Research Ethics Committee Perspectives on the Reuse of Genetic Data: Gatekeepers of Responsible Research

Abstract

Background

Genetic research holds immense potential for advancing personalized medicine, understanding disease mechanisms, and developing targeted therapies with safe and effective outcomes. The re-use of data can accelerate scientific discovery, reduce redundancy, and enhance the value derived from research investments. However, the re-use of genetic data also raises significant ethical, legal, and social concerns. Understanding the perspectives of research ethics committee members involved in the review of clinical trial protocols is crucial for developing policies and practices that balance the benefits and risks to research participants.

Objective

The primary objective of the research was to explore the knowledge, attitude, and practices of research ethics committee members on genetics and its data for re-use.

Design and Method

This was a cross-sectional observation study to explore the perspectives of research ethics committee members [n = 50] on the reuse of genetic samples and their data for future research purposes.

Setting and Participants

The study was conducted in the Clinical Research Department, Karnataka, India. The research involved a diverse group of research ethics committee members, including chairpersons, Medical scientists, clinicians, legal experts, and laypersons. The present study assessed the knowledge, attitude, and practices of research ethics committee members based on their role in the Research Ethics Committee.

Results

The present research KAP assessment revealed significant variability in awareness and understanding of genetic samples and their data reuse. Clinicians (90%) and medical scientists (100%) exhibited the highest levels of knowledge about the genetic data for re-use, while laypersons and legal experts reported lower levels, which might be due to their educational background (p < 0.001). Educational background strongly influenced perspectives, with MSc-PhD holders demonstrating higher knowledge levels. The diverse levels of knowledge and varying concerns among different roles within Research Ethics Committees reflect the complex nature of ethical and legal considerations in the re-use of genetic data.

Conclusion

The present research underscores the need to integrate stakeholder insights into future policy development on genetic data re-use, like ICH-GCP guidelines for clinical trials. Doing so can strengthen ethical governance, ensure participant trust, and guide the responsible reuse of genetic data in research. There are no universally accepted guidelines beyond those by ICMR (2017) and WHO (2024).

Registration

Clinical trial registry in India-CTRI/2011/11/032811 dated 23.11.21

Keywords

bioethics biorepositories/biobanks research ethics clinical trials genetic research

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