Hr Research Proposals by sxq72523


More Info
									    Research Passport
Standard Operating Practice
Roles and Responsibilities

The Principal                The Principal Investigator (PI) is responsible under the
Investigator                 Research Governance Framework for Health and Social Care for
                             ensuring that all members of the research team are suitably trained
                             and qualified and that honorary contracts, honorary research
                             contracts and substantive contracts are held where required.
                             To issue the honorary research contract or letter of access after
Human Resources              discussion and agreement with the Research Governance
department of the NHS        Facilitator/or to liaise with the R&D Department dependent on local
Trust                        model.

The Research
                             To liaise with the HR department.
Facilitator/R&D Offices.     To ensure that all research governance checks are carried out and
                             adequate recording and monitoring systems established. Keep
                             details of those holding Honorary Research Contracts/Letters of
                             Access obtained through the Research Passport System, relevant to
                             their Trusts.

                             The researcher downloads form, completes and passes to HR. The
                             HEI, as the researcher’s substantive employer, will need
substantive employer,        to arrange for pre-engagement checks which are
normally this would be
University of Bath for our   commensurate with the nature of the research.
                             The HEI will then arrange for the researcher to be issued with
                             a Research Passport.

Researchers                  Researchers are required to work in a way that respects the Trust
                             and PCTs’ policies and procedures. A breach of them may lead to
                             termination of the Honorary Research Contract or Letter of Access.
                             Researchers are also required to disclose any new information which
                             may affect their CRB status.


1.1       This standard operating practice implements the NHS Research Passport Scheme,
          introduced by the UK Clinical Research Collaboration (UKCRC) to streamline NHS
          approval for clinical access by non-NHS researchers. Procedures are included for its
          implementation in the trust, and for new arrangements for governance of access to
          trust facilities, staff and service users for all health researchers. .

1.2       Research is an integral part of NHS activity.
         It identifies innovative ways of preventing, diagnosing and treating illness.
         It provides information on the costs, effectiveness and broader impact of health
         It provides the evidence base for the organisation, management and delivery of
          healthcare services to increase the quality of patient care, ensure better patient
          outcomes and contribute to improved population health.

1.3       The UK Clinical Research Collaboration (UKCRC) is a partnership of organisations
          working to establish the UK as a world leader in clinical research, by harnessing the
          power of the NHS. The UKCRC is working to promote a streamlined regulatory and
          governance environment that facilitates high-quality clinical research while protecting
          the rights, dignity and safety of patients. As part of its activities, it has coordinated the
          development of a Good Practice Resource Pack to help the NHS and other research
          employers take a consistent approach to handling Human Resources (HR)
          arrangements for those undertaking research in the NHS. The Pack forms the basis
          for this standard operating practice, and is available on the National Institute for Health
          Research website. The Pack also includes template documents including example
          honorary research contracts, letters of access and letters of agreement with other NHS
          organisations. All relevant documents are included in this standard operating practice
          as appendices.
1.4       Research within the NHS relies on working in partnership with the Higher Education
          sector and is often undertaken by non-NHS staff, including staff employed by Higher
          Education institutions. This relationship calls for clear understanding about
          responsibility, accountability, patient safety and duty of care. The Research
          Governance Frameworks published by the UK health departments require all parties
          undertaking research within the NHS to be clear about responsibilities and liabilities.
          One of the ways this is achieved is through appropriate use of honorary research

1.5       Inconsistency and the lack of clear guidance about the requirement for honorary
          research contracts have meant that they have been issued inappropriately in parts of
          the NHS. Where they have been underused, this has resulted in lack of clarity about
          liability. Where they have been overused, this has not only wasted the resources and
          time of HR, Research and Development (R&D) departments and researchers
          themselves, but has also placed inappropriate liability on NHS organisations.
1.6   Duplication of pre-engagement checks and inappropriate use of honorary research
      contracts wastes considerable amounts of time and resource for both HE and NHS
      organisations. Frustration with inconsistent approaches can harm working


2.1   This standard operating practice and procedure applies to all R&D conducted by
      individuals whose substantive employment is external to the Trust.

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


3.1   The Research Passport is one standard form for each researcher which provides
      evidence of .one set of checks on a researcher conducting research in the NHS. The
      form is completed by the researcher and her/his employer, and validated by an NHS
      organisation. The completed Research Passport is presented to all the relevant NHS
      organisations in order for an honorary research contract to be issued rapidly, with no
      duplication of checks.

3.2   The Honorary Research Contract is between the NHS organisation and the
      Researcher. It allows the Researcher access to the Trust premises, patients, clinical
      samples and clinical personal information.

3.3   A Letter of Access will be issued to those who do not require an Honorary Research
      contract. The standard letter concerns responsibilities of such Researchers and may
      be used for one project or a series of projects.

3.4   HEI’s- Higher Education Institutions.


4.1   The University is responsible for:

         ensuring the implementation and the requirements outlined within this Standard
          operating practice are observed.

         ensuring their individual Departments are made aware of the standard operating
          practice and their responsibilities within it and that staff are appropriately trained.

4.2   The University HR Department is responsible for:
              providing a single point of contact for its employees seeking to obtain Research

              training staff within the HR Departments to ensure compliance with the Research
               Passports Standard operating practice.
              ensuring appropriate pre-engagement checks are completed for its researchers, in
               order to complete a research passport.

              ensuring that procedures for pre-engagement checks and the issuing of honorary
               research contracts enable the research process.

              keeping records as appropriate.

4.3       Trust R&D offices are responsible for:

              Assessing the need for an honorary research contract from the individual’s
               employment status and the nature of the proposed research project or programme.

              Issuing a standard Letter of Access where an honorary research contract or further
               pre-engagement checks are not needed

              ensuring that Research Passports are forwarded to the appropriate Trust HR
               Directorate so that an honorary research contract can be issued if needed

4.4        The Researcher is responsible for:

The Universities requires all employees, full-time, part-time, salaried or honorary, students, who
plan or who are authorised to conduct research in the Trust or to use Trust facilities or
resources in the conduct of research, to observe the highest standards in the conduct of their
research. In pursuing such high standards, they shall:

          Notify the relevant Trust R&D Office at the earliest stage in the development of
           research proposals which involve the Trust.

          Provide the Trust R&D Office with a copy of any research proposals submitted which
           involve Trust patients, staff, data or facilities.

          Not start any research project prior to receiving written Trust management approval
           and a favourable ethical opinion.

          Ensure that they only undertake research activities for which they have relevant
           training qualifications and experience.

           Ensure that they have appropriate contractual status and indemnity arrangements to
           undertake research at the Trust.
         Follow relevant legislation and guidance on the appropriate conduct of research
          including the Research Governance Framework for Health and Social Care, the EU
          Directive for Clinical Trials and other relevant legislation and guidance.

         Only conduct research that is in line with the approved protocol including the
          arrangements for obtaining the consent of participants for all aspects of the research.

         Ensure that research participants have information about whom to ask questions about
          the research and to how to raise any complaints.

5.        KEY THEMES

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


6.1       The procedure for an external researcher to gain access to the Trust for research will
          vary depending on the researcher’s employment status, and the nature of the project.
          For all requests for access, the R&D Department will be the first point of contact.

6.2       The researcher will provide a full protocol for their research project together with details
          of their employment status. The R&D Department will then assess the need for the
          issuing of a research passport, to obtain an honorary research contract or letter of
          access. The Research Passport template document is accepted as the standard form
          either for application for a new Research Passport, or when complete, as the basis for
          issuing an honorary research contract. The Pre-Engagement Checks Grid (available in
          the UKCRC/NIHR Good Practice Resource Pack) details the requirements for different
          categories of staff, and should be used in making the judgement as to whether an
          honorary research contract is needed.

6.3       If a letter of access with no further pre-engagement checks is all that is required, the
          R&D Department will issue the letter of access using the standard template letter.

6.4       Researchers with no contractual relationship with the NHS require an honorary
          research contract only if the planned activities of the researcher involve interacting with
          individuals in a way that has a direct bearing on the quality of their care, i.e. the
          researcher could foreseeably directly affect the type, quality or extent of prevention,
          diagnosis or treatment of illness or foreseeably cause injury or loss to patients or
          service users to whom the Trust has a duty of care. Appendix 1 indicates how this
          influences the need for pre-engagement checks and the decision to seek an honorary
          research contract. Appendix 5 is a template honorary research contract and covering
          letter for use by the Trust.

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

6.6       Honorary research contracts do not provide a mechanism for access to confidential
          patient information without consent. Access to confidential patient information, either
          with patient consent or statutory support, does not require an honorary research

6.7       Researchers who do not require an honorary research contract may require additional
          pre-engagement checks to undertake permitted research activities in NHS

6.8       All external researchers will have an identified Trust Manager providing managerial
          supervision for their NHS activities.

6.9       Criminal Records Bureau (CRB) checks will be accepted as part of the Research
          Passport as a valid pre-engagement check up to a maximum of three years since the
          last check was completed.

6.10      Occupational Health screening performed by another NHS organisation will be
          accepted as part of the Research Passport’s pre-engagement checks without the need
          to routinely repeat this, unless the specific research project requires this. The Good
          Practice Resource Pack includes examples of occupational health screening
          documents recommended for use in processing research access requests.


         UKCRC/NIHR Good Practice Resource Pack, available at:

         Honorary Contracts- Principles and Requirements (NHS RD Forum Document-
          Appendix 9 to this standard operating practice)

To top