Participants in research: Patients in clinical trials are protected by consumer regulation

doi:10.1136/bmj.331.7508.110

BMJ 2005;331:110 (9 July), doi:10.1136/bmj.331.7508.110

Letter

Participants in research

Patients in clinical trials are protected by consumer regulation

The first 150 words of the full text of this article appear below.

EDITOR—Sackett discussed the role of participants in trials.¹By volunteering as participants in clinical trials, patientsenter a legal contract with the trial sponsor. The informationsheets for patients, and a consent form signed by both parties,contain the contract terms. The contract creates legally bindingobligations for both patient and sponsor.

What is supplied to the patient under the contract is additionaltreatment, which may be a new and beneficial drug. The patientpermits valuable data to be collected and used.

The contract, counter-intuitively, seems to be a "consumer contract"(because it is a contract with standard terms, between an individualacting for purposes which are outside his business (the patient),and a supplier (the sponsor) acting in his business or profession).

All consumer contracts are governed by the Unfair Terms in ConsumerContracts Regulations 1999.² Those regulations, for the protectionof the consumer, make fairness, plain . . . [Full text of this article]

Desmond R Laurence, professor emeritus, University College London

London NW3 1ST d.laurence@virgin.net