Transcript JG presentation

The NHS Research Ethics
Service in Scotland
How to get a Favourable
Opinion
10th Feb 2010
Judith Godden
Manager/ Scientific Officer
West of Scotland Research Ethics Service
NRES National Research Ethics
Service
• Protecting the rights, safety, dignity and wellbeing of research participants
• Facilitating ethical research which is of
potential benefit to participants, science and
society
NHS REC Structure in Scotland
4 Regions
WoSRES
NoSRES
Lothian
5
2
4
Tayside
3
REC Governance
NRES
UKECA
Health Board
CSO
CTIMPs
NHS REC
WoSRES
Benefits of a Regionalised Service
• Standard procedures across four
Scottish regions
• The West of Scotland regional service
covers the requirements of five health
boards and draws committee members
and expertise from across the five
health boards.
West of Scotland
Research Ethics Service
WoSRES
Regional research ethics service
Ayrshire & Arran HB
Dumfries & Galloway HB
Greater Glasgow & Clyde HB
Lanarkshire HB
Special HB (Golden Jubilee)
Others
WoSRES
WoS 1
Recognised
Type III
WoS 2
Authorised
WoS 3
Authorised
WoS 4
Authorised
Tissue Bank
WoS 5
Authorised
CTIMPS
Multicentre
Dental
Paediatrics
General
Dental
Paediatrics
General
Paediatrics
Primary Care
Mental Health
Biorepositories
Neonatal
General
General
Research
ethics
enquiries
Research Ethics
Co-ordinators
Scientific
Advisor
Local Data Protection
Caldicott Guardian,
Clinical Audit/Clinical
Governance Departments
Committee
Chairs
Local Health
Board R&D
Departments
Why is there an ethics service?
• Nuremberg Code, WMA Declaration of Helsinki
Ethical Principles for Medical Research
Involving Human Subjects, European Union
Directive 2001/20/EC
• Run by the National Research Ethics Service
(NRES). A single ethical opinion given by a
Research Ethics Committee (REC)
• To protect the rights, safety, dignity and wellbeing of (potential) participants
• To provide independent, competent and timely
review of the ethics of proposed studies
NHS Research Ethics
Committee
• Comprises of volunteer expert and lay members
(one third of members lay)
• Chaired by an expert or lay member
• REC run by coordinator
• Committee can run with 7-18 members
• In Scotland overseen by Scientific Officers
When is NHS Research Ethics
approval required?
• Is
it research?
NRES guidance ‘Defining Research’
Research
• The primary aim of research is to derive generalizable
new knowledge, whereas the aim of audit and service
evaluation projects is to measure standards of care.
• Neither audit or service evaluation uses an intervention
without a firm basis of support in the clinical or health
community.
• Neither audit or service evaluation allocate treatment or
service by protocol. It is a joint decision by the clinician
and patient.
• If it involves randomisation it is nearly always research.
When is NHS Research ethics
required?
• Is it research?
Yes
•Is the research within the
remit of an NHS REC?
What is the Remit of an NHS REC?
GAFREC
Governance arrangements for NHS Research Ethics Committees in
Scotland July 2001 (to be replaced shortly)
 Patients or users of the NHS
 Relatives or carers of NHS patients/users
 Access to the personal data or bodily material of
NHS patients
 Foetal material and IVF involving NHS patients
 The recently dead in NHS premises
 The use of, or potential access to, NHS
premises/facilities
 NHS staff recruited as research participants by
virtue of their professional role
When is NHS Research Ethics
approval required?
• Is it research?
Yes
•Is the research within the
Yes
remit of an NHS REC?
Are you
collecting tissue?
Scientific peer
review
Study numbers
(power calculation)
•
•
•
•
•
Recruitment
Who?
How?
How long to
consider?
Are you collecting
data?
ISD
CHI number
• Children
• Adults with incapacity
• Other special groups eg
prisoners etc
PIS
Questionaires
Adverts
Consent form
Payments involved?
Sponsor
Indemnity
IRAS
• Integrated Research Application System
https://www.myresearchproject.org.uk/
• Enables you to enter information about your
intended research project in one place.- generating a
number of research applications.
• Operates via filters/sieves to generate the forms
your project requires
NHS REC Form
NHS R&D Form
Project
Data
SSI
MHRA Form
ARSAC Form
IRAS forms
• REC
– ethics application form
• R&D
– outlines the proposed research project
• SSI
– Site Specific Information
– outlines the research team activities and
individual responsibilities at the site
Integrated Research Application
System (IRAS)
www.myresearchproject.org.uk
IRAS captures the information required to complete
multiple application forms simultaneously
IRAS training module
www.myresearchproject.org.uk
How to apply to a REC
• Fill out an application using IRAS
• Submit a paper copy of the ethics application
form and all supporting documentation to the
WoSRES office
• If valid you will receive an acknowledgement
and a time/date for the meeting. If not valid, the
application will be withdrawn
• You cannot submit any more information
Which REC do I send
the application to?
• Dates for meetings are on the NRES website
• Non-CTIMP, non-AWI studies. Single-site or
multi-site research to any WoS REC.
• CTIMP, Adults with Incapacity, (other flags).
Approach via Central Application System: 0845
270 4400
• Cross-border AWI studies are the only studies
requiring more than one ethical review
What is a valid Application?
• Use the checklist
• Signatures: Chief Investigator, Educational
Supervisor, Sponsor (letter or signature). Can
use electronic signatures
• Include questionnaires, adverts, GP letters, PIS
& consent
• Date and version control everything
What happens at the meeting?
• The committee will discuss the application
• Invite the investigator in and the Chair will lead
a discussion and then ask you to leave
• The REC will make a decision:
–
–
–
–
Final Favourable opinion
Provisional opinion
Unfavourable opinion
Refer to specialist referee
What happens after the meeting?
• Coordinator will take notes and send a letter
within 10 days detailing the decision including
any changes that need to be made
• Send further information to the coordinator
• Receive ethical approval
• Decision within 60 days
• You can appeal
Post approval
• Amendments: any changes to the protocol,
PIS, CF, any change to the risk/benefit ratio.
You will get a decision within 35 days
For CTIMPs the Sponsor decides what is
substantial
For non-CTIMPs the REC decides
• A new protocol requires a new application
• Progress reports: once a year
• Final reports: within a year
What is R&D approval?
• Legal requirement
– ensures protection for patients and staff
• Condition of
– ethics approval
– grant bodies
– publication
• Indemnity
– no R&D approval = no insurance
All research conducted within the NHS must
have R&D Management Approval
Enquiry to WoSRES
Office
Enquiry to R&D
Office
Is this research ?
NO
Letter issued detailing
the decision and recommending
local governance arrangements
for study
Does it involve
NHS patients
or staff?
Ethics
Ask investigator to
complete IRAS form and
submit to R&D & ethics
ensuring all sponsor
requirements
are in place
Favourable
opinion
R&D
Management
Approval
MHRA
(CTIMPs only)
CTA
Useful websites
IRAS
https://www.myresearchproject.org.uk
National Research Ethics Service (NRES)
http://www.nres.npsa.nhs.uk/
Data & Tissues Tool Kit
http://www.dt-toolkit.ac.uk/home
Clinical Trials Tool Kit
http://www.ct-toolkit.ac.uk/
Stem Cell Tool Kit
http://www.sc-toolkit.ac.uk/
WoSRES [email protected]