research passports and letters of access document number:...

SOP 002: Research Passports and Letters of Access


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Research Passports and Letters of Access

Document Number: 002

Version: 1

Ratified by: RFL R&D Committee

Date ratified: 03.06.2014

Name of originator/author: Liba Stones, R&D Manager

Directorate: Medical Directorate

Department: Research and Development

Name of responsible individual: Liba Stones, R&D Manager

Date issued: 01.07.2014

Review date: 30.06.2014

Target audience: All Trust staff and external researchers

Intranet:

Key related documents: RFL SOP006 Roles and Responsibilities for the Conduct of Research Studies

This document supports:

Standards and legislation

Research in the NHS – Human Resources Good Practice Resource Pack (NIHR, 2010, v.2.0)

Research Governance Framework for Health and Social care (2005, 2nd ed.)

Date equality analysis completed. 02.06.12

This is a controlled document Whilst this document may be printed, the electronic version maintained on the RFL website is the controlled copy. Any printed copies of this document are not controlled.



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Version Control

Version Date Author Status Comment



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Contents

Section Page

1 Introduction 4

2 Objective 4

3 Definitions 4

4 Equality statement 5

5 Duties 6

6 Details of procedure 6

7 Policy 9

8 Risk management/liability/monitoring & audit 9

9 Forms/templates to be used 9

Appendices

Appendix 1 SOP reading log 10

Appendix 2 Research Passport application process (RFL as the Lead NHS Site)

11

Appendix 3 LoA / HRC pathway 12

Appendix 4 Equality analysis guide and tool 13



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1. INTRODUCTION

Research within the NHS is often undertaken by NHS staff not directly employed by the host NHS organisation, or by non-NHS staff, particularly researchers employed by universities. A clear process for handling contractual HR arrangements for external researchers who require access to the Royal Free London NHS Foundation Trust (RFL) premises, patients and patient data is needed to ensure that the issues of responsibility, accountability, patient safety and duty of care are appropriately addressed and that all parties undertaking research at RFL are clear about their responsibilities and liabilities.

2. OBJECTIVE

This document defines the Trust’s research SOP for issuing honorary research contracts and letters of access to researchers external to the Trust. This SOP implements the Research Passport Scheme via the adoption of the Research in the NHS – HR Good Practice Resource Pack (Version 2.0, February 2010) and the related guidance which is available from: http://www.nihr.ac.uk/systems/Pages/systems_research_passports.aspx The Resource Pack describes the Research Passport system, which offers a standard approach to issuing NHS honorary research contracts (HRCs) to those who have no employment contract with the NHS, and who need to undertake their research activities in the NHS. The Resource Pack also provides clear guidance regarding good HR practice for those who already have a contractual relationship with the NHS (i.e. those with either a substantive employment contract or honorary clinical contract) and who need to undertake their research activities across several NHS organisations.

This SOP identifies the groups of staff covered by the Research Passport scheme and the NHS to NHS arrangements for sharing and accepting pre-engagement checks. It describes the RFL procedure and responsibilities for:

The administration and oversight of the Research Passport scheme, Honorary Research Contracts (HRCs) and Letters of Access (LoAs).

Making applications for HRCs and LoAs under the Research Passport scheme. This procedure is applicable to the employees of Higher Education Institutions (HEI) with no contractual arrangements with the NHS who wish to undertake research within the RFL.

Making applications for LoAs as part of the NHS to NHS arrangements for sharing and accepting pre-engagement checks. This procedure is applicable to staff employed by other NHS organisations who wish to undertake research within the RFL.

Notifying the R&D Department of any changes to research teams and any changes in the circumstances of researchers that may have an impact on their suitability to conduct research.

http://www.nihr.ac.uk/systems/Pages/systems_research_passports.aspx



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3. DEFINITIONS

3.1 Higher Education Institution (HEI) University or College employing the researcher who wishes to undertake research within the NHS where there is no existing contractual arrangement in place.

3.2 Honorary Research Contract (HRC) The document which defines the terms and conditions applicable to a Higher Education Institution (HEI) employee with no contractual arrangements with the NHS organisation who plans to undertake research which requires access to patients and identifiable patient data and has a direct bearing on the quality of patient care (e.g. provision of healthcare, personal care and guidance on well-being).

3.3 Lead NHS Site The Lead NHS Site is the first NHS Trust that received application under the Research Passport scheme.

3.4 Letters of Access (LoA) (a) The document which confirms the extension of NHS terms of employment for an

NHS employee undertaking research in another NHS organisation. (b) The document which defines the terms and conditions applicable to a HEI

employee with no contractual arrangements with the NHS who plans to undertake research which requires access to NHS premises or access to patients and patient data with no direct bearing on the quality of care (e.g. qualitative interviews, focus groups, on-site analysis of patient data)

3.5 NHS to NHS Confirmation of Pre-engagement Checks Form

The document used to collect the information required to issue a LoA to an existing NHS employee undertaking research in an NHS site different to where their employment contract is held. The form is completed by the researcher’s employer.

3.6 Research Passport form The document used to collect the information required to issue an HRC or LoA for a HEI employee with no contractual arrangements with the NHS organisation where they plan to undertake research.

4. EQUALITY STATEMENT

The Royal Free London NHS Foundation Trust is committed to creating a positive culture of respect for all individuals, including job applicants, employees, patients, their families and carers as well as community partners. The intention is, as required by the Equality Act 2010, to identify, remove or minimise discriminatory practice in the nine named protected characteristics of age, disability (including HIV status), gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex or sexual orientation. It is also intended to use the Human Rights Act 1998 to treat fairly and value equality of opportunity regardless of socio-economic status, domestic circumstances, employment status, political affiliation or trade union membership, and to promote positive practice and value the diversity of all individuals and communities.

This document forms part of the trust’s commitment. You are responsible for ensuring that the trust’s policies, procedures and obligation in respect of promoting equality and diversity are adhered to in relation to both staff and service delivery.

The equality analysis for this SOP is attached at Appendix 4.



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5. DUTIES

The Trust is committed to the delivery of world class care and expertise to both staff and patients, and our values of positively welcoming, actively respectful, visibly reassuring and clearly communicating are fundamental to the delivery of this. This policy has been developed with our values in mind, and is intended to be implemented within the spirit of these values.

The Trust is committed to the delivery of world class care and expertise to both staff and patients, and our values of positively welcoming, actively respectful, visibly reassuring and clearly communicating are fundamental to the delivery of this. This policy has been developed with our values in mind, and is intended to be implemented within the spirit of these values.

This SOP applies to the Royal Free R&D Department, all external staff applying to conduct research at the Trust and those already conducting research under the remit of an existing Honorary Research Contract (HRC) or Letter of Access (LoA), Trust Principal Investigators, and any study related Co- Investigators and Research Supervisors.

5.1 The Royal Free R&D Department The RFL R&D Department will provide a single point of contact for external researchers wishing to conduct research within the Royal Free London Hospital NHS Foundation Trust (RFL). The R&D Department will assess the need for a Research Passport or Letter of Access (NHS) based on the individual’s employment status; assess the need for pre‐engagement checks based on the nature of the proposed research project or programme and also the appropriateness of pre‐engagement checks already conducted by the researcher’s substantive employer; process access applications; issue the relevant contractual documents and maintain records and oversight of the Research Passport scheme and Letters of Access.

5.2 External researchers

External researchers are responsible for applying to the RFL R&D Department to obtain access to the Trust premises, patients and patient data. Researchers issued with LoAs and HRCs are responsible for observing the terms and conditions of their contractual documents and notifying the Trust R&D Department of any changes in their circumstances that may have an impact on their suitability to conduct research (e.g. changes in employment status, registration status and criminal record).

5.3 Trust Principal Investigators and any study related Co-Investigators and Research

Supervisors The Trust Principal Investigators, Co-Investigators at sites and Research Supervisors are responsible authorising the issue of HRCs and LoAs for external staff and for notifying the R&D Department of any changes to research teams and any changes in the circumstances of researchers that may have an impact on their suitability to conduct research.



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6. DETAILS OF THE PROCEDURE

6.1 NHS staff and staff with honorary NHS contracts (‘Clinical Academics’)

The substantive employing organisation will complete all necessary pre-engagement checks in line with NHS Employers' pre-engagement check standards.

The applicant will complete the ‘NHS to NHS confirmation of pre-engagement checks’ form. All current application forms can be accessed at: http://www.nihr.ac.uk/systems/Pages/systems_research_passports.aspx

The applicant will contact the HR Department of their substantive employing NHS organisation to sign the form and submit the signed form to the RFL R&D Department. A copy of the applicant’s most recent CV must be provided alongside the application.

For staff with honorary NHS contracts (‘Clinical Academics’), the Trust holding the honorary clinical contract may need to liaise with the substantive HEI employer in order to issue the signed pro-forma confirmation of pre-engagement checks.

The R&D Department will: o Contact the Principal Investigator, site Co-Investigator or Research Supervisor

asking them to accept responsibility for the researcher when on site. o Ensure that NHS Permission has been granted for the research study. o Issue ‘NHS to NHS LoA’ to the researcher. o A copy of the ‘NHS to NHS LoA’, accompanied by a copy of the proforma

confirming completion of pre-engagement checks, will be sent to the researcher’s employer.

6.2 HEI researchers

6.2.1 HEI researchers applying for their first Research Passport and HEI researchers

applying to renew an expired Research Passport where RFL is the Lead NHS Site

The applicant will complete the latest Research Passport form (Sections 1, 2, 3 & 6) available at: http://www.nihr.ac.uk/systems/Pages/systems_research_passports.aspx

The form must be signed by the applicant’s Supervisor/Manager (Section 4) and the HR representative of their HEI employer (Section 5). Section 7 should be completed by the HR in the Lead NHS organisation (here RFL), only if additional checks are undertaken.

The applicant will present the Research Passport form with all the accompanying documentation to the RFL R&D Department for review and validation.

The RFL R&D Department will: o Review the submitted documents ensuring that the type and/or degree of

pre-engagement checks are commensurate with the role of the researcher and the type of research activity. If additional checks are required for the purpose of the research, it is the responsibility of the applicant’s substantive employer to arrange for these to be undertaken. The researcher should re-submit a new research passport form with these confirmed by their employer.

o Contact the Principal Investigator, site Co-Investigator or Research Supervisor asking them to accept responsibility for the researcher when on site.

o Ensure that NHS Permission has been granted for the research study.

Once all appropriate pre-engagement checks are confirmed and the supervisor has accepted responsibility for the researcher on site, the R&D Department will:

o Validate the Research Passport form (Section 8)





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o Issue either an HRC or LoA, depending on the nature of the research activity (See Appendix 3).

o Take a photocopy of the completed form and attachments to provide an auditable system for their records.

o Return the Research Passport form and along with the HRCs or LoA to the researcher.

o If an HRC is required, 4 signed copies should be sent to the researcher, with a request for them to return 3 copies back to the R&D department. When they are returned a copy should be sent to Human Resources, a copy to their Substantive employer and a copy filed in R&D.

o If a LoA is issued, this should be copied to Human Resources of the applicant’s substantive employer.

The applicant is required to retain the original Research Passport so that it can be used for subsequent applications to conduct research in other NHS organisations.

6.2.2 HEI researchers with a current validated Research Passport (RFL as a host site)

Unless a new check is required due to a change in activity, the existing pre-engagement checks remain acceptable. There will be no requirement to undertake a new enhanced level CRB disclosure, until the current Research Passport requires renewal.

Where RFL is being added as a site, but the activity is similar to the activity for which the Research Passport was validated then the researcher should submit the already validated form and supporting documentation to the R&D Department.

The applicant will present the validated Research Passport form and their most recent CV to the RFL R&D Department.

The RFL R&D Department will o Review the Research Passport ensuring that the type and/or degree of

pre-engagement checks are commensurate with the role of the researcher and the type of research activity. If additional checks are required for the purpose of the research, it is the responsibility of the applicant’s substantive employer to arrange for these to be undertaken. The researcher should re-submit a new research passport form with these confirmed by their employer.

o Process the application on the basis of the validated Research Passport. The R&D Department will not routinely require the original supporting documents for review. The original supporting documents might be requested for high-risk studies as advised by the RM&G Manager/Deputy R&D Director.

o Contact the Principal Investigator, site Co-Investigator or Research Supervisor asking them to accept responsibility for the researcher when on site.

o Ensure that NHS Permission has been granted for the research study.

Once all appropriate pre-engagement checks are confirmed and the supervisor has accepted responsibility for the researcher on site, the R&D Department will:

o Complete Section 8 of the Research Passport form. o Issue either an HRC or LoA, depending on the nature of the research

activity (See Appendix 3). o Take a photocopy of the completed form and attachments to provide an

auditable system for their records. o Return the Research Passport form and along with the HRCs or LoA to

the researcher. o If an HRC is required, 4 signed copies should be sent to the researcher,

with a request for them to return 3 copies back to the R&D department.



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When they are returned a copy should be sent to Human Resources, a copy to their Substantive employer and a copy filed in R&D.

o If a LoA is issued, this should be copied to Human Resources of the applicant’s substantive employer.

6.2.3 Changes in role affecting the checking requirements

If an individual is already research active under a current validated Research Passport and there is a significant change in the research activity e.g. moving to a position where their research involves direct contact with children where previously they worked only with adults, or a direct impact on care, where previously there was none, the individual will need to complete the new Research Passport Form.

If changes only relate to occupational health requirements, the appropriate additional checks should be undertaken and the existing Research Passport Form updated as described in the Resource Pack and new details provided to all host sites.

6.3 Staff not covered by the Research Passport scheme

Commercial research staff will not be given a Research Passport, or be issued with an HRC or LoA or any other document that could be construed as indicating that the NHS organisation is accepting liability for their actions.

RFL will not extend HRC’s to independent contractors if they are conducting research as part of their NHS practice.

Independent contractors who undertake research under separate contract with the NHS will be dealt with as NHS staff as appropriate to the individual circumstances.

Independent contractors who undertake research under separate contract with an HEI will be dealt with as HEI staff as appropriate to the individual circumstances.

Students conducting research as part of their healthcare placements do not required HRCs or LoAs.

6.4 Further provisions

Substantive employers will retain responsibility for other research activities that do not affect the Trusts duty of care to a participant, i.e. study management, data entry.

Honorary Research Contracts do not provide a mechanism for access to confidential patient information without consent from the participant. The necessary regulatory approvals must be in place to access data without consent.

Honorary Research Contracts and Letters of Access will not be issued for a period that will exceed the remainder of the life of the researcher’s substantive contract, the researcher’s right to reside and work in the United Kingdom or 3 years after the CRB was issued.

External researchers must wear their ID badge at all times while on the Trust premises. External researchers issued with an HRC must contact the Royal Free R&D Department once the contract is signed to arrange for Royal Free ID badge to be issued.

7. POLICY

This SOP is mandatory and non-compliance with it may result in disciplinary procedures.



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8. RISK MANAGEMENT/ LIABILITY/MONITORING & AUDIT

The SOP Working Group will ensure that this SOP and any future changes to this document are adequately disseminated.

The R&D Department will monitor adherence to this SOP via the routine audit and monitoring of individual clinical trials and the Trust’s auditors will monitor this SOP as part of their audit of Research Governance. From time to time, the SOP may also be inspected by external regulatory agencies (e.g. Care Quality Commission, Medicines and Healthcare Regulatory Agency).

In exceptional circumstances it might be necessary to deviate from this SOP for which written approval of the RM&G Manager/Deputy R&D Director should be gained before any action is taken.

SOP deviations should be recorded including details of alternative procedures followed and filed in the Investigator and Sponsor Master File.

The Research and Development Directorate is responsible for the ratification of this procedure.

9. FORMS/TEMPLATES TO BE USED

All current application forms can be accessed at: http://www.nihr.ac.uk/systems/Pages/systems_research_passports.aspx




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APPENDIX 1

SOP Reading Log

READ BY

NAME TITLE SIGNATURE DATE



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APPENDIX 2

Research Passport Application Process (RFL as the Lead NHS Site)

The Applicant completes the Role Assessment Form - sections 1, 2, 3 & 6 of the Research Passport form.

The Supervisor/Manager of the research project

completes section 4 of the Research Passport form.

The RFL HR Department: completes section 7 of the

Research Passport form only if additional checks are

undertaken.

The R&D Department: reviews the application, validates the Research

Passport form, contacts Trust PI, Co-Investigator and/or Research Supervisor for

authorisation, checks that NHS permission has been granted, and issues LoA or

HRC.

The HEI HR Department: completes section 5 of the Research Passport form.



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APPENDIX 3

LoA / HRC pathway

No

Does the research involve indirect contact with patients?

Yes No

Does an applicant’s research involve direct access to patients or service users?

No Yes

Will the applicant have access to identifiable

data/tissue?

LoA required Will there be an impact on patient’s care?

No

LoA required

Yes

HRC required

Will there be an impact on patient’s care?

No

LoA required

Yes

HRC required

Yes

Does the research have a direct impact on the patient’s care?

(Providing diagnosis and/or treatment)

No Yes

HRC required LoA required



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APPENDIX 2

Royal Free London NHS Foundation Trust Equality Analysis guide and Tool

An equality analysis is a review of a policy, practice, function, business case, project or service change which establishes whether there is a negative effect or impact on particular social groups. This In turn enables the organisation to demonstrate it does not discriminate and, where possible, it promotes equality to meet the needs of the diverse patients and communities we serve.

This check list is a way to help you think carefully about the likely impact on equality groups and take action to improve services. This is also an opportunity to evidence positive practices in our services and demonstrate strategic integrity to ensure that our services and employment practices are fair, accessible and appropriate for all patients, visitors and carers, as well as our talented and diverse workforce.

Name of the policy / function / service development being assessed Standard Operating Procedure for Research Passports and Letters of Access

Briefly describe its aims and objectives: This document defines the Trust’s research SOP for issuing honorary research contracts and letters of access to researchers external to the Trust.

Directorate and Lead:

Medical Directorate, Liba Stones, R&D Manager

Evidence sources: DH, legislation. JSNA, audits, patient and staff feedback

Research in the NHS – Human Resources Good Practice Resource Pack (NIHR, 2010, v.2.0)

Research Governance Framework for Health and Social care (2005, 2nd ed.)

Is the Trust Equality Statement present?

Yes if no do not proceed with Equality Analysis (EA)



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If you are conducting an EA on a procedural document please identify evidence sources and references, who has been involved in the development of the document, process or strategy, and identify positive or negative impacts. It is the discussion regarding the equality impact of the document that is important.

Equality Analysis Checklist

Go through each protected characteristic below and consider whether the policy, practice, function, business case, project or service change could have any impact on groups from the identified protected characteristic, involve service users where possible and get their opinion, use demographic / census data (available from public health and other sources), surveys (past or maybe carry one out), talk to staff in PALS and Complaints and Patient Experience.

Please ensure any remedial actions are Specific, Measureable, Achievable, Realistic, and Timely ( SMART).

Equality Group Identify negative impacts

What evidence, engagement or audit has been used?

How will you address the issues identified?

Identifies who will lead the work for the changes required and when?

Please list positive impacts and existing support structures

Age

None identified R&D

administrative document

N/A N/A

Disability

None identified R&D administrative

document

N/A N/A

Gender Reassignment


document

N/A N/A

Marriage and Civil Partnership


document

N/A N/A

Pregnancy and maternity


N/A N/A



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Equality Group Identify negative impacts

What evidence, engagement or audit has been used?

How will you address the issues identified?

Identifies who will lead the work for the changes required and when?

Please list positive impacts and existing support structures

document

Race


document

N/A N/A

Religion or Belief


document

N/A N/A

Sex


document

N/A N/A

Sexual Orientation


document

N/A N/A

Carers


document

N/A N/A

It is important to record the names of everyone who has contributed to the policy, practice, function, business case, project or service change.

Equality Analysis completed by: (please include every person who has read or commented and approval committee(s). Add more lines if necessary)

Organisation Date

SOP Development Group Royal Free London NHS Foundation Trust 21.05.2014

R&D Committee Royal Free London NHS Foundation Trust 03.06.2014

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