Knowledge and Recommendations of Stakeholders Regarding Ethical Oversight of Data Science Health Research: Protocol for a Qualitative Study
Notice bibliographique
Résumé
BACKGROUND: Data science health research (DSHR) uses novel computational methods and high-performance computing to analyze big data from conventional and nonconventional health and related sources to generate novel insights and communications. DSHR creates assets but generates ethical, legal, and social challenges. Key gaps in current ethical oversight of DSHR include blurred boundaries between research and nonresearch data use, inadequate protection of data donors, power imbalances that risk extractive research practices, algorithmic biases, and regulatory inadequacies. Nigeria, a typical low- and middle-income country with rapidly expanding DSHR, exemplifies this environment and concerns. OBJECTIVE: This study will elicit answers from Nigerian DSHR stakeholders and contribute to understanding the ethical, legal, and social implications (ELSI) of DSHR and developing novel ethical oversight frameworks. METHODS: Between October 2024 and January 2025, we conducted Key Informant Interviews with 65 stakeholders of 87 individuals. The Key Informant Interview guide comprised 11 construct-based question domains addressing awareness of policies and laws, ethical oversight processes, ELSI considerations in policy development, experiences addressing DSHR challenges, organizational and procedural frameworks, ideal oversight components, stakeholder roles, research impact on ethics and policy, regulatory influences on research practices, equity-enhancing policies, and balanced regulations. The interviews lasted 60-90 minutes and were transcribed. We analyzed the transcripts using a hybrid deductive-inductive approach. A priori codes derived from research objectives provided the analytical framework while allowing for the identification of emergent concepts. The iterative 3-level coding process involved initial code generation, evaluation, and refinement, with codes grouped into thematic families and semantic networks representing hierarchical concept relationships. Query tools and Boolean operators were used to interrogate the codes to extract findings. RESULTS: Of 87 invited individuals, 22 (25%) were unable to participate. The 65 participants (age: mean 47.9, SD 7.9 years; 50/65, 77% male) included data science health researchers (25/65, 39%), biomedical researchers (17/65, 26%), Health Research Ethics Committee members (12/65, 19%), and policymakers (11/65, 17%). Most held doctoral degrees (38/65, 57%) and were affiliated with academic institutions (45/65, 69%) and government organizations (26/65, 40%), and had received general research ethics training (50/65, 77%). However, only 12% (8/65) had received predominantly short-duration ethics-specific DSHR training, while 92% (60/65) acknowledged the need for specialized DSHR ethics education. As of January 2025, the interview transcripts have been generated, with checking completed, with qualitative analysis scheduled for completion by March 2025 and completion of primary manuscripts by the end of 2025. CONCLUSIONS: This study will generate stakeholder-informed recommendations for ethical oversight of DSHR that address issues relating to broad consent, ELSI, data ownership, benefit-sharing, and donor protection in resource-limited settings. Our findings will inform global DSHR and research ethics communities on the development of contextually appropriate oversight mechanisms that promote equitable partnerships, co-ownership, and tiered data governance. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/78557.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,094 | 0,104 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,002 |
| Méta-épidémiologie (sens large) | 0,003 | 0,002 |
| Bibliométrie | 0,005 | 0,004 |
| Études des sciences et des technologies | 0,009 | 0,008 |
| Communication savante | 0,006 | 0,007 |
| Science ouverte | 0,005 | 0,007 |
| Intégrité de la recherche | 0,007 | 0,010 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,042 | 0,011 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».