1. Ethical review and approval is required on all research projects, guidance on the process is available via the National Research Ethics Service (NRES) website:

www.nres.npsa.nhs.uk

With the actual application forms accessed via the Integrated Research Application System (IRAS) at:

www.myresearchproject.org.uk.

2. The review and approval can be by the North of Scotland Research Ethics Committee (NOSREC) OR any other REC in the UK (see NRES site).
 

The NOSREC (Ethics) meetings are held twice a month (timetable attached).  Before you start your IRAS form you must book a slot for your ethical review appointment, see contact details above.  Please note the date for the submission of the application and all associated relevant docs is 3 weeks before the Ethics committee meeting.  You will be given an Ethics number, eg 09/S0801/36, which you add to your application form. 

Choose a meeting that allows you plenty of time to get everything done.

3. If NOSREC meetings are full, or you don’t want to use NOSREC you can apply to any REC in the UK to get your project reviewed and approved (see NRES site).

4. Your ethics application is done on the Integrated Research Application System (IRAS) form, accessed via www.myresearchproject.org.uk.  IRAS enables you to enter information about your project once instead of duplicating info in separate application forms (by using IRAS you can apply to the REC, R&D, ARCAC CTAC, MHRA, Ministry of Justice and others all at the same time if necessary).  It also gives guidance notes and uses filters to ensure that the data collected and collated is appropriate to your study type. 

5. On the IRAS form, navigation page, select the full set of project data (integrated data set) to complete your application.  When your form is complete and you are ready to submit it to the REC, select NHS REC form and refer to the “help” given on the website (if you need more help contact Frances Hines, R&D Manager on 01463 255822 or email – frances.hines @nhs.net).

6. For your submission to NOSREC you need to send ONE COMPLETE SIGNED HARD COPY, (if submitting to any other REC please check with them on number of hard copies required) of your project docset:
 The list below covers all project types therefore not all these documents would be relevant to your project, eg an investigator brochure would be required only for an Investigational Medicinal Product project:
 One copy of the signed IRAS
 Complete a Site Specific Information form if required (SSIs are required for interventional projects –  if  unsure check with the R&D Office)
 Research protocol
 Patient Information Sheet
 Consent Form
 Peer Review
 Investigator CV
 Sponsor Confirmation Letter (not needed for commercial projects)
 GP/consultant letter
 Invitation letter/advertisement
 Questionnaire, Interview schedule
 Sample diary card/patient card/case report form
 A summary CV for the Supervisor (for Student Projects)
 Investigator's brochure or summary of product characteristics data sheet for all drugs
 Any grant application and approval letter
 Copy of the Sponsor’s Insurance Certificate
Note:  Each document requires a name, version number and date, eg

Participant Information Sheet, Version 1, 04/11/09.

The REC lists all approved docs by name, version number and date and this information must not be altered unless an amendment is being submitted to the REC for approval.  Ten percent of NHS Highland research projects are reviewed by our auditors annually so it is important to log all changes to your docset with the REC, and R&D Office.

Please Do Not use an automatic dater (eg on microsoft word)
as the date changes every time the doc is printed.

7. Following receipt of the REC approval letter, the process for obtaining NHSHs R&D Management Approval process can be progressed.  Research cannot begin until the R&D Management Approval letter, signed by NHSHs R&D Director, is issued.

R&D Management Approval Information

1. To access the R&D application form in IRAS, select the NHS/HSC R&D Form (project info) and refer to the “help” given on the website (if you need further help phone Frances Hines in the R&D Office, tele:  01463 255822).

2. For your submission to R&D you need to send ONE COMPLETE SIGNED HARD COPY (see list in item 6 above), and where applicable on appropriate NHSH departmental headed paper (eg any doc being sent to participants, eg letters, participant info sheets and consents, etc).

3. If your project requires an SSI ensure all NHSH departments involved in the project have given authorisation on the SSI form (eg from the relevant radiologist, pharmacist, etc).  Send the form to Frances Hines, R&D Manager, who will carry out a Site Specific Assessment to make sure that your project can be supported locally.

4. It is important that R&D is confident that your project is financially secure.  To provide evidence of this and  to work out any costs where relevant the following should be undertaken:

  If your project is eligibly funded (check with the R&D Office if unsure) it may attract service support costs and if this is the case you will need to fill in a cost form (available from R&D) for these costs and send it to the R&D Office for costing;
 
  If your project is non-eligibly funded, it will not attract service support costs but you may wish to calculate any local costs for the NHS and if this is the case you will need to complete a cost form (available from the R&D) and send this to R&D who will discuss whether your project is financially viable within NHS; or
 
  If your project is not funded at all but you know it has costs you need to discuss this as a matter of urgency with Frances Hines, R&D Manager.

Amendments
Any Minor, Modified or Substantial Amendments must be submitted to the REC for approval, and to the R&D Office.

Annual and Final Reports
Annual Reports must be submitted to the REC and also the R&D Office.

Multicentre Research Projects AND the NHS Research Scotland Co-ordinating Centre (NRSCC)

1 If you are setting up a multicentre study, ie covering 2 or more NHS Boards, you need to involve NRSCC.
  

The NHS Research Scotland Co-ordinating Centre (NRSCC) contact details are:

NHS Research Scotland Co-ordinating Centre (NRSCC)

Research & Development Office

Foresterhill House Annexe

Foresterhill

Aberdeen

AB25 2ZB

Tele:  01224 552 690

Email:  

nhsg.nrscc@nhs.net

The NRSCC has been put in place to review and disseminate docsets for multicentre projects involving 2 or more NHS sites, eg NHS Highland and NHS Grampian.  Their role is to:

 Appoint one Lead Reviewer who will review the project for the whole of Scotland and contact you (in your role as the Chief Investigator) with any queries;
 Receive and upload the research docset to the Scottish national research database;
 Notify participating NHS sites when the docset is available for downloading;
 Track when participating sites give R&D approval; and
 Receive, upload and track any project amendment and approval.

2 The NRSCC office will accept the docset in:

 Signed paper form;
 Electronic form (with electronic signatures or signature pages faxed separately or posted); or
 An XML file which will transfer directly to NRSCC.

For further advice please do not hesitate to contact either
NOSREC
Tele:  01224 558474 / email nosres@nhs.net

or

Jackie Fraser, Research & Development Administrator (details below)
NHS Highland Research & Development Office
Room S101, Centre for Health Science, Old Perth Road, Inverness,  IV2 3JH
Tel No:  01463 255820     Email:  jackie.fraser3@nhs.net

NORTH OF SCOTLAND RESEARCH ETHICS SERVICE MEETINGS 2010
MEETINGS ARE HELD IN THE CONFERENCE ROOM, SUMMERFIELD HOUSE

CLOSING DATE - 12 NOON DATE OF MEETING

Bold indicates Grampian (2) Committee

It should be noted that the closing date has been extended from 2 to 3 weeks in order that the Scientific Advisor can triage applications.