Table 6.

Participant Safeguards

Theme	Relevant Papers and Findings
Ethics review committee members' views of psychiatric protocols	• UK study (N = 107 ethics review committees): informed consent, confidentiality, and certain procedures (especially placebos and washout periods) frequently raise concerns in reviews of psychiatric protocols.234
Patients' perspectives regarding specific safeguards	• Research participants (N = 28 pts with SCZ) viewed consent forms as meant to protect both themselves as participants, as well as the researcher.232
	• Pts and psychiatrists both viewed 5 safeguards (informed consent, IRB review, data safety monitoring boards, confidentiality measures, and alternative decision makers) as protective; all but alternative decision makers were viewed as positively influencing participation decisions.46
Participant advocate procedures	• Survey of NIMH CATIE schizophrenia study site PIs, research coordinators, participants, and “subject advocates” (see Stroup, Bredthauer, and Appelbaum,224 in this issue). Most sites reported no specific impact of subject advocate procedures on recruitment or retention; most viewed procedures favorably. Among subject advocates, most felt the procedure helped participants to make their own decisions; among subjects themselves, half felt it positively affected their decision to enroll; a small number felt that the procedures interfered with their autonomy.
Scaling/rating of risk	• Pts and psychiatrists rated risks of numerous research-related procedures similarly overall, although pts rated certain procedures (eg, symptom provocation, spinal tap, and medication discontinuation for 2 weeks) as more risky, in relation to the risks encountered in the everyday lives of people with SCZ, than did psychiatrists (Roberts et al., in press).89
General public's views on mentally ill persons' ability to consent	• Online survey of 3140 adults (see Muroff et al.,126 in this issue). Mentally ill research participants described in vignettes were viewed as less able to consent for themselves than medically ill research participants; this stigmatized perception appeared to be mediated by the belief that mentally ill people are less decisionally capable—even when the vignette described that an independent physician had deemed the patient competent.

Note: Abbreviations used: CATIE = Clinical Antipsychotic Trials of Intervention Effectiveness; IRB = institutional review board; NIMH = National Institute of Mental Health; PI = principal investigator; pts = patients; SCZ = schizophrenia. Unless otherwise specified, “patients” refers to patients with schizophrenia.