NUS (National Cohorts Office)

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Data sharing with Other Researchers

Optimise secondary use of data and generation of new data from biological materials

Dr Alex would like to investigate genetic risk factors of type 2 diabetes. He is working with Dr Rachel to use data and human biological materials she has collected in her cohort. Additional data will be generated on the stored human biological materials. Dr Rachel as the cohort custodian and Dr Alex as the third-party researcher have similar considerations.

Key considerations

  • To allow secondary use of data and biological materials.
  • To allow sharing of coded data and human biological materials with third parties.
  • To obtain re-consent from participants or obtain waiver from the institutional review board (IRB) if consent was not sought for secondary use and/or sharing. Re-consent is not required for “legacy human biological materials” as the Human Biomedical Research Act (HBRA) does not apply to studies conducted prior to 1 November 2019.
  • Dr Rachel’s cohort study is affiliated with or has registered as a tissue bank.
  • Dr Rachel and/or Dr Alex has the appropriate IRB approval to use the human tissues.
  • Appropriate approvals governing the accession and secondary use and access of data and/or biological materials.
  • Legal agreements binding parties to the use of the data and/or biological materials.
  • Minimise possibility of re-identification of participants through the data.
  • Linked de-identified data to be provision for research use with the appropriate approvals and security controls for data storage, access and use.

i. Data Access Committee (DAC)

    • To oversee data access based on ethical considerations, legal requirements, confidentiality, and scientific validity.

ii. Trusted Research Environment (TRE) 

    • To provide secure environment for data access, storage, sharing, linkage, and analysis.

    • To allow federated analysis, enabling researchers to analyse data without downloading it.

    • Examples of TREs include:
      1. Research Analysis Platform (UK Biobank)

      2. Researcher Workbench (All of Us)

      3. HUNT Cloud (HUNT Study)
  • To allow secondary use of data and biological materials.
  • To allow sharing of coded data and human biological materials with third parties.
  • To obtain re-consent from participants or obtain waiver from the institutional review board (IRB) if consent was not sought for secondary use and/or sharing. Re-consent is not required for “legacy human biological materials” as the Human Biomedical Research Act (HBRA) does not apply to studies conducted prior to 1 November 2019.
  • Dr Rachel’s cohort study is affiliated with or has registered as a tissue bank.
  • Dr Rachel and/or Dr Alex has the appropriate IRB approval to use the human tissues.
  • Appropriate approvals governing the accession and secondary use and access of data and/or biological materials.

  • Legal agreements binding parties to the use of the data and/or biological materials.

  • Minimise possibility of re-identification of participants through the data.

  • Linked de-identified data to be provision for research use with the appropriate approvals and security controls for data storage, access and use.

i. Data Access Committee (DAC)

    • To oversee data access based on ethical considerations, legal requirements, confidentiality, and scientific validity.

ii. Trusted Research Environment (TRE)

    • To provide secure environment for data access, storage, sharing, linkage, and analysis.

    • To allow federated analysis, enabling researchers to analyse data without downloading it.

    • Examples of TREs include:
      1. Research Analysis Platform (UK Biobank)

      2. Researcher Workbench (All of Us)

      3. HUNT Cloud (HUNT Study)

References

  1. Global Alliance for Genomics & Health. Data Access Committee Guiding Principles and Procedural Standards Policy (v1.0) https://www.ga4gh.org/document/data-access-committee-guiding-principles-and-procedural-standards-policy-v2/

  2. UK Health Data Research Alliance, NHSX. Building Trusted Research Environments – Principles and Best Practices; Towards TRE ecosystems. Zenodo; 2021. doi:10.5281/zenodo.5767586.