Submit a Project Evaluation Panel 1 (PEP1) form

This outlines your internal & non-commercial idea to the RNOH to determine if the RNOH is happy to take on sponsor responsibilities (only one page!). Download Project Evaluation Panel 1 (PEP1) form or request & and submit at research@rnoh.nhs.uk

Set up an IRAS account

Integrated Research Application System (IRAS) is the single place to submit Ethics ethics and regulatory applications in the UK. Set up your account at www.myresearchproject.org.uk Have a look round but make an appointment with the R&D Department for assistance, because procedures change all the time....

R&D appointment

It's vital you come and see us before proceeding with research or applications. Book an appointment by emailing research@rnoh.nhs.uk. We'll explain processes relevant to your project; any expedited routes that may be open to you and help you understand IRAS. This will save you a lot of time!

Funding: If you need funding this can take time to find. The R&D department Department will help you. All projects should have funding in place.

Project Evaluation Panel every two weeks

Your PEP1 form will be used in informal R&D discussions chaired by the Director of R&D Professor Marsh. The RNOH must determine if they are able to take on sponsor responsibilities. Feasibility is assessed and constructive input is given on ethics and design issues. These are held every other Tuesday in the R&D Department from 17.00pm. Investigators are invited to attend and are likely to find it useful to do so.

Prepare IRAS Applications (inc. REC & R&D applications)

Done on IRAS, applications take time to prepare, and you'll need to have your forms authorised (usually electronically) AFTER any final amendments, by the Chief Investigator, the Principal Investigator and the Sponsor (Iva Hauptmannova, R&D Manager, on behalf of the RNOH).

1. Write your protocol 1^st (templates available by email at research@rnoh.nhs.uk)
2. Complete IRAS forms, if you have completed the forms prior to PEP1 feedback these may require some editing (The top 3 are the mandatory forms).
   1. IRAS Ethics form
   2. IRAS SSI form (Site site specific information)
   3. IRAS R&D form
   4. + any regulatory body forms necessary, for example an MHRA (the Medicines and Healthcare Regulatory Agency) form in a device or investigational medicinal product trial. For additional details on how to set up clinical trials see the Clinical Trials Toolkit.
3. Prepare additional documents - we have templates for the top two - email research@rnoh.nhs.uk.
   1. Patient information sheet
   2. Patient consent formCVs of investigators and staff
   3. Any other documents requested by IRAS

Submit applications

Ethics applications need to be printed out and sent to the Research Ethics Committee. You will get the address when booking your appointment for ethical review (see box below). The protocol will need to be printed six times.

The SSI (Site specific information) and R&D forms are submitted electronically- however, there are two routes - you need to find out from R&D whether route one (via CSP) or route two (not via CSP) is suitable for your project.

Ethical review

Independent ethics committees review all research*. Book a slot with a research ethics committee (REC) centrally via 020 8846 7289 (there is usually a two week wait on average)

1. Await favourable opinion or other response (up to two weeks after the review)
2. (If additional information/amendment is required wait one to two - weeks following your additional submission for a further response)

*If your  project contains no material ethical issues (meaning research is using data anonymous to the researcher, existing tissue samples with consent already taken, questionnaire research not including sensitive areas etc.) then it may suitable for 'Proportionate Review', an ethics review process that takes 14 days maximum. To find out if your project qualifies view the 'No Material Ethical Issues Tool'.