Medical researchers require access to your medical records for studying the causes, prevention and treatment of disease, writes Ivan Perry
The organ retention controversy has highlighted the fundamental importance of informed consent, both in clinical practice and in biomedical research.
In recent decades ethicists, scientists and practitioners have clarified the notion of informed consent as one of the fundamental ethical principles in clinical practice and research, reflecting respect for individual autonomy, in particular the need to ensure that people are not used as means to an end. On a more practical level, consent is critical in ensuring openness, accountability, trust and mutual respect in relations between patients and health professionals.
There is a danger, however, from the uncritical and indiscriminate application of the concept of informed consent.
In particular there are now concerns that vital health research is impeded, delayed and sometimes distorted by inappropriate and unnecessary concerns about informed consent and the related issues of patient confidentiality and access to records.
We now have a situation in many countries, including Ireland, where custodians of medical records adopt the most cautious interpretation of data protection legislation and are fearful of litigation if they allow any access to individual patients' records for research without each patient's informed consent.
In July of this year the British Medical Journal (BMJ) published a "theme issue" on the subject of research regulation, or in contemporary jargon "research governance", under the headlines of "Research is drowning in bureaucracy" and "Ethics committees are out of control and discouraging research".
The BMJ theme issue highlighted the experience of a research group studying the causes and transmission of Creutzfeldt-Jakob Disease (CJD), the condition linked with ingestion of meat from BSE- infected cattle and more recently with blood transfusion. This is a high-priority research issue with significant implications for the health of the population as a whole.
The researchers wished to contact a random sample of healthy control subjects drawn from general practice lists where there had been at least one case of CJD. Because of concerns about patient confidentiality it proved impossible to recruit an appropriate sample of healthy controls.
Only 16 per cent of potentially eligible controls were recruited, and the scientific value of the data generated by the study was therefore seriously undermined.
Commenting on their experience with this study, the researchers make the point that ethics committees should weigh the benefits to society against costs to the individual when considering studies.
Clearly, we would all object if health professionals were careless with our medical records and willing to exploit them for personal or commercial gain. On the other hand, I suspect that most people would permit use of their health records for research of potential benefit to other patients and society as a whole provided adequate safeguards were in place, including independent review of research protocols and strong sanctions for research misconduct.
I would argue that the contract we enter with the health system when we present with a health problem should include provision for sharing our health records with professional health researchers, who are bound by the same ethical codes and regulatory framework as the doctors, nurses and other health professionals directly involved in our care.
For example, I have recently undergone minor knee surgery. From my perspective, in an ideal world all of the clinical details from my operation would be added to a national database, linked with the rest of my health records and tracked over time, using a unique patient number or identifier.
This would greatly facilitate health services research on the optimum treatment of my specific knee problem. I would not wish to be contacted to give my explicit informed consent on each occasion my records were accessed by a professional medical or health researcher.
Moreover, if there were unused blood samples in the laboratory following my operation, I would be happy for researchers to use these for research of benefit to others without my consent.
Indeed, I would prefer if researchers did not write to me requesting consent to access my data or use biological specimens as I would probably forget to return the form, and I would prefer to see scarce resources spent on research rather than bureaucracy.
I would not have any concerns for my privacy or other civil liberties in this scenario, as I know that the relevant research protocol would be vetted by an independent research ethics committee (including lawyers and members of the public) and those holding my records would be subject to independent and rigorous scrutiny from the Office of the Data Protection Commissioner.
While I clearly have a vested interest in facilitating access to records and specimens as an academic health researcher, I am sure that I am not alone in holding these views. We need a broad-ranging public discussion and debate on these issues so that we can, as a society, reach a consensus on how best to facilitate vital health (and social science) research without compromising fundamental human rights and ethical principles.
In the Government's health information strategy there is a commitment to develop a unique patient identifier to facilitate linking and tracking of patients' health records in the interests of patient safety and quality of care as well as health research.
This is a welcome and long-overdue proposal. I would hope that in the debate on legislation required to fully implement the health information strategy, we can place concerns about threats to civil liberties in context.
Developments in information technology offer unparalleled opportunities for research on the causes, prevention and treatment of disease. To avail of these opportunities researchers and practitioners need to move on from the paternalism of the past. We need to make the case for a culture and environment that facilitates and uses research as a vital ingredient in creating a modern, evidence-based health system.
Prof Ivan Perry is head of the department of epidemiology and public health at University College Cork. He is co-organiser of a summer school on ethical and practical issues in public health practice which concludes in the college today