A Positive Step Forward: Update on the Issues I had While Trying to Participate in a Vaccine Trial
by Chris Sabine
In April 2020, at the onset of the pandemic, I applied to participate in a clinical trial of a promising vaccine candidate for the emerging COVID-19 virus. As a member of the National Federation of the Blind (NFB), business owner and child of aging parents, I felt obligated to do my part to contribute to mitigating a virus that had so far claimed thousands of lives and essentially placed our economy and society on hold.
On July 30, 2020, following the US Food and Drug Administration’s approval of the Pfizer - BioNTech COVID-19 Vaccine Candidate for Phase III clinical trials, I received a call from a recruiter at the Gamble Vaccine Research Center at Cincinnati Children’s Hospital Medical Center (CCHMC), the local research site to which I had applied, informing me that I was eligible to take part in their trial.
While reviewing my qualifications to participate with the hospital, I explained that I needed reasonable accommodations because I am blind. After a week of emails between me, the recruiter, and staff managing the trial, I received a message stating that it would be best for me not to take part in the trial. The notice insinuated that several tasks necessary for participants to complete, such as taking body temperature and reporting symptoms, required sight.
I eventually filed a complaint with the Office of Civil Rights of the US Department of Health and Human Services (DHHS) alleging discrimination based on my blindness, and on September 24, the NFB joined my complaint. In December, I received a notice from DHHS stating that my case was being investigated for potential violation of Section 504 of the Rehabilitation Act of 1973 and Section 1557 of the Affordable Care Act of 2010. These laws require health care providers and others receiving federal funds to make reasonable modifications to allow people with disabilities to participate in their programs, activities, or services; both laws applied in my case.
The investigator in charge of my case interviewed me and spoke with a senior attorney at CCHMC who was responsible for compliance. Through this process, it was found that the selection criteria for participation in the clinical trial had changed when the FDA approved the vaccine candidate to only include those with underlying health conditions or health care workers. That information was never communicated to the recruiter who reached out to me. Since I fit neither category, the recruiter should have never called me in the first place. [Even so, the low expectations of the recruiter would have excluded me from participating and that is inexcusable.
The compliance attorney for CCHMC conceded that the research and recruitment staff showed poor communication with me regarding my participation in the study, and he agreed to work with me to modify their policies to better accommodate blind participants in future clinical trials. After consulting with members of my NFB affiliate and negotiating with the compliance attorney at CCHMC, I was given the opportunity to prepare and organize a professional in-service training on best practices for including blind people in clinical trials.
The training consisted of an overview of the alternative techniques blind people use to accomplish tasks necessary to participate in a clinical trial and perform other daily activities, such as Braille, the white cane, and assistive technology. Information on resources to accommodate blind research participants as well as patients and family members was also provided to clinical and family relations staff at CCHMC.
On July 21, 2021, I received notice from DHHS that my case was officially resolved. Our NFB affiliate and I plan to continue to work with the hospital on accessibility initiatives in the future and help CCHMC to improve access to materials and information for members of the blind community.
I was surprised and thrilled to hear our efforts recognized by President Mark Riccobono during his 2021 Presidential Report at national convention. It is empowering and humbling to realize that my efforts have played a role in helping the blind of this country truly live the lives they want.