Governance and Access Control for Clinical Research Database

The CRIS Oversight Committee (which evolved from the Stakeholder Committee, after CRIS received research ethics approval as a de-identified database) comprises the central governance entity overseeing security. Access to CRIS is application-based. Potential users submit an application to the CRIS Oversight Committee, in which they are asked to describe their project and the variables of interest. The committee, chaired by a mental health service user, also includes a child and adolescent mental health clinical representative, a representative of the Trust’s Caldicott Guardian, a Research Ethics representative, the CRIS academic project lead and the CRIS project manager. Potential applications looking to conduct audit of clinical services using CRIS need to gain approval from the relevant audit committee (within SLaM) before applying to use CRIS. Likewise, research project applicants need a senior university or NHS affiliated supervisor attached to and taking responsibility for the project and applicant before applying to use CRIS. Each applicant must have a formal affiliation in the form of an honorary or substantive contract with the hospital or the university before applying to access CRIS. These formally bind the applicant to the NHS duty of confidentiality when dealing with patient data (including de-identified patient data) [27 ].
Upon submission, the Oversight Committee determines whether a project is deemed suitable to access the CRIS database. “Suitability” is ascertained by verifying the need for the project, the scientific robustness of the application, and any patient confidentiality concerns to which the project may give rise. Any projects with the potential to identify patients, such as those investigating rare disorders or outcomes, are carefully discussed with the researcher and their supervisor and, where possible, alternatives provided (for example, the applicant is encouraged to obtain patient consent).
If researchers receive approval to use the CRIS system for the submitted project, they are permitted to access CRIS only within the SLaM security firewall and must follow a set of rules which facilitate responsible handling of data and uphold duties of confidentiality. All projects are audited weekly to ensure searches are being carried out within the remit of the submitted and approved project. Approval to use CRIS can be withdrawn in cases where inappropriate searches have been made in violation of the terms of the approved project. These procedures focus on close regulation of access to CRIS, as well as close monitoring of use of CRIS (Figure 3). The researcher must commit to ensuring that s/he will uphold the NHS duty of confidentiality when handling the data and adhere to the guidelines set out by CRIS (including not carrying data out of the Trust firewall for any purpose). In this way, the security model endeavours significantly to mould the researcher’s intentions – and hence behaviour – when encountering the data, so as to minimize any threats posed to patient anonymity identified above.