Publication | Open Access
The legal status of clinical and ethics policies, codes, and guidelines in medical practice and research.
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2001
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Biomedical EthicClinical GuidelinesLawLegal StudyMedicolegal IssueResearch EthicsPatient RightsHealth LawSoft LawMedical LawBioethicsHealthcare EthicMedical PracticePublic HealthMedical StandardsHealth PolicyLegal EthicsEthical IssuesLegal PhilosophyLegal StatusMedical EthicsMedical MalpracticeInformed ConsentPatient SafetyClinical PracticeEthics Policies
Many areas of clinical practice and research involve complex, rapidly changing issues for which the law offers no guidance, so physicians and researchers rely on “soft law”—non‑legislative, non‑regulatory sources such as ethics policy statements, codes, and guidelines from professional or quasi‑governmental bodies. The article examines the legal status of soft law in medicine and research, tracing its evolution, creation, adoption, and court acceptance, while considering legal and ethical concerns about the weight of professional norms. The study examines how soft law instruments are created, adopted, and accepted by courts, and analyzes judicial approaches to these instruments. The authors find that courts adopt professional norms as legal standards of care in some contexts but not others, demonstrating that such practices and policies can become enforceable legal norms.
This article examines the legal status of "soft law" in the fields of medicine and medical research. Many areas of clinical practice and research involve complex and rapidly changing issues for which the law provides no guidance. Instead, guidance for physicians and researchers comes from what has often been called "soft law"--non-legislative, non-regulatory sources, such as ethics policy statements, codes, and guidelines from professional or quasi-governmental bodies. This article traces the evolution of these "soft law" instruments: how they are created, how they are adopted within the professional community, and how they become accepted by the courts. It studies the relationship between soft law instruments and the courts. It includes an examination of the approaches to judicial analysis used by the courts in theory and in practice. The authors then examine the jurisprudence to see how courts will adopt professional norms as the legal standard of care in some circumstances and not others. They consider the legal concerns and ethical issues surrounding the weight attached to professional practices and norms in law. The authors demonstrate how practices and policies that guide professional conduct may ultimately bear weight as norms recognizable and enforceable within the legal sphere.