WORKFORCE/RESEARCH & DEVELOPMENT
POLICY ON USE OF THE RESEARCH PASSPORT
Policy Manager
Tayside Medical Science Centre (TASC) R&D Manager / Policy Group
Area Partnership Forum
Policy Established
June 2010 / Policy Review Period
February 2012 / Last Updated
December 2010

UNCONTROLLED WHEN PRINTED

ContentsPage Number

  1. Introduction1
  2. Scope of Protocol and Objectives2
  3. Definitions/Glossary3
  4. Responsibilities3
  1. Key Themes4
  1. General Process4
  1. Related Information Sources6
  1. Responsibilities and Organisational Arrangements6

Appendices

Appendix 1Research Passport Algorithm of Research Activity and Pre-Engagement Checks

Appendix 2(i)Flowchart 1 Research Passport – Research at a Single Site

Appendix 2(ii)Flowchart 2 Research Passport – Research at more than one site

Appendix 2(iii)Flowchart 3 Research Passport – NHS to NHS arrangements

Appendix 3(i)Research Passport Form Version 2

Appendix 3(ii)Research Passport Form Appendix Version 2

Appendix 4Example honorary research contract and letter for university researchers - Version 1.0

Appendix 5Example letter for university researchers, where the NHS siteaccepts an existing honorary research contract - Version 1.0

Appendix6Example letter of access for university researchers who do not require an honorary research contract - Version 1.0.

Appendix 7Example NHS to NHS letter of access - Version 1.0

Appendix 8Example letter of agreement between NHS organisations - Version 1

Appendix 9Example Honorary Research contract and letter Version 2.1

Appendix 10Example Letter for University Researchers Accepting an Existing Honorary

Research Contract Version 2.1

Appendix 11Example letter of access for University researchers who do not require an honorary research contract Version 2.1

Appendix 12Example NHS to NHS Letter of Access Version 2.1

Appendix 13Example occupational health assessment questionnaire

Appendix 14Example evidence of occupational health clearance/cont.

Appendix 15Example confidentiality code of conduct

Policy/Strategy Approval Checklist

Equality and Diversity Rapid Impact Assessment

Rapid Impact Summary Sheet

1.INTRODUCTION

This protocol implements the use of the Research Passport Scheme, introduced by the UK Clinical Research Collaboration (UKCRC) to streamline NHS approval for clinical access by researchers whose substantive employment is external to NHS Tayside and a common approach to issuing honorary NHS research contracts and letters of access. Guidance is included for its implementation in NHS Tayside and for new arrangements for governance of access to NHS Tayside facilities, staff and service users for all health researchers. This has been revised in the light of updated National Institute for Health Research (NIHR) guidance:

  • Research in the NHS – HR Good Practice Resource Pack, The Research Passport: Algorithm of Research Activity and Pre-Engagement Checks Interim Update September 2010
  • Protecting Vulnerable Groups (PVG) Scheme – Guidance for Individuals, Organisations and Personal Employers June 2010.

1.2Research is an integral part of NHS activity.

  • Research identifies innovative ways of preventing, diagnosing and treating illness.
  • Research provides information on the costs, effectiveness and broader impact of health technologies.
  • Research provides the evidence base for the organisation, management and delivery of healthcare services to increase the quality of patient care, ensure better patient outcomes and contribute to improved population health.

1.3The UK Clinical Research Collaboration (UKCRC) is a partnership of organisations working to establish the UK as a world leader in clinical research by harnessing the power of the NHS. The UKCRC is working to promote a streamlined regulatory and governance environment that facilitates high quality clinical research while protecting the rights, dignity and safety of patients. As part of its activities it has coordinated the development of anHR Good Practice Resource Pack to help the NHS and other research employers take a consistent approach to handling Workforce Directorate arrangements for those undertaking research in the NHS. The Resource Pack forms the basis for this protocol and is available on the National Institute for Health Research (NIHR) website: The Pack also includes template documents including example Honorary Research Contracts, Letters of Access, Letters of Agreement with other NHS organisations and Frequently Asked Questions (FAQs). Relevant documents are included in this Policy as Appendices.

1.4Research within the NHS relies on working in partnership with the higher education sector and is often undertaken by non-NHS staff, including staff employed by Higher Education Institutions. This relationship calls for clear understanding about responsibility, accountability, patient safety and duty of care. The Research Governance Frameworks published by the UK health departments require all parties undertaking research within the NHS to be clear about responsibilities and liabilities. One of the ways this is achieved is through appropriate use of Honorary NHS Research Contracts.

1.5Inconsistency and the lack of clear guidance about the requirement for Honorary Research Contracts has meant that they have been issued inappropriately in parts of the NHS. Where they have been under-used, this has resulted in lack of clarity about liability. Where they have been over-used, this has not only wasted the resources and time of the Workforce Directorates, Research and Development Departments and researchers themselves, but has also placed inappropriate liability on NHS organisations.

1.6Duplication of pre-engagement checks and inappropriate use of Honorary Research Contracts wastes considerable amounts of time and resource for both Higher Education Institutions (HEIs) and NHS organisations. Frustration with inconsistent approaches can harm working relationships.

1.7Those involved in conducting and supporting research in the NHS fall into a number of categories:-

  • staff with substantive NHS employment contracts
  • researchers with substantive university employment and an honorary NHS clinical contract e.g. clinical academics
  • researchers with substantive university employment contracts and no honorary NHS clinical contract
  • researchers who are contracted to provide NHS services e.g. GPs who may or may not have a substantive university employment contract
  • researchers with substantive employment contracts with other employers e.g. social workers, clinical research organisations (CROs)
  • university undergraduate or postgraduate students (some of whom may also have substantive NHS employment contracts)
  • researchers in any of the above categories conducting research where the participants are NHS staff.

1.8NHS Tayside is a partner in the UK Clinical Research Network, andNHS Tayside has agreed to implement the Research Passports Scheme as part of relevant obligations. The Chief Scientist Office (CSO) within the Health Department of the Scottish Government is supporting Research Development Managers across NHS organisations to adopt an approach to implementation that is as uniform as possible to reduce inconsistencies and ensure a smooth process for NHS access for researchers.

2.SCOPE OF PROTOCOL AND OBJECTIVES

2.1This guidance applies to all research and development conducted by individuals whose substantive employment is external to NHS Tayside, or who do not hold a current honorary clinical contract with NHS Tayside.

2.2The primary objective is the implementation of the Research Passports Scheme via the adoption of the HR Good Practice Resource Pack.

3.DEFINITIONS/GLOSSARY

3.1Research Passport

Thisis one standard form for each researcher that provides evidence of one set of checks on a researcher conducting research in the NHS. The form is completed by the researcher and her/his employer and validated by a lead NHS organisation. The completed Research Passport is presented to all other relevant NHS organisations in order for an Honorary Research Contract or Letter of Access to be issued rapidly with no duplication of checks.

3.2Honorary Research Contract

Thiscontract is between the NHS organisation and the employer of the researcher. The Honorary Research Contract allows the researcher access to NHS Tayside premises, patients, clinical samples and clinical personal information.

3.3Letter of Access

This will be issued to those who do not require an Honorary Research Contract. The standard letter concerns responsibilities of such researchers and may be used for one project or a series of projects.

4.RESPONSIBILITIES

4.1NHS Tayside is responsible for:

  • ensuring the implementation and the requirements outlined within this protocol are observed and will issue an annual report from theR&D Approvals team ofTayside Medical Science Centre (TASC) and from Workforce Directorate
  • ensuring NHS Tayside directorates and the research community are made aware of the protocol and their responsibilities within it, and that staff are appropriately trained.

4.2The R&D Approvals team within Tayside Medical Science Centre (TASC) is responsible for:

  • providing a point of contact for externally employed individuals seeking to conduct research in NHS Tayside
  • assessing the need for an Honorary Research Contract from the individual’s employment status and the nature of the proposed research project or programme
  • assessing the need for a Letter of Access from the individual’s employment status and the nature of the proposed research project or programme
  • issuing a standard Letter of Access, where an Honorary Research Contract or further pre-engagement checks are not needed
  • ensuring that Research Passport applications are forwarded to the Workforce Directorate so that an Honorary Research Contract can be issued if needed
  • training TASC staff within NHS Tayside to ensure compliance through management of Research Passport applications
  • auditing NHS Tayside’s performance in using the Research Passports process to speed up researcher access to the NHS.

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4.3The Workforce Directorate is responsible for:

  • confirming all appropriate pre-engagement checks are completed for external researchers in order to complete a Research Passport when NHS Tayside is the first NHS organisation approached by the researcher for an honorary research contract
  • ensuring that an Honorary Research Contract is issued in response to a request from TASC for an external researcher where a Research Passport already exists
  • work in partnership with TASC staff within NHS Tayside to ensure compliance with the Research Passport Policy
  • work with TASC to audit compliance, in particular in the monitoring of expiry/renewal of honorary contracts.

5.KEY THEMES

5.1Implementation of the Research Passports must comply with anti-discrimination legislation and particular care should be taken not to include discriminatory conditions or requirements in relation to age, colour, disability or illness (including HIV/AIDs), ethnic origin, gender, marital status, nationality, race religion or belief, sexual orientation or social background.

6.GENERAL PROCESS

6.1The procedure for an external researcher to gain access to NHS Tayside for research will vary depending on the researcher’s employment status and the nature of the project. For all requests for access,TASC should be the first point of contact.

6.2 The researcher will provide a full protocol for their research project together with details of their employment status. TASC will then assess the need for the completing of a Research Passport (if NHS Tayside is the first NHS organisation an external researcher has approached), or more commonly an Honorary Research Contract or Letter of Access. The Research Passport template form is to be used, either for completion of a new Research Passport or, when complete, as the basis for issuing an Honorary Research Contract or Letter of Access (see Appendices). The Pre-Engagement Checks Grid (Appendix 1) and Part 1.7 of the Introduction Section to this document,detailing the requirements for different categories of staff should be used in making the judgement as to whether an Honorary Research Contract or Letter of Access is needed.

6.3If only a Letter of Access with no further pre-engagement checks is required, TASC will issue the Letter of Access using the standard template letter (see Appendices).

6.4 The procedure for processing requests for access is indicated in the flowcharts shown in Appendix2(i, ii, iii), depending on whether a single or multiple sites are involved in the research.

6.5 Researchers with a Substantive Employment Contract with one NHS organisation do not need an Honorary Research Contract to conduct research in another NHS organisation. NHS Tayside will normally allow a request for access on this basis, but additional pre-engagement checks may occasionally be required. A Letter of Access should be issued detailing the researcher’s responsibilities (see Appendices). NHS organisations allowing access should inform the researcher’s substantive employer of her/his activities in their organisations via a copy of the Letter of Access. A Letter of agreement should be put in place between NHS Tayside and the employing organisation to cover this (Appendix 8).

6.6 Researchers with an Honorary Clinical Contract with one NHS organisation do not need additional Honorary Research Contracts to conduct research in other NHS organisations. Additional pre-engagement checks may occasionally be required. NHS organisations allowing access should inform the researcher’s substantive employer of her/his activities in their organisations by way of a Letter of Access (see Appendices).

6.7Researchers with no contractual relationship with the NHS require an Honorary Research Contract, only if the planned activities of the researcher involve interacting with individuals in a way that has a direct bearing on the quality of their care i.e. the researcher could foreseeably directly affect the type, quality or extent of prevention, diagnosis or treatment of illness or foreseeably cause injury or loss to patients or service users to whom NHSTayside has a duty of care. Appendix 1 indicates how this influences the need for pre-engagement checks and the decision to seek an Honorary Research Contract. This will not apply to commercially sponsored research, where other contractual obligations are required.

6.8 Substantive employers (usually Higher Education Institutions) retain responsibility for other research activities that do not affect the NHS organisation’s duty of care.

6.9 Honorary Research Contracts do not provide a mechanism for access to confidential patient information without consent. Access to confidential patient information out-with research, which can be obtained either with patient consent or statutory support, does not require an Honorary Research Contract.

6.10 Researchers who do not require an Honorary Research Contract may require additional pre-engagement checks to undertake permitted research activities in NHS organisations.

6.11 All external researchers must have an identified NHS Tayside Supervisor providing managerial supervision for their NHS activities.

6.12 Disclosure Scotland/Criminal Records Bureau checks (if applicable)will be accepted as part of the Research Passport as a valid pre-engagement check up to a maximum of three years since the last check was completed. Researchers being employed directly from abroad will also be required to obtain a Police check from their country of origin. Guidance on when a Disclosure Scotland/Criminal Records Bureau check is required is given in Appendix 1. The Protecting Vulnerable Groups(PVG) Scheme will be managed and delivered by Disclosure Scotland, which is an agency of Scottish Government.

6.13Occupational Health screening performed by another NHS organisation will be accepted as part of the Research Passport’s pre-engagement checks up to a maximum of three years since the last check was completed without the need to routinely repeat this, unless the specific research project requires this (see Appendix 1). The HR Good Practice Resource Pack includes examples of occupational health screening documents recommended for use in processing research access requests.

7.RELATED INFORMATION SOURCES

  • UKCRC/NIHR HR Good Practice Resource Pack, available at:
  • NHS Tayside Single Equality Scheme and Action Plan 2010–2014, available at:

8. RESPONSIBILITIES AND ORGANISATIONAL ARRANGEMENTS

Details of the responsibilities across R&D (TASC) and Workforce directorate are set out separately in Working Instruction documentation, as issued by Tayside Medical Science Centre (TASC). The relevant personnel are:

  • R&D Approvals Manager/Senior Non-commercial R&D Administrator (TASC)
  • Workforce Services Manager/Workforce Assistant (Workforce Directorate).

1

APPENDIX 1

Research Passport Algorithm of Research Activity and Pre-Engagement Checks (Excerpt from HR Good Practice Resource Pack- September 2010)

APPENDIX 2 (i)

Flowchart 1 Research Passport – Research at a Single site

(Excerpt from HR Good Practice Resource Pack - September 2010)

APPENDIX 2 (ii)

Flowchart 2 Research Passport – Research At More Than One Site

(Excerpt from HR Good Practice Resource Pack - September 2010)

APPENDIX 2 (iii)

Flowchart 3 Research Passport – NHS to NHS Arrangements

(Excerpt from HR Good Practice Resource Pack - September 2010)

APPENDIX 3 (i)

Research Passport Form Version 2

Research Passport Application Form – Version 2 04/03/10

Please refer to the guidance notes before completing the form.
Section 1 - Details of Researcher
To be completed by Researcher
1. / Surname: / Prof Dr Mr Mrs
Miss Ms Other
Forename(s):
Home Address:
Work Tel: Mobile: Email:
2. / Date of birth: / Gender: Male Female
Ethnicity: / National Insurance number:
3. / Professional registration details (if applicable): N/A
4. / Employer: or place of study:
Work Address/Place of Study:
Post or status held:
Section 2 - Details of Research
To be completed by Researcher
5. / What type of Research Passport do you need? Project-specific Multi-project
If you will be conducting one project only please complete the details below. If you anticipate that you will be undertaking more than one project at any one time, please give details in the Appendix.
Project Title:
Project Start Date: End Date:
Proposed start and end date of three-year Research Passport: Start Date: End Date:
NHS organisation(s): / Dept(s): / Proposed
research activities: / Manager in NHS organisation:
Section 3 – Declaration by Researcher
To be completed by Researcher
6. / Have you ever been refused an honorary research contract? / Yes No
Have you ever had an honorary research contract revoked? / Yes No
If yes to either question, please give details:
I consent to the information provided as part of this Research Passport and attached documents being used, recorded and stored by authorised staff of the NHS organisations where I will be conducting research.
For researchers undertaking regulated activity as from July 2010, and mandatory as from November 2010: I understand that the information I have provided may be used by my employer and the NHS to access the ISA on-line service to receive updates on my ISA-registration status.
Signed: / Date:
When Sections 1-3 have been completed, the researcher should forward the form to the appropriate person to complete Section 4.
Section 4 - Suitability of Researcher
To be completed by researcher’s substantive employer, e.g. line manager, or academic supervisor
7.a / Will this person’s research activity mean that they may be undertaking regulated activity (please use the Research Passport algorithm to make this judgement) / Yes No
7. b / I am satisfied that the above named individual is suitably trained and experienced to undertake the duties associated with the research activities outlined in this Research Passport form.