Participants in research: Patients in clinical trials are protected by consumer regulationBMJ 2005; 331 doi: https://doi.org/10.1136/bmj.331.7508.110 (Published 07 July 2005) Cite this as: BMJ 2005;331:110
EDITOR—Sackett discussed the role of participants in trials.1 By volunteering as participants in clinical trials, patients enter a legal contract with the trial sponsor. The information sheets for patients, and a consent form signed by both parties, contain the contract terms. The contract creates legally binding obligations for both patient and sponsor.
What is supplied to the patient under the contract is additional treatment, which may be a new and beneficial drug. The patient permits 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 individual acting 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 Consumer Contracts Regulations 1999.2 Those regulations, for the protection of the consumer, make fairness, plain language, and good faith legal requirements in such contracts.
The Central Office for Research Ethics Committees urges the following words on ethics committees for use in clinical trial contract documents, concerning injuries to patients in the trial: “Broadly speaking… ‘the sponsor,’ without legal commitment, should compensate you without you having to prove that it is at fault.”3
Non-lawyer patients would understand that the sponsor had arranged for the certain and easy availability of compensation in the event of injury in the trial. In reality, the words used give nothing beyond the hope of an unenforceable ex gratia payment. So the words are not plain language; and consumer law would not permit them (because they do not meet the legal requirement of fairness and openness).
If the contract actually is not a consumer contract, then it must be said that the public has less legal protection when it volunteers for a clinical trial than when it buys double glazing.
Survivors of serious adverse events can only hope that clinical trial contracts are indeed governed by consumer protection legislation.
Competing interests DRL is a prospective patient volunteer in a clinical trial.