competence

o   Moral Character?  Hard to specify or enforce

o   Conflicts of interest:

§  Intrinsic: interested in gaining knowledge verses care for the patient

§  Extrinsic: funding, reputation

§  Clinical equipoise

·        Balancing harms and benefits:

o   Principle of non-maleficence 

o   Healthy problems: only very small risk acceptable. Problem of financial inducements (attract people to take too much risk?)

o   Extrapolation from healthy volunteers not always possible

·        Equitable subject selection:

o   Respect for people (informed consent)

o   Principle of justice (equal sharing of benefits and burdens) 

o   Vulnerable groups: reduced capacity to protect their own interests: eg incompetent, dying, minority groups, 3^rd world countries (but nothing in ethical codes to preclude their use – justification becomes harder as degree of risk and degree of vulnerability increases)

·        Therapeutic orphans:

o   = Drugs not licensed for some groups, eg: 

o   Children: difficulties of doing research on children. So package says “not recommended” ® informed consent issues for the doctor and patient 

o   Women: pregnancy and lactation, financial implications of teratogen testing

·        Problems with informed consent:

o   People often don‟t easily understand things like randomisation

o   People often reticent to ask questions

·        Role of Ethics Committees:

o   No statutory requirement for ethical review – but defacto requirement

o   Composition: Lay chairperson, 50% lay membership (following Cartwright)

o   Should journals publish research that hasn‟t undergone ethical review: 

§  For: if its sound, would deprive society of valuable information and would require the study to be repeated 

§  Against: journal editors should be ethical gatekeepers

·        Problems with Prof Greens cervical cancer experiment:

o   Poor study design but still approved

o   Consent not gained from patients

o   Study not monitored properly (should have been stopped due to evidence of harm)

o   Concerns of other doctors not acted on properly

·        Questions it raises:

o   To whom should the doctor be accountable: their own conscience, patients or colleagues 

o   Women were vulnerable, being examined by men Þ asymmetry of power exaggerated