IFFS surveillance 01

Abstract

Statement of general purpose: Internationally, there is a wide divergence of views on the methods and the content of surveillance of assisted reproductive technologies. This was clearly brought out by a December 3, 1997 survey that was published in Fertility and Sterility (1999;71[Suppl 2]) entitled “IFFS Surveillance 98.” These 1998 data were presented to the national delegates who had participated in the 1998 survey at the International Federation of Fertility Societies meeting in San Francisco, California, in October 1998 in the hope that at least some of the discrepancies brought out by the survey could be resolved. This effort had limited success, as the delegates were concerned that they were not empowered to authorize a deviation from the situation as revealed by the survey. Thus, consensus on the various issues remains elusive. The divergence of views on various issues makes it seem likely that the exact purpose of surveillance is uncertain. Historically, surveillance was initiated in response to public concern about a new technology that dealt with the mysterious origin of a human being. Thus, the details may be unimportant as long as the public feels that surveillance of some type is in place. However, the scientific community should strive for a higher goal. Indeed, the current discussions about multiple pregnancies and the number to transfer is evidence of this scientific aspiration. The purpose of this survey, “IFFS Surveillance 01,” is to document the current status of the various issues in the hope that it is a further step along the road to a scientifically based consensus. Preface: The development of IVF and its subsequent variations and extensions, all now included under the umbrella of assisted reproductive technology (ART), seems to have generated more interest and concern among religious leaders, bioethicists, and the general public than any other medical procedure. This widespread interest and concern attracted the attention of, or was called to the attention of, the political process, not only by ethicists and moral theologians but by consumer groups, some members of which expressed dissatisfaction with one or another aspect of their treatment or lack of access thereto. As a result of these events, many committees and commissions, some governmental, some not, have examined the ethical, legal, religious, medical, and public policy aspects of ART, resulting in the establishments of guidelines and/or government regulations in many sovereign states practicing ART. For the purpose of this discussion, the word “guidelines” will be used to designate sets of rules to be followed voluntarily and the word “regulations” will be used to designate sets of rules adopted by legislative action, with assigned penalties for violations. Such guidelines/regulations have taken various forms and have often expressed not only a particular medical perspective but sometimes reflected the social and religious mores of the particular sovereign state. Some of the guidelines/regulations have been formulated to accommodate special interest groups. Furthermore, surveillance of compliance with guidelines/regulations has taken forms from none at all to the issuance of a license by a governmental licensing body, after fulfilling designated requirements, and often including follow-up periodic inspections. The specific purposes of this project are: 1. Tabulation of the practice of sovereign nations or political subdivisions thereof with respect to the adoption of guidelines/regulations. 2. Tabulation of the methods of surveillance, if any, of such guidelines/regulations. 3. Tabulation of the similarities and differences of the guidelines/regulations themselves concerning the various procedures under the umbrella of ART and especially to identify within the guidelines/regulations any that may be medically naive or contradictory, or not supportive of the best interest of the patients, their families, and society in general. 4. Highlighting of the changes between this survey and the previous one, i.e., IFFS Surveillance 98. Materials and methods: A survey form was developed (see Appendix), and one or more individuals from the principal sovereign nations known to be practicing ART were invited to fill out the questionnaire. The response has been very satisfactory. Completed questionnaires were codified by the coordinator, Dr. Jacques Maas, and the situation as of December 31, 2000, was tabulated under several subheadings of the questionnaire. Results from 39 countries were tabulated. In some situations, Australia was tabulated four times because three states (South, Victoria, and West) have regulations, while the remaining states operate under guidelines. Over 2,000 individual centers were represented in the survey (Table A). The analysis of the survey, the discussion, and the summaries were prepared by the editors.