Research Studies

The 'Research Governance Framework for Health and Community Care in Scotland' was published in 2001 and revised in 2006. The Framework sets out the principles and standards to which all research involving the NHS should adhere to.

Research Studies

If you are considering conducting a Research Study you should be aware of your duties and responsibilities. It is important that you classify your proposed study correctly. If your study involves a drug you should confirm it is not a clinical trial.  You can do this by using the MHRA algorithm.  If you are in any doubt you should contact the Research Regulations and Compliance Office for further advice.
Some research involving humans may not involve NHS patients, staff, data or facilities. These studies are classed as 'Healthy Volunteer Studies'.  A healthy volunteer, in this instance, is anyone who is recruited to a research study without reference to a medical illness or condition and without making use of any NHS facilities.  If you are a University employee or student and are involved in this type of research please refer to the Healthy Volunteer section for further information.

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All research involving humans must have appropriate ethical approval. Where the research involves the NHS this can be achieved by using the Integrated Research Application System (IRAS). IRAS is also used to capture the information needed for NHS management approval. If your study does not involve NHS patients you will need University ethical approval (this includes studies involving NHS staff).  Please refer to the Healthy Volunteer section for further advice on University ethics.

During the conduct of a Research Study an investigator may wish to make an amendment to the study protocol. Investigators must ensure that the sponsor and relevant ethics committee are aware of, and approve, any amendments.

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All studies that fall under the remit of the Research Governance Framework must have a sponsor. A sponsor is an organisation or institution that takes on the responsibility for the initiation and management of a research study, but is not necessarily the funder.

**The University of Glasgow does not co-sponsor Research Studies**

Where a study utilises NHS patients, staff and/or facilities researchers should contact the relevant NHS Research and Development Office for further information on sponsorship.

**In most instances NHS GG&C will take on sponsorship of Research Studies even if you are fully employed by the University or you are a University student**

For sponsorship issues out with NHS GG&C please contact the Research Regulation and Compliance Office for advice.

In some circumstances where human tissue comes directly from the NHS to the University and will not be returned to the NHS the University may agree to sponsorship.

Post approval and completion

Once a study has been completed investigators should inform the relevant sponsor and ethics committee who will be able to advise as to archiving requirements. At present, the University requires all records to be retained for a minimum of ten years. However, individual ethics committees may impose more stringent requirements.

If you are in any doubt as to sponsorship of a Research Study, please contact the Research Regulation and Compliance Office for further advice.