Research Governance: Submitting a Research Application to the Research Operations Unit for NoCLoR

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Research GovernanceSubmitting a Research
Application to the Research Operations Unitfor
NoCLoR
 

• Guy Eaton, BSc, MSc, LDIP
• Research Operations Office St Pancras Hospital
• mabel.saili_at_camdenpct.nhs.uk
• 020 7445 8506
• www.noclor.nhs.uk

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Learning Outcomes

• To learnt about what NoCLoR is and how to contact
  its staff as well as where to obtain further
  information.
• To understand the concept of Research Governance,
  its derivations and why it exists.
• To have a greater understanding and knowledge of
  the process of Research Governance within the
  North Central London Research Consortium.

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Who and Where

• Research Development Unit for NoCLoR
• Research Governance Operations Office
• Camden PCT
• 3rd Floor West Wing
• St Pancras Hospital
• 4 St Pancras Way
• London
• NW1 0PE
• www.noclor.nhs.uk (all documents can obtained
  from here)
• 020 7445 8506 or email mabel.saili_at_camdenpct.nhs.u
  k
• 0207 530 5375/3055/3944

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What is NoCLoR and Who Does it Serve?

• NoCLoR is an acronym that stands for North
  Central London Research Consortium. It serves
  five PCTs and two mental health trusts with
  regard to governing their research.
• CAMDEN PCT
• ISLINGTON PCT
• BARNET PCT
• ENFIELD PCT
• HARINGEY TPCT
• CAMDEN ISLINGTON MENTAL HEALTH AND SOCIAL CARE
  TRUST
• BARNET ENFIELD AND HARINGEY MENTAL HEALTH TRUST

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• Why is there a need for Research Governance?
• An Infamous Example
• Eight months after it emerged that the organs
  of 893 children were removed and retained without
  their parents' consent, Europe's biggest
  children's hospital is still struggling to come
  to terms with the crisis. The bright cartoon
  murals that decorate the corridors and wards of
  the Liverpool complex belie a darker mood among
  staff and parents Strain is telling on staff as
  they pick up the pieces at Alder Hey, its
  reputation shattered by retention of children's
  organs without consent
• The Guardian Saturday June 3, 2000

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NoCLoR's Definition of Research Governance (RG)

• RG refers to a governance of research that
  utilises the principles of high quality ethical
  research in health and social care.  It is the
  key to ensuring research is conducted legally  to
  high methodological and ethical standards.  It
  applies to any research on "normal
  volunteers" carried out in settings for which the
  Secretary of State for Health and Social Care has
  ultimate responsibility.  The Research Governance
  Framework sets standards for the research process
  and formalises the responsibilities of all those
  involved.

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The Department of Health's Definition Of RG

• Research governance improves research quality
  and safeguards the public by- Enhancing ethical
  and scientific quality- Promoting good
  practice- Reducing adverse incidents and
  ensuring lessons are learned- Preventing poor
  performance and misconduct Research governance
  is for all those who- Participate in research-
  Host research in their organisation- Fund
  research proposals or infrastructure- Manage
  research- Undertake research 

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Sources of RG

• RG rules and regulations are derived from the
  following two sources
• 1. Framework Documents. These include
• The Research Governance Framework for Health and
  Social Care First Edition (2001).
• The Research Governance Framework for Health and
  Social Care Second Draft Edition (2003).
• There is now a Second Edition 2005.
• 2. Legal / Legislative Sources. These include,
  for example, the Human Rights Act 1998, the Data
  Protection Act 1998, the Freedom of Information
  Act 2000 and EU law. Honorary contracts may also
  be important for non-NHS staff, or staff who are
  conducting research in other NHS Trusts.

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Sources of RG Continued

• Honorary Contracts
• Generally, university and other non-NHS staff
  who conduct research in the NHS are required to
  hold an honorary NHS contract.  These are to be
  used by the NHS to ensure that the non-NHS
  researchers are contractually bound to take
  proper account of the NHS duty of care and to
  follow the requirements of Research Governance in
  the conduct of their research.  It also ensures
  that these researchers are covered by the NHS
  indemnity HSG96/48 (arrangements for clinical
  negligence). Also, for UCL clinical psychology
  trainees if you are carrying out your study in a
  trust other than CI, you need to get an honorary
  contract from that trust's Human Resources
  department. If this is part of the NoCLoR area
  Camden PCT will issue this contract on behalf of
  that trust.

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Project Registration Process

• In Order for Your Research Proposal to Be Valid
• You are required to register with NoCLoR Research
  Operations Office at St Pancras Hospital if your
  proposal entails conducting research in NoCLoR's
  area.  Proposals will be registered with NoCLoR
  through the online database ReDA, and also
  submitted to the Department of Health's  National
  Research Register. Barnet, Enfield and Haringey
  Mental Health Trust have a separate registration
  system, for which you need to contact Cecilia
  Burns a Research Governance Officer for this
  area.

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• If your proposal will involve any of the 6 NoCLoR
  Trusts' resources, staff, staff time, patients
  and/or their records, then your proposal will
  require registration with NoCLoR.  In order to
  register the proposal, NoCLoR will require that
  you send the following to the Registrar
• Signed Registration Form.
• Protocol.
• Service Managers local support.
• Honorary contracts (if applicable).
• Criminal Records Bureau Disclosure (if
  applicable).
• Peer review comments and peer reviewers CV or
  academic supervisors comments and academic
  supervisors CV.
• Funding letter (if applicable.
• Intellectual Property rights form.
• COREC application form.
• Patient information sheets, consent forms,
  questionnaires, etc.
• LREC favourable ethical opinion or MREC
  favourable opinion letter and Site Specific
  Assessment (if applicable).

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What the R D Unit does... and why are Research
Projects Registered

• Ensures research is conducted in accordance with
  the Research Governance Framework for Health and
  Social Care
• Assesses and accounts for Infrastructure Costs
  accrued due to research, including costing of
  staff, facilities and services.
• Registers Research on the National Research
  Register.
• Research registration is a prerequisite to
  obtaining approval to conduct research using
  Trust patients, staff or resources
• Maintains communication with researchers and
  informs them about funding opportunities
• Deals with ad hoc RG enquiries.

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Submitting a Project to the RD Unit

• Acquire forms The Trainee Clinical Psychologists
  short form or the standard longer registration
  forms for C and I or BEH.
• Establish who will be supervising the project.
• Find a peer reviewer.
• Obtain service manager support.

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• Governance issues assessed by all RD units
• Service Manager Approval
• Peer Review and methodological quality of the
  research
• Assessment of adherence to RG / audit
• Honorary Contracts
• Infrastructure costs and any funding
• Data Protection
• Intellectual Property Assessment
• Research Ethics Committee Approval

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• Research Project Data Collection Form
• Who should use this form?
• This form is intended for Clinical Psychology
  Trainees who are both
• Employees of Camden Islington Mental Health and
  Social Care Trust, and
• Conducting research in organisations other than
  the Care Trust, Camden PCT, Islington PCT, Barnet
  PCT, Enfield PCT or Haringey PCT
• This information is being collected for research
  governance purposes and to ensure the appropriate
  indemnity cover is in place before you begin your
  research.
• Why do we need this form?
• All research supported by the Care Trust,
  (either in its own services or if conducted by
  Care Trust staff at other sites) must be
  conducted in accordance with the Department of
  Health Research Governance Framework for Health
  and Social Care. It is a requirement of research
  governance that Trusts need to be aware of such
  research.
• We therefore ask that you complete a version of
  our project registration form, which has been
  abbreviated to take into account that the
  research will not be taking place in
• CAMDEN ISLINGTON MENTAL HEALTH AND SOCIAL CARE
  TRUST
• CAMDEN PCT
• ISLINGTON PCT
• BARNET PCT
• ENFIELD PCT
• HARINGEY PCT
• PLEASE NOTE THAT IF YOUR RESEARCH USES THE
  PATIENTS, STAFF, PREMISES OR OTHER RESOURCES OF
  THE ABOVE TRUSTS YOU MUST APPLY FOR APPROVAL TO
  UNDERTAKE RESEARCH USING A STANDARD PROJECT
  REGISTRATION FORM.
• Please return to Angela Williams
• Research Development Unit
• 3rd Floor, West Wing

• Research Project Data Collection Form for
  Clinical Psychology Trainees
• Name
• Telephone number
• e-mail
• Title of the project
• Academic Institution
• Supervisor
• Supervisor Telephone number
• Supervisor e-mail
• NHS organisation's) where participants are being
  recruited for the project. (If recruited through
  primary care, give PCT if not being recruited
  through the NHS state how recruitment will be
  conducted, any non-NHS bodies involved and give
  the geographical area).
• All NHS organisations named above (at question
  9) need to give approval for your research.
  Please provide a copy of the approval letter or
  give contact details of the RD office that has
  approved your research (if possible quoting any
  reference number they have issued you with)
• 11. Please indicate which Research Ethics
  Committee this project has been reviewed by.
• Please attach copies of letters with appropriate
  reference number's)
• 12. Your ethics application form will have asked
  you about indemnity or insurance for the project.
  Please reproduce the information you gave.
• 13. Project start date
• 14. Project end date

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Signatures

• Applicants signature
• Service Manager of service where you will be
  working
• Peer Review

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After submitting an application

• Time-frame Once all documents have been
  received by the Research Operations Office, there
  will be a pre-screening meeting 13 days later to
  discuss issues relevant to the proposed research
  project. If all documents have not been received
  the application is not valid and will not be
  pre-screened for the RG approval process.
  Timescales should not be underestimated as the
  whole process could take up to 3 months
  especially if Criminal Record Bureau Clearance is
  required together multiple honorary contracts.
• Letter of ApprovalThis is the last stage in
  the RG process before the research has been
  approved to commence.

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After Research Projects Have Commenced 10
of Research Projects are Subject to a Random
Audit to Determine Whether RG Guidelines are
Being Adhered to.Audit has two basic
functions1. To Police the adherence of
RG2. To help researchers.
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After Finishing a Project

• Researchers are required to inform the unit when
  their project has finished.
• Researchers are required to adhere to the
  authorship guidelines of the unit.