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Patient data

A second area of concern is the way patient data is being used. The Declaration of Helsinki mandates those involved in human participant research protect the privacy and confidentiality of personal information gained from research participants. The UK has two pieces of legislation that enshrine this right in law: the General Data Protection Regulation (GDPR), which also applies to the European Union, and the Common Law Duty of Confidentiality, “which is basically the idea of ‘no surprises’ when it comes to patient information”, Dr Kolstoe says.

However, at the beginning of the pandemic, and due to a specific emergency clause in the UK’s Control of Patient Information (COPI) regulations, the duty of confidentiality was suspended to allow researchers access to confidential medical records from COVID-19 patients without consent. The purpose was to enable the data to be used to help understand COVID-19 and its impact, and to plan the government’s pandemic response.

Dr Kolstoe is not overly concerned that this legislation was relaxed in the first place, because it is perhaps a reasonable action to take in an emergency situation, but is concerned that the UK government has not yet reinstated the legislation. Instead, the COPI notice has now been extended twice and a review is underway to look at whether healthcare data-sharing legislation should be permanently relaxed (with a consultation launched in June 2021).

Dr Kolstoe is worried that if the suspension is made permanent a major protection for patients’ confidential medical data will no longer exist.

Dr Kolstoe is a member of the Department of Health and Social Care’s Confidentiality Advisory Group, whose job, in normal times, is to authorise – or not – research that asks to use patient data without consent. That means reviewing questions such as whether the research justifies the suspension of the duty of confidentiality, whether it is too difficult to achieve consent and whether there are safeguards in place to protect the data.

“Using patient data without consent is contentious and potentially harmful. Our committee makes sure the right questions are asked and right checks are in place,” he says. “But with the suspension of the duty of confidentiality, a significant proportion of the group’s work has simply vanished.”

Dr Kolstoe is generally supportive of freer access to the medical data of patients who make use of a public healthcare system such as the NHS, saying it’s a “philosophically good idea”. His issue is that he doesn’t believe there are currently enough protections in place to ensure that data doesn’t end up in the wrong hands or is not used for the wrong purposes.

“Without the common law duty of confidentiality, I don’t trust the processes that are in place to protect the data and stop it leaking, perhaps intentionally or inadvertently selling it to big business that may do something really unsavoury, such as linking it to insurance premiums,” he says.

Has the pandemic had a positive or negative effect on research?

The pandemic has presented both a challenge and an opportunity for clinical research; rarely has there been greater support for medical research to deliver knowledge that can help understand, prevent, diagnose and treat a disease. But a pandemic threatening the lives of billions demands that research be conceived of and conducted at breakneck speed.

The experience of the past year or so has reinforced to Dr Kolstoe the importance of ethics committees and ethical scrutiny of research. “It would be great if you didn’t need ethics committees, and you didn’t need research governance,” he says. “But the consequences of making mistakes in how trials and research are conducted, and how their results are disseminated, can have profound and far-reaching effects.

“That is the big responsibility researchers have, because important decisions that affect all of our lives are based upon research data. While there have been some clear successes like the development of vaccines, it is still too early to say whether the pandemic has had an overall positive or negative effect on how research is conducted and communicated.”