Guidelines for the Creation of Accessible Consent Materials and Procedures: Lessons from Research with Autistic People and People with Intellectual Disability

Abstract

Informed, voluntary, ongoing consent is a central tenet of ethical research. However, consent processes are prone to exclusionary practices and inaccessibility. Consent materials are often too long and complex to foster understanding and ensure that people make truly informed decisions to participate in research. While this complexity is problematic for all people, these challenges are compounded for autistic people and people with intellectual disability. Consent materials and procedures rarely incorporate accommodations for processing and communication differences common in autism and intellectual disability. Failure to provide such accommodations ultimately threatens the conduct of ethical research. We describe lessons learned across multiple major U.S. research institutions that improved informed consent materials and procedures, with the goal of fostering responsible inclusion in research for autistic people and people with intellectual disability. We used these alternative materials and procedures in multiple research projects with samples of autistic people and people with intellectual disability. Each contributing team partnered with university human research participant protections personnel, accessibility experts, community members, and researchers to develop rigorous procedures for improving the readability and accessibility of informed consent materials. We present guidelines for designing consent materials and procedures and assert that participatory methods are vital to the success of ongoing accessibility initiatives. Adoption of understandable consent materials and accessible consent procedures can cultivate more equitable, respectful, and inclusive human research practices. Future work should expand on this work to design inclusive practices for populations with additional considerations.

Community Brief

Why is this topic important?

The consent process is how researchers share information with people so they can decide if they want to be in a research study. However, the information shared is often difficult to read and studies often do not offer accommodations. People may not truly understand the risks of the study they agree to be in, or they may not be allowed to make their own decisions about taking part in a study because they cannot understand the study information. Improving consent documents and processes is critical for people to make an informed decision about being in research.

What is the purpose of this article?

We created guidelines for improving consent materials and protocols. Our guidelines aim to support accessible and inclusive informed consent processes in autism and intellectual disability research.

What personal or professional perspectives do the authors bring to this topic?

We put together a “consortium” or a group of teams. Our consortium includes teams of neurodivergent (e.g., autistic, attention-deficit/hyperactivity disorder, acquired neurodivergence) and neurotypical researchers, community members, and advocates. Members bring both lived and professional experiences working to improve inclusive and ethical research procedures. We used participatory methods because lived experience is central to respectful, impactful science that is tailored to the needs of specific populations.

What did the researchers do?

We created guidelines for improving informed consent materials and processes for research with autistic people and people with intellectual disability. We based these guidelines on our experiences working with our universities on multiple research studies with autistic people and people with intellectual disability. The guidelines were acceptable both to the community and our universities.

What do the authors recommend?

Improve the understandability of consent materials:

• Start with consent checklists instead of templates.

• Improve written language and formatting.

• Use participant-centered language.

• Use precise and concrete phrasing.

• Structure documents in a logical order.

• Integrate visuals and/or multimedia.

• Simplify and integrate authorization language, as needed.

Create accessible consent procedures:

• Minimize environmental and executive functioning barriers.

• Allow the use of electronic consents, as applicable.

• Provide options for a range of communication needs.

• Support decision making.

• Consider whether a consent competency assessment is necessary.

• Consider people with decisional impairment.

We offer accessible language, checklists, and consent document examples. We recommend that researchers work with their universities or other research institutions to make changes to university-wide templates and guidance. We highlight the importance of developing strong community partnerships and including community members in attempts to make research more inclusive.

How will these recommendations help autistic adults and people with intellectual disability now or in the future?

Making an informed decision to participate in research is a right. However, researchers often use complex informed consent language in disabling environments. These guidelines encourage researchers to partner with community members and representatives of research institutions to change informed consent forms and processes. These guidelines also encourage researchers to evaluate and make changes to consent procedures to be more inclusive. We believe such efforts can improve the ethical inclusion of autistic people and people with intellectual disability in research.