ETHICAL PROBLEMS IN CONDUCTING RESEARCH IN ACUTE EPIDEMICS: THE PFIZER MENINGITIS STUDY IN NIGERIA AS AN ILLUSTRATION
ETHICAL PROBLEMS IN CONDUCTING RESEARCH IN ACUTE EPIDEMICS: THE PFIZER MENINGITIS STUDY IN NIGERIA AS AN ILLUSTRATION
复制标题
DOI：
10.1111/j.1471-8847.2008.00239.x
复制
发表时间：
2010-04-01
影响因子：
2.2
通讯作者：
Simon, Christian
中科院分区：
文献类型：
--
作者：
Ezeome, Emmanuel R.;Simon, Christian
在流行病情况下进行研究的道德规范尚未充分考虑到流行病的比例和严重程度等因素的差异。虽然流行病通常是由传染病引起的，但并非所有传染病都达到流行病的程度，也并非所有流行病都是急性发生的。这些和其他变化限制了道德决策的泛化，并以一种以前没有强调的方式对个体研究人员提出了道德要求。本文讨论了一些这样的限制和强加。它适用的伦理原则阐述了伊曼纽尔等。1有争议的辉瑞公司在尼日利亚的研究，以突出急性流行病研究的特殊伦理问题，并建议如何应对这样的挑战。本文建议，流行病期间的研究应部分评估其自身的优点，以确定其伦理适当的具体情况。应抵制在急性流行病期间进行研究的仓促决定。需要社区参与、公共通知和良好的信息管理，以促进在急性流行病期间进行研究的道德。个人同意最有可能受到损害，应尽一切努力确保其得到维护和有效。数据安全管理委员会的使用应该是常规的。急性流行病也为提高研究的社会价值和最大限度地造福社区提供了机会，如果事先考虑到潜在的挑战并采取适当的预防措施，就有可能在急性流行病中进行符合伦理的研究。
The ethics of conducting research in epidemic situations have yet to account fully for differences in the proportion and acuteness of epidemics, among other factors. While epidemics most often arise from infectious diseases, not all infectious diseases are of epidemic proportions, and not all epidemics occur acutely. These and other variations constrain the generalization of ethical decision-making and impose ethical demands on the individual researcher in a way not previously highlighted. This paper discusses a number of such constraints and impositions. It applies the ethical principles enunciated by Emmanuel et al.1 to the controversial Pfizer study in Nigeria in order to highlight the particular ethical concerns of acute epidemic research, and suggest ways of meeting such challenges.The paper recommends that research during epidemics should be partly evaluated on its own merits in order to determine its ethical appropriateness to the specific situation. Snap decisions to conduct research during acute epidemics should be resisted. Community engagement, public notification and good information management are needed to promote the ethics of conducting research during acute epidemics. Individual consent is most at risk of being compromised, and every effort should be made to ensure that it is maintained and valid. Use of data safety management boards should be routine. Acute epidemics also present opportunities to enhance the social value of research and maximize its benefits to communities.Ethical research is possible in acute epidemics, if the potential challenges are thought of ahead of time and appropriate precautions taken.