Accessing DECOVID Data

All the information you might need to submit a Data Request Form in order to access DECOVID data

DECOVID supports a transparent data access process based on the following principles:

 

  1. DECOVID maintains the highest standards of integrity in all aspects of research and data access;

  2. DECOVID will ensure that research which includes DECOVID data is conducted according to appropriate ethical, legal and professional frameworks, obligations and standards;

  3. DECOVID supports a research environment that is underpinned by a culture of integrity and based on good governance, best practice and support for the development of researchers;

  4. DECOVID works together with clinicians, researchers, patients and the public to strengthen the integrity of research and to review our processes for data requests regularly and openly.

DECOVID will consider any request for data access made from healthcare providers, academic researchers, policy makers and members of the public but not from industry at the current time. 

 

There are two examples of how this might occur.

 

  1. Healthcare providers, patients and policy makers can suggest clinical questions which the DECOVID analytic team will build into a research methods protocol and perform the analysis.  See the “Building up a clinical question” section below.

  2. Research teams can propose both the question and the methodology, without requiring analytics support from the DECOVID team.  Here the research team will complete their own Data Request Form. See the “Complete research request” section below.

In both cases, data access will only be considered when a Data Request Form has been completed and a Due Diligence check performed, where needed.

 

All requests for data will be considered against the following guiding values:

  1. Answering the research question has demonstrable patient benefit

  2. The data access request meets the “5 safes” These are:

    • Safe projects - Is the requested use of the data appropriate?

    • Safe people - Can the researchers be trusted to use the data appropriately

    • Safe data - is there a risk that a person could be identified from the data and ow can this be minimised

    • Safe setting. - Is the data stored in a safe manner which limits the possibility for unauthorised use

    • Safe outputs - could the results of the analysis cause any individual to be identified and how can this be minimised.

  3. The prioritisation of the question or data request form will also depend on the urgency of the clinical need for this question to be answered.

 

Building up a clinical question

Clinical questions without a methodological plan can be submitted through the DECOVID Data Request Form page

This will include what the question is and why it is considered important in both scientific language (if from a healthcare professional or scientist) and plain English. 

  • All questions will be reviewed by the DECOVID programme manager’s team to see if the question could be answered using the data held within DECOVID. 

  • Receipt of the question will be acknowledged with a timeframe for turnaround.

  • Not all questions can be answered by a hospital dataset, and if the question can’t be answered using the DECOVID data, we will try and signpost you to a more appropriate dataset. 

  • Questions will be checked to make sure we have not answered them before

  • All novel clinical questions that could theoretically be answered by DECOVID will be reviewed by the clinical team supporting the Scientific Steering Committee (SSC- a group of national clinical and scientific experts and patient, public members) to help prioritise which questions are the most pressing for the nation and should be answered first.

  • Sometimes a question might be very important to you but not an immediate priority for the nation as a whole.  In this case, DECOVID will inform you if your question is likely to be answered in the foreseeable future.

  • A question that is a priority, as assessed by the SSC, will be forwarded to the analytics team within DECOVID, and the clinical question will be transformed into a data led question and methodological plan  (what data is needed, from how many patient records, how will the analysis be performed, etc.). 

  • The analytics team will be chosen for their specific expertise in answering a particular type of question, but they will do so in close collaboration with a clinical team to “sense check” the answers and help translate the clinical data.

  • The clinical question and methodological plan will be used to complete the Data Request Form (DRF).

 

Complete Research Request

  • Where a research team propose both the research question and the methodological approach, they can complete the Data Request Form (DRF). 

  • The completed DRF can be submitted using the form in the DECOVID website

  • This form will be reviewed by the Programme Manager and their team to ensure the needed data is available and a due diligence check performed if needed.  The DRF and due diligence check results (where needed) will be forwarded to the SSC.

 

How can I tell what information is within DECOVID?

  • The DECOVID team will generate a metadata catalogue and data dictionary which is freely available on the HDR-UK Gateway and the DECOVID website [link coming soon...]

  • As this is an evolving health crisis it is likely that both the metadata catalogue and data dictionary will evolve as well.  There will be a version number, a date of last refresh and a table of recent changes to enable researchers to see how the data dictionary is evolving.

 

What is the process after the Data Request Form (DRF) is completed?

  • The researchers will receive an email to acknowledge the DRF has been received and that it is complete.

  • Incomplete DRFs will be returned to the researcher or DECOVID analytics team for completion

  • The DRF will be reviewed by the Scientific Steering Committee (SSC) or their delegated Data Enabling Network (DEN).

  • If the research question has already been prioritised by the SSC, the SSC will approve the request for data access licensing purposes.

  • If the research question has not been prioritised by the SSC (where a complete research request was submitted), the SSC will prioritise the DRF into high, medium, low or unsuitable.  This will be based on published criteria (Box 3 of protocol) and a data request risk assessment will be made by the DECOVID programme management team based on published criteria (Box 5 of protocol).  

  • The priority of the DRF will be fed back to the submitting researchers with brief feedback where possible.

  • If not supported or priority is low, researchers will have the opportunity to resubmit an amended DRF. 

  • Due to the interest in COVID-19, it is expected that some data requests will not be able to be supported by DECOVID.

  • Where priority is medium or high and the risk registry supports data access, UHB will initiate data licensing agreements (DLA)

  • The DLA will be between the substantive employee of the research team and UHB, and will stipulate data use, no secondary use, no data sharing, timeframe, outputs etc…

  • Currently it is envisaged that data access will include a separate cache of the datahaven, where specified data points will be accessible within a given timeframe.

 

Data Trust Committee and transparent reporting

 

Public and patient trust and transparency are central features of DECOVID.  All requests for data access, data request forms, prioritisation processes and data access activities will be reviewed by the Data Trust Committee.  The DTC are public and patients who will help guide DECOVID processes and decisions by reviewing what data decisions were made.  All requests and outputs mandate a lay summary to facilitate this process.

 

A full report of all DECOVID activities (including who data requestors were, data requests and data request outcomes) will be given the Ethics Committee each year,

 

DECOVID will summarise data requests (but not who the data requestors were) and outcomes of data requests on a publicly accessible page of the website [coming soon....]