Download KCL/SLaM Sponsorship Guidance

SLaM/IoPPN R&D Office Sponsorship Guidance – V14
Important: Before reading this guidance please read ‘Sponsorship_guide_HRA approval - February 2016’
(in this sponsorship guidance pack) for information on current changes to national approvals processes
for NHS research
This guidance is for researchers (including students) at the Institute of Psychiatry, Psychology &
Neuroscience (IoPPN) or South London and Maudsley NHS Foundation Trust who require confirmation of
sponsorship for health research applications that come within the remit of the Health Research Authority,
for example:
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NHS Research Ethics
NHS R&D approval
HRA CAG section 251 application
Information about the Health Research Authority (HRA) and approvals for health research can be found
here: http://www.hra.nhs.uk/
The sponsor is the institution or organisation which takes on the legal responsibility for the initiation and
management of a research study. The sponsor is required to review and sign off research applications
before submission and maintain oversight during the life of the study. These functions are managed by the
SLaM/IoPPN R&D office where the study involves South London and Maudsley NHS Foundation Trust
(including where SLaM has been awarded external funding for the study).
Where a study has no SLaM involvement but involves King’s College Hospital and/or Guys and St Thomas
NHS Foundation Trusts, the R&D offices at KCH or GSTT will be your point of contact and will assist you with
sponsorship arrangements, including KCL lead sponsor sign off.
If you are a King’s College London researcher and your project doesn’t fall within the remit of the Health
Research Authority it will be reviewed by the college ethics committee instead:
http://www.kcl.ac.uk/innovation/research/support/ethics/index.aspx
If your research project only involves recruitment of NHS staff as participants, it will be reviewed by the
college ethics committee but will also need NHS R&D approval. Contact the R&D office of the NHS Trust
where you will recruit staff from for guidance on how to obtain R&D approval (for studies recruiting SLaM
staff contact the SLaM/IoPPN R&D office)
If your study is a service evaluation or audit rather than research, please contact the R&D office of the NHS
Trust where the project will take place for guidance on how to obtain approval within that trust (for SLaM
projects contact the SLaM/IoPPN R&D office)
Sponsorship review
The purpose of sponsorship review is to support you to ensure that your research project complies with
national regulations pertaining to research, and with local organisational policies and procedures for IoPPN
and SLaM.
The process for seeking sponsorship is as follows:
Please refer to the following sections
 A. Appendices
 B. KCL insurance exclusions
 C. Requirements for registration of clinical trials
Then go to:
 D. Sponsor sign off for NHS Research Ethics and NHS R&D IRAS applications
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A. APPENDICES
Please check any of the following appendices that apply to your study, if these haven’t been provided to
you please request them from the R&D office.
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Appendix A - Protocol template and required inclusions (ALL, unless you are a student using your
course protocol template)
Appendix B - Peer review (for studies that have not undergone peer review as part of a competitive
funding process that resulted in secured funding)
Appendix C - Risk assessment (for all studies that involve administering a drug or substance)
Appendix D – If you are taking any tissue samples (including blood, saliva, urine)
Appendix E – local services and initiatives (Denmark Hill CRF, SLaM Consent for Contact, Centre for
Neuroimaging Sciences, IMANOVA, BRC Bioresource)
Appendix F – Training and resources
Appendix G – SLaM/KCL Secure Voice Recordings guidance - please use this guidance if you are
doing any audio recording as part of your study.
B. King’s College London insurance exclusions (KCL sponsored studies):
KCL insurance has certain exclusions, although it may be possible to obtain cover through insurers. Full
details of the college insurance cover and exclusions are found here:
https://internal.kcl.ac.uk/about/ps/finance/treasry/insure.aspx , the exclusions are listed below.
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Injury to any subject in a pregnancy trial.
Injury to any subject who is under the age of 5 years at the time of the trial.
Any claim arising from Hepatitis or any condition directly or indirectly caused by or associated with
Human T-Cell Lymphotropic Virus Type iii (HTLV iii) or Lymphadenopathy Associated Virus (LAV)
or the mutants derivatives or variations thereof or in any way related to Acquired Immune Deficiency
Syndrome or any syndrome or condition of a similar kind howsoever it may be named.
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Any claim arising from the condition directly or indirectly caused by or associated with CreutzfeldtJakob Disease (CJD) variant Creutzfeldt-Jakob Disease (vCJD) or new variant Creutzfeld-Jakob
Disease (nvCJD).
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Trials or research involving more than 5,000 subjects.
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Any overseas trial.
If you think your trial comes under one of these exclusions please send the following information to
[email protected], Finance Department, Room 8.20, James Clerk Maxwell Building.
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Copy of the trial protocol.
Copy of the informed consent form.
Confirmation of the country where the trial is taking place.
You should expect confirmation that your research is agreed with the insurers and this should come
from Herman Codner once he has received confirmation from the insurers that they are content to take on
the College’s risk. Without this confirmation KCL insurance cover will not apply and you will therefore be
personally liable for any claims that may arise from the trial.
Please advise the R&D office if any of the exclusions apply to your study and foward the communications
with Herman Codner. This will need to be done before we can confirm sponsorship
C. Requirements for registration of Clinical Trials (all researchers)
From 30 September 2013 all clinical trial applications which receive a favourable opinion from an NHS
ethics committee are required to be registered on a publicly accessible trial register. This is a condition of
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the ethical favourable opinion and failure to register will be regarded as a serious breach of good research
practice by the National Research Ethics Service (NRES).
Registration applies to the following categories of research, which are defined as the first four categories of
the IRAS project filter question 2:
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Clinical trial of an investigational medicinal project (CTIMP)
Clinical investigation or other study of a medical device
Combined trial of an investigational medicinal project and an investigational medical device
Other clinical trial to study a novel intervention or randomised clinical trial to compare
interventions in clinical practice
It is expected that studies are to be registered before the first participant is recruited, however research
given a REC favourable opinion will not be considered in breach of the favourable opinion if the study is
registered within 6 weeks of the first participant having been recruited.
Formal confirmation that a study has been registered will need to be provided to the REC and to the R&D
office as sponsor.
If you are unsure whether your study is a clinical trial or not, please contact us to discuss
D. Sponsor sign off for NHS Research Ethics and NHS R&D IRAS applications
Applications for NHS research ethics and NHS R&D are made via the online Integrated Research Application
System (IRAS). https://www.myresearchproject.org.uk/ . IRAS is also the mechanism by which
applications for other health research approvals are made (for example to the National Information
Governance Board NIGB).
The following documents are required for confirmation of sponsorship.
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Sponsorship cover form
CV for Chief Investigator
IRAS full project dataset – this can be produced by going to the project on IRAS, selecting ‘click here
to access the integrated dataset for all project forms’, go to the ‘Save/Print’ tab, and then ‘Print full
dataset for this project’. Wait for the file to download (click ‘HERE’ if this doesn’t happen straight
away). The pdf file of the application form will appear, save this file to your computer and you can
then email the file as an attachment or save on disk.
Protocol
Confirmation of secured funding.
o Where there is external funding please forward the funding award letter along with details
of which organisation has received the funding (for example, KCL or SLaM).
o Studentships - If you have been awarded funding from KCL for the purposes of your
studentship, please forward the award letter from KCL.
o For non-student studies, where a study has not been awarded full funding, please contact
the R&D office for an internal costings form. Unfunded studies will also require
confirmation from the department or CAG involved that they are happy to support the
study.
o If your study is funded by the BRC / BDU we do not need a formal award letter, but please
advise us whether the BRC / BDU funding covers the cost of the entire study and forward
any confirmation that you do have (an email is fine).
Students: confirmation that your protocol has been reviewed and approved by your course
supervisor, and for PhD students confirmation that your study is formally registered as a PhD
project with the Institute of Psychiatry, Psychology & Neuroscience (IoPPN).
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Consent documents – please use the Health Research Authority guidance and templates:
http://www.hra.nhs.uk/resources/before-you-apply/consent-and-participation/consent-andparticipant-information/
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Confirmation of scientific review (either 2 x external reviews, or confirmation from R&D office, or
competitively awarded external funding for single project)
Confirmation completion of SLaM/IoPPN risk assessment (if your study involves a drug)
Sponsor & administrative entries on IRAS
 A6-1 IRAS
This section requires a lay summary. This will be published publicly by the National Research Ethics Service
(NRES) along with a summary of ethical issues to fulfil requirements under the freedom of information act
and also to come in line with requirements of the Clinical Trials Regulations.
 IRAS A72
If any research activities with participants are taking place at the Institute of Psychiatry, Psychology &
Neuroscience (IoPPN) please tick ‘educational establishment’. You do not need to tick this option if the
activities at the IoP are limited to storing and analysing data.
 IRAS A76 1 &2
If KCL will be taking on the role of sponsor or co-sponsor the “other” box will need to be ticked and quote
details of the KCL insurance policy. A copy of the KCL indemnity documents should be included with the
submission to ethics. These will be emailed to you by the R&D office when sponsorship is agreed.
If SLaM is taking the role of sponsor then you would need to tick the NHS indemnity answer.
 IRAS A76 3
If the research is NHS based (whether or not it is SLaM or another NHS organisation) then you would need
to tick the NHS indemnity answer. If you are not using the NHS then you would need to tick other again
quote details of the KCL insurance policy.
 IRAS A77 (NRES Form A36)
If the lead or sole sponsor of the study is KCL then no fault liability insurance is in place for clinical trials. If
SLaM is the sole sponsor no fault liability is not available (Trusts are not allowed to provide this).
Sponsorship arrangements and IRAS entries: please note that where both KCL and SLaM are involved, the
study will be co-sponsored by both organisations. The exception to this is for KCL student studies that are
below doctoral level. These are KCL sponsored only, for example if you are a KCL MSc student and your
study is recruiting from SLaM, KCL will be your sole sponsor.
SLaM Chief Investigator
If the Chief Investigator is substantively employed
by SLaM, and SLaM is the main site for the study
then SLaM will be the sole sponsor
Question A64-1
Jennifer Liebscher
South London and Maudsley NHS
Foundation Trust
R&D Department
Room W1.11
Institute of Psychiatry, Psychology &
Neuroscience (IoPPN)
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KCL Chief Investigator
If the Chief Investigator is employed by KCL and are
using SLaM patients, data, equipment or samples for
your research, you will need to name both SLaM and
KCL as co-sponsors unless we advise you differently.
KCL is the lead sponsor in question (A64-1) and SLaM
is the co-sponsor in question (A64-2):
Question A64-1
Keith Brennan Director of Research
Management
Director of Administration (Health Schools)
Room 1.8 Hodgkin Building
De Crespigny Park
London SE5 8AF
020 7848 0251
Guy's Campus
King's College London
London SE1 4UL
Tel: 020 7848 6960
E-mail: [email protected]
A68
Jennifer Liebscher
South London and Maudsley NHS
Foundation Trust
R&D Department
Room W1.11
Institute of Psychiatry, Psychology &
Neuroscience (IoPPN)
De Crespigny Park
London SE5 8AF
020 7848 0251
[email protected]
A4 Should be
Jennifer Liebscher
South London and Maudsley NHS
Foundation Trust
R&D Department
Room W1.11
Institute of Psychiatry, Psychology &
Neuroscience (IoPPN)
De Crespigny Park
London SE5 8AF
020 7848 0251
[email protected]
Please select “yes” to the “are there any co-sponsors”
question (A64-3) as this will declare co-sponsorship
between the Trust and the College on the form.
A64−2.
Jennifer Liebscher
South London and Maudsley NHS Foundation
Trust
R&D Department
Room W1.11
Institute of Psychiatry, Psychology &
Neuroscience (IoPPN)
De Crespigny Park
London SE5 8AF
020 7848 0251
[email protected]
A68 Should be
Jennifer Liebscher - address as above
A4 Should be
Keith Brennan – address as above
A64-2.
Please explain how the responsibilities of sponsorship
will be assigned between the co-sponsors listed in A641
The lead sponsor, King's College London, will
take primary responsibility for ensuring that
the design of the study meets appropriate
standards and that arrangements are in place
to ensure appropriate conduct and reporting.
King's College London also provides cover
under its No Fault Compensation Insurance,
which provides for payment of damages or
compensation in respect of any claim made by
a research subject for bodily injury arising out
of participation in a clinical trial or healthy
volunteer study (with certain restrictions). The
co-sponsor, South London and Maudsley NHS
Foundation Trust, takes responsibility for
ensuring that appropriate standards, conduct
and reporting are adhered to regarding its
facilities and staff involved with the project.
Please email the study documents to the SLaM/IoPPN R&D office: [email protected]
What happens next:
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We will acknowledge receipt of your application by email and allocate you to a research facilitator
who will undertake the sponsorship review. We may request changes to your IRAS form if these
are needed, or suggest changes for advisory purposes
We will confirm sponsorship and will give you instructions on how to request the sponsor
electronic signature, and how to make the NHS ethics and R&D submissions.
If you need any guidance while you are putting your study documents together please contact us.
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