because in one study of low-income women (many of whom had low levels of literacy, were recent immigrants, or were illegal aliens), the written informed-consent process was too intimidating. The IRB allowed the use of verbal consent in conjunction with mailing of explanatory information on the study to all participants. Use of verbal consent dramatically increased the level of recruitment of members of this population.
Tom Welty described logistical considerations related to the recruitment of American Indians into cancer research. The Indian Health Service (IHS) acts like a health maintenance organization and is faced with the rationing of health care services because of budget constraints. IRB concerns are very lengthy, involving the IHS or tribal facility, a second level of federal approval, and tribal approval. Publication of trial results requires approval of the tribe, the Area Publication Committee, and the IHS Publication Committee. Strategies to improve the IRB process in the IHS setting are needed. However, the safeguards have been adopted for good reasons, because much of the previous work provided little benefit to the Indian population and was intrusive and offensive to many.
Recommendations from this panel included the following:
analyses, however, are sometimes complicated by several statistical and data limitations (J. Unger, Southwest Oncology Group, personal communications, 1998). For example, information regarding incidence is typically derived from Surveillance, Epidemiology, and End Result (SEER) program data, which are less reliable for some populations (e.g., American Indians)and nonexistent for others (e.g., rural medically underserved populations), as discussed in Chapter 2. Furthermore, as Tejeda et al., (1996) state:
[T]rue determination of proportional representation [of minorities] in trials is difficult because the United States does not have a national, population-based cancer registry from which the racial/ethnic composition of the population with cancer can be counted. Such a registry would make the determination of racial/ethnic composition of the newly diagnosed population with cancer a simple arithmetic exercise (p. 815).
Calculation of the percentages of members of ethnic groups with cancer