Documentation

North of Scotland REC Review and Approval

PLUS

NHS Highland R&D management Approval Information

Please contact the R&D office for guidance on documentation relating to research studies.

1. 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.

2. 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:

 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

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.