UNIVERSITY OF SHEFFIELD
PROCEDURE FOR
HEALTHCARE RESEARCH
GOVERNANCE
[nb. UoS sponsored Clinical Trials (ie. Any healthcare research study involving a human intervention) are
administered by the team in R&IS. , please contact Catherine Wynn in the R&IS Quality and Governance Team,
ext 21400, c.wynn@sheffield.ac.uk]
Why Healthcare Governance?
It’s where the Buck Stops.
The process is controlled by the Health Research Authority’s Framework for Health and
Social Care
It ensures that a clearly designated organisation takes on the overall responsibility for
the health care research project…
The majority of Healthcare Research carried out within the University is sponsored by
Sheffield Teaching Hospitals; other NHS trusts or private pharmaceutical companies.
However, the University will sponsor research (but not Clinical Trials of Investigational
Medicinal Products) where no other sponsor is appropriate (see Annex One of the
Devolution Information).
What is covered by Healthcare Governance?
Department of Health Definition of Healthcare Research:
Research which is:
- being concerned with the protection and promotion of
public health
- taking place in or by the Department of Health and the
NHS
- by Universities within the healthcare system which may
have an impact on the quality of these services
Sponsors Responsibilities
The Key Concerns of the Healthcare Research Governance Framework are:
- to protect participants in Healthcare Research
- To further strengthen scientific quality
- to clarify accountabilities and responsibilities
The Governance Sponsor must:
i.
Ensure that the healthcare research projects are adhering to any conditions set by
research ethics committees (including procedures for informed consent)
ii. Have arrangements to monitor the health care research projects
iii. Have a system to record any adverse events, should they occur
iv. Have a system to inform service users and the public about the research
v. Have arrangements to ensure that the research is appropriately disseminated
vi. Have a system for identifying, owning and exploiting research-based intellectual
property
The University’s Approach
The University has devolved the compliance with the RG Framework to the individual
Investigators and their Heads of Department.
This is set down in writing alongside the confirmation of the University’s sponsorship of
the Research (see Devolution materials Annex 4)
The work of the Devolved process is overseen by a sub committee of the Research and
Innovation Committee: the Health and Human Interventional Studies Research Sub
Committee.
Clinical Trials (Human Interventional Studies) undergo an additional risk assessment to
ascertain what level of process oversight is required.
This contrasts with the approach of STH where the Clinical Research Office takes an
active role in post award monitoring (for example, checking the content of the Project
Site Files)
OVERVIEW OF THE TUOS
PROCESS PRIOR TO
INVOLVEMENT OF THE
HEALTHCARE CONTACT
(unless involved through an additional job role)
1. INITIAL DECISIONS STAGE (nb. This should already have been established prior to details
being sent to the Healthcare Research Governance Contact)
Decide if the project is a healthcare research project
(consult: http://www.sheffield.ac.uk/ris/other/gov-ethics/governance/definition)
Decide which organisation is the project’s research governance sponsor
(consult: http://www.sheffield.ac.uk/polopoly_fs/1.121332!/file/sponsor.pdf)
For work within the NHS it may be that an honorary research contract or letter of access is
needed. If so, the Research Passport application form needs completing
(consult the guidance: http://www.sheffield.ac.uk/ris/other/gov-ethics/governance/passport]
2. REGISTRATION STAGE: nb. In terms of Healthcare
University:
Register the project on the University Research Management System (URMS)
(consult: http://www.sheffield.ac.uk/ris/application/pricing- URMS helpline: 222 1450)
This includes Student Projects even if they are not funded. There are guidance notes on how to do
http://www.researchoffice.dept.shef.ac.uk/shef-only%20/Tutorials/Student%20Governance.swf
NHS:
AND IF THE PROJECT INVOLVES THE NHS THEN ALSO
Register the project with the NHS Trust(s) and/or Primary Care Trust(s) which are involved
(the list of Trust R&D contacts is at: www.rdforum.nhs.uk/044.asp)
Nb. RIS’s Pricing & Contracts team is automatically notified about all studies registered with the STH
3. HEALTHCARE GOVERNANCE SPONSORSHIP CONFIRMATION
Confirmation of Sponsorship is the Responsibility of the Healthcare Research Governance Contact.
The Devolved Process is outlined on the following slides
HEALTHCARE GOVERNANCE
CONFIRMATION OF
SPONSORSHIP
CONTACT RESPONSIBILITIES:
PROCESS OVERVIEW
Receive an email from the Pricing Team
Email received from the pricing team by the Governance Contact
The email includes:
- URMS number- Programme name/Project title
- Name and Department of Principal (Primary) Investigator (PI)
- Research governance sponsor (as on URMS)
- If a funded project: confirmation that a letter confirming the award of funding
has been received (which can be taken as scientific approval)
You should enter these details onto your Healthcare Research Governance
Spreadsheet (found in the electronic Devolution Resources (see next slide))
Project details should not be passed on to Research Finance by the departmental
governance contact until the governance checks are complete (these checks are outlined in the
following slides)
The details for non funded projects do not need to be returned to Research Finance, however,
the project should not start until the Governance checks are complete and the Sponsorship
confirmed
Record the stages of the Governance Check in the
spreadsheet
(Blank Spreadsheet can be found in the electronic ‘Devolution’ resources)
URMS Student
PI
PI
Project Research Date IF UoS IS
IF UoS IS
IF UoS IS
IF UoS IS
IF UoS IS If UoS IS NOT
No. Name (super- (super- title governance email SPONSOR: SPONSOR: SPONSOR: SPONSOR: SPONSOR: SPONSOR:
visor) visor)
sponsor receiv Date of
Date of
Date IRAS
Date of
Date of
Date of
Surname First
ed Confirmatio conditional Declaratio Confirmatio sponsor confirmation
Name
from
n of
sponsor
n by
n of Ethics authorisatio of research
Pricin Scientific authorisatio Sponsor
Approval
n letter
governance
g
Approval
n letter (if Authorised
sponsor
Team
required)
Included
in Email
from
URMS
Team
STEP 3
STEP 4
Additional Comments
STEP 5
STEP 1
Enter these details if UoS is the
sponsor (n/a if not)
STEP 2
Complete
if non UoS
sponsor
See note (under STEP 5, regarding
conditional authorisation)
Eg. progress/
people
contacted/
description of
evidence of
sponsorship
provided
Research Governance Sponsorship Checks
STEP 1: CONFIRM WHO IS THE RESEARCH GOVERNANCE SPONSOR
Is it a funded project?
If YES, move to STEP 2
If NO, contact PI to ask who the RG sponsor should be
NB. The RG sponsor is not necessarily the same as the financial sponsor…
see Annex 2 (of Devolution resources) (Slide 3) for guidance on appropriate RG sponsors
See Annex 3 (of Devolution resources) for template emails for seeking further information
Nb. Prior to contacting the PI, it is worth looking through the future steps to determine
what further information may be required so that the emails can be merged
File and record the response.
Then move to STEP 2
Research Governance Sponsorship Checks
STEP 2: IF TUOS is not the Research Sponsor.
Is the RG sponsor an organisation other than the University of Sheffield?
- If YES, contact the PI to ask for a copy of a letter/email from the organisation
which confirms its agreement to be the RGsponsor (template emails are included
Documents)
File and record the response.
MOVE TO STEP 6 (Steps 3 – 5 are not required).
- If NO, (i.e. if the University of Sheffield is the RG sponsor) move to STEPS 3 - 5
STEP 3: SCIENTIFIC APPROVAL (Uos Sponsored Projects):
Has the project been independently scientifically approved?
this
If YES, record date on spreadsheet and file a copy of the email from
If NO, obtain written confirmation that the project has been
approved
(template emails are included at Annex 3)
NB – Please read Step 4 before contacting the PI: it may be that evidence of
review is required and therefore both can be requested in the same email.
STEP 4: EVIDENCE OF ETHICAL APPROVAL (UoS Sponsored):
Obtain written evidence that the project has been independently ethically approved
Contact the PI if necessary (template emails are included at Annex 3)
[NB. ethics approval should not be sought until the project has been scientifically approved]
Record and file the evidence
Move to STEP 5
See next Slide (Step 4a) in the cases where Ethics approval needs to be sought via the NHS).
STEP 4A - ETHICS APPROVAL VIA THE NHS (UoS Sponsored Projects)
IRAS application needs to be signed electronically by an authorised signatory
a physical copy is signed and filed)
IRAS authorisation should not be granted until a project is registered on URMS
and the Research Governance contact has received confirmation of Scientific
Approval.
If the department wishes to do so, it can arrange for the departmental
such emails and to have access to the relevant signatory’s password for the IRAS
authorise the form on the signatory’s behalf (ensuring that a hard copy if signed
A detailed guidance document about the electronic approval process is available
materials
[NB. Where a researcher is applying for NRES (i.e. NHS) ethics approval and needs to
insurance s/he should send an email to insurance@sheffield.ac.uk requesting a copy of the
FINAL CHECK: YOU SHOULD NOW HAVE...
Confirmation of who the RG Sponsor is
PLUS....
IF THE RGSPONSOR IS NOT THE UNIVERSITY OF SHEFFIELD...
- Evidence confirming that the RGsponsor agrees to take on this responsibility
OR
IF THE RGSPONSOR IS THE UNIVERSITY OF SHEFFIELD...
- Confirmation of independent scientific approval
- Confirmation of independent ethics approval
STEP 5: ONLY REQUIRED IF THE RGSPONSOR IS THE UNIVERSITY OF SHEFFIELD
Send RG Sponsorship Letter to the PI/ student
This officially authorises the project to start on behalf of the University as Rgsponsor.
Send the letter to the PI, cc. the Head of Department (if a student project, send to the student
cc. the Head of Department and supervisor)
(template letters are provided at Annex 4).
The letter should be signed by one of the department’s authorised signatories.
Record the date the letter was sent and file a copy.
ADDITIONAL NOTE REGARDING CONDITIONAL AUTHORISATION
In some cases, projects may need to commence BEFORE independent ethics approval has been
sought (i.e. if the aspect of the project requiring ethics approval will not take place until a later
stage in the project, but the funding needs to be released immediately by Research Finance). In
such cases, a CONDITIONAL letter authorising the project to start can be sent, and STEP 6
followed; however, evidence of ethics approval must be provided by the PI as soon as possible,
and a standard authorisation letter should then be sent to the PI and a copy emailed to the
Pricing Team.
STEP 6: FOR FUNDED PROJECTS ONLY
Email the Pricing Team in Research & Innovation Services to confirm that
governance checks on the project are complete
Attach EITHER the evidence confirming that the RGsponsor agrees to take on this
OR a copy of the letter authorising the project to start (or conditional
(a template email is included at Annex 3 of the Devolution materials)
STEP 7: FOR ALL PROJECTS
Ensure all relevant documents are filed and record keeping is up to date
(for guidance, refer to the record keeping factsheet at Annex 5).
Example of an ongoing spreadsheet (staff applications)
Supporting guidance and documentation for the administration of the procedure
are provided on the following pages, as follows:
Summary Devolved Governance Procedure supported by:
Annex
Annex
Annex
Annex
Annex
Annex
Annex
1:
2:
3:
4:
5:
6:
7:
Flow diagram showing the full research governance procedure for researchers
Guidance on establishing who the Research Governance Sponsor should be
Template emails for key stages in the process
Template sponsor authorisation letters
Record keeping factsheet and example spreadsheet
Template email responses to common queries
IRAS electronic authorisation – guide for authorisers
Current Departmental Contacts:
Department/School
Person(s) responsible
Nursing and Midwifery
Miss Jennifer Gray j.l.gray@sheffield.ac.uk (22 22055)
Clinical Dentistry
Dr Lynne Bingle (overall responsibility) l.bingle@sheffield.ac.uk (817953)
Sue Spriggs (administration) s.spriggs@sheffield.ac.uk (817953)
Psychology
Christie Harrison c.harrison@sheffield.ac.uk (22 26650)
Human Communication Sciences
Patty Cowell (overall responsibility) p.e.cowell@sheffield.ac.uk (22 22426)
Kathryn Sharpe (administration) k.sharpe@sheffield.ac.uk (22 22402)
Medical School
Gaurika Kapoor (STH – Clinical Research Office) gaurika.kapoor@sth.nhs.uk (226 5937)
ScHARR
Dr Jennifer Burr (overall responsibility) j.a.burr@sheffield.ac.uk (22 20792)
Kirsty Woodhead (administration) k.woodhead@sheffield.ac.uk (22 25453)
Other Departments
Catherine Wynn c.wynn@sheffield.ac.uk (22 21400)
Current Authorised Signatories
Medical School
Prof Tim Skerry (Human Metabolism) 271 : T.Skerry@sheffield.ac.uk
Prof John Newell-Price (Human Metabolism) 226 1309 j.newellprice@sheffield.ac.uk
Prof Moira Whyte (Infection and Immunology) 271 2355 M.K.Whyte@sheffield.ac.uk
Prof Ian Sabroe (Infection and Immunology) 271 3243 I.Sabroe@sheffield.ac.uk
Dr Sheila Francis (Cardiovascular Science) 271 2233 s.francis@sheffield.ac.uk
Prof Chris Newman (Cardiovascular Science) 271 3194 c.newman@sheffield.ac.uk
Prof Paul Ince (Neuroscience) 222 2234 p.g.ince@sheffield.ac.uk
Prof Malcolm Reed (Oncology) 271 3167 m.w.reed@sheffield.ac.uk
Prof Hilary Powers (Oncology) 226 1346 h.j.powers@sheffield.ac.uk
Nursing and Midwifery
Prof Anne Peat a.m.peat@sheffield.ac.uk 222 2059
(Penny Curtis) p.a.curtis@sheffield.ac.uk 222 2040
(Sharron Hinchcliff) s.hinchliff@sheffield.ac.uk 222 2045
School of Clinical Dentistry
Professor Paul Speight p.speight@sheffield.ac.uk 281 7960
(Dr Lynne Bingle) l.bingle@sheffield.ac.uk 281 7953
Department of Psychology
Dr Andrew Thompson a.r.thompson@sheffield.ac.uk 222 6637
(Prof Michael Barkham m.barkham@sheffield.ac.uk 222 6527
Prof Gillian Hardy g.hardy@sheffield.ac.uk 222 6572
Dr Georgina Rowse g.rowse@sheffield.ac.uk 222 6574
Dr Lisa Berry l.berry@sheffield.ac.uk 222 6577
Human Communication Sciences
Professor Patty Cowell p.e.cowell@sheffield.ac.uk 222 2426
(Prof Shelagh Brumfitt) s.m.brumfitt@sheffield.ac.uk 222 2406
School of Health and Related Research
Professor Petra Meier (temporary replacement for John Brazier who is on study leave until Sept 14) p.meier@sheffield.ac.uk 222 0735
(Dr Jennifer Burr) j.a.burr@sheffield.ac.uk 222 0792
(Professor Jon Nicholl) j.nicholl@sheffield.ac.uk 222 5453
(Dr Ravi Maheswaran) r.maheswaran@sheffield.ac.uk 222 0681
(Professor Steve Goodacre) s.goodacre@sheffield.ac.uk 222 0842
Research and Innovation Services
Deborah McClean d.mcclean@sheffield.ac.uk 222 1449
RESEARCH AND INNOVATION
SERVICES SUPPORT AND
AUDIT
GOVERNANCE PROCESS
University wide oversight is provided by the Health and Human Interventional
Studies Research Sub Committee
Meetings 4 times per year:
Representatives:
Medicine
ScHARR
Psychology
Dentistry (on behalf of Dentistry, Nursing and HCS)
University Ethics Committee
Reports to University Research and Innovation Committee
The team in R&IS also fulfil an ‘Intelligence’ function: looking for changes;
responding on behalf of the University to consultations; attending workshop etc
AUDIT PROCESS (Under review by the Health and Human-Interventional Studies
Research Sub Committee)
Annual Review in Feb/ March
1. Submit Spreadsheet of recorded applications to RIS team
2. R&IS select up to 5 cases and request copies of the necessary documentation.
3. Results are reported to the HHISRSC and guidance/ assistance provided
where identified
Departmental visits by member of HHISRSC
To be conducted throughout the 2014/2014 Academic Year.
- primarily to assess the Departmental Monitoring of Low Risk Clinical Trials
(Human Interventional Studies)
- also review applications processed and feedback on the processes for
Healthcare Governance