1. Our Ethical Review Process
September 2016
Lois Neal
FMS Research & Innovation Office

2. Aim of this session:
Understand why ethical review of research is needed
Appreciate the governance that surrounds research
Know the UK’s various ethical review routes and authorities
Know the University’s starting point for ethical review
Understand the likely ethical review route for your piece of research
Appreciate the practical content of an ethical review application

3. Focus of this session
A. Research that involves people but also consider: B. Research that doesn’t involve people

4. Historical Perspective
Horror of WWII human experimentation 1947 Nuremberg code Declaration of Helsinki USA outburst about Tuskegee Syphilis Study in Alabama USA establish the Office for Human Research Protection USA Institutional Review Boards and the “Common Rule” 1984 UK Gillick Competence & Fraser ruling 1995 UK Bristol Paediatric Heart Surgery Scandal 2001 UK Alder Hey Children’s Organ Scandal 2001 UK NHS GAfREC 2004 UK Adoption of EU Clinical Trials Directive UK NHS Research Governance Framework 2004 UK Human Tissue Authority 2005 UK Mental Capacity legislation UK Human Fertilisation and Embryology Authority 2016 UK NHS Health Research Authority (HRA) and we haven’t thought of all the issues yet!

5. I’ll just test this out on some people..
Do I need to tell anyone? Do I need permission? Does it matter what I do? Does it matter how I do it? Does it matter where I do it? Does it matter how I make and keep test records? Does it matter if one of them gets upset? Does it matter if one of them gets hurt? Who owns this “work”?

6. This work doesn’t involve people..
Do I need to tell anyone? Do I need permission? Does it matter what I use? Does it matter what I do? Does it matter where I do it? Does it matter how I make and keep my records? Who owns this “work”?

7. Research Governance The rules & regulations surrounding research
“Owner” & responsible authority (sponsor)
Qualifications of investigators
Health & Safety
Risk management
Indemnity insurance
Codes of research practice
Data management
Medical legislation
Resources
Academic peer agreement
Researcher’s responsibilities
and
Our moral code (ethics)
Ethical Review

8. Are you sure I need ethical review?

9. Without ethical review how do you know:
your participants’ rights are preserved;
your experimental objects or sources are properly respected;
your activity is within our current moral code;
your findings will be accepted and published.

10. An ethical review is needed irrespective of the
the experimental subject matter
the academic accepted hypothesis
the experimental design
how it is to be resourced
where it is to take place
who is actually going to do the work

11. ALL research proposals are subject to ethical review
before any work commences
(and it is wise to have evidence of the ethical review!)

12. What does “All” mean here?
“All” means every proposal
and it really does mean every proposal
Every proposal no matter who, what, how or where!
Every proposal that doesn’t involve humans (as well as those that do)
Proposals that reuse data
Proposals that are purely laboratory based
Proposals that are only observational

13. BUT……. The level of detail that needs to be explained for an ethical review depends on what the investigation entails
review of existing literature
Phase III drug trial
very little detail
lots of detail

14. Our Underlying Principles
Common approach across disciplines
Applies to ALL research and consultancy
Takes place after discipline peer review
Supports approval from the right authority
Based on the ESRC Framework for research ethics

15. All proposals considered against a series of triggers
Involving animals?
Involving NHS patients?
Carried out beyond the EU?
etc……

16. Outcome of trigger check
Already have approval or nothing triggered: No further formal ethical review required Something triggered: Further formal ethical review is required and which authority to apply to

17. Licences via NU - Animal Welfare Ethics Review Board
NHS Research Ethics Committees &
Social Care Research Ethics Committees
Faculty Research Ethics Committees

18. Where to go next?
If approval is already in pace or nothing is triggered: confirmation of completion of ethical review – research can commence NHS or Social Care trigger confirmation of need to go to the HRA/IRAS web-site, complete and submit an application Home Office trigger confirmation of need to contact the Comparative Biology Centre to discuss requirements Human investigation in a non-clinical setting trigger simply complete the remainder of the on-line application that follows

19. Where is this ethical review process?
It is on the NU web site
Route: NU staff home page>Research & Enterprise Support>Research Services>Governance, Ethics & Data
Everything is here!
Ethics web form is via Ethics Procedures>Ethics Forms & Process
It is at:

22. Help!

23. https://newcastle-ethics. limequery. com/index

24. There are requests for basic project parameters followed by specific ethics and governance questions to ascertain any high risk aspects

25. Answer “NO” to the first question and a set of additional questions pop up

29. The system responds with… Next Steps
Based on your responses your project ………….
depending on the answers to the earlier questions the system will indicate:
the proposal is deemed low risk in terms of ethical considerations; or
(b) requires review and approval from a body such as a REC/SCREC or the Home Office;
(c) requires review and approval from the University via the Faculty’s Ethics Committee.

30. These questions need to be answered in full!
So there may be a requirement for the proposal to go to:
The Newcastle Joint Research Office
The Animal Welfare Ethics Review Board
The Faculty Ethics Committee
and further questions may pop up so that additional specific information can be given to support the next stage of the process
These questions need to be answered in full!

31. For review by a REC or SCREC go to the Health Research Authority

33. go towards the bottom of the page

34. Links to another web-site – the IRAS web-site

35. New Users - must create an account
go here for guidance on new projects
Then complete and submit the electronic IRAS form

36. For further guidance and queries: Lois Neal, FMS Research & Innovation Office or