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Patients do not read consent forms

Patients tend to assume that any research that they enter into is safe. They often do not read consent forms carefully because they assume that someone else has scrutinised the risks and benefits on their behalf.

Interviews with 103 patients showed that many factors influence a decision to take part in medical research (Hastings Center Report 1996;26(5):25-9). The main motivation for subjects enrolled in therapeutic research was that the experimental intervention was better than any existing alternative and offered some personal benefit. Many patients thought that they had tried everything else and had little choice.

Doctors' recommendations were also powerful factors influencing the decision to participate in trials. Many of the respondents believed simply that the doctor knows best. Respondents were also trusting of the hospitals where they received their medical care, as well of the research system, believing adequate checks and balances were in place. Many of the patients interviewed said that they had decided to take part in a trial before they had been given the consent form to sign and that they did not pay attention to the details on the form.

The study authors from the United States advisory committee on human radiation experiments said: "Clinicians should be mindful of the tremendous influence they have over their patients, given that the mere suggestion of enrolment in research by a patient's personal physician was interpreted by many patients to be an endorsement."

They suggest that research should not be presented simply as a new intervention with possibilities for beneficial effects but as an intervention with little evidence suggesting whether effects will be beneficial or harmful. They also say that research committees should ensure that any benefits are not overemphasised and strike out any comments on consent forms for phase I trials which suggest the likelihood of personal benefit to participants.--JACQUI WISE, BMJ

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