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2-1 “Subjects” are now to be called “participants.” 2-2 In addition, authors have to declare competing interests and to state sources of funding. Minerva for some time now has required submissions to her page to “include signed consent to publication from the patient.” This even applied apparently when the subject was a 3500 year old Egyptian mummy with aspergillosis. When the ABC of Sexual Health was recently published in the BMJ the journal occasionally warned on its front cover that it contained sexually explicit material. Everything we write or say has to be quantified and qualified, particularly in the medical press. The BMJ’s new policy may do this.Įditor-We live in an increasingly accountable and politically correct age. Authors must not be encouraged to claim that such participation has taken place when it has not.

#RESEARCH PARTICIPANTS FULL#

In truth, many of the implications of the term “subject” remain accurate for most clinical trials in which most subjects (and, indeed, many other participants) are not, and never can be, “active participants in the process of deciding what research should take place, commissioning research, interpreting the results, and disseminating the findings.” 1-1 It is laudable to suggest that every trial should be designed with consumers in mind but unrealistic to suggest that every patient or volunteer can be a full participant in that sense. In this case, although I do not like the term “subject” (with its implications of subservience), it does have a clarity that is lacking from the term “participants.” An alternative for use in many circumstances might be “volunteers.” Is either “subject” or “participant” really a better alternative to the use of this long established term in most clinical research reports? In some studies “patient” is inappropriate, as those under investigation are not unwell. This applies to all trials, whether or not those who are being studied have played any part in their design.Īs most clinicians will testify, the term “patient” no longer implies passivity. The issue is to find a term that separates those who are randomised from those who care for them and handle the resulting data.

All these people are “participants” in the trial. 1-1 I am currently writing about a multinational trial involving over 7000 patients, 800 clinical investigators, 40 clinical monitors, 6 regional coordinators, 6 members of the steering committee, and many other staff in local and regional centres and at the trial headquarters. Maybe organisations like Consumers for Ethics in Research could help researchers and medical journals by suggesting appropriate terminology across the whole spectrum of research designs.Įditor-The BMJ’s decision to use the term “participant” instead of “subject” for a patient taking part in a clinical trial is well intentioned but may cause confusion. “Patients” may be appropriate in some circumstances, but not all. Choosing appropriate terms to describe people who were not actively involved in the research being reported (for example, because they were dead) presents a greater challenge. The journal will find that the term “participants” works well for those types of research (such as controlled trials) in which active involvement of the people being studied is required, although some may prefer the word “volunteers” to describe participants in non-therapeutic research. I applaud the BMJ’s prompt and positive response to Boynton’s suggestion. 4 After noting that psychologists owe a debt to those who agree to take part in their studies, who therefore deserve to be treated with the highest standards of consideration and respect, the society recommended that the term “subject” should be abandoned and replaced by “participant.” In an article published in 1995 3 I suggested that medical researchers would do well to follow the example set by the British Psychological Society. I was particularly disappointed that I failed in 1989 to persuade a lay group-Consumers for Ethics in Research-to purge the organisation’s literature of the word. Although I changed my terminology from that moment on, I found it difficult to persuade others. 1 It was Curt Meinert, formerly editor of Controlled Clinical Trials, who first pointed out to me that the word “subject” is demeaning. Editor-Congratulations to Boynton for suggesting that the word “subject” should be banned from reports of research on humans.

Research participants