1. Application for research Ethical Approval in Practice
Grace Lindsay
Jan 2011

2. Integrated Research Application System (IRAS)
Part of the national Patient Safety Agency
NHS based research
Form available on line from their web site
Current version 2.3
Improved direction to help complete the form
Ability to add extra copies of some documents on the checklist

3. Research Governance: Ethical Approval - When is this required?
For any research that involves:-
Patients and users of the NHS
Relatives or carers of patients and users of the NHS
Access to data, organs or other bodily material of past and present NHS patients
The recently deceased in NHS premises
The use of, or potential access to NHS premises or facilities and
NHS staff – recruited as research participants by virtue of their professional role

4. Glasgow Caledonian University Ethics Committee
Chair- Paddy McQuillan
EC1form (available from my caledonian website)
Three copies of completed proposals
Submitted to Clerk of the Ethics Committee
Committee aim to respond within 10 working days

5. NHS Ethics www.myresearchproject.com Local R&D office contact
Scientific officer- advice on project status- research/ audit/service evaluation

6. Key ethical principles
Respect for autonomy-respect for the rights of people to determine their own lives
consideration of freedom of choice; whether and when there is any legitimate right to intervene or persuade people to a particular course of action
  Beneficence -doing good
  Non-maleficence -doing no harm
Justice- being fair and equitable

7. Practicalities
How will potential participants, records or samples be identified
Consider your relationship to potential participants
Data storage

8. Practical ethical considerations
· excessive visits that you know could be tiring and not practical
· are participants being asked to give too much time, blood samples,
genetic analysis
· are some of the test/samplings too invasive;
·  are you dealing with very sensitive issues
problems of approaching vulnerable groups who may not be able to give informed consent or may have conditions that already that have a big impact on their health eg chronic disease, learning disability, emergency care, terminal care

9. Full summary of research design and methodology
Clarity on inclusion and exclusion criteria
What will participation entail for research participants
Use template for information for research participants provided by IRAS and consent form

10. Research questions Are they clear and answerable in the data that is proposed to be collected?? Methodology Appropriateness to the research questions

11. Quantitative methods: Statistical power Validated tools/measurements statistics for data analysis Qualitative methods: Topic guide for interviews Data saturation considerations

12. Feasibility Timescale Competing demands Access Funding Number of participants Analysis Writing up Dissemination