R&D approval

WAHT approval process

Under the Research Governance Framework for Health and Social Care (RGF) and the Medicines for Human Use (Clinical Trials) Regulations 2004 (Clinical Trials Regulations) the Trust is required to have oversight of research it sponsors and hosts.

The sponsor is defined in two ways:

RGF: Sponsor: 'Individual, organisation or group taking on responsibility for securing the arrangements to initiate, manage and finance a study.'
Clinical Trials Regulations: "sponsor" means, in relation to a clinical trial, the person who takes responsibility for the initiation, management and financing (or arranging the financing) of that trial'.

Prior to requesting any study approvals (REC, R&D, MHRA etc) sponsorship arrangements and funding must be in place and confirmation of portfolio adoption received, where appropriate.

Applications for approvals to conduct research in the NHS are made using the Integrated Research Application System (IRAS). This is a single system which streamlines the process for gaining ethics and governance permissions and approvals. The system allows researchers to enter information about their study once only and is designed to save time and effort by preventing duplication of information in separate applications for each type of approval. Follow this process map to guide you .

A Site Specific Information form should be created and completed for each NHS Trust where research activity takes place.

Researchers requesting Trust approval for their study should:

before starting the approval process, look through this process map and follow the steps
gain authorisations from supporting departments using relevant pro formas.
complete the Site Specific Information form (SSI)
submit it electronically with the required documents including evidence of support department authorisation.

For portfolio studies submit to Western Comprehensive Local Network. (Where WAHT is not the lead site only local documentation needs to be sent.)

For non portfolio studies submit to the Research & Development Dept.

In order to review your application for NHS Permission, we will use the RSS Planning Tool

The research office or Clinical Trials Unit will then seek the remaining authorisations on behalf of the investigator. These will include legal, financial and divisional authorisation.

Authorisations must be in place and formal approval given before the project begins.

Additional support

Help and advice on the study approval process is available from the Research Design Service (RDS) and staff in the Research & Development Dept.