世界科学技术-中医药现代化
世界科學技術-中醫藥現代化
세계과학기술-중의약현대화
WORLD SCIENCE AND TECHNOLOGY-MODERNIZATION OF TRADITIONAL CHINESE MEDICINE
2013年
4期
729-734
,共6页
李慧%梁兆晖%曾令烽%刘军
李慧%樑兆暉%曾令烽%劉軍
리혜%량조휘%증령봉%류군
生物样本库%知情同意%医学伦理学%组织剩余物
生物樣本庫%知情同意%醫學倫理學%組織剩餘物
생물양본고%지정동의%의학윤리학%조직잉여물
Biobank%informed consent%medical ethics%tissue residue
生物信息库对医学研究者是一个效用显著的资源,可也引起一系列伦理问题,如对其组织剩余物应采用何种类型知情同意;在没有获得捐赠者知情同意前提下,生物信息库研究是否可以展开、如何进行等;基于捐赠的伦理原则、捐赠者个人权利和社会共同利益的要求,本研究针对生物信息库在多大程度上进行知情同意,在特定情景下应采用哪种类型的知情同意等,提出样本及其数据处理2种可行选择,即对样本不可逆或可逆匿名化处理,同时对生物信息库建设中知情同意获取的必要性和合理性进行相关评估,以期为当前生物信息库研究的伦理实践提供参考。
生物信息庫對醫學研究者是一箇效用顯著的資源,可也引起一繫列倫理問題,如對其組織剩餘物應採用何種類型知情同意;在沒有穫得捐贈者知情同意前提下,生物信息庫研究是否可以展開、如何進行等;基于捐贈的倫理原則、捐贈者箇人權利和社會共同利益的要求,本研究針對生物信息庫在多大程度上進行知情同意,在特定情景下應採用哪種類型的知情同意等,提齣樣本及其數據處理2種可行選擇,即對樣本不可逆或可逆匿名化處理,同時對生物信息庫建設中知情同意穫取的必要性和閤理性進行相關評估,以期為噹前生物信息庫研究的倫理實踐提供參攷。
생물신식고대의학연구자시일개효용현저적자원,가야인기일계렬윤리문제,여대기조직잉여물응채용하충류형지정동의;재몰유획득연증자지정동의전제하,생물신식고연구시부가이전개、여하진행등;기우연증적윤리원칙、연증자개인권리화사회공동이익적요구,본연구침대생물신식고재다대정도상진행지정동의,재특정정경하응채용나충류형적지정동의등,제출양본급기수거처리2충가행선택,즉대양본불가역혹가역닉명화처리,동시대생물신식고건설중지정동의획취적필요성화합이성진행상관평고,이기위당전생물신식고연구적윤리실천제공삼고。
The biobank for medical researchers is a resource of significant utility , which also causes a series of ethical issues. For example, the question of what kind of informed consent should be adopted for the biobanking tissue residue, whether related study can be conducted without the donors' consent and how to accomplish the biobank research. Based on ethical principles of donation, individual rights of donor and common interest of the society, this study suggested the informed consent that to which extent can be accepted for biobank and which type should be adopted in different scenes with two feasible choices. One is the irreversible, and the other is the reversible anonymization process for samples. The necessity and rationality of informed consent for biobank con-struction were also evaluated in order to provide references for the ethical practice of biobank research.