Northern Ireland Research Quality Group NIRAQ

1. Northern Ireland Research & Quality Group (NIRAQ) Helping nurses to promote excellence in care through research & quality improvement: the Northern Ireland approach. Gillian McCorkell, NIRAQ Chair 2010

2. What is the NIRAQ Group? RCN Regional Network Established 1999, following amalgamation of Northern Ireland Dynamic Quality Improvement Network & RCN Research Group Practice Development Provides support network for nurses interested in research ,practice development & quality improvement

3. Aims of NIRAQ Facilitate networking & communication on issues relating to research & quality and practice development improvement in healthcare Provide framework of support, information & education to nurses & other HCP, striving to improve quality of care through evidence based practice Act as interface between practice & policy development at local, national & international level

4. NIRAQ Includes nurses and midwives working in the areas of practice, education, management, research, quality improvement and governance 2 events in 2010 , areas relevant and of interest to members.

5. The Office for Research Ethics Committees Northern Ireland Dr Siobhan McGrath Office for Research Ethics Committees Northern Ireland June 2010

6. Local and National Research Ethics Service ORECNI HSC REC (part of NHS REC Network) NRES

7. ORECNI Mission To maintain a Research Ethics Service to protect the rights, dignity and welfare of research participants within the HSC/NHS, and to protect the rights of researchers to perform ethical research and legitimate investigation.

8. ORECNI Objectives To support the HSC RECs and link with the National Research Ethics Service (NRES) Ensure the HSC RECS comply with governance arrangements as set out in the Northern Ireland Research Governance Framework, GAfREC and the UK Clinical Trials Regulation (2004) Provide training and administrative support to the HSC RECs Ensure all stakeholders understand arrangements Develop and maintain effective working arrangements

9. The Declaration of Helsinki �The well-being of the human subject should take precedent over the interests of science and society.� Consent should be in writing Use caution if participant is in a dependent relationship with researcher Limit use of placebo Participants benefit from research

10. HSC RECS REC 1 Chair Mr Mark Nelson REC 2 Chair Dr Ronnie Atkinson REC 3 Chair Dr Hilary Russell

11. HSC REC Meetings 3 HSC RECs 3 opportunities to submit new applications per month See: www.orecni.org.uk

12. Committee Composition Maximum 18 Chair, Vice-Chair and Alternate Vice-Chair At least 1/3 lay membership Quorate- 7 members Experts Social Care and Clinical All volunteers-public appointees

13. HSC RECs -Remit All health and social care research HSC staff premises patients services users carers Access to service user or patient records Access or collection of tissue Qualitative or quantitative research

14. Research Category? CTIMPs Clinical Investigations of Medical Devices Research Administering questionnaires for quantitative analysis Research involving qualitative methods Research working with new tissue samples Non-interventional research Other

15. When should I apply? Is your research in the field of health and/or social care? Does it involve HSC service users/patients? Does it involve HSC staff or premises? Do you need access to user/patient/staff data? Do you need to take human tissue samples? Does your research involve qualitative or quantitative methodologies?

17. Types of decision No opinion Invalid Favourable opinion Unfavourable opinion Provisional opinion

18. Principles Autonomy �respect for persons Beneficence/ non-maleficence - doing good, active kindness Justice- justness, fairness

19. Timelines 60 calendar days new study review 35 calendar days for amendments Applications using IRAS

20. What do I need to submit for review? Completed Ethics IRAS Protocol Participant consent and information sheets Questionnaires Indemnity , where appropriate Evidence of peer review Adverts other recruitment documents

21. What is Informed Consent? Consent given by a competent individual who: Has received the necessary information Has adequately understood the information After considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement or intimidation

22. Protection for Research Participants Potential Risk Vulnerable populations Psychological /emotional harm Negative impact on services Risks to researcher Potential Benefit Clearly state background and rationale Describe likely impact of research findings Describe benefits to research participants Evidence of appropriate peer review

23. ORECNI- Useful Details Web: www.orecni.org.uk/ Email: info@orec.n-i.nhs.uk Tel: 028 9260 3107 Fax: 028 9260 3619

24. Useful Contacts- ORECNI Dr Siobhan McGrath Head of the ORECNI HSC REC Administrators: Kathryn Taylor- HSC REC 1 Katrina Walls -HSC REC 2 Jan Daley- HSC REC 3

25. Research and Development Offices Process and Role This presentation is being delivered to highlight the role, responsibility and reasons why the research offices in the trusts exist.This presentation is being delivered to highlight the role, responsibility and reasons why the research offices in the trusts exist.

26. Key relationships The offices whilst physical entities, exist within an organisational structure that seeks to promote research activity in the HSC (believe it or not) At the heart of the processes and structures that exist lies the researcher/research. The function of the office is to ensure that the research and those carrying it out meet an acceptable standard, and that the resources are in place to ensure the successful completion of the project and the appropriate integration of the new knowledge into the evidence base. This function relates directly to a particularly context and environment The offices whilst physical entities, exist within an organisational structure that seeks to promote research activity in the HSC (believe it or not) At the heart of the processes and structures that exist lies the researcher/research. The function of the office is to ensure that the research and those carrying it out meet an acceptable standard, and that the resources are in place to ensure the successful completion of the project and the appropriate integration of the new knowledge into the evidence base. This function relates directly to a particularly context and environment

27. Context  DHSSPS Research Governance Framework Legislative Frameworks Standards in a Quality Organisation Accountability and Responsibilities Health and Social Care Infrastructure There are a variety of threads that taken together weave into a pattern of operational and legislative control and to some extents constraint. These strands create a pattern that protect all involved in the research process, including the integrity of project design and outcome. Therefore by moving through the approvals process as it currently exists , a researcher is quality assuring their project.There are a variety of threads that taken together weave into a pattern of operational and legislative control and to some extents constraint. These strands create a pattern that protect all involved in the research process, including the integrity of project design and outcome. Therefore by moving through the approvals process as it currently exists , a researcher is quality assuring their project.

28. Research Governance - Purpose Ensure research meets requirements of Research Governance Framework [including statutory obligations] To ensure the dignity, rights, safety and well-being of patients/clients To prevent poor performance and adverse incidents To help prevent misconduct and fraud.

29. Research Governance Framework Covers 5 key areas:- Ethics Science Information Health & Safety Finance

30. Role of the Research Office Training and Education Partnership Working Project Management Grant Application Financial Management Research Governance Resource Management Integrated systems development The Research Offices have various roles and responsibilities, they can assist and support researchers from project inception right through to integration into practice/ dissemination of findings. A key principle in successfully moving a project through the Trust is that of communication. With regular and honest communication then the office will be able to offer support/advice that facilitates the researcher. Of particular note is that Research Governance, is only part of the role, not the only role.The Research Offices have various roles and responsibilities, they can assist and support researchers from project inception right through to integration into practice/ dissemination of findings. A key principle in successfully moving a project through the Trust is that of communication. With regular and honest communication then the office will be able to offer support/advice that facilitates the researcher. Of particular note is that Research Governance, is only part of the role, not the only role.

31. Management R&D can be complicated, not for all projects, some are simpler than others, but common issues exist for all partners, is the project feasible, is it ethical, has it adequate resources, is it grounded in science, does it meet regulatory controls, does the project have indemnity/insurance, has the project been adequately risk assessed, to name a few. These questions need to be addressed within the contextual framework in which the research exists. The office also is managed within the organizational, regional and national context. Isolation does not exist.R&D can be complicated, not for all projects, some are simpler than others, but common issues exist for all partners, is the project feasible, is it ethical, has it adequate resources, is it grounded in science, does it meet regulatory controls, does the project have indemnity/insurance, has the project been adequately risk assessed, to name a few. These questions need to be addressed within the contextual framework in which the research exists. The office also is managed within the organizational, regional and national context. Isolation does not exist.

32. Management Preparation of statutory returns and reports - R&D Annual Report - Controls Assurance - Regular reports to the Trust Board Management of honorary contracts to external researchers Management of project set up process providing link to finance department for costing expertise Undertake audits of research projects to monitor progress Along with Director of Research & Development lead on Trust intellectual property issues providing link to HSC Innovations specialist Here are a few of the functions that the office perform on a regular basis, of particular note is the importance of IP management and creationHere are a few of the functions that the office perform on a regular basis, of particular note is the importance of IP management and creation

33. Collaborative Working Develop and support research partnerships with: NICRN CTU HSC R & D Division PHA Universities HSC INNOVATIONS CRSC INDUSTRY Regional Partners in the devolved nations Funders Charities Public Trust Staff Regulatory Authorities A variety of partnerships exist within the research infrastructure, at local, regional and national levels. Policy is about building capacity and activity and supporting researchers in gaining the expertise to drive relevant clinical research agendas. A variety of partnerships exist within the research infrastructure, at local, regional and national levels. Policy is about building capacity and activity and supporting researchers in gaining the expertise to drive relevant clinical research agendas.

34. Communication Manage R&D communications to a wide and varied audience Provide advice and support to researchers Build and develop excellent working relationships with networks Again we note the importance of communication and relationship building, with a wide variety of support being offered to researchersAgain we note the importance of communication and relationship building, with a wide variety of support being offered to researchers

35. Quality and Development Key Performance Indicators Controls Assurance Standards Adherence to RGF and Legislation Evaluation of HSC Permissions Process Evaluation of Training and Education To ensure our quality of service, we have been and are in the process of developing a variety of measures to quantify performance, such as turn around time for project approvals. We are therefore tied to a clock, much as ethics are, when a function relating to project approval is the responsibility of the Trust then the clock runs, when a function relating to a project is the responsibility of the researcher then the clock stops. Simply put if the office asks for clarification, the office will only restart the clock when the researcher comes back with the information. A project can only be approved speedily when office and researcher communicate effectively, as alluded to previously.To ensure our quality of service, we have been and are in the process of developing a variety of measures to quantify performance, such as turn around time for project approvals. We are therefore tied to a clock, much as ethics are, when a function relating to project approval is the responsibility of the Trust then the clock runs, when a function relating to a project is the responsibility of the researcher then the clock stops. Simply put if the office asks for clarification, the office will only restart the clock when the researcher comes back with the information. A project can only be approved speedily when office and researcher communicate effectively, as alluded to previously.

36. Those Governed by HSC Research Governance Permission Patients Staff Resources Premises (For secondary care studies only)

37. Rationale of Permissions Process Introduction of IRAS MoU between HSC Trusts (endorsed by PHA R&D) Single point of contact for multi-centre projects Identification of Lead/Local HSC Trust(s) Standardise governance checks (global/local) Reduce duplication Streamline process for researchers Share and build on best practice models Manage volume regionally Meet requirements of research governance framework and other regulatory and legislative requirements

38. The Process In general terms there are three phases in the life of a project Pre- Approval Approval Post Approval

39. Pre-Approval The Researcher should consider and identify the following Funding Sponsorship Peer review PPI IP Honorary Contracts Point of contact in the Trust Feasibility Other regulatory requirements

41. The Application Process This reflects the actual approvals process, the project should have a minimum standard on submission as evidenced by validation, thus the need to communicate before submission with a Trust and/or University research office. You should note that we want to approve a project, it is important that we actually do research in the Trusts, thus the increasing reliance on the partnership approach.This reflects the actual approvals process, the project should have a minimum standard on submission as evidenced by validation, thus the need to communicate before submission with a Trust and/or University research office. You should note that we want to approve a project, it is important that we actually do research in the Trusts, thus the increasing reliance on the partnership approach.

42. Post-Approval Audit Monitoring Reporting

43. In Conclusion Partnership Communication Understanding In conclusion, we all have a role to play, this will best be achieved if we all understand that we partner to ensure the safety of the subject, the integrity of the data, and the dissemination of the information to inform the evidence base, through communication and understanding Thanks you.In conclusion, we all have a role to play, this will best be achieved if we all understand that we partner to ensure the safety of the subject, the integrity of the data, and the dissemination of the information to inform the evidence base, through communication and understanding Thanks you.

44. Trials & tribulations of gaining ethical approval Marina Lupari PhD student UU/ Head of nursing- research & development NHSCT

45. Challenges for PhD students I am the one undertaking the research but I am not the Chief Investigator I can lead the UU application process I will be completing IRAS I will be presenting to REC I will be completing the Research Governance report I cannot be the local principal investigator

46. Specific to funded studies Funding body has granted funding for specific study Sponsor will not be your funding body Sponsor/ Ethics decisions may require significant changes to that funded study May involve significant time in negotiation between ethics sponsors and funders

47. You don't know what you need to do until you do it...... Role of and results of pilot study Participant Research- research is �emergent�, rather than fully structured in advance Ethnography emphasising reflexivity � can�t forsee what research and relationships will develop In Participant Research work over anticipation of the structure of the research is contrary to the spirit of the approach. For the PR practitioner research is �emergent�, rather than fully structured in advance. This has raised particular concerns with regard to Informed Consent, which may be negotiated in an ongoing way rather than formally agreed. (See Participant Research: Research Ethiccs Committees) Ethnography emphasizing reflexivity gives rise to similar problems with regard to foreseeing exactly how research and relationships with those researched will develop. The methodology is at odds with the structured requirement of RECs. (See Global Context: Ethics, Politics and the Reflexive Researcher) In Participant Research work over anticipation of the structure of the research is contrary to the spirit of the approach. For the PR practitioner research is �emergent�, rather than fully structured in advance. This has raised particular concerns with regard to Informed Consent, which may be negotiated in an ongoing way rather than formally agreed. (See Participant Research: Research Ethiccs Committees) Ethnography emphasizing reflexivity gives rise to similar problems with regard to foreseeing exactly how research and relationships with those researched will develop. The methodology is at odds with the structured requirement of RECs. (See Global Context: Ethics, Politics and the Reflexive Researcher)

49. Health service research...... My study looked at Carer�s strain Following analysis of the carer strain data I wanted to explore that evidence structure focus groups around those results BUT ETHICS NEEDED TO KNOW WHAT QUESTIONS I WAS GOING TO ASK

50. Ethics process based on.... a �one size fits all� model of research, in which aims, methods and outcomes are known before the research commences ethics as static, �ours�, non-negotiable, non-relational Espousing a hegemonic �ethics�, designed to protect from �harm�, but which can also serve to disempower and obstruct �good� practice.

51. University ethics submission Adds to the linear process of ethics submission Trust-UU-REC Different version of information/ different form

52. Alternative approaches..... Flexibility to constitute ethics as an ongoing process of critical reflection throughout the research ethics are developed: step by step, not all in one go; and in response to changing research priorities and procedures. agree procedures for continuing ethical review as a condition of approval

53. Positive changes - Complete one form Reduce duplication in secondary care research applications Reduce administration

55. Time Remains a potentially very lengthy process Turn around time of 60 days for HSC trust Add University changes Add sponsor changes Add funders changes

56. It is all about the participant.... Great care is needed in balancing the interests of research with those of the participant