2014-01-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/642755摘要:從疫苗研發到上市應用等各階段,除科學研究所著重的專業判準、建立國家級的疫苗研發團隊外,尚應涵蓋倫理、法律、社會、經濟及政治等國家制度等面向之研究與討論。本整合型計畫包涵四個子計畫,擬由倫理、法律、社會政策、公衛等面向來分工合作,期能較全面性地來探討本「前瞻疫苗技術開發研究」計畫項下「六、倫理、法律及社會的影響(Ethical, legal, and social implications, ELSI)」,所規劃之五大子題中之「3. 疫苗研究過程中法律及倫理之遵守與治理機制之建構。4. 疫苗研究成果及其應用指標與社會認知之調查與分析。5. 疫苗研究所涉生物安全問題,及相關倫理與法律規範之研議」。 本計畫根據近年國內外疫苗研發、試驗與應用之相關議題進展,針對其中對我國較具重要性與迫切性之主題,規劃為總計畫及子計畫一疫苗研發、試驗與應用之倫理探討(蔡甫昌教授)、子計畫二疫苗傷害風險與正義(吳建昌助理教授)、子計畫三疫苗研發與應用之社會風險與溝通(林子倫助理教授)、子計畫四全新與未充分驗證疫苗導入之公共政策與社會認知(蔡奉真助理教授)。藉由較全面性地對倫理、法律、社會問題進行綜覽,建立問題意識與研究主題綱要,進而發展子計畫研究與彼此間之相互呼應與支援,由倫理、法律分析、社會調查與風險溝通等方法來達成研究結果,回饋我國疫苗研發之國家政策。<br> Abstract: This integrated research program intended to investigate the ethical, legal, social, policy, and risk communication problems arising from the development, clinical trial, application, and distribution of vaccine. The research team is composed of ethics, law, politics, policy and public health scholars to jointly collaborate and investigate this comparatively new ELSI field of medical advancement in vaccination development. Sub-project 1 will explore examine vaccine ethics in stages of vaccination program, including: (1) research (e.g., selection of objects and virus sharing); (2) clinic trial (e.g., the right to privacy and personal data protection issues); and (3) allocation/ration (e.g., vaccine allocation policy and compulsory vaccine). It will also outline the general pictures, identify and analyze the key ethical issues which are of domestic relevance and importance. Sub-project 2 will study the justice issues and the harm and risks resulting from vaccination. This will concentrate on both legal and ethical issues. Sub-project 3 will research on the social risk and communication in vaccine development and application. Sub-project 4 will explore the public policy and social recognition in implementing the newly developed and not entirely approved vaccination. It will analyze the public policies, governance, public trust and social cognition of implementing the new and under-utilized vaccines. Overall, this integrated research project is intended to combine expertise of ethic, legal and social disciplines and work closely with medical vaccine and infection experts with the hope of identifying and resolving the most important ELSI issues in vaccine development and application in Taiwan.Ethical Issues of the Research, Development, and Application of Vaccines (I)