Leading researchers have appealed to Connecting for Health to put in place better communication methods so that patients understand why and how their medical data could be used for clinical research.
Addressing the Commons Health Select Committee, Professor Simon Wessely of Academy of Medical Sciences, Mark Walport of the Wellcome Trust and Professor Carol Dezateux of the Institute of Child Health defended the use of electronic records being used for research purposes, saying it will be of great benefit for public health.
“Medical research can bring great benefits to public health. Ask the patients and the response is that they are overwhelmingly OK with their data being used to help improve public health. It is crucial now with electronic records that this use is explained properly by CfH and it is pivotal that the use of this data is governed,” Professor Dezateux said.
The researchers stressed that identity of patients was no issue to them for the purposes of research, though sometimes pseudonymised data is necessary for researchers to find certain information that would be vital to public health.
However, consent was said to be difficult to obtain in most situations, and in some cases should not be necessary to seek. Professor Wessely said: “If data can be pseudonymised, why should there be an issue? For example, postcodes are semi-identifiable but without them you cannot look at social demographics and geographic demographics in research.”
Walport added: “The issue is about consent and where that is appropriate and what can be done to maximise confidentiality. One should strip away as much identifiable information as possible but recognise that if you need other information you might need to keep certain data, such as geographic information.
“Pseudonymisation strips out as much as it can, but ultimately someone can link the record to an individual if they really wanted to. It is not perfect, but if you did it and you were caught you would be breaking the law. It is not always possible to ask the patient to gain consent, nor is it appropriate in the context of medical research. A balance must be struck between consent and confidentiality.”
Professor Dezateux expanded on this saying it was a matter of weighing out the greater public good against individuals rights.
“It is extremely difficult to get consent, but through record linkage with electronic records, we will be able to get data that will help patients with certain conditions. In this way, the invasion of privacy is sometimes necessary. For us, it’s a case of transparency and accountability.”
The researchers re-iterated that any application they make for clinical records must be looked at by an ethics committee and full and proper reasons for requesting the data must be cited. Walport said it was now important that mechanisms to protect data were followed all the time.
“There needs to be proper mechanisms to make sure that records are properly guarded. Researchers can only have data stored on one stand-alone PC. The onus is on us to ensure we strip the data we receive to the bare minimum that we require for a concise research investigation. At the moment, there is insufficient guidance to clinicians and practitioners and CfH could look into this.”
Professor Dezateux said that CfH should adopt an approach similar to the ones being used in the Nordic regions.
“We need legacy data to answer questions rapidly and not have to wait for consent and we need full demographic records, and for some opportunities we need real-time access to data. To address our concerns, we need access to data sets in the same way that it is currently possible in the Nordic regions.
“The Secondary Uses Service should engage primary care, pathways and the private sector. We must have the ability to link with records to answer important questions that society wants us to address.”