into prevention trials. Minority individuals who believe themselves to be healthy may experience a greater reluctance to participate in prevention trials, especially if they have no immediate experience with cancer among their family and friends. This wariness may again be traced to the history of medical abuse and exploitation of ethnic minority group members. Despite the considerable patient protections present in human subjects research today, many ethnic minorities, especially older individuals, have firsthand experience with civil rights violations that occurred despite the existence of legal protections that supposedly applied to all Americans. Lessons from these experiences are not likely to be altered, despite the institution of lengthy informed consent procedures (indeed, such procedures may heighten suspicion), especially for individuals who are asymptomatic.

As noted in several of the presentations at the NCI conference on recruitment and Retention of Minority Participants in Clinical Cancer Research (Box 5-1), the informed-consent process should not be seen as a "barrier" to the recruitment of ethnic minority and underserved populations into clinical trials. The informed-consent process is the first step in developing a bond of trust between the researcher and the patient. Improvements in the informed-consent process, particularly alternative means of obtaining consent (e.g., oral consent methods), may help to clarify the research process for potential subjects and help define roles and expectations for both the patient and the researcher. Such alternate means of obtaining consent may also help improve the accrual of populations with low levels of literacy, which may disproportionately include ethnic minority and medically underserved individuals. The committee urges NCI to continue to encourage examination of the informed-consent process.

Recommendation 5-2: NCI should continue to work with other appropriate federal agencies and institutional review boards to explore creative approaches to improving patients' understanding of research and encouraging them to provide consent to participate in research. These approaches should address cultural bias, mistrust, literacy, and other issues that may pose barriers to the participation of ethnic minority and medically underserved groups.

Another potential reason for the low rate of accrual of ethnic minorities in prevention trials is that the physicians who recruit subjects into prevention trials are different from those who recruit subjects into treatment trials. For example, many oncologists are not involved in prevention and screening trials, whereas they are more likely to participate in treatment trials. In addition, investigators with some of the large NCI-supported



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