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

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

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

Historical Perspective Horror of WWII human experimentation 1947 Nuremberg code 1975-2013 Declaration of Helsinki 1972+ USA outburst about Tuskegee Syphilis Study in Alabama 1979+ USA establish the Office for Human Research Protection 1979+ 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 2001-2005 UK NHS Research Governance Framework 2004 UK Human Tissue Authority 2005 UK Mental Capacity legislation 1990-2008 UK Human Fertilisation and Embryology Authority 2016 UK NHS Health Research Authority (HRA) and we haven’t thought of all the issues yet!

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”?

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”?

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

Are you sure I need ethical review?

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.

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

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

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

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

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

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

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

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

Where to go next? If approval is already in pace or nothing is triggered: e-mail confirmation of completion of ethical review – research can commence NHS or Social Care trigger e-mail confirmation of need to go to the HRA/IRAS web-site, complete and submit an application Home Office trigger e-mail 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

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: http://www.ncl.ac.uk/res/research/gov-ethics/ethics_procedures/ethical-review-process/index.htm

http://www.ncl.ac.uk/res/research/gov-ethics/ethics_procedures/index.htm

http://www.ncl.ac.uk/res/research/gov-ethics/ethics_procedures/ethical-review-process/index.htm

Help! http://www.ncl.ac.uk/res/research/ethics_governance/ethics_governance_toolkit/index.htm

https://newcastle-ethics. limequery. com/index https://newcastle-ethics.limequery.com/index.php/survey/index/sid/865378/newtest/Y/lang/en

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

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

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.

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!

For review by a REC or SCREC go to the Health Research Authority http://www.hra.nhs.uk/

go towards the bottom of the page

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

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

For further guidance and queries: Lois Neal, FMS Research & Innovation Office lois.neal@ncl.ac.uk or FMSethics@ncl.ac.uk