Advance Therapies

Research involving healthy volunteers

UCL supports a large number of studies that involve healthy volunteers as research subjects and in these studies ethics approval is via the National Research Ethics Service Research Ethics Committee (NRES REC) OR UCL Research Ethics Committee depending on the nature of the study.

If you are a UCL employee or student and your study does not involve the NHS in any way - in other words the study doesn't involve NHS patients, their records or tissue, or NHS premises or facilities - then your study does not need to be reviewed by a NRES REC. Instead you will need to seek ethics approval from the UCL Research Ethics Committee  for this type of study. 

Studies to be reviewed only by an NRES REC include:

1. Clinical trials of investigational medicinal products (CTIMPs)

2. Clinical investigations of (not simply using) medical devices that are not CE-marked or CE marked medical devices that have been modified or are being used for a new purpose.

3. Research involving exposure to ionising radiation

4. Studies involving the collection of human tissue samples including blood from healthy volunteers. 

5. Investigators at the UCL Institute of Neurology/UCL Institute of Cognitive Neurology planning a study which involves Transcranial Magnetic Stimulation (TMS) should speak to their research Lead/Head of Department or Centre Director for guidance on submitting an application to an NRES REC.

Studies to be reviewed by UCL REC include:

1. UCL mechanistic studies involving the administration of a medicinal product or substance or experimental invasive procedures on healthy volunteers. 

2. Studies recruiting participants are healthy volunteers, UCL students, members of the public and/or involve NHS staff as participants, or using NHS premises and facilities.

3. If samples are being taken from healthy volunteers but do not contain cells (e.g. plasma or serum) then it is exempt from the Human Tissue Act then such studies can be reviewed by UCL REC.

Contact for more information

Dave Wilson (Database & Information Officer)

Telephone: 020 3447 5199

For information about UCL Research Ethics Committee contact the UCL Graduate Office on 020 7679 7844

For information about conducting a study at the Birkbeck-UCL Centre for Neuroimaging (BUCNI) contact:

Jeannette Bayliss: 020 7679 5475 for help and advice.