STARTING A RESEARCH PROJECT
Most research carried out at the Clinical School using human participants falls under the
Dept of Health’s “Research Governance Framework for Health and Social Care”
This requires a sponsor for the study, peer review, insurance and ethics approval before
the study can start. All studies using NHS patients, their tissue and data requires NRES
(National Research Ethics Service) ethics approval. Recent changes to legislation,
however, mean that research just involving NHS staff (for surveys, questionnaires etc), or
NHS facilities with healthy volunteers, no longer require NRES ethics approval. Such
studies should now go to one of the University ethics committees
HOWEVER some research requires NRES ethics approval whether or not the NHS is
involved. Examples of such research are set out below
a) your study involves human tissue and you do not have a licensed facility for storage OR
consent
b) your participants are unable to give consent or
c) your study is a CTIMP (Clinical Trial of an Investigational Medicinal Product) in which
case NRES approval is required
d) your research involves the clinical investigation of a non-CE marked medical device
e) your research involves social care
For full guidance on whether or not your research requires NRES ethics approval
please see weblink.
http://www.nres.nhs.uk/applications/approval-requirements/ethical-review-requirements/
and click on “Does my Project Require Review by a Research Ethics Committee”
If it does not fall under the NRES categories for review then it should be reviewed by an
internal University Ethics Committee
Information to help you get started - ethics approval and sponsorship
Clinical School Research
Governance Officer
Carolyn Read
01223 769291
Cad50@medschl.cam.ac.uk
CAMBRIDGE RESEARCH OFFICE
BASED IN THE CLINICAL SCHOOL
BUILDING
Assistant Director
Senior Contracts Manager
Contracts Manager
Jo Martindale
Denise Pinto
Beth Collins
01223 765145
01223 765191
01223 764192
Jo.martindale@admin.cam.ac.uk
Denise.pinto@admin.cam.ac.uk
Beth.collins@admin.cam.ac.uk
CUH (Addenbrooke’s) R&D OFFICE
R&D Senior Manager
R&D Manager
R&D Officer
R&D Officer
Honorary Research Contracts
r&d@enquiries.nhs.uk
Stephen Kelleher
Louise Stockley
Tracey Assari
Helen Street
Debbie Richards
01223 217418
01223 348491
01223 348455
01223 349321
01223 274660
stephen.kelleher@addenbrookes.nhs.uk
louise.stockley@addenbrookes.nhs.uk
Tracey.assari@addenbrookes.nhs.uk
Helen.street@addenbrookes.nhs.uk
Deborah.richards@addenbrookes.nhs.uk
Nirvana Croft
01223 348492
Nirvana.croft@cpft.nhs.uk
R&D@cpft.nhs.uk
Cambridgeshire and Peterborough
FT R&D OFFICE
R&D Officer
Enquiries and Research Passports
CLINICAL TRIALS OFFICE
Director
cctu@addenbrookes.nhs.uk
Ian Wilkinson
http://www.cuh.org.uk/cms/research-anddevelopment/clinical-trials/cambridge-clinical-trialsunit-cctu
General information
RESEARCH PASSPORTS
PhD students
University Employees
Sarah Pickard
Sarah Hickling
01223 338387
01223 769257
sarah.pickard@admin.cam.ac.uk
slc46@medschl.cam.ac.uk
INSURANCE
Insurance Manager
Insurance Assistant
Bernadette Mclellan
Ross Elliott
01223 339659
01223 332216
bernadette.mclellan@admin.cam.ac.uk
ross.elliott@admin.cam.ac.uk
WHERE DO I START? WHO SHOULD I CONTACT?
Clinical Trials falling under the EU Clinical Trials Directive
You should have already contacted the Clinical Trials Office before completing your grant
application. If you have not yet contacted them do so now. They will then guide you
through the processes required to start a trial. Please note that if you wish the University
to be involved in sponsorship of these types of trials you must work with the Cambridge
Clinical Trials Unit or equivalent elsewhere if this is not suitable
Research involving Addenbrooke’s patients, data or tissue
All studies involving Addenbrooke’s Hospital – their patients, data, or tissue will be jointly
sponsored by Addenbrooke’s and the University.
1. Your first point of contact is Addenbrooke’s R&D department and they will set
out the requirements required before you can start the trial
2. You should also contact the University insurance office as you will need
insurance to cover the design of the protocol. This is necessary even if you
hold an honorary NHS contract
3. Send to the research governance officer, within the Clinical School, a copy of
the protocol so they are aware that the study will be taking place
4. When filling in the IRAS (NRES application) form the point of contact will be
the R&D officer in the R&D office and they will sign the sponsor declaration
page on the application form .
Research involving CPFT patients
CPFT R&D pages are a good source of advice for studies involving their patients
http://www.cpft.nhs.uk/professionals/information-for-researchers.htm
Most studies involving CPFT patients will be jointly sponsored by CPFT and the
University. (Under new arrangements some studies where CPFT is just a Participant
Identification Centre the University may solely sponsor)
1. In all cases where CPFT patients are involved in research your first point of
contact is CPFT R&D office, which is situated within the Addenbrooke’s R&D
office
2. You should also contact the University insurance office as you will need
insurance to cover the design of the protocol. This is necessary even if you
hold an honorary NHS contract
3. Send to the research governance officer, within the Clinical School, a copy of
the protocol so they are aware that the study will be taking place
4. When filling in the IRAS application form the point of contact will be one of the
CPFT R&D officers. They will also sign the sponsor declaration page on the
application form
For information about, and clarification of, portfolio studies please see weblink below
http://www.crncc.nihr.ac.uk/about_us/processes/portfolio
Research involving other NHS Trusts
Please contact the research governance officer at the Clinical School. It is the
University’s policy to jointly sponsor research involving another trust wherever possible. If
no agreement is currently in place with the relevant trust the University research office will
try and put one in place
You will also need to contact the University insurance office for insurance to cover the
design of the protocol. This is necessary even if you hold an honorary NHS contract
Please also check whether you need a research passport and NHS honorary research
contract http://www.admin.cam.ac.uk/offices/hr/policy/passports/
Research with healthy volunteers using NHS facilities
In such cases the first point of contact should be the R&D office of the Trust. You will
need ethical approval but it may not necessarily be NRES approval. Under new guidance
from NRES you may be able to use the internal University committees. Please speak to
the University research governance officer for more information. Please note that R&D
approval is always required when using NHS facilities
You should contact the University insurance office for insurance to cover the design of the
protocol. This is necessary even if you hold an honorary NHS contract
Research involving more than one facility
If as well as using NHS facilities you are using University facilities to conduct your
research you may need to submit a Non-NHS SSI form to the NRES ethics committee.
This will need to be signed off by the Assistant Director in the University research office.
Please contact the research governance officer for further information
Research involving GP surgeries
When using GP surgeries in research you must get R&D approval from the relevant PCT
before starting your research. You must also ensure that GPs have appropriate insurance
in place to carry out research. The Research Office can provide you with the necessary
GP letter
Research with healthy volunteers using University facilities
Such studies will be solely sponsored by the University and the research governance
officer should be contacted to arrange sponsorship
Ethics approval will still be required but in most cases researchers can apply to the
University Human Psychology Ethics Committee or the University Human Biology
Committee. However if you are using human tissue samples (this can include saliva,
urine, blood etc) and they are being stored somewhere which does NOT have a human
tissue licence or you do not have consent for use you will need to get NRES ethics
approval NOT University approval. This also applies for studies where your participants
are unable to consent for themselves or if you are carrying out a CTIMP or medical
device study or the study involves social care
For further information please see
http://www.nres.nhs.uk/applications/approval-requirements/ethical-review-requirements/
If you are carrying out studies that involve any administration of drugs, even if
these are on healthy volunteers on University premises, the Clinical School
requires that NRES ethics approval be obtained, NOT internal ethics approval. Any
such projects also need to be undertaken in the Wellcome Trust Clinical Research
Facility or other appropriate clinical research facility (eg WBIC or the Vascular
Research Unit). NRES has agreed to review such projects even though they may
fall outside its’ normal remit. Please contact the research governance officer for
further advice/information.
In all cases insurance to cover the design of the protocol will still be required from the
University insurance office and you should inform them of your research. No research
study is covered by University insurance unless the insurance office has been specifically
informed about it and provided a letter confirming cover for the study so do not assume
that insurance is automatically in place.
To apply for university insurance please contact Ross Elliot
Ross.elliott@admin.cam.ac.uk
He will provide you with the relevant forms which should be filled in and returned to him
with a copy of the participant information sheet
Using the Herchel Smith Building for research
If you wish to use the Herchel Smith Building for research purposes you should contact
Karen Enright - Ke242@medschl.cam.ac.uk
Or
Sarah Ayerst - Sa719@medschl.cam.ac.uk
Research involving multiple sites/trusts
As well as the procedures mentioned earlier in the document you should also contact the
senior contracts lawyer at the University as agreements will need to be drawn up between
the various parties.
Denise.pinto@admin.cam.ac.uk
Research involving tissue samples moving to and from the University involving
another legal entity
For this type of research it may be necessary to put a material transfer agreement in
place. You should speak to Karen Ruffles in the research office re any material transfer in
or out of the University
Karen.ruffles@admin.cam.ac.uk
Research involving overseas site
Overseas research can take some considerable time to sort out and there may be
insurance costs. You should seek advice from the research governance officer at the
earliest possible point in your study discussions
Cad50@medschl.cam.ac.uk
USEFUL INFORMATION
Department of Health’s Research Governance Framework for Health and Social Care
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH
_4108962
Applying for NRES research ethics approval
http://www.hra.nhs.uk/research-community/
This new site has plenty of guidance under the resources area and several decisions making
toolkits
Accessing the IRAS application form
https://www.myresearchproject.org.uk/
Applying for internal University research ethic approval
Cambridge Human Biology Ethics Committee: http://www.bio.cam.ac.uk/sbs/hbrec/
Cambridge Psychology Research Ethics Committee: http://www.bio.cam.ac.uk/sbs/psyres/
Cambridge Clinical Trials Unit Website
http://www.cuh.org.uk/cms/research-and-development/clinical-trials/cambridge-clinicaltrials-unit-cctu
Addenbrooke’s R&D Website
http://www.cuh.org.uk/research/research_index.html
R&D approval
Where research involves an NHS Trust/PCT in ANY form then the researcher will need permission
from the Trust/PCT to carry out the research.
Guidance & Application Process for obtaining Insurance for Clinical Research Studies
http://www.admin.cam.ac.uk/offices/insurance/clinical/
Independent Peer review
What counts as independent peer review?
The “Research Governance Framework for Health and Social Care” says that every proposal for
health and social care research must be subjected to review by experts in the relevant fields able
to offer independent advice on its quality.
The supervisor can only act as a reviewer if the project is for a Masters project or below. PhD
projects require independent review.
Research Passports
A Research Passport is the mechanism for non-NHS staff to obtain an Honorary Research
Contract or Letter of Access when they propose to carry out research in the NHS. This replaces the
previous Honorary Research contract process. It has to be completed by your substantive
employer. Your department administrator should be able to help you. For further information see
website below.
http://www.admin.cam.ac.uk/offices/hr/policy/passports/