Research

The GMC states that seeking consent is fundamental to research involving people and that consent is only legally valid and professionally acceptable when patients have the capacity to give consent, have been properly informed, and agreed to participate in the research programme without coercion.

The GMC goes on to state “You must ensure that any individuals whom you invite to take part in research are given the information which they want or ought to know, and that is presented in terms and a form that they can understand.”11 The information that should be provided is set out in Box 10.

Box 10: What patients should know before agreeing to participate in clinical trials and research

  • What the research aims to achieve, an outline of the research method and confirmation that a Research Ethics Committee has approved the project;
  • The legal safeguards provided for participants;
  • The reasons that the patient or participant has been asked to participate;
  • If the project involves randomisation, the nature of the process and the reasons for it, and the fact that in double blind research trials, neither the patient nor the treatment team will know whether a patient is receiving the treatment being tested or is in the control group;
  • Information about possible benefits and risks;
  • An explanation of which parts of treatment are experimental or not fully tested;
  • Advice that they can withdraw at any time and, where relevant, an assurance that this will not adversely affect their relationship with those providing care;
  • An explanation of how personal information will be stored, transmitted and published;
  • What information will be available to the participant about the outcome of the research and how that information will be presented;
  • Arrangements for responding to adverse events;
  • Details of compensation available should participants suffer harm as a result of their participation in the research.

GMC, Research: The Role and Responsibilities of Doctors (2002), para 20

Section 30 of the Mental Capacity Act deals with medical research where the patient lacks capacity, making intrusive research unlawful unless it is (a) part of a research project approved by a recognised Ethics Committee and (b) has the potential of benefiting the patient without posing a disproportionate burden or is intended to shed light on the causes or treatment of their medical condition or something similar.

Any research that does not benefit the participant directly must carry negligible risks of harm. Moreover, it must not interfere with his/her freedom of action or privacy.

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