Impaired decision-making capacity includes an inability to understand and retain information and an inability to communicate one’s decision or decision-making process (Eriksson, 2012). People who experience impaired decision-making include those who are suffering from “dementia, stroke, schizophrenia, or traumatic brain injury; people that are comatose; and others with mental or cognitive disorders” (Eriksson, 2012, p. 15). Cohen, McGarvey, Pinkerton, and Kryzhanivska (2004) examined individuals in a psychiatric inpatient facility to determine their ability to decide whether to participate in research and to assess the level of risk a research study presents. They found that patients with schizophrenia demonstrated equal impairments in decision-making
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The NBAC provides insight that even if a study presents minimal risk, it “could nonetheless be highly threatening to those who are unable to appreciate the procedure’s context or the nature of the current situation” (Backlar, 1999). Thus, they recommend that studies put forth assessments of potential risks and anticipated benefits to IRBs and to the subject population that accounts for the circumstances of the participants and considers the additional risk for this population. This same sentiment is echoed by others who find that these individuals may react very differently to a minor impact than individuals with unimpaired functioning (Eriksson, 2012). Eriksson (2012) asserts that “to state that it is all right to involve them in research as long as the risk or burden is comparable to what a normal person meets on a daily basis is arguably to set the bar much too low” (p. 18). Therefore, researchers have to consider the symptoms and other characteristics of people with impaired decision-making capacity to accurately determine the level of minimal risk for this
The NBAC provides insight that even if a study presents minimal risk, it “could nonetheless be highly threatening to those who are unable to appreciate the procedure’s context or the nature of the current situation” (Backlar, 1999). Thus, they recommend that studies put forth assessments of potential risks and anticipated benefits to IRBs and to the subject population that accounts for the circumstances of the participants and considers the additional risk for this population. This same sentiment is echoed by others who find that these individuals may react very differently to a minor impact than individuals with unimpaired functioning (Eriksson, 2012). Eriksson (2012) asserts that “to state that it is all right to involve them in research as long as the risk or burden is comparable to what a normal person meets on a daily basis is arguably to set the bar much too low” (p. 18). Therefore, researchers have to consider the symptoms and other characteristics of people with impaired decision-making capacity to accurately determine the level of minimal risk for this