Patient information

LONDON — For nearly 20 years, the international medical and research community has been wrestling with the problem of how to safeguard computerised patient information from abuse. It's an issue that affects everyone from the GP seeking the patient's consent to use such information, to the scientists teasing out findings from the data. But in recent years the debate over how much data protection is needed, what's an agreed definition of informed consent and who will eventually own the information, has been given added impetus by rapid progress in gene sequencing. Now the issue is not just about who should have access to confidential patient files, but who has the right to the ownership of their genetic blueprint? The World Medical Association (WMA) is attempting to agree international guidelines that will help to safeguard confidentiality and respect the rights of the individual, but which will also meet society's need for access to good data that can further research. It also wants measures in place that will prohibit 'inappropriate or unauthorised' use of this information. It hopes such guidance will eventually become enshrined in the principles of medicine and research, something that aspiring clinicians and scientists learn to accept very early on in their professional careers. In the UK, the General Medical Council — the body that regulates the medical profession — already has clear guidance on doctors' duty to preserve individual patients' privacy and confidentiality. It states doctors should seek consent to disclosure of any information 'wherever possible, whether or not you judge that patients can be identified from the disclosure'. But when it comes to research, the boundaries are rather more blurred. The new WMA guidelines will stress the importance of getting consent from patients if the information held on a database is to be shared by a third party. It has been spurred into action by the controversy surrounding Iceland's 270,000 citizens, whose entire genetic history has been handed over to a private company to set up a computer database to study the nature and origin of genetic diseases. Last year, the government of Iceland sold an £8m licence to deCode Genetics, which allowed it access to every inhabitant's medical records in order to compile its genetic catalogue. The decision fuelled controversy over whether private companies should be allowed ownership of such public information and whether there was a danger they would deny other research organisations access to vital genetic data. Critics argued the scheme should not even have gone ahead without the informed consent of every individual Icelander on the database. After pressure from the Icelandic Medical Association, the government agreed any individual can have their personal data removed from the database if they wish. Jim Appleyard, a senior figure within the British Medical Association helping to compile the WMA guidelines, concedes that individual patient consent is an impossible task in certain situations — such as large population-based studies. In that case, he says, it should still be necessary for researchers to meet certain ethical safeguards. But there are anomalies in the regulations governing use of patient information, he adds. "There's no doubt that certain databases, like those for infectious diseases - which are legally notifiable — break confidentiality because the law tells doctors to. They are 'acceptable' databases. "So if a child has a notifiable disease the doctor should tell the mother or father they are notifying the authorities. I'm sure people do not always tell patients but they should do." Appleyard said very little data is completely anonymised. Instead, the bulk is what he calls 'pseudo-anonymised', meaning although there is no direct link between the information and the individual, it is possible to connect them if someone is determined to do so. Although there seem to be few documented cases of this happening, it's still a citizen's right to expect protection of privacy, he said. And as genetic databases become more common, this right will come under increasing threat. "Theoretically, a company could own your genes and that gives them enormous control. This is about who owns your information and the potential for misuse of that information. I'm not against private companies [being involved] but when you get one owning you, they are not responsible to you as a patient but to their shareholders." Nevertheless, the need to find a way to progress genetic research without compromising patient confidentiality is pressing. In the UK, the Wellcome Trust and the Medical Research Council (MRC) are gradually picking their way through the ethical issues as part of their proposals to set up Biobank UK — a genetic library of the DNA from half a million people. If the project goes ahead — it would first need Government approval — blood samples would be taken from 500,000 healthy volunteers aged between 45 and 64 and DNA extracted for storage. Lifestyle and demographic information would also be collated and, over the following decades, researchers would monitor disease patterns in a bid to study the interaction between genes and the environment and the consequences for illnesses like heart disease and cancer. So far, the project has focused heavily on assessing the views of those who would be involved — including the public. This has confirmed that many people initially have serious reservations about 'handing over' personal information to faceless researchers but, once they have been briefed on how it will be used, are happy to accept it providing there are suitable safeguards to prevent unauthorised access. Informed consent, too, was seen as vitally important. Yet people also appreciated the difficulties of repeatedly obtaining individual approval every time scientists wanted to use their DNA for a new project. Instead, it would have to be made clear at the outset that patients' samples could be used in ways that are currently now known. A spokeswoman for the MRC said: "We know that if we collect genetic data, we have to ensure the public is confident that their samples of DNA have safeguards. There is no way that any of the details would be passed on to insurance companies or employers." The samples would be anonymised as much far as possible, the MRC said, but some identifying information will have to be retained in order to track each volunteer in the years to come. Ultimately, the challenge will be to strike a balance between society's need for genetic data that stimulates research into new drugs and treatments and the individual's right of privacy. But can it be done? "Yes, it can," said Appleyard, "but it depends where you balance it. We would naturally favour the individual and everything that society extracts from genetic information has to be justified."

Patient information

The Scientist ARCHIVES

Become a Member of

Keywords

Meet the Author

Pat Hagan

Related Research Resources

How Do Embryos Know How Fast to Develop

Research Resources

Podcasts

Webinars

Videos

Infographics

eBooks

The Advent of Automated and AI-Driven Benchwork

Become a PCR Pro

Genetic Insights Break Infectious Pathogen Barriers

Navigating Cold Storage Solutions

Products

Product News

BRAND® Dispensette® S Bottle Top Dispensers for Precise and Safe Reagent Dispensing

Sapio Sciences Makes AI-Native Drug Discovery Seamless with NVIDIA BioNeMo

New DeNovix Helium Nano Volume Spectrophotometer

Olink® Reveal: Accessible NGS-based proteomics for every lab