DMT constructs | RTRE approach (AHHA trial decisions/outcomes) | Key themes |
---|---|---|
Ethical principles: Do good, do no harm, empowerment, social responsibility, participation, openness, accountability, fairness | Education sessions with Trial Implementation Team and TPs | Responsive and constructive approaches to tackling diverse ethical issues during research implementation A catalysts for participant engagement and reflections on participant roles A catalyst for enhanced informed consent |
Maize field visit, flour processing visit, dish sharing get-together meeting, Tailored information education sessions | ||
Recruitment of community volunteers | ||
Engagement with local leaders | ||
Ethics workshops, ethics approval, study protocol | ||
Informed consent, information sheets | ||
Evidence | Focus groups discussions | Acknowledgement of study participants’ lived world |
Trial reports | Â | |
Observations | Â | |
In-depth Interviews | Â | |
Suppositions on appropriate actions | Delivering Respect for autonomy | A catalyst Enhanced Informed consent |
Supporting Voluntariness | ||
Respect for persons | ||
Protecting Privacy and confidentiality | ||
Enhancing Safety | ||
Decisions | Study design and trial activities, the safety of study participants, community engagement, strategies to enhance positive experiences, trial results dissemination protocol, community exit strategies, ethics training | A catalyst for participant empowerment |