Evaluating Use of Genetic Information: A Model Process

Multiple elements contribute to the successful translation of genetic advances into improved health outcomes. This project will address these elements through analysis of a series of genetic testing case examples. The specific aims are: 1) to identify a series of case examples that demonstrate a spectrum of plausible uses of genetic information to improve health outcomes; 2) to convene an expert Working Group that will work collaboratively with the Investigator Team to develop a model process that incorporates provisional clinical practice guidelines for the case examples, an inventory of ethical, legal and social issues raised for each case example, decision models based on the provisional guideline and ELSI inventory to assess the implications of uncertainties in key parameters of the testing process, compares the use of genetic information to accepted, non-genetic interventions in terms of medical, economic and social costs and benefits for each case example, and identifies research and educational priorities related to each case example; 3) to identify the characteristics that define genetic tests that are likely to improve health outcomes; 4) to compare the results of the different case analyses to determine the extent to which genetic testing requires special measures for informed consent and protection of privacy and patient autonomy; and 5) to conduct an evaluation of the model process within a large health care system.