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An Ongoing Struggle: Access to information and Vaccinations for Covid-19 and My Experience Applying to Participate in a Vaccine Trial

Jan 04, 2022 at 02:55 pm by Christopher

Though the current Covid-19 Pandemic continues to rage--with hospitals and health care providers stretched beyond their abilities, testing in short supply, and nearly all aspects of our society impacted, the media and public health officials at all levels have given very little attention to the needs of people with disabilities and special needs populations for testing, treatment, and vaccinations.

Earlier this year, I wrote an entry on the National Federation of the Blind's Voice of the Nation's Blind Blog on the difficulties of blind people in accessing information from public health agencies and scheduling vaccination appointments. Unfortunately, these difficulties remain despite efforts by organizations such as the National Federation of the Blind, which continues to work with vaccine providers and purveyors of information and testing resources to ensure their accessibility to people with disabilities using assistive technology and other means of access.

People with disabilities, particularly members of the blindness community, have also faced barriers to participation in clinical trials of vaccine candidates for Covid-19. This blog entry focuses on my own experience applying to participate in a Covid-19 clinical trial, which I also discuss on the Voice of the Nation's Blind Blog.

In April 2020 as the Pandemic was just beginning, I responded to an ad from the Gamble Vaccine Research Program at Cincinnati Children's Hospital Medical Center for volunteers to participate in clinical trials of vaccine candidates for the emerging Covid-19 virus. My mother also expressed interest in participating, and we both submitted initial online screenings.

On July 27, 2020, the U.S. Food and Drug Administration (FDA) approved the Pfizer BioNTech Covid-19 Vaccine Candidate for Phase III clinical trials, enabling widespread vaccine testing on the general population. The next Thursday, July 30, I received a call from a recruiter at the Gamble Vaccine Research Center, indicating that I had met the eligibility criteria to take part in their vaccine trial. Despite having Optic Nerve Hypoplasia and being Blind, I am otherwise healthy--without many of the risk factors for contracting the virus.

I explained that I would be glad to take part in the trial, but I needed information and accommodations because I am Blind. For one, I needed information on the location of the testing site. Cincinnati Children's Hospital Medical Center consists of several sprawling campuses scattered throughout the City of Cincinnati and beyond. the main campus facilities are constantly expanding and under construction with new buildings being added regularly. To complicate things further, the hospital leases facilities at other hospital campuses for some of its programs. It is possible for a Blind person with good travel skills and a fair amount of patience to navigate the campuses independently, but prior knowledge of the campuses and the general layout of the surrounding area and transportation is extremely helpful. I also needed to have the paperwork in either a PDF that I could complete prior to my appointment or an accessible web-based form which I could complete privately online. I agreed to participate once I had the information I needed to take part in the trials. I explained that this would take about 24 hours, and I would email her back to confirm my interest in taking part in the study.

After I received and reviewed the consent form, I discussed my participation with my mother, and she asked me if we could take part in the study together on the same day. This would enable her to assist me with the paperwork at the site of the vaccine trial.

I emailed the recruiter the next day and received a response that this would not be possible due to Covid protocols. When I asked if accessible versions of the forms I needed to complete were available, the recruiter indicated that she needed to reach out to the research team for this information.

On August 5, 2020, I received a forwarded message from a member of the research team (I have some reason to think this was the principal investigator of the vaccine trial.) expressing that he did not believe that it would be best for me to take part due to the activities required of participants. These activities, according to the consent form, included monitoring the area around the injection sight for swelling, redness, or another sign of an allergic reaction, checking my body temperature at regular intervals, and reporting my results to the research team via an app. All these activities are possible for me to perform--with or without accommodations as a blind person with assistive technology and other techniques. After questioning the recruiter further, she confirmed that the research team thought it would be best for me not to take part in this study as someone who was "otherwise healthy".

I eventually filed a discrimination complaint with the U.S. Department of Health and Human Services, Office for Civil Rights (OCR), the government agency responsible for regulating vaccine trials. In September, the National Federation of the Blind officially joined my complaint, and I received notice that OCR was officially investigating.

An investigator from OCR interviewed me and served a copy of my complaint to Cincinnati Children's Hospital Medical Center, where a senior compliance attorney responded and promised to investigate the matter. It turned out that the U.S. Food and Drug Administration (FDA), which is ultimately responsible for human clinical trials, amended the eligibility criteria for who can participate in the Pfizer BioNTech Covid-19 Vaccine Candidate, excluding all but essential health care workers, first responders, and those considered high risk for contracting the virus. The recruiter should never have contacted me in the first place.

I expressed to the compliance attorney that I thought the team managing the vaccine trial managed my case poorly. If they had simply said to me directly in one of their emails to me that the eligibility criteria had changed, excluding me from the trial, I wouldn't have filed the complaint. Instead, their email suggested to me that they were working from the premise that a Blind person was unable to take part in any clinical trial the program administered. I forwarded my emails to several leaders within the National Federation of the Blind of Ohio, and they had the same view of the emails as I.

Several telephone meetings between the Senior compliance attorney at Cincinnati Children's Hospital Medical Center and I ensued, which the investigator from OCR moderated. I expressed concern that the research staff at the hospital--as well as others serving patients and their families--needed training on the techniques and resources Blind people use to carry out the requirements of a vaccine trial and other daily life activities, and the research team's communication with me reflected ignorance of the capabilities of members of the Blind community. Having worked at the hospital in the past, I also had concerns about the availability of written materials for patients and families in Braille and other accessible formats and the ability of all hospital staff to give even basic directions to a blind person to reach medical appointments on the hospital's campuses. The training would focus on best practices for working with members of the Blind community, either as patients, family members, or participants in a research program or clinical trial.

The hospital's compliance attorney agreed to this. After some further negotiations, the date for the staffing was set for May 20, 2021, a date which happens to be Global Accessibility Awareness Dayy.

Dr. Carolyn Peters, Chair of Opportunities for Ohioans with Disabilities, Ohio's vocational rehabilitation agency, conducted the training, which 54 staff members from CCHMC attended. The training took place virtually.

The training covered Braille, travel techniques, use of the white cane, and assistive technology and accommodations that a Blind person would use to participate in a clinical trial of a vaccine, including talking thermometers and visual interpreter services for smartphones such as AIRA and Be My Eyes.

The centerpiece of the training was a pamphlet from the National Federation of the Blind entitled "Courtesy Rules of Blindness" which CCHMC provided to all staff attending the training and posted to its private intranet.

Following the training, the compliance attorney from CCHMC agreed to work with the hospital's patient relations staff to increase the numbers of accessible materials for Blind patients and family members. Dr. Peters and I shared information during and after the training about local and statewide resources for the hospital to obtain assistive technology and accessible materials for Blind patients, family members, and participants in clinical trials. I also extended an invitation for the compliance attorney and other staff to attend the 75th Annual Convention of the National Federation of the Blind of Ohio which was held in November.

On July 9, 2021, during the annual Convention of the National Federation of the Blind, I was thrilled to hear the organization's President, Mark Riccobono, recognize my work with CCHMC in his annual presidential report to its members. However, access to timely information on Covid-19, testing, and vaccinations continues to be an ongoing struggle for members of the Blind community and people with other disabilities, putting them at increased risk of contracting and spreading the virus.

Sections: Adult Perspectives