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

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 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?

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