医学与哲学
醫學與哲學
의학여철학
MEDICINE AND PHILOSOPHY
2014年
13期
26-29,45
,共5页
三大研究理事会政策宣言%多中心伦理审查%医学科研伦理
三大研究理事會政策宣言%多中心倫理審查%醫學科研倫理
삼대연구리사회정책선언%다중심윤리심사%의학과연윤리
TCPS%multi-center ethical review%medical research ethics
1998年,三大研究理事会政策宣言(Tri-Council Policy Statement ,TCPS)正式通过,2011年通过了第二版,是加拿大多中心伦理审查领域的重要准则。TCPS通过构建适宜的多中心伦理审查决策框架、注意多中心伦理审查的沟通及透明度、确保充足的资源以支持多中心伦理审查进程以及妥善处理操作层面问题等途径,提高多中心伦理审查的效率与成功率。可以在强化多中心伦理审查立法、注意协调多方关系、确保研究项目的科学性以及对审查人员进行教育培训等方面为我国多中心伦理审查提供借鉴。
1998年,三大研究理事會政策宣言(Tri-Council Policy Statement ,TCPS)正式通過,2011年通過瞭第二版,是加拿大多中心倫理審查領域的重要準則。TCPS通過構建適宜的多中心倫理審查決策框架、註意多中心倫理審查的溝通及透明度、確保充足的資源以支持多中心倫理審查進程以及妥善處理操作層麵問題等途徑,提高多中心倫理審查的效率與成功率。可以在彊化多中心倫理審查立法、註意協調多方關繫、確保研究項目的科學性以及對審查人員進行教育培訓等方麵為我國多中心倫理審查提供藉鑒。
1998년,삼대연구리사회정책선언(Tri-Council Policy Statement ,TCPS)정식통과,2011년통과료제이판,시가나대다중심윤리심사영역적중요준칙。TCPS통과구건괄의적다중심윤리심사결책광가、주의다중심윤리심사적구통급투명도、학보충족적자원이지지다중심윤리심사진정이급타선처리조작층면문제등도경,제고다중심윤리심사적효솔여성공솔。가이재강화다중심윤리심사입법、주의협조다방관계、학보연구항목적과학성이급대심사인원진행교육배훈등방면위아국다중심윤리심사제공차감。
In 1998 ,Tri-Council Policy Statement (TCPS) was formally adopted .In 2011 the second edition was passed .It is an important criterion of Canadian multi-center ethical review .TCPS plays an essential role in improving the efficiency and success rate of the multi-center ethical review through the construction of an appropriate decision framework of multi-center ethical review ,the attention to the communication and transparency of multi-center ethical review and the assurance of sufficient resources to support the multi-center ethical review process and to properly handle the problems at the operational level .TCPS ,which strengthens the legislation of the multi-center ethical review ,pays attention to coordinate the relationship between parties and ensures the scientific nature of the research project and the education and training of the staff ,can serve as a reference for multi-center ethical review in China .