Some autistic people with communication challenges need extra
support before they can participate in research. To give informed
consent, they need to have the risks and benefits of a study explained
to them in ways they can understand.
The United States’ Common Rule, which regulates human subjects
research, requires “additional safeguards” for participants “vulnerable
to coercion or undue influence.” While that description applies to some
autistic people — particularly those who are non-speaking or
intellectually disabled — the Rule doesn’t specify what safeguards
should look like. The federal Office for Human Research Protections
(OHRP) acknowledges that regulations “are silent on the consent procedures specific to subjects with impaired decision-making capacity.”
Minimally verbal and intellectually disabled autistic people are underrepresented in research, and even projects meant to highlight the lived experiences of autistic people seldom include
those with high support needs. But provided that institutional review
boards (IRBs) include members or consultants who have the requisite
expertise, the boards are free to develop informed consent processes
“that best match the needs of [research] subjects,” according to the
OHRP. By working with IRBs, investigators can create accessible informed
consent processes and include a fuller range of autistic participants.
Here, we explain what those processes can look like.
Is informed consent just paperwork?
The groundwork for informed consent begins before any forms are
signed. Advertisements, recruitment materials and informational phone
calls are all tools investigators can use to relay key information to
potential participants.
Even after someone expresses initial interest, it’s not enough to
simply give them a list of facts about the study, according to the
Common Rule. Investigators also need to help them understand why they
might or might not want to join.
A written consent form can help document this process and act as an
informational resource, but informed consent should really be an ongoing
conversation between researcher and participant — one grounded in
respect for the participant’s autonomy to “choose what shall or shall
not happen to them,” as set forth by the 1979 Belmont Report.
This should include the investigator explaining the study and its
purpose as well as potential risks and benefits. They should explain
that the participant can withdraw at any time, and they should offer to
answer any questions. If the study is offering an experimental
treatment, the participant should hear about existing alternatives.
How can investigators ensure that participants understand the study’s details?
While investigators explain the specifics of a study, they also need
to pay attention to participants’ levels of comprehension, explains Paul Appelbaum, professor of psychiatry, medicine and law at Columbia University in New York City.
If someone doesn’t seem to understand, the research team may bring in an outside clinician, says Benjamin Silverman,
instructor of medical ethics at Harvard Medical School and an IRB chair
at several Boston-area hospitals. That clinician will talk to the
participant and make a determination about their “decisional capacity.”
In studies that are higher risk or involve groups of people more
likely to “lack capacity,” all participants may be required to undergo
more formal screening, says Appelbaum. Just because participants already
have a diagnosis that involves some level of cognitive impairment, he
says, that doesn’t necessarily mean they’ll be unable to consent.
However, the required level of decision-making capacity increases in
tandem with “the level of risk or burden” of a study, Silverman says.
For example, a participant may have enough decisional capacity to
consent to an online survey, but not an experimental surgery.
How can researchers support potential participants who struggle to understand?
If an autistic person is having difficulty understanding information
about the study, they may need extra support. Investigators are free to
adapt communication strategies as necessary to help, and indeed, the
Common Rule requires that information “be in language understandable to
the subject.”
Autistic people can especially benefit from asynchronous and
text-based communication options like email, which allows people who
process information more slowly to have the time they need to think and
respond.
The Autistic Self-Advocacy Network (ASAN) suggests using specific
communication formats intended to facilitate comprehension, such as “Plain Language,” an easy-to-understand writing style required in some government documents, and “Easy Read,”
a format designed to be more accessible to readers with intellectual
disabilities. Researchers should also be prepared to take all the time
necessary to work with participants who use augmentative and alternative
communication systems, says R. Larkin Taylor-Parker, legal director at
ASAN.
Using the supported decision-making (SDM) model — originally
developed to help disabled people retain legal autonomy over
responsibilities like finances and health care — can also help
participants who need help making decisions about research, according to
a recent commentary in Nature Medicine
that Silverman co-authored. People using SDM draw upon formal or
informal networks from their own communities to help them think through
decisions rather than rely on a legal representative to make choices in
their stead.
What if someone is legally incapable of giving informed consent at all?
Surrogate decision-making models — most notably guardianships —
remain common for autistic adults. People under guardianship legally
lack any capacity to consent to research because a court has transferred
their ability to make decisions about some or all areas of their life
to a third party.
Guardianship law varies by state. Some states prohibit research on
those under guardianship, while others allow it in specific
circumstances, such as research meant for rehabilitation or prevention
of a serious health risk. IRBs also restrict guardians’ ability to
consent to research on their wards’ behalf. An IRB might approve a study
if it involves minimal risk, but as the level of risk goes up, the
potential benefits to the ward must also increase. Institutions often
restrict or prohibit altogether the use of surrogate decision-making to
enroll people in research “that’s greater than minimal risk with no
direct benefit,” says Silverman.
Even when the law requires that investigators first secure consent
from a legally authorized representative, investigators can also plan to
get “assent” from participants themselves, Appelbaum says. Assent —
intentionally seeking a participant’s yes or no in addition to that of
their legal representative — is already common in research that includes
children.
Many people under guardianship can still communicate their wants and
needs, says Taylor-Parker. Even if a participant lacks legal autonomy,
they say, researchers should be prepared to use all the communication
tools at their disposal to make sure that the individual understands the
research and wants to be part of it.
Where do these guidelines come from? Why do they matter?
The current approaches to informed consent are often grounded in a
“desire to protect,” Silverman explains. For example, the Belmont
Report, which provided the ethical foundation for today’s Common Rule,
was developed in the context of 20th century research transgressions targeting vulnerable members of society.
But underrepresentation of groups of people in research can have
long-lasting consequences, according to Appelbaum. The exclusion of
women and children, for example, produced “lacunae in our knowledge
base,” he says — holes that, decades later, scientists are still working
to fill.
“If you exclude people with disabilities from research,” Silverman
says, “the outcome of the medical products that get approved won’t be
helpful for them.”
Full Article & Source:
Decisional capacity and informed consent, explained
