Research ethics during a pandemiC
First published in issue 3 of SOLVE magazine, 2021
In 1946, 20 Nazi doctors stood trial in Nuremberg, Germany, for their part in the torture and murder of prisoners, conducted under the guise of medical experiments.
The Doctors’ Trial, as it was named, laid the foundations for the 1964 Declaration of Helsinki, which addresses issues such as consent, risk, purpose and design when conducting human experimentation.
Central to the Declaration of Helsinki is the clear statement that the pursuit of knowledge should never come at the expense of the rights and interests of the research participants. These principles have guided research ethics committees ever since.
But the context and subject of medical research changes, so ethics committees have to constantly consider how these principles can be applied in new contexts. This has been especially relevant during the COVID-19 pandemic, says Dr Simon Kolstoe, Reader in Bioethics and expert on research ethics at the University of Portsmouth.
“The historical view of ethics committees is that they are solely about protecting participants from nasty researchers who are trying to harm them,” says Dr Kolstoe, who chairs research ethics committees (RECs) for the National Health Service (NHS), the Ministry of Defence and Public Health England. “But while the protection of participants is clearly still central to a REC’s role, our central concern is to support researchers in designing and conducting the best research, because good research will be ethical research.”
When looking at whether a trial should go ahead, RECs ask:
Does it need to be done?
Is it asking the right question?
Is it appropriately designed to elicit a useful answer to that question?
How are researchers considering the safety and needs of participants?
This system has worked well in normal times, but the urgency of the COVID-19 pandemic has thrown up major challenges.
One concern caused particularly by the fast-moving nature of the pandemic relates to the rigour that goes into justifying the requirement for new research. In normal times researchers may be expected to spend months conducting extensive literature, or even systematic, reviews prior to proposing an experiment or trial. But the pandemic has not allowed time for such careful preparation.
“We’ve been seeing researchers who have been saying, ‘because of COVID we’re going to do this’,” Dr Kolstoe says. He notes a lack of the usual systematic groundwork that should happen before a proposed study even gets to an ethics committee.
“This has been something I’ve certainly pushed back on, because in an emergency situation it is even more important that results are robust,” Dr Kolstoe says. “If you do not have a good research question to start off with, your results are never going to be reliable, which raises the potential for misuse.”
Even prior to COVID-19, researchers in evidence-based medicine have estimated that as much as 85 per cent of clinical trial research is wasted effort because it asks the wrong questions or was not properly designed or is not reported accurately.
“And that’s something humanity cannot afford, especially during a public health emergency,” says Dr Kolstoe.
“If we are not doing useful research, then it’s wasted money. Even worse, it potentially could kill people if the wrong results are put out there and government decisions are being made on the basis of poor research.”
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.
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.”
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