Intended for healthcare professionals

Education And Debate

How To Do It: Get patients' consent to enter clinical trials

BMJ 1995; 311 doi: (Published 16 September 1995) Cite this as: BMJ 1995;311:734
  1. Elizabeth Wager, medical writera,
  2. Peter J H Tooley, head of medical affairsa,
  3. Michael B Emanuel, research and development directora,
  4. Stuart F Wood, senior lecturerb
  1. aJanssen-Cilag, PO Box 79, High Wycombe, Buckinghamshire HP14 4HJ
  2. bDepartment of General Practice, University of Glasgow, Woodside Health Centre, Glasgow G20 7LR
  1. Correspondence to: Mrs Wager.
  • Accepted 15 June 1995

Gaining patients' consent to enter clinical trials is essential, but not easy. Giving careful thought to the design of the study itself, information which patients receive, and the use of a signed consent form may all help. To be properly informed, patients need to know something about their condition, the proposed study, and alternative options. The type and amount of information will vary and investigators need to judge the level appropriate for each person. Patients should understand that taking part in a clinical trial is voluntary and that their decision will not affect the quality of care they receive. The process of obtaining consent requires time and good com-munication. Working with young, elderly, or mentally impaired patients, or those particularly vulnerable to coercion, requires special sensitivity to the potential dangers.

Although about 3000 papers on informed consent have been written since 1989, little practical guidance is available for doctors recruiting patients to clinical trials. Many view the process as a legal safeguard,1 though there is no doctrine of informed consent in English law.2 The process should therefore be seen as enabling patients “to make a choice or state a preference about the treatment on offer” rather than a prudent form of defensive medicine.3

Outside a trial, doctors can decide how much patients participate in decisions about treatment. Some have argued that this discretion should extend to trials with a complex range of options. Otherwise, confronting the fact that there is no agreed optimum treatment may do the patient more harm than good.4 5 Our aim in this article is not to debate whether it is ever morally justifiable to include patients in trials without obtaining their consent, but to offer some practical help when patients explicitly give their consent.

Study design

Before starting to recruit patients you should …

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