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To address several key questions in social science research, repeated interviews of individuals drawn from difficult populations are required. This article describes an approach for addressing the challenges associated with longitudinal interview studies, including locating research participants, obtaining reliable and valid interview data over time, and retaining participants across the course of the study. We applied this approach to conduct a study designed to identify changeable risk factors for violence among high-risk people with mental illness. To successfully conduct weekly interviews of these individuals in the community across a 6-month period, we developed a flexible and personalized interview format; carefully selected, trained, and supervised staff; and developed incentives to maximize participant retention. Each of these three steps is discussed as a guide for future longitudinal studies that involve interviewing difficult populations.

What Is Therapeutic Misconception? For over three decades, bioethics scholarship and research ethics guidelines have identified concerns about the boundaries between research and standard clinical care [1,2]. Ethicists have argued [...]

To address several key questions in social science research, repeated interviews of individuals drawn from difficult populations are required. This article describes an approach for addressing the challenges associated with longitudinal interview studies, including locating research participants, obtaining reliable and valid interview dam over time, and retaining participants across the course of the study. We applied this approach to conduct a study designed to identify changeable risk factors for violence among high-risk people with mental illness. To successfully conduct weekly interviews of these individuals in the community across a 6-month period, we developed a flexible and personalized interview format; carefully, selected, trained, and supervised staff; and developed incentives to maximize participant retention. Each of these three steps is discussed as a guide for future longitudinal studies that involve interviewing difficult populations. Keywords: weekly interviews; longitudinal studies; high-risk participants; violent subjects; operational issues; methods; data collection; weekly interviews

Studies repeatedly have shown that clinical research subjects have trouble appreciating the implications for their clinical care of participating in a clinical trial. When this failure is based on a lack of appreciation of the impact on individualized clinical care of elements of the research design, it has been called the 'therapeutic misconception'. Failure to distinguish the consequences of research participation from receiving ordinary treatment may seriously undermine the informed consent of research subjects. This article reports results concerning appreciation of the risks of trial participation from intensive interviews with 155 subjects from 40 different clinical trials at two different medical centers in the USA. Working from transcripts of the interviews, every statement of a risk or disadvantage of trial participation was identified and coded into one of 5 different categories. Totally, 23.9% of subjects reported no risks of disadvantages in spite of being explicitly asked about them. Another 2.6% reported only incidental disadvantages such as having to drive a long way to get to the experimental site. In all 14.2% reported only disadvantages associated with the standard treatment (usually side effects). Another 45.8% told the interviewer about disadvantages and risks associated with the experimental intervention (usually side effects). Only 13.5% could report any risks of disadvantages resulting from the research design itself, such as randomization, placebos, double-blind designs and restrictive protocols. The results of this research suggest that subjects often sign consents to participate in clinical trials with only the most modest appreciation of the risks and disadvantages of participation. Keywords: Clinical trials; Risk; Informed consent; Therapeutic misconception; USA