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Northumberland, Tyne and Wear NHS Foundation Trust RGP-PGN-04 – Honorary Research Contract Process – V01 – Issue 1 – Issued Dec14 Part of NTW(O)47 – Research Governance Policy

Research Governance Policy Practice Guidance Note

Honorary Research Contract Process - V01

Date Issued Planned Review PGN No:

Issue 1 – Nov 14 November 2017 RGP-PGN-04

Part of NTW(O)47 – Research

Governance policy

Author/Designation Simon Douglas - Senior Manager for Research Innovation and

Clinical Effectiveness

Responsible Officer

/ Designation Dr. D. Gee - Medical Director

Contents

Section Description Page No

1 Introduction 1

2 Purpose 1

3 Procedure 1

3.2 Honorary Research Contracts (HRC) 2

3.3 Letter of Access (LoA) 2

3.4 Research Passport Scheme 2

3.5 NHS to NHS Engagement 3

3.6 Categories of Researchers 4

3.6.2 Staff with substantive NHS employment contracts (Group 5)

(Including the process flowchart)

4

3.6.3 Researchers with substantive university contract and an honorary NHS contract (Group 2) (Including the process flowchart)

5

3.6.4 Researchers with substantive university employment contracts and no honorary NHS clinical contract (Group 1)

(Including the process flowcharts for HRC and LoA)

6

3.6.5 Researchers who are contracted to provide NHS services (Group 6)

7

3.6.6 Researchers with other substantive employment contracts (Group 6)

8

3.6.7 Undergraduate or postgraduate students (Groups 3 and 4)

(Including the process flowcharts for HRC and LoA)

8

3.6.8 Researchers conducting research where the participants are NHS staff

10

3.6.9 NTW employed researchers (Including the process flowchart) 10

3.6.10 Northern Deanery Doctors (Including the process flowchart) 11

3.6.11 Service User/Carer Researchers (Including the process flowchart)

11

4 NTW Site/Service Visits 12

5 References 12

6 Related documents 12

Northumberland, Tyne and Wear NHS Foundation Trust 2 RGP-PGN-04 – Honorary Research Contract Process – V01 – Issue 1 – Nov14 Part of NTW(O)47 – Research Governance Policy

Appendices – listed separate to PGN

Document No:

Description Issue Issue Date

Review date

Appendix 1 Summary of forms of contractual arrangements available for individuals undertaking research in the NHS

1 Nov 14 Nov 17

Appendix 2 NHS to NHS proforma confirmation of pre-engagement checks form

1 Nov 14 Nov 17

Appendix 3 Research Passport Application form 1 Nov 14 Nov 17

Appendix 4 Researcher access application form 1 Nov 14 Nov 17

Northumberland, Tyne and Wear NHS Foundation Trust RGP-PGN-04 – Honorary Research Contract Process – V01 – Issue 1 – Nov 14 Part of NTW(O)47 – Research Governance Policy

1

1 Introduction 1.1 The Research Governance Framework for Health and Social Care published by

the Department of Health requires all parties undertaking research within the NHS to be clear about their responsibilities and liabilities in relation to research. The underlying principles for issuing an honorary research contract or a letter of access are to ensure that:

2 Purpose

2.1 This practice guidance note (PGN) describes the process for applying to

Northumberland, Tyne and Wear NHS Foundation Trust (the Trust/NTW) for a letter of access or an honorary research contract in order to undertake research related activity within the Trust. This PGN is relevant for NTW employed staff wishing to undertake research in other NHS Trusts, NHS employed staff conducting research in NTW, university employed researchers as well as those researchers external to the NHS and not associated with a university. This PGN has been written in line with the Trust’s NTW(O)47 - Research Governance Policy.

Non-NHS researchers (who have no paid contract with an NHS organisation) are contractually bound to take proper account of the NHS duty of care and to follow the requirements of research governance and other research regulations at every stage of their research process

Research participants, researchers, services users, care/host organisations are protected

There is a clarity in legal situation should adverse incidents occur with respect to research activity

3 Procedure 3.1 This PGN outlines the differences in what type of access is granted to the various

types of researchers and the employment routes of researchers applying to undertake research within NTW. Researchers will be issued either an Honorary Research Contract (HRC) or a Letter of Access for Research (LoA).

3.2 Honorary Research Contracts (HRC) 3.2.1 Researchers require an HRC only if:

The research is hosted in the NHS and they have no contractual relationship with the NHS and the activities which the researcher plans to undertake in the host NHS site involve interacting with individual patients in a way that has a direct bearing on the quality of their care.

3.2.2 A researcher’s activity may be deemed to have a direct bearing on the quality of

patient care if:

The researchers activity could directly influence decisions made on:

o A patients access to care

o The care pathway which the patient follows

o The type, quality or extent of prevention, diagnosis or treatment of illness

The researcher’s action could foreseeably cause injury or loss to patients or service users to whom the NHS organisation has a duty of care, leading to a possible case of clinical negligence being made against the NHS organisation.


3.2.3 Examples of activities that could have a direct impact on care include:

Taking consent for an interventional study (as this will determine an individual’s access to a specific treatment)

Delivering a treatment that forms part of the research study

Performing phlebotomy on trial patients (as this is an invasive procedure which could lead to injury or infection)

3.2.4 Activities that would not have a direct impact on care include:

Some types of interview study, where information from the study will

not feed into the patients care plan or decision-making in relation to the

care of the patient

Undertaking the randomisation procedure to allocate trial patients to a specific treatment, as this is preceded by the consent process. Randomisation is considered a research procedure

3.3 Letter of Access (LoA) 3.3.1 For Higher Education Institution (HEI) researchers a LoA should be issued in the

following circumstances:

Where the research is hosted by the NHS and the researcher needs to access NHS facilities or patients or data to undertake their research and it is judged that the researcher’s activity will not have a direct bearing on patient care.

3.3.2 For HEI researchers where the NHS site accepts an existing HRC, a LoA should

be issued in the following circumstances:

Where the lead NHS organisation has already validated a Research Passport form and the lead NHS organisation judged that the research activity had a direct bearing on patient care and the lead organisation issued an HRC and the researcher now needs to undertake the same research activity in a different NHS organisation

3.3.3 For NHS researchers and clinical academics1 an NHS to NHS LoA should be

issued following the procedures outlined below:

Researchers with an existing substantive NHS or honorary clinical contract do not require an HRC

The NHS organisation which hosts their research can accept their existing relationship with the NHS

The NHS to NHS LoA gives permission for any type of research activity to be undertaken at the host site

The researcher’s substantive NHS employer remains fully responsible for undertaking and updating the pre-engagement checks

3.3.4 The procedure for researchers who require an NHS to NHS LoA is as follows:

The R&D office for the employing Trust is responsible for ensuring this confirmation is issued by their Trust for all staff requiring NHS to NHS LoAs. For clinical academics, the Trust holding the honorary clinical contract may need to liaise with the HEI who is the substantive employer, in order to issue the signed proforma

The NHS researcher/clinical academic can then submit this declaration, along with their CV, to all NHS organisations who are hosting their

1 Clinical academics hold joint appointments across NHS and HEI organisations to conduct clinical activity,

teaching and research


research. The host site can accept this declaration as confirmation that the required pre-engagement checks have been undertaken by the employer and issue the NHS to NHS LoA to the researcher, copied to the researcher’s substantive employer. The copy NHS to NHS LoA sent to the employer will also be accompanied by a copy of the proforma confirming completion of pre-engagement checks submitted to the host organisation.

3.5 The NHS to NHS LoA:

Accepts the employees existing NHS contract

Accepts confirmation from the substantive employer that the pre-engagement checks and associated contractual obligations are in place (through receipt of the NHS to NHS LoA proforma confirmation of pre-engagement checks)

Places the obligation fully on the substantive NHS employer to ensure these checks continue to be in place for the role to be undertaken in the NHS organisation hosting the employee’s research activity.

3.4 Research Passport Scheme – university employed staff only

3.4.1 The Research Passport procedure is the mechanism that researchers can use in

order to obtain an honorary research contract (HRC) or a letter of access (LoA). The procedure enables researchers to complete a single set of documents in order to be able to access a single or multiple NHS sites.

3.4.2 The Research Passport system:

Is a single set of standard forms and associated documents [identity checks, CV, Disclosure and Barring Service (DBS) and Occupational Health (OH)] completed by the researcher and her/his employer, and validated by an NHS organisation, enabling an Honorary Research Contract or Letter of Access to be issued, according to the nature of the research activity;

clarifies accountability and responsibility for researchers, resulting in increasing patient safety, improving risk management, and employers improving quality assurance of research staff;

is completed, validated and presented to all the relevant NHS organisations where the study is to be conducted with no duplicate checks at those sites as they rely on assurances offered by those employers who have already conducted these checks and the NHS organisation who validated the passport and accepted the checks.

3.4.3 The Research Passport form and more details can be found at the NIHR website

http://www.nihr.ac.uk/systems/Pages/systems_research_passports.aspx 3.4.4 There are a number of documents and checks that will need to be completed by

the researcher in order for them to be able to use the Research Passport System. However, depending on what group the researcher falls into, a Research Passport may not be required or allowed. The types of researcher and their activities are outlined in the sections below.

3.5 NHS to NHS Engagement – NHS employed staff only

3.5.1 Staff already employed within an NHS Trust are not able to use the research

passport scheme and are required to request their Trust HR department to complete an NHS to NHS proforma confirmation of pre-engagement checks confirming that the individual is substantively employed by an NHS Trust.

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

NHS%20to%20NHS%20confirmation%20of%20pre-engagement%20checks.doc


3.6 Categories of Researchers

3.6.1 Researcher’s conducting and supporting research within the NHS fall into a number of categories, each requiring a specific application process depending on who their substantive employment is with. The following sections detail the categories and the process required for each.

3.6.2 Staff with substantive NHS employment contracts (Group 5)

Where NHS staff wish to conduct research in another NHS organisation

that will not have a direct bearing on the quality of care, the vicarious

liability for the actions of the individual rests with the substantive NHS

employer. Researchers who are NHS employed should submit their CV

and the NHS to NHS proforma confirmation of pre-engagement checks

(completed by their substantive employer) to the NHS organisation

hosting their research. The NHS organisation hosting the research can

then issue the researcher with an NHS to NHS letter of access (LoA).

The researcher’s substantive employer is informed of their activities by

being sent a copy of the NHS to NHS LoA

Staff with substantive NHS employment contracts

Researcher provides R&D with:Completed NHS to NHS proforma and

copy of signed CV

R&D sends NHS proforma to HR with R&D/HR proforma

R&D enters information on to the

R&D HR tracker

HR issue LoA to the researcher. Copy of the letter to be sent to the substantive NHS employer and to

R&D

See internal process/timeframe doc

o This is for researchers who will have no direct bearing on

participant’s quality of care

o If the NHS to NHS proforma is signed electronically, it will only be

accepted if it is sent directly from the substantive employers HR

department

o Liability for the researcher’s actions rests with the substantive NHS

employer


3.6.3 Researchers with a substantive university contract and an honorary NHS contract e.g. clinical academics (Group 2)

Individuals with a substantive university contract and honorary NHS

contract are commonly referred to as clinical academics. Such

individuals include medical staff as well as other clinical staff.

Clinical academics do not need an honorary research contract (HRC) in

order to undertake research in the partner NHS organisation where they

undertake their clinical duties. This will be covered by their honorary

clinical contract. In accordance with the recommendations of the Follett

Report, universities and NHS organisations responsible for medical

education and research are expected to have joint strategic planning

arrangements, with joint subsidiary mechanisms responsible for human

resource policies and procedures for staff with academic and clinical

duties. Therefore when clinical academics wish to conduct research in

other NHS organisations they should be treated as staff with substantive

NHS contracts.

Researchers who are clinical academics should submit their CV and the

NHS to NHS proforma confirmation of pre-engagement checks

(completed by their substantive employer) to the NHS organisation

hosting their research. The NHS organisation hosting the research can

then issue the researcher with an NHS to NHS LoA. The researcher’s

substantive employer is informed of their activities by being sent a copy

of the NHS to NHS LoA.

Researchers with a substantive university contract and an honorary NHS contract e.g. clinical academics

Researcher provides R&D with:Completed NHS to NHS proforma and

copy of signed CV

R&D sends NHS proforma to HR with R&D/HR proforma


R&D HR tracker

HR issue LoA to the researcher. Copy of the letter to be sent to the substantive NHS employer and to

R&D


o Clinical academics do not need an HRC in order to

undertake research in the partner NHS organisations

where they undertake their clinical duties


3.6.4 Researchers with substantive university employment contracts and no honorary NHS clinical contract (Group 1)

Arrangements for researchers with substantive university employment contracts and no honorary NHS clinical contract differ depending on whether or not the research activities could have a direct bearing on care. Activities that could have a direct bearing on the quality of care are those that could foreseeably directly affect the type, quality or extent of prevention, diagnosis or treatment of illness or foreseeably cause injury or loss to an individual to whom the organisation has a duty of care. Where a researcher is conducting activities that will have a direct bearing on the quality of care, the individual will be accountable to the NHS organisation that gave permission for this activity. An honorary research contract should be issued to clarify and confirm this accountability

When researchers conduct activities with no direct bearing on the quality of care, the vicarious liability of the actions of the individual rests with the university substantive employer and an HRC is not required

In both cases, this type of researcher will be processed through the Research Passport System

Researchers with a substantive university contract and no honorary NHS clinical contract

Researcher provides R&D with a valid research passport application

R&D sends application to HR with internal proforma


R&D HR tracker

HR issue HRC to the researcher, acknowledgement to the substantive employer and copy to R&D


o The researcher will be accountable to the NHS organisation giving permission for this activity

o For use when the researcher is conducting activities that will have

a direct bearing on the quality of care – HRC to be issued


Researchers with a substantive university contract and no honorary NHS clinical contract




R&D HR tracker

HR issue LoA to the researcher, acknowledgement to the substantive employer and copy to R&D


o Liability of the researcher’s actions rest with the

substantive employer

o To be used when the researcher’s actions will have no

direct bearing on the quality of care – LoA to be issued

3.6.5 Researchers who are contracted to provide NHS services (Group 6)

Where Independent Contractors such as GPs, or practice staff,

undertake research as part of their routine clinical services, their

personal professional indemnity arrangements are expected to provide

them with adequate cover for that activity. It is the contractor’s

responsibility to check that the professional indemnity will cover the

proposed research or whether additional premiums are required

Where Independent Contractors undertake research on patients

outside their routine clinical practice, their personal professional

defence arrangements may not extend to cover such research

activities. NHS Indemnity arrangements specifically do not extend to

Independent Contractors (or their staff) while they are working under

contract for services to the NHS

Independent Contractors may be employed by an NHS organisation

under certain circumstances, in which case NHS Indemnity

arrangements would apply in the same way as for other NHS staff.

Where an Independent Contractor is undertaking research as an NHS

employee, the NHS to NHS LoA can be used

Researchers with substantive university employment contracts who are

also Independent Contractors (e.g. GPs) may wish to undertake

research involving patients outside their routine clinical practice.

Where an Independent Contractor is undertaking research as an HEI

employee, the Research Passport system may be used


3.6.6 Researchers with other substantive employment contracts e.g. social workers (Group 6)

The arrangements for researchers conducting research within the NHS who

are employed by local government, charities or other organisations are

similar to those described above for university-employed staff. However,

except where local arrangements have been made to extend the research

passport system between NHS organisations and other partners, there will

be no established method to share information from employers about pre-

engagement checks. Where there are no local arrangements to enable

sharing of information about pre-engagement checks to take place, NHS

organisations hosting research may themselves need to undertake

appropriate checks on researchers and claim the costs of such checks from

the employer or research funder.

Researchers not attached to the NHS or to a university

Researcher and study team approach R&D to discuss researcher involvement

Researchers roles and requirements agreed upon. Researcher completes the access application form

and sends to R&D

If direct contactIf no direct

contact

DBS and occ health checks undertaken

Information sent to HR to

issue LoA

LoA issued on receipt of clearance

3.6.7 Undergraduate or postgraduate students (Groups 3 and 4)

Undergraduate and postgraduate students may conduct research as

part of their healthcare placements. A memorandum of understanding

between the HEI and the NHS organisation will be in place for

healthcare placements. This should confirm the accountability

arrangements between organisations. Students on healthcare

placements should have appropriate pre-engagement checks

conducted when they start their healthcare placement in the NHS. Any

research conducted as part of healthcare placements should come

within the existing arrangements for such students. Students should

be supervised within clinical settings by NHS employees or HEI staff

with honorary clinical or research contracts who themselves are

covered by NHS indemnity. Therefore, students conducting research

as part of their healthcare placements do not need to complete a

Research Passport Form and do not require an honorary research

contract or LoA.


Postgraduate students may conduct research within the NHS other

than through healthcare placements. If the student is not appropriately

clinically qualified to undertake research activities that may have a

direct bearing on the quality of care, the student should be supervised

by a clinical supervisor who is an NHS employee or an HEI employee

with an honorary clinical or research contract. Therefore, students

supervised under close clinical supervision may not require honorary

research contracts.

Where a postgraduate student is appropriately clinically qualified and

experienced, direct supervision is not appropriate and the student must

complete a research passport form and be issued with an HRC (if the

research will have direct and foreseeable impact on the duty of care) or

an LoA.

Where NHS staff are undertaking a course of study that includes a

research component, e.g. a nurse undertaking a PhD, the

arrangements for NHS staff undertaking research should be used (see

NHS employed staff flowchart).

Where students are undertaking research as part of a Masters or PhD,

and that course is not subject to a healthcare placement agreement

with clinical supervision, then the Research Passport system should be

applied. On submission of a complete and validated Research

Passport, the NHS organisation may issue the student with an HRC or

LoA, depending on the nature of the research activity.

Undergraduate or postgraduate students HRC




R&D HR tracker

HR issue HRC to the researcher, acknowledgement to the substantive employer and copy to R&D


o Where researcher’s actions will have a direct bearing on the

quality of care


Undergraduate or postgraduate students LoA




R&D HR tracker

HR issue LoA to the researcher, acknowledgement to the substantive employer and copy to R&D


o Where the researcher’s actions will have no direct bearing on the quality of care

3.6.8 Researchers conducting research where the participants are NHS staff

All employers have a common-law duty of care for the health, safety

and welfare at work of all their employees. Where research involves

NHS employees as participants, the duty of care of the NHS

organisation to its employees is non-delegable and the NHS

organisation will always be liable, regardless of who employs the

researcher. Dependent upon the researchers substantive employer,

the researcher will need to apply for a LoA either via research

passport, NHS to NHS pre-engagement form or researcher access

application form (please refer to the relevant process flowcharts)

3.6.9 NTW Employed Researchers

Staff employed by NTW who wish to be part of research projects in

other NHS Trusts will need to request an NHS to NHS proforma

confirmation of pre-engagement check form to forward (along with a

CV) to an appropriate named person in the relevant NHS Trust.

NTW employed researchers

Researcher informs R&D about need for LoA

R&D requests HR to complete the NHS to NHS profoma


R&D HR tracker

HR issue signed proforma to the researcher, copy of the email to R&D


o R&D involvement to allow monitoring of the process for timescales


3.6.10 Northern Deanery Doctors

If Northern Deanery doctors are on rotation within NTW they are

covered as employees of the Trust, however, if they wish to conduct/be

part of research whilst on rotation outside of NTW they will need to be

issued with an LoA via medical staffing

Process for Northern Deanery Staff

R&D contacts medical staffing

Medical staffing confirms if researcher

has attachment to NTW

Researcher not on medical staffing list for

NTW

No further action required

LoA is required for researcher

Need to follow the LoA process through

medical staffing

3.6.11 Service User/Carer Researchers 3.6.11.1 Letter of access only - Service user and carer researchers will have one of two

roles in the research team:

Direct Contact

o Direct contact with patients/service users and carers but with no

impact on their care e.g. face to face interviews, observations.

In this instance Disclosure and Barring Service (DBS) and

occupational health clearance are required

Indirect Contact

o Indirect contact with patients/service users, carers or staff e.g.

telephone interviews, analysis of data. In this instance DBS

and occupational health clearance are not required

o The route taken is entirely dependent upon the study and the

individual’s role in that study

o Any checks required to allow the researcher to be involved in

the study will need to be paid for via the study budget


o The researcher would need to be reminded of confidentiality,

safeguarding and would require appropriate supervision to be in

place. Any appropriate/necessary training will be provided by

the study team/NTW link person in the study/research staff

training package

Service user and carer researchers

Researcher and study team approach R&D to discuss researcher involvement

Researchers roles and requirements agreed upon

If direct contactIf no direct

contact

DBS and occ health checks undertaken

Information sent to HR to

issue LoA

LoA issued on receipt of clearance

4 NTW Site/Service Visits 4.1 Any individual/group wishing to visit NTW’s sites/services must make a formal

request regarding their proposed visit to the Trust well in advance. This request must be made in writing to Gary O’Hare, Executive Director of Nursing and Operations, St Nicholas Hospital, Jubilee Road, Gosforth, Newcastle upon Tyne. If you have any queries please contact his PA via email: [email protected]

5. References

National Institute for Health Research (2010) Research in the NHS – HR Good practice

Resource Pack - Available: http://www.nihr.ac.uk/systems/Pages/systemsresearch _passports.aspx.

6. Related Documents

NTW(O)47 – Research Governance Policy

mailto:[email protected]

http://www.nihr.ac.uk/systems/Pages/systemsresearch%20_passports.aspx


Appendix 1 Summary of forms of contractual arrangement available for individuals undertaking research in the NHS

Substantive Employer

Forms of contractual arrangement that can be issued to cover research activity

(1) HEI

Substantive Employee

(2) Substantive HEI with

Honorary Clinical NHS Contract (Clinical

Academic)

(3) HEI Student on

a formal healthcare placement

(4) HEI Student NOT

on a formal healthcare placement

(5) NHS

Substantive Employee

(6) Independent

Contractor e.g.; GP (providing NHS services

under contract)

(7) Commercial Researcher

(8) Commercial

Researcher under contract to HEI

(non-commercial research)

2

HRC YES3 NO NO YES

2 NO NO NO YES

2

LoA accepting an HRC YES3 NO NO YES

3 NO NO NO YES

3

LoA (no HRC required) YES4 NO NO YES

4 NO NO NO YES

4

NHS to NHS LoA NO YES5 NO NO YES

5 NO NO NO

Service Level Agreement

NO NO NO NO NO NO YES6 NO

Healthcare Placement Agreement

NO NO YES NO NO NO NO NO

Is a Research Passport needed?

YES7 NO NO YES

7 NO

8 NO NO MAYBE

9

1 Applies only to HEIs contracting researchers to undertake research funded and sponsored by non-commercial bodies

3 Appropriate where the Trust owes a duty of care to research participants and the researchers activity will have a direct impact on patient care

3 Appropriate where the Trust owes a duty of care to research participants and the researchers activity will have a direct impact on patient care and the researcher already holds an HRC with

another NHS organisation 4 Appropriate where the Trust owes a duty of care in respect of the research activity and the researchers activity has no direct impact on care but involves access to NHS patients, data or

facilities. 5 Covers all types of research activity ie; direct and indirect impact on patient care, where the researcher has a contractual relationship with the NHS

6 HR issues should be addressed in a service level agreement unless covered by Trial Agreement eg; Data Monitors

7 Yes, where evidence of pre-engagement checks are required

8 NHS to NHS proforma confirmation of pre-engagement checks should be used for those with an existing substantive or honorary clinical NHS contract

9 Yes, to facilitate sharing of pre-engagement checks


Appendix 2

NHS to NHS letter of access: proforma confirmation of pre-engagement checks

For NHS researchers who have a substantive NHS contract of employment or clinical academics with an honorary clinical contract with an NHS organisation, and who need an NHS to NHS letter of access from an NHS organisation hosting their research

CONFIRMATION OF PRE-ENGAGEMENT CHECKS

To: R&D Office

Address of NHS site hosting the research Re: Researcher’s name: Job title: Contract end-date: Workplace and postal address:

Electronic Staff Record number:

As the representative of the NHS employer4 of the above-named person, I can confirm that s/he is employed by this organisation. I understand that the responsibility for ensuring that the appropriate pre-engagement checks have been undertaken rests with us as the individual’s substantive employer. I can confirm that the appropriate pre-engagement checks have been completed, commensurate with her/his job description and proposed research role in your NHS organisation, and in line with NHS employment checks standards Name of employer’s representative: Job Title: Workplace address: Tel: Email:

4 For clinical academics, this would be a representative from their HEI employer


Appendix 3

Research Role Assessment Form

Section 1 - To be completed by researcher

Name: Date of birth:

Post title:

School/Institute/

Directorate

Contact address:

Email address: Tel no.:

Professional reg. no:* ISA reg. no.:

Research Categories - Please tick all that apply to your work, or will do during course of current project(s)

√ Description of research

Direct contact with patients/service users and direct bearing on the quality of their care (not children or vulnerable adults)

Direct contact with children and direct bearing on the quality of their care

Direct contact with children but no direct bearing on the quality of their care

Direct contact with vulnerable adults and direct bearing on the quality of their care

Direct contact with vulnerable adults but no direct bearing on the quality of their care

Direct contact with patients/service users, but no direct bearing on the quality of their care (e.g. observer)

Indirect contact with patients/service users and direct bearing on the quality of their care (e.g. some types of telephone interviews)

Indirect contact with patients/service users, but no direct bearing on the quality of their care (e.g. telephone interviews, postal questionnaires)

Access with consent to identifiable patient data, tissues or organs with likely direct bearing on the quality of their care

Access with consent to identifiable patient data, tissues or organs, but no direct bearing on the quality of their care

Access without consent to identifiable patient data, tissues or organs, but no direct bearing on the quality of their care

Access to anonymised patient data, tissues or organs only (including by research staff analysing data)

Working on NHS premises (e.g. laboratory work) only

Direct contact with staff (e.g. interviews)

Access to identifiable staff data

Access to anonymised staff data only

Give brief description of role:

Where relevant I consent to details relating my current CRB and Occupational Health checks being provided by my employer to the appropriate NHS organisation to confirm details as necessary to assist with an assessment of my suitability to undertake the research category given above.

Signed Date


Project Title Start Date End Date NHS Manager

HEI staff with no contract with the NHS should now complete the Research Passport Application Form and meet with the HEI research services department

NHS staff should now complete section 2 below.

Section 2 – To be completed by NHS employer for NHS staff only

For completion by Line Manager:

I confirm that the above information is correct

Signed: Date: Print name: Job Title:

Date employed: Date contract ends:

CRB check level: Standard Enhanced

Checked for working with children? Yes No

Checked for working with vulnerable adults? Yes No

Date of disclosure: Ref no.:

Comments:

ISA status checked? : Yes No NA Date:

Comments:

Signed Date

Print name:

Post title/designation:

Employers stamp:


Research Passport Application Form To be completed for all HEI staff (i.e. those with no substantive contract with the NHS) wishing to carry out research in an NHS organisation. This form and the attached documents will form your application for a Research Passport, Honorary Research Contract or Letter of Access, whichever is applicable to your role.

Section 1 - Details of Researcher To be completed by Researcher

1. Surname: Prof Dr Mr Mrs Miss Ms Other Forename(s):

Home Address:

Work Address/Place of Study:

Work Tel: Mobile: Email:

2. Date of birth: Gender: Male Female

Ethnicity: National Insurance number:

3. Professional registration details (if applicable): N/A

ISA registration no.:

4. Employer : or place of study:

Name of School/Institute/Directorate:

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 Three-year

If you will be conducting only one project please complete the details below. If you will be undertaking more than one project at any one time, please give details in the Appendix.

Project Title:

Project Timetable: 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 requested in this Research Passport (including attached documents) being processed and held by authorised staff of the NHS organisations where I will be conducting research. 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. Date employed: Date contract ends:

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.

Signed: Date:

Name: Job Title:

Organisation: Department:

Address:

Email:

When Section 4 has been completed, the researcher should forward the form to the appropriate person to complete Section 5.

Section 5 - Pre-engagement checks To be completed by the HR department of the researcher’s substantive employer or registry at place of study

8. Can you confirm that a clear criminal record disclosure has been obtained for the above-named individual, with no subsequent reports from the individual of changes to this record?

Yes No N/A

Comments:

If yes, please provide details of the clear disclosure

Date of disclosure: CRB Ref No.:

Type of disclosure: Standard Enhanced

Checked for working with children Yes No

Checked for working with vulnerable adults Yes No

Organisation that requested disclosure:

9. Have the pre-engagement checks described below been carried out with regard to the above-named individual?


Employment/student screening:

o ID with photograph

o two references

o verification of permission to work/study in the UK

o exploration of any gaps in employment

Yes No

Yes No

Yes No

Yes No

Evidence of current professional registration Yes No N/A

Evidence of qualifications Yes No

Occupational health screening Yes No N/A

Signed: Date:

Name: Job Title:


Address:

Email:

Please return the form to the researcher.

Section 6 - Instructions to applicants To be completed by Researcher

Please indicate which of the following documents are attached to this Research Passport:

Current curriculum vitae, including details of qualifications, training and professional registration (please use the template C.V. at http://www.rdforum.nhs.uk/docs/template_cv.doc)

Yes No

Researcher’s copy of criminal record disclosure (if question 8 is answered Yes) Yes No N/A

Evidence of occupational health screening Yes No N/A

Appendix Appendix numbers:

N/A

Please send the completed form and original documents to the lead R&D office. The completed form and original documents will be returned to you. This package of documents will form your completed Research Passport. You may, where relevant, provide the Research Passport to other NHS organisations. You must inform all NHS organisations that have received this Research Passport of any changes to the information supplied above. Failure to do so may result in withdrawal of your honorary research contract or letter of access. As part of the quality control procedures for the Research Passport, random checks on the accuracy of the information held on this Research Passport may be made.

http://www.rdforum.nhs.uk/docs/template_cv.doc


Section 7 This section should be completed by HR in the lead NHS organisation, only if additional checks are undertaken

Having undertaken the necessary additional pre-engagement checks, I am satisfied that the above named researcher is suitable to carry out the duties associated with their research activity outlined in this Research Passport.

Signed: Date:

Name: Job Title:


Email:

Section 8 - For Office Use Only

This section should be completed by the NHS R&D office that received the initial application. The NHS R&D office must countersign and date retained photocopies of the documents. The grey section must be completed before returning the form to the applicant.

CV reviewed? Yes No Training? Yes No

Evidence of qualifications? Yes No Appendix pages reviewed? Numbers:

Registration details reviewed?

Yes No N/A Occupational health evidence reviewed?

Yes No N/A

Criminal record disclosure reviewed?

Yes No N/A Date of disclosure:

Certificate No:

Enter Electronic Staff Record Number (if issued):

Valid Research Passport issued: Project specific Three-year

Signed: Date:

Name:

Date Honorary Research Contract/letter of access issued (delete as appropriate)

This section should be completed by the NHS R&D office receiving the valid Research Passport. The NHS R&D office must countersign and date retained photocopies of the documents. The original Research Passport and documents should be returned to the applicant.

CV reviewed? Yes No Training? Yes No

Evidence of qualifications? Yes No Appendix pages reviewed? Numbers:

Registration details reviewed?

Yes No N/A Occupational health evidence reviewed?

Yes No N/A

Criminal record disclosure reviewed?

Yes No N/A Date of disclosure:

Certificate No:

ISA registration/status reviewed?

Yes No N/A Checked Electronic Staff Record:

Yes No N/A

Signed:

Date:

Name:


Date Honorary Research Contract/letter of access issued (delete as appropriate)

Passport Appendix. List of projects and amendments

Appendix Number: If you are applying for a three-year Research Passport, please use this section to enter details of projects and activities that will be covered by this Research Passport. Once you have a complete Research Passport, you may add details of subsequent projects during the three years that this Research Passport is valid. If you are applying for a project-specific Research Passport, but need to subsequently add further sites to the project, please enter the details below. Whenever you add further details, the full Research Passport and accompanying documents must be submitted to the relevant NHS organisations.

Title Start Date End date

NHS organisation(s):

Dept(s):

Proposed research activities:

Manager in NHS organisation:

Amendments to the Research Passport Please state what these are, e.g. they might be a change in name or employment details, or a change in research activities. Please check with the NHS organisation where you are undertaking your research if you are unsure whether you will need a new Research Passport.

Date Old Details New Details Office use only

NHS R&D signature

To add more projects please copy this page or download further blank pages. Each appendix page should be numbered.


Appendix 4

Researcher Access Application Form

To be completed by researchers not employed via the NHS or a university (HEI) wishing to apply for a letter of access to conduct research within Northumberland, Tyne and Wear NHS Foundation Trust

Part 1 – to be completed by the researcher

Title

First Name

Last Name

Work Address

Contact Telephone Number

Email Address

Professional Registration (if applicable)

Current Employment Information

Employer Name

Address

Length of current contract

Date of last DBS check

Research Information

Project Title

Project duration (start and end date of your involvement)

Location

Name of NTW supervisor


Outline of research duties

I confirm that the information given in Part 1 is true and complete and request an honorary contract / letter of access to enable me to undertake research in the Trust

Signed Date

Part 2 – To be completed by line manager

I confirm that:

1 The information given by name in Part 1 is consistent with that contained in the records of my organisation;

2 I believe the applicant to be a suitable person to undertake the research activity described above

Signed Date

Please print name

Job Title

Organisation