Informed Consent in Adults with Autism: Ethical and Legal Considerations in the United States

Background: The process of obtaining informed consent is guided by many ethical values such as autonomy, beneficence, and justice. At times these principles are in conflict, directing researchers to seek guidance at the institutional, state and federal level. When it comes to consenting individuals who may lack the capacity to make a truly informed decision about participation, a disparity arises between autonomy (the ability for a person to make their own decisions) and justice (the fair selection of research participants). Historically protections have been put in place to shield potentially vulnerable populations including children, prisoners, pregnant woman and individuals who may have reduced capacity to consent. The protections set in place for these groups were patriarchal in nature, in that, these groups were thought to be at greater risk for exploitation and misuses. However, this protection has lead to the restriction of participation in research in turn diminishing the evidence-base for vulnerable populations.

Objectives: A large proportion of adults with autism have intellectual disability and/or are non-verbal making it difficult to assess their capacity, and thus challenging to obtain  informed consent. The current investigation aims to evaluate the matter of informed consent with regard to these low-functioning adult individuals with autism.

Methods: We conducted a search in Lexis Nexis for legal and news related articles, Casemaker for case law and statutes, and PubMed for relevant scientific articles in policies and practice with intellectual disability/capacity to consent.

Results: Our investigation of the law and scientific literature revealed that federal regulations are silent on who can act as a legally authorized representative for adults with autism regarding participating in research. This leaves the onus at the state level. Six states in the US have enacted surrogate consent statutes for research, however, all but one limit the surrogate’s authority. When no laws exist, it is often the institution that sets the bar in regard to safeguards for human subjects; remarkable variability between institutions suggests a need to create a “common practice.” Our research investigating adults with autism and their transition to adulthood has found that approximately 50% of our participants are their own legal guardians for a variety of reasons, not limited to the financial burden associated with seeking guardianship, avoidance of seeking judicial involvement, or lack of a sufficient surrogate.

Conclusions: We recognize that a diagnosis does not define a person’s level of capacity, thus when obtaining consent, we have proposed and currently use a ‘consent survey’ to assess the perspective participant’s understanding of the research and its personal relevance. However, we have yet to develop means of assessing capacity in individuals who are non-verbal; protocols involving surrogate and/or waived consent in certain circumstances are an option for consideration. It is crucial that we allow all individuals to participate in research that is of minimal or minor over minimal risk. Not only are there ethical considerations in denying these participants the potential benefits that research can offer, it is a necessary step toward obtaining knowledge about all adults with autism.