Govt to opt patient data into trials

The government wants to change the NHS Constitution so that patient information is automatically included in clinical research.

The move, which will be subject to consultation, is part of a raft of government announcements designed to boost investment in Britain’s life sciences sector and to drive innovation in the NHS.

The headline announcement, that data linking hospital and primary care data could be released to drug and other companies, created a storm of controversy in the national media, with privacy watchdog groups warning that it would herald the “death of privacy”.

However, in a press release conflating a number of different plans, the Department of Health insisted that the move to change the NHS consultation came “in response to calls from research charities and clinicians for government to get patients more involved in supporting the research agenda.”

It also said patients would still have “a clear opportunity to opt-out if they wish to.”

Other moves to increase participation in research include allowing patients to be approached about research studies for which they may be eligible, and creating a website and app to tell them about studies in which they might like to be involved.

Prime Minister David Cameron, in his speech on life sciences given yesterday afternoon, said the government would be consulting on the idea.

“We’re going to consult on actually changing the NHS Constitution, so that the default is for patients’ data to be used for research – unless of course they want to opt out,” he said.

“The end result would be that every willing patient is a research patient…that every time you use the NHS you’re playing a part in the fight against disease, at home and around the world.”

Big Brother Watch director Nick Pickles said he heard health secretary Andrew Lansley on BBC Radio 5Live yesterday morning say that the constitution would be amended; with no mention of consultation.

The Guardian quoted Lansley as saying: "We will amend the NHS constitution so that from the patients’ point of view there is a presumption that the NHS is a research-related activity”.

Pickles said the public expected decisions made about the NHS to be taken with the upmost care and concern and the contradictory statements about the new data sharing plans did “little to inspire confidence.”

British Medical Association head of science and ethics Dr Vivienne Nathanson said patient records must be kept confidential and must be anonymised if they were going to be used for research, unless explicit patient consent had been obtained.

She said the use of anonymised health data could benefit patients, but the BMA was concerned that elements of the government's proposals could undermine patient confidentiality.

Earlier this month, the government quietly launched the Health Research Authority as a special health authority. The creation of the HRA was another element of the government’s Plan for Growth, first announced in the March Budget, and reprised in Chancellor George Osborne’s Autumn Statement.

The HRA is supposed to both reduce the “regulatory burden” on research-driven businesses and organisations and to promote the interests of the public and patients in health research. It will oversee approvals for trials.