Title: Outcome Statement: Written By: Confirming Research Study Capacity and Capability Researchers will be informed about the procedures and requirements for obtaining permission to conduct a research study in NSFT. Bonnie Teague, Research Manager Tom Rhodes, Research Facilitator Reviewed: In Consultation With: Approved By and Date: With Reference To: Associated Trust Policies: Applicable To: For Use By: Louise McCarthy, Research and Development Lead (Suffolk) NHS R&D Forum V1.0 Research Governance Committee 26 th September 2013 V2.0 Research Committee 24 th November 2016 Department of Health: Research governance framework for health and social care: Second edition, 24 April 2005 Medicines for Human Use in Clinical Trial Regulations (2004) Health & Social Care Act 2008 Section 251 Governance arrangements for research ethics committees: a harmonised edition (2012) R&D005 Conducting Clinical Trials of Investigational Medicinal Products R&D008: Research Trial Management: Trial Master and Site-Specific Files R&D009: Research Auditing and Monitoring Procedures Trust staff working on research studies taking place in NSFT. Research Teams, Research Networks, Research and Development, Clinical Teams, External Investigators and Institutions R&D001 Reference Number: Version: 2.0 Published Date: V1.0 27 th September 2013 V2.0 1 st January 2017 Review Date: October 2019 Impact Assessment: Reason for Development Implementation and Monitoring Yes 19 th September 2013. To inform Trust staff and research teams about the requirements and processes for obtaining the correct permissions for all research studies being undertaken in the Trust. To be implemented immediately through the Research Office and distributed across the researcher database, intranet and Research training programme. The policy will be monitored annually through an internal Research Office review of processes. R&D001 Obtaining Research Approvals in the NSFT Page 1 of 9
1.0 Introduction Health Research Authority (HRA) approval is the process for the NHS (England), that involves a review from an NHS Research Ethics Committee (REC) and an independent assessment of regulatory compliance and documentation undertaken by national HRA staff. This process has replaced the requirement to obtain individual R&D approvals in each NHS organisation. It is now the duty of NHS Organisations to review and confirm capacity and capability of delivering each research study at the local level. HRA approval applies to NHS organisations across England. For studies originating in Scotland, Wales and Northern Ireland, the HRA has compatibility arrangements in place to share information regarding the set-up of research studies. 2.0 Purpose To inform all researchers about the procedure and requirements when applying to the Trust for Confirmation of Capacity and Capability to conduct a research study at NSFT. This policy and the stated procedures apply to all research conducted in the NSFT, regardless of Sponsor organisation. 3.0 Definitions and Abbreviations Confirmation of Capacity and Capability: The local feasibility procedure undertaken by an NHS Organisation to assess and confirm whether the organisation has the resources, policies and service users required to successfully deliver the research study to time and target. Health Research Authority (HRA): The national non-departmental public body established by the Government to oversee health and social care research. HRA approval has replaced the need for individual organisational approvals for research. Integrated Research Application System (IRAS): An integrated web-based application system, in which one information dataset is completed by the researcher to apply for multiple research approvals, as required for the needs of the study Minimum Documentation Set: A number of research documentation, including the study protocol and participant documentation, which makes up a valid research application. Research Ethics Committee (REC). RECs safeguard the rights, safety, dignity and well-being of people participating in research in the National Health Service. A favourable opinion from REC to conduct a research project involving NHS patients or identifiable patient data must be obtained prior to the start of any research activity involving direct contact with participants. 4.0 Duties and Responsibilities Sponsor: The organisation/institution with overall responsibility for the conduct of the clinical trial in the UK. The sponsor will arrange: Indemnity, financial and contractual arrangements for the whole study. Necessary approvals required to be in place by the start of the study. Study set-up and provide full trial documentation and study training to local research teams. Continued communication about updates to study and documentation to the local site. R&D001 Obtaining Research Approvals in the NSFT Page 2 of 9
Chief Investigator: The lead researcher with responsibility for the conduct of the clinical trial across all research sites, including but not limited to the following areas. Qualifications and agreements (Good Clinical Practice (GCP) Training, delegation of trial-related duties) Arrange adequate resources to conduct the overall study time, funding, demonstrate ability to recruit (via pilot etc) On-going communication with research approving bodies throughout the trial. Principal Investigator (PI): A person that has overall delegated duty for the conduct of the research study at each individual participating research site. The PI will be selected and/or confirmed by NSFT Research. Duties will include: Study feasibility on behalf of the Organisation in conjunction with NSFT Research. Reasonable assessment of potential recruitment numbers Highlighting any difficulties or challenges in delivering the study. Assessing and organising training needs of the supporting research team. Attending site selection, set-up and initiation visits. Identify co-investigators as required for each research study. NB The PI cannot make a decision to withdraw from a study assessment alone, without consultation with NSFT Research. If a PI feels that they cannot or do not wish to act as PI, an alternative investigator should be sought before the Trust communicates a non-confirmation status. Research Nurse (RN), Clinical Studies Officer (CSO)/Research Assistant (RA): A research practitioner employed by research team, Trust or research body with delegated duties to carry out specific allocated duties as identified in Trust approval documentation and supported by the delegation log. Duties could include: Input on study feasibility and capability as required by the PI and NSFT Research. Organising training and attending study set-up meetings as required. Identifying any delivery challenges of the study, based on prior experience. Communicate with PI and Co-Is about study feasibility and set-up. Research and Development Offices (R&D): Research and Development Offices review the local feasibility of conducting research studies in the relevant NHS premises. Duties Include: Lead on confirmation of capacity and capability assessment on behalf of the organisation Agree potential participant numbers and targets with the PI and CI/Sponsor. Assign research team members to support the PI. Review and sign any financial and contractual arrangements arising from the study. Report study confirmation details to NSFT Research Committee. Agreeing outsourcing arrangements with partner organisations for clinical support services.. R&D001 Obtaining Research Approvals in the NSFT Page 3 of 9
5.0 Obtaining Permission to Conduct research studies in NSFT. 5.1 Site Invitation It is expected that researchers contact NSFT Research via research.review@nsft.nhs.uk to invite NSFT to act as a research site. This feasibility may be informed by a final draft protocol or summary of the study, but a full study documentation set is not expected at this stage. The invitation will provide an opportunity to start engagement and discussion with clinical and research teams across the Trust. Expressions of interest to assess potential NSFT involvement may occur prior to HRA approval being obtained if required. 5.2 Site Selection Once the sponsor has selected NSFT as a Research Site, the sponsor should send the minimum documentation set to research.review@nsft.nhs.uk. The date that the minimum documentation set is received is defined the start point for assessing, arranging and confirming capacity and capability of the research study. This start point is expected to occur after the research has submitted final versions of study documentation to HRA for approval. 5.3 Research Capacity and Capability Assessment The NSFT Research Office will conduct the following activities to formally assess feasibility of the research study, in accordance with the following procedures: a) Assessing Assessing if the Trust has the capacity and capability to participate in the study through completion of the Capacity and Capability check-list (v1.0 16 th November 2016, Appendix 1). b) Arranging Put practical arrangements into place to provide the capacity and capability to deliver the study successfully, through completion of the Study Capability Assessment tool (v1.0 16 th November 2016, Appendix 2) c) Confirming Confirm that the Trust has the capacity and capability to deliver the study to time and target, through mutual confirmation of the Statement of Activities for non-commercial studies or sign-off of a formal agreement between the Sponsor and the Trust (Appendix 3). Internal office procedures to support these activities are maintained centrally by Research Office staff. The procedures will be updated regularly to reflect new or updated legislation and frameworks. A copy of all Office procedures and templates is available upon request. 5.4 Non-Confirmation Status If NSFT Research confirms that there is no capacity and capability to deliver the study, NSFT Research will formally confirm in writing the decision and reasoning to the Sponsor organisation. If the sponsor declines the site confirmation, the sponsor is expected to email NSFT Research and the study will not proceed at the site. 5.5 Post-HRA approval procedure R&D001 Obtaining Research Approvals in the NSFT Page 4 of 9
All applications to conduct research in NSFT must be in receipt of a HRA approval letter, prior to NSFT confirming the Capacity and Capability. 5.6 Research Reporting HRA-approved studies which have received a Capacity and Capability assessment by NSFT Research will be reported on a monthly basis to the NSFT Research Committee. 6.0 Training and Updates Dedicated Training modules and hand-outs about obtaining Research approvals and management permissions are included within the NSFT Research Programme. The Research Office is also available in core office hours to answer any queries about research approvals, IRAS and review processes. Fundamental updates to legislation or guidance which affect the submission and review process for research approvals will be disseminated to all researchers through the Trust Intranet, Trust Update and through further training and communication. Implementation of the policy by researchers will be assessed on an individual study basis through standard research auditing and monitoring procedures. 7.0 Implementation Date: This policy will apply to all research studies being submitted for Capacity and Capability assessment to NSFT Research after 1 st January 2017. Studies submitted before this date will not fall under this policy retrospectively. R&D001 Obtaining Research Approvals in the NSFT Page 5 of 9
Monitoring Statement Aspects of the policy to be monitored National approval requirements, systems and procedures Monitoring method To be monitored by R&D in accordance with national publications Individual/Team responsible for monitoring Research Manager (Research and Development) Frequency Annually to be reviewed, changes monitored constantly in response to national publications. Findings: Group/Committee that will receive the findings/monitoring report Research Governance Committee Action: Group/Committee responsible for ensuring actions are completed Research Governance Committee R&D001 R&D001 Obtaining Research Approvals in the NSFT Page 6 of 9
Appendix 1: HRA : Trust Confirmation of Capacity & Capability NSFT Feasibility Checklist Study Name IRAS Number R&D Number REC Number PI/LC Portfolio? Commercial? Clinical? Int / Obs? ASSESSING Capacity and Capability Minimum Document Set received Principal Investigator or Local Collaborator required Required population to meet the recruitment target Staff available to deliver the study Site Selection Visit NSFT receiving accruals Is the Trust willing to be selected to take part in the study ARRANGING Capacity and Capability Agreement of Statement of Activities Study Specific Training Localisation of Documents Confirmation from Services involved Confirmation from outsourced services Agreement of financial arrangements Site Initiation Visit Letters of Access / Honorary Contracts Any other arrangements required CONFIRMING Capacity and Capability HRA Approval Received Fully executed Agreement / Statement of Activities Letter of Agreement between Trusts Confirmation Email of Capacity and Capability Yes/No/NA Yes/No/NA Yes/No/NA Further Information Further Information Further Information R&D001 Obtaining Research Approvals in the NSFT Page 7 of 9
Appendix 2 HRA Research Study Participating Organisation: NSFT Capability Management Tool Organisation: Short Study Name/CSP reference: Completed by: (Initials) on: DD MM YY The above study is assessed to have the following local delivery risks to the NSFT, requiring additional management or actions: Additional Management Actions Details of Additional Management/Capability Arrangements Participant Details A Potential Patient Population Have all relevant participating NSFT services been identified? B Local Targets Has a recruitment strategy been agreed to achieve target number of recruited participants and 30 day FPFV based on info available? Local Research Team C Local Research Team Has the PI and Co-Investigator(s) team been selected? Is there a local lead coordinator from NSFT Research named? D Research Training Have any additional training or support requirements been identified and agreed for the local research team? Will training be completed within target times? Study Delivery E Equipment and Facilities Are any additional equipment and clinical or research facilities required to support the study? F Pharmacy Has Pharmacy agreed to support the study, and are SOPs in place for the study? G Non-NSFT Support Services/organisations Have non-nsft Clinical support services been identified and agreed to support the study? [Are SLAs required?] Service User Considerations H Patient Safety Have all additional patient safety requirements of the study been agreed? (i.e. unblinding, on-call rotas etc) I Informed Consent Does the organisation have all relevant experience/guidance/training needed for working with any vulnerable groups as part of the study? Finance and Contracting J Finance Based on financial assessment, have additional clinical resources been agreed to cover for Excess treatment costs? Any other Concerns/Delivery Management points R&D001 Obtaining Research Approvals in the NSFT Page 8 of 9
Appendix 3 Agreement between Trust and Sponsor to confirm capacity and capability. A template of the mutual agreement documents for Commercial/Non-Commercial studies can be found through the following links: Non Commercial Studies http://www.hra.nhs.uk/resources/hra-approval-applicant-guidance/statement-activities-hra-approval/ Commercial Studies http://www.ukcrc.org/regulation-governance/model-agreements/ R&D001 Obtaining Research Approvals in the NSFT Page 9 of 9