Enrolling underserved women in research projects: Overcoming IRB culture to improve access

Background: Documented abuses and ethical violations led to creation of institutional review boards (IRBs). Both IRBs and researchers must operate under a set of rules and regulations; however, IRBs have broad latitude in interpreting regulations. IRB concern for protecting subjects may inhibit enrollment of target populations. To ensure underserved women's access, investigators must understand the IRB's orientation and, if necessary, educate the IRB. Purpose: To describe barriers encountered in implementing a population-based study examining neighborhood effects on breast cancer survivors' quality of life and how these barriers were overcome. Approach: Missouri Cancer Registry (MCR) staff, previously focused on building a high-quality surveillance database, began participating in a National Cancer Institute-funded research project, using MCR's database to identify subjects who would be asked to participate in two telephone interviews. Investigators submitted a protocol and supporting documents to the University's Health Sciences IRB without understanding the IRB's orientation. The IRB classified the study as high risk and required modifications that inhibited enrollment of older women, women with less education/lower income, rural women and women of color. Results: Poor communication, lack of guidance and misunderstandings led to lengthy delays and low enrollment of target populations, particularly African-American women. Face-to-face meetings with the IRB and support staff led to changes that improved enrollment of target populations. Conclusions: Moving from public health surveillance to research involving cancer patients is a learning experience for investigators and IRBs. Clear and ongoing communication is essential.