RD SOP12 Research Passport Honorary Contracts / Letters of Access

RD SOP12 Research Passport Honorary Contracts / Letters of Access Version Number: V2.1 Name of originator/author: Dr Andy Mee, R&I Manager Name of responsible committee: R&I Committee Name of executive lead: Medical Director & Director of Quality Assurance Date V1 issued: July 2010 Last Reviewed: November 2016 Next Review date: July 2018 Scope: Trust wide MMHSCT Policy Code Page 1 of 15

Document Title / Ref: Lead Executive Director Author and Contact Number Type of Document Document Purpose Document Control Sheet RD SOP12 Research Passport Honorary Contracts/Letters of Access Medical Director R&I Manager 0161 276 3301 Standard Operating Broad Category Research Procedure To make all NHS / University staff involved in the preparation, administration and issue of Research Passports aware of how this must be carried out. This includes instructions for NHS and non-nhs Applicants. This SOP is in accordance with the National Guidance issued by the National Institute for Health Research (NIHR). Scope Trust-wide Version number 2.1 Consultation R&I Committee Approving Committee R&I Committee Approval Date 19 September 2016 Ratification and Date Trust Programme Board /Operational Management Team / Committee Date of Ratification 19 September 2016 V1 Valid from Date July 2010 Current version is valid from approval date Date of Last Review November 2016 Date of Next Review July 2018 Procedural Documents to be read in None conjunction with this document: Training Needs Analysis Impact There are no Training requirements for this procedural document Click here to enter text. Financial Resource Impact There are no Financial resource impacts Click here to enter text. Document Change History Changes to this document in different versions must be detailed below. Rationale for the change should also be given Version Number / Name of procedural document this supersedes 1.0 Type of Change i.e. Review / Legislation / Claim / Complaint Review Date January 2013 Details of Change and approving group or Executive Lead (if done outside of the formal revision process) 2.0 Review July 2016 Minor updates, e.g. CRB/DBS changes. External references used in the creation of this document: If these include monitoring duties upon the Trust for this policy the specific details should be recorded on the Monitoring and Compliance Requirements sheet Privacy Impact N/a Any issues? Choose an item. Assessment submitted Fraud Proofing submitted N/a Any issues? Choose an item. If not relevant to this procedural document give rationale: Page 2 of 15

Policy authors are asked to consider each of the nine protected characteristics under the Equality Act 2010. We expect you to demonstrate that throughout the policy process you have had regard to the aims of the Equality Duty: 1. Eliminate unlawful discrimination, harassment and victimisation and any other conduct prohibited by the Act; 2. Advance equality of opportunity between people who share a protected characteristic and people who do not share it; and 3. Foster good relations between people who share a protected characteristic and people who do not share it. Please provide a brief account of how you have done this, further work to be completed and any support you have had in considering the aims and working in compliance with the Equality Duty. If you are unclear on how to do this or would like further advice and support then you may contact quality.admin@mhsc.nhs.uk. It is the responsibility of the approving group to ensure this statement reflects the Trusts objectives and position with compliance as set out within the NHS Equality Delivery System In line with the Trust values we may publish this document on our External Website. Is there any reason you would prefer this is not done? It is the Authors responsibility to ensure all procedural documents comply with the Trust values If you are unclear on any of the requirements in the document control sheet then please email quality.admin@mhsc.nhs.uk before proceeding Page 3 of 15

Monitoring and Compliance Requirements Sheet For audit, Registration and NHSLA purposes all procedural documents must have monitoring requirements or key performance indicators set by the authors, Committees or Lead Directors. This allows the Trust to routinely monitor the effectiveness and impact of their procedural documents on a regular basis. Procedural Document Title: RD SOP12 Research Passport Honorary Contracts/Letters of Access Does this procedural document offer support or evidence for the Trusts registered activities and outcomes? No Primarily Additional Not Applicable Additional Is this an NHSLA Document? No Which Standard does this relate to? Governance Which Criterion Not Applicable Choose an item. Choose an item. If other Monitoring requirements are necessary i.e. Health & Safety Act and you should include them here and record them in the External References section Specify where the requirement originates Minimum Requirement / Standard / Indicator to be monitored & Section of document it appears Process for monitoring Audit Audit Audit Audit Responsible Individual / Group Additional Details i.e. Section number, Code of Practice Frequency of Monitoring Yearly Yearly Yearly Yearly Responsible Group for review of results / action plan approval / implementation Comments NB: If you have selected audit you should complete the required audit registration form and standards document and submit these with your expected timescales for completing the audit to quality.admin@mhsc.nhs.uk as soon as possible and no later than 4 weeks prior to the audit commencing. The Group / Committee should also ensure the monitoring work is added to their yearly schedule of monitoring and action logs as appropriate. Page 4 of 15

Contents Page Section Title Page Number 1 Introduction 6 2 Purpose 6 3 3.1 3.2 Roles and Responsibilities Duties within the organisation Specific to this SOP 4 4.1 4.2 4.2.1 4.2.2 4.2.3 4.2.4 4.2.5 4.3 4.4 4.4.1 4.4.2 4.4.3 4.4.4 4.5 4.5.1 4.5.2 4.6 4.7 4.8 Detail of Procedure Who needs to apply for an Honorary Contract/Research Passport? Application Process Passport Form and Guidance Completion of the Passport form Approval of Research Projects Validation of the Application HRC signatures Revisions to Research Passport Access Pre-employment checks Occupational health clearance Criminal Records Bureau Disclosure (CRBD) Foreign Nationals Students on healthcare placements Accepting a Research Passport Issued by another Trust Research Passports used to obtain a HRC at another Trust Processing a request Non-NHS Applicants who DO NOT require an Honorary Research Contract Researchers holding an NHS Contract with another Trust (Substantive or Honorary) Review, renewal and expiration 7 7 8 9 9 9 9 9 9 10 10 10 10 10 11 11 11 11 11 12 5 Equality Impact Assessment 12 6 6.1 6.2 7 7.1 7.2 Consultation, Approval and Ratification Process Consultation and Communication with Stakeholders SOP Approval Process Dissemination and Implementation Dissemination Implementation of Procedural Documents 8 8.1 8.2 Review, Monitoring Compliance With and the Effectiveness of Procedural Documents Process for Monitoring Compliance and Effectiveness Standards and Key Performance Indicators KPIs 13 13 13 9 References and Bibliography 14 10 10.1 Associated Trust Documents Table 1 - - Summary of forms of contractual arrangement available for individuals undertaking research in the NHS 6 6 7 12 12 12 13 13 13 14 15 Page 5 of 15

Introduction 1.1 The Department of Health Research Governance Framework for Health and Social Care 2005 requires that researchers not employed by an NHS organisation who interact with individuals in a way that has direct bearing on the quality of their care must hold an NHS honorary contract. 1.2 In October 2007 the Research Passport was launched nationally by UKCRC. The Passport is a proforma which is used by non-nhs employers to provide assurance to the NHS organisation that appropriate pre-employment checks have been carried out, allowing a contract to be issued. If a Passport has been used to obtain an HRC, then that contract can be accepted at other Trusts, reducing the need for multiple honorary contracts to be issued. The Guidance also highlights the potential for NHS researchers to work easily in different Trusts without the need for new employment arrangements being put in place. 1.3 MMHSCT has been using the Research Passport since the national launch and accepts Research Passports submitted from researchers employed outside the Great Manchester area. Note: All staff involved with the preparation, administration and approval of Research Passports, Honorary Research Contracts and letter of access on behalf of MMHSCT must refer to this SOP and to the national Guidance (link below): http://www.nihr.ac.uk/policy-and-standards/research-passports.htm There is a full set of guidance documents, plus the Tables referred to below and the Passport Proforma available on the above website. 2. Purpose 2.1 To make all NHS / University staff involved in the preparation, administration and issue of Research Passports aware of how this must be carried out. This includes instructions for NHS and non-nhs Applicants. This SOP is in accordance with the National Guidance issued by the National Institute for Health Research (NIHR) above. 3. Roles and Responsibilities 3.1 Duties within the Organisation 3.1.1 It is the responsibility of the Research Governance co-ordinator (or proxy) to make Trust R&I SOPs available to all research active staff working on Trust-approved research studies. 3.1.2 It is the responsibility of the study Chief Investigator (CI) or local Principal Investigator (PI) to ensure that up-to-date copies of Trust R&I SOPs are available to research staff. Page 6 of 15

3.1.3 It is the responsibility of the study Chief Investigator or local Principal Investigator to inform the Research Governance Co-ordinator of the names of all research staff involved on a study so that copies of SOPs can be distributed appropriately, and to ensure that up-to-date copies are filed in the Investigator Site file and are available to research staff. 3.1.4 It is the responsibility of the study Chief Investigator or Principal Investigator to designate if the SOPs of another organisation are to be followed for a study. For example those of a Clinical Research Network or commercial sponsor. If there is significant conflict between the external SOP and the Trust R&I SOP it is the responsibility of the CI or PI to resolve these with the Research Office prior to starting the study. 3.1.5 It is the personal responsibility of all staff to follow Trust (or the designated alternative organisations) procedural documents. 3.2 Specific to this SOP 3.2.1 Principal Investigator/Study Coordinator: To recognise individuals who are not contracted to the Trust and initiate a Research Passport application if appropriate. 3.2.2 The Applicant: To complete the Passport proforma and obtain all necessary signatures/authorisations required and to sign an HRC (if applicable) with the Trust confirming adherence to Trust rules and policies. 3.2.3 Research Governance Co-ordinator: It is the responsibility of the Research Governance co-ordinator to adhere to the guidance set out in this procedure. 3.2.4 R&I Manager: It is the responsibility of the R&I Manager to ensure that this procedure has been correctly followed by Research Office Administrators and sign the Research Passport proforma on behalf of the Trust. 3.2.5 R&I Director: It is the responsibility of the R&I Director to cover the duties set out above, in the absence of the R&I Manager. 3.2.6 Trust HRC signatories: It is the responsibility of the delegated signatory e.g. R&I Manager & R&I Director to ensure that the HRC is completed correctly prior to signing the contract. 4. Detail of Procedure 4.1 Who needs to apply for an Honorary Contract/Research Passport? The Table within the national guidance document The Research Passport information for researchers: http://www.nihr.ac.uk/policy-and-standards/research-passports.htm (which is now defined as Table 1 for the purposes of this SOP) outlines whether a Research Passport and/or Honorary Research Contract (HRC)/Letter of Access is required. Page 7 of 15

At MMHSCT, where an HRC is not required and the applicant is working on Trust premises, a Research Passport is still necessary to confirm the applicant s identity and credentials. A letter of access would be issued with the Research Passport if this is the case. Researchers must provide a satisfactory Disclosure and Barring Service (DBS) certificate. 4.1.1 Who doesn t need to apply for a Research Passport? Those employed by an NHS organisation Independent contractors (e.g. GPs) or employed by an independent contractor Those having an honorary clinical contract with the NHS (e.g. clinical academics) Students who will be supervised within clinical settings by an NHS employee or HE staff member with an honorary clinical or research contract The research being carried out does not require any checks or honorary research contract. Whether an HRC is required or not, each applicant must be reviewed and assessed in terms of their normal role, relevant experience, supervision and pre-employment checks required. Note: Section 4.7 provides instructions on how to process requests for access by NHS contract holders. 4.1.2 Those who MAY need a HRC (subject to Table 1) Non NHS employed Researchers Note: use the same principles for researchers using the Wellcome Trust Clinical Research Facility (WTCRF) whether they are seeing patients, users or healthy volunteers. 4.2 Application Process After referring to the previous section, and Table 1, to ascertain if a Research Passport application is appropriate, researchers must complete and submit the Research Passport form for authorisation to their employer, line manager and then to the Trust for review and signature. 4.2.1 Passport Form and Guidance The form and guidance are available in electronic format via the R&I office or directly from the national guidance pages detailed above. Note: Applicants also must to adhere to MMHSCT s enhanced DBS requirements. The Research Passport form must be submitted with: The original DBS (if applicable), within 3 years of issue Evidence of Occupational Health screening (if applicable) An up-to-date CV Page 8 of 15

4.2.2 Completion of the Passport form The Principal Investigator/Study Coordinator will initiate the completion of the Passport proforma with the Applicant. The Passport must be completed up to and including Section 6. This includes signatures by the Applicant, by the Line Manager and by representatives from the Employer of the Applicant. Educational supervisors and line managers (within the University) can also sign Section 5 to show that the necessary pre-engagement checks have been obtained. Appendices should be completed when there are a number of studies, or additional studies after the Research Passport has been issued. Forward the completed Passport with original documents to the Research Office in the Trust. 4.2.3 Approval of Research Projects All Research Passport applications will refer to one or more research projects. These projects must be approved by the Trust prior to any research activities commencing on Trust premises (see RD SOP4 Research Approval Process and RD SOP22 Approval Procedure for Clinical Trials of Investigational Medicinal Products) and therefore Research Passports may be issued simultaneously with or subject to receiving R&I approval. 4.2.4 Validation of the Application If the Research Passport is completed correctly, signed by the appropriate personnel and is accompanied by the above enclosures (as required), this is a valid submission and can be processed. Otherwise, the Research Office will notify the Applicant as soon as possible. The Research Office will contact the Applicant for additional information as required, and will forward three copies of an unsigned Honorary Research Contract for signature to the applicant and request two copies are returned for Trust signature. 4.2.5 HRC signatures The Applicant must sign the HRC to confirm agreement to adhere to Trust rules and policies. Two copies must be returned to the Research Office to progress the HRC. The HRC will not become active until the review of the application is complete and a fully signed Research Passport and fully signed HRC has been issued by the Research Office to the Applicant. Appropriate Trust signatories are the R&I Manager and R&I Director. 4.3 Revisions to Research Passport Access Access to the Trust and/or patients will be on the basis described in the Passport Application and any changes (additional projects within the Trust) must be discussed with the Research Office, and using the Research Passport Appendix to revise the signed Passport. Page 9 of 15

4.4 Pre-employment checks Refer to Table 1 for a summary of the pre-employment checks required (e.g. DBS and occupational health), and also take into account MMHSCT s requirements relating to enhanced DBS: Note: Pre-employment checks may still be required for researchers who do not need an HRC. 4.4.1 Occupational health clearance This is required for those who will interact directly with patients as part of their normal duties. For non-nhs employed researchers, where occupational health screening is required, this must be arranged with the employer s Occupational Health Department. NHS employees must have received appropriate OH checks on employment, unless deemed appropriate by the HR Advisor, this check would normally suffice. (Refer to Section 4.7). 4.4.2 Disclosure and Barring Service (DBS) checks A clear, valid DBS (within 3 years of issue) is required for all those who will have access to, or contact with, patients. The original DBS must be enclosed with the Passport application (dated within 6 months for the NHS organisation issuing a Passport/HRC or letter of access). Any researchers wishing to work at MMHSCT must provide a satisfactory enhanceddbs, whether they will be working in a clinical area or not and regardless of whether they will have patient contact.. The original DBS must be seen by the HRC Issuer and a copy retained by the Trust for 1 month only before being destroyed. Information may only be shared between organisations with the consent of the disclosure by the applicant. 4.4.3 Foreign Nationals The Trust requires foreign nationals to have a DBS (or similar) issued by their country, within 3 years prior to the application. Additionally, if they have been living in this country more than 1 week a DBS from this country is required. 4.4.4 Students on healthcare placements These must provide an appropriate level of DBS disclosure when they start working in the NHS, although the level of supervision must be taken into account if their role has changed. Page 10 of 15

4.5 Accepting a Research Passport Issued by another Trust 4.5.1 Research Passports used to obtain a HRC at another Trust These must be submitted to the new Trust with the following: copy of research passport form (authorised by an R&I Lead) copy of fully signed HRC a current CV completed Research Passport Appendix outlining details of the project, the local supervisor/liaison and the Applicant s role in the project 4.5.2 Processing a request The passport form must be reviewed by the HRC Administrator to ascertain level of DBS check and confirm that OH checks were carried out. The checks must be appropriate to the level of involvement of the Applicant in the project at MMHSCT. If the researcher does not have an enhanced DBS check, the Applicant must apply for an enhanced DBS through their employer. If pre-employment checks are satisfactory the Research Office will write to the Applicant with reciprocal agreement for access to the Trust and/or its patients/staff. 4.6 Non-NHS Applicants who DO NOT require an Honorary Research Contract Some Applicants may be carrying out low risk research or their involvement in the research project may not have any impact on the care provided to the patients involved. Table 1 must be used to establish if this is the case. At MMHSCT there are enhanced DBS requirements. The Research Passport process is still completed in the same way, however, the HRC Administrator will not offer an Honorary Research Contract, but will issue a Letter of Access to the Trust outlining the conditions of access, who the Applicant will report to within the Trust and confirming that the Employer of the Applicant retains the liability for the Applicant s actions. 4.7 Researchers holding an NHS Contract with another Trust (Substantive or Honorary) These researchers do not require an Honorary Research Contract and must not be processed using a Research Passport, but a letter of authorisation from the employing Trust must be submitted to the Research Office with a copy of the researcher s CV. This letter must state the following: The applicant is employed by the NHS Trust concerned. The applicant has the necessary skills and experience to carry out their project duties The applicant has received the necessary pre-engagement checks on Appointment (not necessarily in the last 6 months) including Occupational Health clearance and enhanced DBS (as required). Page 11 of 15

If the level of access required differs from the employee s usual role, i.e. they have not received DBS or enhanced DBS then the Applicant may be required to apply for an enhanced DBS check, and/ or undergo additional Occupational Health checks or may be required to undergo additional training and/ or supervision. If the arrangements are acceptable after review, a letter will be issued to the Applicant, copied to their local liaison and to their employer. 4.8 Review, renewal and expiration The maximum duration of a Research Passport is three years. If a researcher requires a Research Passport for longer than this, a repeat application should be completed and the relevant checks should be re-assessed. This is in line with the advice on arrangements for highly mobile NHS staff groups, where criminal record and other appropriate checks should be undertaken at three-yearly intervals. Applicants must start their renewal application at least 2 months prior to the expiry date (a reminder will be sent by the Research Office (see RD SOP2 Research Database), the Applicant must contact the Research Office to confirm if they will need their HRC or letter of access extending. If the Applicant s role has changed this may mean re-application for enhanced DBS and/or Occupational Health Clearance. Once an HRC has expired, a letter will be sent to the Researcher, and their immediate line manager, from the Research Office confirming that access to the Trust and/or its staff or patients, for the purposes of research, is denied. Receipt of this letter must be confirmed to the Research Office. 5 Equality Impact Assessment 5.1 This SOP has been equality impact assessed by the author using the Trust s Equality Impact Assessment (EqIA), which has been submitted to the Equality and Diversity Department for Service Equality Team Sign Off. 5.2 No significant issues in relation to equality, diversity, gender, colour, race or religion are identified as raising a concern. 6 Consultation, Approval and Ratification Process 6.1 Consultation and Communication with Stakeholders All Trust R&I SOPs are written by a member of the Research Office staff with relevant expertise and experience. Additional advice is sought from members of the research community within the Trust, including the R&I Operational Group, R&I Committee, or external advisors, as necessary. 6.2 SOP Approval Process All Trust Wide Research Office SOPs are subject to approval by the R&I Committee. The SOP will then be sent to the Trust Management Board for ratification. Page 12 of 15

7 Dissemination and Implementation 7.1 Dissemination 7.1.1 When approved, this SOP will be made available through the Trust Research Office website and Q-Pulse. The Trust intranet will contain a link to direct staff to the approved SOPs on the external website. Only the current version will be available. 7.1.2 All researchers listed on the Research Office active researcher mailing list will be notified by email when an updated version of an SOP is available. 7.2 Implementation of Procedural Documents 7.2.1 Support and advice on the implementation of this SOP can be obtained via the Research Office. 8 Review, Monitoring Compliance With and the Effectiveness of Procedural Documents 8.1 Process for Monitoring Compliance and Effectiveness 8.1.1 Review will be undertaken by the Research Office Management. Compliance with the Research Office Trust-wide SOPs by researchers will be monitored via the Trust s Research Governance Monitoring Programme where appropriate. 8.1.2 SOP contents will be reviewed against any changes to the applicable guidelines and regulations and taking into account any feedback received from researchers or via the Monitoring Programme. 8.1.3 Review and monitoring will be conducted based on an initial risk assessment of the project. This process may change based on results on any monitoring visit. 8.1.4 The outcome of the review and any resulting amendments - will be reported to the Research & Innovation Committee. 8.2 Standards and Key Performance Indicators KPIs 8.2.1 This SOP will be available on the Trust website and Q-Pulse. 8.2.2 This SOP must be reviewed at least every two years or when there are significant changes to the document. Page 13 of 15

9 References and Bibliography Department of Health Research Governance Framework for Health and Social Care 2005 http://www.nihr.ac.uk/publications/pages/default.aspx http://www.nihr.ac.uk/policy-and-standards/research-passports.htm 10 Associated Trust Documents RD SOP2 Research Database RD SOP4 Research Approval Process (including amendments) RD SOP22 Approval Procedure for Clinical Trials of Investigational Medicinal Products (CTIMPs) Page 14 of 15

10.1 Table 1 - Summary of forms of contractual arrangement available for individuals undertaking research in the NHS This table only applies to researchers who may need a Research Passport. Highlighted activities require a Research Passport. The NHS organisation hosting the research will confirm: if you require a Research Passport; if you require an honorary research contract; and which checks you need. Type of research activity researcher will be conducting Direct contact with patients/service users and providing prevention, diagnosis or treatment of illness (not children or vulnerable adults) Direct contact with children or vulnerable adults and providing prevention, diagnosis or treatment Direct contact with patients/service users but not providing prevention, diagnosis or treatment (e.g. observer) Indirect contact with patients/service users and providing prevention, diagnosis or treatment (e.g. some types of telephone interviews) Honorary research contract Criminal record check necessary? necessary?# Yes Yes, standard or enhanced Yes Yes, standard or enhanced No Yes, standard or enhanced Yes Yes, standard or enhanced Occupational health clearance necessary? Yes Yes Yes No Indirect contact with patients/service users but not providing prevention, diagnosis or treatment (e.g. some telephone interviews, postal questionnaires) Access to identifiable patient data, tissues or organs with likely impact on prevention, diagnosis or treatment Access to identifiable patient data, tissues or organs with no likely impact on prevention, diagnosis or treatment Access to anonymised patient data, tissues or organs only (including by research staff analysing data) Working on NHS premises (e.g. laboratory) only No No No Yes No No No No No No No No No No In some situations Direct contact with staff (e.g. interviews) No No No Access to identifiable staff data No No No Access to anonymised staff data only No No No Page 15 of 15