Insurance and Indemnity

It is extremely important that appropriate insurance is in place for each project involving human participants in order to cover them against possible harm.  Insurance must be in place before any subject is recruited to a trial protocol.

Why do I need insurance?

Insurance is needed to provide cover against two types of harm which could potentially be experienced by a human subject as a result of their participation in research.

  • Negligent Harm:  Any action or process that is held by a court to have caused harm as a result of lack of due diligence, lack of care, omission of duty or an act of carelessness towards a participant in a research project.
  • Non-Negligent Harm: Circumstances where there is no specifically identified causative factor relating to the harm of a participant in a research project, but harm is likely, on the balance of probabilities, to have arisen from the participant taking part in the research. 

‌If you wish to conduct research involving human subjects you must complete the following form:

For Clinical Trials of Investigational Medicinal Products and of Non CTIMP Drug Trials please return the completed form to:

For all other types of trials please return the completed form to:

  • Paul Ellis
    Senior Contract Manager
    Research Support Office, Room 241,
    Old Estates & Building Offices
    University of Glasgow
    G12 8QQ
    Paul.Ellis@glasgow.ac.uk
    0141 330 3875

Definitions

The current University insurance policy has very specific definitions for studies involving humans as described below:

Hazardous - Research involving an investigation for a medicinal purpose. A medicinal purpose is defined by the University insurers as:

  • The treatment or prevention of disease.
  • The diagnosis of a physiological or psychological condition.
  • Affecting conception.
  • Inducing anesthesia.
  • Altering the normal operation of a physiological or psychological process.

The University must report all research which falls into the “hazardous” category to the insurers on a yearly basis. These annual returns are then used to set the University insurance premium for the following year. It is therefore extremely important that the annual returns to the insurer are as accurate as possible.

Non Hazardous - Research involving contact with research subjects (including blood sampling and the use of non invasive physiological measurements) which will not result in any of the outcomes described for hazardous research.

Although studies that are classed as “non hazardous” do not form part of the annual insurance returns the University must keep up to date records of all research of this kind. Please contact the Research Regulation and Compliance Office for further advice regarding insurance for studies involving human partcipation.

Excluded categories of research

Some types of research are automatically excluded from the current University insurance policy as detailed below:

  • Involving more than 5000 research subjects.
  • Administering genetically engineered materials to human subjects.
  • Research involving conception or contraception.
  • Research involving pregnant women.
  • The inclusion of research subjects who are resident out with the UK.

If you are considering conducting research which falls under the excluded categories please contact the University's Research Regulation and Compliance Office for further advice.

If your proposed research falls under an excluded category it does not mean the study cannot take place. In most cases a small insurance top up premium to the University insurers enables cover to be extended to excluded categories.

Investigators should note that the University requires researchers to keep records of all research involving humans for a minimum of 10 years after the research has stopped.

How do I apply for insurance?

‌If you wish to conduct research involving human subjects you must complete the following forms:

For Clinical Trials of Investigational Medicinal Products and of Non CTIMP Drug Trials please return the completed form to:

For all other types of trials please return the completed form to:

  • Paul Ellis
    Senior Contract Manager
    Research Support Office, Room 241,
    Old Estates & Building Offices
    University of Glasgow
    G12 8QQ
    Paul.Ellis@glasgow.ac.uk
    0141 330 3875