HCV Research UK has established both clinical databases and a tissue biorepository from individuals who have given consent for their clinical details and samples to be used for research into hepatitis C virus infection. The research data produced from the use of clinical samples has also been stored in a research database.

Ethics and Tissue Data Access Committee

Ethical approval for recruitment of individuals into HCV Research UK, and to collect clinical data and samples, was granted by the East Midlands National Research Ethics Committee (NREC) in 2011 (REC references 11/EM/0314, 11/EM/0323 and 11/EM/0353) and renewed in 2018 (REC references 17/EM/0414 and 17/EM/0415). This approval has been amended to accommodate changes in HCV Research UK operations (e.g. extension of recruitment of individuals into the cohort).  The East Midlands NREC receives annual reports on progress.

Management and approval for access to data and tissue is performed by a Tissue and Data Access Committee (TDAC), which is composed of members of the HCV Research UK consortium and a lay representative. By operating under Standard Operating Procedures (SOPs) approved by the Research Ethics Committee (REC), the TDAC has been granted permission for tissue and data use and ethics approval. The TDAC peer reviews all applications for tissue or data, to assess the quality of the application, priority, statistical power along with any preliminary data. The TDAC has appropriate biomedical, population, viral genomics and statistical expertise to allow expert analysis of most anticipated requests for access, but co-opts additional external expertise as required. Access to the Tissue Bank is dependent on agreement to deposit all data generated with HCV Research UK, linked to the source sample, to allow efficient, coordinated use of samples, reduce duplication of effort and help with data mining and analysis.

The Clinical Network

In total, 58 clinical sites have been involved in the recruitment of the HCV Research UK cohort. Click this button to view the sites.

Databases

HCV Research UK holds three databases; a Clinical Database, Tissue Repository Database and a Research Database.

Clinical Database

Data from individuals (demographics, HCV diagnosis, disease status, comorbidities, treatment outcomes etc) are recorded in a centralised Clinical Database that is held within the NHS N3 network. The data collected in the Clinical Database reflects routine clinical practice and was obtained by a mixture of direct questioning, downloads of laboratory results from hospital IT systems and medical records. Access to these records was sought as part of the consent process.

Tissue Repository Database

This database holds information about all samples collected from individuals who have provided consent to participate in HCV Research UK studies. It contains details about the date of sample collection, date of processing and any aliquots derived from a sample donated by an individual. These samples are recorded against the Study Identifier assigned to an individual at the time of consent. However, the Tissue Repository Database does not hold any clinical information about an individual. The database is held within a secure location at the MRC-University of Glasgow Centre for Virus Research.

Research Database

Following the release of samples for research studies, any data produced from samples has to be returned to HCV Research UK for inclusion in a Research Database. This data can then be released to other researchers who wish to perform studies on both the clinical data and research data held by HCV Research UK. The availability of research data, combined with clinical data, avoids duplicated efforts and reduces possible wastage of samples. It also enhances the scale of studies possible through the HCV Research UK resource.

  • It is recommended that anyone who wishes to request data and/or samples from HCV Research UK makes informal contact with Will Irving, John McLauchlan or Sarah McDonald in the first instance to assess whether HCV Research UK has the capability to support any planned studies. Thereafter, a formal application is made for access to data and/or samples, which is either approved or declined by TDAC. The data and samples requested by any researcher are then agreed and a Material Transfer Agreement is completed with the Contracts Team at the University of Glasgow, which is the Managing Party for HCV Research UK. Data and/or samples are then released for the research study that has been approved by TDAC.

  • The application form to request data and/or samples from HCV Research UK can be obtained from Sarah McDonald, who should also receive the completed form. The application is considered by the TDAC and decisions are made based on the quality of the application and its suitability for deepening our understanding of hepatitis C virus infection. The review panel communicates largely by email, with the aim of processing most applications within 3 weeks. If a member of the review panel has a connection with the application being considered, they do not take part in any discussion of the application. Final decisions based on submitted reviews are made by the Chair of TDAC.

  • Following approval by the TDAC, there are discussions between the applicant and HCV Research UK to agree on the final datasets to be released from the Clinical and Research Databases along with any samples to be provided from the Tissue Repository. HCV Research UK has a draft template for Material Transfer Agreements, which can be amended through discussion with the Contracts Team at the University of Glasgow and the legal representatives of the applicant’s academic institution or company. The MTA sets out the conditions for releasing any data and samples to the applicant, including the timeframe for completion of the study, return of any data to HCV Research UK and publication of data using the HCV Research UK resource. A draft MTA can be provided before any application is submitted.

  • After completion of a MTA, the requisite data and samples (if requested) are provided to the applicant. Clinical data is provided in the form of a password-protected spreadsheet; the password for accessing the data is provided separately. For each research study approved by TDAC, HCV Research UK study identifiers are replaced with a unique set of identifiers to prevent linkage of data between research studies unless this is agreed with the TDAC. Samples from the Tissue Biobank are also released with the same unique identifiers used for clinical data along with unique barcodes that cannot be linked by external researchers to the original barcodes assigned to samples at their time of collection. Clinical data and samples cannot be transferred to any third parties other than those agreed in the MTA In addition, samples cannot be used for commercial purposes. The time taken to release data and samples is highly dependent on the scale and complexity of any approved application.

Accessing Resources

Gaining access to the data and samples held by HCV Research UK requires an application describing the planned research study. The application is considered by a Tissue and Data Access Committee, and after completion of a Material Transfer Agreement, data and samples are released.