The Five Safes Framework

The Five Safes are a set of established standards which enable research studies such as ADVANCE to provide safe research access to your data and biomedical samples. The framework was developed in the 2010s by the Office for National Statistics (ONS) and has become best practice in data protection whilst fulfilling the demands of open science and transparency.

By following the Five Safes, ADVANCE can provide approved researchers with considered access to detailed data, meaning Data Users can access and use datasets in a secure and responsible way.

The Five Safes

  1. Safe data: data is treated to protect any confidentiality concerns.
  2. Safe projects: research projects are approved by data owners for the public good.
  3. Safe people: researchers are trained and authorised to use data safely.
  4. Safe settings: a secure environment prevents unauthorised use of data.
  5. Safe outputs: screened and approved outputs that are non-disclosive.

How we comply with the Five Safes:

1. Safe Data

Researchers can only access the data they require.

The raw data collected from participants on visit days is kept secure, and Data Users do not have access to it. We make sure that an individual cannot be identified in any released dataset as all data is de-identified, by removing names, addresses and any other details that would directly identify individuals.

Data Users are only allowed access to data that is specifically required to answer their research questions.  Also, unique research IDs are created for each project and cannot be used by anyone else, so each dataset is isolated from all others.

2. Safe Projects

Data will only be used ethically, for high-quality academic research.

Any Data Users requesting access to the ADVANCE study data must submit a detailed project overview.  This must include how the data will be used, and stored, and what questions their results will answer.  This information will be reviewed by the Project Board to ensure that the project will be an appropriate and ethical use of the data based on a stronghypothesis-driven, academic question.

3. Safe People

Data Users accessing study data are trained and accredited.

All Data Users are required to complete an application which must be approved by our Project Board.  Application requirements include being associated with a reliable academic institution or research organisation, having up to date GDRP and data protection training, signing our user agreement, and signing our data security agreement.  This means Data Users agree to abide by current data protection legislation and are bound to always protect the confidentiality of the data and study participants.

4. Safe Settings

The physical and digital settings used to access data are secure.

When Data Users are given access to study data they download it and store it following the safe storage rules they have agreed to. Transfer of datasets to others is not permitted.  Any data received with consent from the NHS will always be held securely in a Data Safe Haven accessible only to specific staff who will sanitise and de-identify any data before Data Users are allowed access to it.

5. Safe Outputs

All research outputs are checked to ensure individuals cannot be identified.

Before any research using study data is submitted to academic journals for publication it is checked to ensure it meets our high confidentiality standards.  The work is reviewed by the study statistician and the ADVANCE study Project Board to ensure that no individual study participants can be identified, and the analysis can be published safely.