Cardiff and Vale UHB Bwrdd lechyd Prifysgol Caerdydd a’r Fro NHS R&D Overview How to avoid the common pitfalls? Thomas Fairman Research Liaison Manager 10 th September 2015

Cardiff and Vale UHB Bwrdd lechyd Prifysgol Caerdydd a’r Fro

Objectives Overall R&D Structure Purpose of Governance Review How to make an application Common problems and how to avoid these Sources of help and useful contacts

Cardiff and Vale UHB Bwrdd lechyd Prifysgol Caerdydd a’r Fro Overall R&D Structure in Wales

Cardiff and Vale UHB Bwrdd lechyd Prifysgol Caerdydd a’r Fro Health and Care Research Wales Ethics Committee’s Ethical Approval Global Governance Review Permissions Coordinating Unit Local Governance Review Health Boards Study Start Other Approvals (where relevant) e.g. MHRA, CAG, NOMS, ARSAC

Cardiff and Vale UHB Bwrdd lechyd Prifysgol Caerdydd a’r Fro Purpose of Governance Review

Cardiff and Vale UHB Bwrdd lechyd Prifysgol Caerdydd a’r Fro Governance Review To ensure that study meets all legislative frameworks and legal requirements To ensure that all necessary approvals are obtained from relevant organisations To ensure that the risks of the study are identified and addressed, to organisation, participants, researchers. To ensure that appropriate insurance and indemnity arrangements are in place To ensure that the study can be practically supported at site and that it is feasible taking into account service requirements To ensure that the study has received appropriate peer review To ensure that all relevant contracts have been reviewed and signed by the site To ensure appropriate access arrangements for researchers are in place to NHS premises, patients and data.

Cardiff and Vale UHB Bwrdd lechyd Prifysgol Caerdydd a’r Fro How to make an application

Cardiff and Vale UHB Bwrdd lechyd Prifysgol Caerdydd a’r Fro How to develop an application Consider if proposal is best considered as research Seek advice and guidance at the earliest opportunity from the local R&D office. They can advise on local study review processes and provide lots of templates and advice to assist in making the submission and the best means of doing so. Identify the research sponsor and research funding, particularly if no external grant will be applied for. If application will need to be made for external funding develop and submit this. Develop study documents, e.g. Protocol, PIS, Consent Form etc Obtain independent scientific review –Scientific review looks at the proposal to see whether it is something worth investigating, and will the study design enable the aims and objectives to be met. Science review can be done by the sponsor organisation, the study funder, or the academic organisation. But it must be independent and robust – review within the study team is not satisfactory. Complete IRAS application forms indicating in project filter that application will be made to R&D. Amend other study documents if necessary. – Get sponsor authorisation and other signatures Make submission

Cardiff and Vale UHB Bwrdd lechyd Prifysgol Caerdydd a’r Fro How to make a submission Determine which organisations you will need to submit to, R&D, REC, others (CAG, NOMS, Social Care REC) Complete IRAS application forms and study documents For REC –Ring Central Booking Service on to discuss submission and identify committee –Must be ready to submit the same day application is booked –Documents should be uploaded to REC checklist and electronically submitted to the committee For R&D –NHS R&D form, SSI forms and all study documents should be ed to Health and Care Research Wales Permissions Coordinating Unit at –They will inform you whether the application constitutes a complete submission and forward to sites for local governance review –They will inform sites when global governance review is complete and this is one of the checks that needs to be completed before local approval can be issued. –Approval is received from sites and will only be issued once global approval is complete.

Cardiff and Vale UHB Bwrdd lechyd Prifysgol Caerdydd a’r Fro Common problems and how to avoid these

Cardiff and Vale UHB Bwrdd lechyd Prifysgol Caerdydd a’r Fro Problems in application and submission Authorisations not appearing on the application when submitted and DRAFT watermark appearing on application –Ensure that no changes are made to any IRAS applications forms following authorisation. –Ensure that the ‘Submit’ button is pressed. This will remove the draft watermark and add in the authorisation text Application checklist not submitted –There are different checklists within each application form, all of which should be submitted and completed. Documents re uploaded to the REC checklist but not to the R&D and SSI checklist. These documents should be produced as a PdF, button available at end of , and attached to the submission . Sponsor details, A4 and A64 stated incorrectly –These details should be details of a member of R&D staff, in C&V the R&D Director. Information on what details to enter here can be obtained from the sponsor. This should not be a member of the research team. SSI Application –The SSI application should be specific to each site. Though information will copy through from the R&D application form this should be checked and amended in each form as necessary to ensure that it is relevant to the specific site. Appropriate Applications –Has the IRAS project filter been completed correctly. In particular is Human tissue being taken and is radiation involved in the study, even if part of standard care.

Cardiff and Vale UHB Bwrdd lechyd Prifysgol Caerdydd a’r Fro Problems encountered post submission (1) Lack of Consistency between documents –All documents should be consistent both internally and with each other. The PIS, Protocol and IRAS application forms should all clearly refer to the same application and therefore give the same details in all areas, such as recruitment numbers and methodology. Please proof read documents carefully prior to submission and cross check important details. Lack of Internal Authorisations –Studies will need local approval from support departments indicating that they are able to support the study. This will form part of the local governance checks. Your R&D office will be able to identify relevant individuals to you and they should be approached as early as possible as it may take time for them to review. Funding Arrangements unclear –Applications are often unclear regarding how the research will be funded, particularly if no grant application has been made. All research involves costs, such as staff time to participate in research, travel expenses to participants, additional use of facilities etc. It should be clear how these costs will be met and that whoever holds the budget has agreed to this. Your R&D office will be able to advise regarding project specific costs and who to discuss this with. Access Arrangements unclear –How will you have authority to access NHS premises to conduct research or patients data. This could be as a member of the care team but if not then researchers will need either a contract or Research Passport/Letter of Access with the relevant NHS organisation in addition to consent from the patients. This may involve a CRB check and so should be applied for early. Your R&D office can identify if this will be necessary. How are participants identified and recruited –R&D need to be satisfied that the approach to participants is by an appropriate individual. How will the researchers access the information identifing potential participants, particularly if they are not a member of the care team. This is often unclear in the submission

Cardiff and Vale UHB Bwrdd lechyd Prifysgol Caerdydd a’r Fro General points of Advice Double check your application, and then double check it again. Consistency is King !!!!! Talk to the R&D office at the earliest opportunity for advice on study development, local processes and authorisations Where possible involve Patients and Service Users in the development of documents and study processes. Make use of the array of available templates, guidance and advice in developing study documents to ensure they meet governance standards.

Cardiff and Vale UHB Bwrdd lechyd Prifysgol Caerdydd a’r Fro Sources of help and useful contacts

Cardiff and Vale UHB Bwrdd lechyd Prifysgol Caerdydd a’r Fro Health Research Authority (Ethics) Ethics South East Wales REC Phillips / Jagit Sidhu Website contains lots of guidance, including: Is ethical review required? Proportionate Review Scheme Participant information sheet & consent form templates How to submit and book application Process overview and timelines Amendments – substantial versus non-substantial

Cardiff and Vale UHB Bwrdd lechyd Prifysgol Caerdydd a’r Fro Cardiff & Vale UHB R&D Office Non Commercial Trials: Commercial Trials: Grant Applications/Research passports/Honorary research contracts: R&D approval process guidance/General Enquiries Research governance / adverse event reporting: GCP training:

Cardiff and Vale UHB Bwrdd lechyd Prifysgol Caerdydd a’r Fro Others Is my study research? IRAS Health and Care Research Wales submission guidance PIS/Consent Form guidance