Study registration and sponsorship

Studies with ethical and/or research governance implications should be logged on an appropriate University system.


What is a Sponsor?

A Sponsor is the person or institution who takes responsibility for the initiation, management and financing (or arranging the financing) of that study.

Research sponsorship is required under the Research Governance Framework (RGF) for  all studies that involve the NHS or Social Care Organisations (eg patients or carers). It is also required for Clinical Trials of Investigational Medicinal Products (CTIMP), and studies of devices, human tissue and invasive research involving prisoners or adults lacking capacity.  All these studies will need an  NHS Research Ethics Committee or Social Care Research Ethics Committee review. The Research Governance Team will assess your study for possible sponsorship by the University of Bristol.

 

What is a high risk study? 

  1. clinical trials of investigational medicinal products
  2. trials of medical devices
  3. studies requiring NHS ethics review
  4. studies falling under the Research Governance Framework
  5. human tissue research
  6. international research
  7. anything that falls into insurance exclusion definitions:

drug/medical devices; children under 5; pregnant women; cohorts of more than 5000 participants; conception/contraception research; trials undertaken outside the UK; genetic engineering; clinically invasive procedures; and research into Hepatitis, HIV/AIDS, CJD.