AREC Presentation: The Only Way is Ethics

Annya SekulaDeputy Regional Manager, Manchester REC Centre

The following topics will be covered:

• What needs ethical review?

• Applying for ethical review – Integrated Research Approval Process (IRAS)

• Submitting to a REC and the approval process

• Proportionate Review – what type of research is suitable?

• Substantial Amendments

20 April 2023

The role of NRES

Protecting the rights, safety, dignity and well-being of research participants and facilitating ethical research…

Where NRES fits in:

• Is my study research? (R&D/NRES)

• Does it require NHS REC approval? (if not University/Departmental Ethics Committee)

Governance Arrangements for Research Ethics Committees (GAfREC)

Our remit:

• Potential research participants identified from, or because of, their past or present use of the NHS.

• Potential research participants identified because of their status as relatives or carers of past or present users of the NHS.

Governance Arrangements for Research Ethics Committees (GAfREC)

Our remit:

• Collection of tissue (i.e. any material consisting of or including human cells) or information from users of the NHS.

• Use of previously collected tissue or information from which individual past or present users of the NHS could be identified.

Timeline of things to do

• Does it need ethical review – if so where?

• Contact R&D Department/Supervisor

• Complete online Research Ethics application form using IRAS and prepare all supporting documentation

Role of Sponsors

All research involving the NHS requires an organisation to act as research sponsor

Responsible for clinical governance issues for the project.

Ensures the design of the study meets appropriate standards.

Integrated Research Application System (IRAS)

Tips on completing the IRAS form

• www.myresearchproject.org.uk

• Complete dataset once to populate multiple forms.

• Question specific advice on the form

• Complete the project filter page correctly.

National Research Ethics Service

IRAS Project Filter:

11

Enter study title here

Clicking on the green info icon provides question specific

guidance

National Research Ethics Service

IRAS Project Filter:

12

Research using tissue: check section B4 & B5 are fully completed

Ionising Radiation: check section B3 is completed. Check declaration signed by lead Clinical Radiation Expert

Mental Capacity Act

Research involving prisoners?

Student Project?

Tips on Preparing Study Documentation for Submission to the REC

• Participant Information Sheet and Consent Forms

• Separate PIS for different study groups

• Research involving children

• Questionnaires/Interview Schedules

• Advertisements (including web adverts/ emails)

• Document Control

Submitting an application for ethical review

Timeline of things to do

• Complete IRAS form and obtain all required authorisations

• Book in your application

• Submit application within 4 days (2 working days for Proportionate Review

• Be prepared to make changes if the application is not valid.

• RECs have 60 days from receipt of a valid application to issue an opinion.

What happens at a Research Ethics Committee meeting?

• Application sent to the members 2 weeks prior to the meeting date.

• Volunteers; Mix of lay and expert members.

• Various RECs may have special expertise

• Pre-discussion and discussion with the researcher

• Ethical Opinion issued.

What decisions are available?

• Favourable Opinion

• Favourable Opinion with Conditions

• Provisional Opinion

• Unfavourable Opinion

• No Opinion – Proportionate Review applications only

Proportionate Review

Proportionate Review

Where a research study presents ‘no material ethical issues’ (for instance, where there is less risk, burden or intrusion to the participants), it can be reviewed and approved by a Proportionate Review Sub-Committee within 14 days of receipt.

Proportionate Review (cont…)

• No Material Ethical Issues Tool (NMEIT) – screening tool which sets out the categories of study which are eligible for Proportionate Review.

• National Proportionate Review booking line: 0161 625 7704

The operator will screen the application to check whether it is suitable before accepting the booking.

No Material Ethical Issues Tool (NMEIT)

• Research using data or tissue that is anonymous to the researcher.

• Research using existing tissue samples already taken with consent for research.

• Research using ‘surplus or extra tissue’ with consent. • Questionnaire or Interview research that does NOT

include highly sensitive areas or where accidental disclosure would NOT have serious consequences

• Research surveying the safety or efficacy of established non drug treatments, involving limited intervention and NO change to the patient’s treatment.

• Minimally invasive basic science studies involving healthy volunteers.

Some studies always require review at a full REC meeting….

• Clinical Trials of Investigational Medicinal Products (CTIMPs)

• Investigations of Medical Devices• Research involving adults lacking capacity and subject

to the Mental Capacity Act 2005• Invasive basic science studies involving healthy

volunteers• Research involving exposure to ionising radiation which

could be additional to that received in routine clinical care for any participant

• Research tissue banks• Research databases

How are Proportionate Review meetings held?

• All NHS Research Ethics Committees are required to take part in Proportionate Review.

• PRSC meetings can take place face to face, via teleconference or via email correspondence.

• 3 REC members including one lay members and one

expert member.

• Researchers do not attend the meeting but may be contacted by telephone or email to provide clarifications.

What decisions can be given at a Proportionate Review meeting?

• Decision letter will be issued in 14 days.

• Same decision as before but also includes ‘No Opinion’ decision for applications which have material ethical issues.

• If a ‘No Opinion’ is issued the application will be transferred to a full REC meeting.

Once the study has been approved …….

• REC has minimal monitoring responsibility

• Substantial Amendments

• Minor Amendments

• Annual Reports

• End of Study and Final Report

Useful Web Links

• NRES website: www.nres.nhs.uk

• Integrated Research Application System (IRAS): www.myresearchproject.org.uk

• ‘Is my project research?’ decision tool:

http://www.hra-decisiontools.org.uk/research/

• ‘Does my project require review by an NHS Research Ethics Committee?’ decision tool:

http://www.hra-decisiontools.org.uk/ethics/

Thank you for listening……

• Questions?