Ethics and autism research
In a story from September 2008, Harold LD (an east coast Canadian blogger) calls attention to a large multi million dollar study, headed by Dr. Stanley Greenspan, professor of psychiatry at George Washington University. Greenspan, a long time researcher and expert on emotional and development disorders, will identify infants at risk for either autism spectrum disorder or attention deficit disorder, provide half of them with intensive behavioural intervention (IBI therapy — also sometimes referred to as ABA therapy) while the other half will have no therapy. All the children will be followed through to age 5.
Here’s the story From Harold LD’s blog: Autism Research Ethics – Is It Ethical to Deny ABA to Autistic Infants for Research Purposes?
It’s been proven that two things are beneficial for kids diagnosed with autism. The first thing is early intervention. Early identification that a child is “at risk” is a good indicator of a possible diagnosis. Many parents spend months and years, going from generalist to specialist, trying to find a diagnosis for their child. By the time some kids are diagnosed with autism, the window for effective early intervention may be closing. The second thing is IBI. Now, IBI is not without its critics — based on principles of behavioural therapy, it is incredibly expensive, highly focused on outcomes and rewarded reinforcement and frankly, it’s not a panacea for every kid diagnosed with some form of autism. However, there is clear evidence that this intensive therapy, when offered in various, individualized forms and delivery modes, can help many kids with autism to develop generalizable skills in areas of communication and socialization — two commonly affected areas in kids who are autistic.
The literature supports these two things as beneficial. Early intervention and at least a trial with IBI therapy is a good thing for most kids with autism, notwithstanding that if you have 20 kids with autism in a room, you’ll have 20 very different kids. But it’s pretty easy to say that, across the board, early intervention with effective therapy benefits these kids.
So, back to the question posed in the headline — is it ethical to deny some kids with autism or who are at risk of autism, access to IBI therapy? In medical trials, the principle of clinical equipoise is an important consideration. It is the ethical foundation of sound medical research projects that assign subjects to more than one arm. If it is evident that one arm or treatment is superior to another, the trial should not begin (if it hasn’t been started) or should not continue (if it is already underway). The notion of clinical equipoise implies real uncertainty over the relative benefits of one arm of treatment over another. A trial, designed to meet the criterion of clinical equipoise should, at it’s completion, be able to answer the question, “Which treatment is preferable?”. In this case, I would posit that we already know the answer to that question…
In this case, we know that early intervention is beneficial to kids at risk of autism or diagnosed with autism. (Note — the study notes that these kids are “at risk” of autism — not necessarily kids diagnosed with autism. So at risk kids in this group who are never diagnosed with autism will arguably benefit from close observation by simply being enrolled in the trial, through to age 5.)
However, it is foreseeable that a good number of these kids likely will be diagnosed with autism somewhere along the way and hopefully well before age 5 (it would make sense that they would be diagnosed early if they are being observed so closely). Should the children who go from being identified as at-risk to then being diagnosed with autism be removed from the trial in order to receive the clearly documented benefits of early intervention and treatment….?
Updates on this story to follow.
To read more about autism and IBI, here’s a good straightforward Q&A on autism and IBI therapy from the Sick Kids Hospital (Toronto, Canada) website.
To read more about clinical equipoise, here’s a short, clear article from the BMJ by Weijer, Shapiro and Glass: Clinical equipoise and not the uncertainty principle is the moral underpinning of the randomised controlled trial.