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Liability Arising from Clinical Trials

FOUR NEW SQUARE LINCOLN’S INN. Liability Arising from Clinical Trials. Leigh-Ann Mulcahy. Porton Down. Research ethics. Nuremberg Code 1947 Declaration of Helsinki 1964 – various revisions – current one: 2000 Beecher (USA) & Pappworth (UK) Royal College of Physicians 1967

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Liability Arising from Clinical Trials

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  1. FOUR NEW SQUARE LINCOLN’S INN Liability Arising from Clinical Trials Leigh-Ann Mulcahy

  2. Porton Down

  3. Research ethics • Nuremberg Code 1947 • Declaration of Helsinki 1964 – various revisions – current one: 2000 • Beecher (USA) & Pappworth (UK) • Royal College of Physicians 1967 • ABPI Guidelines 1970 • Department of Health 1987

  4. Regulatory Context • Clinical Trials Directive (2001/20/EC) • Medicines for Human Use (Clinical Trials) Regulations 2004 • EC Commission Guidance • Good Clinical Practice Directive (2005/28/EC)/ ICH GCP Guidelines

  5. Bodies involved • Trial sponsor • Investigator • Ethics committees • Competent authority – in UK, MHRA

  6. Sources of civil liability • Negligence • Product Liability Directive/CPA • Contract • Human Rights Act 1998, Arts 2, 3, 8 (public authorities only) • Rylands v. Fletcher liability? • Trespass to the person – assault/battery

  7. Criminal liability for injury • Common assault/battery • Assault contrary to ss. 47, 20 and 18 OAPA 1861 • Administering a noxious substance contrary to ss. 23 or 24 OAPA 1861 • Any interference with bodily integrity is unlawful unless: (1) In excepted category & justified “for good reason in the public interest” AND (2) Consent

  8. Criminal liability for death • Unlawful act manslaughter • Requires a criminally unlawful act with risk of harm (e.g. assault) • Gross negligence manslaughter • Civil negligence • To criminal degree – jury question

  9. Regulatory offences • Section 49 Clinical Trials Regulations 2004 – offence to breach certain regulations • Section 50 – offence to provide false or misleading information to ethics committee or MHRA • Defence of due diligence • Penalties – fine/2 years imprisonment

  10. Case-law • US • Whitlock v. Duke University (1986) • In re Cincinnatti Radiation Litigation (1995) • Grimes v. Kennedy Kreiger Institute Inc (2000) • UK • Maddison Inquest (2004) • Pearce v. United Bristol Healthcare NHS Trust (1999) & Chester v. Afshar (2004) - move to US “informed consent” approach?

  11. Health Select Committee 2005 Criticisms of: (1) Limited information given to trial participants “….the information patients receive before they enter a trial fails to adequately disclose the risks they might incur….” (2) Exposure of participants to unacceptable risk

  12. Conclusions • Importance of informed consent (and ethics compliance?) • Aim to avoid negligence liability regardless of agreement to compensate • Greater risk - non therapeutic research; issues over competence/voluntariness • Note time limits – none for criminal liability; 6 years trespass to person

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