Clinical/Non-Clinical Trials Insurance

In the case of clinical trials or clinical research studies where certification of university insurance is required, certificates of appropriate cover take the form of a Certificate of Clinical Trial Insurance or a Non-Clinical Trial Insurance Certificate. To simplify the issue of documentation those responsible are requested to complete the CT3 application form that can be found here.

Documents required for certification are:

  • Completed CT3 application form
  • Patient information sheet & protocol
  • Copy of Ethical committee application form or similar
  • How to make a claim

Clinical Trials

Any risks involving the following must be prior disclosed to insurers to agree cover:

  • Pregnant women
  • Under 5s
  • Blood plasma products - Where blood is being transferred into a patient with a risk of transmission of blood-borne diseases
  • Special access / Compassionate use
  • Overseas trials
  • First in man trials

To make a claim, please contact the insurance team.

GDPR

 The General Data Protection Regulation (GDPR) comes into force across the EU, including the UK on 25 May 2018, and will replace the current UK Data Protection Act 1998.

The University Research Ethics Committee (UREC) has updated the University's 'Ethics Policy Governing Research Involving Human Participants, Personal Data and Human Tissue' (now approved by Senate) and is developing associated guidance to assist researchers in ensuring that research involving personal data meets the new requirements. This includes additional information that you will need to provide to your participants if any personal data will be collected from them after the 25 May. Changes to the online Ethics Application Form will also be made in time for 25 May.

A new webpage has been developed to provide key details, including a 1-page summary of the changes and an audio recording of the UREC's information session held on 16 April. This page will be updated as more guidance becomes available:

https://sites.google.com/a/sheffield.ac.uk/gdpr/home

For anyone undertaking NHS research, please note that additional information applies - please refer to the webpage above for details.

If you have any queries about these changes after referring to the guidance available, please contact your departmental Principal Ethics Contact in the first instance. Further advice can be sought from Lindsay Unwin (Secretary to the UREC - l.v.unwin@sheffield.ac.uk, x21443) or Anita Kenny (Minute Secretary to the UREC - a.j.kenny@sheffield.ac.uk, x21400)

Need Help or More Information on Insurance?

Who to Contact
Please contact Joanne Rollitt in the insurance team for advice and guidance on insurance issues, email insurance@sheffield.ac.uk, or telephone 0114 2221510.

FAQs
Please see our frequently asked questions.