University of Glasgow Dental School and NHS Greater Glasgow & Clyde – Project Guidance

In these pages we set out the processes and requirements to support and advise in relation to attaining approval for your project from both the University of Glasgow Dental School and NHS Greater Glasgow & Clyde Health Board

Project Guidance Process

The Preliminary Study Proposal Form MUST be completed by the Lead Researcher on the project within the Dental School as early in the planning process as possible in order to ensure that the research can be fully supported within the Research Groups/ Dental School.

This approval process covers:

  • Undergraduate Student Electives / Intercalated Degree Projects
  • Postgraduate Research (Phd, MSc) Student Projects (theses)
  • Postgraduate Taught (PGT) Student Projects (dissertations)
  • Principal Investigator on funding / grant applications
  • Co-applicant on funding / grant applications (in-house or externally-led)

AND / OR

  • Projects with potential NHS service implications (not just within the Dental Hospital / Oral Health Directorate)

The Preliminary Study Proposal Form MUST be submitted and the project approved before:

  • PAF will be signed off by Head of School
  • PG Student offers will be approved by Director of Postgraduate Student Affairs

Applying for Funding

Contact Deirdre Kelliher, Project coordinator for the Dental School and SOHRC, room L7, level 9, tel ext 9764  or 330 8521 (Thursdays only) Deirdre.Kelliher@glasgow.ac.uk for information and assistance on:

Funding opportunities and funder terms and conditions

University approval processes – all applications for funding both grants and contacts are recorded on the University Research System. The approval process is electronic and has three stages: the principal investigator, the School, the College. Please allow sufficient time for the process – minimum five working days – as this must be complete prior to submitting an application to a funder.

Costing of applications according to funder requirement, completion of financial information in application forms and checking of the justification of resources.

Liaison with Finance R&D and external universities.

Submission and final checks for electronic funding applications


Preliminary Study Proposal Form and Process

Submit Completed Preliminary Study Proposal Form to evelyn.wallace@glasgow.ac.uk

Forms will be logged and triaged by the Research Management Committee Convenor

  • If a project involves NHS services / patients form will be forwarded to:
    • Research Coordinator NHS Greater Glasgow and Clyde R&D
    • Research Governance Officer MVLS College

Researcher may be invited to present proposal to Glasgow Dental School and Hospital Research Management Group – membership includes NHS GG&C R&D, NHS GG&C Oral Health Directorate Management and University of Dental School colleagues. 

  • If project is aligned to Oral Sciences research group, the form will be forwarded to OS Research Leads for comments. Researcher may be invited to meet with Leads.

  • If project is aligned to Community Oral Health research group, the form will be forwarded  to COH Research Leads for comments. Researcher may be invited to meet with Leads.

  • If project is aligned to Scottish Oral Health Research Collaboration or the Education Research theme, the form will be forwarded to Director of Research. Researcher may be invited to meet with Education Director to discuss.

  • If project involves postgraduate students, the form will also be forwarded to Director of Postgraduate Student Affairs.

Feedback:

Comments from Research Leads / NHS Management / meetings will be collated by Research Management Committee Convenor and emailed back to researcher by Evelyn Wallace. 

Aim for 2 week turn around time for comments back, may be longer if meetings are required.

Notes:

It is important that research undertaken by University of Glasgow Dental School staff is within the Dental School’s Research Strategy‌ and undertaken within the Research Group themes – namely Community Oral Health and Oral Sciences.

In addition, research can also be undertaken within:

Scottish Oral Health Research Collaboration http://www.sohrc.org/
or
University of Glasgow College of Medical, Veterinary and Life Sciences Research Instituteshttp://www.gla.ac.uk/colleges/mvls/researchinstitutes/


Pre-Submission Peer Review

Before submitting a grant application or PhD studentship proposal, please ensure that appropriate peer review has been undertaken. Providing evidence of this peer review process is a necessary step for the application to be approved and signed off by Head of School for research grant applications, and by Director of Postgraduate Student Affairs for PhD studentships. 

The level of peer review required depends on the nature and value of the grant applications For those worth:

  • <£100K - internal Dental School peer review will be needed.
  • £100K+ - internal Dental School peer review + MVLS Research Institute peer review will be needed

For all competitive PhD studentships - internal Dental School peer review + MVLS Research Institute peer review will be needed

For non competitive PhD studentships - internal Dental School peer review


How to apply for NHS R&D Management Approval

The Preliminary Study Proposal Form should be completed at an early stage in your study development. The researcher may not even have consulted local NHS Management prior to completion and submission of the form - although the form will prompt you to do so. Advice will be provided regarding liaison with local NHS Management after the form has been submitted.

Principal Investigators / Researchers intending to submit substantial research funding proposals (e.g. to CSO) should submit the Preliminary Study Proposal form and also attend a Clinical Research Management meeting to discuss their project with University and NHS colleagues. Link to CRM group

Who provides NHS R&D Management Approval?

The NHS Greater Glasgow and Clyde Research and Development Management Office, who are a multidisciplinary team promoting, co-ordinating and facilitating all aspects of high quality research within NHS Greater Glasgow and Clyde. 

How to identify a sponsor?

http://www.nhsggc.org.uk/content/default.asp?page=s513_3   

The sponsor is the individual, or organisation (or group of individuals or organisations) that takes on responsibility for confirming there are proper arrangements to initiate, manage, monitor and finance a study.

What is NHS R&D Management Approval?

  • Formal review of all research conducted within the NHS
  • Ensures indemnity / insurance for research activity
  • Applies to all studies involving:
    –        participation of NHS employees
    –        use of NHS resources or facilities
    –        NHS patients or their tissues & data
  • Applies to both commercial and academic studies
  • Condition of ethical opinion

 It includes the assessment of:

  • Scientific quality
    –        regulatory approvals
  • Information
  • Health & safety
  • Finance and resource
  • Quality research culture
  • Responsibilities and accountabilities
    –       study sponsorship

 NHS R&D Management Approval is a formal review by designated staff of projects to be conducted across NHS GG&C involving patients, patient tissues, patient data and involving NHS staff. This approval aims to fulfil the legal obligations of the health board outlined in the Research Governance Framework and is issued when a study has received all of the appropriate regulatory and internal approvals.

Without NHS R&D Management Approval indemnity / insurance can’t be assumed to be in place to cover proposed research activity.  R&D management approval also indemnifies the researchers and covers their involvement in the study under the Clinical Negligence and Other Risks Indemnity Scheme (CNORIS)

Ethical approval is issued on the premise that R&D Management Approval will be obtained before the initiation of study.

The NHS R&D Management Approval process involves the following:

  1. Assessment of the scientific quality of the proposal (if required)
  2. Ensure final Favourable Ethical Opinion from Research Ethics Committee
  3. Ensure appropriate regulatory authorisations are in place
  4. Ensure appropriate risk/benefit analysis
  5. Ensure provisions for appropriate insurance/indemnity
  6. Ensure the financial and resource implications of the project are assessed
  7. Ensure trial registration
  8. Ensure all researchers have substantive or honorary contracts with NHS GG&C
  9. Ensures the study has departmental support and approval
  10. Ensures any formal agreements or contracts with external bodies have been finalised and meet the requirements of the board

Decision on sponsorship of non-commercial studies


Is your project research, audit, or service evaluation?

The onus of this decision is the lead researcher’s / supervisor’s. Guidance is available from the National Research Ethics Service: http://www.gla.ac.uk/media/media_145648_en.pdf 

Additional advice on this decision can be sought in writing from Dr Judith Godden, Scientific Officer for NHS West of Scotland Ethics Committees.

Email Judith.Godden@ggc.scot.nhs.uk and include a one page outline of your proposal.


How to apply for ethics approval?

All studies involving NHS patients, data, or human tissue (including blood samples) need ethics approval from the West of Scotland Research Ethics Service using the NRES IRAS system www.myresearchproject.org.uk.

Changes to the Requirements for Ethical Review: From 1st September 2011 changes to the Governance Arrangements for Research Ethics Committees (GAFREC) mean that it is no longer necessary to submit to the National Research Ethics Service for review of studies where the requirement is based solely on the use of NHS staff as participants or the use of NHS premises. Other changes will mean some studies involving only tissue or data may be exempt however a large number of exceptions necessitate review of each study against the www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_126474 . This change relates only to the National Research Ethics Service (NRES), studies (including staff related studies) not requiring NRES approval still require NHS R&D Management Approval and/or University Ethics Approval and should still be processed through IRAS.

You should have NHS R&D Management Approval before applying through NRES IRAS.

University of Glasgow staff undertaking research projects
which do not need NHS ethics approval still need to be submitted to the University College (MVLS) Ethics Committee http://www.gla.ac.uk/colleges/mvls/informationforstaff/researchadministration/collegeethicscommittee/

Contact:

Mr. Stuart Morrison and the MVLS Ethics Admin Team
Room 330, Wolfson Medical School Building
University Avenue
Glasgow G12 8QQ

tel: +44 (0)141 330 5519

email: mvls-ethics-admin@glasgow.ac.uk

Note: Ethics approval is essential for publication. If the project is a clinical audit confirmation from the Research Ethics Committee Scientific Officer (email: Judith.Godden@ggc.scot.nhs.uk) that ethical approval is not required is sufficient for publication. See also Research, Audit, or Service Evaluation?.


How to apply for clinical audit approval

If your project is an audit you do not need to apply for ethical approval. Confirmation of this (which is essential if you plan to publish) can be sought in writing from Dr Judith Godden, Scientific Officer for NHS West of Scotland Ethics Committees.

Email Judith.Godden@ggc.scot.nhs.uk with a one page outline of your proposal. 

All audits should also be registered and approved by the NHS Clinical Effectiveness via the Audit Proposal Pathway using the Quality Improvement Project Charter and the Quality Improvement Project Planning Template.


How to apply for service evaluation approval

If your project is a service evaluation you do not need to apply for ethical approval. Confirmation of this (which is essential if you plan to publish) can be sought in writing from Dr Judith Godden, Scientific Officer for NHS West of Scotland Ethics Committees.

Email Judith.Godden@ggc.scot.nhs.uk with a one page outline of your proposal.

All correspondence (including one page proposal) with Judith Godden in relation to decision that the project is a “service evaluation” to be sent to Linda.Armstrong@ggc.scot.nhs.uk Clinical Governance Officer, NHS GG&C Oral Health Directorate. The proposal will then be directed to the appropriate committee within the Oral Health Directorate for approval.

If the audit/service evaluation project is to be conducted outwith NHS GG&C Health Board area, the researcher must refer to the appropriate territorial Health Board NHS R&D Office.

If the audit/service evaluation project is to be conducted within multiple Health Board areas, there is no central coordination point. Multiple submissions must be made to the local Clinical Directorate within each NHS Health Board.


Awards

Contact Deirdre Kelliher, Project coordinator for the Dental School and SOHRC, room L7, level 9, tel ext 9764  or 330 8521 (Thursdays only) Deirdre.Kelliher@glasgow.ac.uk for information and assistance on:

Funder terms and conditions for awards

University approval and funder acceptances

Setting up an account with the Finance Office

Liaison with University Contract Office

Postaward  – grant and contract accounts, budget issues, extensions