The ethical basis of psychiatric research: Conceptual issues and empirical findings

Problem areas in the understanding of informed consent for research: study of middle-aged and older patients with psychotic disorders

“…Studies of comprehension of informed consent by various patient populations (i.e., psychiatric, medical, and surgical patients) reveal that inadequate understanding of basic but important aspects of study protocols, such as the procedures to be used and the risks of participation, is widespread (Taub 1986;Roberts 1998;. While individuals with psychiatric disorders, particularly those illnesses affecting cognition, appear to be at an elevated risk of impaired understanding of consent, they also manifest heterogeneity in their performance on measures of understanding (Grisso and Appelbaum 1995;Roberts and Roberts 1999).…”

Enhancing Informed Consent for Research and Treatment

“…Although a subject of debate, several commentators criticize the recommendations of the commission for their potentially stigmatizing effects. Thus, it has been pointed out that not just patients with psychiatric disorders, but also patients with a variety of other medical conditions, have been shown to be potentially vulnerable to impaired decision making (Oldham et al 1999;Roberts 1998;Roberts and Roberts 1999). Furthermore, it has been argued that the NBAC report did not take into consideration the available research on decision making by psychiatric patients, which indicates the variable nature of performance by patients with psychiatric illnesses as well as patients with medical or surgical conditions (Roberts 1998;Roberts and Roberts 1999).…”

“…Thus, it has been pointed out that not just patients with psychiatric disorders, but also patients with a variety of other medical conditions, have been shown to be potentially vulnerable to impaired decision making (Oldham et al 1999;Roberts 1998;Roberts and Roberts 1999). Furthermore, it has been argued that the NBAC report did not take into consideration the available research on decision making by psychiatric patients, which indicates the variable nature of performance by patients with psychiatric illnesses as well as patients with medical or surgical conditions (Roberts 1998;Roberts and Roberts 1999). In addition, several studies recently found that consent-related capacity of patients with schizophrenia was enhanced with straightforward educational interventions (Wirshing et al 1998;Carpenter et al 2000).…”

Reviews: Emerging Empirical Evidence on the Ethics of Schizophrenia Research

“…(Although beyond the scope of this article to review these in detail, excellent reviews of these early studies are available. 45,130 ) In addition, investigators began to examine consent procedures themselves, suspecting that difficulties with informed consent resided at least partially in those procedures and not just in characteristics or symptoms of the patients. Intriguing results emerged from these early studies, including findings that (1) many consent forms and disclosures were inadequate, but even with improved disclosures, many patients continued to have difficulty understanding research; 129 (2) many participants in research did not understand randomization and double-blind procedures and seemed to believe that the research was conducted for their personal benefit; 129,131,132 (3) cognitive symptoms, conceptual disorganization, and acute psychosis were related to decision-making abilities; [133][134][135][136] and (4) patients with neuropsychiatric disorders showed both heterogeneity, as well as strengths, in informed consent contexts (relating both to research and treatment).…”

“…Prominent themes in this revitalized literature include constructive approaches to the ethical dilemmas of certain scientific designs, research participants' strengths and vulnerabilities related to informed consent and decision-making capacity, attitudes toward clinical research and influences on research participation, protocol review, and broader considerations of scientific integrity in mental health research. 5,24,25,[43][44][45][46][47][48][49] In this article we provide an overview of data-based publications in schizophrenia research ethics and outline possible directions for additional inquiry.…”