Table 1 Setting up a managed access data resource: project checklist

Pre-project

✓

Have all pre-collected sample collections been identified for inclusion in the project?

✓

For these studies, do the sample custodians agree in principle to the potential inclusion of their sample sets in the project?

✓

For those studies willing to participate in the project, have the sample custodians confirmed total sample numbers available within the required timeframe for the project?

✓

Have they also confirmed the REC approval status for these samples?

  Specifically has the sample custodian provided signed assurance that:

  • appropriate consent and/or REC approvals are in place for the use of samples in the project, and are compatible with the terms of data sharing proposed by the project;

  • where appropriate consents and/or REC approvals are not in place, there is sufficient time to correct this within the timeframe of the project (if not, these studies should be excluded at the outset);

  • a mechanism is in place for sample custodians to withdraw the use of their samples;

  • the potential risks of participant identification (however minimal) have been explained;

  • all of these points have been documented in, for example, an Ethical Governance Framework, and is this document available to data users both inside and outside the consortium.

Data collection stage

✓

Has it been made clear to the sample custodian that DNA samples must be submitted in a linked (coded) anonymized form, with the sample custodian retaining the linkage key?

✓

Do the sample custodians agree with the timeframe for submitting their samples, and the amount and quality of material required for sequencing?

Preparing for managing data access

✓

Has a comprehensive, project management committee-approved data-access document been prepared that includes:

  • a description of all available datasets and any constraints on the use of the data;

  • the project’s publication policy;

  • a clear explanation of the publication moratoria (if applicable) and its expiry dates;

  • a named point-of-contact to whom completed applications (and any queries) should be submitted; in the UK10K example this was the project manager (PM).

✓

Has the data access document been made available for download at the site of released data (that is, the resource; in this case the EGA), and/or on the project website?

✓

Has a person or group independent from the project been identified and appointed to function as a Data Access Committee (DAC)? Have they been briefed on the terms of data access?

✓

Is there a mechanism in place to arrange for approved data users to access the datasets in the resource once the DAC has approved the data request? If not, this needs to be put in place.

Data release stage

✓

Have the data been deposited into the Resource in a linked anonymized (pseudonymized) form, so that third-party data users are unable to identify study participants?

✓

Is the project tracking applications that are made to use project data? (For UK10K, applications were monitored by the PM from the point of receiving an application through to the DAC notifying the PM that the application had been formally approved.)

✓

Providing information as to how datasets are being used may be a condition of some studies’ permitting the inclusion of their samples in the project; and failure to do so may result in the dataset being withdrawn.

✓

Are approved data users notified as and when additional datasets are added to the resource?

Post-project

✓

If the project is of a fixed duration, has a mechanism been put into place for managing data access once the project’s management structure dissolves?