HR66 Research Passports Policy

Transcription

1 Research Passprts Plicy Plicy: HR66 Plicy Descriptr The NHS wrking with Higher Educatin Institutins (HEIs) has a Research Passprt system. It cnsists f a series f pre-engagement checks fr University staff/students wh are undertaking research in the NHS. The checks cnfrm t the standards required f all NHS bdies, and are therefre transferable acrss NHS Trusts D yu need this dcument in a different frmat? Cntact PALS r dpn-tr.pals@nhs.net Dcument Cntrl Plicy Ref N & Title: Versin: v1.1 HR66 Research Passprts Plicy Replaces / dated: Previus July 2009 Authr(s) Names / Jb Title respnsible / Ratifying cmmittee: Directr / Spnsr: Primary Readers: Additinal Readers Tbit Emmens Managing Partner, Research & Innvatin tbit.emmens@nhs.net Lcal Partnership Frum Darran Armitage Acting Directr f Wrkfrce and Organisatinal Develpment Staff engaging in Research Studies All staff Date ratified: May 2016 Date issued: May 2016 Date fr review: May 2018 Date archived:

2 Cntents 1. Intrductin Purpse Definitins Duties Access fr Research Related Dcuments Templates

3 1. Intrductin 1.1. Research is an integral part f NHS activity. It is cnsidered t be cre NHS business and is ften undertaken in partnership with a Higher Educatin Institutin (HEI) and thers. It identifies innvative ways f preventing, diagnsing and treating illness. It prvides infrmatin n the csts, effectiveness and brader impact f health technlgies. It prvides the evidence base fr the rganisatin, management and delivery f healthcare services t increase the quality f patient care, ensure better patient utcmes and cntribute t imprved ppulatin health As a result f the partnership arrangements that characterise research, this activity raises Human Resurces (HR) management issues fr NHS rganisatins Research within the NHS is ften undertaken by NHS staff nt directly emplyed by the hst NHS rganisatin, r by nn-nhs staff, particularly researchers emplyed by HEIs. Cnsequently there are questins abut respnsibility, accuntability, patient safety and duty f care Research is als frequently undertaken acrss a number f NHS rganisatins and requires arrangements fr bth NHS and nn-nhs staff t wrk acrss thse rganisatins The Research Gvernance Framewrks published by the UK Health Departments require all parties undertaking research within the NHS t be clear abut respnsibilities and liabilities. One f the ways this is achieved is thrugh using HR prcedures apprpriately The NHS and HEIs have respnsibilities as emplyers f researchers. Only the emplyer can be accuntable fr the suitability f the individual in terms f training, experience and cnduct. The substantive emplyer retains the primary accuntability and liability fr the actins f their researchers Once NHS rganisatins have given permissin fr research that affects their legal duty f quality and cmmn law duty f care, they then accept vicarius liability fr harm due t clinical negligence (Research in the NHS: indemnity arrangements Department f Health 2005 and Respnsibilities, liabilities and risk management in clinical trials f medicines, Department f Health and Universities UK, 2004) Incnsistency and the lack f clear guidance abut the requirement fr hnrary research cntracts has meant that they have been issued inapprpriately in parts f the NHS and have als placed inapprpriate liability n NHS rganisatins Duplicatin f pre-engagement checks and inapprpriate use f the hnrary research cntract wastes cnsiderable amunts f time and resurce fr bth HEIs and NHS rganisatins The UK Health Departments thrugh the auspices f the Natinal Institute fr Health Research (NIHR) prmte streamlined regulatry and gvernance prcesses that facilitate high-quality clinical research while prtecting the rights, dignity and safety f patients. As part f these activities a Research in the NHS HR Gd Practice Resurce Pack has been develped t help the NHS and ther research emplyers take a cnsistent apprach t handling HR arrangements fr thse undertaking research in the NHS. This cnsists f: A Research Passprt Scheme / system fr HEI researchers wh need t undertake their research within NHS rganisatins. The Research Passprt scheme prvides: 3

4 clear guidance n the relevant pre engagement checks required a rbust prcess fr HEI emplyers t dcument and evidence the checks that have been undertaken clear principles that enable NHS rganisatins t have a recrd and rely n thse checks fr the duratin f the Research Passprt standardised prcedures fr issuing NHS Hnrary Research Cntracts (HRCs) r Letters f Access (LAs), in line with the nature f the researchers activity, and the NHS and / r emplyer s respnsibility fr that activity standardised prcedures fr handling HR arrangements fr NHS and HEIs researchers wh need t wrk acrss ne r mre NHS rganisatins clarifies the areas f respnsibility, and hence liability, f NHS rganisatins and HEIs in relatin t researchers neither NHS rganisatins nr HEIs shuld take respnsibility fr issues that are utside their ability t fully discharge The benefits f the HR Gd Practice Resurce Pack are that it: clarifies accuntability and respnsibility fr researchers in the NHS, resulting in increased patient safety and imprved risk management imprves emplyers management versight and quality assurance f their research staff prvides clear HR prcesses, in line with NHS Emplyers' Check Standards, resulting in mre efficient wrk prcesses minimises duplicatin f activity, resulting in better use f resurces facilitates research within the NHS, resulting in faster study set-up The Trust is a partner f the NIHR and as such is required t adpt and implement the Research Passprt Scheme. These guidelines utline the prcess fr using the Research Passprt Scheme, intrduced by the NIHR t streamline NHS apprval fr access by bth NHS and nn-nhs researchers Prcedures are included fr its implementatin in the Trust, and fr arrangements fr gvernance assciated with access t trust facilities, staff and service users fr all health researchers The Research Passprt des nt remve the need t apply t the Research & Develpment (R&D) department f the NHS rganisatin fr permissin t undertake the research study. Researchers must check with the relevant Principal Investigatr that R&D apprval t cnduct the research in the NHS rganisatin has been granted by the Trust Other Trusts may differ when passprt applicatins are apprved. Trust plicy is that an Hnrary Research Cntract r Letter f Access will nly be issued: prviding all checks and dcuments are cmplete and valid as part f the Research Passprt applicatin prcesses etc. and - The Research Study has been granted Trust R&D apprval; unless special permissin is requested and apprved by the R&D Manager r authrised deputy, where cnditinal apprval may be issued instead where a generic (3 years) HRC/LA is requested. This will be issued as abve prviding a relevant research study has already btained valid Trust R&D apprval r when the first apprpriate study is granted Trust R&D apprval. 4

5 2. Purpse 2.1. These guidelines apply t all externally emplyed researchers undertaking their activities in the NHS (n site with the Trust) The primary bjective is the implementatin f the Research Passprts Scheme via adptin f the NIHR Research in the NHS HR Gd Practice Resurce Pack (September 2012) 2.3. This plicy and prcedure applies t all R&D cnducted by HEI based individuals whse substantive emplyment is external t the Trust. 3. Definitins 3.1. The Research Passprt (RP) is ne standard frm fr each researcher which prvides evidence f ne set f checks n a researcher cnducting research in the NHS. The frm is cmpleted by the researcher and her/his substantive emplyer, and validated by an NHS rganisatin. Once the frm has been authrised by ne NHS rganisatin it becmes a valid Research Passprt that yu can prvide t ther NHS rganisatins fr the issue f an NHS Hnrary Research Cntract/ Letter f Access. The cmpleted & validated Research Passprt must be presented t all the relevant NHS rganisatins in rder fr an hnrary research cntract / Letter f Access t be issued rapidly, with n duplicatin f checks. RPs will fllw the accepted frmat and details as per current NIHR recmmendatins. The Research Passprt is issued fr up t 3 years maximum. Researchers must re apply where an extensin beynd 3 years is required The Hnrary Research Cntract (HRC) is between the NHS rganisatin and the substantive emplyer f the Researcher. It allws the Researcher access t the Trust premises, patients, clinical samples and clinical persnal infrmatin. HRCs will fllw the accepted frmat and details as per current NIHR recmmendatins A Letter f Access (LA) will be issued t thse wh d nt require an Hnrary Research Cntract. The standard letter cncerns respnsibilities f such Researchers and may be used fr ne prject r a series f prjects. LAs can be issued as study specific r generic where the research is invlved in mre than ne study. LAs will fllw the accepted frmat and details as per current NIHR recmmendatins. 4. Duties 4.1. The Trust Bard is respnsible fr: prviding delegated authrity t the Trusts R&D Department fr the implementatin, management and cnduct f the Research Passprt Scheme ensuring the implementatin and the requirements utlined within this Plicy are bserved and will receive Perfrmance Reprts frm the R&D Department as required ensuring their individual Directrates are made aware f the guidelines and their respnsibilities within it and that staff are apprpriately trained The R&D Department is respnsible fr: prviding a single pint f cntact fr externally emplyed individuals seeking t cnduct research in the Trust assessing the need fr an hnrary research cntract/ frm the individual s emplyment status and the nature f the prpsed research prject r prgramme 5

6 issuing a standard Letter f Access where an hnrary research cntract r further preengagement checks are nt needed auditing the Trust s perfrmance in using the Research Passprts Scheme t speed up researcher access t the NHS ensuring apprpriate pre-engagement checks are cmpleted fr external researchers, in rder t cmplete a research passprt, when the Trust is the first NHS rganisatin apprached by the researcher ensuring that an hnrary research cntract r letter f access is issued in respnse t a request t the R&D Department fr an external researcher, where a research passprt already exists ensuring that prcedures fr pre-engagement checks and the issuing f hnrary research cntracts enable the research prcess 5. Access fr Research 5.1. The prcedure fr an external researcher t gain access t the Trust fr research will vary depending n the researcher s emplyment status, and the nature f the prject. Fr all requests fr access, the R&D Department will be the first pint f cntact Fllwing the Trust apprval prcess, the researcher will prvide details f their emplyment status and CV. The R&D Department will then assess the need t apprve a research passprt (if the Trust is the first NHS rganisatin an external researcher has apprached), r mre cmmnly an hnrary research cntract HRC r Letter f Access LA - See Where the Trust is the first NHS rganisatin an external researcher has apprached: if a Research Passprt is cnsidered necessary (as per Appendix 1 matrix); researchers and their HR department must cmplete the Research Passprt Applicatin Frm; (available frm the R&D Office) and submit it t the R&D Department; where a decisin will be made n whether an hnrary research cntract HRC r Letter f Access LA is issued; whichever is apprpriate Where an Hnrary Research Passprt is cnsidered nt necessary (as per Appendix 1 matrix); i.e. fr NHS substantive emplyees r substantive HEI staff with Hnrary Clinical NHS cntracts e.g. Clinical Academics; an NHS t NHS prfrma cnfirmatin f preengagement checks must be cmpleted by the applicant s emplyers instead (available frm R&D Office) Researchers must cmplete the applicatin frm fllwing the flw charts in Appendices 3A (single site) and 3B (Multi centre) and guidance ntes available frm the R&D Department. The Pre-Engagement Checks table (Appendix 4) detailing the requirements fr different categries f staff; shuld be used in making the judgement as t whether CRB; Occupatinal Health is needed and whether a HRC r LA is needed Disclsure and Barring Service (DBS); (frmerly knwn as Criminal Recrds Bureau (CRB)) checks will be accepted as part f the Research Passprt as a valid pre- engagement check up t a maximum f three years since the last check was cmpleted. Guidance n when a DBS check is required is given in Appendix 4. It is expected that where research invlves the Trust s service users/patients/carers they will be cnsidered a vulnerable grup, s that enhanced DBS checks will be the nrmal requirement Occupatinal Health screening perfrmed by anther NHS rganisatin will be accepted as part f the Research Passprt s pre-engagement checks withut the need t rutinely repeat this, unless the specific research prject requires this. Under these circumstances the R&D ffice will request evidence such checks have been undertaken. 6

7 5.8. The R&D ffice will issue either a LA an (HRC) using standard NIHR / DH endrsed template letters, dependant n emplyment status and research activity t be undertaken Researchers with a substantive emplyment cntract with ne NHS rganisatin d nt need an HRC t cnduct research in anther NHS rganisatin. The Trust will accept an NHS t NHS prfrma, additinal pre-engagement checks may ccasinally be required. A LA shuld be issued detailing the researcher s respnsibilities. NHS rganisatins shuld infrm the researcher s substantive emplyer f her/his activities in their rganisatins via a cpy f the LA Researchers with an hnrary clinical cntract with ne NHS rganisatin d nt need additinal hnrary research cntracts t cnduct research in ther NHS rganisatins. Additinal pre-engagement checks may ccasinally be required. A letter f access shuld be issued detailing the researcher s respnsibilities. NHS rganisatins shuld infrm the researcher s substantive emplyer f her/his activities in their rganisatins via a cpy f the letter f access Researchers with n cntractual relatinship with the NHS require either an HRC; where the planned activities f the researcher invlve interacting with individuals in a way that has a direct bearing n the quality f their care, i.e. the researcher culd freseeably directly affect the type, quality r extent f preventin, diagnsis r treatment f illness r fresee ably cause injury r lss t patients r service users t whm the Trust has a duty f care. Otherwise a Letter f Access will be issued. Researchers wh d nt require an hnrary research cntract may require additinal pre-engagement checks t undertake permitted research activities in NHS rganisatins. Appendix 4 indicates hw this influences the need fr pre- engagement checks and the decisin t seek an hnrary research cntract Substantive emplyers (usually HEI s) retain respnsibility fr ther research activities that d nt affect the NHS rganisatin s duty f care Hnrary research cntracts d nt prvide a mechanism fr access t cnfidential patient infrmatin withut cnsent. Access t cnfidential patient infrmatin, either with patient cnsent r statutry supprt, des nt require an hnrary research cntract All external researchers will have an identified Trust Emplyee f suitable senirity prviding managerial versight and supervisin fr their NHS activities Where applicable all researchers issued with an HRC r LA undertaking research within Devn Partnership NHS Trust will be asked t sign a standard Trust cnfidentiality frm prir t cnducting any research Researchers wh carry ut research activity within health and scial care settings in respect f healthcare and scial care activity will be subject t the Prtectin f Freedms Act 2012 (PFA), which came int effect in September Researchers and their emplyers shuld ensure that where applicable new Research Passprt applicatins are supprted by an apprpriate disclsure. In particular, frm September 2012 nwards emplyers shuld nly request a check against the Independent Safeguarding Authrity (ISA) barred list(s) fr psitins that fall within the pst-september definitin f regulated activity. Please nte, anyne within the pre-september 2012 definitin f regulated activity will remain eligible fr enhanced DBS (CRB) checks, whether r nt they fall within the pst-september definitin f regulated (see Appendix 5) The Department f Health has published infrmatin n the scpe f regulated activity in relatin t adults, as defined in the Safeguarding Vulnerable Grups Act 2006 (SVGA) which has been amended by the Prtectin f Freedms Act 2012 (PFA). The Department f Educatin has published infrmatin n the scpe f regulated activity in relatin t children. See Appendix 5 fr a summary f the new definitin f regulated activity. 7

8 5.18. The 10 September changes are mst likely t affect researchers wh need a Research Passprt fr the first time, r whse Research Passprt needs renewal, r whse research activity changes significantly. If researchers are already wrking under a current valid Research Passprt r NHS t NHS prfrma, prviding that their rles, respnsibilities and level f cntact with adults r children d nt significantly change, they may cntinue wrking under the assurances prvided by their emplyer until their research passprt expires. As had been the case befre the September 2012, the key triggers fr a new CRB check fr individuals wrking under a valid research passprt are when: the researcher has never had a criminal recrd check befre and are mving t a psitin that nw requires them t have a check. The level f check is dependent n the rle the respnsibilities f their research rle has changed and they require a higher level f check, r a check against ne r bth barred lists. 6. Related Dcuments HR28 Equality and Diversity HR48 Criminal Recrds Disclsures Plicy UKCRC/NIHR Research in the NHS - HR Gd Practice Resurce Pack, available at: 7. Templates 7.1. Standard versins f the NHIR templates fr the Research Passprt letters fr LAs and HRC and NHS-NHS Pre engagement checks prfrma are als available frm: 8