Ekusai-Sebatta Deborah, Kyaddondo David, Kaawa-Mafigiri David, Barugahare John, Ssentongo Jimmy Spire, Singh Shenuka, Mwaka Erisa
Makerere University, Kampala, Uganda.
University of KwaZulu Natal, Durban, South Africa.
Res Ethics. 2025 Aug 1. doi: 10.1177/17470161251361575.
While genomic data sharing enhances transparency and research efficiency, it also raises significant ethical and social challenges. This study explored stakeholders' perspectives on these issues, particularly around privacy, confidentiality, and equity in collaborative research. A phenomenological qualitative study was conducted between August and December 2023 at Makerere University College of Health Sciences, other research-intensive institutions, and national regulatory bodies. The study engaged 86 participants: 47 key informants (16 researchers, 14 ethics committee members, nine community advisory board members, and eight research regulators) and four deliberative focus group discussions with 39 participants. Interviews were transcribed verbatim, and thematic analysis was conducted using NVivo 14. Three major themes emerged: (1) stakeholders' experiences in genomic research, including their roles as participants, implementers, or overseers; (2) ethical concerns, such as informed consent, third-party data access, inequities between high-income and low- and middle-income country (LMIC) researchers and participants, and the lack of benefit-sharing frameworks; and (3) social implications, including stigma, discrimination, labeling, community perceptions of fairness, and the need for meaningful engagement. Participants emphasized the importance of protecting participant rights, promoting equity, and ensuring robust data governance and security. The theoretical frameworks of principlism and distributive justice provided a valuable lens for examining these concerns, particularly by highlighting the need to safeguard privacy and fairly distribute responsibilities and benefits in global collaborations. Participants also noted that perceptions of fairness are shaped by trust, local context, and past experiences with research factors that are critical for building equitable and respectful partnerships. This study underscores the urgent need to strengthen protections for research participants and promote fairness in genomic data sharing. Policies should, if adopted, emphasize culturally contextualized consent, active community engagement, restricted third-party data access, and strong data protection mechanisms to address existing inequities and prevent misuse.
虽然基因组数据共享提高了透明度和研究效率，但它也带来了重大的伦理和社会挑战。本研究探讨了利益相关者对这些问题的看法，特别是围绕合作研究中的隐私、保密和公平性。2023年8月至12月，在马凯雷雷大学健康科学学院、其他研究密集型机构和国家监管机构开展了一项现象学定性研究。该研究有86名参与者：47名关键信息提供者（16名研究人员、14名伦理委员会成员、9名社区咨询委员会成员和8名研究监管人员），以及与39名参与者进行的4次审议性焦点小组讨论。访谈内容逐字记录，并使用NVivo 14进行主题分析。出现了三个主要主题：（1）利益相关者在基因组研究中的经历，包括他们作为参与者、实施者或监督者的角色；（2）伦理问题，如知情同意、第三方数据访问、高收入国家与低收入和中等收入国家（LMIC）研究人员及参与者之间的不平等，以及缺乏利益分享框架；（3）社会影响，包括污名化、歧视、标签化、社区对公平的看法，以及有意义参与的必要性。参与者强调了保护参与者权利、促进公平以及确保强大的数据治理和安全的重要性。原则主义和分配正义的理论框架为审视这些问题提供了有价值的视角，特别是通过强调在全球合作中保护隐私以及公平分配责任和利益的必要性。参与者还指出，公平感受到信任、当地背景以及过去对研究因素的经历的影响，这些因素对于建立公平和相互尊重的伙伴关系至关重要。本研究强调了加强对研究参与者的保护并促进基因组数据共享公平性的迫切需求。如果采用相关政策，应强调文化背景下的同意、社区的积极参与、限制第三方数据访问以及强大的数据保护机制，以解决现有不平等问题并防止滥用。
