This month our spotlight section focuses on strategies to strengthen informed consent for persons with disabilities. The first article is by Boie et al., publishing in Investigative Ophthalmology & Visual Science – Adaptations to the administration of informed consent when conducting research with older adults that are deafblind. The authors investigate ways that new technologies can be used to overcome barriers faced by people living with “deafblindness”. They propose easy-to-implement adaptations of IC content to alternative and adapted formats for the administration of informed consent/assent helping protect patient autonomy and dignity, as well as confidentiality.
ASL Consent in the Digital Informed Consent Process by Kosa et al., appears in the Journal on Technology & Persons with Disabilities. In this article, the authors propose to use machine learning technologies in an app which enables consent transactions via American Sign Language. This innovation – which they coin as “ASL consent” – helps to overcome existing text/spoken language barriers to help reach patient populations who may be otherwise excluded from research.
Adaptations to the administration of informed consent when conducting research with older adults that are deafblind
Norman Robert Boie, Atul Jaiswal, Walter Wittich
Investigative Ophthalmology & Visual Science, June 2023
Abstract
Purpose
Multiple access barriers exist for persons with deafblindness that want to participate in research. The process of informed written consent is not easily accessible for persons with deafblindness, and its administration is often regulated by institutional review boards that have little or no experience accommodating this process. The purpose of this study was to explore alternative and adapted formats for the administration of informed consent/assent in research with older adults living with reduced or absent functional vision and hearing.
Methods
Within the context of a larger project on deafblindness and health service access during the COVID-19 pandemic, we recruited 32 persons (Age 59 to 91, M = 77) with deafblindness, through rehabilitation centres in Canada. The research assistant systematically tracked communication formats and accessibility requirements and coordinated with the rehabilitation centres to adjust the consent process according to the requirements and preferences of each participant. He took systematic field notes and compiled all adaptations, which were later analyzed using qualitative description.
Results
We converted our approved consent text into free-format electronic versions or paper-format without logos, line boxes, or bullet points, to facilitate easy access through scanners or screen readers. For participants who communicated through interpreters, we adapted the process to make interpretation into sign language easier. Verbal consent could be recorded for individuals where paper signatures posed a barrier. For the administration of demographic questionnaires, we eliminated check boxes and accepted verbal or signed response formats that could be more easily recorded. The main outcome of these adaptations was to allow our research participants with deafblindness to access and complete their informed consent process as independently as possible. Not only did these adaptations protect confidentiality and dignity, but their implementation facilitated the subsequent qualitative interviews in the most autonomous way possible.
Conclusions
These adaptations contributed to the experience of our participants and increased the capacity of our team by developing skills centered around flexibility, patience, respect and trust. This improved communication and empathy, while facilitating equity, diversity and inclusion in research through accessibility.
ASL Consent in the Digital Informed Consent Process
Ben S. Kosa, Ai Minakawa, Patrick Boudreault, Christian Vogler, Poorna Kushalnagar, Raja Kushalnagar
Journal on Technology & Persons with Disabilities, 2023
Abstract
There is an estimated 500,000 people in the U.S. who are deaf and who use ASL and live in the U.S. Compared to the general population, deaf people are at greater risk of having chronic health problems and experience significant health disparities and inequities (Sanfacon, Leffers, Miller, Stabbe, DeWindt, Wagner, & Kushalnagar, 2020; Kushalnagar, Reesman, Holcomb, & Ryan, 2019; Kushalnagar & Miller, 2019). Much of the disparities are explained by the barriers in the environment, such as the unavailability of materials in ASL and lack of healthcare professionals who know how to provide deaf patient-centered care. Intersecting social determinants of health (e.g., intrinsic – low education; and extrinsic – barrier to healthcare services) create a mutually constituted vulnerability for healthdisparities when a person is deaf (Kushalnagar & Miller, 2019; Lesch, Brucher, Chapple, R., & Chapple, K., 2019; Smith & Chin, 2012). Moreover, the longstanding history of inequitable access to language and education, and a lack of printed information and materials, leave people who are deaf and use ASL unaware of opportunities to participate in cutting-edge research/clinical trials. An unintended consequence, therefore, is that PIs neglect to include people who are deaf and use ASL in their subject sample pools, and this marginalized population continues to be at disparity for health outcomes and also clinical research participation. One barrier is the unavailability of informed consent materials that are accessible in ASL. The current research study conducted by our team at the Center for Deaf Health Equity at Gallaudet University attempts to address the language barrier to the consent process through a careful reconsideration of its traditional English format and the development of an American Sign Language (ASL) informed consent app. This team successfully leveraged existing machine learning methods to develop a way to navigate and signature an informed consent process using ASL. We call this new method of navigation and signature “ASL consent.” In our findings, we found that deaf people who are primarily college educated were more likely to agree that the process for obtaining ASL consent through an accessible app is comparable to traditional English consent.
Center for Informed Consent Integrity 