健康志愿者对临床研究的认知调查  

Healthy volunteers' knowledge and perception of clinical research

作　　者：魏豫东[1,2] 杨丽[3] 张双[2] 郭京川[2] 李海燕[4] 孙玉梅[1] 

机构地区：[1]北京大学护理学院,北京100191 [2]北京大学第三医院药物临床试验机构,北京100191 [3]北京大学第三医院药剂科,北京100191 [4]北京大学第三医院心内科,北京100191

出　　处：《中国临床药理学杂志》2014年第9期828-829,832,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的研究参加I期临床试验的健康志愿者对临床研究的认知程度及其影响因素。方法用公众对临床研究的认识和对临床研究知识的知晓程度(PARTAKE)问卷对北京大学第三医院药物临床试验机构100例曾参与I期临床试验的健康志愿者进行问卷调查。结果 100例志愿者中,96.0%认为临床研究对社会有益;91.0%认为人体试验对于开发新的治疗方法是必要的;90.0%以上对于临床研究中自愿参与、信息保密等受试者保护问题持认可态度;18.0%认为在临床试验中发生的伤害事件,肯定是由于试验治疗造成的;81.0%认为在临床研究中,如果参与者出现任何不良结果,都会得到充分的补偿。结论在Ⅰ期临床试验中,健康志愿者对临床研究的认知总体较好;对受试者保护有一定理解,但对知情同意过程中伤害补偿问题理解不充分。Objective To study knowledge of healthy volunteers involved in Phase Ⅰ Clinical Studies to clinical researches and related factors. Methods The public awareness of research for therapeutic advancements through knowledge and empowerment（ PARTAKE） questionnaires,designed by Duke University,were administered to 100 participants in phase Ⅰclinical study in Peking university third hospital. Results The following perceptions were reported： research benefited our society（ 96. 0%）,human experiment was necessary for developing new therapeutic method（ 91. 0%）,confidentiality and voluntary participating were adequately approved（ 90. 0%）,all the undesirable effects were caused by the research（ 18. 0%）,and volunteers would be paid for any undesirable adverse reactions completely（ 81. 0%）. Conclusion Results suggest that the healthy volunteers have a good command of clinical research generally. They are aware of protections to participants,but they do not have a full understanding of compensation for damages.

关 键 词：Ⅰ期临床试验 问卷调查 受试者保护 补偿 

分 类 号：R195[医药卫生—卫生统计学]