The NHS Research Ethics Service in Scotland

How to get a Favourable Opinion

10th Feb 2010Judith Godden

Manager/ Scientific OfficerWest of Scotland Research Ethics Service

NRES National Research Ethics Service

• Protecting the rights, safety, dignity and well-being of research participants

• Facilitating ethical research which is of potential benefit to participants, science and society

NHS REC Structure in ScotlandNHS REC Structure in Scotland

4 Regions

WoSRES NoSRES Lothian Tayside

5 2 4 3

REC GovernanceREC Governance

Health Board

NHS REC

UKECANRES

CSOCTIMPs

WoSRESBenefits 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

WoSRESRegional research ethics service

Ayrshire & Arran HBDumfries & Galloway HB

Greater Glasgow & Clyde HBLanarkshire HB

Special HB (Golden Jubilee)Others

WoSRESWoS 1RecognisedType III WoS 2

AuthorisedWoS 3Authorised

WoS 4AuthorisedTissue Bank

WoS 5Authorised

CTIMPSMulticentre

DentalPaediatricsGeneral

DentalPaediatricsGeneral

PaediatricsPrimary CareMental Health

BiorepositoriesNeonatalGeneral

General

Research Ethics Co-ordinators

Scientific Advisor

Research ethics enquiries Committee

Chairs

Local Health Board R&D Departments

Local Data Protection Caldicott Guardian, Clinical Audit/Clinical Governance 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 well-being 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?

•Is the research within the remit of an NHS REC?

Yes

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?

•Is the research within the remit of an NHS REC? Yes

Yes

Scientific peer review

•Children•Adults with incapacity•Other special groups

eg prisoners etc

Are you collecting tissue?

RecruitmentWho?How?How long to consider?

•PIS•Questionaires•Adverts•Consent form•Payments involved?

Study numbers(power calculation)

Are you collecting data?ISDCHI number

SponsorIndemnity

IRAS•Integrated Research Application Systemhttps://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

Form Fi lte r

NHS R&D Form

SSI

MHRA Form

ARSAC Form

Project Data

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)

IRAS captures the information required to complete multiple application forms simultaneously

www.myresearchproject.org.uk

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 substantialFor 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 ?Letter issued detailing

the decision and recommending local governance arrangements

for study

Does it involve NHS patients

or staff?

Ask investigator to complete IRAS form and submit to R&D & ethics

ensuring all sponsor requirements are in place

Favourableopinion

CTA

ManagementApproval

NO

Ethics

R&D

MHRA (CTIMPs only)

Useful websitesIRAS

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 Kithttp://www.sc-toolkit.ac.uk/

WoSRES judith.godden@ggc.scot.nhs.uk