Ethical Approach to Informed Consent for Adults with Intellectual Disabilities
Some researchers have developed novel approaches to improve their informed consent materials for clinical trial participants living with cognitive impairments. “However, this is largely seen as procedural, and is rarely described in published articles. We are missing out on innovative, ethical practices that could benefit the research field,” says Jesse Strickler, MS, a doctoral candidate at The Ohio State University Nisonger Center.
Strickler and his doctoral advisor evaluated a novel informed consent process to help adults living with intellectual disabilities understand key elements of research.1 The authors asked 21 adults living with intellectual disabilities to complete an iterative teaching process. Next, they asked participants about their attitudes toward the materials, and their comprehension of the materials.
Only two participants achieved a perfect comprehension score, with up to three opportunities to learn the material. “This finding supports the idea that the criteria to demonstrate sufficient capacity to consent should be flexible — and proportional to the complexity and risks of each individual study,” Strickler suggests.
Researchers must consider individual differences and be prepared to use a variety of methods. “Researchers should accommodate the needs of the unique individual sitting in front of them, rather than assuming one accommodation will benefit everyone equally,” Strickler says.
For researchers working with a population with cognitive impairment, Strickler offers these approaches for the informed consent process:
• Create a plan to measure comprehension of consent and assent. “It doesn’t have to be formal or rigid,” Strickler says.
Researchers simply need a way to collect feedback on whether a certain approach was effective. It is possible the researcher needs to provide additional accommodations. “This is not unique to individuals with intellectual disability or other populations with cognitive impairment,” Strickler notes. “People regularly sign things they do not read thoroughly or understand, and that is not unique to research.”
• Ensure the threshold for demonstrating capacity to consent is proportional to the complexity and risk of a study. “It’s worth having at least two or three methods of presenting information ready for those who have some trouble fully comprehending the first time around,” Strickler offers.
Instead of highly technical, jargon-filled forms, research staff might offer conversational verbal prompts. “This can make connections to relatable examples in individuals’ lives,” Strickler says.
• Use a script or checklist to guide research staff in verbal consent processes. Some participants struggle with reading, or prefer a conversation instead of a written document. “Use open-ended questions to assess comprehension in a low-pressure, conversational manner,” Strickler advises.
For instance, researchers might ask: What will happen in the study? What are the potential risks of the study? What could go wrong if you decide to be in the study?
• Take the informed assent process just as seriously as the consent process. When an individual does not possess capacity to consent, a designated proxy decision-maker must complete the informed consent process and sign documents on their behalf. However, the study participant still has to assent. The ethical concern is that often, the emphasis of the consent process is on ensuring the proxy comprehends. “There’s limited effort made to ensure the potential participant understands the study, because a legal representative has already signed on their behalf,” Strickler observes.
If the potential participant lacks decision-making capacity, researchers may not see the value in trying to ensure the participant understands what will happen in the study. “Legally, they are already in the clear, with the consent signed,” Strickler explains.
However, the study participant should always retain the right to decline to participate. This situation can be challenging for research staff. “But it is still their responsibility to monitor for any demonstrations of dissent, such as shaking one’s head, attempting to leave the study visit space, or refusing study procedures,” Strickler says.
Importantly, even if someone does not have the legal right to consent independently, they always retain the right to withdraw whenever they want. “This is true even in the middle of the study — and the proxy decision-maker who signed the consent forms has no authority to overrule that,” Strickler says.
1. Strickler JG, Havercamp SM. Evaluating an informed consent process designed to improve inclusion of adults with intellectual disability in research. Res Dev Disabil 2023;134:104413.
The criteria to demonstrate sufficient capacity to consent should be flexible — and proportional to the complexity and risks of each individual study. Researchers must consider individual differences and be prepared to use a variety of methods.
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