Table 3 Quotations for the theme of ‘Rapidly evolving research ethics landscape’

Risk to benefit analysis as a moving target

What precedents can we live with? (REC3)

I think the vaccines, the new vaccines, directed vaccines, repurposed vaccines, I think the risks have not all been elucidated because they bought them on out quite quickly as best as you can. And so, we have to deal with different decision making around not understanding all the risk and accepting the fact that there may be adverse effects that haven’t been identified, but getting the vaccine out there with proper reporting, proper monitoring, evaluation, and learning from overseas (REC1)

And many of the other repurposed medicines or the medicines that are being used now, the preclinical work has not been to the level of we usually accept… so we would want to make sure that we’ve adjudicated appropriately on the risks (REC15)

…the fact that we have a global emergency, doesn't mean we should throw all research and scientific standards overboard and just dive into anything and everything and hope that there will be an outcome that we like, and that that's probably something that sometimes gets a little lost, if you've got one trial after another coming through one protocol and you are seeing the patients dying in the hospital (REC8)

…it's difficult because you've got the tension, you don't want to be too restrictive, because, you want obviously wanting research to progress, but it's a challenging space (REC19)

…there are potential justice issues there. But I don't know how you balance justice with harms, potential harms and safety. And you have to call it somewhere. I suspect patient safety would be a little bit higher on the hierarchy than justice. But yeah, I think there are some areas that might be seen as being unjust, but I think there are usually good reasons for it (REC9)

Placebo use in ongoing vaccine research

…the biggest conversation is when we stop and decide especially from a placebo point of view, when a placebo is not important (REC20)

…how can you allow people in studies to carry on not being vaccinated and following them up for the next few months, knowing that they could have been protected by the vaccination and after all, a trial is supposed to be a high resource environment, so they're supposed to be able to afford these sorts of things? (REC8)

Of course, now, of course, the latest issues with the potential lack of efficacy with “South African variant” does that now open the door to placebo-controlled trials again, but I mean, still you don't know (REC11)

Standard of care

Things were viewed more in terms of a public health emergency than in terms of just pure science as they normally are…in the age of COVID, we've kind of viewed it a little bit differently. Perhaps what one might consider to be the best standard care has been assumed on the basis of what is being used, rather than what has been shown to be evidence based. Usually, we would want the best standard of care in the world to be on the basis of maybe two, phase three clinical trials or something like that what happens to the vaccine programme? What is that commentary when you can suddenly get vaccinated in emergencies in high-risk populations but, people are still running some clinical trials? (REC7)

Post-trial access

…how much post trial access became part of the deliberations in rapid views and trying to get our heads around protecting participants for putting themselves out there in an area that's so unknown, and what that means in terms of holding sponsors of especially the clinical trials accountable (REC2)

Because people that have been on the vaccine trial, does that mean that their families should be eligible and get some sort of priority? I don't know. And it became quite a fraught issue, but the positive of it is also conscientizing our reviewers to looking at issues of post-trial access (REC5)

Social value

Navigating those realities of for example the very ill patients in COVID-19… we had to carefully reflect on that and make plans around that. Because we also understand that this is important, this has to be done. For the greater good, it might not benefit that specific patient (REC4)

…it didn't even have to be a guarantee, it just had to be a commitment that they would take steps to ensure that our people would in some way get access to vaccines. So there was goodwill, and all the rest of it. But that's an ethical issue, our people put their necks on the line and have contributed to the success of that vaccine, which, after all, is going to make them an awful lot of money. And we are just sort of left carrying the can. I am not saying that we won't benefit eventually. But there was no commitment upfront, no stipulation that we would have any kind of benefits from, from allowing our people to participate in those trials (REC6)