Schizophrenia research participants' responses to protocol safeguards: recruitment, consent, and debriefing.
OBJECTIVE
To examine the perspectives and preferences regarding ethically important aspects of recruitment, consent, and debriefing of people with schizophrenia who volunteered for research protocols.


METHODS
A structured interview to assess research-related views of people with schizophrenia was developed and piloted. Data collection occurred at three sites. For this analysis, we examined the subset of responses from schizophrenia patients currently enrolled in a protocol.


RESULTS
Data from 28 schizophrenia research volunteers were analyzed. Of these, 22 were men and 11 were voluntary inpatients. Most (n=23) recalled speaking with someone before enrolling in the protocol, and most (n=26) reported trusting the person who told them about it. Participants reported a moderate understanding of their protocols. All but one person (n=27) remembered signing a consent form. Twenty-one volunteers indicated that consent forms are meant to help both the patient and the researcher. Most (n=23) reported making the enrollment decision alone, with 22 making this decision prior to reviewing the consent form. The decision was described as relatively easy. Respondents felt some pressure to enroll, with women experiencing more pressure. Debriefing practices were strongly endorsed by participants. All 28 of the volunteers wished to be informed if a health problem (i.e., "something wrong") was discovered during the protocol.


CONCLUSIONS
The persons living with schizophrenia who were interviewed for this project expressed interesting perspectives and preferences regarding ethically important aspects of recruitment, consent, and debriefing in clinical research that may help guide efforts to make research processes more attuned to participants and merit further inquiry.
Empirical Ethics Group, University of New Mexico Health Sciences Center Institute for Ethics, MSC09 5030, 1 University of New Mexico, Albuquerque, NM 87131-0001, USA. lroberts@salud.unm.edu
Laura Weiss
LW
Roberts
Teddy D
TD
Warner
Charles T
CT
Anderson
Megan V
MV
Smithpeter
Melinda K
MK
Rogers
D000328:Adult; D000704:Analysis of Variance; D001290:Attitude; D003657:Decision Making; D004992:Ethics, Medical; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D018579:Patient Selection; D012107:Research Design; D012108:Research Personnel / Q000523:psychology; D012559:Schizophrenia; D012565:Schizophrenic Psychology