Human Research protections-current Status in Taiwan and Policy Proposals

目標：本研究主要目標為分析國內研究受試者保護之現況。方法：本研究分析國內有關研究受試者保護相關之法令或法現。此外，本研究於民國89年2月至90年1月間針對12家醫學中心及教學醫院之院長進行深度訪談，收集66家國內醫學及公共衛生相關領域期刊雜誌之投稿須知並針對其期刊主編進行問卷調查。同時，本研究亦針對全國11家醫學中心及教學醫院之醫師進行問卷調查，以了解台灣生物醫學界對受試者保護之態度與看法。結果：根據本研究結果發現，在整體國家層面而言，國內目前有關研究受試者保護之政策仍侷限於新藥、新技術及新的醫療器材。在機構層面，除臨床試驗依法律規定必須送審倫理委員會外，研究者並未被要求將研究計畫送倫理委員會審查。在個人層面，醫師與期刊雜誌主編對於受試者保護相關之規定也並不熟悉。然而雖然大多數醫師認為將研究計畫送審倫理審查委員會將會影響研究發展，但大多數的期刊主編對於那些未受醫療法現範之介入性研究計畫、觀察性研究以及調查研究送審倫理審查委員會都持正面的態度。結論：嚴謹的研究其研究行為的道德面必須受到同樣的重視。唯有透過政府、學術界及其他專業團體的共同努力，始能改革台灣受試者保護的現況以確保參與研究者之利益。根據本研究之結果與參考國外之經驗與作法，本研究建議短期內國內可採納目前國際上現有的受試者保護規定、國內的專業期刊雜誌將有關研究受試者保護之規定納入其投稿須知中，以及加強因參與研究受到傷害之財務保護機制之安全網。至於中期目標則是於國內建立一個中立之機構以負責領導及協調國內受試者保護系統之建立，並且將研究受試者保護政策納入醫院及大學評鑑中。長期目標則是加強所有參與或涉及有關人方面研究的醫學院及其他相關領域之研究所、機構及經費支持者必須提供研究受試者保護方面相關之課程訓練。

關鍵字

研究受試者保護；研究倫理；倫理審查委員會

並列摘要

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.

並列關鍵字

Human Research Protections ； Research Ethics ； Institutional Review Boards

參考文獻

National Science Council. National Survey on Science and Technology Activity. Indicators of Science and Technology (Charts), Republic of China (2003).http://www.nsc.gov.tw/tech/pub_data_main.asp