GMC issues new guidance on clinical researchBMJ 2002; 324 doi: https://doi.org/10.1136/bmj.324.7334.0/b (Published 16 February 2002) Cite this as: BMJ 2002;324:b
The General Medical Council—the body that registers doctors in the UK—has issued new guidance on the standards expected for research in the NHS, universities, and the private sector.
Trust between participants in research and healthcare professionals is emphasised as the central principle in conducting ethical clinical research. The guidance warns: “Doctors involved in research have an ethical duty to show respect for human life and respect peoples' autonomy. Partnership between participants and the health care team is essential to good research practice and such partnerships are based on trust. You must respect patients' and volunteers' rights to make decisions about their involvement in research.”
Sir Cyril Chantler, chairman of the GMC standards committee, which developed the guidance, commented: “Our guidance sets out the ways that public trust can be maintained through honesty and openness, and how partnerships can be made and sustained through respect for participants.” He explained that the recommendations had been developed in response to several cases of professional misconduct by doctors during the course of research.
“It's a pity that we have to spell it out, but we thought that it was important to set down explicit standards for people working in research.” The guidance was developed, after wide consultation, by a working group of representatives from medicine, research bodies, the Department of Health, and the pharmaceutical industry.
The guidance is designed to help doctors implement the principles of informed consent, voluntary participation, and confidentiality in clinical research. It points out that researchers should not put pressure on patients or volunteers to participate in research and that they should ensure that “no real or implied coercion” is used on people who are in a dependent relationship to them, such as medical students or junior colleagues. The guidance also addresses the issue of uncertainty about the benefits of research, warning researchers that they must be satisfied that their research is not contrary to the interests of the participants.
Effective communication is emphasised as the key to enabling participants to make informed decisions. The guidance recommends that information should be tailored to fit each participant's understanding, beliefs, and culture: “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 it is presented in terms and a form that they can understand.”
It suggests that researchers undertake an initial discussion with participants, after which they should give each participant a leaflet or sound recording covering the aims of the research, an outline of the research method, and information on possible risks and benefits. Sir Cyril explained: “The important thing is that you tell the patient what they need to know—not what you think they need to know. The patient should set the agenda.”
Peter Walsh, director of the Association of Community Health Councils in England and Wales, welcomed the emphasis on improving patients' understanding of research. “In my experience, the commonest problem patients have with research is understanding the nature of the possible benefits and risks involved. They sometimes complain that their expectations were raised, when this may not have been appropriate.” He said that this might be solved if doctors ensured that patients had a full understanding of all aspects of a research programme.
Research: The Role and Responsibilities of Doctors is available from the GMC (http://www.gmc-uk.org/ or tel 020 7915 3507).