Submitting a CTA application - Imperial College · PDF [email protected] 3.5 Ineligible Studies If your study is deemed to be ineligible for inclusion onto the

Joint Research Compliance Office

SOP Ref No: JRCO/SOP/033 V4.0 25 Oct 2017 Page 1 of 24 © Imperial College of Science, Technology and Medicine

This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be

classed as uncontrolled.

Researchers and their teams may print off this document for training and reference purposes but are responsible for regularly checking the JRCO website for more recent versions

Version

Date Reason for Change

Version 1.0 14 Jul 2011 New Procedure

Version 2.0 03 Dec 2012 Annual Review

Version 3.0 18 Feb 2015 Scheduled Review

Version 4.0 25 Oct 2017 Scheduled Review

NIHR studies

SOP Reference: JRCO/SOP/033

Version Number: 4.0

Effective Date: 25 Oct 2017

Review by: 25 Oct 2020

Author: Ruth Nicholson, Research Governance Manager

Approved by: Gary Roper

Date: 24 Oct 2017



Table of Contents

1. Purpose Page 3

2. Introduction Page 3

3. Procedure

3.1 Portfolio Eligibility

3.2 Applying for portfolio adoption

3.3 Feasibility process

3.4 Capacity and Capability Approval at ICHNT

3.5 Ineligible studies

3.6 Amendments

Page 3

Page 3

Page 4

Page 4

Page 5

Page 5

Page 6

4. Monthly Reporting Page 6

5. References Page 7

6. Appendices

Appendix One: Eligibility criteria for NIHR Clinical Research Network Support

Appendix Two: Current List of NIHR non-commercial partners

Appendix Three: Appendix 3- Portfolio Adoption Flow Chart

Page 8 Page 8 Page 14 Page 24



1. PURPOSE This Standard Operating Procedure (SOP) details what National Institute for Health Research is and how to apply to have your study adopted onto the NIHR portfolio. 2. INTRODUCTION The goal of the National Institute for Health Research (NIHR) is to create a health research system in which the NHS supports outstanding individuals, working in world class facilities, conducting leading edge research focused on the needs of patients and the public. The NIHR is directed by Professor Dame Sally C. Davies, Chief Medical Officer and Director General of Research & Development at the Department of Health.

The NIHR now brings together government support for research in the NHS in England, through the NIHR Clinical Research Network Coordinating Centre (CRNCC). The NIHR CRN Portfolio is a database of clinical research studies being undertaken in the NHS that are supported by the NIHR Clinical Research Network (CRN) in England.

Details of clinical research studies which meet specific eligibility criteria (see Appendix 1) are recorded in a database known as the UK Clinical Research Network Portfolio, which comprises the NIHR CRN Portfolio in England and the corresponding Portfolios of Northern Ireland, Scotland and Wales.These four Portfolios are held on a single information system: the Central Portfolio Management System (CPMS). The Network has a list of funding partners (see Appendix 2).

Advantages of applying for NIHR adoption include Expert advice on how your study will work in the NHS environment; help with site selection, review of Statement of Activities and Schedule of Events and access to NHS Service Support.

Until March 2016 the NIHR used a system called CSP (Coordinated System for Gaining NHS Permission) in order to upload study documents onto their central document repository. This has now been replaced by the HRA (Health Research Authority) approval process.

Imperial policy is that if a study meets the criteria for portfolio adoption then they should apply.

3. PROCEDURE

3.1: Portfolio Eligibility

Research Studies will only be adopted onto the NIHR Portfolio if they meet the adoption criteria. Studies can be automatically eligible if they have some research funding provided by the NIHR, central government or NIHR non-commercial partner organisations, potentially eligible if initiated by non-commercial investigators with the majority of research being funded by a commercial organisation, funded by overseas Governments or funded by overseas charities. To be eligible studies must also have two independent, external peer reviews in place (see Appendix 1 and 2 for full details).

3.2 Applying for Portfolio adoption.



To apply for portfolio adoption you must generate a Portfolio Adoption Form (PAF) in the Integrated Research Application System (IRAS) www.myresearchproject.org.uk . You must tick England in the project filter question 3, No to question 5a and Yes to 5b. If your study does not have funding secured, the Networks will not accept your study for adoption.

If your Lead R&D site is Imperial College Healthcare NHS Trust then in question A68-2 North West London CRN should be selected as your Local Clinical Research Network.

Once you have ticked the questions mentioned above, a Portfolio Application Form will appear in the menu of your IRAS application form. This should be completed and submitted through IRAS by the Chief Investigator (CI) or delegated member of the study team. You will receive an acknowledgment email from the Portfolio Adoption Team. The local CRN (North West London) may also be in contact to discuss study support services.

If your study is potentially eligible, the CI will then be emailed and asked to complete and submit the IRAS form to the HRA. Please note you can only submit your IRAS form to the HRA once you have sponsorship approval from the JRCO.

The HRA will then complete the study validation (including REC validation if required). The study is then received by the CRN CC (Clinical Research Network Co-ordinating Centre) through CPMS who assess for CRN support. The HRA will share information with the CRN CC in order to help with portfolio eligibility assessment. The HRA will also indicate on their initial assessment letter and approval letter that the study intends to apply for portfolio adoption. If your study needs to be considered for the NIHR Clinical Research Network Portfolio in order to receive service support funding or research infrastructure support through the Comprehensive Clinical Research Network, the Network will email you to confirm whether your study is eligible which could take up to 30 working days after the Network receive your IRAS Form and the associated documents including the funding letter. If the Network has any questions then these will need to be responded to within 5 working days. If the study is considered eligible then it will go through the non-commercial adoption process and be added to the portfolio.

3.3 Feasibility Process

Imperials JRCO feasibility process was introduced in May 2014 with the aim to combine and

replace aspects of the current review by the Joint Research Compliance Office (JRCO). Support at this early stage in the process will give the study the best possible chance to be completed successfully within budget, on time and generating high quality data.

The feasibility study will be coordinated by the CI/PI/study team and the final decision rests with the relevant ICHT Clinical Division research manager to assess whether the study is deemed feasible, it is advisable to consider a range of criteria, with the help of other teams around the College and Trust, including evaluations of patient recruitment targets, inclusion/exclusion criteria, equipment and resources, facilities and locations.

Before submitting the study to the HRA the study will need to be submitted to the clinical divisional manager allocated to its speciality. They will give approval prior to sponsorship and approval prior to the issuing of Capacity and Capability at ICHNT.

https://www.myresearchproject.org.uk/

http://www.myresearchproject.org.uk/



Contact details are as follows:-

Donna Copeland Divisional Research Manager - Surgery and Cancer [email protected] Ella Johnson Divisional Research Manager - Medicine [email protected] Debra Matich Divisional Research Manager – Women’s and Children’s [email protected] or [email protected]

3.4 Capacity and Capability Approval at ICHNT

Studies that are adopted onto the Portfolio now follow the same HRA and Capacity and Capability approval process as described in JRCO/SOP/039 Health Research Authority Approval for Research Studies and SOP 031 Obtaining ICHT Approval for Healthcare Research. The only difference being that it should be confirmed that Portfolio Adoption is in place with the Local CRN (North West London), that Portfolio Adoption is in place before Capacity and Capability is issued and that North West London CRN should be copied into Capacity and Capability emails for Portfolio Adopted studies approved at ICHNT at [email protected] 3.5 Ineligible Studies

If your study is deemed to be ineligible for inclusion onto the Portfolio it cannot proceed through the NIHR system. This does not affect whether your study can go ahead or not. Please see JRCO/SOP/031 if your study is deemed ineligible.

When everything is in place a Capacity and Capability email will be issued for the study and the project can commence. A copy of the Capacity and Capability email should be placed in the site file and the CI/PI/Study team will have 30 days from the date of approval to recruit its first participant.

3.6 Amendments

mailto:[email protected]








Amendments for portfolio adopted studies now follow the same process as described in JRCO/SOP/032 Obtaining ICHT confirmation of continued Capacity and Capability for Amendments to Healthcare Research. If the JRCO is sponsor then please refer to the JRCO Amendments SOP Reference –JRCO/SOP/006

4. MONTHLY REPORTING

If your study is accepted by the NIHR for adoption onto the Portfolio, you will have to submit monthly reports on the number of participants you have recruited to the study. For more information on how to do this, please contact the R&D Office or the study coordinator at the Trust at which your study is being conducted. If the site is within Imperial College Healthcare NHS Trust a recruitment Data Contact needs to be nominated and will require access to Documas or Edge.

Recruitment Data Contact (RDC) Recruitment data for your study must be uploaded on a monthly basis to Documas or for Cancer Portfolio studies to Edge. The monthly reporting of accurate recruitment data, or indication that there has been no recruitment, is a condition of inclusion of your study in the NIHR CRN Portfolio. A suitable person should be assigned the role of Recruitment Data Contact (RDC) for the study. This person will be responsible for uploading recruitment data for your study on a monthly basis. However, it is still the responsibility of the CI/PI to be accountable for the data upload. Data is centralised via CPMS. Recruitment data is measured against key performance indicators (Higher level objectives) which are used to demonstrate the success of the Clinical Research Network (CRN) and will feed into the process of allocating future funding for NHS infrastructure for research across the Clinical Research Networks. This ensures that infrastructure resources are directed to where they are required for the most patient benefit.

Frequently Asked Questions about recruitment data can be accessed via -

https://www.nihr.ac.uk/funding-and-support/study-support-service/performance-monitoring/recruitment-data





5. REFERENCES www.nihr.ac.uk https://www.nihr.ac.uk/funding-and-support/study-support-service/eligibility-for-nihr-support/ https://www.nihr.ac.uk/funding-and-support/study-support-service/eligibility-for-nihr-support/portfolio-faqs.htm https://www.nihr.ac.uk/research-and-impact/nihr-clinical-research-network-portfolio/ https://www.nihr.ac.uk/research-and-impact/nihr-clinical-research-network-portfolio/how-to-apply-for-nihr-crn-support.htm https://www.nihr.ac.uk/about-us/how-we-are-managed/managing-centres/crn/ https://learn.nihr.ac.uk/course/index.php?categoryid=28 https://www.nihr.ac.uk/research-and-impact/documents/NIHR-CRN-Portfolio/CPMS-support/CPMS_Recruitmentdataupload-Howtoguide.pdf https://www.myresearchproject.org.uk/help/hlpupdates.aspx http://www.ct-toolkit.ac.uk/routemap/r-and-d-submission

6. APPENDICES

http://www.nihr.ac.uk/

https://www.nihr.ac.uk/funding-and-support/study-support-service/eligibility-for-nihr-support/

https://www.nihr.ac.uk/funding-and-support/study-support-service/eligibility-for-nihr-support/portfolio-faqs.htm

https://www.nihr.ac.uk/funding-and-support/study-support-service/eligibility-for-nihr-support/portfolio-faqs.htm

https://www.nihr.ac.uk/research-and-impact/nihr-clinical-research-network-portfolio/

https://www.nihr.ac.uk/research-and-impact/nihr-clinical-research-network-portfolio/how-to-apply-for-nihr-crn-support.htm

https://www.nihr.ac.uk/research-and-impact/nihr-clinical-research-network-portfolio/how-to-apply-for-nihr-crn-support.htm

https://www.nihr.ac.uk/about-us/how-we-are-managed/managing-centres/crn/

https://learn.nihr.ac.uk/course/index.php?categoryid=28

https://www.nihr.ac.uk/research-and-impact/documents/NIHR-CRN-Portfolio/CPMS-support/CPMS_Recruitmentdataupload-Howtoguide.pdf

https://www.nihr.ac.uk/research-and-impact/documents/NIHR-CRN-Portfolio/CPMS-support/CPMS_Recruitmentdataupload-Howtoguide.pdf

https://www.myresearchproject.org.uk/help/hlpupdates.aspx

http://www.ct-toolkit.ac.uk/routemap/r-and-d-submission



Appendix One: Eligibility Criteria for NIHR Clinical Research Network Support

Introduction 1.1 The purpose of this paper is to set out the criteria governing the eligibility of studies for NIHR Clinical Research Network (NIHR CRN) support. It therefore relates only to England.

1.2 Details of the aims and purpose of the NIHR Clinical Research Network can be found at: https://www.nihr.ac.uk/about-us/documents/4.01-Clinical-Research-Network.pdf

The NIHR Clinical Research Network is the English component of the UK Clinical Research Network (UKCRN).

1.3 The main role of the NIHR CRN is to support later phase clinical trials and other well-designed studies. The NIHR supports Experimental Medicine studies primarily through its Clinical Research Facilities, Experimental Cancer Medicine Centres, and Biomedical Research Centres and Units. However, those Experimental Medicine studies funded by the NIHR or its Partners but conducted in the NHS outside these centres will have the necessary NHS Support provided by the NIHR CRN.

1.4 The NHS is responsible for meeting the Treatment Costs of research via the normal arrangements for commissioning patient care1. 2 Definition of ‘research study’

2.1 Research can be defined as the attempt to derive generalisable (i.e. of value to others in a similar situation) new knowledge by addressing clearly defined questions with systematic and rigorous methods2. This excludes: audit; needs assessments; quality improvement and other local service evaluations. It also excludes routine banking of biological samples or data except where this activity is integral to a self-contained research project designed to test a clear hypothesis. NHS Research Ethics Committee approval and NHS permission are requirements for research to be supported via the NIHR CRN.

2.2 The Study Sponsor (as defined by the Research Governance Framework for Health and Social Care) has the formal responsibility for confirming that a study is ‘research’. 2.3 The definition of a research study as set out above applies to all studies for which NIHR Clinical Research Network support is sought regardless of the research funder. 3. Eligibility for NIHR CRN support 3.1 All studies must already have full research funding (i.e. funding to meet all research costs as defined in HSG (97)32 and in compliance with the AcoRD guidance) before they can be considered for NIHR CRN support3.

3.2 NIHR CRN support for non-commercial studies includes meeting the NHS Support Costs of these studies. As these are funded via the public purse, non-commercial studies seeking NIHR CRN support must also meet the requirements detailed in Appendix 1.

https://www.nihr.ac.uk/about-us/documents/4.01-Clinical-Research-Network.pdf



3.3 The source of research funding is the principal determinant of eligibility for NIHR CRN support. Automatically eligible non-commercial studies 3.4 Studies that are automatically eligible for consideration for NIHR CRN support are those that are funded by the NIHR, other areas of central Government and NIHR non-commercial Partners, which meet the definition of ‘research’ as defined in 2.1.

3.5 NIHR non-commercial Partners are those organisations that: i) Award research funds as a result of open competition across England with high quality peer review (definitions are set out in Appendix 1); and

ii) Fund research that is of clear value to the NHS; and

iii) Take appropriate account of the priorities, needs and realities of the NHS in making decisions about the research that they fund. 3.6 NIHR non-commercial Partner status is confirmed via a self-declaration process. NIHR non-commercial Partners are required to sign a self-declaration that they meet the criteria set out in 3.4, and to confirm the funding streams that are applicable. Non-commercial funding organisations that self-declare as NIHR non-commercial Partners may be audited to ensure that they meet the criteria. The list of NIHR non-commercial for NIHR CRN support, which includes NHS Support Costs (and for the NHS to meet the Treatment Costs, including Excess Treatment Costs, of the study), the potential field of researchers who could be awarded the funding must not have been restricted to specific Universities or NHS Trusts within England. Funders of investigator-initiated, commercial collaborative studies are required to provide the NIHR CRN Co-ordinating Centre with written confirmation that the funding opportunity was open to all qualified researchers in England. It is also essential that all investigator-initiated commercial collaborative studies must have been subjected to high quality peer review before they can be considered for NIHR CRN support. Peer review should be commensurate with the size and complexity of the study. The study Sponsor should provide confirmation of appropriate peer review.

3.7 Individual studies funded as part of programme or centre grants, or as part of research training awards, will be required to have undergone protocol peer review before they can be considered for NIHR CRN support (see Appendix I for the definition of high quality peer review). The study Sponsor should provide confirmation of appropriate peer review.

3.8 A non-commercial study supported by multiple funders is automatically eligible for NIHR CRN support if one of the funders is the NIHR, other areas of central Government or an NIHR non-commercial Partner.

3.9 Studies where the funder providing the research costs is different from the funder managing the funding competition, including the peer review process, will have their eligibility determined by the funder responsible for managing the funding competition. Potentially eligible non-commercial studies

3.10 ‘Potentially eligible’ non-commercial studies undergo additional eligibility checks to ensure the study meets the criteria described in section 2.1 and 3.5 (definitions in Appendix



1) via the non-commercial adoption process. The NIHR CRN manages the non-commercial adoption process on behalf of the Department of Health

3.11 The following types of non-commercial studies are considered potentially eligible: • Investigator-initiated, commercial-collaborative studies (Industry-funded, non-industry sponsored studies) • Non-commercial studies funded by overseas governments • Non-commercial studies funded by overseas charities • Certain other high quality studies (see 3.14) 3.12 Investigator-initiated, commercial collaborative studies are studies that are initiated by non-commercial investigators (e.g. University or NHS staff) with the majority of the research funding being provided by a commercial organisation (e.g. a pharmaceutical, biotechnology or devices company) specifically to support that study. Contracts for such studies should include provision for the investigator to take responsibility for analysis, interpretation and publication of findings. This investigator-initiated commercial collaborative research includes pilot studies and nested exploratory studies. It is recognised that commercial organisations do not usually award this funding by means of a structured competition. Nevertheless, to be eligible for NIHR CRN support, which includes NHS Support Costs (and for the NHS to meet the Treatment Costs, including Excess Treatment Costs, of the study), the potential field of researchers who could be awarded the funding must not have been restricted to specific Universities or NHS Trusts within England. Funders of investigator-initiated, commercial collaborative studies are required to provide the NIHR CRN Co-ordinating Centre with written confirmation that the funding opportunity was open to all qualified researchers in England. It is also essential that all investigator-initiated commercial collaborative studies must have been subjected to high quality peer review before they can be considered for NIHR CRN support. Peer review should be commensurate with the size and complexity of the study. The study Sponsor should provide confirmation of appropriate peer review. 3.13 Non-commercial studies funded by overseas governments will be considered for NIHR CRN support via the non-commercial Adoption Process.

3.14 Non-commercial studies funded by overseas charities will be considered for NIHR CRN support via the non-commercial Adoption Process.

3.15 Certain other high quality studies funded by any source of funding not mentioned above, but which appear to meet the criteria set out in 3.5 will be considered for NIHR CRN support via the non-commercial Adoption Process. Potentially eligible commercial contract research 3.16 The aims of the NIHR CRN include facilitating high quality studies of benefit to patients that are funded and sponsored by the life-sciences industry, strengthening research collaboration with industry and ensuring that the NHS can meet the health research needs of industry. This includes meeting regulatory requirements. In order to be eligible for NIHR CRN support, the study must meet the definition of ‘research’ as defined in section 2.1 and the study must receive NHS Research Ethics Committee approval and NHS permission prior to initiation at individual sites. If the study is eligible, the NIHR CRN will work with the study sponsor to determine feasibility within England. This will focus on site interest, capability to deliver and recruitment targets. If the study is both eligible and feasible within



England, it will receive NIHR CRN support. NIHR CRN manages the Eligibility Review process for commercial contract research on behalf of the Department of Health.

3.17 Pharmacovigilance studies and other post authorization safety studies required by regulatory authorities that meet these criteria are in scope. This is in keeping with NIHR's mission to improve the health and wealth of the nation (growth) through research. Studies whose primary objective is to support product marketing will not be eligible for the NIHR CRN portfolio. 3.18 Studies that are eligible for NIHR CRN support require full funding from industry i.e. funding of the activities that are additional to treatment outside the context of the study, including funding for all Research Costs and NHS Support Costs. 4 Assessing need for NIHR CRN support

4.1 It is the responsibility of the relevant Local Research Network (Comprehensive, Topic Specific or Primary Care) to consider a study’s requirement for NIHR CRN support at each site. This process will be co-ordinated by the Main Network4 on behalf of the Chief Investigator. This assessment will be made only for studies that have been accepted as eligible for NIHR CRN support by the NIHR CRN Co-ordinating Centre (as set out in sections 2 and 3). For multi-centre studies the NIHR CRN support required may vary across Local Research Networks and sites.

4.2 Timely reporting of recruitment data to the NIHR CRN Co-ordinating Centre by the Chief Investigator or their team, and acknowledgement of Network support in relevant publications, are conditions of accessing NIHR CRN support. 5 Prioritisation of NIHR CRN support 5.1 The resources needed in the NHS to support research, both NHS Support and availability of suitable/appropriate patients, are finite. To enable the Government to meet its commitment to provide the necessary NHS Support for its own and its Partners' research, whilst also allowing other important research to be undertaken within the Network, there is a need to prioritise eligible studies. When resources are stretched it is important that NIHR CRN effort on studies with the highest priority is not diminished. Studies with a lower priority can still receive NIHR CRN support but patient recruitment may take a little longer. High priority studies 5.2 Studies that have a high priority for NIHR CRN support are those eligible and feasible studies that are: a) Funded by the NIHR, other areas of central Government or an NIHR non-commercial Partner or b) Commercial contract research. The Government is committed to providing the necessary NHS Support for its non-commercial Partners’ research. Therefore there should be no need for there to be any prioritisation of NIHR non-commercial Partner studies on the basis of the costs of support.



Medium priority studies 5.3 Studies that have a medium priority for NIHR CRN support are those eligible and feasible studies that are: a) Funded by overseas governments; or

b) Investigator-initiated commercial collaborative studies Low priority studies 5.4 Studies that have a low priority for NIHR CRN support are those eligible and feasible studies that are: a) Funded by overseas charities; or

b) Funded by any source of funding not mentioned above, but which meet the criteria set out in 3.5 Department of Health [April 2013]



APPENDIX 1 Definitions for non-commercial studies seeking NIHR CRN support, which includes support to meet NHS Support Costs 1. NIHR non-commercial Partners are those organisations that: i) Award research funds as a result of open competition across England with high quality peer review; and ii) Fund research that is of clear value to the NHS; and iii) Take appropriate account of the priorities, needs and realities of the NHS in making decisions about the research that they fund. Open competition 2. Open competition ensures that the best range of researchers is able to apply for the funding. Open competition is defined by: a) The competition being open to all appropriately qualified individuals, and b) Knowledge of the competition being available to all appropriately qualified individuals, and c) The research funder being completely independent of the recipient organisation. High quality peer review 3. Peer review must be independent, expert, and proportionate: a) Independent: At least two individual experts should have reviewed the study. The definition of independent used here is that the reviewers must be external to the investigators’ host institution and not involved in the study in any way. Reviewers do not need to be anonymous. b) Expert: Reviewers should have knowledge of the relevant discipline to consider the clinical and/or service based aspects of the protocol, and/or have the expertise to assess the methodological and statistical aspects of the study. c) Proportionate: Peer review should be commensurate with the size and complexity of the study. Large multicentre studies should have higher level (more reviewers with broader expertise and often independent review committee or board), and potentially international peer review5. Clear value to the NHS 4. This requirement is specified in the ‘Statement of partnership on non-commercial R&D in the NHS in England’ (Annex B of ‘Responsibilities for meeting the Patient care Costs associated with Research and Development in the NHS’, HSG(97)32). As part of the self-declaration as an NIHR non-commercial Partner, funding organisations are required to confirm that the research they fund is of clear value to the NHS.



Appendix Two: NIHR Non-commercial Partner List 1 Introduction 1.1 The Eligibility Criteria for NIHR Clinical Research Network Support (April 2013) effective

from 7 May 2013, sets out the criteria governing the eligibility of studies for National Institute for Health Research (NIHR) Clinical Research Network (CRN) support. It therefore relates only to England. Studies that are automatically eligible for consideration for NIHR CRN support are studies that are funded by the NIHR, other areas of central Government, and NIHR non-commercial Partners.

1.2 The purpose of this document is to provide a list of non-commercial funding

organisations that meet the NIHR Partner criteria below. This reference guide is intended to enable researchers and other users to easily identify NIHR non-commercial Partners and is updated every two weeks by the NIHR CRN.

2 NIHR Partner Criteria 2.1 As set out in the Eligibility Criteria for NIHR Clinical Research Network Support (April

2013) effective from 7 May 2013, NIHR non-commercial Partners are those organisations that:

Award research funds as a result of open competition across England with high quality peer review; and

Fund research that is of clear value to the NHS; and

Take appropriate account of the priorities, needs and realities of the NHS in making decisions about the research that they fund.

2.2 NIHR non-commercial Partner status is confirmed via a self-declaration process. Non-commercial organisations are required to sign a self-declaration that they meet the NIHR non-commercial Partner criteria and to confirm the funding streams that are applicable. Further information on self-declaration as an NIHR non-commercial Partner is available on the CRN website1.

2.3 It is important to note that:

NIHR non-commercial Partners that operate multiple funding streams must self-declare against the NIHR Partner criteria with respect to all of the existing funding streams they administer. NIHR non-commercial Partners that operate a mixture of funding streams, some of which are eligible and some of which are not (or operate funding streams that are not intended to provide funds for research purposes), are shaded in the table provided in section 3. You are advised to contact a member of the Eligibility Team at the NIHR CRN (via

1 (http://www.crn.nihr.ac.uk/can-help/funders-academics/nihrcrn-portfolio/which-studies-are-eligible-for-clinical-

research-network-support/)

http://www.crn.nihr.ac.uk/wp-content/uploads/About%20the%20CRN/Eligibility%20Criteria%20for%20NIHRCRN%20support.pdf

http://www.crn.nihr.ac.uk/can-help/funders-academics/nihrcrn-portfolio/which-studies-are-eligible-for-clinical-research-network-support/

http://www.crn.nihr.ac.uk/can-help/funders-academics/nihrcrn-portfolio/which-studies-are-eligible-for-clinical-research-network-support/



[email protected]) for further information on the eligibility of these NIHR non-commercial Partners’ funding streams.

All studies supported by an NIHR non-commercial Partner are still required to meet all other NIHR Clinical Research Network Eligibility Criteria before being considered automatically eligible for consideration for NIHR CRN support.

The research funders denoted by (‡) in the table provided in section 3 have “self-declared” that at least one funding stream they administer meets the NIHR non-commercial Partner criteria as stated in the Department of Health policy document Eligibility Criteria for NIHR Clinical Research Network Support (April 2013). The NIHR Clinical Research Network has included these organisations in good faith.




Appendix 3 Current list of NIHR non-commercial Partners

Funder Name AMRC

Member?

Abbeyfield Society and the Abbeyfield Research Foundation ‡ Y

A Academy of Medical Sciences N

Action for A-T ‡ Y

Action for M.E. ‡ N

Action Medical Research Y

Action on Hearing Loss (formerly Royal National Institute for Deaf People, The

(RNID))

Y

Aerosol Society, The ‡ N

Alcohol Research UK ‡ Y

Alzheimer's Research UK Y

Alzheimer's Society Y

Anaphylaxis Campaign ‡ N

AOUK ‡ N

Army of Angels ‡ N

Arthritis Research UK (formerly ARC Arthritis Research Campaign) ‡ Y

Association for International Cancer Research (AICR) Y

Association for Multiple Endocrine Neoplasia Disorders (AMEND) ‡ N

Association of Breast Surgery ‡

Association of British Clinical Diabetologists (ABCD) ‡ N

Asthma UK Y

Ataxia UK Y

Autistica (formerly Autism Speaks UK) ‡ Y

B Baily Thomas Charitable Fund, The N

BASO ~ The Association for Cancer Surgery ‡ N

Best Beginnings ‡ N

Big Lottery Fund Y

Bliss N

Bloodwise ‡ Y

Bone Cancer Research Trust N

Bowel and Cancer Research ‡ N

Bowel Disease Research Foundation (BDRF) N

Brain Tumour Charity, The ‡ Y

Brain Tumour Research ‡ N

Brain Tumour Research Campaign ‡ N

Breakthrough Breast Cancer Y

Breast Cancer Campaign Y



Breast Cancer Research Trust (BCRT) ‡ N

British Academy (For the Promotion of Historical Philosophical and Philological

Studies), The ‡

N

British Academy of Childhood Disability (BACD) N

British Acupuncture Council ‡ N

British Association for Behavioural & Cognitive Psychotherapies (BABCP) ‡ N

British Association for Counselling & Psychotherapy Research Foundation

(BACP Research Foundation) ‡

Y

British Association for Sexual Health and HIV (BASHH) ‡ N

British Association of Critical Care Nurses (BACCN) ‡ N

British Association of Hand Therapists ‡ N

British Association of Oral and Maxillofacial Surgeons (BAOMS) ‡ N

British Association of Plastic Reconstructive and Aesthetic Surgeons (BAPRAS) N

British Cardiac Research Trust (BCRT) ‡ N

British Council for Prevention of Blindness ‡ Y

British Dental Association Trust Fund, The ‡ N

British Dietetic Association, The (BDA) N

British Elbow & Shoulder Society (BESS) ‡ N

British Geriatrics Society, The ‡ N

British Heart Foundation (BHF) ‡ Y

British Hip Society N

British HIV Association (BHIVA) ‡ N

British Infection Association (BIA) N

British Isles Paediatric Ophthalmology and Strabismus Association (BIPOSA) ‡ N

British Liver Trust N

British Lung Foundation ‡ Y

British Lymphology Society ‡ N

British Maternal and Fetal Medicine Society (BMFMS) ‡ N

British Medical Association (BMA) ‡ N

British Occupational Health Research Foundation (BOHRF) N

British Oculoplastic Surgery Society (BOPSS) ‡ N

British Orthodontic Society Foundation (BOSF) N

British Orthopaedic Association (BOA) Y

British Orthopaedic Foot and Ankle Society ‡ N

British Paediatric Neurology Association ‡ N

British Paediatric Surveillance Unit (BPSU) ‡ N

British Pain Society ‡ Y

British Renal Society, The (BRS) N

British Rhinological Society ‡ N

British Scoliosis Research Foundation (BSRF) Y

British Sjögren's Syndrome Association Y

British Skin Foundation, The Y



British Society for Antimicrobial Chemotherapy (BSAC) N

British Society for Haematology, The ‡ N

British Society for Paediatric and Adolescent Rheumatology (BSPAR) ‡ N

British Society for Rheumatology (BSR) N

British Society for Surgery of the Hand ‡ N

British Society of Breast Radiology (BSBR) ‡ N

British Society of Interventional Radiology (BSIR) N

British Society of Periodontology ‡ N

British Society of Rehabilitation Medicine ‡ N

British Thyroid Foundation N

British Tinnitus Association (BTA) ‡ N

Butterfly Thyroid Cancer Trust ‡ N

C Cancer Research UK ‡ Y

Castang Foundation N

Chartered Society of Physiotherapy (CSP) / Physiotherapy Research

Foundation ‡

N

Childhood Eye Cancer Trust ‡ Y

Children with Cancer UK Y

Children's Liver Disease Foundation Y

Christopher’s Smile ‡ N

Cicely Saunders International ‡ N

Circulation Foundation (The Vascular Foundation) ‡ N

CLIC Sargent Cancer Care for Children N

Clinical Endocrinology Trust, The ‡ N

Coeliac UK N

College of Emergency Medicine, The N

College of Optometrists, The ‡ N

Colt Foundation, The N

Core - The Digestive Disorders Foundation ‡ Y

Crohn's in Childhood Research Association (CICRA) Y

Cure Parkinson's Trust, The Y

Cystic Fibrosis Trust Y

D Daphne Jackson Trust, The ‡ Y

Deafness Research UK (Hearing Research Trust) N

DEBRA UK ‡ Y

Diabetes Research & Wellness Foundation (DRWF) Y

Diabetes UK Y

Difficult Airway Society ‡ N

Dimbleby Cancer Care N

DISCS (Diagnostic Investigation of Spinal Conditions and Sciatica) N

Duchenne Now ‡ N



Dunhill Medical Trust, The Y

Dystonia Society ‡ N

Dystrophic Epidermolysis Bullosa Research Association (DebRA) Y

E Elimination of Leukaemia Fund (ELF) ‡ N

Epilepsy Action (British Epilepsy Association) Y

Epilepsy Research UK Y

F Fetal Medicine Foundation ‡ N

Fight for Sight (British Eye Research Foundation) Y

Florence Nightingale Foundation, The ‡ N

Foundation for the Study of Infant Deaths, The (FSID) N

Foundation of European Nurses in Diabetes (FEND) ‡ N

Foundation of Nursing Studies (FoNS) ‡ N

G Gauchers Association, The ‡ N

Gawthorn Cardiac Trust ‡ N

General Nursing Council for England and Wales Trust, The ‡ N

Genesis Breast Cancer Prevention ‡ N

Get AHead Charitable Trust ‡ N

Great Ormond Street Hospital Children's Charity ‡ Y

Guarantors of Brain, The N

Guide Dogs for the Blind Association, The N

Guillain-Barré Syndrome Support Group UK ‡ N

H Haemophilia Nurses Association (administered by Haemnet) ‡ N

Healing Foundation, The ‡ Y

Health Foundation, The ‡ N

Healthcare Infection Society ‡ N

Heart Research UK Y

Henry Smith Charity, The N

Howard Foundation, The ‡ N

Hughes Syndrome Foundation ‡ N

Hull and District Diabetes Support Group ‡ N

Huntington's Disease Association ‡ Y

I Infection Prevention Society (IPS) N

INSPIRE Foundation, The Y

Institute of Maxillofacial Prosthetists and Technologists, The ‡ N

Insulin Dependent Diabetes Trust (IDDT) ‡ N

Intensive Care Foundation, The (c/o Intensive Care Society, The) ‡ N

International Glaucoma Association ‡ N

ITP Support Association N



J J P Moulton Charitable Foundation ‡ N

June Hancock Mesothelioma Research Fund ‡ N

Juvenile Diabetes Research Foundation Limited (JDRF) Y

K Kay Kendall Leukaemia Fund, The N

Kidney Cancer UK ‡ N

Kidney Research UK (KRUK) Y

Kids Kidney Research Y

Kidscan ‡ N

King's Fund, The N

L Leuka ‡ Y

Leukaemia & Lymphoma Research (now Bloodwise) ‡ Y

Leverhulme Trust, The ‡ N

LIVErNORTH ‡ N

Lowe Syndrome Trust, The N

Lullaby Trust, The ‡ Y

Lupus UK N

M Macmillan Cancer Support ‡ N

Macular Society Y

Marie Curie Cancer Care ‡ Y

McPin Foundation, The N

ME Research UK N

Medical Detection Dogs ‡ N

Medlock Charitable Trust ‡ N

Meniere’s Society, The ‡ N

Meningitis Now (formerly Meningitis UK) Y

Meningitis Research Foundation Y

Mental Health Research UK ‡ N

Midlands Gastroenterological Society‡ N

Migraine Trust, The ‡ Y

Motor Neurone Disease Association (MNDA) ‡ Y

Movember Foundation ‡ N

MPD Voice ‡ N

MQ: Transforming Mental Health ‡ Y

Multiple Sclerosis Society (of Great Britain & Northern Ireland) (MS Society) ‡ Y

Multiple Sclerosis Trust N

Muscular Dystrophy UK ‡ Y

Myasthenia Gravis Association ‡ N

Myeloma UK Y



N National Association for Colitis and Crohn's Disease, The (NACC) (also known

as Crohn's and Colitis UK)

Y

National Back Pain Association (BackCare) N

National Eye Research Centre (NERC) Y

National HIV Nurses Association ‡ N

National Institute of Academic Anaesthesia (NIAA) ‡ N

National Lung Cancer Forum for Nurses ‡ N

National Obesity Forum N

National Osteoporosis Society Y

Neuroblastoma Society, The N

Newlife Foundation for Disabled Children N

Novo Nordisk UK Research Foundation, The Y

Nystagmus Network ‡ N

O Obstetric Anaesthetists' Association (OAA) N

Oral and Dental Research Trust, The ‡ N

Orthopaedic Research UK Y

Otorhinolaryngological Research Society, The (ORS) N

Ovarian Cancer Action ‡ Y

P Paediatric Intensive Care Society (PICS) ‡ N

Paget's Association (National Association for the Relief of Paget's Disease) N

Pain Relief Foundation, The ‡ N

Pancreatic Cancer Research Fund N

Pancreatic Cancer UK Y

Parkinson's UK (Parkinson's Disease Society of the United Kingdom) ‡ Y

Pelican Cancer Foundation, The Y

Pharmacy Research UK ‡ Y

Platelet Charity, The ‡ N

Polycystic Kidney Disease Charity (PKD) ‡ N

Preoperative Association, The ‡ N

Primary Immunodeficiency Association, The N

Prostate Action ‡ N

Prostate Cancer UK ‡ Y

PSC Support ‡ N

Psoriasis and Psoriatic Arthritis Alliance, The (PAPAA) N

Psoriasis Association, The Y

PSP Association, The ‡ Y

Pulmonary Hypertension Association UK ‡ N

Purine Metabolic Patients' Association ‡ N

R Radiological Research Trust ‡ N

Raynaud's & Scleroderma Association Trust N



Remedi Y

Research Autism N

Research into Ageing (Age UK) ‡ Y

Resuscitation Council (United Kingdom), The N

Roald Dahl’s Marvellous Children’s Charity ‡ N

Rosetrees Trust (The Teresa Rosenbaum Golden Charitable Trust) ‡ Y

Roy Castle Lung Cancer Foundation, The ‡ N

Royal College of General Practitioners, The N

Royal College of Emergency Medicine, The ‡ N

Royal College of Obstetricians and Gynaecologists (RCOG) ‡ N

Royal College of Ophthalmologists, The N

Royal College of Pathologists, The N

Royal College of Physicians, The N

Royal College of Physicians and Surgeons of Glasgow, The N

Royal College of Psychiatrists ‡ N

Royal College of Radiologists, The ‡ N

Royal College of Surgeons of Edinburgh, The N

Royal College of Surgeons of England, The ‡ Y

Royal Society ‡ N

Royal Society for the Prevention of Accidents, The ‡ N

RP Fighting Blindness (British Retinitis Pigmentosa Society) Y

S Samantha Dickson Brain Tumour Trust N

Sarcoma UK ‡ Y

Sir Jules Thorn Charitable Trust Y

Society and College of Radiographers (SCoR) ‡ N

Society for Computing and Technology in Anaesthesia ‡ N

Society for Mucopolysaccharide Diseases, The ‡ N

Society for the Advancement of Anaesthesia in Dentistry, The (SAAD) ‡ N

Society for the Study of Addiction ‡ N

SPARKS Charity ‡ Y

Spinal Research (International Spinal Research Trust) Y

Stillbirth And Neonatal Death Society (Sands) ‡ N

Stroke Association ‡ Y

Stuart Strange Vasculitis Trust (The UK Vasculitis Trust) ‡ N

Sue Harris Bone Marrow Trust, The N

T Target Ovarian Cancer ‡ Y

Tommy's Y

Tourettes Action ‡ N

Tuberous Sclerosis Association ‡ Y

U UK and Eire Glaucoma Society (UKEGS) N



UK Children's Neurological Research Campaign (UKCNRC) (also known as

Child Brain Research) ‡

N

UK Clinical Pharmacy Association (UKCPA) ‡ N

UK Dermatology Clinical Trials Network (DCTN) ‡ N

UK Occupational Therapy Research Foundation (UKOTRF) (College of

Occupational Therapists Limited)

N

UK Respiratory Research Foundation (UKRRF) N

UK Spinal Cord Injury Research Network (UKSCIRN) ‡ N

UK Stem Cell Foundation (UKSCF) ‡ N

Urology Foundation, The ‡ Y

W Waterloo Foundation, The ‡ N

Wellbeing of Women Y

WellChild Y

Wellcome Trust ‡ Y

World Cancer Research Fund Y

Y Yorkshire Cancer Research ‡ Y

12 April 2017



Appendix 3- Portfolio Adoption Flow Chart

Documents

Submitting a CTA application - Imperial College · PDF [email protected] 3.5 Ineligible Studies If your study is deemed to be ineligible for inclusion onto the