Table 2 An outline of activities facilitated by the Bioethics Team and the recorded outcomes
Date/time | Activity | Task | WHO | Issues | Data type | BT responsibility | Outcome |
|---|---|---|---|---|---|---|---|
Annual Planning workshop October 2018 | Face to face interactions by trial implementing team | Facilitate discussion to identify ethical issues with the overall study activities | Bioethics Team, Laboratory Team, Soil Experts, Trial Management Team, Economists | Patient safety, Informed Consent procedures, study design, compensation, community engagement, maize distribution | Ethno-Notes | Facilitated discussion of impact of study design and activities, Discussion on safety and informed consent procedures | Development of safety reporting tools, development of an educational community engagement process, training on ethics to the study team, development of Informed consent evaluation strategies |
Formative Research | Survey or questionaires between potential trial participants and trial team members | Gauge community perceptions and potential areas of concern | 6 FGD, 7 In-Depth Interviewa with community members | Family planning concerns leading to infertility, fears regarding blood sampling and witchcraft and social stigma | Interviews | Ensure comprehension of study aims and procedures | Edit Protocol, Incorporate real time ethics approaches |
Maize Field Visit April 2019 | Face to face interactions with community representatives | Gauge community perceptions and potential areas of concern about the maize production procedures | Community respresentatives, LUANAR team members and the ethics team | Rumours about maize field, growing protocol, fertility issues, double blinding procedures, flour consumption | Ethno-Notes | Feedbac to Trial implementing Team on TPs experiences, concerns and perspectives | Develop community education sessions |
Baseline Study July 2019 | Â | Â | Â | Â | Â | Â | Â |
Community engagement and Information Sharing session July 2020 | The face-to-face interactions with wider community members | Enforce honest discussion, facilitate interactice process between communities and trial implementation team | Community members, LUANAR team members and the ethics team | Safety of flour and flour consumption procedures. To higlight milestones on study activties and reminder on study roles and responsibilities | Ethno-Notes | Promoted consistency, Cemented trusting relationship | Developed community engagement approaches and enhanced informed consent frameworks to highlight participants roles and responsibilities, address concerns and myths. Exist strategies |
Flour Processing Visit July 2019 | Â | Â | Â | Â | Â | Â | Â |
Dish Sharing get together meeting August 2019 | The face-to-face interactions with community representatives | Gauge community perceptions and potential areas of concern about the flour production process | Community representatives, LUANAR team members and the ethics team | Mechanism to nullify rumours, alleviate fear about the flour and cement trust | Ethno-Notes | Facilitated undertanding of information needs, safety concerns | Alleviation of fear, addressed safety concerns, cemented trusting relationships, enhanced informed consent, increased study roles and capability |
Endline community Information sharing session Sept 2019 | Â | Â | Â | Â | Â | Â | Â |
Endline Study Sep 2019 | Active dialogue between Trial Participants and the Ethics Team | Assess ethical and societal issues of the AHHA trial and determine best practises for respect for persons | 5 FGD, 7 In-depth Interviews with community members | Blood donation procedures, trial access, compensation rewards | Interviews | promoted ethical mindfulness on how to share study results | Development of study results dissemination protocol |