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Are we paying COVID-19 vaccine trial participants enough?

“I’m going to review the risks now. This is an experimental vaccine that hasn’t been evaluated in humans before. It’s been tested in animals and didn’t show any serious side effects,” the nurse said. I was a second-year medical student enrolling in a Phase 1 HIV vaccine trial, which would evaluate the vaccine’s safety before it could progress to Phase 2 efficacy trials.

Like many healthy Phase 1 trial participants, I had several motivations for joining. Even if the vaccine worked, there was little chance it would benefit me since I was at low risk of contracting HIV, but I wanted to help save lives. I also felt it would be hypocritical for me to later prescribe medicines developed through clinical trials without participating in myself. But I was also broke, already more than $100,000 in debt and not even halfway through medical school.

During study visits, I’d need to give ten or so vials of blood, and I’d also be inconvenienced by having to skip class to attend them. There would be long questionnaires to fill out and study personnel would be contacting me for years to follow up. But I’d also receive $800, which seemed like a lot at the time. In retrospect, given the risks of serious bodily harm, I believe those payments should have been much higher.

With COVID-19 vaccine trials underway worldwide, the world anxiously waits to see if a vaccine candidate will be safe and effective. Some studies are being conducted in middle and lower-income countries, like South Africa and Brazil, exciting. Developing countries have long been left out of pharmaceutical research, though their populations sometimes benefit the most from investigational drugs and vaccines. Vaccines can also be more effective in some populations than others, so waiting until one is approved in the developed world before testing it at home is a gamble for developing countries. 

These countries must be cautious, though. Various ethical concerns have been raised about previous trials in the developing world, including inadequate informed consent, insufficient reporting of serious adverse events, and no restitution for participants seriously harmed or killed. Additionally, when treatment works, developing countries often don’t gain anything from it due to prohibitive pricing.

There’s also the sticky issue of participant compensation in the developing world to contend with. Compensation in human subjects research has been a challenge ever since clinical trials began, with some arguing we shouldn’t provide it at all. There’s a fine line between ethically compensating participants for their time and efforts versus coercing their enrollment via the allure of financial gain. Overcompensation can be a serious problem, with some individuals even making careers out of trial participation. But low compensation can leave the poor bearing more of the burden of advancing medicine. However, tunnel vision focused on preventing financial coercion can also lead to exploitation since researchers aren’t accounting for the serious risks participants are taking, which can sometimes include death. Such issues came into widespread awareness recently, when AstraZeneca temporarily halted a COVID-19 vaccine trial after a participant developed transverse myelitis, a serious neurological condition.

In current US COVID-19 vaccine trials, participants are paid as little as $500. Compensation rates in developing countries are much more difficult to locate, though it can be safely assumed they’re significantly lower. In the developing world, where people often live on around a dollar a day, small amounts of cash can drastically influence decision-making. But ethicists from those countries have argued they deserve the same compensation as participants in developed countries, which I believe to be a valid point.

Soon after my clinical trial experience, I worked on a tuberculosis study in Malawi. We weren’t putting anything into participants’ bodies, and they were already coming to our clinic for tuberculosis testing on their own accord. However, many of them walked several hours — sometimes even days — to reach us, often with children on their backs, HIV in their veins and tuberculosis in their lungs. If they agreed to join our study, not only were they providing important data to us, but we would also be inconveniencing them by keeping them longer to collect blood and sputum samples and delaying their journey home. Afterward, all we gave them was a piece of bread and a Fanta.

As a physician, I now know how dangerous side effects from treatments can be and better understand clinical trial dangers. With ever-increasing efforts to speed up COVID-19 vaccine development, there are severe risks for trial participants,  some of which may not be discovered until after trials are complete. And while participants could benefit if a vaccine works, most vaccine candidates will fail.

We need to ensure that we’re ethically paying COVID-19 vaccine trial participants for their sacrifices. With companies behind vaccine candidates standing to make billions if one is successful, shouldn’t the heroes tested on have something to show for putting their lives on the line? Humanity owes these people its gratitude, but it also owes them adequate pay for their bravery, no matter where they live.

Brian Barnett is a psychiatrist and assistant professor of Medicine at the Case Western Reserve University School of Medicine.

Tags COVID-19 Vaccine vaccine trials

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