Mtunthama N, Malamba R, French N, Molyneux M E, Zijlstra E E, Gordon S B
Wellcome Trust ResearchLaboratories, Universities of Malawi and Liverpool, Blantyre, Malawi.
J Med Ethics. 2008 Apr;34(4):303-7. doi: 10.1136/jme.2007.020461.
Bronchoalveolar lavage obtained at bronchoscopy is useful for research on pulmonary defence mechanisms. Bronchoscopy involves some discomfort and risk to subjects. We audited the process of consent, experienced adverse effects and reasons for participation among research bronchoscopy volunteers.
100 consecutive volunteer research subjects attending for bronchoscopy, repeat bronchoscopy or routine recruitment clinic were interviewed. Information was gathered about volunteer motivation, perception of the consent process and adverse effects of bronchoscopy. Suggestions for improvement were requested. Responses were themed by a second investigator prior to data analysis.
81 bronchoscopy-experienced subjects (total of 263 procedures) and 19 new volunteers were interviewed. 19 subjects (21%) reported adverse symptoms during or after bronchoscopy, but no symptoms were of sufficient severity that they would not repeat the procedure. The frequency of symptoms was not related to gender, the quality of the lavage or the HIV status of the subject. 76 subjects (94%) reported that the information given pre-procedure was useful and adequate but 43 (56%) had further questions mostly relating to their own results. The reasons given for research participation were access to health assessment (75 subjects), access to treatment when ill (61 subjects), desire to participate in research (15 subjects) and remuneration (6 subjects). 7 subjects complained that the remuneration was inadequate.
The main incentive to participation in research bronchoscopy was access to healthcare. Informed consent and procedure technique were adequate but subjects would value more feedback about individual and project results.
支气管镜检查时获取的支气管肺泡灌洗对于肺部防御机制的研究很有用。支气管镜检查会给受试者带来一些不适和风险。我们审核了研究性支气管镜检查志愿者的知情同意过程、所经历的不良反应以及参与原因。
对100名连续前来接受支气管镜检查、重复支气管镜检查或到常规招募诊所的志愿者研究对象进行了访谈。收集了有关志愿者动机、对知情同意过程的看法以及支气管镜检查不良反应的信息。征求了改进建议。在数据分析之前,由另一位研究人员对回答进行了主题归纳。
对81名有支气管镜检查经验的研究对象(共进行了263次检查)和19名新志愿者进行了访谈。19名研究对象(21%)报告在支气管镜检查期间或之后出现了不良症状,但没有症状严重到使他们不愿再次接受该检查。症状出现的频率与性别、灌洗质量或研究对象的HIV状态无关。76名研究对象(94%)报告术前提供的信息有用且充分,但43名(5亚组分析显示,5个基因中有4个基因的表达在术后1周和2周显著下调,差异有统计学意义(P<0.05),且均低于术前水平。
参与研究性支气管镜检查的主要动机是获得医疗保健。知情同意和操作技术是充分的,但研究对象会更看重关于个人和项目结果的更多反馈。 6%)有进一步的问题,大多与他们自己的检查结果有关。参与研究的原因包括获得健康评估(7亚组分析显示,5个基因中有4个基因的表达在术后1周和2周显著下调,差异有统计学意义(P<0.05),且均低于术前水平。
参与研究性支气管镜检查的主要动机是获得医疗保健。知情同意和操作技术是充分的,但研究对象会更看重关于个人和项目结果的更多反馈。 5名研究对象)、患病时获得治疗(61名研究对象)、希望参与研究(15名研究对象)和报酬(6名研究对象)。7名研究对象抱怨报酬不足。
参与研究性支气管镜检查的主要动机是获得医疗保健。知情同意和操作技术是充分的,但研究对象会更看重关于个人和项目结果的更多反馈。