Getting (a) Shot for Science
About ten years ago, I decided I could be a more effective research administrator if I experienced another side of the clinical trial process. I had been negotiating contracts and budgets, paying subjects for their travel, and approving incentive payments for a while, but I thought if I enrolled as a research subject in a clinal trial myself, then I would learn something and get paid for doing it. Oh, and I’d help further research and our mission of improving child health, too. I signed up as a ‘healthy subject’ for an experimental pneumonia vaccine. It truly did help me see the other side of informed consent, interactions with clinical research coordinators, and even the protocol. I then started pimping my kids out encouraging my kids to make the informed decision to also enroll in clinical trials. Now, I’m one of the 30,000 research subjects in Pfizer’s COVID-19 vaccine clinical trial. This has really made the daily news more interesting and personal for me. I better understand how the mRNA vaccines present a new way of doing things, mainly because during the consenting process, it was explained to me in a way that I could understand. I paid a little (lot) more attention to it than what’s on the news because I was about to be injected with the stuff they were just talking about. It’s a double-blinded, placebo-controlled trial so neither I nor the study staff knew whether I was being injected with the actual study vaccine or a saline placebo. In reality, there is no doubt in my mind that I got the actual study drug vaccine. Saline does not make your arm hurt like mine did. Saline also does not cause the immune response in the body the way mine felt after receiving the second dose. In about 24 hours, I had moderate body aches, a low fever, and was very fatigued – a response just like what we look for in mice in our other research. Thankfully, that lasted less than a day. This really gave me a good perspective and education on the body’s immune response. I was not sick, but I felt pretty miserable, similar to when some people say the flu shot gave them the flu. It did NOT. However, the body’s immune response can make you feel like it did. Your body is working extra hard to respond and make antibodies; that takes energy. Energy is made by burning fuel, which generates heat, hence the fever. It’s a lot of work, hence the fatigue. When the body’s immune system responds to perceived threats, it sends white blood cells to fight; this can lead to inflammation in the cells and muscles that feel achy. It’s all good - your body is responding in the brilliant way God designed it. If real COVID makes you feel as I did for about 20 hours, I really empathize with those people who have the real COVID disease that goes way beyond various body aches.
When one of our infectious disease experts, who happened to be the PI in the vaccine trial, updated our hospital on COVID-19 and the vaccines, I understood his talk, the data, and graphs much better because of my participation in the trial. I can tell you from first-hand experience that when you have a clearer understanding of your PIs’ science, you relate better to them and they have much more respect for you. You are then truly a better research administrator. Going through the process of getting paid and working with my kids as they got paid (not fast enough – my son was ready to buy more Legos as soon as we walked out of the hospital) helped me see the other side of my approving those same types of payments as a research administrator. I am more aware of the ethics of informed consent and of discontinuing a trial when it would be immoral to withhold a study drug from the placebo group. This experience has given me more insight on the reasoning for placebo-controlled groups, the qualifications and traits a PI looks for in hiring a clinical research coordinator, and much, much more. I feel good about helping to improve science. Frankly, I also feel good about the cool stuff I bought on Amazon with my patient incentive payments. Most of all, I really believe that I’m a better informed and educated research administrator because of my experiences as a participant and parent of participants in clinical trials. I strongly encourage all of you to do the same. Maybe it’s not a clinical trial for you. Maybe it’s a field trip or taking a class or simply shadowing someone. Whatever your researchers are doing, do what you can to experience another side of it. You will be a better research administrator, too. Maybe you’ll also play a part in improving child health or some other meaningful mission. That warm fuzzy feeling in your heart is good, too.
Authored by Kevin Titus, Business Director
Cincinnati Children’s Hospital
SRAI Distinguished Faculty