Module232025

07/05/2025

Ethics Approaches

The two main ethical approaches: • Teleological: outcome-based, e.g., utilitarianism • “Reaches a good outcome for the many” • Utilitarianism is a form of consequentialism which considers whether an act is good or bad by its foreseeable outcome • Concern with risks and dangers denotes a broadly utilitarian outlook, primarily concerned with maximising benefit to the wider community • Deontological: duty or rule-based • “Something we must do, we are morally obliged to do” • Requires that we respect each person as an individual, rather than only as a member of the community • Unacceptable to sacrifice the rights or interests of individual research subjects for the greater good of society • Respect for persons as ends in themselves and not merely or exclusively as a means to an end; consent denotes choice

The Organisation for Professionals in Regulatory Affairs

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Ethics and Clinical Trials

Properly conducted, clinical trials can satisfy both major approaches

Teleological (utilitarian, consequential) • New drugs/devices should better (?) treat medical conditions • Subject safety is paramount, and subject to stringent reporting requirements • New drugs/devices will enable better understanding of diseases even if they don’t work

Deontological • We all have a duty to look for new treatments to alleviate suffering • The consent process ensures respect for trial participants • Ethics review process protects the interests of individuals over those of society

Do the deontological principles apply in paediatric research? Do children have such a duty? Can they shoulder such a duty? Children cannot consent –is parental permission sufficient? Is the ethics review process always adequate?

The Organisation for Professionals in Regulatory Affairs

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