1 - HRA - Setting up research in the NHS: practical and ethical considerations

HRA Approval Implementation

Janet Boothroyd 25 February 2016

Health Research Authority

• Established 2011• Protect and promote the interests of

patients and the public in research • Consensus and collaboration on standards

rather than inspection

20 January 2016

This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk

• To make it easier to undertake responsible health research in the NHS in England as part of a UK-wide system

Vision

• To simplify the process for approval of health research for researchers, thus reducing the time and cost of setting up studies

Aim

http://www.hra.nhs.uk/


REC Favourable

Opinion

HRA assessment

HRA Approval

Other approvals

15 November 2015



HRA Approval

• Provides assurance to NHS organisations in England that the study can be undertaken in NHS.

• A study can start at an organisation when the organisation has confirmed they have capacity and capability to deliver the study– Execution of contract– Agreement of Statement of Activities


Single application HRA Approval

Assess Arrange

HRA Approval and sites

HRA

NHS/ CRN

Site selection

Confirm

Site list View status

Sponsor Site confirmed

Arrangements in place

Agreements signed

Sponsor invitessite


When fully implemented

• NIHR CSP no longer required• All studies (non-portfolio and NIHR CRN

portfolio)• NHS in England must have regard to HRA

guidance• Compatible with rest of UK• Supports preparation for EU Clinical Trials

Regulation

28 December 2015



Pharmacy and radiation

Clinical support assurances

Controlled roll out by study type

Cohort 1

Staff studiesMay 2015

Cohort 2

Primary care studiesAug 2015

Cohort 3

Non-trialsNov 2015

Cohort 4

Trials/ InvestigationsBy March 2016

Am

endm

ents

/ new

site

s al

l stu

dies

28 December 2015


This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk 2 May 2023

Update on implementation

• Cohort 1 – Live 11th May 2015• Cohort 2 – Live 10th August 2015• Cohort 3 - Live 30 Nov 2015

• HRA now accepting Cohort 4 and Cohort 5 type studies – please email [email protected] to discuss


mailto:[email protected]



• Confirmed by the end March 2016, HRA Approval will be the route for submission and Approval in England.

• CSP will be closed for all new applications• No requirement to submit SSI forms in NHS

England




• Cohort 4 - clinical trials and clinical investigations in secondary care

• Cohort 5 – single site, site sponsored studies. – No requirement to submit Statement of Activities

or schedule of events for Cohort 5 type studies

• Cohort 6 - Studies solely for educational purposes are currently excluded – continuing to collect views on appropriate way to manage these studies



• PAF will remain in IRAS and should be submitted as early as possible via IRAS to CRN– No change– Please continue to advise researchers– Support from CRN is separate to HRA Approval

• Reminder: beyond PAF stage– HRA Approval studies do not appear in CSP




• Assessment Standards and Criteria (updated 1 Feb 2016)

– Important applicants at least have an idea what is expected

– IRAS number on participant facing documents– More clarity re studies that do not require

confirmation of capacity and capability• Statement of Activities

– Updated version – Word document plus excel Schedule of Events


http://www.hra.nhs.uk/resources/hra-approval-applicant-guidance/hra-assessment-criteria-and-standards/


Statement of Activities – non-commercial

• Submit one template per ‘site type’ to HRA

• Add known local information before sending one to each site as part of local information package

• Complete the template during site set-up

• Can act in place of any other form of site agreement/contract).



Schedule of Events – non-commercial

• Submit one template per ‘site type’ to HRA• Details activities and their cost attribution• HRA Approval will not be conditional on

correct attribution or full research costs but information will be passed to sites.


This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk 02/05/2023

Sponsor

The sponsor takes responsibility for securing the arrangements to set up, start, manage and finance a study. Including:

a) confirming that everything is ready for the research to begin; b) putting and keeping in place arrangements to set up, start, finance and manage the study, including its competent project management and risk management; c) ensuring that roles and responsibilities of the parties involved in the research are agreed and appropriately documented.


This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk 02/05/2023

Key premise – sponsor confirms that everything is ready

• Study is well planned before application to HRA• Application is of high quality• Clarity over finance being provided to sites• CI being clear on their responsibilities to deliver• Whole system improvement in research delivery starts

with sponsors



HRA Expectations of sponsors

• HRA expects that studies applying for HRA Approval will be ready to start promptly once HRA Approval issued

• To work closely with participating sites to jointly agree participation

• Work with sites in a timely fashion to enable them to confirm capacity and capability



Sponsor

HRAMHRA

CRN Participating sites

Sponsor communications

Via study support service


High level proposed process with HRA Approval

Applicant identifies

sites

Applicant sends local package to

site team

Joint arrangemen

t capacity and

capability

Organisation confirms capacity

and capability

Applicant completes IRAS Form

Applicant submits

IRAS pack to HRA

HRA issues outcome of

initial assessment

HRA issues HRA

Approval to CI

Applicant sends HRA Approval to

site

Applicant adds initial

HRA letter to local package


Site team = R&D team + research delivery team (PI, research nurses, etc) +LCRN team (for portfolio studies)See www.rdforum.nhs.uk contacts

28 December 2015


http://www.rdforum.nhs.uk/

Local Information Pack

12 November 2015

Copy of IRAS application form (combined REC and R&D form) as submitted for HRA Approval Protocol and amendmentsParticipant information and consent documents (without local logos/ headers)Relevant model agreement Statement of Activity and Schedule of Event templates – non-commercial onlyNIHR Costing template (validated) and delegation log– commercial onlyAny other documents that the sponsor wishes to provide to the site to support the set up and delivery of the study Copy of HRA Initial Assessment letter

HRA Initial Assessment Letter

• Clarifies if any site types do not need to confirm capacity and capability (eg some PICs)

• Flags issues to be resolved so sites don’t duplicate

• Applicant provides to sites as part of local document package

2 February 2016

HRA Approval Letter

No provisional or conditional. If approved:• Lists documents approved –

including any revised documents

• Reports outcome of assessment – including resolution of issues

2 February 2016

1.Identify 2.Assess 3.Arrange 4.Confirm 5.Site Initiation

Site identification

Assess capacity & capability

Practical arranging

Exchange contracts

Sponsor initiates site

• Starts before or after HRA application

• Network support if needed

• Send final protocol to research team and R&D/ LCRN support

• Official site selection

• Send local information pack to research team and R&D/ LCRN support (includes HRA Initial Assessment Letter)

• Send contract for signature

• Site should be ready to recruit to agreed plan

• Send IMP• Undertake

site initiation visit

HRA submissionHRA initial

Assessment letter issued

HRA Approval letter issued

Site ready to recruit

This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk 28 December 2015


Cross-border studies

• HRA shares outcome of HRA Approval with devolved nations’ coordinating functions which conduct additional nation-specific checks

• Site level process for devolved nation sites according to each country’s instructions

• Each R&D office for a devolved nation site will issue a permission letter as well as signing the contract

2 February 2016

2 May 2023

HRA - England

Research Ethics ServiceAssessment teamTechnical Assurance teamConfidentiality Advice Team

UK-wide IT system

UK-wide arrangements

Devolved administrations:• RECs• R&D

Cross-border studies

• Based on existing UK compatibility• If Lead R&D office in England – HRA Approval• If Lead R&D office elsewhere – study-wide

review • Outcome shared UK-wide and country-specific

aspects added• Site set-up according to country process• REC may be anywhere in UK

2 February 2016

Guidance: available on HRA Website

• Guidance for applicants (updated 30 November 2015)

• Guidance for NHS Organisations (updated 30 November 2015)

• Guidance for sponsors/CIs (updated 30 November 2015)

• Illustrative studies (updated 30 November 2015)

http://www.hra.nhs.uk/resources/hra-approval-applicant-guidance/

http://www.hra.nhs.uk/resources/hra-approval-nhs-organisation-guidance/

http://www.hra.nhs.uk/resources/hra-approval-guidance-for-sponsorschief-investigators-working-collaboratively-with-nhs-organisations-in-england/

http://www.hra.nhs.uk/resources/hra-approval-nhs-organisation-guidance/illustrative-examples-of-hra-approval-documentation/

Guidance available

• HRA Approval Cohort definitions (updated 2 Feb 2016)

• Assessing, Arranging and Confirming: Clarifications on HRA Terminology (updated 23 November 2015)

• Example template for email to confirm capacity and capability (created 30 November 2015)

• Listening to feedback during implementation of HRA Approval (created 30 November 2015)

http://www.hra.nhs.uk/documents/2016/02/hra-approval-cohort-definitions.pdf

http://www.hra.nhs.uk/documents/2016/02/hra-approval-cohort-definitions.pdf

http://www.hra.nhs.uk/documents/2015/03/hra-approval-cohort-definitions-version-2-0-2015.pdf



http://www.hra.nhs.uk/documents/2015/11/example-template-confirmation-email.docx



http://www.hra.nhs.uk/about-the-hra/our-plans-and-projects/assessment-approval/hra-approval-programme-listening-to-feedback/



HRA Approval will continue to develop further

• Amendments for studies processed through previous systems will be incorporated

• Revisions to remaining model agreements• Revisions to Research Passport guidance• Develop REC – HRA assessment interaction• Develop IRAS further• Prepare for EU Clinical Trials Regulations

20 January 2016

Amendments


Amendments: Historic studies

• When CSP is switched off, all studies with amendments or new sites will be processed through HRA Approval

Applies to all studies: • led from England, • with NHS sites in England• set up prior to CSP• through CSP• non-portfolio studies

28 December 2015



Submitting Amendments

• Amendments requiring REC Approval - continue to submit to REC. Information will be shared internally with HRA Assessment Team

• Amendments not requiring REC Approval (non-Substantial Amendments) - submit to [email protected]

• Sponsor still responsible for determining whether Amendment is Substantial or non-Substantial

28 December 2015




MHRA approval

HRA categorises amendment

REC review

HRA confirms compliance with

HRA assessment standards

Applicant submits

amendment to HRA

HRA confirms continuing HRA

Approval

28 December 2015



Regional Change Lead

Programme implementation queries [email protected]

Specific application [email protected]

Check for updates and register for HRA Latest: www.hra.nhs.uk


http://www.hra.nhs.uk/about-the-hra/our-plans-and-projects/assessment-approval/vacanciesandappointments/




1 - HRA - Setting up research in the NHS: practical and ethical considerations

Health & Medicine

Transcript of 1 - HRA - Setting up research in the NHS: practical and ethical considerations