Assessments by Patients With Schizophrenia and Psychiatrists of Relative Risk of Research Procedures

Abstract

Substantial congruence exists between patients and psychiatrists regarding their views of research procedure risks. Further work is needed to determine how these assessments may be used in evaluating protocols.

Worth the Risk? Relationship of Incentives to Risk and Benefit Perceptions and Willingness to Participate in Schizophrenia Research

“…15 Relative to the general population, those with schizophrenia are at greater risk for impaired consent capacity, 16 may be more vulnerable due to economic circumstances, 17 and often have cognitive impairments that conceivably could affect risk assessments. 18 For these reasons, incentives for participation by persons in this group raise ethical concerns. 15,[19][20][21] Given the large numbers of clinical trials enrolling people with serious mental illnesses and the substantial public health contributions deriving from these research endeavors, this topic carries immense importance.…”

Research Risk for Persons With Psychiatric Disorders: A Decisional Framework to Meet the Ethical Challenge

“…Three general categories of studies have examined the risk posed by this type of research: those that retrospectively examined the adverse reactions of persons with psychiatric disorders who participated in such studies (12,14), those that examined the expected risks of participation as judged by psychiatrists (15–17), and those that examined the expected risks as judged by persons with psychiatric disorders (15–18). …”

“…Two categories of studies have examined the risk posed by this type of research: those that examined the expected risks of participation as judged by psychiatrists (15,16) and those that examined the expected risks as judged by persons with psychiatric disorders (17,41). The first category of studies found that psychiatrists consistently rated studies involving more invasive physical procedures, such as undergoing an MRI with sedation or taking a new experimental medication, as a moderately risky category of research for people with psychiatric disorders and that they considered that the risk involved is less than or equal to the daily risks encountered by persons in this population (15,16). The second category of studies found that persons with schizophrenia viewed research involving these physical procedures to be about as risky as daily life and moderately more risky than the procedures that we have characterized as minimal-risk research (17,41).…”

“…Consumers who responded to a survey about their reasons for not participating in research gave the following reasons: the obligation to switch medications, the length of time required for stabilization, and lack of knowledge about whether the provided drug was a placebo (47). In previous studies psychiatrists have consistently rated three types of studies as riskier than the daily risks encountered by persons with psychiatric disorders: those that involve more than a two-day medication washout, those in which patients receive a medication that causes symptoms, and those in which patients receive a placebo instead of a medication (15,16). Studies that included persons with schizophrenia indicated that this population has similar views of research involving these physical procedures, rating them as riskier than daily life and significantly riskier than the studies characterized above as involving minor increment over minimal risk (17,41).…”

Protecting or Empowering the Vulnerable? Mental Illness, Communication and the Research Process

“…A study in the USA suggested a reasonable degree of overlap in assessment of risks by psychiatrists and people with schizophrenia [21,22]. There were enough differences, however, to suggest patient' s views still need exploring [23].…”