The UK Local Information Pack
A ‘UK Local Information Pack‘ will be introduced on the 5 June 2019 to support the set-up of NHS / HSC research in the UK.
The ‘UK Local Information Pack’ is the set of documents that NHS / HSC organisations use to formally start preparing to deliver the study. You can find more information here, including what comprises the pack. All researchers wishing to set-up their study at an NHS/HSC site from 5 June, will need to be aware of this change.
The Organisation Information Document
Researchers and research teams may be aware of a document called the ‘Statement of Activities’ – this is essentially a document that allows the sponsor to make clear to the research site, what activities will be undertaken locally. The document can also act as the agreement between the sponsor and site. Researchers setting up their study before 5 June should continue to use this document.
From 5 June the Statement of Activities will be replaced by a document called the ‘Organisation Information Document‘. For non-commercially sponsored studies, that are not clinical trials or clinical investigations, the ‘Organisation Information Document’ should be used as the agreement between sponsor and participating NHS / HSC organisation.
A new delegation log template
Another feature of the UK Local Information Pack is the inclusion of a delegation log template, which is intended to be used at participating NHS / HSC organisations. This will allow NHS/HSC organisations to locally record who will be working on the study and who is authorised to undertake study tasks.
Schedule of Events or Schedule and Events Cost Attribution Tool (SoECAT)
For non-commercially sponsored studies studies an IRAS Schedule of Events or a SoECAT will be a part of the IRAS Form submission and is used in the UK Local Information Pack as a way of providing clarity to participating NHS / HSC organisations on the cost attributions associated with a study.
Further help and guidance
Guidance on the use of the UK Local Information Pack has now been published in the Site Specific page of IRAS Help to help applicants get ready for the change.
If you are making an IRAS Form submission or planning to set up research in an NHS / HSC organisation from 5 June 2019 please read the transition guidance so that you prepare the correct materials.
If you have any queries regarding any of the information provided above, or would like some guidance with regard to implementing your research in a healthcare setting – please get in touch with BU’s Research Ethics team.
You can also take a look at the Clinical Governance blog for documents, links and training opportunities.
Involving patients and/or the public in your clinical research is a great way to ensure that your study is designed and set-up in a way that will be attractive to participants. By carrying out PPI (patient and public involvement) you can also ensure that your research will be of benefit, not only to individuals but also the wider population and healthcare in general.
In 2018 the Health Research Authority (HRA) released guidance to help applicants better identify where they have involved the public in their research applications, and the difference that it made to their studies.
In addition, in January of this year two HRA blog posts were advertised, following the journey of a Research Fellow at the University of Surrey, who conducted PPI for her research project. The first and second posts can be found on the HRA website alongside other news items.
The HRA have just released the third blog post in which they talk to one of the lay Research Ethics Committee (REC) members who sat on the panel that reviewed the fellow’s study. The post explores the Committee member’s views on how public involvement benefited the research application. You can find it here.
Remember that support is on offer at BU if you are thinking of introducing your research ideas into the NHS, social care or healthcare institutions – email the Research Ethics mailbox, and take a look at the Clinical Governance blog.
‘Researchers, sponsors and funders have responsibilities – that may be legal requirements or ethical and moral expectations within an accepted governance framework of best practice and standards – to participants in research, patients and the wider public and research communities.’
The HRA have recently released a page of useful links and guidance that encompasses areas such as ‘top tips for transparency’, making your research results public, and also registering your study.
Related to this, hopefully you will have seen a recent blog post regarding the HRA’s commitment to ensuring research transparency. This has been a hot topic lately, and the subject of a recent House of Commons Science and Technology Committee report.
Take a look at the HRA guidance here.
BU has access to the ClinicalTrials.gov system so get in touch if you would like access. This is a great opportunity to register your study and study results in the public domain. It is free to use.
Despite the name, the system may be used for other clinical research projects.
An updated Code of Conduct for the application of data-driven technologies in the NHS was published on Tuesday of this week – the code ‘sets out what the NHS expects from companies who are developing new technologies for the health system, and what they can expect in return.
In order to assist applicants and researchers, the HRA have created new pages that set out the approvals process for data-driven technology research.
The section incorporates two pages of support –
The help pages will be added to the Clinical Governance section of the blog, for ease of access.
The House of Commons Science and Technology Committee released a report last year on clinical trials transparency, as it was evident that a nearly half of clinical trials fail to publish their results. In their report, the committee made a number of recommendations to the Health Research Authority in order to rectify the situation.
At the time the HRA issued a response but today have published a further statement which sets out their commitment to research transparency. This is especially pertinent given the article published simultaneously in BMJ Open, which details the numbers of clinical trials that are publicly registered, compared with those that have received favourable opinion (approval) from a UK NHS research ethics committee.
BU has access to the ClinicalTrials.gov system so get in touch if you would like access. This is a great opportunity to register your study and study results in the public domain. It is free to register your study.
Despite the name, the system may be used for other clinical research projects.
Tuesday saw the annual NHS Research Ethics Committee (REC) members training day in London. The learning outcomes of the day were:
- To provide overview of the pilot work being undertaken in preparation for EU Clinical Trials Regulation
- To introduce the REWARD Alliance and,
- To consider how ethics committess can encourage researchers to engage more fully with the scientific literature both before and after studies are conducted
The morning focussed on updates on ethics regulatory procedures, the EU (see link below for slides) and changes in the Data Protection Act (but not the law of confidentiality) that have implications beyond healthcare research. There is also movement for a Public Involvement in Ethical Review (PIER) service, as well as adopting ‘e-consent’ for participation in health research.
EU Regulation_UK Research Ethics Service
The afternoon focussed on the REWARD Alliance and how ethics committees (and researchers) can help reduce waste in research. This group was established to promote a series of articles on research published in early 2014 in The Lancet.
Figure: Stages of waste in producing and reporting of research evidence (Chalmers & Glasziou, The Lancet 2009).
As a researcher and ethical reviewer, the day was insightful, interesting and relevant. Knowledge of the REWARD Alliance, particularly how researchers should diligently plan and prepare projects with clear pathways to dissemination. Although publishing demands differ between academia and industry (including pharmaceutical companies), all research should be designed fom the outset with clear outputs to communicate the findings.
If you would like further information from the day, send me an email.