The Research Passport Scheme for non-clinical researchers

The Research Passport Scheme for non-clinical researchers

If you will be working within the Imaging Centre of Excellence (ICE) Facility as part of your University role, please contact Dr Debra Stuart (debra.stuart@glasgow.ac.uk) directly for advice and support in proceeding with gaining access to the facility.

These webpages describe the Research Passport system which has been put in place by the NHS for non-clinical researchers. This new initiative simplifies administrative procedures when issuing honorary research contracts to researchers with no contractual arrangements with the NHS, and who carry out research in the NHS that affects patient care.

These pages were developed with extensive support from the NHS R&D Forum working with our partners in the UK Clinical Research Collaboration (UKCRC). They set out guidance and good practice standards so that individual NHS bodies can be confident of the process used to carry out criminal record and other checks on honorary researchers.

The Department of Health recommends "Research Passport" to the NHS, to Higher Education Institutions (HEIs) and to other research employers working in partnership with the NIHR. The UKCRC Partners also endorse the routine use of the Research Passport system.

This guidance below consists of:

  • a Research Passport system, which provides a mechanism for assuring NHS organisations of the pre-engagement checks conducted on a researcher; and
  • other standardised procedures for handling the HR arrangements for researchers. The Research Passport system and associated procedures have been developed in parallel with the development of the Integrated Research Application System and other arrangements across the UK to streamline the arrangements for obtaining permission for research from NHS organisations.

The implementation date for new starts will be 1st March 2009.  For eligible existing staff a research passport must be applied for on starting a new study, or now if necessary for multi-centre studies. 

Advice on whether or not a Research Passport is required must be obtained before applying from:

Dr Debra Stuart
College of Medical, Veterinary and Life Sciences
University of Glasgow
Room 327
Wolfson Medical School Building
University Avenue Glasgow
G12 8QQ

Tel: 0141 330 4539

Index:

1. Important information about the Research Passport

1. Important information about the Research Passport

Before you can be considered for appointment in a position of trust within the NHS, each NHS organisation needs to be satisfied about your character and suitability.

The law requires the NHS to promote equality of opportunities and to treat all applicants for positions fairly and on merit regardless of age, disability, gender, race, ethnic origin, nationality, religion, belief, or sexual orientation. The NHS shall not discriminate unfairly against applicants on the basis of any criminal conviction or other information declared.

Prior to making a final decision concerning your application, each NHS organisation should discuss with you any information declared by you that it believes has a bearing on your suitability for the position. If any information is not raised with you, this is because the NHS organisation believes that it should not be taken into account. In that event, you remain free to discuss any of that information or any other matter that you wish to raise. As part of assessing your application, the NHS organisation will take into account any relevant criminal record and other information declared.

In accordance with the Data Protection Act 1998 you are advised that your personal data will be processed by each NHS organisation to which you submit the Research Passport. In completing and submitting the Research Passport you are deemed to have given consent to processing personal data about you. Processing includes: holding, obtaining, recording, using, sharing and deleting information. The Data Protection Act 1998 defines ‘sensitive personal data’ as including ethnic origin, physical or mental health, commission or alleged commission of offences and any proceedings for any offence committed or alleged to have been committed.

The information that you provide in this Research Passport will be processed in accordance with the Data Protection Act 1998, and may also be used for the purpose of determining your application for this position. It may also be used for the purpose of enquiries in relation to the prevention and detection of fraud. Once a decision has been made concerning your appointment, for successful applicants the Research Passport will be retained on their personal file; if unsuccessful, the Research Passport will be destroyed one month after receipt of the application. This form will be kept securely and in confidence, and access to it will be restricted to designated persons within the NHS organisation who are authorised to view it as a necessary part of their work.

While conducting research in the organisation, all researchers should comply with NHS organisation policies relating to safety and confidentiality. These may include the following:

  • incident reporting;
  • research governance;
  • misconduct and fraud;
  • data storage and handling.

2. What is the Research Passport?

2. What is the Research Passport?

  • One set of checks on a researcher conducting research in the NHS.
  • One standard form for each researcher.
  • The form is completed by the researcher and her/his employer, and validated by an NHS organisation.
  • The completed Research Passport is presented to all the relevant NHS organisations.
  • No duplication of checks.
  • Faster study start-up.

3. Who does not need a Research Passport?

3. Who does not need a Research Passport?

You will not need a Research Passport or an honorary research contract if:

  • you are employed by an NHS organisation; or
  • you are an independent contractor (e.g. GP) or employed by an independent contractor; or
  • you have an honorary clinical contract with the NHS (e.g. clinical academics); or
  • you are a student who will be supervised at all times within clinical the setting by an NHS employee or HE staff member with an honorary clinical or research contract; or
  • the research you are doing does not require any checks or honorary research contract.

4. Who needs a Research Passport?

4. Who needs a Research Passport?

If you are not in any of the above categories and you have no contractual relationship with the NHS, you may need a Research Passport.  The NHS organisation hosting the research will confirm if you require a research passport under any of the following circumstances when it is likely to be required:

  • 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)
  • Access to identifiable patient data, tissues or organs with likely impact on prevention, diagnosis or treatment
  • [Working on NHS premises (e.g. laboratory) only]
  • A Research Passport may be project-specific or may be valid for a period of three years for a number of projects. ID badges will also be issued by each NHS organisation where researchers will have face-to-face contact with patients or staff.

Under certain circumstances a letter of access may be sufficient to allow you to conduct your proposed research. Letters of access are issued when the University Research Governance Officer and the NHS Research and Development Office consider the research proposed to be of low risk to patients. In most cases, no criminal records check or occupational health screen will be required for a letter of access to be issued. However, you will still need complete the Research Passport form to obtain an access letter. 

5. What type of pre-engagement check is needed?

5. What type of pre-engagement check is needed?

The NHS organisation hosting the research will confirm which pre-engagement checks will be required.

Criminal Records Checks

These will be required where:

  • there is no current contractual relationship with the NHS ( ie. You do not have a current clinical contract)  and
  • you will have a direct bearing on the quality of the patient’s clinical care through direct contact with a patient.

The University undertakes enhanced disclosure checks on all new members of staff but the research passport system will require additional checks to be carried out within 6 months of an application for a research passport.

A Disclosure is a document containing impartial and confidential criminal history information held by the police and government departments. Currently there are three types of disclosure: Basic, Standard and Enhanced. The research you propose to undertake will determine which level of Disclosure is required.

It is important to note that the Protection of Vulnerable Groups (PVG) Scheme came into effect in February 2011 and replaced Enhanced Disclosure ONLY for individuals working with vulnerable groups. More information on the PVG scheme can be found at:

If you think your research will involve interaction with vulnerable groups you should contact the Research Governance Officer who can advise if PVG scheme membership is required.

Occupational Health Checks

These will be required where:

  • There is no contractual relationship with the NHS ( i.e. you do not have a current clinical  contract) and
  • You will have direct contact with patients regardless of the impact of the research on clinical care and
  • If you will be working on NHS premises. In such circumstances checks may be required at the discretion of the NHS hosting organisation.
  • Further information on Occupational Health checks is available on the Occupational Health website at www.gla.ac.uk/services/occupationalhealthunit/researchpassports-nonclinicalresearchers/

The table on p.28 of the link below (highlighted in yellow) summarises the checks required but always check with the Research Governance Office if you are unclear:

6. How do I get a Research Passport?

6. How do I get a Research Passport?

  • Read the attached guidance for completing the Research Passport form in section 7 below.
  • Complete sections 1-3 of the Research Passport form.
  • Ask your line manager (or other authorised person) to complete section 4.
  • Students should contact the Research Governance Officer for completion of section 5 of the form.
  • You may need to complete occupational health assessments, and/or a criminal record disclosure application, and/or provide additional documents.
  • Your HR Service will sign off the form and return it to you.
  • Take the completed Research Passport form with attachments to the lead NHS organisation.
  • Once the form has been authorised by one NHS organisation it becomes a valid Research Passport that you can provide to other NHS organisations.

The Principal Investigator must apply for permission to conduct the research in the NHS organisation. The Research Passport does not remove the need to apply to the NHS organisation for permission or to apply for ethical review.

7. HEI flowchart

7. HEI flowchart

8. Guidance notes for completion of the Research Passport documentation

8. Guidance notes for completion of the Research Passport documentation

Section contents:

If the Research Governance Officer confirms that a Research Passport is required please use the following link to download the Research Passport form in word format.  You should not complete this form until eligibility has been checked:

Please note that the following forms also need to be completed:

Section 1 - Details of Researcher

Section 1 - Details of Researcher

To be completed by Researcher

Question 1. Please state your name and contact details.

Question 2. Please provide basic details about your identity. This information is used to complete the Electronic Staff Record (the NHS HR system).

Question 3. If you are registered with a professional body please give details.

Question 4. Details of your substantive employer or, for students, place of study should be given. Please give your job title or type of study (e.g. undergraduate). NB NHS organisations need to be informed of any changes in employment.

Section 2 - Details of Research

Section 2 - Details of Research

To be completed by Researcher

Question 5. There are two types of Research Passport: the project-specific Research Passport and the three-year Research Passport.

  • The project-specific Research Passport is for researchers who will be involved with only one project over the course of three years. If this is the case please provide details in this section.
  • The three-year Research Passport is for researchers who will be working on a number of studies over the course of three years and have an ongoing research portfolio. Please give details in the Appendix instead of completing this section. You may add as many Appendix pages as required. Please number each Appendix page. You should update the Appendix with any new studies and present the updated Research Passport to all relevant NHS R&D offices before commencing the new project.

Either here or in the Appendix, as appropriate, please provide the title, and the start and end dates of the project. The start date should be when you plan to be involved in the study at the first site, and the end date should be when you plan to complete your involvement in the study at the last site. Please list the NHS organisation(s) and School/RI(s) where you will be working. Describe very briefly what activities you will be undertaking, e.g. prescribing medicine, taking blood, conducting behavioural therapy etc. If you know who will manage or supervise you or be responsible for your conduct in the NHS organisation, e.g. the Principal Investigator, please insert her/his name.

If you subsequently find that you need to conduct a study in additional NHS organisations, the details should be added in the Appendix, and the Research Passport should be submitted to the relevant NHS organisation(s).

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Section 3 - Declaration by Researcher

Section 3 - Declaration by Researcher

To be completed by Researcher

Question 6. Please tell us if you have ever been refused an honorary research contract or had it revoked by an NHS organisation and the reasons for it. Disclosing this information does not necessarily mean that you will be turned down in your application for an honorary research contract or letter of access this time, but it could be that particular training needs have to be addressed by the NHS organisation where you plan to undertake research or your substantive employer.

The Research Passport system relies on information about you in the Research Passport being shared with relevant NHS organisations instead of being duplicated by each NHS organisation. You are required to consent to this information being shared.

Section 4 - Suitability of Researcher

Section 4 - Suitability of Researcher

To be completed by researcher’s substantive employer, e.g. line manager, or academic supervisor

Question 7. This section should be completed by an appropriate manager from your employer who is responsible for ensuring that you are suitably trained, qualified and experienced to carry out the research. It could be your line manager or Head of School/RI. For students, your academic supervisor should complete this section.

Training should be commensurate with the nature of the research study and the research environment. Please ask the Principal Investigator or Chief Investigator for the study about your training needs in relation to Good Clinical Practice, data protection, use of equipment etc.

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Section 5 - Pre-engagement checks

Section 5 - Pre-engagement checks

To be completed by the HR Service of the researcher’s substantive employer or registry at place of study

This section is for the Human Resources (HR) Service of your substantive employer to complete and sign. Students should contact the Research Governance Officer for advice on completion of this section.

Question 8. For Regulated Activity:

**this section of the form is currently under review**

Your employer/place of study needs to confirm that you have a criminal record disclosure with no convictions or police information listed. The criminal record disclosure should have been obtained in the last six months. Details of the disclosure should be provided.  Your employer/place of study will not be asked to pass on any information in your criminal record disclosure. Your original copy of the disclosure (not a photocopy) should be provided when you submit the Research Passport to the NHS R&D office.

If you have not had a criminal record disclosure conducted in the appropriate time scale, you should arrange for a criminal records disclosure to be obtained through your employer/place of study.

If any convictions or police information have been reported in your disclosure, the NHS organisation receiving the Research Passport will need to request a criminal record disclosure. This is to ensure that it has relevant and up-to-date information on which to base decisions about issuing an honorary research contract.

Overseas staff/students should endeavour to have the necessary documents to show they do not have any previous convictions in their country of origin. The CRB overseas helpline can provide information on specific countries (0870 010 0450).

Question 9. Your employer/place of study must confirm that it completed checks with regard to identity, professional registration status and certificates of qualifications prior to employing/admitting you. It must also verify that you have had occupational health screening and are fit to carry out the research activities you plan to undertake. Your employer or, where appropriate, your place of study should provide written evidence of completion of the following checks:

  • employment screening:
    • ID with a photograph;
    • two references;
    • verification of permission to work/study in the UK;
    • exploration of gaps in employment;
  • occupational health screening;
  • evidence of professional registration;
  • evidence of qualifications.

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Section 6 - Instructions to applicants

Section 6 - Instructions to applicants

To be completed by Researcher

You are now ready to complete your Research Passport application. Indicate here which documents you have attached. If you do not require a criminal record disclosure or occupational health screening for the research activities you will be conducting, you should tick “Not Applicable”. If you have completed any Appendices, please give the numbers, otherwise tick “Not Applicable”.

Submitting the Research Passport

Submitting the Research Passport

When you have completed the form, obtained all the relevant signatures and collected the relevant documents to accompany your application, you should submit the Research Passport application to the R&D office at the lead NHS organisation where you wish to undertake your research. The lead NHS organisation may be the R&D office that is nearest to you, or the one that you originally approached about the project. You should provide original copies of all documents. The R&D office will complete the shaded sections of the form and take a photocopy for its records. The original Research Passport form and documents will be returned to you. Your honorary research contract or letter of access can now be issued to you by the NHS organisation.

The NHS organisation will take copies of the Research Passport and attachments for its records to provide an auditable system. Please note that, in accordance with criminal record disclosure guidance, photocopies of criminal record disclosures are not retained.

Once the shaded part of Section 8 has been completed and the form and documents have been returned to you, you have a complete Research Passport. This Research Passport will be valid for the duration of the project or for three years, as indicated in Section 8. You should keep it safe so that you can use it to apply to any other NHS organisation for an honorary research contract or letter of access.

In some cases it may be necessary to undergo additional screening in one NHS organisation because of the nature of the environment where you will be carrying out research. For example, if you are working with immune-compromised individuals you may have to undergo additional screening in line with the policy of the School/RI in which you will be undertaking research. The R&D office will let you know if you need to have additional checks. Please add the written evidence of these checks to the attachments to your Research Passport. If any additional checks are undertaken by an NHS organisation, this will be documented in Section 7.

To obtain an honorary research contract or letter of access from another NHS organisation listed on your Research Passport, you should submit the valid Research Passport (with the shaded sections completed) and the original documents to the R&D office at that NHS organisation. As before, a photocopy will be taken and an honorary research contract or letter of access issued.

Appendix

Appendix

Please ensure that you keep your Research Passport up to date. You should inform any NHS organisation where you are conducting research of any change in details, e.g. employment status, registration status, criminal record etc. Any failure to do so may result in termination of your honorary research contract or letter of access. Additions and amendments to the Research Passport appendix should be countersigned by the relevant R&D office. The R&D office will take a photocopy of any amendments and additions to the Research Passport. You should check that you do not need additional pre-engagement checks if you are taking on an entirely new research activity.

9. When will the NHS issue an honorary contract?

9. When will the NHS issue an honorary contract?

An honorary contract will be applied for, on production of the research passport, when authorised by the lead NHS organisation, to each NHS organisation where you will be conducting research, including the lead organisation. 

An honorary contract will be issued in the following circumstances:

  • Where there is no contractual relationship with the NHS ( i.e. you do not have a clinical contract) and
  • Where you will have a direct bearing on the quality of a patient’s clinical care (either through direct contact or indirectly by access to records.

In some situations when an honorary contract is not deemed necessary a letter of access will be provided.

10. What will be required for Students?

10. What will be required for Students?

If the research student is not appropriately qualified to undertake and it has a direct bearing on care then the supervisor must have an NHS honorary contract (or clinical contract) in place.

The student may need an honorary contact or letter of access. Please contact the Research Governance officer for advice

If the student is appropriately clinically qualified and experienced and the research has a direct bearing on clinical care, the student should be issued with an honorary contract.