Change to the Permissions process for Clinical
Research
Health Research Authority
&
UCLH Response
UCL/UCLH Joint Research Office
2015/16
National Changes, led by the
Health Research Authority
(HRA), will affect the process
by which clinical research is
approved
Who are the HRA?
What are these
changes and why?
1
2
What does this mean
for UCLH?
What’s next:
Divisions
Support
Next Steps
3
4
Who are the HRA?
1
Established as a Strategic Health Authority in December 2011
“promote and protect the interests of patients in health research and to streamline the regulation of research”
•
•
•
Leading improvements that make it easier to conduct good quality research in the UK
Improving efficiency and effectiveness of systems, and of advice and guidance
Building and consolidating productive relationships with public and professional stakeholders
HRA have, and will, be implementing changes to the way research studies are managed through regulatory
approvals (e.g., Ethics and NHS permissions).
+ guide sponsors on regulatory requirements, use of standardised templates, transparency in research findings
and outputs
Less time
and effort
setting up
studies
More global
first
participants
What are these changes and
why?
What are these changes and why?
• A new process which makes undertaking research easier and reduces the
time and cost of setting up studies
• New single applications for regulatory approvals, which will avoid
duplication of work and efforts by different organisations
• Reduce the number of studies reaching their targets by improving quality
submissions, increasing speed of approvals and focusing research sites on
feasibility and assurances of delivery
The typical process today
•
•
•
•
•
•
•
•
•
•
Funding
Risk Assessment
2008
Regulatory risks
Management
Site level questions
Pharmacy input
Radiology input
Legal
Contracts
Oversight
•
•
•
•
•
•
•
Funding2009
Risk
Regulatory risks
Management
Ethical considerations
Legal
Oversight
•
•
•
•
•
•
•
Funding
Risk
2010
Management
Ethical considerations
Legal
Contracts
Oversight
•
•
•
•
•
•
•
•
•
•
Site Funding
2011
Risk Assessment
Regulatory
Management
Site level authorisations
Pharmacy input
Radiology input
Legal
Contracts
Oversight
The proposed new process (HRA)
• Funding including site
level funding
2008to
template
• Risk Assessment for all
sites
• Regulatory risks
• Management
• Site level
questions/inputs
• Pharmacy input
• Radiology input
• Legal
• Contracts – identify all
templates
• Oversight
• Funding2009
– confirm in
place
• Risk - regulatory and
confirm sponsor has
considered these
• Management – has the
sponsor a plan?
• Ethical considerations +
HTA, CAG
• Legal – has sponsor
outlined all templates
and “risks”
• Oversight – is there a
plan?
• Global Pharmacy and
Radiology
•
•
•
•
•
•
•
Funding
Risk
2010
Management
Ethical considerations
Legal
Contracts
Oversight
Assess
Arrange
Confirm
2011
What does this practically mean for individual
Researchers?
•
One IRAS application for regulations (except for MHRA)
•
HRA will conduct a number of governance and consistency checks alongside the review of ethics
•
Sponsor will liaise with sites (PI) to ensure they have all the necessary resource to run the study and are
ready to start and able to meet time and target (active discussions on what is feasible for the site)
•
Pharmacy and Radiology reviews are conducted at “global level” by the HRA. Local teams take these
assurances and focus on ability to deliver and on set-up
•
R&D/LCRN department will not need to review your study documents – researchers (and R&D) take
assurances from the HRA review
•
No CSP – CLRN divisions will work with local R&D’s and Divisions to support requests for support and the
set-up of NIHR adopted studies
•
R&D will execute finances and contracts based on local feasibility
•
R&D escalation point for problems, bottlenecks, issues during the assessment and approval stages
What is the Feasibility role for the site?
•
•
•
•
•
•
•
•
•
•
•
Resource (staff, space, equipment) and have these been supported by the Sponsor in the
available “templates”
Sufficient Capacity
Management of the study
Availability of patients
Any competing studies
Likelihood of delivering to time and target
Ensure all relevant departments are aware and on-board
All staff are adequately trained and able to work at UCLH
Strategic fit/appetite for the study
Division is happy to proceed (including Clinical Director)
All documents and materials available
What does this mean for
UCLH?
3
Our Aim’s at UCLH
To be ready for these new procedures and expectations
1: Have a seamless transition
• All relevant groups are aware and comfortable
• Clear and unified approaches across UCLH
• Identifying (removing) erroneous and /or outdated
systems and practices which may impede successful delivery
Model at UCLH
2: Supporting a “new” way of working:
Local (divisions and hubs) systems for assessment and oversight
JRO support, guidance and direction for divisions (tools such as templates and SOPs to
follow)
Sponsor Site
Interest
Division Led Feasibility and Delivery
assessment of the study
Inputs from
Service
Support
Departments
R&D
execute
agreements
Division oversight and monitoring of
study to time and target
Inputs from
R&D and LCRN
as required
R&D/Hubs supporting the resolution of bottlenecks and system issues
Focus on delivery and rapid start up of studies
Ability to Plan the study set-up and delivery
Ability to influence/address performance
Support and
performance
from R&D
Can local feasibility and input’s affect Performance?
Performance against 70 day
benchmark all providers (mean),
UCLH and comparable Trusts (%)
UCLH:
Q2 (14/15) = 72.7%
Q3 (14/15) = 80.5%
Q4 (14/15) = 78.8%
Q1 (15/16) = 85.5 %
Q2 (15/16) = 88% (tbc)
90
80
70
60
Q1
50
40
30
Q2
78.8
57 73 81.5
20
Q3
65 63 55
63
58 60 55
Q4
34 36 32 34
36
10
0
All boards
(n = 69, 81, 61, 63)
Specialist Hospitals
(n=32,41,34,36)
Surgery and Cancer
(n= 26,28,21,22)
Medicine
(n=11,12,6,5)
Our Aim’s at UCLH : Already started!
• Focusing on performance, understanding the portfolio and identifying key
infrastructural support/issues (JRO, Hubs)
• Supported increases in local capacity for research (specialist posts
appointed via RCF funding)
• Develop closer working practices/relationships with larger research groups
and piloted new ways of working – including feasibility
• Identified and eradicating unnecessary hurdles to setting up research
• Feasibility Champions – change leads
What’s next:
Role of Divisions and
Research Groups
Next Steps
4
Division led Feasibility
Monitor your systems
and Feedback
How will you Division
determine if a study is
feasible or not?
- Tools/procedures
- Mechanisms
- JRO support
- Discuss model with the JRO
Set up and run
Feasibility System
- In-line with requirements
(including JRO inputs)
- On-going support and training
from the JRO
- Problems and deviations
to JRO
- Monitor study
performance
Division led Feasibility
Reminder: what is feasibility?
•
•
•
•
•
•
•
•
•
•
•
Resource (staff, space, equipment) and have these been supported by the Sponsor in the
available “templates”
Sufficient Capacity
Management of the study
Availability of patients
Any competing studies
Likelihood of delivering to time and target
Ensure all relevant departments are aware and on-board
All staff are adequately trained and able to work at UCLH
Strategic fit/appetite for the study
Division is happy to proceed (including Clinical Director)
All documents and materials available
Division led Feasibility
How?
Each Division to determine best model:
• a group (TFC)
• a remote process
• a combined process
but should:
• Address key points of “feasibility”
• Be “quick” and responsive
• Work to common SOP’s for UCLH
JRO will support throughout including working with Divisions to conduct
joint-feasibility until Divisions are ready/comfortable
R&D support throughout
•
JRO provide all templates and expectations (SOPS and guidance) for Divisions
to follow for costings and contracts and “safety”
•
JRO issue permission at site and will complete contracting and finalise and add
“corporate” costs – based on the direction of the Division/Research Group
•
JRO escalation point and support
•
Study is sponsored by UCL or UCLH – JRO will combine the sponsorship review
with the Divisions assessments
•
Support in seeking additional funding/resources from the LCRN and others
•
Audit, monitor
•
Performance Management
Next Steps
Inviting you to consider setting up local research feasibility assessments (or let
us know if you wish JRO to do so for a period of time)
•
Research Officer support to determine which type of feasibility assessment
suits your division and the core (trust) expectations
•
Research Officer support with setting up new systems/refining existing
systems (in line with other departments)
•
Research Officer/other JRO support with new studies
•
JRO training and awareness “modules” on the detail of feasibility and
sponsorship and finances (amongst others)
•
JRO drop in sessions for support and guidance
•
JRO support with performance oversight, reporting and invoicing
•
Invite units to join feasibility champions/change leads
HRA cohorts now rolling out!