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

BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.331.7508.110 (Published 07 July 2005) Cite this as: BMJ 2005;331:110
  1. Desmond R Laurence, professor emeritus, University College London (d.laurence@virgin.net)
  1. London NW3 1ST

    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 …

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