Medical research carries risks for the subjects who take part. The subjects accept these risks, because they are interested in the area of the research and in the general good achieved by better medical knowledge. If the research is a clinical trial, there is also the chance, however random, of obtaining an effective new treatment. From time to time, things go wrong – a trial drug causes harm, an accident occurs, or a subject feels aggrieved – and the investigators may need to find money to redress the wrong. Indemnity involves both protection for the investigator (by various forms of insurance) and the payment to injured parties (if appropriate). This chapter examines these two aspects of indemnity, the first by notes for investigators on the insurance schemes and the second by showing the pathways by which a subject might claim financial compensation.

Forms of indemnity

Indemnity by the employing organisation

National Health Service (NHS) Staff and people who have paid or honorary contracts with NHS hospitals are covered by the NHS indemnity for clinical trials involving NHS patients. This scheme compensates for injury arising from negligence, for example, a failure to follow a research protocol, an accident caused by poor maintenance of a building or harm resulting from personal medical information falling into the wrong hands. In the re-organised NHS, the costs of a successful claim fall primarily on the employing NHS trust, which may have to borrow from the Department of Health to settle very large clinical negligence claims, unless it is a member of the Clinical Negligence Scheme for Trusts (CNST) run by the NHS Litigation Authority (NHSLA).