Abstract

BACKGROUND: The availability of costly safety measures against transfusion-transmissible infections forces Western countries to confront difficult ethical questions. How to decide about implementing such measures? When are such decisions justified? As a preliminary to addressing these questions, we assessed which concerns shape actual donor blood safety policymaking in five Western countries. STUDY DESIGN AND METHODS: Our qualitative study involved determining which issues had been discussed in advisory committee meetings and capturing these issues in general categories. Appropriate documents were identified in collaboration with local decision-making experts in Canada, Germany, the Netherlands, the United States, and the United Kingdom. The introduction of hepatitis B virus nucleic acid testing and selected measures against variant Creutzfeldt-Jakob disease, West Nile virus, and Q-fever were chosen as cases representing decision-making on safety measures with high costs and low or uncertain added safety. RESULTS: A broad inventory of concerns was established, including: 1) nine categories of advantages and disadvantages of candidate safety policies; 2) six kinds of difficulties in assessing risks and forecasting the effects of safety policies; 3) 13 decision-making principles; and 4) six kinds of practical barriers hampering the translation of candidate policies into decisions. CONCLUSION: Blood safety policymaking involves a wide variety of competing concerns, and approaches to reconcile these considerations are themselves contested. Developing a systematic decision-making approach requires ethical reflection on, among others, reasonable costs of safety and the value of transparency in public policy.