sean jennings: research ethics and governance team
TRANSCRIPT
Research Ethics and Governance Team
Dr Sean Jennings
Research Governance
and Ethics Manager
Contents:
Who we are and why we’re changing Getting through the regulations to do
research with the NHS:– Getting started– During the project– At the end of the project
Research Governance and Ethics
RG&E Manager: Dr Sean Jennings
Research Governance Officer: Dr Clark Crawford (0.6fte till Mid-April)
Governance Admin: vacant
Research Insurance Officer: Catherine Hargrave
Research Ethics Officer: Sue Cottam
Deputy Research Ethics Officer: Gemma Williams
Research Ethics Admin: Jane Mitchell
All research with people:
Funding Insurance Ethics approval Access Permissions
Research in the NHS
Comes under the Department of Health Research Governance Framework
Needs to meet NHS requirements for data security and standards for medical confidentiality
May involve ‘relevant material’ or DNA analysis so comes under the Human Tissue Act
Getting started:
Identify a Sponsor Get a favourable ethical opinion (ethics
approval) Get NHS Research and Development
Approval
Getting started: Identify a Sponsor
– Usually UoB. Let us know if not.– We just need Pink Form and signature
sheet that you can get from Research Facilitators
– Get in touch early if there’s something complicated or difficult (e.g. things requiring insurance referral such as giving drugs, working with children or pregnant women, working abroad...)
Getting started:
Get a favourable ethical opinion (ethics approval)– Submit a Ethics Self Assessment Form– If patients involved will need to go
through NRES using IRAS system– If just staff (or ‘Service Evaluation’) will
need to go through our REC
– http://tinyurl.com/cdatdc2
Getting started: Get NHS Research and Development
Approval– Contact R&D office early (ideally before
bid goes in). Contact details at:
http://www.rdforum.nhs.uk/044.asp
– Application is through the IRAS system
www.myresearchproject.org.uk
Use IRAS for: NHS Ethics through National Research
Ethics Service Research and Development Approval MHRA National Offender Management Service etc
During the project– things to remember:
Annual reports to Ethics and Sponsor You can only do what you have ethics
approval for If you change what you are doing you will
need to submit an amendment
During the project– things to remember:
From a regulatory point of view: Tissue is people. And so are data. If tissue isn’t held under license then it is
tied to a project. – So if you change what you are doing
with it you may need to amend the project.
So:
For any piece of tissue (or data) you hold you need to be able to:– Say where it came from– Say what project it belongs to– Say what consent was given for it– Show that it was collected under ethics– Show the R&D approval was granted for
its use
After the project:
Submit end of project declarations to REC and Sponsor
Send ‘end of project’ report to REC Close down NHS Sites Publish your research Archive the project data
What happens to your tissue????
Contacts:Governance:
Ethics: [email protected]
Web: http://tinyurl.com/c4uqth5
https://intranet.birmingham.ac.uk/finance/accounting/Research-Support-Group/Research-Governance/research-governance.aspx