Development of Data Transfer Ethics Framework (daTEF): A participatory approach to delivering evidence-based...

In Nepal, insufficient healthcare infrastructure and limited funding contribute to unmet public healthcare needs and reduced quality of care. While foreign health researchers have stepped in to support local research initiatives, their involvement has sparked ethical concerns regarding the sharing and ownership of data. This study aims to develop a locally governed framework for ethical healthcare data exchange, establish an evidence base to understand local challenges in data transfer, and to identify potential solutions for data sharing with international research teams.

This cross-sectional qualitative study was conducted in Kathmandu, Nepal, using 11 multiple-choice and 12 open-ended questionnaire models. We conducted a pre-structured questionnaire survey to best identify local ethics issues related to international data transfer and proposed solutions for these challenges. The key representatives identified from the non-governmental and not-for-profit research institute (n = 14) and the life sciences society (n = 7) were invited to one-to-one blind interviews, and their recorded transcripts were coded using the QDA Miner Lite software (version 3.0) for analysis.

The ratio of female to male participants was 2:3, while the ratio of junior-level staff to senior staff (≥3 years of experience in the sector) was 1:9. Approximately 42.86% of participants shared both raw and analytical data, while <5% shared no data with collaborators. Concerning knowledge, attitudes, and practices, most (38.46%) preferred open-access storage, while approximately 23.1% had limited knowledge, and 15.38% opted for confidentiality. Additionally, < 10% were in the learning process and sought training in data transfer procedures. Within this group of key representatives, participants faced main challenges in the data transfer process from four key categories: (i) the lack of standardized guidelines from government or institutes for data transfer, (ii) inadequate awareness and training in data sharing, (iii) problems related to data sharing, and (iv) problems related to biological sample transfer.

In summary, this study emphasizes the importance of a standardized data-sharing platform, focusing on protecting intellectual property rights and establishing a centralized data repository in Nepal. It also recommends educational reforms, legal measures, well-defined agreements, and dedicated oversight to ensure data integrity and security, while streamlining sample transfer processes to enhance transparency and scientific progress in Nepal's research landscape.