The SRA Symposium - College of Medicine

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sponsors must have some idea of what they expect (hope?) the experimental drug will accomplish.
While researchers walk a fine line between informing vs misleading subjects about possible benefits,
how can subjects make an informed decision if they can’t compare specific risks and specific
benefits?
But deciding to be in a clinical trial requires that subjects understand the risks and benefits of being
in that trail. But if risks and benefits are not clearly articulated, how can patients be expected
to make an informed decision? Although risks are often described as “common,” “uncommon” or
“rare,” unless those terms are defined, patients will make their own definitions. Berry, et al (2003)
compared the frequency of drug-related adverse events by study participants to the frequencies
defined by the European Commission (EC) for events that were “very common,” “common,”
“uncommon,” “rare,” or “very rare.” In every case the study participants rated the risks as likely
to be more frequent than the EC definition. For example, while the EC defined a “very common”
adverse event as one that affected more than 10% of patients, study participants defined “very
common” as one affecting 65% of patients. The EC defined as “rare” an adverse event that affected
.01% - .1% of patients, but the study participants defined “rare” as an adverse event that affected
8% of patients. The point made by both of these studies is that unless risks and benefits are explicitly
defined in measurable ways, patients will be unable to made an informed decision, because
that decision will be based on incomplete or even missing definitions of risk and benefits.
Conventional thinking implies that if only patients could better understand the consent form,
they would use that understanding to make an “informed decision” about whether to volunteer to
be in a clinical trial or not. But beyond that simplistic assumption, the regulatory and bioethical
literature does not address the specifics of how patients actually make that kind of decision—even
though there is considerable psychological research on how people make decision, especially under
conditions of uncertainty. Table #2 summarizes five strategies that can be used by subjects to
arrive at a decision—whether they understand the consent process or not.
Table #2: Decision-making strategies for informed consent
Decision-making strategies Explanation
1. Brain anatomy 1. Informed consent takes place in the brain
2. Logic and emotion 2. Brain includes areas for logical analysis and
emotional reactions
3. Intuition 3. Fast, selective unconscious thinking
4. Heuristics 5. Mental shortcuts to reduce uncertainty or
information overload
5. Cognitive illusions 6. Decisions affected by how information is
“framed”
All decision-making strategies are based on how the brain processes specific information about a
clinical trial from the consent process/consent form, as well as patients’ experiences in the health
care system, their patient-doctor relationship, etc.
1) Brain anatomy: Obviously informed consent takes place in the brain (Hochhauser, 2005). While
the importance of the brain functioning is usually acknowledged if a clinical trial involves subjects
with schizophrenia, or elderly patients with dementia, or unconscious emergency patients, the
role of how the brain processes information in patients without those obvious brain disorders is
seldom recognized. Federal regulators, bioethicists, and consent researchers won’t understand the
consent process unless they understand how the brain processes complex information.
110 2005 Symposium Proceedings Book