[[alternative]]研究受試者保護：台灣之現況與政策改革建議

[[abstract]]Objectives: This study analyzes the current status of Human Research Protections (HRP) in Taiwan. Methods: The laws and regulations covering HRP in Taiwan are first reviewed. Besides, between the February 2000 and the end of January 2001, we interviewed the CEOs of 12 medical centers, collected and studied the instructions to authors sections of 66 Taiwanese peer-reviewed journals, surveyed the chief editors of the same journals, and conducted a survey of physicians in 11 medical centers and medical teaching hospitals to understand the attitudes of Taiwan's biomedical community toward HRP. Results: At the national level, all regulations or guidelines on HRP were limited to studies for new drugs, medical techniques and medical devices. At the institutional level, except for clinical trials, which are required to obtain IRB reviews, few researchers were asked to submit proposals to Institutional Review Boards (IRBs). At the individual level, physicians and chief-editors were generally unfamiliar with HRP issues. Physicians generally considered IRB reviews as hindrances to research, while chief-editors held more positive attitudes toward HRP in intervention studies not regulated by Taiwan's Medical Care Act, observational studies and surveys. Conclusions: As a matter of principle, ethical research practices should go hand in hand with sound research design. Only through collaboration between the government, the academic community, and other professionals can HRP reform be improved and the protection of human beings be ensured. Based on our analysis and experiences from other countries, in the short-term we recommend an existing set of HRP guidelines be adapted to suit our needs, that professional organizations and journals add HRP stipulations to their ITAs, and that we strengthen our financial liability safety net to better cover research injury. In the middle-term, we recommend that a single, independent national office be established to lead and coordinate the HRP system and that HRP be made one of the dimensions of annual hospital and university accreditation. In the long-term, we recommend that medical schools, graduate schools for all disciplines, all institutions and sponsors involved in human research be required to offer research ethics courses to their staff and students