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

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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

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

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

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

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

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

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

Case-law US UK 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?

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

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