As I write, the British Medical Journal is running its poll with the question: “Is participants’ informed consent always necessary for low risk pragmatic trials?” Most researchers would agree that informed consent is a cornerstone of medical research. So why is this provocative question being posed at all?

Informed consent is at the heart of clinical research; a founding principle of research ethics. The patient must understand the purpose of the treatment, along with any benefits and risks, and permission must be freely given. At least, that’s how it should work in theory.

In reality, it has long been recognised that consent is not always practically obtainable, such as during a public health emergency. When I was a PhD student at the Health Protection Agency (now part of Public Health England) we didn’t obtain informed consent for the influenza virus samples that we used, as they were taken from sick individuals to diagnose their infection. I remember submitting my research to a medical journal and having to explain several times during submission why no consent had been obtained. As long as the samples were de-identified, so individual patients couldn’t be recognised, we could publish the results without consent.

The BMJ poll was based on a paper by Rafael Dal-Ré and colleagues from March 2019 arguing that a requirement for informed consent was slowing the progress of medical research. If a trial was to compare the effectiveness of low risk medicines, with little or no risk to patients, then doctors should be able to quickly and easily enrol them.

The use of big data in healthcare presents some challenges for obtaining consent, particularly for secondary research. More use of patient data, and the re-use of that data in subsequent studies, is needed for all of us to reap the benefits of the big data revolution. But should secondary use of data require additional consent from the original participants? This may be hard or impossible to obtain, and may not be deemed necessary if the data has been de-identified.

A possible solution to this is meta consent, where participants can choose to provide consent for specific types of future research, including types of commercial use. It is clear from citizen juries that most patients are happy for their data to be used to develop new life-saving drugs, but are less keen on commercial use purely for profit, especially when access to the data has been sold.

Some argue that the best way to achieve public acceptance is for us to own our data, be able to access it, and decide which clinical trials and studies we wish to enrol in. Interestingly, calls for dynamic consent are increasingly coming from biotechnology companies and industry, as a way to create a market for health data. Hu-manity and CoverUS are just two examples of companies that have established market places for health data, acting as brokers between patients and researchers, secured by blockchain. This allows you as the patient to give consent for individual studies in real time, and financially benefit from the use of your data.

Whether meta consent, dynamic consent, or good old fashioned informed consent is the solution, secondary studies should be considered when consent is obtained, so that data can be re-used, including for commercial use, without alienating patients and the public.

Back to the poll, of the 500 votes, 80% voted “yes” to retain informed consent for low risk clinical trials, suggesting that the medical profession remains supportive of the status quo. Perhaps this shows that more consent is needed, not less?

This is a guest blog for HDR UK and reflects the interests/knowledge of its author. Our blogs are designed to stimulate debate and are not necessarily reflective of HDR UK’s opinion