Presentation on theme: "Preparing for research SSIF / R & D APPLICATION Lynn Green, Research Governance Facilitator Health Sciences Research Institute"— Presentation transcript:
Preparing for research SSIF / R & D APPLICATION Lynn Green, Research Governance Facilitator Health Sciences Research Institute firstname.lastname@example.org@warwick.ac.uk tel: 024 7657 4698
SSIF APPLICATION Introduction A Site Specific Information Form (SSIF) is the process for applying for and obtaining R & D approval for your study with Trusts & Acute organisations and Primary Care organisations – see appendix 1 We’re going to look at how you can make the process easier for yourself, documentation you will be expected to submit, CRB/occupational health checks, and honorary contracts.
SSIF APPLICATION Beginning the Process The first thing to consider before working on your protocol or application is how to make your SSIF application process as painless and short as possible… Bear in mind that working in too many PCTs, Trusts and/or Acute Trusts will involve multiple applications additional in- house forms, occupational health checks, honorary contracts, and in some cases additional CRB checks. This could involve months of preparation before you can even begin to collect data. Before applying for CRB clearance you should consider whether you require Standard, Enhanced or Standard with PoCA or/and PoVA: http://www.crb.gov.uk/Default.aspx?page=310 http://www.crb.gov.uk/Default.aspx?page=310
SSIF APPLICATION Beginning the Process (cont’d) You can complete and submit your SSIF application/s to the NHS Trusts at the same time as you submit your ethics application form. You should aim to do this if at all possible so as to limit any delays to your study. The R & D application/s, once submitted, will then be processed up to the point where evidence of ethics approval of your study will be required. You might find it useful to look at the following webpages that I’m currently developing with relevant links and checklists/reminders http://www2.warwick.ac.uk/fac/med/staff/green/checklist/ http://www2.warwick.ac.uk/fac/med/staff/green/researchgovernance/
SSIF APPLICATION First Step When you have decided which NHS Trust/s you wish to use for your study, visit http://www.rdforum.nhs.uk/links/rdlinks.htmhttp://www.rdforum.nhs.uk/links/rdlinks.htm to find the R & D contacts - see appendix 2 Make contact to inform them of your intention and ask if there are any supplementary forms or requirements they need to accompany your submission, and whether you will require CRB clearance – see appendix 3. Check to see if they belong to a consortium, as this may help to reduce the number of applications you need to make if applying to more than one PCT/Trust in an area.
SSIF APPLICATION UHCW hosts the research management function for this consortium and undertakes the R & D review and approvals process for the following 4 NHS Trusts: Warwickshire PCT Worcestershire PCT Coventry tPCT Coventry & Warwickshire Partnership Trust They have shared systems for research governance/conduct which means they can limit and streamline the amount of bureaucracy involved – thus making your life easier… Example of a local consortium West Midlands South Joint Research Management & Governance
SSIF APPLICATION Second Step (When you have completed your ethics form and are ready to submit to the appropriate REC you must ensure you take at least one photocopy of every document you send, including the final signed IRAS form.) Documents required for SSIF submission : SSIF form All documentation sent with original ethics application (use the ethics checklist to double-check) together with any other supplementary in- house forms the relevant R & D department may require – see appendix 3 Copy of CRB clearance (if required/relevant) Copies of ethics approval letter/s Revised documents e.g., PIS or consent forms, should the Ethics Committee request changes to those you originally submitted
SSIF APPLICATION Second Step (cont’d) If you can present your application in a folder with appropriate dividers it may well help the progress of your application… Points to note: If you are applying for SSIF at the same time as your ethics application you need to note here that you will not have copies of ethics approval letters, CRB clearance or revised documentation at this point. However, this doesn’t prevent you from submitting the SSIF form together with the NRES application paperwork.
SSIF APPLICATION Third Step If a CRB check is required, bear in mind that this will take at least 6 weeks (and sometimes more), so you should start this process as soon as possible. (Remember to consider whether it should be Standard + PoCA/PoVA). If your last CRB check was done more than 6 months ago you will be required to have another check made. Contact the UoW Academic Office or visit the website: https://www.disclosures.co.uk/index.php?companyno=23 https://www.disclosures.co.uk/index.php?companyno=23 Occupational Health checks
SSIF APPLICATION Fourth Step As soon as you receive ethics approval letter/s and CRB clearance, take copies and send to the relevant R & D department/s. Complete and return Occupational Health check forms as soon as possible. R & D departments will then be able to issue you with final approval and any honorary contracts that may be required.
SSIF APPLICATION Fifth Step Upon receipt of your honorary contract (if relevant), make sure you sign and return a copy promptly, and keep your copy safe - some R & D departments will issue an honorary contract based on the fact that you hold one with another Trust. Make sure you don’t begin your study until you have R & D approval and an honorary contract in place.
SSIF APPLICATION Some common causes for delay in obtaining R & D approval Incomplete set of documentation submitted Not submitting revised documents Not submitting copy of CRB/ethics approval letters Applying for a CRB check too late
SSIF APPLICATION Sixth Step – Success! Congratulations. Hopefully you’ve gone through a fairly smooth process and are now ready to commence your study. Good luck.
SSIF APPLICATION And finally… Don’t forget to keep all ethics and SSIF documentation in good order. Ensure you continue to keep comprehensive records as you conduct your study – you could be audited at any time.