Regulating research: who decides?

Many people have raised concerns about how high-risk research on viruses is regulated. Filippa Lentzos, an expert on science and international security at King’s College London, spoke to Chris Smith...

Chris - Filippa, what is the framework for sort of regulation of doing this sort of work both in the UK but also internationally?

Filippa - Well in the UK, we've got pretty good legislation around safety aspects of working with dangerous pathogens. So everything's covered under the Health and Safety at Work Act regulated by the Health and Safety Executive. But that is just looking at safety aspects, it's not looking at ethical or social questions around whether or not this kind of research should go ahead. We've got some security aspects regulated, but not all security aspects regulated. So we've got some kind of framework and it's a statutory framework. In the United States, it's not in law. There isn't a legal basis for the framework, it's guidance. And it's based on whether or not you are in receipt of federal funding. So if you're funded, you're obliged to follow those guidelines. But if you're doing your research on the basis of private money you don't need to follow, necessarily, those guidelines. Although most companies will do that because that is seen as the kind of the standard to follow.

Chris - And is there a sort of minimum level that countries should comply with or is it very much hit and miss? Could it be that if your country is a bit more lax ,or let's a bit more go through, you're a bit more relaxed about what you're willing to let people do, are you likely to become a magnet for people coming to do higher-risk type studies that are perfectly legitimate, but they want to do them with the least friction, so they'll come to you?

Filippa - Oh yeah, you know, science tourism or research tourism. I mean, there is that possibility, or just subcontracting some pieces of work. Although again, if that work is funded by someone in the UK or someone in the states, you know, you have to adhere to that funder's set of regulations. But we do know that internationally there aren't any set standards for this. There is of course guidance from the WHO, for instance, on biosafety. But again, that only covers safety aspects. It doesn't cover, for instance, whether or not gain of function research should be going ahead and implementation of these is inconsistent across different countries.

Chris - Who actually does get to be judge and jury on that? Who decides what should or shouldn't be done? We've heard at the beginning of the program from Ed Hutchinson some very important, very useful examples of how this has been done for flu. It was dangerous research, but it was safely concluded and has borne fruit. Who would have actually had oversight and decided, yes, this is legitimate, yes, we're going to fund this? And then, applying that to what may or may not have gone on in Wuhan at the Wuhan Institute of Neurology, where they were working on coronaviruses and potentially adapting them. We know that grants were submitted asking for funding to make changes to these coronaviruses for perfectly legitimate reasons, but who would have actually decided whether or not that can go ahead?

Filippa - Well it would have been the funder in that case. So if a Department of Defence in the United States, if they wanted to go ahead and fund that, that would be okay. There is no international oversight body that says, no, that can't be done, or "we're the kind of World Lab Police, and we're going to go in and check!" So nobody internationally would say no. So it's really up to the funder and the particular local or national regulatory framework whether that can go ahead. And of course, with that work, we know that the Department of Defence in the United States said, no, we're actually not going to fund this because we think it's too risky. We don't know if it was funded by somebody else or whether it still went ahead

Chris - Yes indeed because you've got the idea, you've written the application, you've thought about how to do the project. If someone says no, you just take the project somewhere else

Filippa - Quite possibly. And often when you do write research proposals you need to do some of that research in advance in order to make sure that you can confidently say that this is a viable research project. So it is also possible that some of that research was already done in advance of the proposal being submitted.

Chris - We heard from Alison Young about some examples of things that have gone wrong. When things are discovered to have gone wrong, how do they get investigated? And then how is change and learning brought in to make sure that the same mistakes don't happen twice? Is there anything that's in place to make sure that we do learn from our mistakes?

Filippa - Well, not enough, I would say. And again, this differs from place to place, right? So in the UK, if there are big accidents, you know, the foot and mouth disease outbreak that Alison was referring to at Pirbright, there was a big inquiry and there were hundreds of pages written up so that we would learn from that incident. At smaller incidents that are less well-known, it's harder to learn from them. Also we don't have these kinds of 'accident registries' that we could go into necessarily. A lot of local accidents, most local accidents are small, of course. And so they don't get reported.