Clinical Research Office. A partnership between Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield

step 1 step 2

Step 3 - NHS Permission

Costs and Contracting

Your R&D Coordinator will work with you to cost your study and put in place the appropriate contracts.

All contracts and agreeements should be reviewed, negotiated and signed off by the Clinical Research Office, not  the researcher. This applies to all kinds of contracts, including Confidentiality Disclosure Agreements.

If you are asked to sign a contract as a Prinicipal Investigator, please refer to your R&D Coordinator for help and advice.

Study Approvals

Your R&D Coordinator will work with you to determine which regulatory and local approvals are required for your study, examples of which are detailed below:

Regulatory Approvals

Ethics (REC)

Nearly all research involving NHS patients will require NHS Research Ethics Committee (REC) approval. This can be obtained electronically through the Integrated Research Application System (IRAS). The main purpose of seeking Ethics approval is to protect the rights, safety, dignity and well-being of research participants. Please see the Health Research Authority website for more information.

MHRA

Clinical Trials of Investigational Medicinal Products (CTIMPs) or trials of Medical Devices may require approval from the Medicines and Healthcare Products Regulatory Authority (MHRA)

Confidentiality Advisory Group (CAG)

If your project requires the use of confidential patient information without consent then it may be necessary to seek approval under section 251 from the CAG within the Health Research Authority (HRA)

Gene Therapy Advisory Committee (GTAC)

If your project involves the use of Gene Therapy, you may need to seek approval from the Gene Therapy Advisory Committee (GTAC) under the Health Research Authority (HRA)

Local Approvals

It is a requirement that the directorate in which the study is taking place give their approval to host the study, along with all support services and facilities involved in the study. Your R&D Coordinator will obtain these approvals with your assistance.

NIHR Porfolio Adoption

Some studies are eligible for adoption onto the NIHR Clinical Research Network Portfolio, which allows you access to local skilled research support staff (including Research Nurses)

Portfolio adoption is achieved by submitting a Portfolio Adoption Form through IRAS to CSP (NIHR Coordinated System for obtaining NHS Permission)

NHS Permission

NHS Permission is provided in the format of a letter with attached conditions. This is your permission to commence your study on STH permises and is only granted once all the governance steps are complete. Once you have received your letter, you may commence your study at STH.