Whose research is it anyway?BMJ 2006; 333 doi: https://doi.org/10.1136/bmj.333.7560.0-f (Published 20 July 2006) Cite this as: BMJ 2006;333:0-f
- Trish Groves, deputy editor ()
Taking part in research has had a bad press. No wonder, given catastrophic reactions to new drugs that were being tested in London and Baltimore, the use of dead children's organs without their parents' consent in Liverpool, and drug trials in India done with inadequate consent. These are extreme examples that do not reflect the careful and respectful approach of most researchers. But even the best researchers struggle to strike a proper balance between the overall public good of their work and the need to respect and protect the privacy of research participants. So this week's BMJ carries the first of a series of articles debating confidentiality and consent in medical research.
The huge patient databases of the NHS provide unique opportunities for clinical and epidemiological analysis. But research involving patients or their personal data in the United Kingdom is now regulated by multiple sets of rules and laws that confuse researchers and inhibit and hamper studies. Add to this the problems of obtaining consent to reuse data for research when patients have died or moved on, and the challenges of ensuring confidentiality, and it's a wonder anyone still wants to do this kind of research.
One solution is to anonymise the data. But this is harder than it looks, argue Dipak Kalra and colleagues (p 196) in the first article in the series. You can remove demographic details and discard the clinically rich narrative data in letters and reports. But patients may still be identifiable because of their unique clinical histories, and some will feel embarrassed or angered if they haven't explicitly consented to the use of their data. Record linkage has its pitfalls too: the genetic research databank in Iceland was declared unconstitutional for breaching privacy.
Asking for consent isn't easy, either. In the second part of the series next week Peter Singleton and Michael Wadsworth look closely at consent and true choice. One of the authors had to sign five forms to have one blood test taken when participating in a study. Faced with this or a 16 page consent form, say the authors, discretion may seem the better part of altruism and people may choose “not to choose.” That's effectively opting out, a choice that Jenny Hewison and Andy Haines debate later in the series. And finally, in three week's time, Christina Davies and Rory Collins suggest how to wade through the necessary bureaucracy and make studies easier for both researchers and patients.
This is a series to cut out and keep (or the electronic equivalent) if you're a researcher. It's not ivory tower stuff. But one would-be surgical researcher may not be quite ready for even this kind of advice. Gwyn Samuel Williams is still struggling with finding something to publish, no matter how trivial, bearing his name (p 207). At each six month training review his reply to “so have you got anything published yet?” is still a glum “no.” And that's despite seeing mirages of published studies on alcohol hand gel, patient care pathways, and hospital holy water.