HRSS Pilot Governance

strengthening and streamlining systems for research management and governance

Pilot Health Research Support Service: Governing the pilot

Keeping patient information safe is a top priority for the Health Research Support Service (HRSS).

The vast majority of data supplied to researchers will be anonymised, so certain details that might identify patients (such as name and address) will be removed before the researcher has access to it. Full written consent will need to be provided by the patient before any data that may identify them is provided to the researcher.

All research studies that are associated with the pilot HRSS have to go through a set of very strict tests before we are able to give access to health information for research.

These include:

An independent scientific review to make sure the research study is using the right method to produce accurate results. In the pilot HRSS access, to information will only be provided for research studies that have scientific endorsement confirming they are well designed and can be expected to produce reliable results. In the case of the pilot HRSS, scientific approval is obtained from the Independent Scientific Advisory Committee (ISAC) of the Medicines and Healthcare Regulatory Agency (MHRA).

Checks to make sure the researchers have strict processes to keep information secure

Assessments to protect the rights, safety, dignity and well-being of the people taking part in research.

The pilot HRSS will only supply data to legitimate research organisations, and projects that have gained ethical, scientific and information governance approval.

For more information on the ethics approvals please visit:
www.nres.npsa.nhs.uk

For more information on the information governance approvals please visit:
www.nigb.nhs.uk/ecc

For more information on the scientific approvals please visit:
www.gprd.com/isac

Overarching Governance Framework (OGF)

An independent audit will be carried out on the pilot HRSS to make sure that all the necessary information standards and policies are being followed.

The Overarching Governance Framework is the document that sets out these standards and procedures and covers the following areas:

Patient and Public Involvement
Information Governance
Ethical Governance
Scientific governance

Each of the above areas has policies and procedures that will be followed as part of the processing of patient information for research purposes.

The OGF document is owned by the Overarching Governance Board and it is their role to audit the pilot HRSS and make sure that the OGF is properly followed.
For more information on the Overarching Governance Framework please click here to view the full OGF document

Information Governance Toolkit

The pilot HRSS and research studies are also subject to review and audit by the Information Governance Toolkit.

The Information Governance Toolkit is a proven and well established tool used by the Department of Health to monitor compliance of NHS Trusts with legal requirements and best practice guidance for protecting information.

Further details on the Information Governance Toolkit can be found at the following website: