December 2021: Webinars for Transitioning to Combined Review

The HRA UK on December 22, 2021, has released an update for the Combined Review process.  They will be running a series of free, live webinars during December and January to provide an overview of upcoming changes and how they can affect individually the CTIMP applicants, sponsors, and NHS/HSC organizations depending on the role.

Bookings would be done online and the user needs to register for an account on the Learning Management System.

November 2021: HRA Announces a New e-Learning Module

The UK, Health Research Authority (HRA) announced a new e-learning module for lay summaries on 26 November 2021.

A plain language summary is mandatory for all the clinical studies registered on the ISRCTN registry. To support researchers in communicating results, the HRA has developed an e-learning module that will give a better understanding of how to produce consistent plain language summaries of research.

For access to the e-learning module, an account needs to be set up on the learning system. This account can be created for free here.

November 2021: Webinars for Combined Review

On 24 November 2021, HRA UK has updated that the Combined review will come into effect for all Clinical Trials of Investigational Medicinal Products (CTIMPs) from 1 January 2022. It was initially run as a pilot that started in 2018 under the name ‘Combined Ways of Working’ (CWoW) but from January 2022 it will be the only way to submit CTIMPs to MHRA and REC. Applications will be completed and submitted in the new part of IRAS.

To facilitate the transition there will be 3 webinars held-Combined Review as an Applicant, Combined Review for Sponsors, and Combined Review for NHS/HSC Participating OrganisationsThe webinars will provide an introduction to upcoming changes, help check the impact of the changes on the organization so as to update any internal processes/procedures as required thereof and provide guidance to available resources for further information and support.

November 2021: Make it Public Annual Report

As part of the delivery of the Make it Public strategy, the HRA has committed to producing an annual report to monitor how researchers are meeting their transparency requirements and what more the organization can to do ensure this is always the case. The first Make it Public annual report has been published for the same on 03 November 2021. The report summarises the transparency parameters in terms of registration of clinical trials, results reporting, informing participants, and sharing data and tissue.

HRA UK has partnered with ISRCTN registry to automatically register all UK clinical trials once they have received a favorable ethics opinion. It is stipulated to go live in 2022. Results reporting has been standardised by providing a  standard set of information to be reported when the research has been completed, including a confirmation that the results have been published. HRA and Medicines and Healthcare products Regulatory Agency are developing a process to share the summary of results collected in the final reports and they plan to track records to follow up with studies that have not yet submitted their end of study information. To keep participants informed, development is ongoing for a new guidance on how to inform participants about study findings and have necessitated Plain Language Summary (PLS) of the study findings to be submitted as part of the final report which is then published on their website. For their fourth pillar of transparency of sharing study data and tissue, platforms such as Wellcome Open Research is in place to allow organisation’s grant holders to rapidly publish all outputs from their research.

For the next phase in development of the transparency strategy a new transparency roadmap will be developed for researchers to see at a glance where they need to take action. The map would trace the study journey from the design and planning stage to completion of research.

 

 

October 2021: Combined Review Service for CTIMPs applications and IRAS Update

The HRA UK has released an update specifying that CTIMP applications via combined review must be submitted using a new part of the Integrated Research Application System (IRAS) and should not be started in the standard part of IRAS. Creating new applications using the standard IRAS system will be disabled from  14 December 2021.

An updated detailed guidance has been released for the step by step guide to using IRAS for combined review.  The guidance comprehensively covers the details required for the creation of an IRAS account, the roles, and tasks of IRAS users, the process of initial submission, and subsequent amendments.

October 2021: Protocol Registration in the UK

A recent update posted by HRA “New partnership guarantees full picture of UK clinical trials” focuses on achieving full registration of clinical trials in the UK.

As per the update posted, “Clinical trials will be automatically registered to guarantee a full picture of research taking place in the UK. HRA has partnered with ISRCTN, to make it easy for researchers to fulfill their transparency responsibilities. From 2022 the HRA will register clinical trials with ISRCTN, taking the burden away from research sponsors and researchers.”.

October 2021: HRA UK ‘Think Ethics Programme’

The HRA UK aims to design a research ethics review service that will focus on five areas for change – differentiated and proportionate review methods, better participant information, the right committee format for the future, a better experience for REC members, and a more consistent REC review.

Through the Think Ethics programme, they will review the different review methods including review at a REC meeting, light-touch review and, building on feedback from researchers, the possibility of self-assessment by researchers and sponsors. Work with research participants, researchers and REC members to improve participant information so as to ensure that review of this information by a REC is consistent and proportionate. Plan to design a committee format that will utilise virtual working and retain the sense of community within and between RECs. Clarify research ethics questions for applicants and ensure REC members review only the information required for ethics review. Work with REC members to determine what level of variation is appropriate and to address the same.

October 2021: MHRA UK-Upcoming Webinars

The MHRA has organized 2 webinars for consultations on medical devices, which are to be held in the upcoming weeks.

The ‘MHRA consultation on future medical devices regulation in the UK – Industry‘ will be held on Tuesday, 05 October 2021 and the  ‘MHRA consultation on future medical devices regulation in the UK – Public‘ on Thursday, 14 October 2021.

 

September 2021: UK Regulatory

Control of Patient Information (COPI) Notice Extended

Department of Health and Social Care (DHSC) updated about the extension of existing Control of Patient Information (COPI) notice, over UK Health Research Authority’s News Section on September 16, 2021:

The COPI notice has now been extended to further 6 months till March 2022. It was also mentioned that the applicants under COPI will be contacted in the duration of September- October 2021 regarding transitioning to permanent legal basis. Contact information and COPI guidance document have also been uploaded for the applicants.

For more information, please click here.