Stakeholder perspectives on ethical issues in genetic data reuse within clinical trials

The ethical reuse of genetic data in clinical trials poses significant challenges, particularly concerning informed consent, data privacy, and governance on genetic data re-uses. Understanding stakeholder perspectives is essential to developing responsible and transparent practices in genetic research.

To explore the perspectives of key clinical trial stakeholders on the ethical issues associated with the reuse of genetic data.

A cross-sectional and questionnaire-based study was conducted at the Clinical Research Department of KLE Society's Dr. Prabhakar Kore Hospital and Medical Research Center, Belagavi, Karnataka, India.

The study involved 225 stakeholders, including clinical trial participants, investigators, ethics committee members, pathologists, and pharmaceutical sponsors/CROs. Data were collected using structured questionnaires designed to assess the ethical issues regarding genetic data reuse.

One-way ANOVA was applied to compare perceptions across stakeholder groups.

Potential misuse of genetic data emerged as a key concern, particularly among clinical trial participants (96%) and pathologists (82%). Ethical and legal uncertainties in data governance were reported by 62% of pharmaceutical sponsors. In addition, 56% of ethics committee members emphasized the importance of returning research results to individuals as a critical ethical issue.

The study highlights pressing ethical concerns surrounding genetic data reuse in clinical trials, particularly in the context of consent, data security, and result disclosure. These insights can guide policy development and assist clinical researchers and ethics committees in fostering trust and ensuring ethically sound data practices.