Future-use consent and human virome research: ethical challenges

Area of Science:

• Bioethics
• Genomics
• Microbiome Research

Background:

• Future-use consent frameworks are standard for biospecimen research.
• These frameworks are being extended to novel areas like human virome studies.
• Human virome research introduces unique ethical and logistical considerations.

Purpose of the Study:

• To examine how human virome research challenges existing future-use consent models.
• To identify key areas of concern within these consent frameworks.
• To propose necessary adaptations for ethical clinical research governance.

Main Methods:

• Analysis of current consent frameworks in the context of virome research.
• Identification and examination of four critical dimensions of concern.
• Review of ethical implications and governance needs.

Main Results:

• Virome research complicates consent due to evolving interpretations of biospecimens.
• Viral findings present unforeseen sensitivities and potential for misuse.
• Unresolved issues regarding sample disposition and return of results pose challenges.
• Existing consent models are insufficient for the complexities of virome research.

Conclusions:

• Human virome research necessitates a re-evaluation of future-use consent.
• Updated governance structures are crucial for maintaining ethical legitimacy.
• Adaptations are required to accommodate the unique nature of virome data and samples.