Research Governance Policy. SI Network Research Governance Policy 2016

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1 SI Network Research Governance Policy

2 Contents Page Introduction 2 What is Research Governance? 2 What are the SI Network s responsibilities for Research Governance? 2 Use of Personal Information 3 Does the SI Network Sponsor Research? 3 Eligibility for SI Network Support 3 The process for gaining approvals for a research study (flowchart) 4 Appendix 1: SI Network Recruitment Support Award Terms and Conditions 5 Appendix 2: SI Network Award Sponsor Agreement 9 Appendix 3: Selection Criteria 12 2

3 Introduction The SI Network is committed to fostering and supporting high quality research into the development, delivery and practice of Ayres SI and other sensory-based interventions. In order to do so, we recognise the need for simple but robust research governance procedures to be put in place to protect our organisation and our members. What is Research Governance? Governance of research is defined as setting standards; defining mechanisms to deliver standards; monitoring and assessing arrangements; improving research quality and safeguarding the public (by enhancing ethical and scientific quality, promoting good practice, reducing adverse incidents, ensuring that lessons are learned and preventing poor performance and misconduct). (DoH, March 2001, pp.2). What are the SI Network s responsibilities for Research Governance? - Ensuring our members have a clear choice as to whether or not they wish to receive information about research studies seeking participants, or not - Arranging for an appropriate person/s to grant permission for research involving our members, students and staff before the research starts (see Appendix 1) - Ensuring appropriate sponsorship arrangements are in place (see Appendix 2) - Conducting our own independent review to assure ourselves that any such research is conducted to the quality standards set out in the research governance framework which governs the study. We use the ethics review checklist, produced by the Open University, to ensure that the necessary ethical considerations have been taken into account by the researcher (Iphofen, R. (2009) Ethical decision making in social research. A practical guide, London: Palgrave Macmillan pages ). - Retaining responsibility for the care of any participants to whom we have a duty - Ensuring that any research we fund provides value for money. We recognise that any research being conducted in collaboration with the NHS is required to comply with the Research Governance Framework for Health & Social Care and also with various NHS and HSC trust research management procedures. Use of Personal information 3

4 The SI Network ensures that at all times we are compliant with the Data Protection Act and our members are given the option to opt in to receiving information about opportunities to participate in research studies. As an organisation committed to furthering research in the field, our membership terms and conditions include an invitation to participate in research. We are clear this is optional and that members may choose to change their mind and withdraw consent at any time. This decision will not jeopardise their membership or access to any of our other services. Does the SI Network Sponsor research? No. A sponsor is responsible for ensuring that arrangements are in place to indemnify the Investigator(s) against claims for harm arising from negligence. The employer of the Investigator(s) may also be liable for non-negligent harm to study participants. Any organisation that is a legal entity may declare itself as a sponsor. Institutions are expected to review candidate studies for sponsorship on a case-by-case basis and should only accept the role of sponsor for studies that lie within their range of competence. We do not have indemnity insurance to act as a sponsor. According to the Research Governance Framework, the supervisor of a student may act as the sponsor for research where the primary objective of the research is educational. However, most institutions insist on institutional sponsorship and do not permit individual sponsorship by supervisors. The SI Network does not advocate sponsorship by individuals or Directors because of the risks and liabilities involved. SI Network logo should only appear where the research sponsors logo is also present to avoid any misunderstandings or assumed sponsorship of the research. Eligibility for SI Network Support The SI Network does not support research activity where primary objective of a particular study is educational e.g. 3 rd year student surveys. This is to ensure that research we facilitate is of the highest quality and will contribute to new knowledge. It is not always obvious whether an individual should be regarded as a student e.g. postgraduate students. Support should be reviewed on a case by case basis by a panel of experts. Post-graduate students MUST have obtained and submitted Ethics Approval obtained from their University. A clear dissemination plan should be in place as a pre-requisite. Independent contractors should be strongly discouraged from becoming sponsors because of the scope of responsibility involved. The SIN is unable to support requests for research facilitation where there is no sponsor (University or NHS for example) involved. The process for gaining approvals for a research study 4

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6 SI Network Recruitment Support Award Aim and Scope Terms and Conditions The SI Network research grants are to support development of the evidence relating to Sensory Integration across the Lifespan: The Art and Science. All grant applications must demonstrate contribution to one or more of the following themes: Evidence from within the field of Neuroscience Assessment and Measures of SI and Sensory Processing Difficulties Evidence for the treatment of Sensory Processing Difficulties: o Ayres Sensory Integration Therapy o Sensory Strategies. : Grant Awards available The grants will be available as per calendar year, from January 1 st. When the financial envelope for each grant has been allocated applications will close. However, grants awards may be re-launched prior to the end of the financial year if all research funds have not been allocated. PhD Research Projects Up to 5000 MSc Research Projects Up to 5000 Small Projects/Studies Up to 7000 Dissemination of Research Up to 3000 Recruitment Support N/A Review Process Applications for Grant awards will be subject to a robust and objective review using the following criteria. Timeline for Review: Initial enquiry sent to the Chair of the Researcher Support Committee Formal acknowledgement letter sent (within 2 weeks of receipt) Proposal and review paperwork sent to reviewers Responses from reviewers returned (within 1 month) Confirmation letter sent 6

7 Responsibility of the SI Network Each application is subject to independent expert review to assess: The quality of the research The experience and expertise of the Chief Investigator and other key researchers Compliance with the principles of Good Clinical Practice. Recruitment Support Award 1. The award will provide access to members of the SI Network for the purpose of recruiting to research, which is relevant to one or more of the research themes stated above. This access will be provided via the SI Network s online forums and via their administration team. Recruitment to relevant studies may also be advertised via the SI Network publications (e.g. SensorNet and/or EmphaSIze). The SI Network will provide forums whereby participants may choose to approach the researchers/recruiters. 2. The study must be conducted in the UK or Ireland and at least one of the applicants must be based in the UK or Ireland at the time of applying. 3. The study must be applicable to one of the research themes noted above. 4. The applicant must be playing a major part and take a leading role in the research project/team 5. Applications must have been reviewed and signed off by the host institution/employer and/or sponsor by completing the Sponsors agreement document and Research Ethics must be clearly articulated in the research proposal. Research Ethics Checklist can be used to confirm this. 6. Proof of any funding of the research must be provided by applicant. 7. If the research includes children, young people and/or vulnerable adults, researchers will need to provide evidence of up to date Data and Barring Checks. 8. Applicants must provide a statement stating that there is no conflict of interest Not Included 1. No individual member information will be given by the SI Network. 2. No costs of sponsorship will be met by the SI Network, therefore any subsequent costs such as printing/posting will be incurred by the applicant. Criteria for Applicant 7

8 1. Lead researchers must be members of the SI Network and paying current subscription. Acknowledgement of the SI Network 1. Applicants and co-applicants must ensure SI Network s support with recruitment is acknowledged in any presentation or publication. 2. Grant applicants must submit a final report to SI Network within two months of the end of the research project. 3. All applicants will be expected to submit a report for SensorNet and for the SI Network Website detailing the results of their research/study and /or contribution to the evidence base for Ayres SI. SI Network (UK & Ireland) and be sent to the Business Manager at Sensory Integration Network (UK & Ireland) 27a High Street Theale Reading RG7 5AH, United Kingdom 8

9 Appendix 2 SI Network Grant Award Sponsor Agreement Title of Study/Research: Level of Programme: MSc/PhD Name of Lead Researcher: Name of Sponsor: Affiliation with Researcher (e.g. Lecturer, Supervisor, Employer): Name of Sponsoring University/Employer/Institute: As Sponsor please confirm the following: 1. The proposed study/research has adequate arrangements to initiate, manage and monitor, and finance a study. 2. The chief investigator, and other key researchers, including those at collaborating sites, have the necessary expertise and experience and have access to the resources needed to conduct the proposed research successfully. 9

10 3. The arrangements and resources proposed will allow the collection of high quality, accurate data, and the systems and resources proposed are those required to allow appropriate data analysis and data protection. 4. Arrangements proposed for the work are consistent with the Research Governance Framework. 5. Organisations and/or individuals involved in the research agree the division of responsibilities between them. 6. There is written agreement about the arrangements for the management and monitoring of the study. 7. Arrangements are in place for the sponsor and other stakeholder organisations to be alerted to significant developments during the study, whether in relation to the safety of individuals or to scientific direction. 10

11 I confirm that the research study detailed above complies with the Research Governance Framework for the sponsoring Employer/ University and or Institution Name: Designation: Signature: I agree to inform my sponsor of any changes in the research that may alter the agreed terms and conditions: Name: Signature: 11

12 Appendix 3 Selection Criteria Coherence of proposal Argument presented Evidence grounded in the base of Sensory Integration theory The scientific value and validity of the proposal Research question and Answer Clear refusal 1/5 Substantially fails to answer the question or to address the topic There are few clear links between statements or sections Little convincing argument presented and is mostly descriptive Minimal reference is made to supportive evidence Proposal lacks rigour, limited value Acceptance 2/5 Relevant material but is sometimes poorly presented Relationships between sections and statements are reasonably coherent Some coherent arguments are produced, though there is limited analysis in places Use of evidence is sometimes descriptive rather than analytical Justifies some aspects of value to the evidence base. Good acceptance 3/5 Evidence of understanding of most of the issues Relationships between statements and sections are not always fully articulated but are coherent There is some demonstration of the ability to provide clear and structured arguments Answers are supported by evidence, though not all sources are contemporary and only some of the evidence provided is critically appraised Provides evidence of value and validity to evidence base Very good proposal 4/5 The question is answered with appropriate emphasis on the analytical, synthesis and evaluation components Relationships between statements and sections follow and there is sound structure There is a clear and convincing line of argument The evidence selected is of high quality, and mot claims are supported by relevant evidence that has been critically appraised Provides critical appraisal of value/validity of proposal ap- Excellent proposal 5/5 The question is answered fully, including excellent analysis, synthesis and evaluation. The quality, originality and criticality of evidence may warrant publication The entire proposal/application is clearly linked, structured and succinct A clear and convincing line of argument is demonstrated throughout Demonstrate creativity and originality in the selection of evidence, provides thorough critical analysis of evidential support, and critical knowledge of theoretical positions Demonstrates a clear proposal of the value and validity of the 12

13 Study design and methodology Ethics to evidence base and/or not valid. Lays out study s design without detail. Methodology lacks organisation, no consideration of sample selection, data collection, data analysis. limited consideration of fundamental ethical principles, acknowledges but no attempt to apply to study Study design presented with basic justification and out line to answer research question. Methodology justified Ethical principles stated with limited detail including Autonomy, Consent, communication, equity, discrimination, beneficence confidentiality and some justification for the study Study design is clear showing appropriate methodology o answer research question. Sample selection, data collection included Ethical principles stated with detail including Autonomy, Consent, communication, equity, discrimination, beneficence confidentiality Trust R & D Ethical approval required praising potential contribution to evidence base. Study design and methodology justified and clearly organised considering sample selection, data collection, data analysis Ethical principles stated with detailed consideration and including Autonomy, Consent, communication, equity, discrimination beneficence confidentiality Trust R & D Ethical approval required study to SI evidence base. Critical appraisal of principles of validity and comprehensive justification for the study Study design is clear, succinct and clearly considers all aspects of methodology and design with clear and well thought out procedures. All aspects of ethical principles clearly laid out and applied to the study. Mitigation of risk and ethical limitations provided. If you have any queries, please get in touch: support@sensoryintegration.org.uk 13