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HRA REC reviews: Registration of Tissue Banks/Biobanks (RTBs)
 
Human tissue samples are collected by various researchers and biobanks across the UK.

However, researchers intending to undertake research into human conditions are often hampered by an inability to find suitable samples.

The UKCRC Tissue Directory and Coordination Centre was established to coordinate bio-banking activity in the UK. Its flagship product is the directory of biobanks that allows researchers to find biobanks across the UK.

In order to make it easier for researchers to find suitable samples, and to maximise the re-use of samples provided by patients, it has now been agreed across the UK that, when applications for REC review of RTBs are made, it will be a condition of the REC favourable opinion that RTBs are registered in the UKCRC Research Tissue Directory.

HRA Latest Volume 23

 

Contents

 

It will also be a condition of the five-year renewal of the ethical opinion. However, we would encourage all designated individuals to register their bank as soon as possible.

It is still working to find all the biobanks in the UK so please register your biobank here.
 Registration of clinical trials: monitoring shows positive findings
 
"Every research study involving human subjects should be registered in a publicly accessible database" (Declaration of Helsinki 2013)


The HRA is committed to promoting research transparency and since October 2013 it has been a condition of the favourable ethical opinion for clinical trials to be registered on a publicly accessible register.

This must be no later than six weeks after recruitment of the first UK participant into the trial. 

In support of this requirement, the HRA has completed a retrospective, two-staged review to identify the proportion of clinical trials that had been publicly registered following favourable opinion from a Research Ethics Committee (REC).  
 
What we did: We focused the review on studies listed as a clinical trial on the Integrated Research Approval System (IRAS) form.

This included Phase 1, medical device and ‘other’ clinical trials. Clinical Trials of Investigational Medicinal Products (CTIMPs) (Phases 2-4) were excluded on the basis that it is a legal requirement to register these on the EU clinical trials register via EudraCT.  

In August 2015 we conducted the registration searches (Stage 1) of clinical trials registries (primarily the International Standard Randomised Controlled Trial Number (ISRCTN) and clinicaltrials.gov). 

We searched using the full study title for studies that received a favourable opinion between 30 September 2013 to 30 June 2015 (Phase 1 trials) and 1 January 2015 to 30 June 2015 (medical devices and ‘other’ clinical trials). 

Stage 2 was carried out in January 2016 and involved a follow up search of the registries to see whether the trial could be found. Where this was not the case, we contacted the Sponsor / Chief Investigator / Contract Research Organisation (CRO) to identify if the trial had been registered and if not, to enquire as to the reason for this. 

The UK is leading the way in terms of the registration of Phase 1 studies.  However, we do have a system in place for sponsors to request a deferral of publication where there may be issues of commercial confidentiality.

What we found: In total 800 clinical trials receiving a favourable opinion were included in the review. 

Figure 1 provides a breakdown of the study type and the numbers found on a publicly accessible registry over the monitoring periods.


Figure 2 highlights a positive change from baseline to follow up across all studies types.


Phase 1 studies had the largest proportion of trials registered with more than 60 per cent at baseline to just over 75 per cent at the end of the monitoring period.

Increased awareness by the HRA to highlight the requirement around trial registration may have acted as a catalyst for registration in many cases. 
 
What next: The HRA recognises that ethical and moral obligations of researchers and research sponsors set out a best practice standard for all health research to be registered. 

Through our commitment to promote research transparency, the HRA will continue to routinely monitor compliance of clinical trial registration requirement.

Where it is still unclear whether or not a trial identified in this review has been registered on a publicly accessible registry, the HRA will follow up.

We do acknowledge valid reasons for trials not being registered, for example recruitment of the first UK participants not having commenced. 
Reporting and dissemination of study results

Thank you to everyone who responded to the recent EQUATOR Network call for comment in relation to IRAS question A51, ‘How do you intend to report and disseminate the results of the study?’

This call will allow us to consider proposed improvements which may further prompt researchers to consider the different ways information generated in research studies can be disseminated.

More than 700 responses were received and so analysis will take some time, but we are very grateful for the high level of engagement from all areas of the research community.

EQUATOR is analysing the feedback and a summary will be published and made publicly available.
 
 

Welcome to our New Patients and Public website section

The HRA is pleased to launch new patient and public pages on our website. 

The new pages will be of interest to patients, service users, carers and members of the public who will find information about research that is regulated and approved by the HRA, public involvement in research and how patients and the public can become involved in our work.

The new pages have been developed by the HRA in partnership with a patient and public group who helped us to write the content, design the layout and feature in the videos we made with them. 

Anne-Laure, who is a member of the patient and public group, said: “Being involved in the complete redesign of the patient and public involvement and engagement pages on the website was a great co-production opportunity.

“The success of this first venture shows that it is worthwhile developing and supporting further close collaborative work between the HRA and patients and the public.”

We would be grateful if you could help us to raise awareness of the new pages within your own organisations and patient and public networks. Thank you!

Spotlight on: the HRA Public and Patient Involvement team 

The HRA understands the value that public involvement has in helping to deliver high quality, relevant health and social care research.

The HRA’s Public Involvement Team consists of Public Involvement Lead, Jim Elliott and Public Involvement Manager, Andrea Horwood.

A key part of our strategy for public involvement in research is to use the HRA’s influence with the research community to support and encourage more researchers to involve the public in their research and to do it better. We would also like to see more organisations that fund and sponsor research doing the same thing.

Our approach will be to use the HRA’s approval processes, starting with ethical review, to promote the ways in which involving the public can have an impact on the design, conduct and management of health and social care studies.

Our programme of work which starts early next year will include collaboration and dialogue with members of Research Ethics Committees (RECs), researchers and research funders and sponsors. This will be to review the information we ask for on public involvement, and to consider better ways to evidence and improve standards for involvement through assessment and REC review processes.

This year we have worked closely with INVOLVE –  the National Institute for Health Research’s advisory group on public involvement – to produce guidance on public involvement for consideration in ethical review and an associated briefing on research evidence to show how involvement can make research ethical. Both these documents are available to download here.

Our goal is that researchers will want to involve the public because they can see how doing so will help make their research better in a way that will best help them and those participating in their studies.

If you would like to talk to us about our work on public involvement, please contact Jim or Andrea in the HRA Public Involvement team: hrapublicinvolvement@nhs.net or 020 7972 2545.
HRA Approval - update on performance

We have made good progress during the past two months in increasing the rate of issuing initial assessment letters and HRA Approval.

A detailed report on performance has been published on the HRA website. We still have work to do to make it easier for site set-up to take place in parallel to the approval process, and be able to issue HRA Approval swiftly after all other approvals are in place.

However, we are already beginning to see a reduction in time and waste across the overall study set-up timeline.

We have been increasing the focus on completing the initial assessment so that applicants can send the local information pack to participating NHS organisations.

This helps progress with putting arrangements in place to set up sites. For example, during October we issued initial assessment letters for 60 per cent of commercial clinical trial applications in a median of four days.

We are now working on extending this to a wider range of studies, as well as getting information from the initial assessment to ethics committees, to make the approval process more integrated.

Processing of amendments and pre-Approval studies is continuing to proceed as planned.  Please remember that confirmation of assessment of substantial amendments can only be given once the relevant REC and/or MHRA approvals are in place.
 
HRA Approval – hints and tips for applicants

We have identified that about 40 per cent of applications for HRA Approval that are valid for REC review have some documents missing which relate to HRA assessment.

We have therefore changed our way of working to try to catch these earlier in the process so that they can be sorted out quickly.

Applications for commercially sponsored studies should include:
  • an Industry Costing Template validated by the Lead NIHR Local Clinical Research Network before application for HRA Approval
  • a template of the agreement the sponsor proposes to use with sites. Where at all possible this should be the appropriate model agreement.
Applications for non-commercially sponsored studies should include:
  • a template Statement of Activities and Schedule of Events for each site type in the study. Applicants should seek advice from their sponsor office or Lead NHS R&D office about attributing costs appropriately
  • a template site agreement – if one going to be used in the study (over and above agreeing the Statement of Activities).
Please use the e-learning for commercial and non-commercial studies on the HRA Approval training resources page and the guidance on the HRA website for detailed information about working with HRA Approval.
 
Proportionate review timeline will change to facilitate improved review
 
The Research Ethics Service (RES) offers a proportionate review service for applications which are considered to have no material ethical issues, aiming to deliver a final opinion within 14 days.

However, a review of the service identified that changing the deadlines within the process could increase the number of applications receiving a favourable opinion at first application by reducing the number that have to re-submit due to missing validation timelines.

The proposed process would allow REC staff to work with applicants after submission to ensure that the application is valid and can be reviewed rather than being rejected due to not meeting the validation criteria.

It would also allow REC members to clarify issues relating to the application or request further information before issuing an initial favourable opinion, rather than issuing a provisional opinion needing subsequent clarification or information.

A six-month pilot involving 15 RECs was undertaken between March and August 2016 to test the revised proportionate review process.

It allowed up to five working days for REC staff to validate the application and work with the applicant and five working days for the REC members to review the application and make any clarifications with the applicant. This was followed by a further five working days (maximum) to complete the administrative process and manage any responses to provisional opinions which may be required.

The pilot indicated that under the revised process applications were more likely to proceed to review on the first submission rather than requiring a resubmission due to not meeting the validation criteria. Applications were also more likely to receive a favourable opinion as the first opinion issued after the review.

In addition, the mean number of days taken to issue a final  opinion was 13 calendar days (not including the time for applicants to respond to provisional opinions), whereas for RECs not in the pilot it was 11 days, which suggests that allowing the additional time for applications which require more support does not significantly increase the average time required. It does, however, add benefit to those applications which require additional support.

A copy of the pilot analysis with further detail is available here.

A recommendation was made to the UK Ethics Committee Authority to adopt the 21 working day process across all UK RECs for applications submitted for proportionate review and this recommendation has been accepted.

The expectation is that the revised timeframe and process will come into effect on 1 January 2017 and we will keep you informed about this.
 
HRA Interim Chief Executive: Teresa Allen
 
As some readers may already be aware, Janet Wisely, our Chief Executive, will need to take some months off to receive medical treatment and recuperate.
 
The Board has therefore asked Teresa Allen, previously Interim Assistant Chief Executive, to act up as HRA Chief Executive until Janet is ready to return.
 
On behalf of the Board, I am grateful to Teresa for providing business continuity while we look forward to welcoming Janet back.
 
If you need to contact Teresa in her new capacity, please email her directly on Teresa.allen5@nhs.net or via hilary.tulloch@nhs.net or on 0207 972 2537.
 
Jonathan Montgomery, Chair of the HRA Board
HRA REC annual reports available on our website
 
The HRA is the appointing authority for all RECs in England, and the HRA board approved and formally adopted the Annual Reports for RECs in England for the period April 2015 – March 2016 at its meeting on 19 October 2016.

The timelines for REC review continue to meet statutory timelines and excellent progress in meeting stretch targets. The Board acknowledged the contribution of the volunteer membership in this work. 

The HRA would welcome applications for REC membership.

The summary reports for each centre plus the annual reports for each committee are available on our website here.
Public Health England advertising Research Advisory Committee positions
 
Public Health England (PHE) Screening is currently advertising for three chairs for its cancer screening programme Research Advisory Committees (RACs).  The three positions are for the following RACs:  
  • Bowel Cancer Screening Programme (BCSP)
  • Breast Screening Programme (BSP)
  • Cervical Screening Programme (CSP).
The RACs are responsible for ensuring that PHE’s screening programmes support good quality research without compromising the day-to-day function of the screening programmes.
Candidates should be able to demonstrate experience in one or more of the following:
  • experience in chairing a multi-disciplinary group.
  • a detailed understanding of screening
  • experience in health services research (ideally in screening programmes).
The time commitment for each post is a minimum of four meetings per year plus associated work as required.
Please apply through the NHS jobs website using the reference number 919-A-16-32351.
The closing date for applications is 7 December 2016.         
NIHR Clinical Research Network Accelerating Digital Programme

The NIHR Clinical Research Network is interested to understand how the research community is incorporating elements of digital technologies into how clinical research is run, and what people’s views are about this, including the opportunities and barriers. If you are interested in feeding back on your experiences from all study types, whether commercial or non-commercial research please visit the survey here.
Please circulate this to your colleagues; you can subscribe to HRA communications here. 
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