Co-design

Co-creation workshops results

1. Background

As a follow-up to the activities of the STRATIGIC project, the first co-creation workshop was conducted with the aim of sharing the results of the literature review, individual and group interviews, use cases that analyze the ethical opportunities and challenges of the use of digital health technologies in Sub- Saharan Africa. The co-creation workshop aimed to:

• • Co-create a culturally sensitive responsible innovation approach for digital health technologies in Africa;

  • Develop a list of options – thematic or interventions area for training – adapted with African cultural contexts and interests;

  • Get feedback on the appropriate training approach.

To achieve the above-mentioned objectives, the workshop participants weredivided into 2 groups in which, based on the presentation of the results of theresearch conducted by STRETEGIC, they answered the following questions: 1)What do you think is missing from our findings? 2) What should be the prioritiesof NECs as regards ethical challenges and gaps? 3) What should be thepriorities for NRAs in making policies regarding ethical challenges and gaps? 4)What could be best practice examples for NECs and NRAs? 5) What are yourrecommendations for training material? These questions guided our co-creationworkshop.

The second workshop, held in person on June 18th (Kigali, Rwanda), aimed to consolidate the findings from the first workshop and draft the framework. To this end, workshop participants were divided into three groups, and the results of the first workshop and different frameworks used on ethical issues in the use of digital technologies in health were presented. Examples include "The Model for Responsible Innovation (https://www.gov.uk/government/publications/the-model-for-responsible-innovation/the-model-for-responsible-innovation)"; ELSI, ELSA, etc. Participants in groups answered three fundamental questions: 1) What are the gaps in the existing framework on DHT for the SSA context? 2) What do you think an African context (SSA) framework for responsible DHT for clinical trials and research should look like? 3) How do you think your framework could be operationalized? (Including identifying potential challenges in operationalization).

The third workshops discussed due ideas of frameworks proposed in the second workshop. Key discussions points looked at the harmonization and the operationalization the frameworks. Bellow we presents the results.

Core anchor:

The Framework is anchored on Decoloniality=Trustworthiness

Decoloniality = Trustworthiness — Power, data, and benefits must shift toward African institutions and communities

Key principles and Values

• • Transparency 

  • Accountability 

  • Respect 

  • Fairness 

  • Inclusion 

  • Care and Compassion 

  • Robustness 

  • Privacy

Care & Compassion — Participants are humans first, trial subjects second.

Awareness – NRAs, NECs

The 5Cs Framework

Context = Understanding where and for whom the DHT will operate

• • Goal is to ensure that interventions are culturally, socially, and infrastructurally grounded to the SSA.

  • Assess connectivity, electricity reliability, device access, health literacy, and language diversity.

  • Engage local leaders and patient groups to identify norms, taboos, and expectations. (Decoloniality: recognise and respect indigenous knowledge systems.)

  • Identify who is most at risk of exclusion (rural, women, low-income) and plan for inclusion.

Care = Embedding participant safety, dignity, and wellbeing

• • Goal is to make technology serve people without compromising their humanity;

  • Ensure truly informed consent: Ongoing, plain-language, culturally appropriate;

  • Ensuring safety monitoring: Rapid escalation pathways with human oversight for all critical alerts;

  • Ensuring low-bandwidth designs, offline data capture, local languages, disability inclusion.

Collaboration = Inclusive partnerships and shared ownership

• • Goal is to prevent extractive research and improve partnership within SSA; African leadership is the focus

  • Participatory co-design: Communities, local clinicians, and patient advocates in design and governance boards.

  • Capacity building: Training, infrastructure investment, and tech transfer to local institutions.

  • Fair benefit sharing: Data access for local researchers, co-authorship, and local IP opportunities.

  • Ownership of data: Ensuring that data subjects or local authorities have control over the data

  • Cross-sector alignment: Involve regulators, ministries, NGOs, and private tech providers early.

Compliance = Adhering to ethical, scientific, and legal standards

• • Goal is to build trust through transparency and accountability.

  • Regulatory integration: Early engagement with national ethics boards and regulators

  • Data governance: Ensuring the key principles of privacy such as Data minimisation, consent-driven access, and adherence to local storage laws.

  • Validation & interoperability: Local population validation for algorithms/devices; use open standards.

  • Audit & accountability: Public reporting on safety, inclusivity, and trial conduct.

Continuity = Ensuring sustainability and post-trial impact

• Goal is to leave lasting, locally owned benefits rather than abandoned tech

• Sustainability planning: Funding and maintenance models for continued use after trials.

• Exit strategies: Ethical decommissioning if tech is discontinued, with participant and community communication.

• Ongoing learning: Publish both positive and negative results; feed lessons into local health systems.

• Resilience planning: Build capacity for future trials and digital health deployments.

• Awareness Raising: Continued Education of key stakeholders: Researchers, NRAs, NECs and the public as the technologies are changing.

• Ensuring that any ecological issues are solved.

• Work towards open science/open data.

The figure below the roadmap and milestones of the co-creation workshops:

Suggestions for Operationalisation

• • The use of the framework should be mandatory for NEC and NRA

  • Integration into Standard Operational Procedures (SOPs) and guidelines

  • Relevant experts in digital technology should be included in the NECs and NRAs

  • Include a comprehensive list of potential ethical issues DHTs raise in clinical trials and research in the SOPs

  • It's not only for the clinical researchers, the review or evaluation process should include the design and development teams.

  • Develop guidelines for the different stages of the innovation process - design, development and use

  • Embed (organization culture) the utilization of the framework within NEC and NRA

  • A digital platform with relevant questions based on the framework for the different stages of the innovation lifecycle

  • The questions will be based on the framework (taking note of the overlaps in the stages)

  • After the initial approval - there needs to be regular reviews.