More focus on research needed in NPfIT, says report

Leading academic medical researchers say that the Care Record Guarantee currently makes commitments that, if strictly interpreted would prevent a significant number of research projects from using Connecting for Health data.

Their comments, which were made in a report from the Academy of Medical Sciences released last week, have stirred controversy with the assertion that medical advances are being “inhibited by unnecessary constraints on the use of patient data.”

The report says: “The National Programme for IT (delivered through Connecting for Health) offers an exceptional opportunity to allow research to inform all aspects of healthcare. However the academy is concerned that that research needs are not being integrated into its development.”

In particular, they set out their concerns about the Care Record Guarantee and say that the Secondary Uses Service being set up by Connecting for Health (CfH) has not yet fully considered research requirements. The report recommends CfH should take urgent steps to set up a research advisory group.

The authors contend that famous life-saving research, such as the studies conducted by Professor Sir Richard Doll that first linked smoking to lung cancer, would not be possible now.

The report drew a flurry of responses to The Times’ letters page. Professor Joan Higgins, chair of the ethics committee of the Care Record Development Board who has been deeply involved in the development of the Care Record Guarantee, wrote in her capacity as chair of the Patient Information Advisory Group. She said: “It is incorrect to say that seminal research, such as that linking smoking and cancer, could not be carried out today because of excessive regulation.

“Legislation specifically allows access to large databases for which the effort of seeking consent from thousands of patients would be disproportionate. Many of the regulations were designed to protect people when they are at their most vulnerable: when they are sick and using the services of the NHS.

“Not all research is good research. Some of the measures were introduced after the tragedy at Alder Hey hospital. The key message of the investigation there was that people are often ready to take part in research, but it is important not to assume consent.”

Information Commissioner, Richard Thomas, also joined the argument. He wrote: “It is wrong for the Academy of Medical Sciences to blame the Data Protection Act — still less ‘overzealous’ interpretation — for denying researchers access to essential patient data. The central issue here is patient confidentiality.

“Since the days of Hippocrates, medical records that identify patients have been protected by the doctor’s duty of confidentiality. Patients do not expect our doctors to pass on their medical details to others without their knowledge or consent, even to medical researchers.

“Most medical research uses anonymised information. Where named records are essential, my office stands ready to help researchers to find solutions, which do exist. It is not normally a problem for patients to be informed about the use of records for research, and for concerns to be taken into account. The law also recognises that consent is not required in every situation.”

The 84-page report covers the legal and governance framework around medical research and looks at the issues of confidentiality, anonymisation, data security, consent and engaging the public.

The report’s overall theme is that the UK has an outstanding record of medical research based on the use of health information and has the potential to become a world leader in this area through opportunities offered by the NHS and by initiatives in the UK countries to develop national care records.

But it criticises constraints on the use of personal health data which are, the reports’ authors argue, inhibiting advances.

They write: "These constraints arise through confusing legislation and professional guidance, bureaucracy of process and an undue emphasis on privacy and autonomy. It is essential that data about the health of individuals are only used for research under condition of confidentiality that enjoy public support.

"However, evidence of public attitudes towards the use of health information in research is largely absent, forcing regulatory and advisory bodies to make assumptions about what the public might find acceptable.

"These factors have created a conservative culture of governance, where disproportionate constraints are imposed on research that can compromise its quality and validity."

A CfH spokesperson commented: "The electronic care records service will be introduced over the next few years and will create a huge and valuable resource for research, for improving clinical care and patient safety. It can only do so successfully if it has the confidence and support of the public who are rightly concerned about the confidentiality and security of their clinical records as well as supporting properly conducted and ethical research.

"The NHS Care Record Guarantee for England sets out the way in which the NHS will collect, store and share our records, when and how we can limit sharing, when and how we will be asked to consent and what happens if something goes wrong. This is the first such guarantee published by a government department and supported by ministers and sets a new standard of transparency and accountability to the public. Far from obstructing good, ethical clinical research the Care Record Guarantee will support it."

Link

Personal data for public good: using health information in medical research