Using personal health information in medical researchBMJ 2006; 332 doi: https://doi.org/10.1136/bmj.332.7534.130 (Published 19 January 2006) Cite this as: BMJ 2006;332:130
All rapid responses
As both a health services researcher currently conducting an
observational study and chairman of a patient organization, I have two
diverse reasons for following with interest the developing debate about
the potential impact on observational and epidemiological research of
increasingly stringent requirements with regards to prior patient consent.
Concerns have been expressed that such constraints may become too
strict – or that they may have done so already(1). There are concerns
that some observational research in emergency and acute settings may
become virtually impossible and that the validity of much and
epidemiological research may be undermined by selection bias resulting
from consent requirements(2-4).
In short, ethical and legal constraints intended to prevent limited
and largely theoretical harm to individuals may lead to a different
ethical problem - the stifling of research activities which offer large
benefits to society as a whole.
Yet the views of those whose privacy and confidentiality these
constraints are intended to protect are curiously absent from the debate.
While much is assumed about patients’ views relating to their personal
medical data, the Medical Research Council acknowledges that “there is
little research evidence on how people view the use of this confidential
Reduced effectiveness in medical and health services research - and
ultimately in medicine and service delivery - is not only a matter of
concern for researchers and clinicians but for individual patients and the
public also. Properly informed and consulted, patients and the public may
well express views not unlike those of worried observational researchers.
The effect of the public being informed about research aims and methods is
highlighted by a recent Irish survey of public attitudes towards retention
of tissue samples: of those willing to allow samples to be stored for
future research, only 50% were willing initially for this tissue to be
‘linked’ to their personal medical records; this increased to 89% when the
potential value to research of being able to link samples to individual
medical histories was explained (6) .
To date the debate about research and patient privacy,
confidentiality and consent has been for the most part philosophical or
ethical and confined to professional circles. Yet a debate of such
importance should be open to all stakeholders and informed by robust,
representative, empirical evidence. There is surely a need for further
research on public attitudes to consent preferences and to the use of
different kinds of personal medical data for research purposes.
Increased clarity regarding public attitudes towards these issues
would be valuable in informing many activities of those involved in the
planning, approval and conduct of research.
1. Walley T. Using personal health information in medical research.
2. Al-Shahi R, Vousden C, Warlow C. Bias from requiring explicit consent
from all participants in observational research: prospective, population
based study. BMJ 2005;331:942-7.
3. Dawson AJ. Commentary: Methodological reasons for not gaining prior
informed consent are sometimes justified. BMJ 2004;329:87-8.
4. Tu JV, Willison DJ, Silver FL, Fang J, Richards JA, Laupacis A, et al.
Impracticability of informed consent in the registry of the Canadian
stroke network. N Engl J Med 2004;350(14):1414-1421.
5. Personal Information in Medical Research. London: Medical Research
6. Cousins G, McGee H, Ring L, Conroy R, Kay E, Croke D, et al. Public
perceptions of biomedical research: a survey of the general population in
Ireland. Dublin: Health Research Board; 2005.
Brian Buckley is a researcher in Primary Care with the National University of Ireland, Galway, and voluntary trustee and Chairman of Incontact (National Action on Incontinence).
Competing interests: No competing interests