The ethics of resource allocation in translational genomic medicine.

Two basic models of the rationale of translational genomic medicine (TGM)-the "Lab Assisting Clinic" (LAC) and the "Clinic Assisting Lab" (CAL) models-are distinguished, in order to address the ethics of allocating resources for TGM. The basic challenge of justifying such allocation is for TGM to demonstrate sufficient benefits to justify the opportunity cost of lost benefits in other areas of medicine or research. While suggested ethics frameworks for translational medicine build on clearly distinguishing these models, actual TGM typically blurs them. Due to lack of and difficulty in collecting evidence, prospects for justifying the LAC model currently seem poor, but this difficulty might be overcome by more research that tests the very concept of TGM. The CAL model aims to thus advance science, but is ridden by ethical hazard, undermining attempts at justification. This leaves the notion of running bona fide controlled trials of entire TGM concepts that have been justified from the perspective of clinical and research ethics (and approved by IRBs). It remains, however, an open question if the outcomes of such trials will demonstrate benefits that can justify the investment in TGM. To advance the prospect of such justification further, charting of the cost-benefit profile of TGM compared to alternative health investments would be helpful.