DURHAM COUNTY COUNCIL CHILDREN AND ADULTS SERVICE RESEARCH APPROVAL GROUP INFORMATION PACK Children and Adults Service Version 4 October 2015 Children and Adults Service Research Approval Group Page 1 of 16
Paragraph Contents Page 1 National and Local Level Research Governance Processes 3 2 Research approved by Health Research Authority (HRA) 3 3 If the research project involves four or more local authorities 4 4 Children & Adults Service Research Projects 4 5 Drivers 4 6 Purpose 4 7 Definition of Research 5 8 Remit of Children and Adults Service Research Approval Group 5 9 Application Criteria 5 10 Research Standards & Principles 5 11 Risk Assessment 6 12 Mental Capacity Act Implications 7 13 Document Retention 7 14 Application & Approval Procedure & Process Flowchart 7 15 CAS RAG Contact Details 10 Appendices 1 Frequently Asked Questions 11 2 CAS RAG Terms of Reference 13 3 Useful things to think about when developing a research project 15 Children and Adults Service Research Approval Group Page 2 of 16
1. National and Local Level Research Governance Processes Research Governance is a way for organisations to assess, record, monitor and avoid duplication of research activity. It also ensures that research is ethical, focused on useful topics and uses appropriate methods and means for dissemination of findings. Research Governance processes are in place at national and local levels to give approval for research to commence. To determine what level of approval is required, before completing an application form, researchers should consider the following. Does your research involve? Adults who lack capacity; Social Care studies with substantial ethical issues; or patients or users of NHS services Social Care studies with substantial ethical issues, and all research with adults (aged 16 and over) who lack capacity to consent MUST be approved by the Health Research Authority (HRA) using the Integrated Research Application System (IRAS). HRA also approve research for projects involving; Social Care studies funded by the Department of Health Integrated health & social care studies where there are no clinical interventions Studies in NHS setting where the approach uses social science or qualitative methods providing it does not involve clinical intervention Adult social care involving changes in or the withdrawal of standard care Patients or residents in residential care homes More information and how to apply to HRA can be found at http://www.hra.nhs.uk/ Research involving patients and users of NHS services should be approved by the HRA using the Integrated Research Application System (IRAS). This service is responsible for approving research for projects involving; Participants identified as carers or relatives of patients and users for the NHS Access to data organs or other bodily material of past and present NHS patients Foetal material and IVF involving NHS patients Use of, or potential access to NHS premises or facilities NHS staff recruited as participants by virtue of the professional role Health related research involving prisoners (in addition to their own approval process) Processing of confidential patient information without consent where this would otherwise breach confidentiality Midwives conducting a clinical trial More information and how to apply to the National Research Ethics Service can be found at http://www.hra.nhs.uk/ 2. Research approved by Health Research Authority (HRA) In principle, an application should only have to go to one Research Ethic Committee for ethical approval. Children and Adults Service Research Approval Group (CAS RAG) would not need to approve projects already scrutinised and approved by HRA. CAS RAG may request a copy of the approval form and supporting documents and share these with an appropriate CAS Strategic Manager for information. Projects rejected by HRA would not be considered by CAS RAG. Children and Adults Service Research Approval Group Page 3 of 16
3. If the research project involves four or more local authorities In this case, approval must be sought from the Association of Directors of Adults Social Services (ADASS) for projects involving adults, and the Association of Directors of Children s Services for projects involving children. ADASS/ADCS approval is not ethical approval but a decision about whether the research is worth doing. Authorities are advised not to collaborate with projects which are rejected by ADASS or ADCS. A local authority should be identified to undertake the lead for projects approved by ADASS /ADCS. 4. Children & Adults Service Research Projects For researchers undertaking research that targets employees, service users or carers of Durham County Council s Children and Adults Service, or involves their personal records, this information document provides details of the requirements and process involved in applying for ethical approval by CAS RAG. 5. Drivers Developed in 2001 and updated in 2005 the Department of Health s Research Governance Framework for Health & Social Care sets out basic standards for the conduct of research in the NHS and Adult Social Care and covers five key areas; Ethics Science Information Health & Safety Finance Research Approval Group s (RAG) are not defined as statutory requirements under the Department of Health s guidance. However, the guidance sets out a basic framework of standards for every party involved in research and calls for explicit agreements about roles and responsibilities to be developed within the NHS and Social Care Services, drawing attention to the laws and good practice which support research governance. 6. Purpose In order to comply with these standards and good practice, Health & Social Care organisations must: be aware of research undertaken through the Research Governance Framework ensure the protection of dignity, rights, safety and well-being of researchers and participants safeguard researcher's integrity and make sure of compliance with standards set out in the application form ensure researchers fully comply with appropriate legal and best practice requirements including for example those of; - Mental Capacity Act 2005 - Data Protection Act 1998 - Freedom of Information Act 2000 - Role of the Caldicott Guardians Children and Adults Service Research Approval Group Page 4 of 16
7. Definition of Research The Department of Health s, Research Governance Framework for Health and Social Care 2nd Edition 2005, defines research as; "The attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods" This inclusive definition covers most forms of disciplined enquiry involving the systematic collection of data and using explicit research methods and techniques. 8. Remit of Children and Adults Service Research Approval Group Formally the Research Governance Framework extends only to adult social care services, although local authorities are encouraged to apply the same principles to research involving children s services. As good practice CAS Management Team has agreed to extend cover to include research projects for all Children and Adults Service and should be used by people who; Undertake Manage Sponsor Fund and or Host research and other information gathering activities. These groups include; Social and Health Care Professionals Contracted providers of the Local Authority Other independent agencies Universities or other research agencies Students CAS Research Governance Framework is the collective name for the Research Approval Group and Research Governance documents used to assist in the decision making process to approve or reject all CAS research projects for Durham County Council. 9. Application Criteria Approval from CAS RAG is required for any internal or external research project or information gathering activity which; specifically targets the participation of Children and Adults Service s employees, service users and/or carers requires access to existing Children and Adults Service data systems to access participant s records or details including staff, service users or carers 10. Research Standards & Principles The CAS RAG provides an independent review of research proposals to ensure they respect the dignity, rights, safety and wellbeing of participants. In scrutinising research applications members of the group consider the following; Ethical considerations to ensure that; - A sponsor is identified to oversee the management and financing of a study. - Arrangements have been made for obtaining informed consent. Children and Adults Service Research Approval Group Page 5 of 16
- Data is used and protected appropriately - Wherever possible service users and carers of their representative groups, are involved in design, conduct and reporting. - Risks to participants have been considered. Scientific considerations to ensure that; - The research is new and where existing sources of evidence are available that they have been used to prevent duplication. - The research meets appropriate regulatory requirements where applicable. For example Mental Capacity Act implications. - The data collected will be retained for an appropriate period. Information considerations to ensure that; - Research is conducted for the benefit of Service Users, care professionals and the public. - Access to information on research being conducted and on the findings will be freely available unless there is a specific reason for this not to be given and anonymity has been considered. - Information is clear and understandable. - Findings must be made accessible to those participating and those who could benefit from them. Health & Safety considerations to ensure that; - The safety of participants, the researcher and other staff is maintained at all times. - Health and Safety Regulations are observed. Financial considerations to ensure that; - The use of public funds to support health and social care research is transparent and demonstrates accountability. 11. Risk Assessment An essential component of the governance arrangements for research is to be able to assess the risks presented to service users when participating in research. A tool to identify and assess the degree of risk to research participants involved in each research project is used to identify whether the particular research project is viewed as high, medium or low risk. Where it is clear that aspects of a research project are considered high risk, CAS RAG will ensure that these areas have been considered by the lead researcher and effective measures have been taken to ensure that such risks are managed appropriately. The questions in the risk assessment cover; Participant s characteristics. Researcher competence. Type of information sought. Methods and nature of data collected (which includes consideration of the legislation governing the right to hold and store personal data. i.e. Data Protection Act 1998 and Freedom of Information Act 2000). Level of privacy. Relationship between investigator and participants. Children and Adults Service Research Approval Group Page 6 of 16
12. Mental Capacity Act Implications Research must fully comply with the requirements of the Mental Capacity Act 2005, in relation to research involving service users who lack capacity to consent (Section 32(3), Mental Capacity Act 2005). The Act's provisions are designed to ensure that the interests and safety of people who lack capacity are protected when they participate in research and to ensure that their current and previously expressed wishes and feelings are respected. Under the Mental Capacity Act 2005, all research with adults (aged 16 and over) who lack capacity to consent, MUST be approved by a National Research Ethics Committee and CANNOT be approved by a local authority. More information is available on the link below; http://www.hra.nhs.uk/resources/research-legislation-and-governance/questions-andanswers-mental-capacity-act-2005/ 13. Document Retention Completed research projects are retained by CAS RAG for 6 years from the date of completion in line with the Service s Retention & Destruction Policy and will be available for reference if required. 14 Application & Approval Procedure & Process Flowchart Actions 1. The Researcher will be signposted and encouraged to access the CAS Research Governance Framework (RGF) website on the internet. http://www.durham.gov.uk/researchgovernance 2. If the Researcher has stated they will be using questionnaires, consent forms etc., CAS RAG may not approve their application until these have been received unless these are attached to the application form. 3. The application form and any attached documents are then circulated to RAG members for their consideration. A meeting may be convened if timescales permit. For each application, the risk assessment form is considered and completed by the group. In approving an application, CAS RAG confirms that the risks and mitigation measures provided by the researcher are satisfactory. 4. RAG members comments are summarised collectively and relayed back to the Researcher within 15 working days along with their decision to approve or decline the research proposal. Changes 5. If CAS RAG suggests that changes are required to an application form or accompanying documentation, the changes will be sent to the Researcher for action by email. Once the Researcher has made the suggested amendments to their application/accompanying documentation, they re-submit this for approval. This process may occur more than once if the changes are not satisfactory. Once all changes are made, the application will be approved and an email will be sent to the Researcher. Children and Adults Service Research Approval Group Page 7 of 16
Approval When an application is approved without any changes or with recommendations only, an automated approval email will be sent to the Researcher. 6. The Researcher progresses and completes their project and forwards the final report and findings to researchapprovalgroup@durham.gov.uk. The Researcher will be asked to complete and return the evaluation questionnaire. Roles & Responsibilities Role Responsibilities Strategic/Senior Manager Is responsible for making the final decision to approve or decline research applications where there is a difference of opinion among RAG members. CAS RAG Members The Team Leader Governance Policy & Procedures is the Chair of the group. When the Chair is unavailable another RAG member will Chair the meeting. Review application forms and associated documents. Provides comments on research applications within 15 working days to contribute towards the RAG approval or decline decision. Completes the Risk Assessment form and in approving confirms that the risks and mitigation measures are satisfactory. Seconded members will be invited for projects where service specific knowledge is required. Research Approval Group Assistant Lead Researcher/ Applicant Provides facilitation and administrative support for RAG by; Organising meetings. Recording application decisions. Co-ordinating the RAG applications. Notifies approval/recommendation of amendments to lead researcher. Ensuring that the application is completed fully Maintaining the RAG website. Returning the feedback of the RAG to research applicants Completes application form Where applicable, makes appropriate amendments and re-submits applications before and during research process. Undertakes the research within the remit of the application form. Provides final report after project completed. Completes the RAG Feedback questionnaire Children and Adults Service Research Approval Group Page 8 of 16
Approval Process Flowchart Researcher completes application form and submits with relevant documentation notifying an appropriate Tier 4 Manager Has the application been fully completed and is all associate documentation attached? NO RAG advises the Researcher that the application is not fully complete and/or documentation is not attached. This is required before the application form can be assessed. YES If approved RAG sends a standard approval email to the Researcher RAG considers the application form and will decide whether it is approved /declined or changes are needed RAG will complete the Risk Assessment form If changes needed RAG inform the Researcher what amendments or further considerations are required RAG sends a standard decline email to the Researcher If declined Researcher makes appropriate amendments to the application form and re-submits their application. The Researcher sends their completed report to RAG for retention and reference. This will be retained for 6 years for reference by appropriate Service Areas if required and will be destroyed after 6 years in line with the council retention & destruction policy If this is a repeat study of a research project which has previously received approval have there been any amendments to the research? NO Continue with the work your approval is still valid End YES Complete and submit a new application form to RAG Children and Adults Service Research Approval Group Page 9 of 16
15. CAS RAG Contact Details CAS RAG email; ResearchApprovalGroup@durham.gov.uk Postal Address: Children and Adults Services Research Approval Group County Hall Durham, DH1 1BR Tel 03000 267 323 03000 267 323 Children and Adults Service Research Approval Group Page 10 of 16
Appendix 1 - Frequently Asked Questions Q. Is it a legal requirement to complete and submit a Research Application Form? If Children and Adult Services staff, service users or carers are be targeted as participants in the research project or information gathering activity then a CAS RAG application form must be completed. Although Research Governance Approval Group s (RAG) are not defined as statutory requirements under the Department of Health s guidance, all researchers must fully comply with the legal and best practice requirements of, for example the: Mental Capacity Act 2005 Data Protection Act 1998 Freedom of Information Act 2000 Role of the Caldicott Guardians Q. What kind of research is covered by CAS RAG? CAS Management Team has agreed to extend cover to include research projects for all Children and Adults Service as good practice. Therefore any research project or information gathering activity within Children and Adults Service is covered by this procedure which: specifically targets the participation of Children and Adults Service s employees, service users and/or carers; requires access to existing Children and Adults Service data systems to access participant s records or details including staff, service users or carers Q. Would research carried out by, or within any other County Council service other than Children and Adults Service be covered? No, this process is only required for research projects that target staff, service users and /or carers of Children and Adults Services. Q. Can I ask for Research to be approved once it has started? No. All research should be approved before it begins. Projects which are already underway will not be considered by CAS RAG for approval. Q. What about external providers of services? For example where the Council contracts with others to provide a service; do they need to comply with this procedure? If they plan to carry out research which specifically targets the participation of Children and Adults Service s employees, service users and/or carers then they will need to submit their research proposal to the CAS RAG. Q. Where can I find further information about the CAS Research Governance Framework? Useful documents and links to other organisations can be found on the CAS RGF website using the link below; http://www.durham.gov.uk/researchgovernance Children and Adults Service Research Approval Group Page 11 of 16
Q. Do I need to submit a CAS RAG application form if the proposed research has already been scrutinised and approved through the Health Research Authority (HRA)? In principle, an application should only have to go to one Research Ethic Committee for ethical approval. CAS RAG would not need to give approval for projects already scrutinised and approved by HRA. CAS RAG may request a copy of the approval form and supporting documents and share these with an appropriate CAS Strategic Manager for information and//or operational purposes. Q. Will research that is on-going be included? Any research such as a survey sent out monthly or on an on-going basis, would need to be subjected to CAS RAG scrutiny. This would however, only need to be done once, unless the research was subject to significant change. Q. How long will it take to get my research approved? Research applications will be considered and feedback provided within 15 working days of receipt. The emphasis is on trying to assist applicants through the process and CAS RAG will try to respond within a few days where the risk associated with the research is considered low. A decision may take a little longer for high risk work. Q. Who will scrutinise applications? Members of CAS, Planning & Service Strategy lead the CAS RAG and scrutinise application forms. Appropriate colleagues from other parts of the Service will be seconded to the Group when necessary, for projects which require specific Service area related expertise. For example, Education or Public Health related research projects will be considered by a member from the Education or Public Health teams etc. Q. Can CAS RAG give ethical approval for projects where participants lack capacity? No. Under the Mental Capacity Act 2005 all research with adults (aged 16 and over) who lack capacity to consent MUST be approved by a National Research Ethics Committee and CANNOT be approved by a local authority. Further information is available on the link below; http://www.hra.nhs.uk/resources/research-legislation-and-governance/questions-andanswers-mental-capacity-act-2005/ Children and Adults Service Research Approval Group Page 12 of 16
Appendix 2 - CAS RAG Terms of Reference Purpose The purpose of the Children and Adults Service (CAS), Research Approval Group (RAG) is to; ensure the rights, safety and wellbeing of researchers, service users, carers and staff participating in research help to safeguard the integrity of the research and uphold standards for ethical review and scientific quality establish a transparent system to approve, monitor and record all research activity Function The function of CAS RAG is to consider applications, complete a risk assessment form and make recommendations for amendments before approving or rejecting any research application form submitted. Membership From the panel of CAS RAG members, where it is possible: A minimum of 3 CAS RAG members must be present at CAS RAG Meetings including the Chair. The Chair is the Team Leader, Governance/Policy & Procedure Review (or another RAG Member if Chair unavailable) CAS RAG members should not consider applications where they may be closely associated with the research being undertaken. Frequency of meetings CAS RAG will meet as required when application forms are received. Emergency 'virtual' meetings may be held for urgent applications. In such circumstances the application form and associated documents will be circulated by email to CAS RAG members who will add their comments using the standard CAS RAG Feedback form. Applicants may be invited to attend the CAS RAG meeting where their application is being considered. Administration and facilitation Facilitation and administrative support will be provided by Planning & Service Strategy. Decision making Where possible, a minimum of 3 CAS RAG members must be present at each meeting. CAS RAG will provide feedback to the Lead Researcher within 15 working days of receipt of an application. Each CAS RAG member will be requested to provide comments and recommendations for each application after which the application will be approved or declined. Where agreement on approving or declining an application cannot be reached among CAS RAG members, full details of the application will be made available to the Strategic/Senior Manager who will be requested to make the final decision. Children and Adults Service Research Approval Group Page 13 of 16
Compliance Where it becomes known that research has been carried out without the necessary approval, this non-compliance must be investigated by the Team Leader Governance/Policy & Procedure Review and then reported to the Strategic/Senior Manager. CAS RAG will be notified of the outcome of the investigation. Accountability CAS RAG will report to P&SSMT as required. Children and Adults Service Research Approval Group Page 14 of 16
Appendix 3 - Useful things to think about when developing a research project Background a) Why is this research important? b) What other studies have there been in this area? c) How will this research add to knowledge in this area? d) What do you want to find out? e) What is the main question you wish to answer? f) What are the specific questions you will ask to address the main question? How will you do your research? a) Will you be doing this research on your own or with others? b) Have you provided full details of anyone else you intend to carry out this research with, including field workers? c) Who are you targeting in this research? d) How many people or case files do you intend to interview or read through? e) Where will the research take place? f) Will participants be clearly informed of the purpose of the research study? g) How will you do this? h) How will participants be clear about the expectations of the researcher? i) Do you have an information sheet and a consent form for participants? j) How do you intend your research to be supervised and monitored and by whom? k) Who will be funding your research? Timetable a) When will your research start and finish? b) Are there particular stages to the research e.g. Piloting, then main research? c) If so what are they? d) Are they realistic? e) Is it influenced by external constraints or deadlines? f) How will you provide regular updates and progress reports and to whom will you provide them? Methodology a) What sort of data will you be collecting- e.g. are you intending to count numbers, talk to people directly or a mixture of the two? b) What is the main method you will use to carry out the research e.g. questionnaire, face-to-face interviews, focus groups, paper reviews etc.? c) How will you select your sample? d) How will you recruit your sample? e) How will you collect your data? f) Will you be paying participants? Ethical Issues a) Is there any potential risk or harm to participants or yourself? b) If so, what are the potential risk and what to you intend to do to reduce them? c) How will you obtain informed consent? d) Where informed consent is unable to be provided, what will you do? How will your research comply with equal opportunities? e) Will you be insured against professional negligence claims? Children and Adults Service Research Approval Group Page 15 of 16
f) How will you deal with any sensitive or criminal matters that may be raised in the course of your research? g) What follow-up support will be available to participants should they require it? h) What will you do if the focus of your research project shifts or changes substantially from the proposal? If it goes outside the original remit, how will you notify the council? You may need new approval. Data Protection a) Will you be using recording or video equipment? b) How will you make sense of or analyses the data? c) How will the data be stored? d) For how long will the data be stored? e) How will it be disposed of? f) How will you ensure confidentiality and anonymity of data? g) Who will have ultimate ownership of the data? h) If you are likely to need to contact a participant later, you need to declare this now Dissemination a) In what form will your findings be presented e.g. report, presentation, journal etc.? b) How will you be disseminating your findings? c) To whom will you be disseminating your findings? d) How will you ensure anonymity in any publications? e) It is a condition of approval that the research will be logged on the council s database. Children and Adults Service Research Approval Group Page 16 of 16