| 摘要: | 企業社會責任（Corporate Social Responsibility，簡稱CSR）的議題廣泛受到社會大眾的重視，亦成為企業經營治理的新趨勢。醫學研究之倫理標準應以尊重及保障所有人體受試者健康與權益為依歸。醫師參與醫學研究時，負有保障受試者生命、健康、尊嚴、人格完整、自主權、隱私以及個人資料保密之職責，醫院運作為了符合企業社會責任與臨床倫理規範，機構中設有人體試驗審議會（Institutional Review Board，簡稱IRB），以保護對人的研究與增進受試者的福祉與安全。
本研究採用質性研究方法之深度訪談為研究方法。企業社會責任體現於IRB以永續經營、倫理治理、社會承諾、正向力量四種面向探討企業之社會責任，訪談設定對象是曾經擔任過三軍總醫院IRB召集人、委員，並有三年以上審查人體試驗/研究計畫案件，曾參與過IRB國際認證業務或財團法人醫院評鑑暨醫療品質策進會(醫策會)實地查核經驗，探討三軍總醫院IRB對於體現於企業社會責任。研究顯示三軍總醫院IRB在於社會承諾、正向的力量二方面有明顯之不足，由於本次訪談對象僅有一家IRB委員，建議未來研究可納入多家醫學中心的IRB或教學醫院，加入不同研究對象來進行訪談，藉此瞭解更多面向之機構及人員對此議題之看法，再進行結果探討與分析，更能深度瞭解其IRB如何協助醫院善盡企業社會責任之關聯。
Corporate social responsibility (CSR) has been widely regarded by the public and has become a new trend in corporate governance. The ethical standards of medical research should be based on respecting and ensuring all human subjects' health and rights and benefits. When a physician participates in the medical research, he has to assume the responsibility of protecting the life, health, dignity, integrity, autonomy, privacy, and personal data confidentiality of the subjects. In order to meet the requirements of corporate social responsibility and clinical ethics, an institutional review board (IRB) for protecting human subjects in study and improving their well-being and safety has been established at the institution.
In this study, a qualitative research method using in-depth interview was employed to investigate the corporate social responsibility, reflected in the TSGHIRB, based on the four kinds of business-oriented social responsibility, i.e. sustainable management, ethical governance, social commitments, and positive strength, through interviewing some key personnel served in the TSGHIRB, such as convener (chairman) (current or incumbent) and senior members , all with experience more than three years in reviewing the protocols regarding human trial/research. In addition, all the interviewees have been involved in the IRB international accreditation for IRBs or site audits sponsored by Joint Commission of Taiwan.
We concluded that, in corporate social responsibility, TSGHIRB still had some weakness in social commitment and positive strength. Since this interview has been carried out in only one IRB, we suggest that future related research be implemented in a number of IRBs at medical centers or teaching hospitals to glean different perspectives to lead to better understanding how IRBs could help the hospital implement corporate social responsibility. |
