Module232025

07/05/2025

What makes any research ethical?

Beauchamp & Childress: Principles of Biomedical Ethics. First published in 1979. Defines four “pillars” on which ethics are based: Respect for autonomy – the patient has the right to refuse or accept their treatment. Beneficence – a practitioner should act in the best interest of the patient. Non-maleficence – "first, do no harm". Justice – the distribution of scarce health resources, and the decision of who gets what treatment must be fair. Other values commonly discussed include: Respect for persons – the patient has the right to be treated with dignity. Truthfulness and honesty – the concept of “informed” consent See also Kamm’s ‘Principle of Permissible Harm’ theory 5 Clinical trials are intended to generate generalisable knowledge, so not all participants will benefit – and sometimes no-one will – but is this acceptable or unavoidable in paediatric research?

The Organisation for Professionals in Regulatory Affairs

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Respect for autonomy (self-determination)

Basic principle of international law and also a foundational element in statehood – pre-dates 1919 League of Nations Encompasses the right of peoples to freely determine their political status and to freely pursue their economic, social and cultural development Perennially problematic - not amenable to objective definition: it is self determined In medicine, autonomy requires physicians to accede to refusal of life saving treatment even where this will result in patient death (Do Not Resuscitate instructions) Best interests –vs– presumed will (risk of paternalism) 6 In research, children cannot consent, but can dissent – is that “autonomy”? Does parental permission = consent? Is this principle actually carried by parents/guardians?

The Organisation for Professionals in Regulatory Affairs

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