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Research Ethics Requirements Compromising Quality of Health Research

Current research ethics requirements are compromising the scientific quality of health research, warn senior doctors in this week’s BMJ.//

Many ethics committees now insist that researchers approach only people who respond positively to a letter from their doctor informing them about an opportunity to take part in research – that is, people must opt in to being contacted by a researcher.

But the ethical benefits of this approach are not proved and it can lead to low response rates, wasted resources, and research of limited validity, argue Professors Jenny Hewison of Leeds University and Andy Haines of the London School of Hygiene and Tropical Medicine.

They believe that some kind of trade-off between confidentiality costs and health benefits is unavoidable, and call for public debate about what it means to protect patients’ interests.

The evidence suggests that public concern about an opt-out approach to being contacted by a researcher is minimal. Particularly sensitive topics might justify a different strategy, but ethics committees should presume that opting out is the best approach and that opting in might occasionally need to be used, they write.

Certain kinds of research have suffered more than others under the present system, but winners and losers are determined by administrative factors not research priorities, they add. The full impact of an opt-in system is seen in those projects that require records to be searched and letters to be sent: recruitment rates are lower and more practice time must be spent recruiting. The arrangement is often unsuccessful and may lead to failure of the study.

They suggest therefore that all NHS users should receive brief information about the potential use of personal information for research and that a strategy to inform individuals about how such research can contribute to improved health should be promulgated.

Since participation in research is likely to be determined by perceptions of trust and fairness, the NHS must have a robust and forthright communications strategy to explain why research using personal information is needed and the importance of ensuring high participation rates, they conclude.

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