1. The Research Project: ethical approval process
John Witton
Addictions Department

2. Outline of the talk
Refresher on why research projects need ethical approval
Audit vs Research
Ethics committees
The application process and the joys and horrors of the IRAS form
Some things to play close attention to
Useful sources of information and guidance

3. Ethical approval
Ethical approval from King’s is mandatory when KCL staff/student research:
includes human participants OR
raises other ethical
AND is undertaken by KCL staff or students

4. What kinds of research?
Research involving human participants includes:
Interviews
Questionnaires
Focus groups
Observation
Taking and using samples
Giving drugs
Physical activity

5. Why do you need ethical approval?
Ensures generally accepted ethical standards are followed –consent, confidentiality, conduct
Ensures you have thought through the research/audit proposed - why, how, when, where and who – so you do not waste people’s time, conduct research that is new and valuable and the research is likely to succeed
Protects you and your study participants
Mandatory requirement of the host university/clinical setting. Not following an approved ‘procedure’ can be reported as misconduct
So you are covered by insurance if anything were to go wrong (and no-fault compensation)
Funders will want to know
Publishers will want to know

6. Research versus audit: research
Research usually involves asking clearly defined questions and setting hypotheses
Uses methods than are replicable
Can use RCTs, cohort studies, placebos, database etc

7. Research versus audit: audit
Audits aim to improve quality of patient care and clinical outcomes
Audits review practice against evidence-based standards
Are clinicians following best practice?
What is happening to patients as a result of current practice?
Results are specific to a particular tem or service
Normally an audit (and service evaluation) does not need ethical approval
But audits should still be conducted within an ethical framework – information sheets for patients etc.

8. Ethics committees King’s College London Committees
Social Care Research Ethics Committee (all social care research funded by the Department of Health)
NHS Research Ethics Committees
patients and users of the NHS, or their carers
NHS staff
NHS premises
Mental Capacity Act 2005
Human Tissue Act 2004

9. Ethic committee composition eg Harrow Research Ethics Committee
Translator
Pharmacist
Consultant anaesthetist
Research nurse
Barrister
Doctor of Medicine
GP Consultant psychologist
Retired IT consultant
Business consultant

10. Where to get guidance

11. Preparing your ethics application
Go to the Research Ethics web pages
Read the guidelines
Speak to your supervisor
Download the current version of the application form and guidelines.
Submit the correct number of copies, with the necessary signatures before the relevant deadline.
Apply in plenty of time prior to your preferred start date.
The length of approval asked for should cover the study up to publication.

12. Getting the application form right
All applications go through a pre-review check by the Senior Research Ethics Officers.
Applications will be assigned a unique reference number and will be sent to the Subcommittee for full review.
Incomplete applications will be returned to the researcher and not sent to the Subcommittee for review.

13. What needs to be submitted?
Application Form
Information sheet for participants
Consent form
Supplementary documents may be needed:
Questionnaire
Topic guide
Permission letters

14. The IRAS form
Integrated Research Application System (IRAS)
Is a single system for applying for the permissions and approvals for health and social care / community care research in the UK
Enables you to enter the information about your project once instead of duplicating information in separate application forms
Uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required
Helps you to meet regulatory and governance requirements
Further information:

15. Outcomes
The results of an application will fall under one the following categories:
Full approval -the research may commence.
Approval in Principle-amendments are requested before full approval can be granted.
Deferred-the Committee will need to seek expert advice before a decision is made.
Not Approved-the application is seriously flawed and must be resubmitted to the full Committee.
Rejected-the study is deemed unethical and cannot be resubmitted.

16. What could you get wrong?
It was sent it to the wrong Committee.
It has track changes.
No information sheet is an immediate return.
You did not submit the required number of copies or collate your application; it is your responsibility to ensure the applications are collated and ready to be sent to the individual committee members.

17. Application not approved because…
Required sections have not been completed
The recruitment process is unclear/insufficiently detailed.
Power calculation if needed not carried out
Consent procedure has not been sufficiently detailed and you have not taken into account:
The age, reading ability or language spoken/written by participants.
Any permission needed from outside organisations.

18. Application not approved because…
Supporting documents have not been submitted which prevents immediate approval. E.g.
Interview schedule/questionnaires.
Consent forms.
Advertising –posters/ s.

19. Application not approved because…
Standard procedures have not been included. Such as:
Arrangements for confidentiality
Exclusion criteria
Risks and benefits.
Regardless of the type of project, the research proposal and procedures must always be of good quality.

20. Application not approved because…
The application does not identify or address how you will minimise/avoid:
Potential risks to the participants (physical or mental) and the researcher.
Any conflict of interest; the researcher has another position within the chosen organisation or is in a position of authority.

21. But experience shows
Careful preparation means your project will get ethical approval
Prepare well in advance
Involve your supervisor

22. Further information Research ethics FAQs:
“Does my research require ethical approval flowchart”:
How to write an information sheet:
Research in the workplace: