Data and ethics in health research

Data protection, participant information, regulatory requirements: reflections from two days of discussions in Bordeaux during the Mereva 2025 seminar.

Last updated on 01 July 2025

Overview

Organized by Mereva – a Franco-Ivorian methodological and management center (CMG) – and supported by ANRS MIE through the PRISME Côte d’Ivoire partnership, the seminar “Data and Ethics in Health Research: Navigating Between Innovation and Responsibility” was held in early April 2025.

The seminar brought together researchers and representatives from French and international institutions to discuss the ethical challenges raised by clinical research conducted in low- and middle-income countries (LMICs). Discussions focused on two major issues: the protection of participants’ data and the information provided to them.

Two days of reflection on data protection and participant information

Adapting research to local realities

At the heart of the seminar, a shared conviction emerged: for international clinical research to be ethical, relevant, and sustainable, it must be rooted in the realities of the contexts in which it is conducted. In low- and middle-income countries (LMICs), this requires taking into account a wide range of factors — including limited access to healthcare, various forms of vulnerability, and diverse national regulatory frameworks, particularly regarding personal data protection.

Discussions highlighted the growing difficulties in reconciling the requirements of the General Data Protection Regulation (GDPR), which has applied to European sponsors since 2018, with the emerging legislative frameworks of partner countries. This situation creates significant constraints for project implementation and underscores the urgent need for coherence, harmonization, and adaptability of reference methodologies, while ensuring the protection of participants’ rights.

Data protection and regulation as key concerns

The first day focused on issues related to data protection and applicable regulations.

In LMICs, clinical research is often sponsored by French or European institutions, which are subject to the General Data Protection Regulation (GDPR). In addition to this European requirement, local legal and regulatory frameworks — sometimes still under development — add a layer of complexity. These frameworks can vary significantly from one country to another and often require nuanced interpretation on the ground.

A roundtable discussion, notably involving the French CNIL and regulatory authorities from Côte d’Ivoire and Senegal, provided an opportunity to exchange experiences, compare practices, and propose concrete solutions. In particular, there is a need to adapt the CNIL’s reference methodologies to the specific contexts of LMICs in order to streamline authorization processes without compromising ethical standards. The CNIL committed to conducting an in-depth review of its reference methodologies to better reflect the realities of international research, emphasizing the importance of close collaboration with all relevant stakeholders throughout this process.

Informing participants: how to adapt to local realities?

The second day focused on issues related to informing participants in health research projects conducted in LMICs.
The reality in many of these contexts is that a significant proportion of adults remain illiterate — nearly half in Côte d’Ivoire, with stark regional disparities and decentralized areas where the vast majority of adults are unable to read or write. In such settings, ensuring truly informed consent is a major ethical challenge. Feedback from the field also revealed that, in some studies, up to 50% of participants were unaware they had been enrolled in a clinical trial.

Towards new approaches to participant information

In response to these findings, alternative educational tools previously used in research projects were presented and served as a basis for discussion. However, several questions remain: Are these formats perceived as appropriate by adult participants? Can they be validated within existing regulatory frameworks? Evaluating these new tools is now absolutely essential.

Several concrete approaches were discussed:

An explanatory comic strip was developed to help participants better understand the objectives and implications of research;
Development of multilingual video clips;
Creation of image banks to illustrate information sheets;
Enhanced training for research teams on ethical communication;
Use of impartial witnesses, particularly in cases of illiteracy.

The essential role of patient associations in participant information

The crucial role of patient associations and civil society representatives in the information process was unanimously reaffirmed. Their involvement from the earliest stages of project co-design helps ensure that educational tools are more accessible and socially acceptable. These groups also act as key intermediaries with communities, fostering trust and transparency in clinical research.

Next steps in collaborative research

The Mereva 2025 seminar highlighted the richness of the partnerships developed between French, Ivorian, and international research and health institutions and authorities, and the relevance of a collaborative approach to addressing the ethical, regulatory, and operational challenges of research in LMICs.

It also underscored the importance of maintaining ongoing dialogue with local authorities, institutional partners, and affected communities in order to evolve practices in a coordinated and context-appropriate manner.

The work and reflections initiated — particularly around the adaptation of regulatory frameworks and the development of participant information tools — must now be carried forward and translated into action. With the support of PRISME Côte d’Ivoire stakeholders, and in line with its strategic priorities, Mereva positions itself as a key player in promoting fair, inclusive, and responsible international research.

Since 2023, ANRS MIE has been committed to supporting LMICs in becoming sponsors of their own clinical trials.

ANRS MIE is also working to strengthen research sponsorship capacities in low- and middle-income countries (LMICs).
The objective is to enable an increasing number of local institutions to take on the regulatory sponsorship of their clinical trials.

Since 2023, ANRS MIE has developed several initiatives aimed at all research partners, with the goal of supporting the evolution of national systems — including the AFRAVIH–ANRS MIE training program and the INTEGRATE project.

Learn more about the AFRAVIH–ANRS MIE training program
Learn more about the INTEGRATE project

Mereva – A pillar of scientific coordination supporting global health research

Mereva is the research management platform that supports PRISME Côte d’Ivoire stakeholders and their partners. This Franco-Ivorian methodological and management center is backed by ANRS MIE and jointly coordinated by the PACCI research center (Côte d’Ivoire) and the Global Health in Global South team (IRD, Inserm, University of Bordeaux) within Bordeaux Population Health.

Mereva specializes in the implementation and management of clinical and operational health research projects conducted internationally. As a research coordinator in over thirty countries — primarily in sub-Saharan Africa — Mereva develops solutions tailored to local technical, regulatory, and cultural contexts, with the goal of promoting fair, rigorous, and sustainable research.

Find out more about the ANRS MIE Ethical Charter

ANRS MIE grounds its work in an evolving ethical approach focused on the respect and protection of individuals participating in research, through its Ethical Charter — a Charter developed collaboratively and regularly updated.
This Charter provides a framework for research conducted in low- and middle-income countries (LMICs), aligning knowledge production with equitable partnerships and sensitivity to local contexts.
Reflections from the seminar contribute to improving practices, strengthening the role of participants within projects, and continuously shaping and advancing the Charter.

ANRS MIE Ethical Charter [FR]