when members of Congress objected, the decision was subsequently rescinded. As of this writing, the four total artificial heart projects are proceeding according to contractors' original plans and with funding committed through September 30, 1993. See Appendix B for a chronology of the NHLBI artificial heart program and related events.

Because of the breadth and complexity of issues involved in evaluating a program like the NHLBI artificial heart program, IOM and NHLBI agreed to a two-stage approach: a 5-month planning study and subsequent 15-month evaluation study. The purpose of the planning study was to identify the scope and particular tasks of the evaluation. Accordingly, in May 1989, the IOM established a committee to undertake the five-month planning study. The planning committee focused on the following question: on what bases can rational decisions regarding allocation of artificial heart research and development funds be made? It then identified nine evaluation questions for use in answering this central question, and drafted a work plan for the subsequent study committee. These nine questions were incorporated into the charge of the second study committee, along with a tenth question addressing communication and cooperation in mechanical circulatory support system research. The questions are listed in Chapter 1, Table 1.3.

The second IOM committee comprised 17 members with expertise in the fields of cardiothoracic surgery, bioengineering, cardiovascular and internal medicine, epidemiology and decision analysis, program planning and evaluation, ethics, health policy, economics, law, social sciences, and third-party payment. In the course of the study, the committee met four times, sponsored a public meeting, and held two workshops in conjunction with its second and third meetings. The list of those making presentations at the public meeting follows at the end of this appendix. The committee also commissioned five background papers from outside experts as resource materials for the workshops, and as background for sections of the committee's report. The committee reviewed a considerable body of medical, scientific, and health policy literature, including earlier reports on the artificial heart from expert groups established by NHLBI, journal articles, and other documents on artificial heart technologies. The committee solicited, in addition to public meeting presentations, the views of more than 75 individuals who could offer insight into issues pertaining to the study. The committee's deliberations covered a total of nine days, including numerous small-group discussions of specific topics and conference-call discussions.

The second IOM committee's report, which forms the main portion of this book, was reviewed twice by all committee members. Consistent with the procedures of IOM and the National Academy of Sciences, the final report was also evaluated through the report review process established by the National Research Council, by a group of anonymous experts possess-



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