Clinical trials internet resource

November 2004
Informed consent

A patient or volunteer must give informed consent before they can be entered into a trial. Among the main problems associated with this are the levels of
uncertainty as to the optimum treatment for a specific condition that are a feature of research and new treatments. The patient/volunteer should be told the
following information to assist them in coming to their decision, and be given adequate time for reflection prior to giving consent:

  • the purpose of the research
  • whether the patient stands to benefit directly and, if so, the difference between research and treatment
  • the meaning of relevant research terms
  • the nature of each procedure, how often or how long each may occur
  • the potential benefits and harms (both immediate and long term)
  • the alternatives open to them if they do not choose to participate in the study
  • the name of the researcher whom they can contact with inquiries
  • whether and how the researcher stands to benefit (e.g. financially)
  • the name of the doctor directly responsible for the participant
  • how participants can withdraw from the project
  • if a patient (rather than a healthy volunteer), participants need to know that withdrawal will not affect the quality of their health care
  • what happens if the trial must terminate early, and what happens at the end of the trial.
As a general principle, non-autonomous patients, such as children and people with impaired capacity, should only be involved in essential research designed to benefit those specific categories of patients. Consent forms for specific populations must recognise their developmental ability to understand the consequences of their participation. Families also need to understand the implications of agreeing on behalf of someone else. For further information on informed consent, please consult the BMA’s Consent Tool Kit here, and for an in-depth analysis of consent in medical research consult Doyal and Tobias [Go to note 2].

Lead investigators should produce high quality written information that doctors can use to pass on information about the trial to patients, their family, and friends. A full and frank discussion with a health professional – usually a doctor or nurse - must be the primary source of information for the patient, however, high quality written information can aide doctors in explaining aspects of the trial to patients and can be used by patients for reference in their own time.

© British Medical Association 2008

Log in to your BMA here