Institutional variability in a minimal risk, population-based study: recognizing policy barriers to health services research.

Objective: To describe (1) the institutional variability in study approval and willingness to obtain federal assurance documents for a federally supported, minimal risk health services research project conducted during the implementation of the Privacy Rule and federalwide assurances, and (2) the potential impact of such policy on selection of research subjects and generalizability of study results.

Data Sources: Primary data collection from 2001 to 2004.

Study Design: We provide a descriptive analysis of a prospective, observational, out-of-hospital study.