RESEARCH & DEVELOPMENT DIRECTORATE FREQUENTLY ASKED QUESTIONS Applying for an Honorary Research Contract (including the Research Passport) What is an Honorary Research Contract? The Department of Health Research Governance Framework requires that researchers not employed by the NHS who interact with users in a way that has direct bearing on their care (i.e. interventional studies) should hold an honorary contract. The honorary contract ensures accountability with the NHS organisation and may be in the form of an Honorary Clinical Contract or an Honorary Research Contract (HRC). Who needs an Honorary Research Contract? Researchers who hold a substantive or existing honorary contract with the Trust do not need an HRC. Researchers with substantive NHS contracts with other Trusts also do not require an HRC, but should forward their contract details to the CMMC R&D Office. It is not always appropriate for an HRC to be issued to some researchers and Table 1 outlines the situations that require an HRC and those that do not. Some researchers may not need an HRC but may still require a pre-employment check and these situations are listed in Table 1. In addition, an HRC is not required where the researcher: has a valid HRC not obtained through the Research Passport system from one of the teaching hospitals in Manchester or has a valid HRC issued through the Research Passport system from any Trust in Greater Manchester, (the HRC must be appropriate for the proposed research activities to be undertaken at CMMC). Researchers should forward their HRC (and Passport) to the CMMC R&D Office is a Specialist Training Registrar (on rotation through the NW Deanery) is an undergraduate student on clinical placement where there is an agreement between the University and the Trust What is the Research Passport? In April 2005, the Greater Manchester Research Alliance (GMRA) adopted the Research Passport. The Passport is essentially a standardised application form used by researchers to apply for an HRC from Trusts in Greater Manchester. The Passport provides assurance to the Trust where the researcher wishes to conduct research that appropriate checks have been carried out. Once a Passport has been validated by one Trust and an HRC issued, then that HRC will be accepted at other GMRA Trusts, eliminating the need for multiple contracts. How do I apply for an HRC? 1 Use the flowchart in Appendix 1 to establish: Is an HRC is required and if so, what type? If an HRC is required, what (if any) pre-employment checks (CRB and occupational health) are required? If an HRC is not required, what (if any) pre-employment checks are required? HRC and RP FAQ v1 May 06 Page 1 of 6
2 Researchers employed by Greater Manchester Trusts should apply for an HRC via the Research Passport. Other applicants must use the HRC Application Form. Both forms can be downloaded from the CMMC R&D intranet site at: http://intranet.cmht.nwest.nhs.uk/directorates/deptrandd/ and are also available from the University of Manchester and other Trusts. 3 If you do not believe an HRC is required for your research, then the CMMC R&D Office must be notified of the reasons and any pre-employment check information must also be supplied. Research cannot commence until confirmation has been received from the R&D Office. 4 Existing valid HRCs (and Passports) must be forwarded to the R&D Office. Research cannot commence until confirmation has been received from the R&D Office. How do I complete the Research Passport? Use the following information to complete sections 1-7 of the Passport. Section 1 Include details of your employer or for students, your supervisor. If you are a student, state your place of study. List your status in the study, e.g. Principal Investigator. Section 2 There are two types of Passport (and HRC), either a fixed term project-specific type or for 5 year type. The project-specific Passport is for researchers who may be involved with a time limited study only or who may be working on a time limited contract on one particular study. Provide the title of the study if this is the case and provide a start and end date. The 5 year type of Passport is for researchers who are working on a number of studies, such as researchers on permanent contracts. Provide a list of titles of studies you are involved with in your application. You may include projects planned in the next year. You should update your passport with any new studies and present the updated form to all relevant NHS R&D offices. State the organisations where you will be working, including details of the departments (and hospitals), who will supervise you or be responsible for your conduct. Section 3 State if you have ever been refused an HRC or had it revoked and the reasons why. Disclosing this information does not necessarily mean that you will be turned down for an HRC. Section 4 This section should be completed by the person who is responsible for ensuring that you are suitable in qualification and experience to carry out the research, e.g. line manager or Principal Investigator. Section 5 The flowchart in Appendix 1 and Tables 1 and 2 should help you and the Human Resources (HR) department at your employing organisation determine whether and what type of preemployment checks you require. Your employer s HR department will sign to confirm that they have completed checks with regard to identity, professional registration status and certificates of qualifications prior to employing you. They must also verify that you have had occupational health screening and are fit to carry out the duties of your post in the environment you have been employed to work in. The University of Manchester Faculty of Medical and Human HRC and RP FAQ v1 May 06 Page 2 of 6
Sciences HR Office are now assisting with Passports for their employees, contact Sandra Walker on 275 2905 or S.Walker@manchester.ac.uk). If required, your HR department should provide you with an occupational health certificate indicating the screening conducted and also a CRB Disclosure that should be no more than 6 months old. 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 help-line can provide information on specific countries (08700 100450). For student projects where the individual is not employed by the University, the signature should be provided by your research supervisor. Section 6 In some cases it may be necessary to undergo additional health screening because of the nature of the environment where you will be carrying out research. The R&D office will let you know if you need additional checks. Section 7 Use this section to indicate what documents you have provided with your form. You should provide original copies of all documents in your application. The R&D Office will take copies of the documents for our records. You should inform any Trust where you are conducting research of any changes of details, e.g. employment status. Additions and amendments to the Passport appendix should be countersigned by the relevant R&D office. You should check that you do not need additional employment checks if you are moving into an entirely new area of work. How do I submit 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 Passport to the CMMC R&D office at: 1st Floor, Postgraduate Centre Manchester Royal Infirmary Oxford Road Manchester M13 9WL Tel: 0161-276-3565 Fax: 0161-276-5766 Where can I get further help? Please contact Andrea Evans for further information on andrean.evans@cmmc.nhs.uk or on 0161 276 5787 or visit the R&D Office website at http://intranet.cmht.nwest.nhs.uk/directorates/deptrandd/. HRC and RP FAQ v1 May 06 Page 3 of 6
Appendix 1 Does the research activity require an HRC (use Table 1)? YES NO Is a CRB check required (Table 1)? Is a CRB check required (Table 1)? YES NO YES NO What type of CRB What type of CRB check is required check is required (Table 2)? (Table 2)? Use Table 1 to determine whether Occupational Health clearance required Forward information about the research and any preemployment check information to CMMC R&D Office Is the HRC required for research involving one project (fixed type) or many projects (5 year type)? Await confirmation from R&D Office before commencing research Download Research Passport form and complete Forward completed Passport and documents to CMMC R&D Office Await HRC to be issued before commencing research HRC and RP FAQ v1 May 06 Page 4 of 6
Table 1 HRC and pre-employment check information Direct contact with patients/service users and direct bearing on their care, jncluding children and vulnerable adults, e.g. interventional study Direct contact with patients/service users but no direct bearing on their care (e.g. observer) Indirect contact with patients/service users and direct bearing on their care (e.g. follow up via telephone) Indirect contact with patients/service users, but no direct bearing on their care (e.g. telephone interviews) Access to identifiable patient data, tissues or organs with consent with likely direct bearing on their care Access to identifiable patient data, tissues or organs with consent but no direct bearing on their care Access to identifiable patient data, tissues or organs without consent, but no direct bearing on their care Access to anonymised patient data, tissues or organs only (including research staff analysing data) HRC required? CRB check required? Occupational health clearance required? Yes Yes Yes Yes Yes Yes Standard disclosure may be required Yes Direct contact with staff Access to identifiable staff data Access to anonymised staff data only HRC and RP FAQ v1 May 06 Page 5 of 6
Table 2 CRB Disclosure requirements at CMMC DIVISION AREA CRB DISCLOSURE LEVEL OF CRB DISCLOSURE REQUIRED? Medicine All Yes Clinical staff - enhanced Surgery All Yes Clinical staff - enhanced St Mary's Hospital All Yes Enhanced for all staff in all areas Clinical & Scientific Services Clinical research Yes Enhanced Phlebomotomy Yes Enhanced Biochemistry Yes Enhanced Immunology Yes Enhanced Haematology Yes Enhanced Theatres Yes Enhanced Anaesthetics Yes Enhanced Virology Yes Standard Cytology Yes Standard MLA Drivers Yes Standard Microbiology Yes Standard Histopathology Yes Standard Radiology Yes Standard Pharmacy Yes Standard Nuclear medicine Neurophysiology Sterile services Corporate Services Wellcome Trust CRF Yes Clinical staff - enhanced Royal Eye Hospital All Yes Clinical staff - enhanced Dental Hospital All Yes Clinical staff - enhanced Children's All Yes Enhanced for all staff in all areas HRC and RP FAQ v1 May 06 Page 6 of 6