Developing the ethics of implementation research in health.
Developing the ethics of implementation research in health.
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DOI：
10.1186/s13012-016-0527-y
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发表时间：
2016-12-09
期刊：
影响因子：
--
通讯作者：
Vahedi M
中科院分区：
文献类型：
--
作者：
Gopichandran V;Luyckx VA;Biller-Andorno N;Fairchild A;Singh J;Tran N;Saxena A;Launois P;Reis A;Maher D;Vahedi M
实施研究（IR）越来越被认为是可转化为卫生政策的实用知识的重要来源。 IR 的目的是回答如何改善干预措施的可及性问题，这些干预措施已被证明有效，但尚未惠及许多可以从中受益的人，IR 涉及一系列特定的伦理考虑因素，而国际卫生研究伦理准则尚未全面涵盖这些考虑因素。指导临床研究的基本伦理原则同样适用于 IR，但这些原则的应用可能会因 IR 问题、背景和拟议干预的性质而有所不同。 IR 问题涵盖广泛的主题，重点是改善卫生系统的运作以及改善公平公正地获得有效的卫生保健干预措施。因此，IR 设计灵活且常常具有创新性，并且伦理原则不能简单地从其在临床研究中的应用中推断出来。与包括社区和研究参与者在内的所有利益相关者进行有意义的接触是一项基本的道德要求，它贯穿 IR 的所有研究阶段，并将大多数道德问题联系起来。 IR 中可能需要仔细修改知情同意流程，以允许研究所需的干预措施。与 IR 相关的风险可能难以预测，并且可能因具体情况而异。 IR 的好处可能不会惠及参与研究的同一群体，因此证明 IR 的风险与收益的合理性可能在伦理上具有挑战性。人们期望通过信息检索产生的知识能够迅速转化为卫生政策和实践，因此决策者必须对有效干预措施的可持续性和可扩展性做出预先承诺。迫切需要提高对 IR 特征的特定伦理影响的认识，以促进 IR 的最佳伦理行为和统一的伦理审查。
Implementation research (IR) is growing in recognition as an important generator of practical knowledge that can be translated into health policy. With its aim to answer questions about how to improve access to interventions that have been shown to work but have not reached many of the people who could benefit from them, IR involves a range of particular ethical considerations that have not yet been comprehensively covered in international guidelines on health research ethics. The fundamental ethical principles governing clinical research apply equally in IR, but the application of these principles may differ depending on the IR question, context, and the nature of the proposed intervention. IR questions cover a broad range of topics that focus on improving health system functioning and improving equitable and just access to effective health care interventions. As such, IR designs are flexible and often innovative, and ethical principles cannot simply be extrapolated from their applications in clinical research. Meaningful engagement with all stakeholders including communities and research participants is a fundamental ethical requirement that cuts across all study phases of IR and links most ethical concerns. Careful modification of the informed consent process may be required in IR to permit study of a needed intervention. The risks associated with IR may be difficult to anticipate and may be very context-specific. The benefits of IR may not accrue to the same groups who participate in the research, therefore justifying the risks versus benefits of IR may be ethically challenging. The expectation that knowledge generated through IR should be rapidly translated into health policy and practice necessitates up-front commitments from decision-makers to sustainability and scalability of effective interventions. Greater awareness of the particular ethical implications of the features of IR is urgently needed to facilitate optimal ethical conduct of IR and uniform ethical review.
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影响因子：
3.3
作者：
Jennings, Bruce;Dawson, Angus
通讯作者：
Dawson, Angus
DOI：
10.1197/jamia.m1749
发表时间：
2006-01-01
影响因子：
6.4
作者：
Harris, AD;McGregor, JC;Finkelstein, J
通讯作者：
Finkelstein, J
影响因子：
5.4
作者：
Benatar, SR
通讯作者：
Benatar, SR
影响因子：
6.4
作者：
Gidado, Saheed O.;Ohuabunwo, Chima;Mahoney, Frank J.
通讯作者：
Mahoney, Frank J.
影响因子：
4.4
作者：
Amico KR;Mehrotra M;Avelino-Silva VI;McMahan V;Veloso VG;Anderson P;Guanira J;Grant R;iPrEx Study Team
通讯作者：
iPrEx Study Team