Liability Arising from Clinical Trials LeighAnn Mulcahy FOUR

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

Porton Down 2

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 3

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 4

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

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 6

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 7

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 8

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 9

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? 10

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 11

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