I have a research question and little else
A protocol is the key document for taking a research question forward; you can download a protocol template from the link at right.
Once you have a draft protocol, it makes the next stages of setting up a study much quicker and easier:
What, how, by whom and when
The protocol is a detailed description of the study that explains all the methods and processes involved from start to finish. If necessary, it should enable unfamiliar researchers to continue to set up the study from the point that another researcher may have left it.
This document forms the basis of getting the right funding, support and ensuring ethical, safe conduct. Download a protocol form from the link at right, and complete as fully as possible; this document forms the basis of discussions of funding and study setup. These discussions will refine and strengthen the protocol, enabling you to conduct your study rapidly and efficiently.
Best practice and advice
The protocol template provides guidance. Where the NIHR Wellcome Trust Clinical Research Facility and/or NHS support departments, such as pharmacy or radiology, are involved it is essential to discuss the implications of the study with them during the protocol development stage.
You need sponsorship – legal, not financial
Under the Research Governance Framework for Health and Social Care all clinical research conducted in the NHS must have a sponsor.
At the protocol stage it is acceptable to name UHS in the protocol as the sponsor of the study, despite formal approval not having been received. In the event of UHS not agreeing to sponsor the study the protocol will, of course, need to be amended.
Find out more and how to gain formal sponsorship here.
Non-UHS staff – the research passport
To perform research that involves UHS premises, staff or patients at UHS must have contractual cover form UHS itself.
More information can be found here on the research passport system that enables NHS employees in other trusts or university employees to achieve this rapidly.
If UHS is your substantive employer, or you have an honorary clinical contract with the Trust, then you are already eligible to carry out research within the Trust (provided the project has received the necessary ethical and R&D approvals to go ahead).