Governance and Ethics

We recognise that our research into disease can proceed only with your participation, your information and samples and – most important – your trust in our ability to protect your interests and support medical research. 

'Governance' is not a word that is used much in everyday conversation. Governance is the way rules, norms and actions are structured, sustained, regulated and held accountable.

 

Put simply, our slogan is:

Say what we do; do what we say.

In practice, this means writing lots of policies and procedures to describe what we do, and then have independent bodies check that this is what we actually do.

On the financial side, we receive funding from the tax-payer – we have a grant from the National Institute for Health Research (NIHR) which ultimately comes from the UK Government Department of Health & Social Care. Our spending is reviewed by both NIHR and an independent Oversight Board to make sure we stay on track.

On the data side, we are regulated by the NHS Health Research Authority, and they (quite rightly) want us to demonstrate that we are treating all the data we are given with appropriate care and attention.

How we do this is discussed in these documents:

It is important to us that our documentation is accessible and of a high standard. We work with local and national patient and public advisory groups to try to achieve this.

Ethics

The BioResource recruits people with common or rare diseases, as well as healthy members of the public, to take part in research studies, or to contribute to research tissue banks.

All these activities will have been reviewed and approved by independent Research Ethics Committees (RECs). RECs review research and give their opinion on whether the research is ethical. They are part of a framework that regulates research, under the NHS Health Research Authority.

The BioResource has the below ethics in place for recruitment:

  • NIHR BioResource – Research Tissue Bank (REC REF: 17/EE/0025)
  • NIHR BioResource – Rare Diseases (REC REF: 13/EE/0325)

The BioResource also has a number of nationally approved cohorts, which have all had REC approval:

Example Patient Information Sheet and Consent Form

Here is an example of a Patient Information Sheet and a Consent Form.  Each group and study can be slightly different to capture specialist study needs. 

The core requirements across the NIHR BioResource are that participants consent to:

  • give a blood sample (or saliva in some cases);
  • DNA sequencing and analysis of sample(s);  
  • access of medical and health records;  
  • be recallable for future studies (consent decision made on an each individual study with no obligation).