People should participate in, not be subjects of, research
BMJ 1998; 317 doi: https://doi.org/10.1136/bmj.317.7171.1521a (Published 28 November 1998) Cite this as: BMJ 1998;317:1521
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Editor
You replied to Petra Boynton's letter, saying that BMJ policy would
change immediately from calling research subjects to calling them
participants, except in rare cases. Given the recent lengthy and
inconclusive debate on the BMJ's policy on publishing reports of research
conducted without patients' consent, we were surprised by the speed of
your decision.
People from whom research data are obtained can be divided into four
groups:
1. Those who influence the design, conduct and reporting of research,
working as partners. They are genuine participants.
2. Those who are unable to consent, like babies or patients becoming
unconscious unexpectedly. They cannot be called participants; subjects
remains a suitable term.
3. Those who could consent, if asked, but who are entered into
research without their knowledge and consent. They can hardly be called
participants; they too, are subjects.
4. Those who can give informed, unpressured consent to their part in
contributing data but who otherwise are not further involved. They can
perhaps be called participants. Doing so may help raise standards of
information and involvement. But as a euphemism, it may simply endorse the
complacency that blunts sensibilities and prevents progress towards
increasing genuine participation.
The question of terminology is therefore not straightforward.
Researchers should spell out exactly from whom, when and how consent was
obtained and whether those researched played any other part. They should
use terms that reflect the experience of those researched and their degree
of active participation.
Charlotte Williamson
Chair
Consumers for Ethics in Research (CERES)
PO Box 1365
London N16 OBW
Competing interests: No competing interests
EDITOR - Your decision to use the term 'participant' instead of
'subject' for a 'patient' taking part in a clinical trial (BMJ 317: 1521)
is no doubt well-intentioned, but may cause confusion.
I am currently writing about a multinational trial involving over
7000'patients', 800 clinical investigators, 40 clinical monitors. 6
regional co-ordinators, 6 steering committee members and many other staff
in local andregional centres and at the trial headquarters. All these
individuals are
'participants' in the trial. The issue is to find a term which separates
thosewho are randomised within the trial from those who care for them and
handlethe resulting data. This applies to all trials, big and small,
whether or not
those who are being studied have played any part in the design of the
trial.
As most clinicians will testify, the term 'patient' no longer
impliespassivity. 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. In this case, while I do not like the term 'subject' (with its
implications of subserviance), it does have a clarity which is lacking
from
the term 'participants'. An alternative for use in many circumstances
might be 'volunteers'.
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 It is
laudable to suggest that every trial should be designed with the
'consumer' in mind, but it is unrealistic to suggest that every patient or
volunteer can be a full participant in that sense. You should not
encourage authors to claim that such participation has taken place when it
has not. Your new policy may do this.
Dr William Jackson
Medical Writer, Editor and Publisher
The Old Chapel
High Street
Harwell, Didcot
Oxon OX11 0EX
1 Standing Advisory Group on Consumer Involvement in the NHS Research
and Development Programme. Aims and values. Leeds: NHS Executive. 1998.
Competing interests: No competing interests
Editor-We live in an increasingly accountable, one might say
politically correct, age. Everything we write or say has to be quantifed
and qualified, particularly in the medical press. The BMJ recently warned
on its front cover that ‘The ABC of Sexual Health' within contained
sexually explicit material. 1 Minerva for some time now requires
submissions to her page to "include signed consent to publication from the
patient." This even applied apparently when the subject was an 3500 year
old Egyptian mummy with aspergillosis. 2 ‘Subjects' are now to be called
‘participants'. 3
Articles furthermore have to be qualified by authors declaring
‘conflicts of interest' and to state sources of funding. Admirable
requirements indeed.
Maintaining these high standards of accountability I have a
suggestion. This is that the Pharmaceutical Industry comes into line with
the Medical Profession. This could be achieved by having all
pharmaceutical advertisements, which contain photographs of ‘patients',
carry a declaration that the subject (or participant !) indeed did, or
does, suffer from the stated disease or ailment; is not an actor/actress
and has benefited from use of the stated product. Furthermore they should
have agreed to be depicted in the given context and ‘financial incentives'
should be declared.
We can all think of myriad happy faces (often curiously young and
attractive people) in adverts and in some cases ‘before and after'
photographs. The most obvious example of the latter is perhaps the
controversial Donepezil (Aricept) advert, which was in fact found to have
breached the advertising code, but not specifically for the images rather
the ‘impression' given. 4
Perhaps pharmaceutical companies are aware of the current discrepancy
between their and medical literature's accountability by their increasing
use of cartoons (Stiefel's Oilatum Plus) or in Schwarz Pharma's Tylex case
the long association with a clown (the ultimate anonymization?)
While the discrepancy may remain between the scientific evidence of a
product's efficacy and the image/photograph displayed (anecdotal), the
subject would be authentic, somewhat more credible but most of all more
accountable.
Dr David Carvel
BMA 7343452
Competing interests: No competing interests
Dear Editor,
So the BMJ is being pulled into the stupidity of political
correctness without thought to the actual meaning of the words too.
(editor's note after letter from P. Boyton, page 1521, volume 317, no
7171, 28 November, 1998)
Has it not occurred to you that, although all the 'subjects' of a
research study may be 'participants', the 'participants' are definitely
not all 'subjects'. To include all 'participants' within the group of
'subjects' introduces a logical fallacy which would be likely to render
the study
results invalid.
(reference to 'Arguing for Beginners', 'O'-level course book in
Logic, published by the Extra-Mural Studies Department, University of
Wales, college at Cardiff. A similar argument would be:
p1. All men are mortal.
p2. Napoleon was a pig. (meaning the film star from Animal Farm)
c. All men are pigs.
Which clearly does not follow.
I hope the BMJ will understand the difference between the two groups,
and empower research participants to be proud of their contribution as
'subjects' in research if they are participating in this capacity.
Yours faithfully
David Church, locum GP, mid-Wales.
Competing interests: No competing interests
Congratulations to Petra Boynton for suggesting that the word
'subject' should be banned from reports of research on humans (1). It was
Curt Meinert, formerly editor of Controlled Clinical Trials, who first
pointed out to me that the word 'subject' is demeaning. Although I
changed my terminology from that moment on, I found it difficult to
persuade others. I was particularly disappointed that I failed in 1989 to
persuade a lay group - Consumers for Ethics in Research (CERES) - to purge
the organisation's literature of the word (2).
In an article in the BMJ published in 1995 (3), I suggested that
"medical researchers would do well to follow the example set by the
British Psychological Society (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."
I applaud the BMJ's prompt and positive response to Petra Boynton's
suggestion. The journal will find that the term 'participants' works well
for those types of research (like 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. Choosing appropriate terms to describe people who have not been
actively involved in the research being reported (for example, because
they were dead) presents a somewhat greater challenge. 'Patients' may be
appropriate in some circumstances, but not all. Maybe organisations like
CERES could help researchers and medical journals by suggesting
appropriate terminology across the whole spectrum of research designs.
Iain Chalmers
1. Boynton PM. People should participate in, not be subjects of,
research. BMJ 1998;317:1521.
2. Consumers for Ethics in Research. Newsletter No.1. Spring 1989.
3. Chalmers I. What do I want from health research and researchers
when I am a patient? BMJ 1995;310:1315-8.
4. British Psychological Society. Code of conduct and ethical
principles. London:BPS, 1991:5.
Competing interests: No competing interests
Re: Subjecting people to research
Charlotte Williamson, writing on behalf of Consumers for Ethics in
Research (CERES), makes some useful distinctions in her response to Petra
Boynton's suggestion that word 'subjects' should be dropped from reports
of research. It is disappointing, however, that CERES apparently wishes
to retain the demeaning word 'subjects'. Even if the word 'participants'
may sometimes be inappropriate - as I suggested in my response to Petra
Boynton's letter - can CERES really not accept that other words are
preferable to 'subjects'? There are plenty of alternatives - 'patients',
'people', 'men', 'women', 'children'.
I am left with the strong impression that CERES wishes to promote
continued use of the word 'subjects' for polemical reasons. I doubt that
this tactic serves the interests of any of the people in the categories
that Charlotte Williamson has outlined. Indeed, the apparent reluctance
of CERES to drop the word 'subjects' seems likely to help perpetuate a
view that people should expect to be 'subjected' to the wishes of
researchers.
Competing interests: No competing interests