A new analysis from an international, multidisciplinary working group that was conducted in light of the “extraordinary nature” of the COVID-19 pandemic provides support for the development of SARS-CoV-2 controlled human infection trials to accelerate development of vaccines and treatments, provided they follow the proper framework.
“Controlled human infection studies have a long history, comprising both important scientific contributions and examples of unethical research. Although they are a bit counterintuitive, since they involve intentionally making healthy people sick, CHIs can be done ethically with steps to promote adequate informed consent and risk minimization, among other protections,” Holly Fernandez Lynch, JD, MBe, John Russell Dickson, MD presidential assistant professor of medical ethics and assistant faculty director of online education in the department of medical ethics and health policy at Perelman School of Medicine, University of Pennsylvania, told Healio.
“The ethical issues become more challenging for emerging infectious diseases that are not yet fully understood and that lack effective treatments,” she continued. “For example, it becomes much harder to minimize risks when you don’t totally understand disease impact or transmission and when there are no proven therapeutic interventions for individuals who become infected.”
According to Lynch, there is currently no way to definitively say whether the ongoing COVID-19 pandemic meets the criteria for a CHI. “Things are more complicated than that,” she said.
Members of the working group — which included clinicians, lawyers and bioethicists, among others — had differing opinions on whether the social value of COVID-19 CHIs would be sufficient to justify their risks, given the uncertainty about both “in a rapidly evolving situation,” Lynch told Healio.
To come to a conclusion on that question, the researchers developed a framework to help research sponsors, communities, potential participants and independent review boards determine which questions they would need to ask and what information they would need to have to be able to evaluate the ethics of proposed CHIs for COVID-19.
The framework laid out by Lynch and colleagues includes developing a challenge strain, outlining consensus protocols that address ethical considerations and engaging stakeholders to enhance the CHI’s social value while minimizing risks and building public trust. Questions they asked while creating the framework included:
- Would a COVID-19 CHI have sufficient social value and a reasonable risk-benefit ratio?
- How can public concerns be addressed and assuaged?
- What sites would be suitable for a COVID-19 CHI to minimize risks?
- How can participants be selected fairly?
- How can high-quality informed consent be obtained?
- How should participants be compensated?
“There’s widespread agreement that a vaccine is what’s going to get us out of this mess, so we need to do what we can to speed vaccine development ethically. COVID-19 CHIs could be done ethically, when the right conditions are satisfied,” Lynch said, noting that — at the moment — those conditions cannot be met. “We need more information about whether or not, and to what extent, this design will really speed things up and, ideally, a better understanding of how best to minimize risks for CHI participants.”
However, the working group “supports taking steps to lay the groundwork for COVID-19 CHIs now,” Lynch told Healio. These steps include developing a challenge strain, drafting consensus protocols that address ethical concerns and engaging stakeholders to enhance the social value of COVID-19 CHIs, minimize risks and build public trust. – by Caitlyn Stulpin
Disclosure: Lynch reports no relevant financial disclosures.