Types of approval
Before starting a research project, you will need to get a number of approvals. These approvals ensure the study is adequately reviewed, resourced and managed, and that the study has met the ethical and governance checks required by local NHS Trusts and national regulators.
The main approvals are:
All studies require Sponsorship. The Sponsor makes sure the study is
adequately initiated, insured, managed and financed. The Sponsor can also take
responsibility for monitoring the study. The Sponsor may not always be the
funder of the research. The Joint Research office is able to provide a number
of different forms of sponsorship for investigators from UCL, UCLH and the
Royal Free.
Research Ethics and MHRA Approval
Most studies will require some form of ethical review. Which form will depend on whether or not NHS patients, staff or resources are involved. Where studies involve an Investigational Medicinal Product (testing the safety and efficacy of a drug), or the testing of a new device, additional approval from the Medicines and Healthcare Regulatory Authority (MHRA) may be needed.
Studies conducted in the NHS need what is called NHS Permission which used to be called R&D Approval. The Joint Research Office will assist in, and provide NHS Permission for studies at UCLH and the Royal Free, and advice on how to obtain NHS Permission at other NHS sites.
