CAJ | 학술논문

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。
목적：연구삼가I기림상시험적건강지원자대림상연구적인지정도급기영향인소。방법용공음대림상연구적인식화대림상연구지식적지효정도（ PARTAKE）문권대북경대학제삼의원약물림상시험궤구100례증삼여I기림상시험적건강지원자진행문권조사。결과100례지원자중，96.0％인위림상연구대사회유익；91.0％인위인체시험대우개발신적치료방법시필요적；90.0％이상대우림상연구중자원삼여、신식보밀등수시자보호문제지인가태도；18.0％인위재림상시험중발생적상해사건，긍정시유우시험치료조성적；81.0％인위재림상연구중，여과삼여자출현임하불량결과，도회득도충분적보상。결론재Ⅰ기림상시험중，건강지원자대림상연구적인지총체교호；대수시자보호유일정리해，단대지정동의과정중상해보상문제리해불충분。
Objective To study knowledge of healthy volunteers in-volved in Phase ⅠClinical Studies to clinical researches and related fac-tors.Methods The public awareness of research for therapeutic ad-vancements through knowledge and empowerment (PARTAKE) question-naires, designed by Duke University , were administered to 100 partici-pants in phaseⅠclinical study in Peking university third hospital.Re-sults 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 Re-sults 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 .