1. Common pitfalls in ethics applications: how to avoid them
School of Healthcare
Faculty of Medicine and Health
Common pitfalls in ethics applications: how to avoid them
Dr Janet Holt
Senior Lecturer, School of Healthcare

2. Aims To discuss the purpose and process of ethical review
To identify key ethical issues
To give some ‘helpful hints’
To distinguish between morally responsible research and a successful application to an ethics committee

3. School of Healthcare
FACULTY OF MEDICINE AND HEALTH
Chair: Faculty of Medicine and Health Research Ethics Committee
Past chair of School of Healthcare Research Ethics Committee
Chair: Bradford Leeds (NHS) Research Ethics Committee
Registered trainer for the National Research Ethics Service ( NRES)
Nurse, midwife, ethicist, educator……and a researcher

4. Ethical review
‘Ethical review is not about preventing or making it difficult to carry out research, but about helping the researcher think through the ethical issues and how to deal with them. The risks and benefits for participants and also the researchers are considered. The principles of good research practice encourage those involved in research to consider the wider consequences of their research and engage with practical, ethical and intellectual challenges inherent in high quality research.’

5. Is my project research?
Research means:
‘the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods.’
The following do not need review by an HRA Research Ethics Committee
Service evaluation
Audit
public health surveillance
System or equipment testing
Case study
Satisfaction survey
Decision making tool to determine how to classify your project:

6. Review options Full review by an HRA or University Committee
Proportionate review by an HRA REC
A faster process (14 days) suitable for projects with no material ethical issues: CHECK the guidance. Can be used when research involves:
Data or tissue that is anonymous to the researcher
Existing tissue samples already taken with consent for research
‘Surplus or extra tissue’ with consent
Questionnaires, interviews or focus groups that do not include highly sensitive areas or where accidental disclosure would not have serious consequence
Surveying the safety or efficacy of established non drug treatments, involving limited intervention and NO change to the patient’s treatment.
Minimally invasive basic science studies involving healthy volunteers

7. Possible opinions
Favourable: a favourable opinion given at initial review
Favourable with Additional Conditions: a favourable opinion given at initial review contingent upon certain stipulations by the REC
Unfavourable: The REC withholds ethical approval
Provisional Opinion: Approval or rejection is deferred, pending a response to queries raised by the REC
Further Information Favourable Opinion: a Favourable Opinion subsequent to a Provisional Opinion
Further Information Unfavourable Opinion: an Unfavourable Opinion subsequent to a Provisional Opinion

8. How long will it take?
RECs are required to give an opinion within 60 days of receipt of a valid application
‘Clock stops’ if further information is required

9. Key ethical issues Informed consent Written Verbal Implied
Protection from harm
Physical
Psychological
Inconvenience
Confidentiality
Date protection and storage
Disclosure

10. HRA Approval Brings together the process of:
assessment of governance & legal compliance previously undertaken by NHS organisations
ethics review
Replaces the need for local checks of legal compliance and related matters by each participating organisation in England.

11. Helpful hints Before you start
Set up an IRAS account and find your way around the site.
Participant Information Sheets
Write your Participant Information Sheet FIRST
Get someone else (but not a colleague) to read it
Spell out in chronological order exactly what you expect participants to do
Don’t forget to mention reimbursement especially if there isn't any

12. The form Give details when asked for them
Make sure you tick the correct filter questions at the start of your application – VERY IMPORTANT otherwise you will get the wrong question set
Take particular care with A6-2 – the opportunity for you to identify the ethical issues and address them and therefore show the committee that you’ve thought through the issues.
Any additional documents e.g. GP letters, invitations, posters must be submitted with your application.
Follow the instructions
Give details when asked for them
Don’t cut and paste
Use lay language

13. Questions that cause problems
A14.1 Involvement of service users, carers, the public
Refers to use of advisory groups, expert patients.
A23 Sensitive, embarrassing or upsetting questions
The committee may have a different perspective to you on what is embarrassing
A26 Risk to researchers
Lone worker policy
Risk assessment
A29 Approaching participants
Give a detailed account

14. The meeting Expect a committee of 15 people
Always attend the meeting – it gives a chance to answer the questions. Otherwise you will have to do this without hearing the context
Prepare and make sure you know what the project is about
Don’t ever agree to attend for a project that you are not fully conversant with
Supervisors should attend with students

15. Morally responsible research
Depends upon:
The integrity of the researcher
‘…I recognise that my income and status depend on my research, and that for this and other reasons, my perspective on what is ethically acceptable may differ from that of other people’
Coggon D Research ethics committees: a personal perspective. Research Ethics Review, 3(4)
Valid informed consent from participants
Scrutiny from ethics committees
Not viewing the approval process as an unnecessary hurdle or barrier impeding research

16. Where to find information
HRA website
IRAS website
Proportionate review guidance