Levels of involvement Consultation Collaboration User control THEME 2: Unit 5 - Part E Levels of involvement in research can range from: Consultation Collaboration Trainer Notes PRESENTATION: There are 3 main levels of involvement in research and development. If you are consulted you are asked for your opinions or views on a matter. They may be taken into account but there is no guarantee this will be the case and you may not know what happens the research project. If you are collaborating, then you are an active partner in the research process and you share or are delegated some of the responsibilities. Users and carers share decision making and their opinions are given equal weight with health and social service staff. They usually find out what happens in the whole process of the research and development project. If there is user control then users and carers lead the research. they may ask health and social service staff to do specific tasks for them, but the overall responsibility for the project lies with the users and carers. User control 1A

Managing research process THEME 2: Unit 5 - Part E Managing research process Project Board Research proposal Research and Development Department submission Peer Review Trainer Notes PRESENTATION: Talk through this model Ethics Committee submission Approval 1B

Project Board/Review and Reference Group - RRG THEME 2: Unit 5 - Part E Project Board/Review and Reference Group - RRG This board or group is a number of health and social services professionals (and lay members) with experience and knowledge of the research topic and methodology They are usually set up prior to submitting a research project for peer review Their role is to support the project until its completion and dissemination Trainer Notes PRESENTATION: Present above points 1C

Purpose of the Project board/RRG THEME 2: Unit 5 - Part E Purpose of the Project board/RRG Monitor, support and guidance Develop and comment on the design and methods used Ensure timing and budget are adhered to Develop a strategy to ensure the results are disseminated and findings put into practice Trainer Notes PRESENTATION: Present above points 1D

Research and Development (R&D) Department THEME 2: Unit 5 - Part E Research and Development (R&D) Department Most trusts/organisations have a Research and Development (R&D) department that is responsible for the overall management of all research undertaken in their organisation Their role is to: ensure the scientific quality of a research project ensure the organisation has the resources and suitable expertise to undertake the research most importantly, ensure its patients are adequately protected Trainer Notes PRESENTATION: Present above points, then say: Each research active organisation should have a policy document to give guidance to investigators on the registering, review and approval of projects. All projects need to be registered with the organisation’s R&D Department. Once registered the review process will begin. An important step is peer review by an experienced researcher or someone experienced in the research topic. 1E

Peer Review At peer review the project is assessed on the: THEME 2: Unit 5 - Part E At peer review the project is assessed on the: Skill and experience of the project team Adequacy of timing and resources Sufficient supporting evidence for the project Aims and objectives clear and appropriate Research questions fulfil the aims Appropriate numbers to fulfil the aims Appropriate methods to fulfil the aims Trainer Notes PRESENTATION: Present above points, then say: Once the proposal has been fully reviewed and they are satisfied that the project can be undertaken by the organisation, the R&D department will approve the project to go ahead. 1F

Research Ethics Committee THEME 2: Unit 5 - Part E Research Ethics Committee NHS ethics committees provide independent advice to participants, researchers, funders, sponsors, employer, care organisations and professionals about issues of quality and safety in the research proposal They are governed and supported by the department of Health and local Health Authority Each committee consists of up to 18 members - at least one third are lay members Each committee has a broad range of ages, diversity, experience and expertise - scientific, clinical and research Trainer Notes PRESENTATION: Present above points, then say: The committee members have a number of responsibilities within their role: completing an application form and standard application process attending initial and continuing training regarding research ethics, research governance and research methodology attending at least two thirds of all scheduled committee meetings maintaining confidentiality throughout the review process 1G

Purpose of the Ethics Committee THEME 2: Unit 5 - Part E Purpose of the Ethics Committee The primary purpose of the ethics committee is to: protect the dignity, rights, safety and well-being of participants and concerned communities take into account the interests, needs and safety of researchers, but this is secondary to participants ensure the burden and benefits of research are fairly distributed across all classes and groups within society (age, gender, economic status, culture and ethnicity) Trainer Notes PRESENTATION: Present above points 1H

The Ethics Committee Review THEME 2: Unit 5 - Part E The Ethics Committee Review Ethics committees assess the project for: Scientific design and conduct Recruitment of participants Protection of participants Community considerations They are also responsible for agreeing any changes to the research protocol at any stage throughout the project Trainer Notes PRESENTATION: Present above points, using the following information: Scientific design and conduct- appropriate design in relation to the objectives and potential for reaching sound conclusions; justification and awareness of possible risks weighted against the anticipated benefits of the project and adequacy of the research site and service provision Recruitment of participants- appropriate population and inclusions/exclusions Protection of participants- the safety of any treatment, the suitability of the investigator, the informed consent process, the physical and psychosocial support mechanisms, confidentiality procedures. Community considerations- the impact and relevance on the concerned community, the steps taken to consult the community during the course of the design and the dissemination strategy 1I

Opportunities for user involvement in managing research THEME 2: Unit 5 - Part E There are potentially several areas where users can become involved with managing research: Member of a project board/RRG Peer Reviewer for new projects Member of an ethics committee Trainer Notes PRESENTATION: Present above points 1J

Why is the managing research stage important? THEME 2: Unit 5 - Part E User involvement in managing research and development is important because having users and carers involved can: change the focus, design and content of a study raise new research questions that professionals may not know or think about ensure interventions and outcomes are kept ‘user-friendly’ encourage stronger commitment to dissemination of the project Trainer Notes PRESENTATION: Present above points, then say: As there may be increased costs and time involved, this must be considered when creating user involvement opportunities in managing research. 1K

THEME 2: Unit 5 - Part E Example 1: The needs of Pakistani and Bangladeshi communities in Newcastle Purpose: The Primary Care Group in Newcastle wanted to find out more about the needs of their Pakistani and Bangladeshi communities so they: understood how they described emotional distress from a cultural perspective knew what support they would need to deal with distress could use the findings to improve local services Trainer Notes PRESENTATION: This is an example of a research project where user consultants were involved in managing as well as doing the research. Present above points. 2A

Setting up the project: THEME 2: Unit 5 - Part E Example 1: The needs of Pakistani and Bangladeshi communities in Newcastle Setting up the project: Pakistani and Bangladeshi community members were invited to join the project team through community advertisements Seventeen people submitted applications and were interviewed Thirteen were employed and joined the project team as paid Community Project Workers (CPWs) Trainer Notes PRESENTATION: Present above points. 2B

THEME 2: Unit 5 - Part E Example 1: The needs of Pakistani and Bangladeshi communities in Newcastle Roles of the user consultants: After training, they co-designed the project under the supervision of experienced service managers and researchers and: developed the interview guides and interview process advised on cultural matters used their community networks to gain participants for the interviews who then encourage others to participate did the interviews analysed the information with a researcher shared outcomes with community members/organisations Trainer Notes PRESENTATION: Present above notes 2C

Support provided to user consultants: Example 1: The needs of Pakistani and Bangladeshi communities in Newcastle THEME 2: Unit 5 - Part E Support provided to user consultants: Went through a 6 month training period – 6 hrs/week – the training was accredited through the National Open College Were supervised by experienced service managers and researchers on a regular basis Were paid project members on a part-time basis – able to work flexible hours Trainer Notes PRESENTATION: Present above notes 2D

Example 1: The needs of Pakistani and Bangladeshi communities in Newcastle THEME 2: Unit 5 - Part E Level of influence or decision-making: The CPWs were paid members of the project team and had strong influence on all aspects of the project design. They: were the main decision-makers about what questions to ask, how to ask them and how to run the interviews were partners in the project analysis guided the researcher in understanding what was said and why in the interviews reviewed and confirmed the final descriptions of what the information meant about community members’ experiences and changes in services Trainer Notes PRESENTATION: Present above notes 2E

Example 1: The needs of Pakistani and Bangladeshi communities in Newcastle THEME 2: Unit 5 - Part E Activities that happened: Discussions about why services needed to be improved for these community members Initial training period Designed how to gain the information Did 104 interviews with community members Analysed information gained in interviews Shared information with different primary care groups, other local services and community members through regular meetings and formal presentations Trainer Notes PRESENTATION: Present above notes 2F

Example 1: The needs of Pakistani and Bangladeshi communities in Newcastle THEME 2: Unit 5 - Part E Outcomes achieved: The project led to these outcomes: found out how mental health services were working for local ethnic minority groups better location of support workers where community members could reach/visit them brought in and trained more counsellors from Asian backgrounds to offer more culturally appropriate services worked on a way to address racism in the local area Trainer Notes PRESENTATION: Present above notes 2G

Example 1: The needs of Pakistani and Bangladeshi communities in Newcastle THEME 2: Unit 5 - Part E Strategies for success: The main strategies were: recruiting people directly from the community who understood how to involve community members listening to their cultural advice with respect and building this into all parts of the project providing extensive training and then doing a test run to help build the CPWs’ confidence providing ongoing supervision for CPWs to help with any problems that occurred communicating the outcomes back to the community so they know what had happened to their input Trainer Notes PRESENTATION: Present above notes 2H

Example 1: The needs of Pakistani and Bangladeshi communities in Newcastle THEME 2: Unit 5 - Part E Problems that occurred: Staff wanted to ask personal details that CPWs said community members would not give Staff learned to balance information they expected they could ask with what was culturally sensitive If not they would lose valuable information because people would not participate or speak in detail There was tension between staff supervising the CPWs and senior staff about how quickly the project should happen Senior staff realised they were so familiar with wider health service issues that they forgot they were working with people who knew little about this - they needed to be more patient Trainer Notes PRESENTATION: Present above notes 2I

Example 1: The needs of Pakistani and Bangladeshi communities in Newcastle THEME 2: Unit 5 - Part E Benefits achieved: employed workers from Asian backgrounds in a community with a high unemployment rate got good participation from a mostly non-English speaking disadvantaged population who had low literacy levels gained in depth information because the process was appropriate to the group had solid information they could use to make service changes learned about different views of what emotional distress is and how people show it – this will reduce misunderstanding between staff and community members Trainer Notes PRESENTATION: Present above notes 2J

Thinking about practical issues – what does it mean for you? THEME 2: Unit 5 - Part E Number of user consultants involved Costs of involvement What is the user consultant role description? Being prepared for the role At what stage are user consultants involved? Office space or equipment Number of methods for gaining user involvement used Trainer Notes PRESENTATION: When you are thinking about the practical issues of involvement there are some key areas that you should check through. You will find that some ideas fit with your expectations for support: Present above points. Note to Trainer: If this group has done Core 2 – Unit 2: Part C then they have covered this material. Remind them that they have already discussed these issues. If the group has not done this part of the training it may be useful to go back and do some of that with them. 3A

Thinking about practical issues – what does it mean for you? THEME 2: Unit 5 - Part E How much information you receive Handling confidential information Training Mentoring Your connection to a network of other users, carers, the public Debriefing opportunities or support Opportunity to reflect on what you learn Dealing with personal difficulties Trainer Notes PRESENTATION: Present above points, then say: Now we need to think about which of these may present some practical issues if you decided to get involved in managing research. 3B