Schizophrenia Daily News Blog

Ethics in research

Influence of ethical safeguards on research participation: comparison of perspectives of people with schizophrenia and psychiatrists.

Roberts LW, Hammond KA, Warner TD, Lewis R.
Am J Psychiatry. 2004 Dec;161(12):2309-11.

Background: Participation in research comes with the assumption that researchers will respect and take care of the volunteer’s rights in an ethical and fair manner. In the United States, there are many safeguards to make sure that rights of participants are not violated. Five of these safeguards are: the use of informed consent procedures, alternative decision makers, institutional review boards, data safety monitoring boards, as well as utmost care towards confidentiality and privacy protection. Such safeguards are especially important for the rights and well-being of those with serious mental illnesses, who may have severe symptoms or fluctuating decision-making abilities and may be at risk for stigma, poverty, institutionalization, and limited access to care. This study wanted to look at how “key stakeholders” (those with schizophrenia and psychiatrists) view these safeguards regarding how well they feel protected and what influences their decisions to participate in research.

Method: The researchers developed a 2.5-3 hour questionnaire for people with schizophrenia that asked ethically important questions in mental illness research and related areas. A trained interviewer administered the survey by reading each question and recording responses. They also developed a written questionnaire for psychiatrists, who were asked to evaluate the protectiveness of various safeguard activities and to predict their influence on patients’ willingness to participate in research. Both groups were asked to rate the protection of the five safeguard activities (see Background section above) on a scale of 1=not protective at all to 5=very much protects. People with schizophrenia also rated the influence of the safeguards on their willingness to volunteer for research on a 5-point scale on which 1=much less willing, 3=no influence, and 5=much more willing, and psychiatrists predicted the influence of these safeguards on patients’ willingness to volunteer.

Results: Their sample included 48 men and 12 women with schizophrenia, majority of whom were unmarried and were an average of 44 years old. Most were white, and 22% were of Hispanic origin. Of the psychiatrist group, 55% were men with a mean age of 42 years, and most were married or living with a partner. Overall, both groups reported that all five of the safeguards were protective. Confidentiality protection, institutional review boards, informed consent, and data and safety monitoring boards were rated as more protective than alternative decision makers. Psychiatrists rated strict confidentiality as more protective than other safeguards. People with schizophrenia rated alternative decision makers as less protective than other safeguards. Psychiatrists’ ratings matched those of the people with schizophrenia and ratings did not differ by gender. Perceived protectiveness influenced willingness to participate in research, more strongly for people with schizophrenia than for psychiatrists.

Interpretation & Limitations: Overall, the researchers found that people with schizophrenia and psychiatrists see all five safeguard efforts as protective and that they perceive most of them as influencing decisions to participate in research. The authors highlight the need to further study safeguard practices in mental health research since such safeguard efforts seem to inspire confidence in prospective research volunteers. Accurate information about these safeguards can help recruit more people to participate in research studies. Limitations of this study are small sample sizes and reliance only on self-report data, which limits the generalizability of these results to everyone in the population. Nevertheless, it highlights the importance of considering the views of those with schizophrenia and their psychiatrists for ethical issues involved in research participation.

Supported by NIMH Career Development Award 1K02 MH-01918 and by National Institute on Drug Abuse grant 1R01 DA-13139.

Click here to find this article on PubMed

Author: Farzin Irani