Ethics Committee Applications

Ethics Committee Applications

Java Management has considerable experience in the procedures and documentation required for Ethics applications in the UK and Ireland. We will arrange for the compilation of the required documentation and submission of a Clinical Trial Application to a Nationally Accredited Ethics Committee for approval.

In Ireland and the UK, Regulatory and Ethical Application review process can be conducted in parallel which can result in a study review and approval timeline of approximately 10-12 weeks. Institutional/Investigator Contracts review and approval can also be done in parallel with the ethical review processes.

In Ireland, the REC application is made to one Recognised Ethics Committee (REC). On receipt of REC approval, each participating site must have a Site Specific Assessment Form (an unsigned copy is included in the application to the REC) approved and signed by the Hospital CEO and Principal Investigator. A standardised HSE Form of Indemnity also needs to be signed by the Sponsor and Hospital CEO before study activities can begin at a site. Likewise, the Clinical Trial Agreement must be signed by all relevant parties before the study can commence.

In the UK, the REC application is completed online via the Integrated Research Application System (IRAS). Once you are ready to submit the application, you contact the NHS Research Ethics Committee – Central Booking System (CBS) who will assign you a review slot at the next available REC meeting. You can also decide to choose the REC you wish to review the application and wait until the next available review slot at this REC.

For NHS Trust Sites, NHS permission is required via the R&D office at each Trust site. Wherever possible, it is advisable to apply to get your study adopted on the NIHR Clinical Research Network Portfolio. If adopted, this enables you to use the NIHR Coordinated System for gaining NHS permission (CSP). The CSP standardises and streamlines the process of gaining R&D approval, via IRAS, to enable a 40 calendar day (median) to grant NHS permission at all sites (from R&D submission to the lead site). Review and approval of the Clinical Trial Agreement and budget for the study forms part of the R&D review process.

Useful links:

 GUIDANCE ON THE APPLICATION FOR RECOGNISED ETHICS COMMITTEE OPINION AND THE ETHICAL REVIEW OF CLINICAL TRIALS ON MEDICINAL PRODUCTS FOR HUMAN USE

IRAS

NHS, National Institute for Health Research