Clinical trials: opportunities and responsibilities.

Abstract

In commenting on the Viewpoint column A Call to Action and the response it is likely to generate, I think it would be useful to note first that social workers already participate in clinical trials as principal or coinvestigators. These investigations have included examining the efficacy and effectiveness of psychotherapy as well as the psychosocial effect of medical treatments on patients and their families. What may be unique about Robins Sadler's call for social workers to participate in a National Cancer Institute (NCI) initiative is her encouragement for social workers working in medical settings to help physician-researchers recruit potential subjects for cancer clinical trials. For me, this call raises two separate but interrelated issues. It encourages the profession to re-examine whether current safeguards for clinical trials are sufficient to encourage social work participation. If such encouragement is indicated, should social workers already involved in the psychosocial care of patients with can cer approach them concerning their participation in a clinical trial? Supporting social work participation in clinical trials at any level only becomes viable if adequate safeguards exist for its use. All human subjects research is federally regulated. The Code of Federal Regulations (Protection of Human Subjects Rule, 1991) directs all institutional review boards (IRBs) to ensure that protocols minimize risks to participants, obtain informed consent, adequately monitor safety, and maintain confidentiality. Moreover, groups identified as intrinsically vulnerable (for example, young children, elderly people, critically ill people, and people with mental illnesses) automatically trigger additional IRB provisions to determine a potential participant's decision-making capacity. People who do not understand all aspects of a study or are vulnerable to coercion or undue influence may still participate but only after they have met additional provisions. These include obtaining consent from the potential participant and family or legal guardian. Consent forms are required to use simple language and concepts to reduce the likelihood for confusion. Although compliance is monitored through institutional and federal agencies that have the authority to dispense sanctions, health professions, including social work, also prescribe ethically appropriate behavior through their codes of conduct. The NASW Code of Ethics (1997) provides all social workers with a guide for everyday professional conduct. According to the Code (1997, p. 2), its principles and standards are relevant to all social workers ... regardless of their professional functions, the settings in which they work, or the populations they serve. Several provisions in the code are directly related to social workers involved in research, including obtaining informed consent [sections 5.02(e)-5.02(h)], avoiding dual relationships when there is a risk of exploitation or potential harm to the client [5.02(o)], protecting the privacy and confidentiality of client records [5.02(1, m)], and following IRB standards [5.02(d)]. Failure to abide by these standards could lead to an investigation by the state licensing board and the national association. Therefore, I believe that the existing institutional and professional safeguards are adequate to guide, monitor, and if necessary, undertake corrective actions for social workers participating in r esearch including clinical trials. If one accepts that there is adequate professional guidance and institutional oversight to participate in clinical trials, the issue then becomes whether social workers involved in patient care should play a role in the recruitment of their clients for clinical trials. Two concerns are readily apparent. First, given that the treatments under consideration in cancer trials are medical interventions (for example, drug therapies), what is the appropriate role for a social worker in discussing the clinical trial? …