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Research Governance and Policy Handbook

Given the diversity and complexity of the policy context which governs the research endeavour, this section is designed to assist you in finding the correct policy to govern a particular research project.  By working through the following “Policy Roadmap” below you should be able to identify the policies which must be read and understood before undertaking a research project, whether the project is externally or internally funded.

Policy Roadmap


Policy Check 1: Common Interest and Public Good

Before you undertake any research project you must read the policy statement: ‘Policy to Govern the Acceptance of External Research Funding’. The purpose of this policy is to establish a set of principles and procedures to prevent the acceptance of research or related funding by the University from awarding bodies whose activities are judged to be counter to the common interest and public good. A copy of the policy is available at:

http://www.somis.dundee.ac.uk/court/policy/acceptance_external_research_funding.pdf

Policy Check 2: Conflict of Interest

The University has established a Code of Practice on Conflict of Interest to help you identify whether or not your proposed research could cause a conflict of interest and to outline a procedure for disclosure of any perceived or potential conflict. The Code of Practice must be read before undertaking any research project and is available at:

http://www.somis.dundee.ac.uk/court/policy/conflict_of_interest.htm

Policy Check 3: Good Practice in Research

Integrity, objectivity, accountability, openness, honesty and leadership are amongst the essential principles which the University expects staff to adopt when undertaking any form of research. In order to familiarise yourself with the University’s requirements in this regard you are required to read the Code of Good Practice in Research which is available at:

Code of Good Practice in Research

Policy Check 4: Research Data Management

The University advocates the highest standards in the management, reuse and open accessibility of research data. This policy establishes a set of principles to govern the management of electronic data arising from the research activities of the University and will help you to meet the requirements of funders to manage and provide open access to your research data. The policy should be consulted before commencing a new research project and is available at:

Policy to Govern the Management of Electronic Research Data

Further information on research data management and an online form to report the deposit of research data in external repositories can be found at:

http://www.dundee.ac.uk/library/research/datamanagement/

Policy Check 5: Open Access

The University supports the principle that the published or publicly presented results of research should be made freely available to the widest possible audience; this is consistent with the requirements of an increasing number of funders that the outputs arising from the studies they fund must be made openly available. The Open Access policy should be consulted before applying for research funding and preparing manuscripts for publication. A copy of the policy is available at:

Open Access Policy

Policy Check 6: Guest Authorship and Ghostwriting

The University’s position on guest authorship and ghostwriting in relation to publications arising from its research activities is contained in the following policy statement – it is important that you familiarise yourself and act in accordance with this policy, which is available at:

Policy on Guest Authorship and Ghostwriting

Policy Check 7: Health and Safety

Before you start your project you must identify and ensure compliance with the University’s health and safety policies which are relevant to the type of research to be undertaken. The policies are available on the University’s Safety Services web-page and cover the following safety topics: General Safety; Biological; Fire; Radiation; and Occupational Health.

 http://www.dundee.ac.uk/safety/

Policy Check 8: Data Protection and Records Management

During the undertaking of your research project you are responsible for ensuring that your research complies with the Data Protection Act 1998, which governs the way in which personal information is held and used. The following link provides information on the Act and how the University operates in light of it; pro-formas are also available to help staff deal with particular areas under the Act such as the registering of research projects and data subject access requests (the latter requires to be completed if you plan to retain data during your research project that can be linked to an identifiable individual, for example by name or by code):

https://secure.dundee.ac.uk/recordsmanagement/dataprotection/

Policy Check 9: Code of Practice for Non-Clinical Research Ethics on Human Participants

If your proposed research project will include the testing, observing or collecting of personal data from humans but will not involve any of the activities listed under the Clinical/Clinically Related Activities list below then it will be governed by the Code of Practice for Research Ethics on Human Participants.

Clinical/Clinically Related Activities*

Any research activity which involves:

  • the investigation of the safety or efficacy of a medicine, foodstuff, therapeutic device or placebo in humans
  • patients, their carers, or staff of the NHS or a social care organisation
  • the collection or use of donor identifiable human biological samples
  • access to anonymised collections of patient data
  • human biological samples obtained from a tissue bank
  • human cadaveric or post mortem materials
  • use of any NHS resources including staff time, clinical support services or NHS facilities

The Code of Practice for Research on Human Participants is available at:

http://www.dundee.ac.uk/main/research/ethics/applicationprocedure/ 

In addition to ensuring compliance with the aforementioned Code of Practice, you must also obtain ethical approval for your project from the University of Dundee Research Ethics Committee (UREC) which reviews the ethical acceptability of projects out with the clinical/clinically related domain. Information on the constitution and remit of the UREC and an application form to seek ethical approval from the Committee for your proposed research project is available at:

http://www.dundee.ac.uk/main/research/ethics/

*If your proposed project will involve any clinical/clinically related activities please read Policy Check 8: Clinical and Clinically Related Research.

Policy Check 10: Clinical and Clinically Related Research

If your proposed research will include any of the Clinical/Clinically Related Activities listed below, the policies which will govern it are available on the website of the Tayside Medical Science Centre (TASC) http://www.tasc-research.org.uk/_page.php?id=157:

Clinical/Clinically Related Activities

Any research activity which involves:

  • the investigation of the safety or efficacy of a medicine, foodstuff, therapeutic device or placebo in humans
  • patients, their carers, or staff of the NHS or a social care organisation
  • the collection or use of donor identifiable human biological samples
  • access to anonymised collections of patient data
  • human biological samples obtained from a tissue bank
  • human cadaveric or post mortem materials
  • use of any NHS resources including staff time, clinical support services or NHS facilities

With respect to the undertaking of clinical trials, the University delegates particular responsibilities to NHS Tayside which are listed at:

http://www.somis.dundee.ac.uk/court/policy/clintrials.htm

TASC combines the research management services of the University and NHS Tayside and is a node of the Scottish Academic Health Sciences Collaboration. Staff within TASC are available to help with any sponsorship approvals, trials management,  policy or governance enquiry related to clinical or clinically related research. TASC is housed on level 3 of the Ninewells Hospital site http://www.tasc-research.org.uk/_page.php?id=156 and is co-located with the East of Scotland Ethics Service.

Policy Check 11: Use of Animals in Research

Whilst the University wishes to minimize the use of living animals in research wherever possible, it is recognised that procedures that involve animals continue to be necessary for the undertaking of many research projects. Should your proposed project involve the use of animals you must familiarise yourself with the contents of the University’s Code of Practice for the Use of Animals in Teaching and Research which is available at:

Code of Practice for the Use of Animals in Teaching and Research Dundee only

The University Code of Practice reflects and complements the law and associated Home Office Guidance. Before beginning work in a University facility, you must agree to abide by this Code of Practice, and any local rules that may exist, by printing out and signing the associated form (Declaration Dundee only).

The University's statement on the use of animals in research describes the process for ensuring that the welfare "costs" that may be experienced by animals during your research project are minimized and consistent with legislative demands.  You should also familiarise yourself with this statement which is available at:

http://www.somis.dundee.ac.uk/court/policy/roa_statement.pdf

If you have not already done so, please contact Biological Services (biolserv@dundee.ac.uk) for further advice on the ethical, legal and practical issues that will have to be addressed before your project can start.

Policy Check 12: Additional Approvals

It is important that you give careful thought to any additional guidelines, approvals or policy compliance that may be required before undertaking your research. You may, for example, require clearance from Disclosure Scotland, or approval of local education authorities, parents, or teachers. Your source of funding or professional body may also have issued guidelines, policies or regulations that must be adhered to.  For further advice on non-clinical/non-clinically related research projects please contact the Chair of the University's Research Ethics Committee (a.schloerscheidt@dundee.ac.uk) and for clinical/clinically related projects contact the Senior Research & Development Manager, Tayside Medical Science Centre (TASC) (k.gillon@dundee.ac.uk).
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