Glossary of terms

Full User

Full Users have the ability to write and run code on pseudonymised data within the secure environment, view unreleased outputs, and request the release of outputs through the OpenSAFELY output checking service. Requirements for full users:

• They are only able to access the secure environment from within the UK
• They must be employed by or studying at a UK-based organisation
• They must have completed ONS Safe Researcher Training or UK Data Service training

Collaborator 

• Collaborators do not have access to the OpenSAFELY secure environment  
• Collaborators do have access to the GitHub project repository (repo), but cannot run or merge code
  • Collaborators can propose changes to code, but these must be reviewed and merged into the project by a Full User on the project
• They are not required to have Safe Researcher Training.

Collaborators are able to: 

• View data results that have been output checked, approved, and released from the secure environment.
  • They can access these results prior to them being approved for public release
• Contribute to the writing of project artefacts, such as journal publications and reports

Project Lead 

The Project Lead is the person with overall responsibility for the OpenSAFELY project, and must be a Full User of the OpenSAFELY Service. They are accountable to their employer (normally the sponsor) for both the project and the project team. They act as the first point of contact with OpenSAFELY for project administration purposes, for submitting their OpenSAFELY Project application, and are responsible for the work conducted by the whole project team.

The Project Lead’s employer must have a valid Data Sharing Framework Contract (DSFC), or equivalent artefact as defined by the data controller, in place with NHS England. The Project Lead must be aware of the Terms and Conditions stated in the DSFC as well as any other written artefacts applicable to the project, for example project ethics approval, Data Sharing Agreement etc. 

The Project Lead can sign the Data Sharing Agreement (DSA), and must have the authority from their employer to do so, including confirming that they will provide a purchase order number if project application charges are applicable.

Project Leads must: 

• Ensure that their OpenSAFELY project proposal;
  • takes into account relevant existing research, or research in progress;
  • makes effective use of patient, service user, and public involvement where appropriate 
  • is scientifically sound, safe, and feasible (i.e. that the risk of harm has been minimised as much as possible and is not expected to outweigh the benefits), 
  • is ethical and legal and remains so for the duration of the research, taking account of developments while the research is ongoing.
• Ensure that their OpenSAFELY project proposal has been submitted for review and obtained necessary approval from a research ethics committee, if required;
• Ensure that everyone in the OpenSAFELY Project Team has the appropriate Full User or Collaborator status, and adhering to the agreed arrangements for sharing project findings, for example writing journal articles, reports etc.

Project Team

The project team is the group of people involved in the research project and may comprise both OpenSAFELY Full Users and OpenSAFELY Collaborators. The overall responsibility sits with the Project lead. Project teams are responsible for:

• Only undertaking work within the OpenSAFELY environment that is consistent with the approved project proposal, and any complementary information (such as ethics), in compliance with any applicable regulatory standards and guidance
• Following direction from the Project Lead and informing them of any changes to their circumstances (e.g. change of employer) that may impact their eligibility to work on the project.

Project Sponsor

The sponsor is the one organisation that takes overall responsibility for ensuring that proportionate and effective arrangements are in place to set up, run, and report on the project. The sponsor is the employer of the Project Lead in the case of non-commercial research.

The sponsor must explicitly accept the responsibilities of the role and have a contract with NHS England before a project can be approved. 

Universities and colleges should accept the role of sponsor for all educational research conducted by their own Ph.D. students, unless the Ph.D. student is employed by a health or social care provider that prefers to take on this role. Sponsors of educational research should ensure that supervisors can and do carry out the activities involved in fulfilling this role. Where the academic supervisor cannot adequately satisfy the sponsor’s oversight responsibilities due to location or expertise, the sponsor should agree appropriate co-supervision arrangements.

Funder

The funder is the organisation or group of organisations providing funding for the research project. 

Students

Ph.D. students 

Ph.D. students can be Full Users or Collaborators but should normally not be the Project Lead unless there are specific requirements for the project. In the circumstance that a Ph.D. student is accepted as the Project Lead they must meet the requirements as detailed above under Project Lead.

Masters or undergraduate students
Undergraduate or Masters students may only be Collaborators, and must be supervised by the Project Lead.