Importance of APHA networking: How information received and contacts made at the 2007 annual meeting helped rescue a research study

Background: The author attended a panel discussion on public health surveillance v. research at the 2007 APHA annual meeting during which she was introduced to the concept of “IRB creep” and participated in discussions about variations in interpreting regulations governing research with human subjects by institutional review boards (IRBs). Purpose: To describe barriers encountered in implementing population-based research studies and public health surveillance projects and how these barriers can be overcome. Approach: The Missouri Cancer Registry (MCR), after a decade focused on building a high-quality surveillance database, expanded its scope to include population-based research, using MCR's database to identify subjects. Investigators encountered barriers to obtaining IRB approval. For example, the IRB classified one telephone-based study as high risk; required modifications that inhibited enrollment of underserved women; and, after 600 subjects had been consented, shut down recruitment of new subjects pending further modifications. In addition, a public health surveillance project was classified as research and rejected. Results: Following telephone consultation with two of the APHA panelists, the investigator used study data to demonstrate that IRB-requested modifications would reduce equity in access and compromise the study design. Face-to-face meetings with the IRB and support staff led to better understanding and changes that improved enrollment of target populations (development of IRB-approved standard operating procedures, less intimidating recruitment materials, etc.). Conclusions: Moving from public health surveillance to research using a cancer registry database to identify subjects is a learning experience for investigators and IRBs. Clear and ongoing communication and mutual understanding are essential.