The document summarizes updates from the Health Research Authority (HRA) board meeting in October 2017. Key points include: more valid applications being received for commercial clinical trials due to training and checklist changes; continued evaluation of the joined-up validation model; and meetings held to review the 70-day benchmark for HRA approval. Work is also underway on model commercial and non-commercial clinical trial agreements and improving guidance on IRAS and the new website. Planning is occurring for implementation of the new EU General Data Protection Regulation and incorporating more public involvement.

1. Highlights taken from the directorate update
produced for the HRA board meeting, Oct 2017
HRA
2 minute
update

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• More valid applications for commercial trials, on the
back of training and changes to IRAS checklists
• Joined up validation model continues while pilot is
evaluated
• Meetings with Department of Health, NIHR, Clinical
Research Network and others to review 70 day
benchmark
HRA Approval

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• Work with ABPI and devolved administrations on model
commercial clinical trial agreement near completion
• Work on remaining section of the model non-commercial
agreement (info governance) underway
Model contracts

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• Large amounts of operational guidance around applying
for approvals moved to IRAS help section as part of new
website roll out
• Work being completed on new IRAS functionality to
make submitting documents electronically easier
Guidance

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• Work with NHS Digital, to support applicants seeking
data, esp around consent, long-term studies and cohort
studies with historical consent
• Memorandum of Understanding signed with Human
Tissue Authority
• Danish delegation welcomed, to discuss ethical review
and EU regulation
• Meetings with Office for Life Sciences and others
around Early Access to Medicines Scheme and support
for innovation
Collaboration

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• EU General Data Protection Regulation due May 2018
• HRA working with partners to get Data Protection Bill
amended
• Current drafting appears to outlaw interventional
research
• Guidance on GDPR and research requires further
drafting as a result
New data protection law

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• Discussions about incorporating public involvement into
upcoming CAG workshop and into HRA operations
training sessions
• Input into British Heart Foundation’s lay review panel on
ethics/HRA processes
• Presentation to Patients and Public Advisory Group at
NIHR Biomedical Research Centre
• Meetings with Office for Life Sciences and others
around Early Access to Medicines Scheme and support
for innovation
Public involvement

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• New modules released, completing suite on regulatory
aspects of research
• Work to support the roll out of the technical assurance
process continues
• REC member induction day revised
• Planning for national REC chairs meeting in Nov and
REC members training day in Dec underway
• Programme Management Office delivering lunchtime
sessions across all offices
Learning and development

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• Stats show HRA good at undertaking advance bookings
• Improvement on use of recycled paper
• HRA Mainline (phone) use remains steady. Work with
Comms ahead of new website roll out
• New apprentice appointed following 330 applications
• Six month forecast predicts slight underspend, which
senior leadership is looking to utilise to support SIP and
service delivery
Corporate

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• HR supporting consultation with staff about proposed
move to Newcastle
• Focus is on issues including travel time and work life
balance
• Agreement reached with NHS BSA for sublease of
Skipton House
• New air cooling system at Skipton House to address
high temperatures
HRA offices

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• UK-wide NHS/HSC
compatibility programme
• EU Clinical Trials
Regulation implementation
• Policy Framework published
• SIP proportionality work
• Research systems
improvements
• HRA/HTA public dialogue on tissue and data sharing
• National Data Opt-out Programme
Full report includes updates on:

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Read the full report at:
www.beta.nhs.uk/BoardUpdate