Andrew JohnstonResearch Management & Governance (RM&G) Manager

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

Research Governance and Sponsorship

Why Have Research Governance?

More recently……

• Bristol and Alder Hey investigations into retained organs

Research Governance Framework implemented in 2001

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 1946 - 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)

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

Research Sponsorship (1)

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

All research conducted in the NHS must have an identified Research Sponsor.

Funding Awarded

Research Sponsorship& governance

Portfolio Adoption Authorisations

Obtained

CSP Governance Review

NHS Permission

Authorisations

Obtained

Funding application Study design

1

2

3

Start study

Choose an appropriate methodology & outcome Provide justification of the sample size Draw up a statistical analysis plan Data HandlingPrepare and present interim reports

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

Definitions of types of NHS costs:

“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

The principle behind AcoRD

Is the activity answering the research question and will it end when the research ends?

Is the activity ensuring the patient is safe and will it end when the research ends?Research cost

Service Support Cost Is the cost of this on-going treatment above the cost of standard treatment?

Treatment Cost

NoYes

Excess Treatment Cost

Yes No

NoYes

AcoRD guidance and annexes: https://www.gov.uk/government/publications/guidance-on-attributing-the-costs-of-health-and-social-care-research

Newcastle JRO: http://www.newcastlejro.org.uk/

Links to useful information:

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

Starting the Application Process

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)

Integrated Research Application System (IRAS)

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.

Research & Development How we can help you through the R&D approvals process

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)

**For further information please visit our website - www.newcastlejro.org.uk/**

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

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

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

Good Clinical Practice (GCP)

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!

• Ensure the protection of the rights and well being of research participants

• Ensure that results of research are accurate and credible

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:

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

Source documentation

Source data:

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)

Essential study documents

Trial Master File/Site file

1. Protocol2. Ethics3. Research and Development4. Regulatory5. Research Team6. Participant Information (including subject lob + original

consent form7. Data Collection8. Safety9. Pharmacy/Product-Related10. Monitoring and Audit11. Correspondence (except Trust & Ethics)

R&D Figures 2012/2013

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

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 - www.newcastlejro.org.uk/

Or contact our team: ( 0191 28 25959 @ trust.r&d@nuth.nhs.uk