GeCIP Eligibility

Most academic researchers and clinical staff from across the world will be eligible to join GeCIP. Specifically, membership of GeCIP is open to any individual, student or member of staff, who is affiliated with:

• UK academic research institutions (e.g. universities, research institutions etc.)
• NHS trusts or authorities
• UK and foreign charitable organisations directly related to the focus of the 100,000 Genomes Project
• Foreign universities and research institutions that carry out significant research activity
• UK and foreign governmental departments that carry out significant research activity (eg. MRC, NIH, PHE)
• Foreign healthcare organisations (private or public) that undertake significant research activity

Membership is not open to those who are employed by:

• Private UK healthcare institutions;
• Commercial companies;
• Self-employed.

Individuals from the above excluded institutions may be eligible to apply if they are able to show that their employer supports a significant amount of independent research within their role, perhaps via an honorary contract with an eligible institution. There may be other circumstances where an exception is appropriate and petitions for such an exception will be assessed  by Genomics England on a case-by-case basis.

GMC Members of Staff

Members of staff from NHS Genomics Medicine Centres that have assisted with participant recruitment to the 100,000 Genomes Project are entitled to GeCIP membership but are still required to complete the GeCIP membership application form so that they can be added to the membership of their chosen domain.

Patient and Participant Involvement Representatives

The above restrictions on GeCIP elgibility may initially appear to exclude some Patient and Participant Involvement (PPI) representatives from joining GeCIP. However, provided the individual concerned is not seeking to access the data directly within the Research Environment, then they may request to opt-out of data access and remain a member of GeCIP.

How to Join GeCIP and Other GeCIP Domains

There are details of how to apply to join GeCIP on the Genomics England website. In short after filling in the online form, the applicant's details will be sent to the domain leads of the domains listed in the application. They will consider the applicant's skills and compatibility with the domain's research interests, and decide whether to accept or reject the application. GeCIP has been founded with a 'Team-Science' mindset, and the domain leads are encouraged to bear this in mind. The applicant will be notified of the domain's decision by email.

If you would like to join another domain or subdomain please contact the domain(s) or subdomain(s) lead(s) listed on our Key Contacts page to discuss your interest and how you may effectively contribute to the domain. Note that membership of domains does not govern members’ access to data – all GeCIP members can see all deidentified 100,000 Genomes Project data within the research environment. GeCIP members should only consider joining a new domain(s) if their intended research activities fit within its scope.

GeCIP Expectations

As a member of a GeCIP domain you will be given access to the 100,000 Genomes Project dataset. However, there are expectations of members and principles for research within  the GeCIP research community that go beyond data access and analysis. These include:

• Contribution to the knowledge base for genome interpretation (for example via PanelApp)
• Active and effective collaboration within your GeCIP domain and with other GeCIP domains
• Expert assistance in genome interpretation to improve diagnostic yield for NHS Genomic Medicine Centres (GMCs)
• Contribution to training within your domain where needed
• Contribution to the ongoing management and administration of the GeCIP domain where requested
• Responsible and safe access to participant data
• Submission to a Genomics England Intellectual Property policy
• Other activities in line with the provisions of the GeCIP Rules

GeCIP researchers should note that their proposed research plans may overlap with the research plans of others both within their domain, and potentially with other domains. Where such overlap exists, we encourage collaboration over competition. new domain members to collaborate with those already undertaking the analysis.

Domain and Institutional Approval 

Once a member of a GeCIP, there are a number of steps through which the domain and researcher must pass before being granted data access

Domain Access Review Committee approval

Prior to being considered for data access, each GeCIP domain must submit a detailed research plan to the Access Review Committee (ARC) who will consider whether the research plans of the domain are in line with the stated acceptable uses of the Genomics England dataset. The acceptable uses are outlined in Research Ethics Committee (REC) approved 100,000 Genomes Project Protocol and the Data Access and Acceptable Uses Policy. The ARC will decide to approve, decline, or amend requests for access to data. The domain leads, or a deputy, will be asked to call in at the appropriate time to answer any questions or queries, and external expertise may be called upon to assist the decision-making process, where appropriate.

Participation Agreement 

Each institution that is represented within GeCIP is required to sign a contract, the Participation Agreement with Genomics England. The provisions of the agreement are manifold, but collectively it outlines the various obligations of both the institution and Genomics England with regard to the data access granted to that institution's researchers. It also deals with the ownership of Intellectual Property (IP) resulting from research on the 100,000 Genomes Project, citing the project's IP Policy . To promote a fair, open and co-operative environment, all GeCIP members are expected to work within the agreed terms of the Participation Agreement signed by their host institution, and abide by the terms outlined in the GeCIP Rules. Detailed information on these and other documentation related to GeCIP guidance and policies can be found on the Important Documents and Resources page.

During the signing process, each institution will provide a verified list of GeCIP members from their institution to Genomics England. The complete list of users and access requirements is then processed by the Genomics England Service Desk.

Account Issue

When it comes time to give you access to the data, a Genomics England account will be issued to you using the institutional email address which we hold for you. Included within this email will be your username and instructions on how to access your password using a secure and encrypted service called ???. Your Research Environment username and password are part of a Single Sign-On system and will be used to gain access to a number of other systems within the Embassy. Their safety is of upmost importance:

• Do NOT share your password with anyone;
• Do take care when using them on shared computers; 

• ##waiting on more from Caroline Moth##
  

Prior to gaining access there are a number of steps to be undertaken:

1. You will need to complete an Information Governance course.
2. You will need to sign the GeCIP Rules agreement.
3. You will need to inform the Genomics England Service Desk of the successful completion of Information Governance #is this still the case?#
   

Information Governance Training

To protect patient confidentiality and ensure that all researchers understand the sensitivity of the data and how to maintain its security, we ask that all individuals requesting access to the Genomics England Research Environment undertake a course on Information Governance. Data access will not be granted until a researcher has successfully passed Information Governance training.

You must first access the Genomics England Moodle training environment. There will be a training course entitled 'Information Governance and GeCIP Rules'. Select this course and work through the pages and final quiz. ##need to work through this step-by-step, from memory the links to click etc are not obvious, maybe get an account reset to work through it##

Signing GeCIP Rules

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Accessing the Research Environment

To access the Research Embassy you should open a browser and navigate to https://embassy.extge.co.uk/ovd/ You'll then be provided with a login dialog box for which you should use the username and password that have been issued to you. If this does not give you access then it would be worth trying a different browser, e.g. either Google Chrome or Mozilla Firefox. If you're still unable to get access please send an email to Genomics England Service Desk stating your username, the operating system you are using, the different browsers you have tried, and any error messages that are shown.

Gaining LabKey Access

Unfortunately LabKey is not immediately accessible when you first enter the Research Environment. To get access you need to:

1. Log into the Research Environment
2. Open LabKey by double-clicking on the LabKey icon on the desktop
3. Sign in using the same credentials you used to access the Research Environment by clicking 'sign-in' in the top-right of the browser window
4. At this point no data will be visible and you will be taken to an empty LabKey page
5. You now need to send an email to Genomics England Service Deskentitled 'GeCIP researcher <username> requesting LabKey access' stating in the email body that you have successfully logged into LabKey within the Research Environment and are not requesting that your account be upgraded and you are given access to the LabKey projects to which you are entitled.
6. You will be notified when this has been completed, and the next time you log into LabKey you should have access to the appropriate data.

Principles of Data Access

The research environment is provided within a framework of underlying principles that define its nature and design. They are driven by the agreements under which the data has been made available control how you can use the data.

Controlled and validated access to the dataset

As you will know from the process you have gone through to get access to the Research Environment, access is granted based on a set of rules:

• Researchers (individuals, students or members of staff) must be affiliated with a bona fide organization that meets the criteria for a research organization and that has itself signed up to Genomics England’s access agreement

• The research project must be real, justified in terms of patient outcomes and be part of a Genomics England domain

• The individual researcher will have been subject to due-diligence processes by Genomics England

It is through these requirements that we are able to maintain our commitment to patient anonymity and security, and to gain the highest possible value from the 100,000 Genomes Project dataset.

Patient consent model and de-identification

While Genomics England has a patient’s data, identifiers such as NHS number and postcode are removed to protect their identity and to make it harder for anyone to attempt re-identification of clinical and genomic information with a particular individual.

The conditions of access to the research environment include a commitment to not attempt to re-identify a patient by reverse engineering a health record.

It is also not assumed that a particular patient’s data will remain part of the dataset. They are entitled to withdraw their consent for their data to be used at any time.

Data security

To ensure a high standard of data security and integrity, access to the research environment is only granted when you, the researcher, has undergone mandatory information governance training. This involves completing an online training session followed by an online test. To access to the research environment, you must achieve a pass mark of at least 80%.

In support of this, researcher activity and behaviour within the environment are monitored. This enables Genomics England to define and maintain the level of standards that will encourage more patients to want to be included in the project and to attract high-calibre researchers from around the world to want to participate.

Intellectual property

Membership of a GeCIP domain and access to the Research Environment is on the understanding that all outputs of the research and all intellectual property (IP) are automatically wholly owned by Genomics England. This is the case when that research is conducted entirely within the GeCIP programme and when not using assets owned by third parties. In other circumstances, where non-GeCIP assets are involved, IP ownership will be negotiable.

It is important that all research outputs and IP be fully disclosed to Genomics England before publication.

There is a separate document, Genomics England IP Policy ##needs link##, available from the Genomics England website, that you are encouraged to read as it includes sections on patents and the licensing of IP.

Publication of results

Genomics England encourages the publication of results - indeed, it is considered an essential aspect of the 100,000 Genomes Project that the results and discoveries resulting from your research are published promptly.

However, Genomics England has in place a nine-month moratorium on the publication of results to provide a degree of preferential permission to publish on participant data. This is in recognition of those domains and individuals that have assisted in recruiting to the project. In effect, the moratorium will prevent other GeCIP researchers from publishing research on that domain’s corresponding data until the domain has had access to the data for at least nine months. The nine-month trigger point is when a meaningful number of whole genomes are available to researchers in a specific domain has been reached. More detail on the Genomics England publication moratorium policy can be found in the Publication Moratorium ##needs link## policy document available on our website.

Given that the research will be based on work carried out in the Genomics England Research Environment, and within a GeCIP domain, all publications will be made ‘on behalf of the 100,000 Genomes Project and Genomics England’ as a banner heading. In general, issues relating to authorship (whom to include, the order of, etc) will follow the guidelines issued by the International Committee of Medical Journal Editors (ICMJE). For a full description of how and when to publish your results, please refer to the Genomics England Publication Policy ##needs link## available at our website. It includes detailed sections on authorship, patentability and review.

To-Do's

• Link to Participation Agreement when updated
• Link to IP Policy when updated
• Get details of the encrypted password thing and password safety tip[s
  
• add in changing password - is this possible?
• Exact steps in IG training course
• Publication Moratorium & Publication Policy link