A Vaccine Trial, Discrimination, and Self-Advocacy
As the nation awakened to the realization in mid-March that COVID-19 was about to have a profound effect on our daily lives, I was acutely aware of the consequences of not obeying proper health protocols. I still live at home, where I help care for my aging parents. My father, a Vietnam veteran, has several health conditions, including severe COPD. He is homebound, and contracting COVID-19 could be a death sentence for him.
On March 15, Governor Mike DeWine of Ohio, where we live, became the first governor in the country to close all nonessential businesses, including restaurants and bars. We were effectively on lock down.
I was very concerned about how my family and I would fair if we contracted COVID-19, and how I would care for them while in isolation or quarantine. I also worried about how my business clients—primarily families of children with the same condition that caused my blindness—would be able to cope with the sudden need for virtual instruction with potentially inaccessible online technologies.
I wanted to be a part of the process of ending the emerging pandemic and I wanted to enable my family to return to our normal lives. As a blind person and member of the National Federation of the Blind, I also wanted to contribute to the development of a vaccine—particularly for our members at greatest risk.
So when the Gamble Vaccine Research Center at Cincinnati Children’s Hospital Medical Center announced that it was seeking participants for a trial of emerging vaccine candidates, I submitted an online application and questionnaire on the center’s website. The questionnaire consisted of a basic health screening and demographic data. I also submitted an application for a family member who wanted to participate.
On July 27, Pfizer and BioNTech announced that their COVID-19 vaccine candidate was entering Phase III clinical trials. Later that same day, our local media outlets reported that the Gamble Vaccine Research Center was one of the sites seeking participants in these clinical trials.
I received a call that same week from a recruiter informing me that I was eligible to volunteer in the trial based on the questionnaire I submitted in April. I explained that I would likely be able to participate, but needed information and accommodations because I am blind.
The recruiter emailed me the informed consent documents. After reviewing these and discussing my participation with my family, the relative who I helped apply for the vaccine trial in April recommended that she accompany me to the testing site and that we participate together in the trial. She and I live in the same household. This would enable her to assist me in completing the medical history forms and other required paperwork.
When I asked the recruiter if this was possible, she responded that this was not allowed due to social distancing protocols. Next, I asked the recruiter if I could receive the required paperwork in advance so I could complete it prior to coming to the testing site—either with a reader or my screen-reading technology. The response I received was that the team conducting the study believed that a blind person could not perform the activities required of participants, such as body temperature and blood pressure monitoring, and reporting any adverse reactions to the vaccine.
After sending the recruiter a follow up email explaining that I could perform these activities with accommodations, and referring her to the National Federation of the Blind, I received a subsequent email indicating that their selection criteria had changed. I was being excluded from participation.
After consulting our affiliate vice president, I filed a complaint with the Office of Civil Rights, U.S. Department of Health and Human Services, and the U.S. Department of Justice on August 1 alleging discrimination by the Gamble Vaccine Research Center in their selection criteria.
I am proud to say that the National Federation of the Blind has joined my complaint on behalf of all the nation’s blind.
With the current rising numbers of COVID-19 cases and the promise of an effective vaccine potentially on the horizon, investigators cannot afford to discriminate against prospective volunteers based on factors unrelated to established protocols, like blindness.
There are many ways that a blind person can meet the requirements to participate in a vaccine trial, including assistive technology and more low-tech solutions. I hope our complaint against the Gamble Vaccine Research Center starts a conversation about the ability of people with disabilities to take part in all clinical trials.