Potential guidelines for ethically infecting vaccine volunteers with coronavirus

Allowing volunteers to be deliberately infected with coronavirus for the purposes of developing a vaccine could be done ethically and potentially speed up its development, an expert has said.

Dr Adair Richards at the University of Warwick has developed a set of ethical guidelines to help researchers on how to approach deliberately infecting volunteers who have been given a vaccine candidate with Covid-19.

He suggests this may significantly speed up the process of vaccine development and potentially save many lives.

Dr Richards, an associate professor in Warwick’s department of chemistry, said: “Currently there are several vaccine candidates that are undergoing human safety testing, but to find out whether they work we need to discover what happens when a vaccinated person is exposed to Covid-19.

“With new infections dropping in the countries where research is taking place, it may be a long time before many of the volunteers in these experiments naturally come into contact with the disease.

“Deliberately infecting volunteers with a disease as dangerous as Covid-19 has previously been considered to be unethical by the research community.

“However I believe that the current global situation is so different to those previously faced, that it is ethical in this case.

“In other areas of life it is not unusual for society to allow individuals to do things that put them at personal risk, such as to be a firefighter or a health professional treating Covid-19 patients.

“Speeding up vaccine development even by a few weeks or months could result in saving many lives.”

The research looks at each of the common arguments against these types of experiments: the risk of harm to volunteers, the risk of no useable vaccine, and he validity of a volunteer’s informed consent.

It also analyses the reputational risk to research; and that this could be a slippery slope to increasingly unethical research.

The researcher provides guidance for regulators and researchers and poses three key questions for those planning vaccine development studies:

– Has reasonable care been taken to maximise the potential benefits of the proposed study and minimise the risks of harm to participants?

– Is the informed consent process sufficiently robust?

– What do we need to do now to amend our processes to speed up the consideration and approval processes for proposed Covid-19 vaccine candidate phase II and phase III trials?

Dr Richards added: “My research shows that it is incorrect to rule out human challenge experiments as unethical in relation to Covid-19 vaccine development. I argue that you can apply the same standards of ethics, but that they lead us now to a different conclusion because the facts are different.

“Very large numbers of people globally are affected both directly and indirectly from Covid-19, and the saving of a few weeks or months of time in vaccine development can be expected to result in saving a large number of lives.

“There are also good ways to minimise the risk of harm to volunteers, and it is ethical, and I argue, admirable to allow a volunteer to choose to take a personal health risk to help serve a greater benefit to humanity.”

The work has been double-blind peer-reviewed and is published in the Journal of Medical Ethics.

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