Methodological reasons for not gaining prior informed consent are sometimes justified
BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.38112.692211.F7 (Published 08 July 2004) Cite this as: BMJ 2004;329:87All rapid responses
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Sir
I think the concept that there is such a thing as an 'incompetent
patient' is abhorrent, does not deserve publication and is deserving of
strong censure.
Perhaps the author could define 'incompetent patient'?
Regards
John H.
Competing interests:
None declared
Competing interests: No competing interests
I welcome the comments by Dawson on informed consent. They raise
important issues that are of particular concern in research to evaluate
new services. Here blinding is clearly not possible. However, the
alternative of not doing the study is not necessarily the only respectful
one, nor does informing patients of the witholding of information have to
lead to anxiety.
In the case of evaluating new services prior-randomisation can be
combined with agreement to withold information to produce a
methodologically robust and ethical design. Thus, post randomisation and
prior to consent, the patients can be told that the service that they will
receive is being compared to another and that for methodological reasons
they can't be told the nature of the comparative service until the end of
the trial but that they will receive full information about the service
that they will receive.
If the cohort of patients is not within the 'vulnerable' groups let's
be less patronising and more respectful by giving them the information
(that information not related to their treatment is being witheld) and let
them make their own mind up about participation.
Competing interests:
None declared
Competing interests: No competing interests
The Politics of Informed Participation
RE: bmj.bmjjournals.com/cgi/content/full/329/7457/87?view=full#REF4
Angus Dawson’s Commentary on informed consent [eBMJ 21-06-04] alludes
to a parallel situation: when is institutional association likely to
influence the results? We designed an investigation and constructed a
simple questionnaire for professional Health Care Interpreters in
consultation with senior interpreters; research approval was obtained
through the university ethics process. When questionnaires are
distributed with an Information Statement, return is accepted as consent
to participate. Each of the four relevant Area Health Service [AHS] Human
Research Ethics Committees requires that the Information Statement and the
questionnaire be printed on Area letterhead and, in addition to the
paragraph describing the process for questions or complaints to the
university, a similar paragraph must appear relating to the Area’s ethics
committee.
The intended recipients are either AHS employees or contractors.
Consultations have indicated that many of these people [most of whom are
immigrants] are wary of providing information that may go to a government
agency, especially their employer. Confidentiality and privacy are
theoretical constructs that bear little relationship to the life
experiences of many of these professionals, including within their
communities in Australia. This may be due to cultural traditions or
oppressive socio-political events in their places of origin. In the
political climate of the moment, even health professionals from certain
ethnic / language / religious communities feel defensive. For these
reasons, we have requested that each AHS HREC approve the Information
Statement and questionnaire with reference to the university but without
mention of the AHS ethics committee. The self-addressed stamped envelopes
go to the university to reinforce this point. We are awaiting responses
to our request.
Roy Laube [D.Psych candidate]
Evaluation & Research Manager
NSW Transcultural Mental Health Centre / Diversity Health Institute
Dr John Cunningham
Senior Lecturer, Department of Psychology
Dr Andrew Baillie
Lecturer, Department of Psychology
Macquarie University
New South Wales 2109
Australia
Competing interests:
None declared
Competing interests: No competing interests