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Thursday 22 February
My.Anglia > Staff > Sec clerk > Research Involving Human Participants (Clinical Trials)

Research Involving Human Participants (Clinical Trials)

Operating theatre

There is a difference between the strict definition of a Clinical Trial and the definition applied by our insurers who use the wider definition of Research Involving Human Participants. It is therefore important for researchers to understand the circumstances in which our insurers need to be consulted before research is undertaken which involves Human Participants.

Research means: an investigation or series of investigations conducted on any person for a Medicinal Purpose.

Medicinal Purpose means:

a) treating or preventing disease or diagnosing disease or

b) ascertaining the existence degree of or extent of a physiological condition or

c) assisting with or altering in any way the process of conception or

d) investigating or participating in methods of contraception or

e) inducing anaesthesia or

f) otherwise preventing or interfering with the normal operation of a physiological function

The cover indemnifies the Institution, its employees and students against legal liability in respect of claims notified to the Institution, its employees or its students during the Period of Cover following accidental bodily injury to any research subject arising out of clinical trials.

This class of cover is on a “claims made” basis. It is imperative that all claims (and also details of any circumstances that might give rise to a claim) are notified to during the Period of Cover. Reference should be made to the claims guidelines issued.

Research involving human participants which fall into the following categories is not automatically covered and requires referral before commencement of the research:

  • Research involving the use of drugs or surgery (human patients)
  • Research subjects known to be pregnant
  • Research subjects under the age of 5 years
  • Investigating/participating in methods of contraception/conception
  • Genetic engineering
  • Clinical Trials outside of the United Kingdom
  • Products designed or manufactured by the Institution
  • Phases of trials which have followed on from previous phases

In these situations researchers should complete a Clinical Trial Questionnaire and send it together with a copy of the research proposal and ethics application to Risk Management, Ground Floor Ashby House, Chelmsford or email it to

This flowchart summarises the process of obtaining appropriate insurance cover.

Frequently Asked Questions