Features
Rewriting the Rules of Informed Consent
A look at efforts to include individuals with intellectual and developmental disabilities in clinical research
When hematologist / oncologist Cecilia Arana Yi , MD , first saw George ( name changed to protect identity ) in her clinic at the University of New Mexico Cancer Center , she thought he would be an ideal candidate for a nationwide registry study . He ’ d been successfully treated for leukemia in his 30s but later developed pancytopenia . Dr . Arana Yi was eager to send his bone marrow aspirate to a central biobank so researchers could identify the molecular mechanisms underlying his cancer .
As it turned out , though , George was not eligible to participate in the study . His intellectual disability related to Down syndrome ( DS ) made him unable to complete the standardized quality-of-life measures required by the study protocol .
“ We don ’ t know much about the biology of secondary leukemias or adult-onset leukemias in people with DS and this is , in large part , because the adult trials for leukemia are very restrictive ,” Dr . Arana Yi told ASH Clinical News .
She couldn ’ t enroll him in an interventional trial , either , even though his father and sister , who are his legal representatives , wanted him to participate . “ In the pediatric setting , patients ’ parents make the decision to enroll children in a clinical trial , and the demands on the patients are less ,” Dr . Arana Yi explained . “ But in adults , if patients are unable to consent or fulfill the protocol requirements , we can ’ t enroll them , even if the treatment is potentially lifesaving .”
Consent has three components : disclosure , capacity , and voluntariness . It sounds simple enough , but the application of this concept can be controversial , complicated , and vague , particularly for individuals with intellectual and developmental disabilities . ASH Clinical News spoke with experts in clinical research and ethics to gain a better understanding of the perceptions , attitudes , and impediments associated with enrolling this population into clinical trials – as well as some ways to make trials more inclusive .
Rewriting the Rules of Consent ?
“ Informed consent ” is a universally recognized fundamental concept in medical ethics and medical law , designed to protect individuals from unwanted intrusion . This simple line item appears in every clinical trial protocol : It is unlawful to touch someone without explicit permission , and that permission can be granted only if the participant understands what is going to happen and gives consent voluntarily .
For conditions of informed consent to be met , the person providing consent must have the capacity to make the decision to receive care or not . In most situations , the absence of clear indication of incapacity is enough to assume capacity . ( The terms “ competence ” and “ capacity ” are often used interchangeably ; competence is a legal term , whereas capacity refers to a person ’ s ability to make a reasoned medical decision .)
Recent research challenges the assumption that individuals with disabilities cannot provide informed consent .
In a 2013 study of 131 adults with intellectual disabilities , researchers used a brief questionnaire to assess the extent to which individuals understood key aspects of a low-risk ( i . e ., mildly interventional ) health-promotion study . 1 After meeting one-on-one with study staff , participants were asked six questions about the study ’ s design and objective ( e . g ., “ In your own words , what is this study about ?”; “ What can you do if you start the study but
58 ASH Clinical News September 2017