Study approval

Why do Research & Development offices review the same information as the ethics committees? Shouldn't they leave the ethics review to the ethics committee?

The Research & Development offices do not conduct an ethics review. However, much of the information required by R&D offices for governance and management purposes is similar to the information required by Ethics Committees for ethical review.

The new site specific information form used by Research & Development offices forms part of the on-line NHS Research Ethics Committee application form, allowing some information from the ethics applications to be pre completed, without having to duplicate it. The Research & Development offices are required to collect this information for the Department of Health and Regulatory Authorities.

I've been asked to say who the 'sponsor' is for my study. What is a 'sponsor' and why do I need one?

Since April 2004 it is a legal requirement for all research to have a 'sponsor'. The sponsor is the organisation that takes the lead in confirming there are proper arrangements for the initiation, management,monitoring, and financing of a study. The sponsor will usually be the Chief Investigator's employing organisation, the lead organisation providing health, social care, or the main funder. For any research study covered by the Research Governance Framework, the sponsor must be satisfied that clear agreements are reached, documented and carried out, providing for proper initiation, management, monitoring and financing. More detailed information regarding the responsibilities of the sponsor are available from the DoH website.