1. Research Governance and Sponsorship
Andrew Johnston
Research Management & Governance (RM&G) Manager

2. Research Governance and Sponsorship
Background to Research Governance
Research Sponsorship
Funding your Project
Gaining Study Wide Regulatory Authorisations
Local/site level NHS R&D approval
NIHR Portfolio
Good Clinical Practice (GCP)
Site files & Essential documentation
Source Documentation
Informed Consent
NuTH R&D figures

3. Why Have Research Governance?
Episodes in history have shaped the regulation of research
led to the introduction of governance and Good Clinical Practice (GCP)
World War II & Nuremberg Trials
(Led to the creation of the Declaration of Helsinki in the foundation of the ethical principles on which GCP was built)
Tuskegee Syphilis Experiment
(US public health study conducted for 40 years to study the progression of syphilis led to changes in the law governing protection of participants in clinical research)
More recently……
Bristol and Alder Hey investigations into retained organs
Research Governance Framework implemented in 2001

4. Research Governance Framework (RGF)
The Research Governance Framework (RGF) was developed by the DoH to set out the principles, requirements and standards for healthcare research (2001).
Ethics
Science
Health & Safety
Information
Finance
Quality Research Culture

5. Research Sponsorship (1)
All research conducted in the NHS must have an identified Research Sponsor.
An individual or organisation that takes on responsibility for ensuring proper arrangements to initiate, finance, monitor and manage a study.
Responsibilities include:
Participant Rights and Dignity
Scientific Quality (Peer review)
Appropriate Ethical Review
Investigators
Intellectual Property
Regulations and legislation
Contractual arrangements
Who?
NHS Trusts, Universities, Government Bodies, Commercial Organisations.
Funding bodies often require a sponsor authorisation on the application form

6. 1 2 3 Funding application Study design Funding Awarded NHS Permission
Choose an appropriate methodology & outcome
Provide justification of the sample size
Draw up a statistical analysis plan
Data Handling
Prepare and present interim reports
Research Sponsorship
& governance 1
Portfolio Adoption
Authorisations
Obtained 2
Authorisations
Obtained 3
NHS Permission
CSP Governance
Review
Start study

7. Definitions of types of NHS costs:
Research Costs - the costs of the R&D itself that end when the research ends. They relate to activities that are being undertaken to answer the research questions – funded by the Grant / Fellowship NHS Support Costs - the additional patient care costs associated with the research, which would end once the R&D study in question had stopped, even if the patient care involved continued to be provided NHS Treatment Costs - the patient care costs, which would continue to be incurred if the patient care service in question continued to be provided after the R&D study had stopped – funded by usual commissioning sources NHS Excess Treatment Costs - an extra cost which is in addition to that of standard treatment

8. The principle behind AcoRD
“The attribution decision for a specific research-related activity is driven by the primary purpose of the activity” i.e. Need to consider what activities are taking place and why – the primary purpose of an activity
Is the activity answering the research question and will it end when the research ends?
Yes No
Is the activity ensuring the patient is safe and will it end when the research ends?
Research cost
Yes No
Is the cost of this on-going treatment above the cost of standard treatment?
Service Support Cost
Yes No
Excess Treatment Cost
Treatment Cost

9. Links to useful information:
AcoRD guidance and annexes: on-attributing-the-costs-of-health-and-social-care-research Newcastle JRO:

10. Authorisations (2) Research Ethics Committee (REC)
Look at the ethical issues that may arise from the research & ensure the participant has all the information required to make an informed decision.
** Proportionate Review **
Medicines and Healthcare products Regulatory Agency (MHRA)
The UK competent authority – approve the use of Investigational Medicinal Products and Devices
The Ionising Radiation (Medical Exposure) regulations 2000 (IRMER)
Ionising radiation (CT Scans, X-Ray) require a IRMER review from a radiation expert.
Administration of Radioactive Substance advisory Committee (ARSAC)
Radioactive substances used in research (MUGA Scans, PET Scans) – site specific
Caldicott & National Information Governance Board (NIGB)
Patient information
NHS Trust R&D approval/NHS Permission (step 3)
Each participating NHS Trust must issue NHS permission

11. Starting the Application Process

12. Trust Approval/NHS Permission (3)
Integrated Research Application System (IRAS)
Using the Integrated Research Application System (IRAS) applicants complete
forms to be issued for review to:
Administration of Radioactive Substances Advisory Committee (ARSAC)
Gene Therapy Advisory Committee (GTAC) – under remit of the HRA
Medicines and Healthcare products Regulatory Agency (MHRA)
Ministry of Justice
NHS / HSC R&D offices (SSI form)
NRES/ NHS / HSC Research Ethics Committees
Confidentiality Advisory Group (CAG)
National Offender Management Service (NOMS)
Social Care Research Ethics Committee
Trust Approval/NHS Permission (3)

13. NHS Trust Permission (3) – last step!!
Why do we have R&D approval?
As detailed in section 3.10 of the Research Governance Framework:
It is the responsibility of organisations providing health or social care in England to be aware of all research undertaken in their organisation, or involving participants, organs, tissue or data obtained through the organisation.
This is achieved via Trust R&D who coordinate the review and issue permission on behalf of the Trust (governance role to ensure patient safety, financial stability and legal protection for the NHS organisation)
Research & Development
How we can help you through the R&D approvals process
The Newcastle Joint Research Office (NJRO) is based on the 6th Floor of the Leazes Wing within the Royal Victoria Infirmary.The NJRO can provide support to researchers across the whole of the research lifecycle, including facilitating pre-award stage, negotiation and acceptance of contracts at award stage, and regulatory and legal research governance requirements.
The R&D Team can provide specific advice in obtaining NHS Permission for a study to run within The Newcastle upon Tyne Hospitals NHS
Foundation Trust
For further guidance please visit our website -
Or contact our team: ( @
**For further information please visit our website -

14. Trust R&D Risk Assessment
A risk assessment is performed for every study that goes to committee:
Finance – all costs must be funded
Support Departments - Pharmacy, Radiology, Labs, Ophthalmology…
Insurance/Indemnity – management/conduct/design
Study Agreements – use of model agreement is encouraged
Publicity Risk to the Trust – will it attract media attention?
Ethics & Regulatory Approvals
Data – Caldicott approval, CAG, if necessary
Tissue/IRMER/ARSAC
Site Specific Assessment – staffing support, suitable facilities available?
Monitoring Arrangements
Pharmacy Details – exit strategy

15. NHS Trust Permission** – Local Process
** In 2015 NHS permission to be replaced with a single HRA approval which will be England wide therefore removing the need to apply to Trusts on an individual basis

16. The NIHR Portfolio
The National Institute for Health Research Clinical Research Network (NIHR CRN) Portfolio is a database of high-quality research studies that are eligible for support from the NIHR Clinical Research Network in England.
Automatically eligible:
Have some or all research funding provided by the NIHR, Other areas of central Government or NIHR non-commercial partners.
Fulfil the research definition “attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods”
Potentially eligible:
Commercial
Overseas Government
Overseas Charities

17. Good Clinical Practice (GCP)
GCP is an international ethical and scientific quality standard for the design, conduct, recording and reporting of trials that involve the participation of human subjects. Its purpose is to:
Ensure the protection of the rights and well being of research participants
Ensure that results of research are accurate and credible
The principles of Good Clinical Practice have their origin in the Declaration of Helsinki and apply to ALL research, not just clinical trials of medicinal products!

18. Informed Consent for Research
Informed consent is a three step process which involves: • The giving of study related information • The discussion and clarification of this information and • The taking of the subject’s written consent All individuals asked to consider taking part in research should be given the fullest possible information, presented in a form that is understandable. This must include, but is not limited to, the Participant Information Sheet (PIS) approved by a REC. ** Participants must be given enough time to read the information about the Research - this is usually at least 24 hours except in an acute or emergency setting

19. Source documentation Source data: Source documents: Case Report Forms:
Details of clinical findings, observations or other activities carried out as part of clinical trial. Source data are contained in source documents (original documents or certified copies)
copies of PIS and consent form to be filed in patient record
original to be stored in the site file
documented consent process & confirmation of eligibility
detail each study visit
Source documents:
Original documents, data and records (e.g. hospital records, clinical charts, laboratory notes, memoranda, subject diaries or evaluation checklists), pharmacy dispensing records, adverse event charts
Case Report Forms:
Data generated by clinical trials are normally recorded in Case Report Forms (CRFs). A CRF is a printed or electronic document designed to record all of the protocol defined data on individual participants in a CTIMP.
For further details please refer to the JRO website - SOP essential and source documentation guide (release date Nov. 2013)

20. Essential study documents
Trial Master File/Site file
Protocol
Ethics
Research and Development
Regulatory
Research Team
Participant Information (including subject lob + original consent form
Data Collection
Safety
Pharmacy/Product-Related
10. Monitoring and Audit
11. Correspondence (except Trust & Ethics)

21. R&D Figures 2012/2013 Number of projects approved: ~324
Recent activity (1st April 2013 to 31st March 2014):
Number of projects approved: ~324
Number of current active projects: ~850
Number of amendments reviewed: 980
Number of requests for sponsorship reviewed: 120
Number of audits performed : 32

22. Research & Development
How we can help you through the R&D approvals process
The Newcastle Joint Research Office (NJRO) is based on the 6th Floor of the Leazes Wing within the Royal Victoria Infirmary.The NJRO can provide support to researchers across the whole of the research lifecycle, including facilitating pre-award stage, negotiation and acceptance of contracts at award stage, and regulatory and legal research governance requirements.
The R&D Team can provide specific advice in obtaining NHS Permission for a study to run within The Newcastle upon Tyne Hospitals NHS
Foundation Trust
For further guidance please visit our website -
Or contact our team: ( @