The ResearchOne project was developed in consultation with the National Research Ethics Service (NRES) and the National Information Governance Board (NIGB). The project received full approval from both of these bodies for an initial 5 year period starting in October 2012.
The National Information Governance Board (NIGB) assesses the governance procedures employed by ResearchOne to collect and store data securely. The board ensure that every reasonable step is taken to prevent identifiability at both patient and provider level. This includes the removal of any hard identifiers, any textual data, any exact geographic indicators and the k-anonymisation of the research records drawn. The NIGB have confirmed, with Secretary of State support, that the ResearchOne database does not store identifiable patient information and so does not require Section 251 approval.
The National Research Ethics Service Research Ethics Committee North East – Newcastle and North Tyneside 1 review the establishment of health research databases. They provided favourable approval for the ResearchOne database and access for the purpose of research as outlined by this programme. Approved research must be likely to bring advances in quality clinical knowledge, benefits to patient outcomes or improve the efficiency of healthcare delivery. The REC reference number is 11/NE/0184.
The privacy of patients and healthcare providers is a paramount concern for the entire ResearchOne project. All data access is monitored, audited and made available to the ResearchOne Database Committee. All ResearchOne staff members are bound by a confidentiality agreement, have a current Criminal Records Bureau check and have gained approval for access from the committees.
The ResearchOne database has undergone a full privacy and impact risk assessment, under the guidance of the NIGB. All future developments will be similarly assessed in order to maintain the exceptionally high ethical and governance standards set.