View on Disability: Trials exclude vulnerable people

When working on technological products — from smartphones and websites to water pumps — designers should keep disabled users in mind from the outset, according to several speakers I heard at a conference last month. Doing this means that products can be used by people with any disability, and that companies have the largest market possible for their wares. 

A similar message needs to get through to the designers of clinical trials, to paraphrase Celia Fisher, director of the Center for Ethics Education at Fordham University in the United States, who I bumped into over coffee at the same meeting. Trials can — and should — be designed so people with disabilities are included, she told me.

They often aren’t because of a misapplication of the principle of informed consent — the idea that participants in trials should understand the potential risks and benefits involved. This is a priority for institutional review boards, the bodies that oversee the ethical conduction of trials, because it is seen as the best way to avoid pressurising or exploiting people.

“Many times, review boards think people with intellectual disabilities should be excluded so we can protect them from coercion or not really understanding the research they’re in,” says Fisher.

“Now the problem with that is that treatments for different health problems are not always effective in all populations, so if people with intellectual, or other disabilities, are not included then it violates the principle of justice, because they don’t have the opportunity to benefit from information that can be derived from that research.”

Fisher’s solution is what she calls the ‘goodness-of-fit’ ethic, an approach she developed and which, she says, has gained approval among her colleagues. The idea is that researchers should adapt the way in which they obtain informed consent to the intellectual strengths and vulnerabilities of the individuals they are recruiting. [1]

For example, Fisher cites her experience of asking intellectually impaired adults participating in a trial if they understood that their data would be kept confidential. In one of her studies, researchers explained confidentiality using phrases like: ‘we won’t put your name on the data’ and ‘we won’t tell anyone about it’.

“These adults would often respond: ‘So you’ll put it in a drawer?’” she tells me. “If we were going to do a straight test of whether they understood what we said, we might say they got it wrong. But for them, that’s how you keep something secret. We should understand that fact, not denigrate their comprehension.”