Policy needs regarding the duty to protect in epidemiological research with high-risk populations

The paper presents an analysis of policy directives needed to respond to threats of harm (e.g., violence against third parties) that may arise in the course of conducting descriptive epidemiological research with high-risk populations. It identifies two key areas where new policies must be developed to guide researchers conducting such investigations. The paper recommends that: (1) an NIH consensus panel be convened to set standards, analogous to Common Toxicity Criteria (CTC) criteria, to classify the severity of different types of indirect, non-research-related risk; and (2) case-based training modules be developed and incorporated into public health research ethics courses and training programs, to enhance researcher judgments in determining the likelihood of harm in different situations. In addition, researchers, Institutional Review Boards (IRBs) and community advisory groups must consider the issue of staff safety and the effectiveness of available responses to reduce the threat of harm. The author reviews and discusses implications for informed consent and IRB review.