Let’s talk about research ethics. I’m Dr. Jeff Kingsley and welcome to another edition of Riding in Cars with Researchers. Let’s talk about research ethics, and then I’ll give a real world example, which is what’s going on right now involving COVID 19 vaccine research.

In research, you can only proceed if the scales balance. There are a lot of things that are on both sides of this scale and they have to weigh out appropriately. What are the scientific merits of the research? What’s the potential patient benefit of the research on the other side, or what are the negatives of doing this research, patient safety issues? Those things and the research has to balance to be able to move forward. You can’t do research if, in fact, your research design will fail. So imagine a research study that was designed in a way that it’s not going to produce a valid result. Well, you can’t do that. It’s unethical because you’re putting patients into a research situation and yet you’ve designed it in a way that you can’t get a valid result at the end. That would be unethical. You can’t proceed.

So now let’s talk about COVID-19. We’re in a situation today where we’ve got ethical challenges pulling in opposite directions, and that’s what’s creating a difficulty for Sponsors today. We have an immense need to do more COVID-19 vaccine research, and we already have several that are FDA emergency use authorization approved in the US and others internationally. And so now you have a situation where patients are in research trials, they’ve given of themselves to be in a research trial. Depending upon if they are healthcare workers or frontline workers, you’re in a situation where they could get the vaccine outside of the research trial.

Do you un-blind that patient? Meaning do we find out if the patient got the vaccine or the placebo in the research trial, or not? Here are the ethical challenges. If I look at an individual patient who is 75 years old and has type two diabetes and she entered a research trial, and now she can qualify to get a known vaccine outside of a research trial from the health department. If I look at an individual patient ethically, what should I do for her – unblind her? If she got the vaccine, you’re cool. If she got a placebo she needs to get a vaccine at the health department.

Now let’s look at all the patients that are in the research trial at the same time. If we say to all the patients, “we’ll unblind all of you so that you can get the vaccine”, we now create a situation where the trial is designed to fail because the blinding had a purpose in the first place. And if we now make a decision that makes the trial fail, that’s unethical to the people that gave them of themselves to be in the trial in the first place, because they entered a trial based upon the assumption that it’s going to produce a scientifically worthwhile result. And if we do something that violates that, well, that was unethical to the people that volunteered in the first place.

Interesting discussion. And I’m thrilled with the industry because here’s what I’m happy to tell you. The industry is taking on this challenge and they’re doing the right thing. They are redesigning the protocols in very smart ways and adjusting to being able to unblind patients who could now qualify for vaccines in their own community. Pfizer has been leading the way on that. I’m super proud of what Pfizer has been doing. And patients now are going to be able to be unblinded. And if they got the active vaccine, they’re fine. If they got a placebo, they can now get an active vaccine within the trial, not at their health department. They can get a known active vaccine and stay in the trial so that we’re still maintaining the integrity of that study data. They are still giving us safety data. We are still caring for them for free, and it’s a win-win for everyone involved. And we’re stair-stepping it according to what patients could get vaccines outside of the research trial. If a patient couldn’t possibly get a vaccine outside of the research trial, you can proceed as is.

It’s really a brilliant solution. I’m proud of the industry. I’ve said it before – COVID-19 has been the silverlining of what it has done to the research industry. We have pivoted. We’ve gotten smarter. We’ve made great decisions. We’ve accelerated home health integration into research. All sorts of wonderful things have come out of COVID-19 from the aspect of how the research industry is behaving. So wanted to talk a little bit about research ethics. The bottom line is I love what the industry is doing regarding research ethics and COVID-19 vaccine work.

Thanks for riding along!

Send me topics you want me to talk about at jeff.kingsley@centricityresearch.com!

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