Unethical Study Explained: Attend Less, Fear More: Elevated Distress to Social Threat in Toddlers With Autism Spectrum Disorder





Everyone can agree that medical studies are necessary to keep society healthy. There is a fine line on the necessity of a study and exploiting disabled babies. Yes, disabled babies.  According to Eric Yan of Harvard medical school, research including developmentally disabled children and adults have contributed greatly for improvements in quality of life but also remembered for major ethics violations. Closer examination of existing codes with respect to developmentally disabled people is because of the past violations that have occurred. 


This study is frighteningly similar to the Little Albert Experiment

In 1920, Watson and Rayner conditions an orphan called Albert B (also called Little Albert) to fear a white rat. Pavlov showed that classical conditioning applied to animals. Watson and Rayner showed that it also applied to humans.

Little Albert was a nine month old infant that was experimented on. They wanted to see his reaction to different stimuli. He was shown a white rat, a rabbit, a money and various masks. Albert showed no fear to any of these stimuli. He was startled when a hammer was striking a steel bar behind his head. When he heard the sudden loud noise, he would cry.

When Albert was eleven months old, the white rat was presented then a few seconds later the hammer hit the steel bar. This was repeated seven times. Every time Albert cried. He tried to crawl away. This caused Albert to be afraid of the rat.  Watson and Rayner noticed that Albert was also afraid of objects that shared characteristics with the rat. Some examples were the family dog, a fur coat, cotton wool and a father Christmas mask. This is called generalization.

Watson and Rayner showed classical conditioning could incite fear. It was a phobia because it was an irrational fear. The next few weeks and months, Albert was observed and 10 days after conditioning his fear was less marked. This dying out of a conditioned response is called extinction. After a month, he was still afraid but the response wasn't as severe.


The Study in Question 

At Yale University, both autistic and neurotypical toddlers were being subjected to stimuli to trigger a fear response. The purpose of this study was to show a link between exposure to a social threat and distress level in an autistic toddler.  The study will be broken down and explained in order for the average person to understand what happened during this study. Their reason for their study is that young autistic children exhibit "atypical reactivity to every day challenges." This means they react differently to stimuli that trigger them emotionally. Some challenges that the study staff consider to be every day but can be more stressful for the autistic person. In order to pathologize autism, the study doctors have the desire to witness babies in distress. 

Who Approved this Study

This study was approved by the Human Investigation Committee of the Yale School of Medicine and informed written consent was obtained from the parents of the participants. The participants were 42 autistic toddlers (average age of 22.42 months) and 22 typical toddlers (average age of 22.97 months) without a family history of autism. 

Who Participated in the Study

The typical toddlers were the control group. The autistic toddlers were referred to a university clinic to confirm an autism diagnosis. The participants were assessed using the Mullen Scales of Early Learning (MSEL) and "severity of autism symptoms (their words not mine)" using the Autism Diagnostic Observation Schedule- 2 (ADOS-2) toddler model. There was a child psychologist, a social worker, and a speech language pathologist assigned to carry out the assessments. Toddlers who had known genetic abnormalities or gestational age under 34 weeks (born before the pregnancy was 34 weeks long) were excluded. 26% of the participants were female. 

Study Procedure

Every toddler was assessed for emotional reactivity to fear inducing probes. This means the reaction to a scary event was recorded. These probes were made to trigger fear though different novel and potentially threatening stimuli. 

The stimuli were:
  • female stranger wearing dark clothing, a hat and sunglasses entering the room approaching the child and leaning towards the child for approximately 3 seconds one time
  • a large mechanical spider crawling towards the child 3 times
  • a mechanical dinosaur with red light up eyes approaching the child 3 times. 
  • female stranger with dark clothes wearing 3 grotesque masks one right after another while entering the room briefly and maintaining a 1.5 meter distance from the child
The examiners did not speak, touch or engage with the toddlers while they were enduring the fear inducing events. There were only 30 second breaks between event. This was not for the benefit of the child. This was so the child would be in a neutral mood before being exposed to the next event. 

All session were video recorded and coded for peak intensity of distress response across facial, vocal channels and visual attention to threatening stimuli for emotional regulation strategies. They expected 22 month toddlers to know how to emotionally regulate on their own. 

Typical toddlers completed fewer trials than the autistic toddlers. Some of the toddlers were terminated due to parent non compliance. 

Ethical Principles when Involving Developmentally Disabled People in Research

People who are developmentally disabled are uniquely vulnerable populations. They experience greater burden from mental health issues because they received poorer quality of care than their typical peers. Because of this, a code of ethics is necessary. The different principles of ethics and they relate to this study will be explained. 

Principle of Validity

The researchers are more likely to understand the nature and purpose of the study better than participants. Because of this, the researchers are responsible for being aware of the requirement of validity. The aims of the study should be the understanding and treatment of a condition. Scaring babies does not allow the researchers to understand autism anymore than they did already. 

Principle of Distributive Justice

The principle of distributive justice considers fair, equitable and appropriate division of risk as well as benefits generated by a given study. 

According to the non profit Friendship Circle, post traumatic stress disorder (PTSD) is prevalent in disabled babies and toddlers. Symptoms of PTSD in babies and toddlers are hypervigilence, separation anxiety or clinginess, emotional distress when reminded of initial trauma, fear or avoidance of places that remind them of original event, trouble sleeping, and nightmares. 

The researchers in this study did not even consider the possibility that being scared at such a young age could cause PTSD in the participants. There was no benefit to the participants. There was no appropriate division of risks and benefits in this study. 

According to Stanford Children's Hospital, PTSD in a child is caused by:

  • something that happened to a child
  • something that happened close to the child
  • something the child saw

Principle of Beneficence and Nonmaleficence

It is important to balance the competing claims of potential benefits and risks assumed by each participant. The four categories of research on children relating  to risks and benefits according to the National Institute of Health Inclusion of Children as participants:
  • not greater than minimal risk/direct benefit
  • not greater than minimal risk/no direct benefit
  • greater than minimal risk/direct benefit
  • greater than minimal risk/no direct benefit
All of these combinations are permitted but the strength of the argument justifying each category must be stronger when the risks to the participants reach greater than minimal levels and when the prospects of direct therapeutic benefits decrease. 

According to this principle, the argument for possible PTSD was never made in any of the statements put out by Yale University or in the study report. The argument was never made therefore the study was against the code of ethics. The PTSD argument is explained in the Principle of Distributive Justice. 

Principle of Autonomy

The principle of autonomy is the informed consent, protection of privacy, and confidentiality. The regulatory procedure allows participants or legal representatives to express free will with respect to various angles of research. This includes risks and benefits. 

According to this principle, autonomy was not met. Because the possibility of PTSD being an effect of this study, informed consent was not given. Free will was impossible to give to the toddlers or their parents. 

Response from Yale after Outrage 

They defend the study by saying it was reviewed and approved by the Yale Institutional Review Board. They claim it was conducted in accordance with strict federal regulations regarding ethics in science and research. They do not address the ethics violations. They do not use an outside review board. They use a review board they employ themselves. They did not address that most of the outrage was by autistic adults. 

They said that the main goal was the advance understanding of development of emotional difficulties. All they had to do was talk to autistic adults that went through it. They did not have to traumatize babies. Some were traumatized so much, their parents withdrew their children from the study. 

At the end of the statement they invite any feedback but they do no take it seriously. Here is an email with the name blocked out. 






Sources: 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3124381/

https://drive.google.com/file/d/1kqiekRj0tGJSorzxmT-xelnMYOumFIk6/view

https://www.friendshipcircle.org/blog/2013/07/12/post-traumatic-stress-disorder-in-babies-and-toddlers-what-are-the-symptoms/

https://medicine.yale.edu/news-article/29344/



Comments

  1. Terrifying. Just terrifying.

    Emily Willingham wrote about this study too.

    ReplyDelete

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