Background <p>As dissemination and implementation research advances, research teams seek guidance on how to apply existing ethical standards to implementation research, given its unique study designs, multi-level intervention targets, and associated risks. This scoping review examines ethical principles and concerns in implementation research, identifies potential risks and unintended consequences, and explores ethical frameworks guiding responsible conduct.</p> Methods <p>We searched PubMed, Web of Science, and Google Scholar for relevant literature published between January 2010 and January 2024. The search utilized a combination of standardized terms and keywords, including bioethics, ethics, research standards, responsible research, health services research, and dissemination and implementation science. Two reviewers independently extracted data on study characteristics, ethical considerations, and recommendations. We applied thematic analysis using deductive coding to identify key ethical domains and unintended consequences.</p> Results <p>The search returned 1,003 articles, of which 791 unique citations underwent screening. We included 44 articles that discussed ethical principles, risks, unintended consequences, or ethical frameworks in implementation research. The most identified ethical challenges were complexities in informed consent for system or multilevel interventions (55% of articles), equipoise regarding established interventions in new contexts (36%), inconsistencies in regulatory oversight (34%), and the need for robust risk–benefit assessments (32%). Frequently discussed unintended consequences included burnout of health providers (25%), failure to sustain interventions (25%), reduced participant autonomy (23%), stigma (20%), and equity concerns (20%). Three key findings emerged. First, while general ethical principles apply, researchers and review boards struggle with their implementation, particularly in informed consent, equipoise, and risk–benefit assessment. Second, implementation research primarily presents socio-behavioral risks, such as stigma, loss of trust, equity concerns, and burnout, rather than clinical adverse events. Third, existing ethical frameworks remain fragmented, with no consensus standards for oversight.</p> Conclusions <p>Ethical challenges in implementation research require clearer oversight and better-adapted frameworks. Existing guidance remains fragmented, leading to inconsistent risk assessments. Addressing socio-behavioral risks and unintended consequences is crucial. Strengthening ethical oversight will require consensus-driven standards, training, and further empirical research on the unique risks posed by implementation research.</p> Trial registration <p>The protocol for this manuscript was registered prospectively and published on the Open Science Framework (<a href="https://doi.org/10.17605/OSF.IO/7XFWY">https://doi.org/10.17605/OSF.IO/7XFWY</a>).</p>

错误:搜索内容不能为空,请输入英文关键词
错误:关键词超出字数限制,请精简
高级检索

Ethical considerations in implementation research: a scoping review of key principles, unintended consequences, and emerging ethical guidance

  • Emmanuel K. Tetteh,
  • Nwaliweaku Anidi,
  • Gifty Aboagye-Mensah,
  • Michelle Doering,
  • Elvin H. Geng,
  • Byron J. Powell,
  • Mark D. Huffman,
  • Alison L. Antes

摘要

Background

As dissemination and implementation research advances, research teams seek guidance on how to apply existing ethical standards to implementation research, given its unique study designs, multi-level intervention targets, and associated risks. This scoping review examines ethical principles and concerns in implementation research, identifies potential risks and unintended consequences, and explores ethical frameworks guiding responsible conduct.

Methods

We searched PubMed, Web of Science, and Google Scholar for relevant literature published between January 2010 and January 2024. The search utilized a combination of standardized terms and keywords, including bioethics, ethics, research standards, responsible research, health services research, and dissemination and implementation science. Two reviewers independently extracted data on study characteristics, ethical considerations, and recommendations. We applied thematic analysis using deductive coding to identify key ethical domains and unintended consequences.

Results

The search returned 1,003 articles, of which 791 unique citations underwent screening. We included 44 articles that discussed ethical principles, risks, unintended consequences, or ethical frameworks in implementation research. The most identified ethical challenges were complexities in informed consent for system or multilevel interventions (55% of articles), equipoise regarding established interventions in new contexts (36%), inconsistencies in regulatory oversight (34%), and the need for robust risk–benefit assessments (32%). Frequently discussed unintended consequences included burnout of health providers (25%), failure to sustain interventions (25%), reduced participant autonomy (23%), stigma (20%), and equity concerns (20%). Three key findings emerged. First, while general ethical principles apply, researchers and review boards struggle with their implementation, particularly in informed consent, equipoise, and risk–benefit assessment. Second, implementation research primarily presents socio-behavioral risks, such as stigma, loss of trust, equity concerns, and burnout, rather than clinical adverse events. Third, existing ethical frameworks remain fragmented, with no consensus standards for oversight.

Conclusions

Ethical challenges in implementation research require clearer oversight and better-adapted frameworks. Existing guidance remains fragmented, leading to inconsistent risk assessments. Addressing socio-behavioral risks and unintended consequences is crucial. Strengthening ethical oversight will require consensus-driven standards, training, and further empirical research on the unique risks posed by implementation research.

Trial registration

The protocol for this manuscript was registered prospectively and published on the Open Science Framework (https://doi.org/10.17605/OSF.IO/7XFWY).