Application for research Ethical Approval in Practice Grace Lindsay Jan 2011

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

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

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

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

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

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

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

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

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

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

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