Research Governance Office (RGO)

The primary function of the Research Governance Office (RGO) is to arrange research Sponsorship and insurance for eligible research projects. The RGO can provide guidance and training to Faculties in respect of their internal governance arrangements, and to researchers submitting projects for external ethical review.

Researchers wishing to conduct research involving human research participants, their tissues, organs or data, and requiring ethical approval (whether external or by a Faculty Ethics Committee), should submit their research details to the RGO in order to obtain Sponsorship and insurance before the research commences. This is a requirement of the University and is in addition to approvals that may be required by external agencies and research partners such as NHS Trusts.

 

Ethics and Research Governance Online (ERGO)

ERGO (Ethics and Research Governance Online) is a centralised online system designed to facilitate the process of gaining ethical, governance and insurance approval for research studies.

NB ERGO will enter the final phase of pilot in September 2011 and it is hoped the system will be rolled out to all faculties by the end of 2011/early 2012

All research involving human participants will need to be registered on the University’s electronic document management system, Ethics and Research Governance Online (ERGO), which is accessible at:

https://www.ergo.soton.ac.uk

The system is intended to promote expedient communication between researchers, supervisors, peer reviewers, ethics committees, the Research Governance and Insurance Offices and minimise any inherent risk of miscommunication as part of the submissions and approvals process.  

Many features of ethics and governance review are common across all Faculties, but there are local differences and so ERGO has been developed with some flexibility to enable Faculties to incorporate this variation.

ERGO can be accessed either directly through the Web, as below, or via a link within the system generated emails.

https://www.ergo.soton.ac.uk/

The ERGO system will prompt researchers to provide information about their research, which will determine the level of risk involved in the study and the level of scrutiny which that study will receive; the FEC will be required to review the study, and if necessary, grant formal approval before the research can start. Submission through the ERGO system will automatically ensure higher risk studies are forwarded to the University’s RGO, to arrange for University Sponsorship and insurance.

In ERGO there are 3 categories of study:

Category A studies will require review and approval of the Research Governance and

Insurance Offices before they can start. Either because this is a requirement by

our insurers or the University Ethics Committee considers this additional review is necessary; some Faculties also require this work to be reviewed by their FEC;

Category B studies require approval only from the FEC before they can start;

Category C studies still require registering on ERGO and the oversight of an FEC but the UEC have agreed these are low risk studies and each FEC can set criteria whereby they can be reviewed and approved by a single member of their FEC, or such other suitably qualified individual designated by them to do so.

Please contact the Research Support Officer for your faculty for further information about the use of ERGO.  Faculty Contacts

 

Research Sponsorship and Insurance

The RGO reviews research proposals/protocols in order to assess them in respect of:

  1. Compliance with legislative frameworks such as the Data Protection Act, Human Tissue Act, Mental Capacity Act and Medicines for Human Use (Clinical Trials) Act, Good Clinical Practice Directive.
  2. Compliance with guidelines that inform best research practice.
  3. NHS Research Governance Framework
  4. Compliance with University of Southampton policies

Following assessment of the proposal/protocol, the RGO will:

  • Register research projects on the University database.
  • Arrange research sponsorship and insurance as appropriate.
  • Offer advice and guidance to researchers to ensure the appropriate approvals are obtained from all the regulatory authorities before the research commences.
  • Monitor ongoing research and assist in investigations in case of complaint against any researcher.

The RGO does not review research proposals in respect of ethical issues, but will ensure that all research projects have ethical approval from an appropriate Research Ethics Committee.

Terms and Conditions of Sponsorship (CTIMP)

Terms and Conditions of Sponsorship (NHS non_CTIMP)