Dr. Wirshing and Colleagues Reply

To the Editor: We found the letters from Drs. Eth and Wystanski challenging and worthy of thought and a reply. In general, the more discussion that is generated around issues related to informed consent in treatment and research, the better our field will become. Although our article did not address the component of consent on which Dr. Eth comments, our future research is pursuing this very avenue. Dr. Eth comments on the impact of transference in influencing the decision to participate in research. While they were undoubtedly true for our population, transference issues influence patients treated by other medical specialists as well. There is little difficulty, for example, in recruiting heart transplant patients for studies of medications to prevent rejection of their newly transplanted hearts. Patients who have undergone life-saving transplant surgeries will naturally be very willing participants in studies suggested to them by their surgeons. We scrutinize the ability of subjects with schizophrenia to give informed consent because they are generally perceived to be members of a vulnerable population. But are they in fact more vulnerable and therefore more exploited than other medical patients with incurable illnesses (e.g., AIDS, various malignancies, Alzheimer’s disease, Parkinson’s disease)?

Dr. Wystanski correctly points out that understanding the information conveyed in consent forms is not the only capacity required to give informed consent. Our goal is to teach our patients to become effective and knowledgeable advocates of their own participation (or nonparticipation) in our research protocols. Understanding the details of the protocol is simply the first small step toward this end. One method that we are developing is a CD-ROM (sponsored by the National Institute of Mental Health; Jim Mintz, principal investigator) that will engage medical and psychiatric patients interactively in a learning process so that they will be able to acquire more information about the associated benefits and risks before deciding to become involved in treatment research. Additionally, we will provide these patients with a workbook so that they can be active learners, and we will assist them with decisions about their own treatment. We realize that it is vitally important to provide the best care for our patients and to engage them in clinical trials that will improve not only their treatment but the treatment of other patients with the afflictions from which they suffer. Our program of research, now under way in earnest, is aimed at improving the consent process for patients with a wide variety of psychiatric and medical disorders.