PDF(Pubmed)
Abstract：
BACKGROUND: Observational studies have generally been viewed as incurring minimal risk to participants, resulting in fewer ethical obligations for investigators than intervention studies. In 2004, the lead author (AN) carried out an observational study measuring sexual behavior and the prevalence of HIV, syphilis, and herpes simplex virus type 2 (HSV-2), among Tanzanian agricultural plantation residents (results reported elsewhere). This article uses an ethical lens to consider the consequences of the observational study and explore what, if any, effects it had on participants and their community.
METHODS: Using a case study approach, we critically examine three core principles of research ethics-respect for persons/autonomy; beneficence/nonmaleficence; and distributive justice-as manifested in the 2004 observational study. We base our findings on three sources: discussions with plantation residents following presentations of observational research findings; in-depth interviews with key informants; and researcher observations.
RESULTS: The observational research team was found to have ensured confidentiality and noncoercive recruitment. Ironically, maintenance of confidentiality and voluntary participation led some participants to doubt study results. Receiving HIV test results was important for participants and contributed to changing community norms about HIV testing.
CONCLUSIONS: Observational studies may act like de facto intervention studies and thus incur obligations similar to those of intervention studies. We found that ensuring respect for persons may have compromised the principles of beneficence and distributive justice. While in theory these three ethical principles have equal moral force, in practice, researchers may have to prioritize one over the others. Careful community engagement is necessary to promote well-considered ethical decisions.
METHODS: Using a case study approach, we critically examine three core principles of research ethics-respect for persons/autonomy; beneficence/nonmaleficence; and distributive justice-as manifested in the 2004 observational study. We base our findings on three sources: discussions with plantation residents following presentations of observational research findings; in-depth interviews with key informants; and researcher observations.
RESULTS: The observational research team was found to have ensured confidentiality and noncoercive recruitment. Ironically, maintenance of confidentiality and voluntary participation led some participants to doubt study results. Receiving HIV test results was important for participants and contributed to changing community norms about HIV testing.
CONCLUSIONS: Observational studies may act like de facto intervention studies and thus incur obligations similar to those of intervention studies. We found that ensuring respect for persons may have compromised the principles of beneficence and distributive justice. While in theory these three ethical principles have equal moral force, in practice, researchers may have to prioritize one over the others. Careful community engagement is necessary to promote well-considered ethical decisions.
摘要：
背景：观察性研究通常被认为对参与者的风险最小，导致研究者的伦理义务少于干预研究。2004年，主要作者（AN）进行了一项观察性研究，测量性行为和艾滋病毒的患病率，梅毒,和单纯疱疹病毒2型（HSV-2），在坦桑尼亚农业种植园居民中(其他地方报道的结果)。本文使用伦理视角来考虑观察研究的后果，并探讨了什么，如果有的话,它对参与者及其社区的影响。
方法：使用案例研究方法，我们批判性地研究了研究伦理的三个核心原则-尊重人/自主性;慈善/非恶意;和分配正义-如2004年观察研究所示。我们的发现基于三个来源：在介绍观察性研究结果后与种植园居民进行讨论；与关键线人进行深入访谈；和研究人员的观察。
结果：发现观察研究小组确保了保密和非强制性招募。讽刺的是,保密和自愿参与导致一些参与者怀疑研究结果。接受艾滋病毒检测结果对参与者很重要，并有助于改变社区关于艾滋病毒检测的规范。
结论：观察性研究的作用可能类似于事实上的干预研究，因此承担与干预研究相似的义务。我们发现，确保尊重他人可能会损害慈善和分配正义的原则。虽然理论上这三个伦理原则具有同等的道德力量，在实践中,研究人员可能不得不优先考虑其中一个。仔细的社区参与对于促进深思熟虑的道德决策是必要的。
方法：使用案例研究方法，我们批判性地研究了研究伦理的三个核心原则-尊重人/自主性;慈善/非恶意;和分配正义-如2004年观察研究所示。我们的发现基于三个来源：在介绍观察性研究结果后与种植园居民进行讨论；与关键线人进行深入访谈；和研究人员的观察。
结果：发现观察研究小组确保了保密和非强制性招募。讽刺的是,保密和自愿参与导致一些参与者怀疑研究结果。接受艾滋病毒检测结果对参与者很重要，并有助于改变社区关于艾滋病毒检测的规范。
结论：观察性研究的作用可能类似于事实上的干预研究，因此承担与干预研究相似的义务。我们发现，确保尊重他人可能会损害慈善和分配正义的原则。虽然理论上这三个伦理原则具有同等的道德力量，在实践中,研究人员可能不得不优先考虑其中一个。仔细的社区参与对于促进深思熟虑的道德决策是必要的。
