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

Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Early childhood exposure to skin-lightening products in Nigeria: prevalence, maternal perspectives and predictors from a cross-sectional study

Por: Ajani · A. A. · Omokanye · C. · Adebayo · A. · Adejumobi · R. A. · Ijiyode · B. · Ogundiran · M. O. · Torimiro · A. · Raheem · O. · Ijadunola · M.
Background

Increasing reports of life-threatening complications in young children exposed to skin-lightening products present a significant public health concern, yet this issue remains under-researched.

Objectives

To determine the prevalence, maternal perceptions and predictors of early childhood exposure to skin-lightening products among mothers in Southwestern Nigeria.

Design

A cross-sectional, questionnaire-based study.

Setting

Three randomly selected government-owned primary healthcare facilities in Ile-Ife, Nigeria.

Participants

Three hundred and sixty-nine mothers aged ≥18 years, each with at least one child under 5, recruited by simple random sampling. Data were collected between May and July 2024 using pretested, interviewer–administer semistructured questionnaires. Mothers with acutely ill children were excluded.

Primary outcome and secondary outcome measures

Primary outcome was the use of skin lightening products on children while secondary outcomes included maternal use, perceptions and sociodemographic/familial predictors.

Results

Participants’ ages ranged from 18 to 54 years (mean: 30.92±6.11 years). Overall, 19.5% (n=72) mothers practised early childhood skin lightening, with 80.6% of exposed children

Conclusion

This study highlights a high prevalence of early childhood exposure to lightening products in a semiurban Nigerian community, with maternal use emerging as a key associated factor. Although awareness of potential health risks was common, aesthetic preferences for lighter skin tones appeared to outweigh safety concerns. These findings highlight the need for culturally sensitive interventions and further research to inform strategies that promote safer childhood skin-care practices.

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