论老年医学临床研究知情同意的伦理审查要点
0 1
知情同意伦理审查的原则
0 2
知情同意书
0 3
知情同意的过程
0 4
知情同意书的签署
0 5
患有认知障碍相关疾病的老年受试者的知情同意
0 6
结语
参考文献
[1]World Health Organization.Ageing Overview[EB/OL].[2020-08-28].https://www.who.int/health-topics/ageing#tab=tab_1.
[3]高超,石冰,于普林.老年医学伦理学的研究进展[J].中华老年医学杂志,2020,39(7):853-856.
[4]Ries Nola M.Ethics,Health Research,and Canada's Aging Population[J].Canadian Journal on Aging,2010,29(4):577-580.
[5]Diener L,Hugonot-Diener L,Alvino S,et al.Guidance synthesis.Medical research for and with older people in Europe:proposed ethical guidance for good clinical practice: ethical considerations[J].J Nutr Health Aging,2013,17(7):625-627.
[6]Ilgili O,Arda B,Munir K.Ethics In Geriatric Medicine Research[J].Turk GeriatriDerg,2014,17(2):188-195.
[8]High D M,Doole M M.Ethical and legal issues in conducting research involving elderly subjects[J].Behavioral Sciences&the Law,1995,13(3):319-335.
[10]Loverde M E,Prochazka A V,Byyny R L.Research consent forms:continued unreadability and increasing length[J].Journal of General Internal Medicine,1989,4(5):410.
[11] Riecken H W,Ravich R. Informed Consent to Biomedical
Research in Veterans Administration Hospitals
[J]. Jama,1982,248( 3) : 344.
[15]北京市卫生健康委员会.北京市卫生和计划生育委员会关于印发《北京地区医疗机构涉及人的生物医学研究伦理管理规范》和《北京地区医疗机构涉及人的生物医学研究伦理审查工作指南》的通知(京卫科教[2018]24号)[Z].2018-03-21.
[16]赵励彦.生物医学研究的知情同意过程及知情同意豁免[J].医学与哲学,2017,38(3A):27-29.
[17]Emanuel E J,Grady C,Crouch R A,et al.The Oxford Textbook of Clinical Research Ethics[M].New York:Oxford University Press,2008.
[18]郑曦,田喜慧.老年病诊疗过程中存在的伦理问题及对策[J].中国医学伦理学,2014,27(3):345-346.
[19]Hallinan Zachary P,Forrest Annemarie,Uhlenbrauck Gina,et al.Barriers to Change in the Informed Consent Process:A Systematic Literature Review[J].IRB:Ethics&Human Research,2016,38(3):1-10.
[21]World Medical Association.Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects[EB/OL].[2020-08-18].https://www.wma.net/policies-post/wma-declaration-of-Helsinki-ethical-principles-for-medical-research-involving-human-subjects/.
[22]The Council for International Organizations of Medical Sciences.International Ethical Guidelines for Health[EB/OL].[2020-08-18].https://cioms.ch/?s=International+Ethical+Guidelines+for+Health.
[23]Thomas G,Antoine B,Thomas-Antérion Catherine,et al.Assessing capacity to consent for research in cognitively impaired older patients[J].Clinical Interventions in Aging,2017,12:1553-1563.
[24]Jeffrey B.Halter,Joseph G.Ouslander,Mary E.Tinetti,等.哈兹德老年医学[M].6版(上卷).北京:人民军医出版社,2015.
[25]孟祥东,董玉宽.2013版《赫尔辛基宣言》对我国知情同意的借鉴[J].医学与哲学,2014,35(8A):37-39.
[27]中华人民共和国执业医师法[EB/OL].(2005-08-01)[2020-08-20].http://www.gov.cn/banshi/2005-08/01/content_18970.htm.
[28]李敏,胡欣,李可欣.老年人体药动学研究设计及其特殊考虑因素探讨[J].中国新药杂志,2014,23(4):446.
[29]贾建平,王荫华,蔡晓杰,等.中国痴呆与认知障碍诊治指南(七):照料咨询及相关伦理[J].中华医学杂志,2011,91(16):1081-1083.
End