The focus of implementation research (IR) is on the systematic approach to understanding and addressing barriers to implementation and scale-up of effective and quality health interventions, strategies and policies. TDR undertakes a range of activities aiming to strengthen IR capacity in low- and middle-income countries, including the development of training tools, such as the IR Toolkit (https://www.who.int/tdr/publications/topics/ir-toolkit/en/).

The IR Toolkit highlights the importance of the submission of IR proposals to research ethics committees. Research ethics committees may not be familiar with reviewing IR protocols. The need was therefore identified to develop guidance for researchers and research ethics committees on the ethical implications of IR.

TDR and WHO’s Global Health Ethics team have jointly developed a training course on the important ethical considerations in IR, with guidance for course facilitators and participants. The ultimate aim of these training materials is to help strengthen national and international capacity for review and conduct of IR.

This participant’s guide is comprised of 6 modules:

Module 1 begins with an introduction to IR and an explanation of how IR differs from basic science, clinical research, epidemiology and surveillance. Overlaps with quality improvement and public health practice are also discussed.

Module 2 broadly discusses the ethical frameworks of medical ethics, research ethics and public health ethics and how these are all relevant to IR.

Module 3 addresses ethical issues related to the planning phase of IR, with an emphasis on the ethical principles and values underpinning the importance of community and stakeholder engagement.

Module 4 addresses the ethical issues related to the conduct of IR, with emphasis on ethical challenges raised with respect to autonomy of research subjects, promotion of justice, and data collection and management. Specific concerns regarding informed consent, standards of care and ancillary findings are discussed.

Module 5 addresses ethical issues in the post-IR phase, including obligations to disseminate research findings effectively and considerations regarding sustainability of successful interventions.

Module 6 permits consolidation of the learnings from prior modules using a case study to illustrate the relevance of the ethical considerations of IR in-depth.

All modules are intended to be interactive with didactic material interspersed with activities including case studies, role-playing and quizzes.

Additional cases for discussion and activity guides are included in 9 Annexes.

This participant's guide contains all teaching materials and copies of activities without guidance explanations.

It is intended for distribution during the teaching course to maximize interaction and learning during sessions.

The facilitator’s guide accompanies the participant’s guide and contains all teaching materials, including explanations and notes for each slide and activity. It guides facilitators on the conduct of the training course and provides background information. A proposed agenda with time allotments for each module is provided to facilitate planning and conduct of the course.