ELSI Working Group of the Global Virome Project

Ethical, legal and social implications for zoonotic viruses with pandemic potential

Overview

The Global Virome Project (GVP) is an international scientific collaborative effort that aims to identify 85% of all zoonotic viruses with epidemic/pandemic potential in order to better predict, prevent, and respond to future viral pandemic threats.  The GVP’s process and objectives will raise ethical, legal, and social issues for which it has formed a specific working group, ELSI.  For example, the process by which viral samples are taken and shared will be subject to changing international laws regulating genetic resources in many of those countries.  Both research findings and resulting benefits from GVP’s work – diagnostics, therapeutics, vaccines –  will require well-designed platforms to maximize sharing opportunities with other scientists and affected populations as well as helping to build the capacity to advance infectious disease research in biodiverse but resource-poor countries.

The ELSI Working Group will analyze:

  • Legal frameworks that affect cooperation. The 1992 UN Convention on Biological Diversity (CBD) and its 2014 Nagoya Protocol regulate the research and development of genetic resources within the territories of biodiverse rich countries.  Both agreements are based on the principle of national sovereignty over genetic resources, prior informed consent, and mutually agreed terms for access to those resources, as well as the sharing of monetary and non-monetary benefits resulting from their utilization.  These provisions have been codified into national law in several GVP-focused jurisdictions. 
  • Biosecurity implications around sample sharing processes. Biosecurity considerations, in particular, where and under whose control will samples be stored and processed and what conditions will apply to their physical transfer, including end-use guarantees and publications of research findings.  The ELSI group will analyze model Material Transfer Agreement (MTA) language of sample sharing processes in place, to develop such processes through the creation of model legal and regulatory language, and work with legislatures to incorporate new rules where they do not yet exist.
  • Legal and regulatory requirements for biobanking around the world, and set standards for biosecurity at the biobanking facilities.  Any effort on biobanking and MTAs associated with biomedical samples must also address consent from humans or animals providing biological samples, and fully explain possible uses of such samples for future global research efforts.
  • Genetic sequence patentability and open databases in participating countries. The patentability in several jurisdictions of genetic sequences could hinder international cooperation in the production of medical technologies deriving from biological materials collected and analyzed.  This possibility may require a patent landscape analysis of participating jurisdictions.  Open databases for sharing sequencing data are a possible mechanism to balance interests and concerns.  

Working Group Members

Sam Halabi, Co-Chair

Gian Luca Burci, Co-Chair

Mehgan Gallagher

John T. Monahan

Rebecca Katz

Michelle Rourke

Materials

For more information on the ELSI Working Group of the Global Virome Project, please contact elsi.gvp@gmail.com