About DoH requirements

Any research coming under the remit of the Department of Health (DoH) involving NHS patients, their tissue or information, staff, equipment or other resources, must comply with the current DoH's Research Governance Framework for Health and Social Care. Researchers and students must be familiar with their responsibilities under the Framework as compliance is mandatory.

The Framework requires a formal Sponsor to take overall legal responsibility for the research project, from concept to completion. Such a sponsor is also required for any research proposal submitted to an NHS Research Ethics Committee (NREC) for approval not withstanding that the proposal may involve NHS patients.

Research involving the storage of human tissue (as defined under the Human Tissue Act 2004) at the University of Bath will, in all circumstances, require NREC approval and your research proposal will also require a Sponsor.

University protocol

The University will adopt the role of Sponsor when:

• work undertaken by a Principal Investigator is a University of Bath employee
  
• University of Bath registered doctoral student is acting as Chief Investigator and the supervisor is a University of Bath employee

The University will not normally adopt the role of Sponsor for any other projects. Undergraduate research or replacement is not considered 'research' as defined by the Framework, unless advised to the contrary, and therefore will not require a sponsor.

The University has agreed a protocol you must follow to meet the DoH and NRES' requirements; where it is proposed that the University acts as a sponsor. Each application to the University, to act as sponsor, is considered on a case by case basis. Application forms must be submitted by the Principal Investigator or supervisor of a doctoral student.

Covid Specific Guidance

All new applications for Sponsorship will need to consider the impact of the COVID-19 pandemic on their studies. In addition to the established process the Restarting Sponsored Projects process needs to be observed.

Guidelines

• Guidelines for applying for University sponsorship to work in the NHS

• Examples of answers to insurance and indemnity questions if you are filling in an IRAS application

• Resources to support and guide researchers through the Health Research Authority (HRA) Approval process

• NHS research Passport Scheme for employers working in partnership with the NIHR

Forms

• Forms you can complete for applying for sponsorship in the NHS

• Complete the Serious Adverse Event Form if there is any serious adverse event, adverse reaction or unexpected adverse reaction caused to a participant, due to your research

• EIRA1 Form for ethical implications of research activity

• Forms you need to complete during the pandemic in addition to the usual forms