Advance Therapies
Life begins with a smile


© Sayandip Mukherjee.

Setting up a new study? What approvals do you need?

There are three main approval processes listed below that must be considered before conducting clinical research at UCL or UCLH. Please note this information applies to research only. If you are unsure whether or not your study is classified as research, click here for guidance.

1. Sponsorship

All research requires a sponsor to take on responsibility for the design and management of a study. The sponsor will usually be the Chief Investigator's employing organisation, the lead organisation providing health or social care, or in some cases the main funder. The JRO carries out the role of the sponsor for UCL and UCLH.

2. Regulatory approvals

Most studies will need to be reviewed by a Research Ethics Committee (REC). Approvals from other regulatory bodies such as The Medicines and Healthcare Products Regulatory Agency may be required. The JRO can help researchers prepare applications for REC and other approval bodies.

3. NHS Permission

Research recruiting UCLH patients or staff and/or taking place on UCLH premises will require NHS permission (often referred to as R&D approval). It is a condition of Research Ethics Committee approval that NHS Permission is obtained before a study starts at a particular site. The JRO acts for UCLH as a Permission Centre, and may issue NHS Permission for your study.

Sponsorship

The JRO will consider studies for UCL or UCLH sponsorship, providing the investigator has a substantive or honorary contract with UCL/UCLH and adequate funding is in place for the study. UCL will also sponsor research undertaken by UCL students.

A sponsorship decision is based on risk. UCLH will generally sponsor simple studies, while UCL sponsor higher risk complex projects.

For more information about whether UCL or UCLH will sponsor your project, please click here.

The Comprehensive Clinical Trials Unit and the Cancer Trials Centre can also sponsor studies. These are specialist units within UCL that can help with the development and management of your study.

If your study is a Clinical Trial of an Investigational Medicinal Product (CTIMP), please find information about applying for sponsorship here. Please click the relevant links below to find out more information about applying for UCL/UCLH sponsorship for all other studies.

Regulatory approvals

To find out whether your study needs REC approval, you will need to consult your sponsor. Alternatively you can visit the Health Research Authority website for NHS research guidance or UCL REC for non-NHS research.

To find out if other approvals from bodies such as The Medicines and Healthcare Products Regulatory Agency are needed, consult your sponsor.

NHS Permission

There are three routes to obtaining NHS permission from the JRO. Please choose the relevant information below based on the nature of your study.

As part of the Harmonisation process, one of four Permission Centres will process and issue NHS Permission for a study to take place at UCLH, depending on disease area.

Click here to see which Permission Centre your study would be reviewed by.

Please note that 'Harmonisation' applies to all commercially sponsored studies and to non-commercially sponsored studies proceeding through NIHR portfolio adoption only.

Process for obtaining NHS Permission:

Documents that need to be submitted for review:

Further Information

Please contact the JRO or use the links below to obtain more information.

Queries regarding Commercial Harmonisation: Harmonis@uclh.nhs.uk

Queries regarding Non-commercial Harmonisation: Ncharm@uclh.nhs.uk

General Non-NHS research queries: JRO.RandD@ucl.ac.uk

All other research related queries: RandD@uclh.nhs.uk 

NIHR Portfolio adoption

UCLP Harmonisation