Protocol for a modified Delphi study of ethical oversight of data science health research (DSHR)

The use of data science for health research produces complex ethical, legal and social challenges that traditional ethical oversight mechanisms struggle to address. In Nigeria, the current ethical guidelines were not designed for these challenges which include pervasive data environments, consent for secondary data use, algorithmic decision-making and bias, privacy risks, involvement of commercial entities, data colonisation, inequitable benefit-sharing and commercial data holdings. To address these gaps, we developed a draft guideline incorporating principles like trust, veracity, global justice and alternative ethical approval mechanisms. Here, we describe the protocol for a study aimed at validating the guideline through stakeholder consensus on the content, feasibility and acceptability of this subcode for national implementation.

We describe the use of a modified e-Delphi approach to iteratively synthesize expert opinions about ethical oversight for data science health research (DSHR) led by a multidisciplinary working group from the Bridging Gaps in the ELSI of Data Science Health Research in Nigeria (BridgELSI) team. We will invite 65 experts, including health researchers, ethics committee members, data scientists, health policymakers, funders and key opinion leaders in Nigeria to participate. Participants will rate 13 core principles, including global justice, algorithmic bias, data governance and related governance provisions on importance, desirability for inclusion in national guidelines, feasibility and confidence in implementation, using 5-point Likert scales, with optional free-text comments. We will summarise responses using descriptive statistics, assess consensus and polarity using pre-specified thresholds for the mean and IQR, and iteratively refine statements between rounds using qualitative content analysis of comments.

Ethical approval was obtained from the Nigerian National Health Research Ethics Committee and the University of Maryland IRB, and participants will provide informed consent. Results will be shared with the expert panel and national regulators and disseminated via publications and conferences.