Presentation by Janet Boothroyd on Health Research Authority approval process

1. HRA Approval
Implementation
Janet Boothroyd 25 February 2016

2. 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

3. 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

4. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
REC
Favourable
Opinion
HRA
assessment
HRA
Approval
Other
approvals
15 November 2015

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

6. 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 invites
site

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

8. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
Pharmacy
and
radiation
Clinical support assurances
Controlled roll out by study type
Cohort 1
Staff studies
May 2015
Cohort 2
Primary care
studies
Aug 2015
Cohort 3
Non-trials
Nov 2015
Cohort 4
Trials/
Investigations
By March
2016
Amendments/newsitesallstudies
28 December 2015

9. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
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
hra.approvalprogramme@nhs.net to discuss
8 March, 2016

10. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
Update on implementation
• 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
8 March, 2016

11. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
Update on implementation
• 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
8 March, 2016

12. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
• 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
8 March, 2016

13. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
Update on implementation
• 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
8 March, 2016

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

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

16. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
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.
3/8/2016

17. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
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
3/8/2016

18. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
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
8 March, 2016

19. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk 8 March, 2016
Sponsor
HRAMHRA
CRN
Participating
sites
Sponsor communications
Via study support service

20. High level proposed process with HRA Approval
Applicant
identifies
sites
Applicant
sends local
package to
site team
Joint
arrangement
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
This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
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

21. Local Information Pack
12 November 2015
Copy of IRAS application form (combined REC and R&D form) as
submitted for HRA Approval
Protocol and amendments
Participant information and consent documents (without local logos/
headers)
Relevant model agreement
Statement of Activity and Schedule of Event templates – non-commercial
only
NIHR Costing template (validated) and delegation log– commercial only
Any 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

22. 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

23. 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

24. 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 submission
HRA 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

25. 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

26. 8 March, 2016
HRA - England
Research Ethics Service
Assessment team
Technical Assurance team
Confidentiality Advice Team
UK-wide
IT system
UK-wide
arrangements
Devolved
administrations:
• RECs
• R&D

27. 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

28. 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)

29. 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)

30. 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

31. Amendments

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

33. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
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
hra.approval@nhs.net
• Sponsor still responsible for determining whether
Amendment is Substantial or non-Substantial
28 December 2015

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

35. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
Regional Change Lead
Programme implementation queries
hra.approvalprogramme@nhs.net
Specific application enquiries
hra.approval@nhs.net
Check for updates and register for HRA Latest:
www.hra.nhs.uk

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