Infrastructure Management Policy
Council approval C2022/03, 22 September 2022 · Implemented 23 September 2022
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UWC Infrastructure Management Policy Council Approval Reference Number First Approval Amendments C20 22/03 (22 September 2022) Implementation Date 23 September 2022 Revision / Amendment n/a Revision / Amendment Date n/a Provisos n/a Policy Owner Infrastructure and Engineering Executive Management Portfolio ED – Finance and Services Contributors EMC, SPRC, SEC, IBDC, Council Circulated by: Executive Director – Finance and Services Circulated to: Institutional Planning and Infrastructure and Engineering staff members. University of the Western Cape Infrastructure Management Policy
University of the Western Cape Infrastructure Management Policy 2 Contents Contents Preamble ................................ ................................ ................................ ................................ ................. 3 1 Purpose ................................ ................................ ................................ ................................ ........... 4 2 Scope ................................ ................................ ................................ ................................ ............. 4 3 Definition of concepts ................................ ................................ ................................ ................... 4 4 Principles, procedures and delegations ................................ ................................ ..................... 4 4.1 Infrastructure development at UWC ................................ ................................ .................... 4 4.2 Management of infrastructure ................................ ................................ .............................. 5 4.3 Spatial development frameworks ................................ ................................ ......................... 7 4.4 ICT infrastructure plans ................................ ................................ ................................ ........ 7 4.5 Infrastructure management plans ................................ ................................ ........................ 7 Annexure A: Principles associated with the management of University infrastructure ................ 9 Annexure B: Universal spatial planning principles ................................ ................................ ......... 11 Annexure C: Infrastructure planning principles ................................ ................................ ......... 14
University of the Western Cape Infrastructure Management Policy 3 Preamble Infrastructure management is not just a matter of maintaining existing infrastructure or providing new infrastructure. The focus of this Policy is on balancing these aspects and providing a high - level strategic framework for infrastructure provision and the utilisation thereof . Such an approach requires direction on decision making throughout the infrastructure planning, delivery, operation and disposal processes , it spans the focus of various management and governance structures and follows a risk - based approach to achieve a balance between whole life cost, risk , performance, and sustainability, through: • providing a defined and agreed level of service and performance monitoring; • taking a life - cycle approach to developing cost effective management strategies for the long term that meet the desired level of service; • identifying, assessing and appropriately managing risks; and • having a medium to long term financial plan which identifies required expenditure and how it will be funded. It is necessary to determine acceptable and functionally appropriate levels of service, so that infrastructure requirements (and performance and utilisation ) can be measured against a set yardstick. Criteria may relate to availability of the service, quality or condition, quantity, reliability, responsiveness, environmental acceptability and financial implications. Levels of service are informed by a combination of stakeholder needs, legislative requirements and internal business objectives, and need to be sustainable over the estimated service life of the infrastructure. This is a vital part of the infrastructure management process that not only affects decisions on existing infrastructure but also informs choices and decisions affecting the maintenance of existing infrastructure and the provision of new infrastructure. Infrastructure assets , which support the objectives of the institution , exist to provide value to the University. To ensure that value is maximised, there is a need to understand what infrastructure is required, what infrastructure exists, how well it is being utilised, what condition it is in , its fitness for purpose , its operational costs, and its ability to evolve in changing circumstances . This Policy will be supported by: 1) The Fixed A sset P olicy; 2) Procurement Policy 3) Budget Policy 4) Campus Development Plan ; and 5) A n annually - updated 3 - 5 - year I nfrastructure M anagement P lan.
University of the Western Cape Infrastructure Management Policy 4 1 Purpose The purpose of this Infrastructure Management Policy is to establish a Council approved policy for key infrastructure - related principles and objectives that the U niversity’s executive management needs to pursue over time . The Policy is supported by a) a long - term spatial development framework (Campus Development Plan) ; and b) an annually - updated 3 - 5 - year infrastructure management plan ; which promote the efficient, economic , effective and sustainable use of resources . 2 Scope This document establishes the University’s policy for the management of its infrastructure. It includes the management of : a) the demand for infrastructure ; b) the creation and prioriti s ation of a pipeline of interventions ; as well as c) the management of land holdings . 3 Definition of concepts Infrastructure comprises immovable assets which are acquired or constructed or which result from construction operations and includes moveable assets which cannot function independently from purpose built immoveable assets. It includes Information and Communication Technology (ICT) networks and systems that are used to communicate and to create disseminate, store and manage information , as well as security technology installations. Asset management seeks to effectively, efficiently , economically and sustainably utilise infrastructure to serve the current and emerging needs of the University. A sset management accordingly considers the entire lifecycle (service life) of the infrastructure asset and the associated costs, from the identification of a need through operating costs, and finally to the final decommissioning and disposal of the asset. 4 Principles, procedures and delegations 4.1 Infrastructure development at UWC In proposing infrastructure development projects that include the acquisition or construction of new buildings as well as the repurposing and modernisation of existing infrastructure, the University will give due consideration to: a) T he alignment of the proposed infrastructure development with the University’s strategic intentions as articulated in its Institutional Operating Plan and the Campus Development Plan ; b) Affordability and future financial commitments. c) Continue to apply and seek to optimise the funding opportunities provided by the DHET's i nfrastructure grants , and in doing so will seek to find a balance between projects focusing on: 1) UWC's academic project, including new programme areas. In this regard the University will seek to find a balance between the repurposing and refurbishment of old infrastructure and new developments / acquisitions ; 2) Student growth and the capacity of infrastructure; 3) The needs of students and improving their university experience, especially at smaller campus sites; and 4) Addressing compliance issues and backlog maintenance. d) Where feasible the university will i ncrease the provision of ablution facilities that are :
University of the Western Cape Infrastructure Management Policy 5 1) A ccessible and that serve s the requirements of disabled students and staff ; and 2) G ender - neutral to support the needs of the University’s gender - diverse student and staff population . e) Optimising appropriate income - generating activities where these opportunities exist or can be established. 4. 2 Management of infrastructure The University will manage its infrastructure based on t he principles set out in Annex ure A. The University’s Executive Management is responsible for all aspects of infrastructure management and these functions are largely executed on its behalf by the Executive Director: Finance and Services . In this regard the University will attend to : 4. 2 . 1 L ife - cycle infrastructure asset management planning for large individual assets or groups of infrastructure assets, which include operation, maintenance and refurbishment requirements. This planning will inform major refurbishment or upgrading requirements which are incorporated i nto the infrastructure management plan. 4. 2 . 2 F acilities management, ensuring that : a) the necessary internal and external facilities management resources are in place; b) e ngineering infrastructure management including the following , occurs: 5) b udget ing and prepar ation for planned as well as un planned maintenance ; 6) regular checking of hard services ( m echanical, e lectrical and p lumbing (MEP) services) to keep them serviceable with special attention being paid to critical infrastructure ; 7) identification and establish ment of condition monitoring and inspection plans as per the operating and maintenance manuals to check, test or replace infrastructure systems, subsystems, assemblies or components ; 8) preventative (scheduled, routine) maintenance plans are drafted and implemented ; 9) all breakdowns are addressed immediately and repairs planned and prioritised ; and 10) a record is made of infrastructure breakdowns and incidents which can be analysed to identify trends to inform decisions ; c) the day to day soft services (e.g. cleaning, security, catering, fire protection, waste management, reception services) are done properly and that staff or contractors and their performance is measured and reported against performance specifications ; and d) d emobilisation of f acilities m anagement (e.g. Service Level Agreements) for infrastructure that will be disposed of as well as for infrastructure earmarked for upgrades, refurbishments or rehabilitation. 4. 2 . 3 P rogressive develop ment of an infrastructure management system to provide reliable, consistent and updated infrastructure information to enable optimised decisions to be made , which should: a) be used to inform infrastructure management activities ; and b) provide improved risk control assurance that the objectives in the infrastructure management policy will be achieved on a consistent basis. 4. 2 . 4 E ntering into leases for infrastructure for use by the University or for the leasing of University infrastructure and the administration thereof. 4. 2 . 5 The manage ment of all occupational health and safety and environmental compliance matters in relation to infrastructure and the usage of land.
University of the Western Cape Infrastructure Management Policy 6 4. 2 . 6 A ccess management and security required to safeguard University infrastructure and land. 4. 2 . 7 Management of all ICT infrastructu r e. 4. 2 . 8 R eport ing of infrastructure management - related matters to the oversight committees identified in Table 1 , who will approve actions that are necessary for the progressive implementation of principles associated with the management of University infrastructure as set out in Annex A. Table 1: Oversight committee s Item Area of management Responsible person Oversight committee 4. 2.8 . 1 Life - cycle infrastructure asset management planning Executive Director: Finance and Services • Senate Physical Resources Committee 4 .2 . 8. 2 Mobili sa tion for facilities management Executive Director: Finance and Services • Senate Physical Resources Committee 4. 2.8 . 3 Development of an infrastructure management system Executive Director: Finance and Services • Senate Physical Resources Committee 4. 2.8. 4 Leases for infrastructure Executive Director: Finance and Services • Finance Committee 4. 2.8. 5 Occupational health and safety and environmental compliance Executive Director: Finance and Services • Safety, Health, Environment and Risk Committee 4. 2.8 . 6 Access and security Executive Director: Finance and Services • Safety, Health, Environment and Risk Committee 4. 2.8 . 7 ICT infrastructure Executive Director: Finance and Services • Information, Communication and Technology Governance Committee 4. 2.8 .8 Infrastructure development implementation oversight Project Boards Executive Director: Finance and Services • Senate Physical Resources Committee • Infrastructure Business Development Committee • Council 4. 2.8 .9 Infrastructure development project proposals Executive Management • Infrastructure and Business Development Committee • Senate Physical Resources Committee 4. 2.8 .10 Infrastructure acquisitions Executive Management • Infrastructure and Business Development Committee • Finance Committee • Council
University of the Western Cape Infrastructure Management Policy 7 4. 2.8 .11 Infrastructure development funding Executive Director: Finance and Services • Executive Management Committee • Finance Committee 4. 2.8 .12 Infrastructure procurement and contract awards Executive Director: Finance and Services • Tender Committee 4. 3 Spatial development framework s 4. 3 .1 The University will have a Campus Development Plan (CDP) providing a long - term overall spatial vision for its campuses drawing upon the universal spatial development principles outlined in Annex B. The CDP is a Council approved document and the University Council will approve any significant changes to it. 4. 3 .2 The Unive r sity will ensure that all planning for new infrastructure is aligned with the Campus Development Plan . 4. 4 ICT infrastructure plans 4.3.1 ICT infrastructure (including software) plans should: a) be modular and adaptable and, as far as possible, accommodate growth, additions, changes and integration with other systems; b) enable changes of components without impacting on the entire system; c) limit the range of technology employed, to make maintenance and support manageable; and d) include planning for replacement as equipment becomes obsolete very quickly. 4.3.2 Changes to any of the University’s ICT infrastructure or systems should follow the Information Technology Infrastructure Library (ITIL) change management framework which include procedures and reporting to control the movement and location of assets and allow for the appropriate decommissioning and responsible disposal of any ICT equipment. 4. 5 Infrastructure management plan s 4. 5 .1 The University will develop an annual I nfrastructure M anagement P lan, that will include planning for new infrastructure, as well as plans for the operation, maintenance, refurbishment and rehabilitation of existing infrastructure, and disposal of infrastructure which is no longer required to meet the U niversity’s objectives , and it will be based on: a) factors such as policies, norms and standards, condition assessments, functional performance, student enrolment trends, student housing demand trends, current and forecasted levels of optimi s ation, and academic requirements ; b) the infrastructure plan ning principles contained in Annex ure C ; c) the grouping of projects into programmes to enable cash flow projections for projects during a financial year to be adjusted and funds to be moved between projects within a programme to avoid under - expenditure without changing the purpose for which funds w ere approved; and d) the readiness of projects for implementation.
University of the Western Cape Infrastructure Management Policy 8 4. 5 . 2 The University will ensure that the following is undertaken for all projects admitted to a pipeline of projects at S tage 0 (Project Initiation) in accordance with the provisions of the University’s Procurement Policy: a) the identif ication of the impediments and constraints to project implementation and establish ment of the timelines required to resolve them; b) the identif ication of high risk critical infrastructure; and c) the prioritis ation of projects and the establish ment of realistic budgets and timelines over a 3 to 5 - year period . 4. 6 Financial Management of Infrastructure Development The University’s large - scale infrastructure development projects are mainly funded through the DHET’s i nfrastructure grants , supplemented by an agreed proportion of University funding and donor funding . Building maintenance is funded through the University’s Council controlled operational funds. Financial management of infrastructure will include: a) annual budget allocation s to support the maintenance and management requirements of the University’s infrastructure b) infrastructure development budget consideration and recommendation to Council by the Council Finance Committee ; c) the approval of infrastructure development project budgets by the Council . ; d) monthly meetings of all infrastructure development Project Boards where the appointed professional team must present reports on project budgets and progress . The reports must at least include a report from the principal agent , quantity surveyor and architect.
University of the Western Cape Infrastructure Management Policy 9 Annex ure A: Principles associated with the management of University infrastructure The principles associated with the management of the University’s infrastructure are: a) T he requirements of the following regulatory framework need to be met: • The Occupational Health and Safety Act including the - Construction Regulations , - Electrical Installation Regulations - Pressure Vessel Regulations , - Lift Escalator and Passenger Conveyer Regulations , - Driven Machinery and General Machinery Regulations ; • T he National Building Regulations and Building Standards Act including the National Building Regulations; and • T he National Heritage Resources Act . • The National Environmental Management Act No. 107 of 1998 • The National Energy Act No. 34 of 1998 b) All D epartment of Higher Education and Training infrastructure - related policies need to be adhered to, including the Higher Educ a tion Act, Space and Cost Norms for Buildings and other Land Improvements and the Policy on the Minimum Norms and Standards for Student Housing at Public Universities . c) The value of infrastructure needs to be optimised i.e. the cost of the infrastructure provided to achieve the U niversity’s objectives and service standards should be minimised, whilst also considering environmental, social and economic impacts . d) Infrastructure needs to be used efficiently and reconfigured or, where practical, disposed of if it does not support the university’s objectives . e) Infrastructure needs to b e maintained and operated in such a way as to minimise life - cycle costs . f) Where possible, changes in demand for infrastructure need to be met with solutions which do not require the acquisition of new infrastructure, taking into consideration the university’s whole portfolio (for example, m aximising the use of existing facilities, or reconfiguring them, rather than building new ones , considering sharing expensive specialist facilities between universities and leasing of existing infrastructure ) . g) Risks relating to the ownership , use and operation of infrastructure need to be managed as follows : • t he possible consequences of failure of infrastructure needs to be identified and mitigated in a cost - effective manner ; • c ritical infrastructure should be identified using a risk - based approach by assessing both the probability of failure and the potential impact on the University’s operations ; • h igh risk infrastructure needs to be prioritised, especially if this is potentially life - threatening or poses a risk to the achievement of the U niversity’s core objectives ; and • t he U niversity’s liability in the event of infrastructure - related claims needs to be minimised.
University of the Western Cape Infrastructure Management Policy 10 • Appropriate and continuing investment in bulk services infrastructure (water, electricity and fire) h) T he University’s infrastructure should be a ccessible, energy - efficient, water - efficient and sustainable . i) Designs need to consider optimal flexibility of use . j) All infrastructure needs to be registered in an infrastructure asset register and linked into the University’s accounting system 1 . The infrastructure asset register should include information such as: • d ate of capitalisation and total acquisition cost ; • o wnership of land, registration, location ; • i nfrastructure identification (including location) ; • i nfrastructure expected useful life and remaining useful life ; • i nfrastructure condition ; • i nfrastructure value (based on Depreciated Replacement Cost) ; • i nsurance if applicable ; • d ates and costs of repairs, upgrades, replacement and disposals ; and • l easing information . k) There needs to be periodic condition assessments of infrastructure, the results of which need to be captured on the infrastructure asset register and used to inform infrastructure plans and budgets . l) There needs to be a periodic assessment of the levels of performance and service that infrastructure delivers, and these should be analysed against the requirements and expectations of users . m) There needs to be a system or process for prioritisation of repairs . n) There needs to be a system for handling of complaints and responding to requests from infrastructure users, which should include standards for reasonable response times . o) There needs to be consultation with relevant stakeholders regarding infrastructure plans. p) The re needs to be ongoing consideration of rapidly evolving technologies (4IR, Smart Buildings etc) and these must be considered in the design , upgrading and utilisation of infrastructure . 1 The Higher Education Act states that the Council of a university must keep complete accounting records of all assets.
University of the Western Cape Infrastructure Management Policy 11 Annex ure B: Universal s patial planning principles The development of a guiding s patial f ramework (Campus Development Plan) for a university gives form, content and meaning to the physical requirements. The design of university campuses should define and celebrate the U niversity’s sense of place, communicating the institution’s purpose, presence and peculiar identity. The influences determining form are multi - faceted and complex. Nevertheless, the following universal design principles have relevance in developing and shaping the U niversity campuses and should inform and be applied in varying forms . 1) Equity and dignity E quity does not imply that everything should be the same. Rather, it refers to equity of access - all people should have the opportunity to access a broadly equivalent set of opportunities. Accordingly, equity of access in a spatial context implies commitment to a movement system anchored by the lowest common denominator , namely people on foot. This requires: • t he promotion of principles of universal access ; • the e stablishing of a network of shared amenities accessible to all students across university campuses ; • e stablishing a balanced movement network, allowing for equitable access to the U niversity by public transport, non - motori s ed transport , pedestrians and private vehicles ; • a commitment to the promotion of pedestrian, non - motori s ed transport and public transport over private vehicular movement ; • t he promotion of pedestrian priority ; and • the d eveloping of non - obtrusive parking strategies. The University is populated by students from many different walks of life. Accordingly, a basic right of all students is to meet in dignified public spaces which are ‘owned’ by all, regardless of personal circumstances. Spatially, the emphasis is on creating dignified places for informal meeting , using all new buildings and objects to define and make space , using selective, powerful landscaping in different ways to define place, to create shade and shelter and to reinforce structural informants. 2) Integration Integration refers to the U niversit y as an institution committed to being place - bound . This is based on a recognition that an increased sense of belonging results in an increased sense of purpose. This has several spatial implications as it; • places gr eat importance on place - based research ; • emphasi s es the need to undertake outreach activities in local communities ; • underpins a need to engage with the host cities / towns , surrounding communities and institutions ; and • i mplies that the University need s to become good neighbo u rs and as such tak e an active interest in their s urroundings on an academic, community and spatial level.
University of the Western Cape Infrastructure Management Policy 12 The promot ion of integration in a society historically obsessed with separation is an important issue to address . Such integration should includ e : • i ntegration with the host - city / host - towns or surrounds ; • i ntegration of m odes of m ovement ; • s ocial and cultural i ntegration ; • i ntegration in s port ; and • a cademic i ntegration . 3 ) Quality of shared/common spaces Any plan for the U niversity needs to consider place making i.e. the creation of a sense of spatial uniqueness and identity. An important part of this is developing an appropriate response to the site. The spatial implications of this include working with the land , working with water , use of landmarks and the appropriate use of indigenous vegetation. The aim of all universities should be to promote a holistic teaching and learning environment, as opposed to just a classroom - based one. Central to this is recogni s ing the importance of informal mixing and social contact between students of diverse disciplinary backgrounds as part of the total educational experience. The implication of this from a spatial perspective is the creation of dignified, pleasant places of meeting in the public realm. A variety of shared spaces should be offered, which represent t he primary informal gathering or meeting spaces for students, staff and residents alike. The dignity of these places will impact on the dignity of the university campuses. Safety and s ecurity and heritage considerations need to be taken into account in the creation of these common spaces. 4) Robustness and flexibility The s patial framework needs to be strong enough to give clear direction yet sufficiently minimalist to accommodate growth and change. P lan ning cannot be driven by programmes - it needs to be based on the elements of public structure i.e. green space, movement of all modes, shared public facilities (libraries, meeting places, sports facilities and recreation, performance and display spaces), hard open space, housing and utility services. These need to be woven together into a coherent framework which creates a logic of access, ranging from very public or exposed to very private. Planning needs to reflect a consistency of thought across scales which requires a ‘package of plans’ approach, with each larger scale providing the fixes for successively smaller scales. Connecting scales and integrating city activities is an important part of the challenge. 5) Phasing and implementation strategies The underlying principle when addressing phasing for campus projects with the larger overall university land is to ensure that each implementation creates its own urbanity and sense of identity right from the start. The aim of campus spatial frameworks should be to establish a microcosm of the completed n ew u niversity c ampus from day one. The phasing pattern focuses not on buildings and
University of the Western Cape Infrastructure Management Policy 13 infrastructure alone, but on establishing complete public spaces. Phasing in this manner reduces large infrastructural costs. 6 ) Sustainability and efficiency Decisions taken in relation to the location, design and management of the institutions need to be geared towards optimal sustainability. The university campuses should play a leadership role in demonstrating sustainable practices . The Universit y should demonstrate best practice in terms of a broad spectrum of environmental and sustainability including efficiency of land utili s ation. The academic vision and the spatial directions of universities should be considered as complementary and synergistic. Direction should accordingly be derived from: • i nterrogating the U niversity’s mission statement , which provides the highest order of direction for the spatial development plan, to explore the spatial implications of the academic mission ; • i dentifying the desirable performance qualities which a university in South Africa in the 21 st century should be seeking to achieve which have spatial implications; and • a comprehensive understanding of the contextual informants (the concrete things which have material substance, shape, topography, environmental character, climate, texture, as well as socio - economic features) which embody very different properties, in accordance with the unique cultural and environmental conditions of the place within which the U niversity campus is located . Academic vision for a particular campus can also have spatial implications for in the creation of: • living and working environments of a quality that attracts and retains world renown academics; • a dequate library, student resource amenities , student accommodation with meals and self - catering and IT facilities . The method employed in the development of spatial plans needs to elevate planning and design from opinion to argument in order to seek sufficient consensus around the desired norms and their spatial implications.
University of the Western Cape Infrastructure Management Policy 14 Annexure C: Infrastructure planning principles I nfrastructure projects are identified, planned and costed , as relevant, by: a) o btaining and considering the expectations and requirements of stakeholders in the U niversity ; b) d etermining appropriate levels of service and identifying the infrastructure required to meet this level of service and to achieve the U niversity’s strategic objectives ; c) e stablishing an infrastructure baseline by reviewing existing infrastructure assets, including the identification of mission - critical assets ; d) a ssessing existing infrastructure assets in terms of their efficiency of use, and proposing improvements ; e) i dentifying any gaps between the existing infrastructure and the required infrastructure ; f) c onsidering all possible ways of meeting the gaps, such as building new infrastructure, renting infrastructure, utilising existing infrastructure more effectively, reconfiguring existing infrastructure or sharing infrastructure with other institutions, to d etermine the best solutions to the gaps ; g) taking a ‘whole - portfolio’ approach when considering options for addressing gaps , enabling all available options to achieve the required levels of service to be considered , ensur ing the provision of infrastructure at the lowest life - cycle cost ; h) a nalysing asset management information ; i) d etermining the functional requirements and required level of service for new infrastructure and applying the space and cost norms to the needs for new infrastructure ; j) c omparing the needs against the budget, and prioritising in terms of this policy if the needs exceed the budget ; and k) p lanning for capital projects taking into account the operation and maintenance of the infrastructure for its entire estimated design life after it has been constructed. l) Integrating sustainability principles and strategies into all projects m) Future proofing all projects, as far as it is practical and cost - effective, against changes in the environmental (e.g. climate change), technological (e.g. 4IR) and regulatory spheres. Adequate access control and monitoring infrastructure needs to be put in place to provide a safe environment for the University community. Credible forecasts of the current and net demand for services or requirements for functionality should be made over a period of not less than ten years.
Research Policy Section 9: Research Ethics Policy
Council revision C2020/04, version 2, 26 November 2020. The C2025/03 consolidation retains the 2020 amendment date for Section 9.
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UNIVERSITY of the WESTERN CAPE RESEARCH POLICY SECTION 9 : RESEARCH ETHICS POLICY UNIVERSITY OF THE WESTERN CAPE RESEARCH POLICY … Section 9: Research Ethics Policy Council Approval Reference Number C2009/04 Implementation Date 26 November 2009 Revision / Amendment Number C2020/04 version 2 Revision / Amendment Date 26 November 2020 2 Nov ember 2019 Policy Owner Department for Research Development Executive Management Portfolio DVC (RI) Contributors Faculties Circulated by: Department for Research Development Circulated to: SR (10 Nov 2019), (14 July 2020), (12 Aug 2020)
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers TABLE OF CONTENTS 1. Foreword 2. Preamble 3 . Application 4 . Structure and Governance of Research Ethics Committees 5 . Institutional Bio - safety Committee 6 . The Administrative Responsibility of the University 7 . Legal and Ethics issues 8 . Selection and Conduct of Resear ch 9 . Guiding Principles 9 .1 Beneficence and Nonmaleficence 9 .2 Informed consent 9 .3 Confidentiality 10 . The Duty of Honesty and Integrity 11 . Safety of Researchers 12 . Experimental therapies 13 . Photography for Research 14 . Data Protection Policy 1 5 . Environment 1 6 . Biohazards 17 . Acknowledgement of University 18 . Disputes between Co - researchers 19 . Disciplinary action Appendix A: Code of Conduct for Research Appendix B: Guidelines for Experimental Therapies Appendix C: Guidelines for Clinical Photography Appendix D: Proposed procedure for Consent for Clinical Photography Appendix E: Example of Co nsent Form
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers Appendix F: Conflict of Interest Disclosure Form Appendix G: Useful Additional Material SECTION 9: RESEARCH ETHICS POLICY I. II. 1. Foreword to the UWC Research Ethics Policy a. In general terms, research includes a wide range of activities conducted by many different disciplines that may use different methodologies and explanatory frameworks. In the physical and biological sciences , research may be described as a systematic study or inquiry, usually using quantitative data, in seeking generalisable new knowledge. Health - related research is increasingly also using qualitative methodologies. The humanities, social and behavioural sciences use both qualitative and quantitat ive methods and analytic frameworks, all of which may be aimed at contributing to knowledge about the human condition in its environment and context. b. The statutory definition can be interpreted as having a wide or a narrow meaning. Many researchers, especially those who work in the humanities and social and behavioural sciences, may find the statutory definition of ‘health research’ to favour biomedical research. In particular, they may perceive that the so - called ‘medical model’ for ethics review dominates and is applied frequently but inappropriately to social science, especially qualitative research . c. These guidelines do not advocate the so - called ‘medical model’ of ethics review, especially not for social science, behavioural or humanities research . For purposes of this document, ‘health research’ has both a broad and narrow meaning. In the narrow sense, it refers to research carried o ut in a health care environment, usually with patients, whether in a hospital, clinic or home - based. In the broad sense, it refers to research conducted outside a health care environment, usually not with patients. d. The core ethics principles outlined in these guidelines apply to all forms of research that involve living human participants and use of animals, placing their safety, welfare and interests of both humans and animals * as paramount . The principles also apply to research that i nvolves use of human biological materials and data collected from living or deceased persons, including human embryos, fetuses, fetal tissue, reproductive materials, and stem cells. i. *live, sentient non - human vertebrate, including eggs, foetuses and embryos, that is; fish, amphibians, reptiles, birds and mammals, and encompassing domestic animals, purpose - bred an imals, farm animals, wildlife # and higher invertebrates such as the advanced members from the Cephalopoda and Decapoda 2 ii. # wildlife : indigenous or non - indigenous self - sustaining species of animals, whether domesticated or 2 e. These guidelines express the view that the core ethical principles apply to all forms of research that involve humans or use of animals, insofar as the welfare and safety interests of both humans and animals are paramount . Health and safety issues include those that may arise in the environment of research e.g. viruses, parasites, bacteria, as well as the air, water and land.
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers Research usually excluded from ethics review: ● Research that relies exclusively on publicly available information or accessible through legislation or regulation usually need not undergo formal ethics review. This does not mean that ethical considerations are irrelevant to the research. ● Rese arch involving observation of people in public spaces and natural environments usually need not undergo formal ethics review, provided that the researcher does not interact directly with individuals or groups the researcher does not stage any intervent ion the individuals or groups do not have a reasonable expectation of privacy dissemination of research findings does not identify individuals or groups. ● Research that relies exclusively on secondary use of anonymous information or anonymous human biological materials usually need not undergo formal ethics review, provided that no identifiable information is generated. ● Quality assurance and qua lity improvement studies (audits), programme evaluation activities and performance reviews usually do not constitute research and thus usually do not undergo formal ethics review. It should be noted, however, that if publication of such studies is desi rable, it is prudent to obtain ethics approval before the study begins. RECs may not grant retrospective ethics approval . Low Risk Studies 3 ➢ L ow risk research can be defined as “research where the only foreseeable risk is one of discomfort”. Discomfort may include , but not limited to, minor side - effects of medication, discomfort related to measuring blood pressure or anxiety induced by an interview. Where the risk, even if unlikely, is more serious than discomfort, the resear ch is not low risk. ➢ R esearch can be described as negligible risk where “there is no foreseeable risk of harm or discomfort; and any foreseeable risk is not more than inconvenience.” The above is taken from the guidelines “Ethics in Health R esearch: Principles, Processes and Structures (2015), produced by the National Health Research Ethics Council (NHREC) Working Group for Norms and Standards (mandated by Section 72 of the National Health Act 61 of 2003). The guidelines are an updated and st rengthened revision of the first edition of the Guidelines issued in 2004. The 2015 1 Guidelines aim to ensure that, in South Africa, research is conducted responsibly and ethically. 2. Preamble This Policy was adopted with due consideration to relevant national documents, including the Constitution of South Africa and also reflects engagement with the Ethics Policy Documents of the University of KwaZulu - Natal. The University of the Western Cape is concerned with protect ing the rights, dignity, safety and privacy of research subjects, the welfare of animals and the integrity of the environment. It is also concerned with protecting the health, safety, rights, and academic freedom of researchers and the reputation of the Un iversity as a centre for high - quality research. With this in mind, the University has developed a Research Ethics Policy that aims to govern the ethics of research across the University, and to promote awareness of the highest ethical standards, principles and issues in the conduct of research activities thereby clarifying for researchers their ethical obligations. The vision, principles and core values of the University are based on it’s commitment to the principles and values enshrined in the Constitution of South Africa. Against this context therefore, this Research Ethics Policy has been developed as the ethics framework for the University community to be considered as part of the research process at all
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers levels of research activity by undergraduate, postgraduate, postdoctoral and members of staff across the University. All research will have ethics implications; however , there are some areas of research where the ethics implications will be particularly important. The following is not an exh austive list, however some examples of such areas of research are: where it involves human subjects (particularly children and vulnerable adults); where it uses human data or human material; where there are serious health and safety implications; where ani mal experiments are involved; where there is a risk of damage to the environment; where the impact of the research may be emotionally damaging; where the research is politically or socially sensitive; where the source of funding for the research has the po tential to compromise the University’s position as a publicly funded charitable body. This Policy aims to promote awareness of and compliance with ethics principles, guidelines and procedures in the conduct of research activities, thereby cl arifying for researchers their ethic s obligations. The vision, principles and core values of the University are based on commitment to the principles and values enshrined in the Constitution of South Africa, with particular reference to the Bill of Rig hts, Section 12. (2) (c), regarding free, informed consent . This Policy should be interpreted accordingly. The University is committed to upholding the highest ethic s standards in a research community that is committed to the principles of integrity, trust, collegiality and justice. This Policy is an explicitly stated ethic s framework for the University community within which all research should be conducted, while being mindful of the goal of developing an enabling environment for all learners and scholars in the pursuit of their studies in accordance with the principles of academic freedom. 3 . Application This Policy on Research Ethics applies, but is not limited to, all members of staff, visiting researchers, those with honorary posts, and postdoctoral, graduate and undergraduate students who are involved in research on or off the campuses of UWC. In addit ion, any person not affiliated with UWC who wishes to conduct research with UWC students and/or staff is bound by the same Research Ethics policy. Each member of the University community is responsible for the implementation of this Policy in relation to s cholarly work with which she or he is associated and to avoid any activity which might be considered to be in violation of this Policy. 4 . Structure and Governance of Research Ethics Committees (RECs) 4 .1 Researc h falls into the portfolio of the DVC ( Research and Innovation ), and she/he as such will be responsible for developing, operating and reviewing policies and guidelines which prevent unethical practices, and which are consistent with recognized standards and best practice. 4 .2 The University has t hree specialist research ethics committees (RECs): the Animal Research Ethics Committee (AREC), the Humanities and Social Sciences Research Ethics Committee ( HSSREC ) and the Biomedical Research Ethics Committee ( BMREC ). They function directly under the auspices of the University Senate Research Committee
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers (SR) where their respective Chairs have representation and are responsible for effecting ethics approval of research proposals. Other special ist committees may be created by the SR when the need arises. 4 .3 Review of research proposals considers academic freedom and its responsibilities while providing accountability and quality assurance to scholars and society in general. Such review a lso provides assurance that, where relevant, the environment will not be damaged and indeed be protected and maintained to the best of the researcher’s ability. Research - related documents will be treated in the strictest of confidence. Any requests for rev iew of these documents outside the respective Committees will have to be forwarded to the appropriate Committee Chair for authorisation. Each specialist Research Ethics Committee functions in accordance with Terms of Reference and comprehensive Standard Op erating Procedures that have been approved by the Senate Research Committee, which in turn is accountable to Council . 4 .4 Research where the biological, clinical, psychological and social processes in human beings and animals are studied and/or wher e harm or damage to the environment is a possibility, requires ethics review and clearance prior to commencement of the project and in particular prior to field work and/or data collection. The researcher is responsible for consulting with the appropriate Committee Chair(s) to ascertain whether the proposed research requires ethic s clearance or not . 4 .5 All masters and doctoral and where appropriate, honours students, members of staff and other persons who, although not affiliated to the University but are involved in research at/or in association with the University, must familiarize themselves with and sign an undertaking to comply with the University’s “Co de of Conduct for Research” (Appendix A) and the Singapore Statement on Research Integrity (2010). This undertaking should be signed by masters and doctoral students at registration, and by staff as part of the staff appointment process. 5. Institution al Bio - safety Committee (IBC) The US National Institutes of Health (NIH) Guidelines require that an Institutional Biosafety Committee (IBC) be established to screen research proposals involving recombinant DNA molecules. This is not only mandatory for institutions seeking National Institute of Health (NIH) funding , but it is also critical to the safe conduct of research involving recombinant DNA molecules and to the fulfillment of an institutional commitment to the protection of staff, the enviro nment, and public health. 6 . The Responsibility of the University The University will facilitate the ethical conduct of scholarly research by developing and providing capacity building programs in research ethics for researchers and members of the Research Ethics Committees. Formal ethics certification is required of all researchers conducting research at or in association with the University, through a process of research ethics education, testing and certification. The DVC ( Rese arch and Innovation ) will ensure that development and implementation of the training programs and the certification process proceeds. The University takes responsibility to ensure that all laboratories and other physical resources for research are maintained and , where applicable, meet all necessary accreditation requirements to allow for ethical and effective research.
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers The necessary administrative support to the RECs and IBC for the implementation of policies and procedures will be provided via the Department of Research Development . The Department of Research Development will oversee and manage the administrative aspects of the research ethics portfolio. It is the responsibility of the DVC ( Research and Inno vation ) to ensure adequate administrative infrastructure to provide support to the following Ethics Committees and the Institutional Bio - safety Committee: - Animal Research Ethics Committee (AREC) - Humanities and Social Sciences Research Ethics Committ ee (HSSREC) - Biomedical Research Ethics Committee ( BMREC ) - And any other specialist university - wide sub - committees established in terms of the constitution by the DVC ( Research and Innovation ). All applications for ethics approval are to be fo rwarded for processing to the Department of Research Development . 7 . Legal and Ethics Issues In cases where an approved, registered UWC research proposal or project is legally challenged, the University must provide the following support based on the Wigmore criteria 4 : ‘The researchers will do everything possible to maintain the confidentiality of information obtained during the study and the anonymity of the sources. If an order is made by a court that the researchers provide information or reveal the identity of their sources, the University will provide legal representation until all available court processes have been exhausted to assist the researchers to maintain confidentiality of information and sources. Even then, the researchers will not reveal any confidential information and will never do so unless they believe it is ethically proper, considering the circumstances, to reveal the information.’ 8 . The Selection and Conduct of Research 8.1 . The choice of a research topic and the conduct of research in accordance with University policy is the responsibility of the individual researcher. In addition to this policy, other UWC policies, regulations or guidelines and other professional codes may apply where appropriate . 8.2 . Where collaborative or team research is being conducted, the Principal Investigator is obliged to ensure that all members of the research team are aware of the contents of this Policy and of other applicable ethical norms governing the conduct of research. The Principal Investigator should take all possible steps to ensure that the provisions of this Policy are complied with by the research team. 8.3 . Where research is to be conducted by students for academic credit, the supervisor will inform the student of her/his obligations i n respect of the ethical conduct of research. In addition, the supervisor will ensure that the student understands her/his obligations in accordance with the University Research Ethics Policy and will take all possible measures to ensure that the student’s research is conducted in accordance with the provisions of this Policy, and with other applicable ethical norms, and that the student has signed the Code of Conduct for Research (Appendix A – section 8) .
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers 8.4 . The supervisor will maintain a record of all research projects undertaken, together with the appropriate ethic s approval documents . 9 . Guiding Principles Research should be undertaken in accordance with commonly agreed standards of good practice, such as those laid down in the Declaration of Helsinki, as follows: ● Beneficence – ‘do positive good’ ● Non - Maleficence – ‘do no harm’ ● Informed consent ● Confidentiality/Anonymity ● Veracity ‘truth telling’ 9.1 Beneficence and Non - Maleficence 9.1.1 Concerns risk(s), harm and hazards, and includes emotional and mental distress, damage to financial and social standing , as well as physical harm. 9.1.2 The research should be scientifically sound and the purpose should be to contribute to knowledge. 9 .1.3 . The research should be undertaken and supervised by those who are appropriately qualified and experienced. 9.1.4 The importance of the objective should be in proportion to the inherent risk to the participants. Concern for the interests of th e participants must always prevail over the interests of science and society. 9.1.5 The research should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the participants or to others. 9.1.6 Research should not be undertaken where the hazards involved are not believed to be predictable. 9.1.7 Adequate facilities and procedures should be in place to deal with any potential hazards. 9.2 Informed Consent Ethically, informed consent is part of the principle of respect for autonomy. Rights of self - determination and “not to be harmed” are implicit in the South African Constitution. Furthermore, the Department of Health makes clear that the primary consideration in any research within health and socia l care is preserving the dignity, rights, safety and well - being of participants and that informed consent is at the heart of ethical research 1 .
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers 9.2.1 Each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the research and any discomfort participation may entail. 9.2.2 Any documentation given to potential participants should be comprehensible and there should be an opportunity for them to raise any issues of c oncern. 9.2.3 Consent should be required in writing and records of consent should be maintained. 9.2.4 Potential participants must be informed that they are free to withdraw consent to participation at any time. 9.2.5 There should be a procedure f or making complaints and participants should be made aware of this. 9.2.6 All participants should be volunteers. Considerable care should be taken where consent is sought from those in a dependent position and it should be made clear that refusal to pa rticipate will not lead to any adverse consequences. For example, students must be assured that any decision not to participate will not prejudice, in any way, their academic progress. 9 .2.7 Any inducement offered to participants should be declared and should be in accordance with appropriate guidelines. 9. 2.8 Specialist advice and appropriate Research Ethics Committee (REC) approval should be sought where consent cannot be obtained. 9.3 Confidentiality 9 .3.1 When personal identifiers are used in a study, researchers should explain why this is necessary and how confidentiality would be protected. 9 .3.2 Procedures for protecting the confidentiality of participants should be followed and include: ● securing individual confidentiality statements from all research personnel; ● coding data with numbers instead of names to protect the identity of participants; ● using codes for identification of participants when transcribing audiotapes, and destroying the t apes on completion of transcription; ● storing data with any identifying information in a locked file to which only one or two persons have access; ● using pseudonyms for participants, agencies and geographical settings in the publishing of reports; ● disposing of information that can reveal the identity of participants or places carefully. 10 . The Duty of Honesty and Integrity (Appendix A – sections 4, 5, 6) 10 .1 Researchers must possess the knowledge and skills compatible with the demands of the investigation to be undertaken and must recognize and not overstep the boundaries of their research competence. Researchers should not accept work they are not qualified to carry out or supervise .
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers 10.2 Researchers are expected to maintain the highest standards of honesty and integrity. Any form of academic dishonesty, including but not limited to the following, is a serious offence: (a) Falsification of Data, Plagiarism, Fabrication (b) Non - declaration of Conflict(s) of Interest (c) Misuse of Research Funds (d) Any other form of dishonesty in research that undermines the integrity of the research and which may bring the University into disrepute . 10.3 This Policy is not intended to censure the actions of the individual who has made an honest error, or who exercises bona fide judgment, or interprets data or designs experiments in a way that may reasonably be the subject of an honest difference of opin ion. 10.4 Failure to observe the requirements of the Code may be grounds for disciplinary action under the Code of Conduct applying to University employees or under the Student Disciplinary Rules as appropriate. 11 . Safety of Researchers Research supervisors have an obligation to make students/researchers aware of potential personal risks and dangers before undertaking field work. Students/researchers are required to sign a declaration indicating their awareness of the potential dangers. Where students/researchers choose to engage in high risk research after the dangers have been identified by the supervisor, such students/researchers are required to sign an indemnity form. 12 . Experimental therapies* 12 .1 Clinicians and researchers should understand the ethical issues involved in using innovative experimental therapies and should assist patients to make decisions concerning experimental therapy that are in their best interes t, by facilitating and enhancing their capacity for decision making in accordance with their perspectives, culture and values (Appendix B) . 12 .2 Experimental therapies carried out in the University require a standardised process of evaluation and approval. This includes the consent format, indications, limitations and reporting procedures. 12 .3 Informed consent must state the nature of the experimentation and must provide the best available information, including the consensus of expertise at the institution and/or national level concerning the use of the experimental therapy, and whether alternative therapies may be available. 12. 4 Review, analysis and reporting of experimental therapy must be carried out at the e arliest possible time when data are judged to be meaningful. This includes adequate numbers (ie, three patients or more). The conclusion should be
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers anonymously available for current or future patients treated with the experimental therapy and should be repo rted to the UWC HREC. * The use of the word ‘therapy’ is synonymous for a drug, a device or a procedure. 13 . Photography for Research Purposes 1 3 .1 Photography guidelines are required to prevent breach of privacy and exploitation of researc h subjects (Appendix C). 1 3 .2 Most scientific journals require authors to obtained informed consent (Appendix D & E) from participants in order to publish their photographs. Due to varying levels of literacy and oral cultural norms, non - written cons ent methods (like audiovisual documentation of oral consent) may need to be used. 1 3 .3 Researchers, teachers and publishers should aim to show only those aspects of a photograph that are not identifiable, even if consent has been given and explore avenues of digital editing where digital images can be altered in a way that disguises the identity of the subject beyond recognition. 1 3 .4 Researchers should act as gate - keepers and protect the rights of patients in their care, and inform them and photographers of the subject’s rights to refuse and the photographer’s obligation to obtain consent, so that over time, patients will learn that they have choices, and to demand that their rights are respected. 1 4 . Data Protection Policy 1 4 .1 The collection and storage of research data by researchers must comply with the Data Protection Act of 1998. 1 4 .2 Researchers should be aware of the risks to anonymity, privacy and confidentiality posed by all kinds of personal inform ation storage and processing, including computer and paper files, e - mail records, audio and videotapes, or any other information which directly identifies an individual. 1 4 .3 Participants must be informed of the kinds of personal information which wi ll be collected, what will be done with it, and to whom it will be disclosed. ‘Consent to process’ may need to be obtained where information collected from individuals is to be used later for research purposes. 1 4 .4 Measures to prevent accidental bre aches of confidentiality should be taken (see Informed Consent section 9.2) and in cases where confidentiality is threatened, relevant records should be destroyed. 1 4 .5 Provisions for data security at the end of a project must be made. Where the res earcher leaves the University, this responsibility should usually rest with the relevant Faculty.
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers 1 4 .6 Current practice is that research data, research transcripts, videos and other related electronic data – tapes and videos should be kept for a two (2) year period after completion of the research study and hard copies of data capture sheets, questionnaires, informed consent forms, transcripts and analysis for a period of five (5) years . 15 . Environment All research must be conducted taking into account Section 24 of the Bill of Rights of the Constitution of South Africa which requires that research should not result in an environment that could lead to harm to health or well - being. The environment must be protected, for the benefit of present and futur e generations. Pollution and ecological degradation must be avoided in order to: i. promote conservation; and ii. secure ecologically sustainable development and use of natural resources while promoting justifiable economic and social development. 1 6 . Biohazards Personnel working in research laboratories at UWC must be protected from possible harm resulting from exposure to hazardous biological or chemical materials. Personnel must comply with the Hazardous Biological Agents Regulations of the Occupational Health and Safety Act No. 85 of 1993. Personnel must be appropriately trained to work with hazardous biological or chemical materials and be accredited as such. Managers of laboratories where hazardous biological or chemical material is used w ill need to inform the Occupational Health and Safety Practitioners on their campuses . Appropriate safety measures must be established for the use of hazardous materials in each laboratory. 1 7 . Acknowledgement of University and Other Suppo rt of Research Research support by the University or any other body must be appropriately acknowledged in any publication resulting from the research. (Appendix A – section 4.4) 1 8 . Disputes between Co - researchers Disputes between co - researchers must be resolved in accordance with existing University policies on dispute resolution. Alternative dispute resolution mechanisms such as mediation and arbitration must be resorted to prior to any litigation. The University Human Resources D epartment may be contacted in this regard. 1 9 . Disciplinary Action In the event of a researcher contravening the research ethics principles and practices as espoused in this Policy any necessary disciplinary action will be dealt with by the University’s existing disciplinary structures. The Senate Research Committee will recommend appropriate penalties such as loss of ethics certification or eligibility for funding.
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers APPENDIX A: CODE OF CONDUCT FOR RESEARCH 1. General 1.1 Guiding principles The pursuit of knowledge is the pursuit of truth. It is to be carried out with: ● Honesty and integrity ● Safe and responsible methods ● Fairness and equity for the participants 1.2 Requirements for observance This code applies to all individuals participating in research under the auspices of the University. This includes: ● Academic Staff ● Post - Doctoral Fellows ● Professional Support Staff ● Staff providing technical or administrative support for research activity ● Staff employed through research grants or contracts administered by the University ● Staff of research Institutes, Centres and Units ● Graduate or undergraduate students participating in research ● Any other individuals, such as honorary and extraordinary appointees , and visiting researchers making use of any University resource All researchers working at UWC must complete a statement confirming that they are familiar with the Code and undertake to observe it. Contracts of affiliation between the University and independent research institutes should ensure that the independent institutes adhere to a comparable code of ethics. Where appropriate, the Code specifies formal procedures and regulations. Nevertheless, it recognise s that, in ethic s questions, it is not possible to legislate for every eventuality. The over - riding principle is an expectation of all researchers that they are expected to act with integrity in the interests of the University and to be scrupulous in con ducting their affairs. 1.3 Breaches of the code Failure to observe the requirements of the Code may be grounds for disciplinary action under the Code of Conduct applying to University employees or under the Student Disciplinary Rules as appropriate. 1.4 Advice and help Advice and help in interpreting the Code may be obtained from the Chairpersons of the current specialist research ethics committees: - Biomedical Research Ethics Committee - Animal Research Ethics Committee
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers - Humanities and Social Sciences Researc h Ethics Committee - Institutional Bio - safety Committee 2. DVC ( Research and Innovation ) Research Office The DVC ( Research and Innovation ) delegates responsibility for developing, monitoring, and maintaining all University ethics policies and procedures, including research ethics. In particular, specialist committees (listed above) are charged with the responsibility of approving and monitoring research proposals and programmes that require specific ethic s clearance. 2.1 Biomedical Research Ethics Committee All health related research involving human subjects requires prior ethic s clearance. Application must be made on the appropriate form to the Biomedical Research Ethics Committee. 2.2 Animal Research Ethics Committee Unive rsity staff intending to make any use whatsoever of animals in their work, whether in research or for teaching purposes, are required to apply to the Animal Ethics Committee for ethics clearance by submitting an application on the appropriate form . 2.3 Humanities and Social Sciences Research Ethics Committee (non - Biomedical/Health) Research involving human subjects, which is non - biomedical/health - related, requires ethics clearance from the Humanities and Social Sciences Researc h Ethics Committee. Application is to be made on the appropriate application form. 2.4 Institutional Bio - safety Committee Projects involving hazardous biological or chemical materials will be reviewed by the Institutional Bio - safety Committee in addition to the usual ethic s review. 3. Management of research data and records “Data and research records form an indispensable part of all research projects. Advances in information technology and digital science over the last few years has changed the broader research perspective, and the amount of data being generated has increase d radically. This has necessitated a need to ensure that research data is managed appropriately to guarantee accessibility and security” (Section 13, UWC Research Policy). The University is committed to openness in research. The data on which p ublished research is based must be available for evaluation by the broader research community. There will be two database registries: one for Health Research and this will be required for annual audit by the Department of Health (NHREC) and the other for a ll research being carried out in the University. Agreements, under which data is kept confidential for a period in order to protect intellectual property rights, must conform with this Code. 4. Publication 4.1. General The University encourages the widest dissemination of research results by appropriate publication. Pressure to publish is a modern fact of academic life with a strong bearing on the career and standing of the researcher. It is important that this pressure does not lead to ethical problems. S uch problems are generally related to one of three causes: ● Failure to give appropriate credit to the work of others.
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers ● Taking more personal credit for collaborative work than is justified by one’s contribution. ● Overuse of a limited body of work to provide more publication credit than is justified. The guidelines that follow cover many aspects of publication but cannot cover every eventuality. Researchers should always satisfy themselves that (i) they have given full credit to the work of others, whether by citation, acknowledgement, or co - authorship, (ii) that they are prepared to take responsibility for all aspects of collaborative work, and (iii) that the work that they are submitting for publication is original and worthy of publication. 4.2 Open Access Publication ● UWC is a signatory of the Berlin Declaration on Open Access to Knowledge in the Sciences and Humanities . As a signatory to the Declaration, UWC has committed itself to adopting and promoting an "open access paradigm" with regard to the management and dissemination of the knowledge it produces. The UWC Open Access Policy (Section 11 of the Research Pol icy) outlines the responsibilities of UWC researchers, both staff and students as creators of original scholarly research, with regard to the depositing of their scholarly research outputs into the UWC Research Repository and therefore their contributi on to facilitating open access to their scholarship . 4.3 Authorship The principles in this section of the code are based on part of the Vancouver Protocol , originally developed at a meeting in Vancouver by a group of editors of medical journals. Many of the principles of the Vancouver protocol are of wider application. III. Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content. IV. One or more of the authors, as corresponding author, should take responsibility for the integrity of the work as a whole. V. Credit as an author should be based only on participation in each of the following aspects of the work: ● Substantial contribution to conception and design, or acquisition of data, or analysis and interpretation of data. ● Either drafting the article or commenting critically on the draft. ● Approving the final version, to the extent that each auth or is prepared to take joint responsibility for it. VI. The acquisition of funding, the collection of data, or the general supervision of the research group, do not, by themselves, justify authorship. Such contributions should be listed in the acknowledgement s. VII. The order of authorship should be a joint decision of the authors, decided at an early stage of drafting the paper.
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers ● In most fields of research the first author is recognised as having made the most significant contribution. This is the preferred style unless the conventions of the field of research require another ordering. ● In joint publications of a graduate student and his or her supervisor, the graduate student should be first author unless the supervisor’s contribution goes well beyond material on which the graduate student has worked. ● Where the graduate student does not publish the research material, UWC through its agents ( e.g . supervisors) may proceed to publish such work. However, t here must be due diligence in terms of informing the student that the work is to be submitted for publication and ensuring that the student has the opportunity to participate in the preparation of the manuscript. Students must be appropriately acknowledged . 4. 4 . Citation and acknowledgement It is important in all publications, including such documents as research proposals, to cite all sources properly. The form of citation is usually specified by the journal in which the article is published. Citations serve two purposes ● To direct the reader to further information. ● To give due credit to the source of ideas, quotations, or data. Any of the following require appropriate citation of the source: ● Direct quotations of published material – lo nger quotations may require a release from the copyright holder. ● The description, summarising, or paraphrasing of any previous work. ● Use of previously published data, presented in any form, such as graphs, calculations, or tables. Use of such data also r equires permission in the form of clearance from the holder of the copyright. ● Ideas that originate from other published or unpublished sources
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers 4. 5 Acknowledgement of financial support The University gives a substantial amount of support to research, indirectly by paying the salaries of researchers, and providing an infrastructure for research, and directly by grants or awards. Outside bodies provide substantial direct research support. Collaborations between researchers may lead to indirect support for a research publication from several different institutions. It is important that all such support is appropriately acknowledged: 4.5.1. Direct acknowledgement of the University’s indirect sup port through salary or basic infrastructure is not necessary but any papers resulting from such support must give the University’s address as the author address ● The author address shall be the University address for work done entirely while an author is a t the University. This applies even if the paper has been published after the author has left the University. ● If the work has been done at more than one institution then the addresses of each institution should be used as the author address, either as alt ernate addresses, or with the main address being that of the institution at which most work was done and a footnote for the addresses of other institutions. ● University staff are paid and get other benefits during sabbatical leave. The author address for w ork done while on sabbatical leave should include the University address. 4.5.2. Direct support for research in the form of grants should be acknowledged at the end of the paper in the form required by the grant - giving body. ● University productivity awards and s imilar university funding need not be acknowledged specifically. 4.6. Peer review The world of academic publishing is dependent on the willingness of researchers to give freely of their time to referee papers submitted to journals and to recommend on their publication. The University encourages its members to participate in this process. Such refereeing is done under conditions of confidentiality and is privileged. Referees should be meticulous about all the following: I. Referees undertake to complete t heir work expeditiously. If they cannot complete the review in a reasonable time they should ask the editor to select another referee. II. No use should be made of any of the ideas or results in the work under review until it has been published. III. Care should be taken to avoid a conflict of interest. If the referee is following a very similar line in his/her own work the work under review should in no circumstances be held up. If the referee is in any doubt of his/her impartiality, the work should be returned t o the editor with the request that another referee be found. IV. It is acceptable to consult a colleague for technical advice, provided that there is agreement that this is done on the same basis of confidentiality as is required of the referee. Such consulta tion should be disclosed to the editor.
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers 4.7. Redundant publication Redundant publication is the unnecessary publication of similar material in different places: I. Publication of the same, or substantially the same, article in different places is not acceptabl e. This does not prevent the later reprinting of an article for a different readership or in an edited compilation by agreement with the editor(s) or publisher(s) involved. II. Researchers should consider carefully the most effective way to publish a particul ar research result or set of research results. This should be done with regard to the best way to communicate the results and not to maximise the publication count. III. The release to the media of research results that have not been peer reviewed is not accep table. Generally, research results should always be published in a peer - reviewed journal before being released to the news media. In the case of very important results, and with the concurrence of the editor of the journal in which they are to be published , such results may be released to the press in advance. This does not prevent the publication of news items about ongoing research, or about problems that are being investigated, provided that these are not used as the medium for the release of new finding s that have not been peer reviewed. 4.8. Plagiarism Plagiarism is the unattributed and uncredited use of the ideas and work of others, whether this is in published work or in unpublished documents. It is not just the word - for - word reproduction of the work of another without attribution. Such reproduction certainly constitutes plagiarism and may also be an illegal breach of copyright, but plagiarism is also the use in any form of another’s original ideas without attribution. There is a range of culpability. As ideas become absorbed into common knowledge, it may become difficult to determine their source. For this reason the highly publicised cases tend to be concerned with the direct reproduction of another’s work as one’s own. Nonetheless, researchers must c ontinually be alert to the possibility that they may be unconsciously using the ideas of others. Care must be taken therefore to acknowledge all sources. 4.9. Predatory Academic Practices Publication in predatory journals compromises the creation and dissemination of rigorous scientific and scholarly work 5 . Research done at the UWC must be published in journals with a rigorous peer review system or scholarly publishing practice. Publication in the so - called “predatory journals” is neither supported nor encouraged and citation of articles in predatory journals should be avoided 5 . NRF Statement of Predatory Publications (2017) ● The National Research Foundation (NRF) of South Africa’s peer review and adjudication system has ide ntified a number of instances where applications for research grants, scholarships and NRF rating include publications in predatory journals or cite invitations by deceptive publishers to serve on editorial boards of journals. ● This practice is neit her supported nor encouraged by the NRF as it challenges the integrity of the NRF’s scientific peer review process. The use of predatory journals and deceptive
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers publishers compromises the creation and dissemination of rigorous scientific and scholarly work within the Digital and Open Access movement. DHET Research Output Policy (2015), Section 52: ● Only articles published in approved scholarly journals are subsidized by DHET. DHET will determine, in consultation with the sector, which li sts of accredited journals and indices are approved. 4.9.1. Publication with Predatory Publishers Predatory publishing exploits the principles of Open Access by profiting from a researchers' need to publish and distribute their research. These publishers often charge lower article processing charges (APCs), provide little or no peer review, and promise remarkably short publishing times. One of their key characteristics is the limited contact information provided. ( https://instr.iastate.libguides.com/predatory ) 4.9.2. Predatory Academic Conferences Predatory conferences appear legitimate, but use an exploitive business model similar to that of predatory publishers. Organisers exercise little or no editorial control over presentations and submitted papers. The involvement of prominent researchers is often claimed (us ually without their knowledge) in an attempt to boost conference attendance numbers, if the conference exists at all . ( https://academicpositions.com/career - a dvice/how - to - avoid - predatory - conferences ) 5. Research Mi sconduct 5.1 Definition of research misconduct The following definition of research misconduct is from the Federal Policy on Research Misconduct issued by the Office of Science and Technology Policy of the Government of the United States of America. The University of the Western Cape subscribes to this definition. Research Misconduct Defined Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. ● Fabrication is making up data or results and recording or reporting them. ● Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. ● Plagiarism is the appropriation of another pers on’s ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or differences of opinion. Findings of Research Misconduct A finding of research misconduct requires that: ● There be a significant departure from accepted practices of the relevant research community; ● The misconduct be committed intentionally, or knowingly, or recklessly; and ● The allegation be proven by a preponderance of evidence
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers Notes: 1. Research, as used herein, includes all basic, applied, product - related and demonstration research in all fields of research. This includes, but is not limited to, research in economics, linguistics, medicine, psychology, social sciences, statistics, and research involving h uman subjects or animals. 2. The research record is the record of data or results that embody the facts resulting from scientific enquiry, and includes, but is not limited to, research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports, and journal articles. Research misconduct as so defined is a serious disciplinary offence. It is classified as misconduct under the Code of Conduct applying to UWC employees and under the St udent Disciplinary Rules. In cases where investigation leads to a recommendation for disciplinary action, this will be taken under the provisions of whichever of these codes is applicable. 5.2 Dealing with research misconduct Research misconduct is rare. Mo st researchers operate according to the highest standards, and, as a consequence, there is generally a high level of trust between them. Individuals are naturally reluctant to entertain any suspicion about the activities of a colleague. A serious case of r esearch misconduct may lead to the end of a research career, and may reflect badly on colleagues and on the University. If suspicion does arise it can lead to considerable agony of mind on the part of a potential whistleblower in deciding how to proceed. It is important, therefore, to emphasize that the University is committed to the following principles: ● Any allegation of research misconduct must be dealt with expeditiously. If such misconduct is established there is an absolute responsibility to expose it. ● A finding that research misconduct has occurred will be dealt with openly, and all steps to correct its effects will be taken. ● The rights of any researcher accused of misconduct must be protected. ● The rights of any individual reporting suspicions of such misconduct in good faith must be protected. An individual who suspects that research misconduct may have occurred is strongly encouraged to discuss the problem in confidence, with the chairperson of the appropriate specialist ethics committee: Health Research Ethics Committee, Animal Research Ethics Committee or the Science and Humanities Research Ethics Committee, who will confidentially provide counseling to determine whether the concerns fall w ithin the definition of research misconduct. Because the consequences of research misconduct are so severe, there are several stages in the process for investigating it: 1. Should an individual believe that research misconduct may have occurred the facts sh ould be reported to the Deputy Vice - Chancellor responsible for research ethics. 2. In consultation with the Human Resources Department and the University Proctor, as appropriate, the Deputy Vice - Chancellor ( Research and Innovation ) shall, without
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers delay, appoint a committee of investigation to establish the facts of the matter and to recommend whether there is a prima facie case to be answered. The committee shall: - Inform, in confidence, those directly affected by the investigation of its nature. T his will include the appropriate line manager, or supervisor of the individual involved. - Conduct an investigation to establish the facts. - Report to the Deputy Vice - Chancellor ( Research and Innovation ) within one month of establishment of the co mmittee. This should either be a final report or a motivation to extend the investigation for a limited period. - The final report shall recommend: ● Whether there is a prima facie case for disciplinary action. ● What immediate action, if any, must be taken to rectify any irregularity. Full details of such action shall be made available to all interested parties inside and outside the University, either immediately, or, if necessary, after the completion of a disciplinary case. 3. On receiving the report, the Depu ty Vice - Chancellor ( Research and Innovation ) will, without delay, take appropriate action, based on the recommendations of the committee, referring the matter for disciplinary action, if necessary. 4. After the completion of any disciplinary case a full report of the facts of the case and the actions that have been taken to rectify the situation will be documented. The decision to make these findings public will rest with the Deputy Vice - Chancellor responsible for research ethics. 5. All steps will be taken to protect the interest of bona fide individuals reporting misconduct. 6 Conflict of interest and conflict of commitment The University encourages its members to interact with the wider community, by undertaking sponsored research, consulting, and engaging in other activities, which may benefit the University, the public, or the individual. Such activities must be consistent with principles of openness, trust, and free enquiry. In such activities it is sometimes difficult to reconcile the responsibi lity of the individual to the University and to the external organisation. The guiding principle is that each member of the University has a commitment to act in the best interests of the University, and must not allow external activities or financial inte rests to interfere with that commitment. 6.1 Conflict of Interest A conflict of interest occurs when a member of the University has an opportunity, whether real, potential, or perceived, to place his or her personal interests, or the interests of external organisations, ahead of the interests of the University. In the academic environment there are many opportunities for conflicts of interest to occur. Not all can be covered by formal procedures. All members of the University are expected to conduct their a ffairs in such a way that they can stand close scrutiny and are in accordance with scrupulous ethical and moral standards. In cases of doubt, advice should be sought before proceeding. If a member of the University has any reason to believe that some activ ity constitutes, or has the possibility of constituting, a conflict of interest involving research, it is required that a disclosure
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers statement be lodged in the Department of Research Development . The disclosure statement (Appendix F) involves: ● A state ment of the nature of the conflict ● A proposal from the staff member of how the conflict of interest is to be managed ● A procedure for the management or elimination of the conflict agreed with the Head of School, Dean, or line manager as appropriate. This procedure may demand public disclosure, varying levels of oversight, and may include prohibition of the activity. To assist members of the University in the process for disclosure, a Disclosure Form is provided, which will also contains a check list to he lp establish the nature of the conflict. Failure to disclose the existence of a conflict of interest may constitute dishonesty in terms of the University’s disciplinary code and may lead to disciplinary action. The emphasis is on self - regulation. 6.2 Conflic t of Commitment A conflict of commitment takes place when the commitment of a member of the University to external activities affects his/her ability to meet his/her University commitments. Generally, University researchers have commitments to their teaching, their research programmes, their research supervisions, and their administrative duties. It is expected that these commitments will be fully met, not just in the formal requirements of u niversity policies and practices, but also in the spirit of the University’s vision of excellence. In undertaking external activities, members of the University should take into account the possibility of conflict of commitment. Members of the University are further required to abide by the University policy governing private remunerative work . 7 Safety The University, in common with all other organisations in South Africa, is subject to t he provisions of the Occupational Health and Safety Act No. 85 of 1993 . All questions relating to this Act and its application should be directed to the Occupational Health and S afety Manager, Risk Management Services, ext 2818. 8. RESEARCH ETHICS POLICY UNDERTAKING I ……………………….., hereby acknowledge that I am familiar with the provisions of the University of the Western Cape Code of Conduct for Research and undertake to comply with its requirements. ……………………. …………….. Signature Date Staff / Student Number: ……………….
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers Appendix B: Guidelines for Experimental Therapies Recommendations and Guidelines for University of the Western Cape Health Research Ethics Committee Clinicians and researchers should not contemplate experimental therapy and the UWC Biomedical Research Ethics Committee ( BMREC ) will not approve any protocols unless an affirmative response can be given to all of the following questions. 1. Does the applicant(s) have sufficient technical skill and experience to optimize the cha nces of success of the experimental therapy? The applicant should be able to demonstrate a comprehensive understanding of the scope of the procedure and its implications based upon research and publications. 2. Does an institutional structure exist within the host centre for integrated clinical care between teams and other clinicians required to optimise short - and long - term care? For example, all units required for optimal pre - and post - operative patient care must possess appropriate professional expertis e and explicitly agree to co - operate in the provision of ongoing support for participating patients. 3. Does a comprehensive and coherent protocol exist for the selection of suitable patients for the experimental therapy? “Suitability” will address the phys ical, psychological and social attributes of the recipient, which will not only optimise the chance of success, but also optimise the potential for giving valid informed consent for the procedure and all aspects of its outcome. 4. Does the REC protocol provide potential patients with adequate information on the basis of which valid informed consent can be given? Methods must be in place to accurately confirm understanding of the information and the sustained character of a choice to proceed. It is of p articular importance that this information should include comprehensive explanations of any known risks. It must be demonstrable that the patient understands what would be involved, both physically and psychologically in the event of failure of the therap y. 5. Does the REC protocol provide adequate information for potential patients about how little is known about some of the risks associated with the experimental therapy? This will be of particular importance for the moral and legal acceptability of any consen t that is given to proceed. 6. If required, does the clinician/researcher have integrated links with a team with appropriate psychological expertise (including psychiatrists and psychologists) to provide support adequate to ensuring that prospective patien ts can give valid informed consent to experimental therapy? For example, the team should determine that the distress of the patient about their condition will not be an impediment to their being able to understand and to weigh up the pros and cons of the e xperimental procedure thus to their being able to make a competent choice. 7. In addition to the clinician or researcher obtaining consent to the experimental procedure, are there others involved in the process of acquiring informed consent and checking un derstanding who are sufficiently independent from the team itself to ensure that they are not explicitly or implicitly influenced by any factors other than respect for and protection of the patient?
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers For example, given the understandable enthusiasm of re search teams to achieve innovative success with experimental therapy, it is essential that risks and benefits are also presented by others with demonstrable independence. Provision should be made for a dedicated program of education and assessment of u nderstanding that is presented in the protocol and which can be tailored to the needs of individual patients. 8. How will the psychological team provide long - term therapeutic support to the patient after success or potential and/or actual failure of the exp erimental therapy? Is there sufficient evidence of expertise across the team for this to be done effectively? The protocol should indicate a clear schedule of long - term care linked to the management of potential problems, observation of patients and for th e maintenance and security of records (DOH, 2015 ). 9. Can the clinical/research team, the psychological team and the host facility guarantee the long - term funding required to ensure that all patients will continue to receive the care and support specifically outlined in the protocol approved by the REC whether the experimental therapy has been successful or unsuccessful? These patients are participants in research and not conventional medical care. For this reason, long - term follow - up is essenti al to protect their best interests, but also to ensure that optimal empirical evidence about the outcome of the experimental therapy is properly collected and assessed. This follow - up care and research must therefore be dedicated, complex, lifelong and in evitably expensive. Unless the financial resources sufficient for such protection and support are identified and accepted as appropriated by the REC, the experimental therapy should not proceed. 10. The composition of the UWC HREC that considers an applicati on for experimental therapies, to ensure appropriate and representative expertise, should include experts in all areas of care including any representative organizations who provide support for such patients. These individuals should be demonstrably indep endent from the applicants proposing the experimental therapy. 11. In their deliberations about specific protocols, members of the REC should be sure that they remain independent from the interests of the institution where the experimental therapy may occur . They should equally ensure that their final decision is consistent with Paragraph 6 of the Helsinki declaration, “in medical research involving human subjects, the well - being of the individual research subject must take precedence over all other interes ts” (WMA, 2008). References World Medical Association, Declaration of Helsinki: Ethical principles for medical research involving human subjects. http://www. wma.net/e/policy/c8.htm. Last accessed 22 June 2009. Ethics in Health Research: Principles, S tructures and Processes. Research Ethics Guidelines. Department of Health, 2015 Guidelines adapted from: Morris P, Bradley A, Doyal L, Earley M, Hagen P, Milling M, Rumsey N. Face transplantation: a review of the technical, immunological, psychological and cli nical issues with recommendations for good practice. Transplantation 2007; 83(2):109 - 28.
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers Appendix C: Guidelines for Clinical Photography in Research and Teaching at the University of the Western Cape Background Ethical photography demands that anyone taking photographs of patients or subjects whether for research, clinical or teaching purposes (i) protect patient autonomy and rights (ii) protect patient data and confidentiality and (iii) preserve the integrity of patient records. These demands c omply with the requirements of the Health Professions Council of South Africa for good record - keeping. They are a demonstration of professionalism because they are virtuous aspects of clinical photographic practice, and because primarily the resultant imag e is a medical record, and any other use is subsidiary. Scope of this guidance This guidance covers all types of audio and visual recordings of patients, carried out for research, clinical, teaching or other purposes. 'Recording' in this guidance means ori ginals or copies of video and audio recordings, photographs and other visual images of patients. A 'recording' does not include pathology slides containing human tissue (as opposed to an image of such a slide). 1. Basic principles When making recordings y ou must take particular care to respect patients' autonomy and privacy since individuals may be identifiable, to those who know them, from minor details that you may overlook. The following general principles apply to most recordings although there are som e exceptions, which are explained later in this guidance. ● Seek permission to make the recording and get consent for any use or disclosure. ● Give patients adequate information about the purpose of the recording when seeking their permission. ● Ensure that pa tients are under no pressure to give their permission for the recording to be made. ● Stop the recording if the patient asks you to, or if it is having an adverse effect on the consultation or treatment. ● Do not participate in any recording made against a p atient's wishes. ● Ensure that the recording does not compromise patients' privacy and dignity. ● Do not use recordings for purposes outside the scope of the original consent for use, without obtaining further consent. ● Make appropriate secure arrangements for storage of recordings. Where children who lack the understanding to give their permission are to be recorded, you must get permission to record from a parent or guardian. When a mental disability or mental or physi cal illness prevents patients giving their permission, you must get agreement to recording from a close relative, guardian or carer. 2. Recordings for which permission is not required You do not need to seek separate permission to make the recordings listed below. Nor do you need consent to use them for any purpose, provided that, before use, the recordings are effectively anonymised by the removal of any identifying marks (writing in t he margins of an x - ray, for example):
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers ● Images taken from pathology slides ● X - rays ● Laparoscopic images ● Images of internal organs ● Ultrasound images Such recordings are unlikely to raise issues about autonomy and will not identify the patient. It may nonet heless be appropriate to explain to the patient, as part of the process of obtaining consent to the treatment or assessment procedure, that a recording will be made. 3. Recordings for which permission is required 3.1 Recordings made for the training or a ssessment of students, audit, research or medico - legal reasons You must obtain permission to make and consent to use any recording made for reasons other than the patient's treatment or assessment. 3.1.1. Before the recording, you must ensure that patien ts: I. Understand the purpose of the recording, who will be allowed to see it - including names if they are known - the circumstances in which it will be shown, whether copies will be made, arrangements for storage and how long the recording will be kept. II. Un derstand that withholding permission for the recording to be made, or withdrawing permission during the recording, will not affect the quality of care they receive. III. Are given time to read explanatory material and to consider the implications of giving the ir written permission. Forms and explanatory material should not imply that permission is expected. They should be written in language that is easily understood. If necessary, translations should be provided. 3.1.2 After the recording, you must ensure th at: I. Participants are asked if they want to vary or withdraw their consent to the use of the recording. II. Recordings are used only for the purpose for which participants have given consent. III. Participants are given the chance, if they wish, to see the recording in the form in which it will be shown. IV. Recordings are given the same level of protection as health records against improper disclosure. V. If a participant withdraws or fails to confirm c onsent for the use of the recording, the recording is not used and is erased as soon as possible. 4. Existing collections used for teaching purposes Some researchers may have existing collections of recordings which they use solely for teaching pur poses within an academic/teaching setting. This guidance requires that permission is obtained to make any recording which is not part of the participant's assessment or treatment, regardless of whether the participant may be identifiable. However, recordin gs may have been made for teaching purposes prior to 2009 without it being recorded whether or not permission had been obtained. Such collections may have a significant value for teaching purposes.
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers You may continue to use recordings from which the participant is not identifiable, and which were made for teaching purposes prior to 2009. You should, however, seek to replace such recordings at the earliest opportunity with similar recordings for which p ermission can be shown to have been obtained. You may also continue to use effectively anonymised recordings that were originally made for assessment purposes. However, you should not use any recording, from which a participant may be identifiable, for tea ching purposes if you cannot demonstrate that consent has been obtained for that use. 5. Recordings for use in public media (television, radio, internet, print) In general, the considerations set out above also apply to recordings for use in public media. There are, however, some issues that are specific to recordings to which the public will have access: I. You must not make recordings for use in publicly accessible media without written permission, whether or not you consider the participant to be identifia ble. 'Publicly accessible media' includes scientific journals. II. Before making any arrangements for external individuals or organisations to film participants in a health care or other University setting, you must inform the University. III. If you are involved in any way with recording patients for television or other public media, you should satisfy yourself that participants' permission has been properly obtained, even if you are not responsible for obtaining that permission or do not have control of the reco rding process. IV. In addition, you should make sure that participants understand that, once they have agreed to the recording, they may not be able to withhold their consent for its subsequent use. If participants wish to restrict the use of material, they s hould get agreement in writing from the owners of the recording, before recording begins. V. You should be particularly vigilant in recordings of those who are unable to give permission themselves. You should consider whether participants' interests and well - being, and in particular their privacy and dignity, are likely to be compromised by the recording, and whether sufficient account has been taken of these issues by the programme makers. If you believe that the recording is unduly intrusive or damaging to p articipants' interests, you should raise the issue with the programme makers. If you remain concerned, you should do your best to stop the recording, for example by halting a consultation, and withdraw your co - operation. 6. Data and Dissemination Specia l consent for electronic publishing: Participants must be made aware of possible forms of publication now in existence and the lack of control that it is possible to exercise over who will see these images.
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers Appendix D: Proposed procedure for obtaining consent for Clinical Photography in Research and Teaching at the University of the Western Cape The clinical photographer must be trained in asking consent from the patient using a uniform consent form. 1. The patient is asked to read through the consent form. 2. The photographer explicitly discusses each of the sections of the consent form with the patient or subject and invites questions. 3. The patient or subject is informed precisely about the nature of the image to be taken and whether t hey will be recognizable. 4. Patients who give consent and who may be identified from the images are given two weeks from the date of photography, allowing them time to reflect, and during which time they can withdraw consent, before the photographs are a vailable for publication. 5. Three categories of consent may be presented to the patient or subject: (i) use of their images in their confidential notes for teaching and publication, (ii) use restricted to patient notes and medical teaching and (iii) use limited to confidential patient notes alone. 6. The patient must be informed about the possibility that the images may be used in electronic publications. 7. The patient may view the images at any time and can withdraw consent, in which case the image is deleted permanently from the database. However, it is emphasised at the time of consent that full recovery of the image may not be possible once it has been made available for publication. 8. It must be made clear that refusal to give consent for the ima ge to be made, or to be used in a specific way, will not affect the patient’s medical or dental care in any way. 9. If the patient is under 16, consent must be requested from the parent or guardian. However, the views of competent minors can be taken into account, and if they refuse to give consent, no images should be taken. 10. After a video image has been taken, the patient or subject is asked to confirm the initial consent.
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers Appendix E: Example of a Consent Form UNIVERSITY OF THE WESTERN CAPE Patient Consent to Clinical Photography and Video Recordings Surname: Name: Date of Birth: Gender: I, .............................................................................................. consent to photographs or video recordings being taken of me/my child as requested, I understand that these photographs and recordings will be treated with th e utmost confidentiality and be part of my health record. I hereby give consent for the images or recordings to be used for: □ Record purposes and my/my child’s future management □ Education and training purposes □ Approved research purposes □ Open publication in journals, text books or conference material • I understand that all efforts will be made to conceal my identity but that full confidentiality cannot be guaranteed. • I understand that my consent or refusal will in no way affect my dental care. Patient Signature: ................................................................ Date.................................... ............ Parent/Guardian (if patient under 16 years) Name: ................................................ ................. Signature.......................................................... Witness Name ................................................................. Signature................................ ......... Requesting Clinician Name (print): ........................................................................................ Date: ...................................... Department: .......................................................... Phone: .......................................................... Patient Name (print): ...................................................................................... ……………….. Views required .............................................................. .......................................................... Required for: ■ Records ■ Teaching/Lectures Research Publication Images taken by: .......................................................... Date................ .................................... Location where copies stored: ............................................................................................... ......
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers Appendix F: Conflict of Interest Disclosure Form Conflict of Interest regarding re search Any member of the University staff, including staff employed in posts funded by outside bodies, is required to disclose to the Dean/Head of School, or other appropriate line manager, any actual or perceived conflict of interest that may arise in the course of his or her research work. Such disclosure may be made on this form or as an equivalent written submission. After completion, the disclosure must be lodged in the Research Office. Failure to disclose a conflict of interest may lead to disciplinary action. Name of staff member making disclosure Staff number School Name of staff member to whom disclosure is being made Check list: Circle “Yes” or “No” for each question. Benefits marked with an asterisk are prohibited. Financial Interest: Do you or a close member of your family have any financial interest in or affiliation with an institution, company, or individual that: Funds or sponsors your research? Yes No May benefit directly or indirectly from access to or use of Univer sity resources? Yes No May benefit directly or indirectly from the purchase of major equipment by the University for this project? Yes No May benefit directly or indirectly by inappropriate delays or controls on the dissemination of the results of the research? Yes No
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers Will you or a close member of your family receive any: * Discounts or concessions or other financial benefits from a company or individual with which an order is placed? (The award of air miles associated with the purchase of air tickets and other travel expenses is permitted and does not require disclosure, provided that mechanisms are in place to ensure that itineraries and fares are appropriate to the travel requirements. The normal mechanism would be a counter - signature on the order by the line manager.) Yes No * Discounts or concessions or other financial benefits from a company or individual that is awarded a contract? Yes No Perception of Nepotism: Will any close member of your family be employed from funds under your control? Yes No Clinical Trials: Does the research involve a clinical trial being conducted by an individual, company, or organisation that has a significant financial interest in the results of the trial? Yes No If the answer to any of the above is “Yes” then: 1. Outline the nature of the conflict. 2. Describe the sense in which the situation is of benefit to the University and the research programme. 3. Propose a mechanism for the management of the conflict.
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers Agreed Procedure for the Management of the Conflict : To be completed by the Dean/Head of School or other appropriate line manager: Certification: I certify that I have disclosed everything relevant to the Dean/Head of School/line manager. I undertake to act according to the Management Plan above. Signature of Researcher: ……………………………………… … Date:..……….….….. I have applied my mind to the situation described above and will monitor compliance with the Management Plan. Signature of Head of School:………………………………… …. Date: …………………
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers Appendix G: Useful additional material These links are listed to provide additional reading. The responsibility for content is the responsibility of the organisations maintaining the sites. ● On being a scientist – Responsible conduct in research , National Academy Press, Washington DC 1995. ● Joint NHMRC/AV - CC statement and guidelines on research practice , Australian Vice Chancellors’ Committee. ● A Guide to Research Ethics for Staff and Students, compiled by the Unilever Ethics Centre, University of KwaZulu - Natal ● Online Ethics Center for Engineering and Science at Case Western Reserve University ● Office of Resear ch Integrity US Department of Health and Human Services ● Bill of Rights of the Constitution of South Afri ca Act 106 of 1996 http://www.crisa.org.za/downloads/billofr ights.pdf. ● National Statement on Ethical Conduct in Research Involving Humans - Preamble National Health and Medical Research Council. http://www.health.gov.au/nhmrc /publications/humans/preamble.htm ● Report of the Review of the Role and Functioning of Institutional Ethics Committees. A Report to the Minister of Health and Family Services, March 1996, Commonwealth of Australia, Canberra. ● The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. T he National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, Department of Health, Education and Welfare Publication No (OS) 78 - 0012, US Government Printing Office Washington, 1978 ● International Ethical Guidelines for Biomedical Research Involving Human Subjects, CIOMS, Geneva,1993,p.11. Council for International Organizations of Medical Sciences (CIOMS) in collaboration with t he World Health Organisation (WHO) ● Large Research Grants Scheme: Guidelines for the year 2000 Grants, Australian Research Council, 1999, p.4. Department of Education, Training and Youth Affairs, ● Guidelines and Policies, University of Waterloo. http://www. research.uwaterloo.ca/ethics/human/guidelines.asp ● Integrity in Research Administrative Guidelines, University of Waterloo. http://www.re search.uwaterloo.ca/ethics/misconduct/guidelines/misconduct_guidelin es.html 8/26/2004 ● Ethical Behaviour Policy 33. University of Waterloo. http://www.research.uwat erloo.ca/ethics/misconduct/guidelines/policy33.htm ● McGill University policy on research ethics. McGill Research at Mc Gill http://www.mcgill.ca/researchoffice/policies/sponsored/policies/ethics ● Regulations governing conflicts of interest in proprietary research McGill Research at Mc Gill. http://www.mcgill.ca/researchoffice/policies/sponsored/policies/proprietary
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers ● Laboratory Biohazards Policy for Research Facilities and Personnel Texas Tech University Health Sciences Centre ● Policy and procedures on Ethics in Research. The University of North Carolina at Chapel Hill, August 1994 ● Human Research Ethics Committee Central Queensland University. http://www/cqu.edu.au/ppmanual/committees/humanresearch.pdf ● Ethics Review of Research Involving Human Subjects Simon Fraser University. http://www2.sf u.ca/policies/research/r20 - 01.htm ● About Ethics at CDU. Charles Darwin University. http://www/cdu.edu.au/research/ethics/ethics_about.html ● Current Students – Postgraduate Research. The University of New South Wales http://www.unsw.edu.au/currentStudents/pos tgradResearch/res/cspgrpolicyproc.html ● Joint NHMRC/AV - CC Statement and Guidelines on Research Practice. Australian Vice - Chancellors’ Committee. htpp://www.avcc.edu.au/news/public_statements/publications/glrespra.htm ● Ethics Policy St Edwards University, Cou r se Policies. http://www.stedwards.edu/educ/minus/read1323/gethicteach.htm
1. DOH Ethics in Health Research, 2015 2. S outh African National Standard ( SANS ) for the Care and Use of Animals for Scientific Purposes ( SANS 10386:2008 ) 3. NHMRC National Statement on Ethical Conduct in Human Research (2007) 4. http://www.sfu.ca/~palys/Wigmore.html 5. https://www.nrf.ac.za/media - room/news/nrf - state ment - predatory - journals - deceptive - publishers Contributors Details Date 1 Research Office Comments & Ownership 10/2018 2 Deputy Deans for Research/ Faculties Comments/Feedb ack 16/11/2018 3 Senate Research Committee Comments/Feedb ack 07/12/2018, 05/03/2019, 11/10/2019, 12/11/2019 4. Deans, Deputy Deans of Research, SARChI Chairs, DVC: Academic, REC Chairs Comments/Feedb ack 11/03/2020 / 09 Sept 2020 4 Senate Research Committee Final draft 30 Sept 2020 6. Senate and Council Final approval
