Important documents for GeCIP members

Participation Agreement

The Participation Agreement outlines the key principles that members of each institution must adhere to including our Intellectual Property (IP) and Publication Policy. These documents have been constructed with input from researchers and funders (MRC, Wellcome Trust, NIHR and Cancer Research UK). Each institution will be responsible for ensuring its members are covered by the agreement. The rights and responsibilities of GeCIP Institutions are as set out in the GeCIP Participation Agreement. To ensure we conform to our ethical approval we cannot grant access to any institution’s researchers where there is not institutional approval of the Participation Agreement and its associated documents.

GeCIP Rules

The individual researchers themselves will sign a specific agreement covering their behaviour and working practice within the data infrastructure. The GeCIP is administered in accordance with these Rules which apply to all individual GeCIP members.

Publication Policy

This document sets out the policy of Genomics England as regards the publication of findings from the 100,000 Genomes Project. This document is not an SOP as it does not define ways of working but it is key to decision-making on publications, and should be used in conjunction with other applicable Genomics England policies. Genomics England has established a Publications Committee to oversee and decide on matters relating to publication of the findings of the 100,000 Genomes Project.

IP Policy and IP Principles

Intellectual Property (IP) is the term given to the material that is generated from original creative thought, for example a piece of art, a piece of music, or, as most relevant to the 100,000 Genomes Project, knowledge gained through research. IP can be protected by Intellectual Property Rights which are granted to the creators of IP, for example an author’s book will be protected by copyright, or a company logo will be trademarked, or the result of some research may be patented. These rights essentially says who ‘owns’ the IP. It is common that the owner of the IP (i.e. the holder of the IP Rights) is not the same as the person that originally created it, for example a graphic designer may be paid to design a new company logo and as part of their contract they will agree that all the IP Rights are owned by the company.

The ownership of IP is important as it is often a source of income for the individual or company, and offers them some protection against forgery or copying of their idea. For example, an inventor may come up with a brilliant invention, but not have sufficient money to actually put it into production. If they patent the invention (so protect the IP) then they can approach a company and suggest they go into partnership to get their idea to market. The company will license the patent and so pay the inventor to be able to use it. Without a patent and its protections, there is nothing to stop the company from just copying the inventor’s idea, taking all the profits, and leaving the inventor with nothing.

Normally in the world of research, any IP generated by a researcher is owned by their host university. When the 100,000 Genomes Project was originally conceived, the Department of Health stipulated that all IP that was generated from research on the data would be owned by Genomics England and managed on behalf of the nation. The idea being that Genomics England would maintain greater control of how participant’s data was used, and that if any commercial company wanted to license any IP they would only need to do so from a single company, Genomics England, rather than having to negotiate with multiple universities. Genomics England requires all of the institutions in GeCIP to agree to this, and they do so by signing a document called the Participation Agreement and agreeing to the IP Policy.

The Genomics England IP Policy sets out the various different scenarios in which IP may be generated and how Genomics England would treat them. In cases where IP is generated entirely by using the data within the Research Environment, then it is expected that Genomics England would own all of that IP. However, where researchers generate IP partly by using the data, and partly by using other data or resources, for example they use a software tool they have developed to generate new IP from the data, then who owns that IP would be different. In this case, the researchers would maintain the IP Rights attached to the piece of software and, depending on the nature of the tool or resources may own any IP Rights resulting from their use in the Research Embassy (either on their own or with Genomics England). By signing the Participation Agreement, the institutions agree to the guidelines outlined in the IP Policy also.

GeCIP Guidance document

This document defines the goals of GeCIP, describes how GeCIP will be organised and who can express interest in joining GeCIP. In addition we describe the opportunities from membership in such a partnership and expectations of GeCIP community.

Project Protocol

This is the initial document issued by Genomics England setting out the protocol for the development, delivery, and operation of the 100,000 Genomes Project. It also details the patient and clinical benefits, the scientific and transformational objectives, the implementation strategy, as well as the ethical and governance frameworks required for the Project.

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