UNIVERSITY OF FORT HARE
UNIVERSITY RESEARCH ETHICS POLICY
1. PREAMBLE
The University of Fort Hare (UFH) is committed to:
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The consistent/faithful pursuit of excellence in teaching, research and community engagement and believes that research is essential for the attainment of qualitative outcomes in the areas of teaching and community engagement.
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Creating and maintaining an environment in which the South African Constitution and the Bill of Rights incorporated therein as well as their underlying values of human dignity, equality, non-discrimination, social justice and fairness are respected and consistently utilized as guide posts in the conduct of all research.
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Its Charter of Ethical Principles and Values in terms of which all staff and students are enjoined to pursue truth, intellectual honesty and openness to ideas through the attainment of the highest professional and ethical standards in research amongst others.
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Encouraging and supporting research that is aimed at the advancement of knowledge that is socially and ethically relevant and capable of application to the scientific, technological and socio-economic development of South Africa, Africa and the globe.
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Requiring that all research be guided by the highest standards of integrity, scientific rigour and accountability while protecting and promoting the constitutional principles of academic freedom and freedom of scientific research.
2. APPLICATION OF THE CODE
2.1 This Code applies to all research and research-related activities, including activities aimed at human and animal research the gathering of research information, such as the conduct of surveys or interviews, the processing and analyses of research data, and the reporting of research findings.
2.2 This Code shall govern the work or activities of all staff and students engaged in research that is in any way associated with the UFH. Similarly, it shall apply to any
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person or organization not affiliated with the UFH but wishing to conduct research with the participation of staff and/or students of the University.
3. GOVERNANCE AND MANAGEMENT STRUCTURES FOR ETHICAL
RESEARCH
The management and governance of ethical research should be conducted in accordance with the principles, practices, procedures and structures as set out in this document.
The University ’s research ethics governance structures consist of the following:
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The University Research Ethics Committee (UREC)
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The Animal Research Ethics Committee (AREC) (Faculty of Science and
Agriculture)
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Faculty Research Ethics Committees (FREC)
3.1 University Research Ethics Committee (UREC)
The University Research Ethics Committee (UREC) shall constitute a standing committee of the Senate of the University
3.1.1 Membership
The UREC comprises of the following members:
(a) The Dean of each Faculty or their nominees
(b) The Vice-Chancellor (Ex officio)
(c) The Deputy Vice-Chancellor Academic Affairs and Research (Chairperson)
(d) The Dean of Research and his/her nominee,
(e) One representative from the medical profession.
(f) One representative from the veterinarian profession
(g) Two community members from outside the University unrelated to research
The UREC shall be free to invite ad hoc members to deal with particular protocols.
Ordinary membership of the UREC will be for an initial three-year term and must be elected by Senate but members may be re-elected for one additional three year period
3.1.2 Functions and Responsibilities

The UREC shall assess protocols submitted for University research projects and class projects and where approved issue an Ethical Clearance Certificate (ECC ) in order to ensure that such projects will, in their use of human and animal subjects as well as research in the Social Sciences and Humanities meet the ethical standards adopted by the University. The ECC will be issued under the signature of the
Chairperson of the UREC
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The UREC confer approval on the protocol of project(s). Alternately, the UREC may suggest amendments to the protocol, in consultation with the project supervisor, where a discrepancy is perceived between the protocol and the standard Guidelines.
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The UREC may require a project to be monitored in such manner as it deems appropriate.
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The approval of the UREC constitutes approval of the ethical standard by the
University where required by a funding agency or sponsors
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The UREC will refer the matter to the Senate where:
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The project supervisor is not prepared to alter the research protocol in order to conform to the suggestions of the UREC, and the project supervisor wishes the decision of the UREC to be reviewed;
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A minority of the UREC wishes to register dissent from the approval, given by the
UREC of a protocol.
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The UREC will investigate, and attempt to satisfy, objections concerning ethical standards in any ongoing or completed project which was subject to review by that
UREC. Where a dispute cannot be resolved the UREC will refer the matter to the
Senate.
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The UREC will clarify and interpret the Policy, Procedures and Ethical Guidelines where necessary, and may from time to time recommend procedural and policy changes to the Senate as well as providing information to staff as appropriate.

The UREC will conduct a review of the performance of each Faculty Research
Ethics Committee at least once in every second year.
3.2 The Animal Research Ethics Committee (AREC)
The AREC functions in the Faculty of Science and Agriculture but is accountable and report to the UREC quarterly or as regularly as might be required
3.2.1 Membership Animal Research Ethics Committee (AREC)
The AREC shall have a membership that will allow it to fullfill its terms of reference. It shall comprise at least of the following persons, including an independent person:
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The Deputy Vice Chancellor, Academic Affairs and Research (Chairperson)
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The Dean of the Faculty of Science and Agriculture
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The Dean of Research
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Two members of staff from the Faculty
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A person (or persons) with qualifications in veterinary science, with experience relevant to the activities of the institution or, in special circumstances, a person with qualifications and experience to provide comparable expertise.
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A person (or persons) with substantial recent experience in the use of animals in scientific or teaching activities;
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A person (or persons) with demonstrable commitment to, and established experience in, furthering the welfare of animals, who is not employed by or otherwise associated with the institution, and who is not involved in the care and use of animals for scientific purposes. The person should where possible be selected on the basis of active membership of and nomination by, an animal welfare organisation. When choosing this member a minimum of two nominees, nominated by separate animal welfare organizations, should be considered; and
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
An independent person who does not currently and has not previously conducted scientific or teaching activities using animals, and who is not an employee of the institution, except under defined circumstances.
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In addition, a member of staff responsible for the procurement, production and daily care and maintenance of the animals shall be in attendance.
3.2.2 Functions and Responsibilities

For a complete discussion of the functions and responsibilities of the AREC see
South African National Standard (SANS 10386:200X ISBN 0-626- Edition 1)
Website: sabs.co.za
The following Functions and Responsibilities provide broader guidelines towards the operational requirements of the AREC:
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Written proposals accompanied by the appropriate AREC protocol form, fully completed, should place before the AREC sufficient information to satisfy the AEC that the proposed use of animals is justified and complies with the principles of
Replacement, Reduction and Refinement.
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Meetings should be scheduled as frequently as the volume of business demands, but not less than quarterly
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The process by which decisions are made shall be fair, consistent and transparent to investigators and teachers, and acceptable to all AREC members.
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Irreconcilable differences between the AREC and an investigator or teacher shall be referred to the governing body of the institution for review
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AREC membership should be such that absenteeism will not result in failure to reach a quorum or lack of balance within the committee.
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The AREC might need to put in place procedures to deal with the immediate use of animals for the diagnosis of unexplained and severe disease outbreaks.
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Only those scientific or teaching proposals that conform to the requirements of all relevant sections of this Code and of legislation may be approved.
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Proposals shall be considered and approved only at meetings of the AREC.
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Where possible, decisions on approval of proposals should be made on the basis of consensus at quorate meetings.
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Investigators and teachers shall be informed of decisions in writing.
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A record of all approved projects shall be maintained.
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Scientific or teaching activities involving the use of animals shall not start before written approval is given. Failure to obtain such permission shall result in projects not being recognized.
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Pilot studies, where proposed or considered preferable, by the AREC, should be regarded as integral to the overall project(s). These enable the assessment of the feasibility and value of the project, and the potential for Refinement and Reduction.
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AREC shall ensure through monitoring that adequate records are kept on the acquisition, breeding, health, care, housing, use and disposal of animals
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With due consideration of bio-safety requirements, announced and unannounced inspections of all animal housing and laboratory areas shall be conducted regularly by members of the AREC and appropriate records shall be maintained to ensure compliance with the Code17.
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AREC shall ensure that any activity that constitutes a major breach of this Code
(i.e. a breach that has immediate negative implications for animal welfare) ceases immediately and appropriate action is taken. This may include referral to the person-in-charge of the institution. For non-compliance that has infrastructural dimensions, a reasonable time shall be given for correction, but the AREC shall be assured and kept informed that the problem is being addressed. The AREC shall initiate investigation into any suspected or alleged non-compliance with this Code, institutional policies or the Animals Protection Act, 1962 (Act 71 of 1962).
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Approved projects of long duration and the long-term continuing use of individual animals shall be reviewed at least annually by the AREC or more frequently if considered desirable.
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Any project can be reviewed if warranted by the emergence of new information
(whether scientific or pertaining to the scientific or teaching activities or investigator.)
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The AREC shall make provisions to audit scientific and teaching activities in relation to an investigator’s or teacher’s compliance with a submitted protocol.
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Where two or more members oppose a proposal, it should not be approved until the
AREC has explored ways of modifying the project that might lead to consensus
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The AREC shall report in writing at least annually to the UREC as Senate
Committee of the University which will report to the Senate of the University

Regardless of the duration of the approval, the continuation of all projects shall be subject to the receipt of written annual reports that should advise on: o What progress has been achieved o Problems that may have interfered with project progress o Number of animals used to date or in total o The wellbeing and animal welfare status of all animals during the study o Unexpected mortalities o Envisaged modifications, amendments, or additions o Whether the project has, or will be able to, achieve the stated objectives o Whether the project is continuing, has been completed, or discontinued, and o What publications have been produced
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Following a review of the annual report, the AREC may determine, on the basis of the report and further consultation with the researcher that a project may continue, be suspended, require modification or terminated.
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The AREC shall adopt or develop a system to categorise proposals, to help identify areas of special concern.
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Where projects are to be conducted at more than one institution, AREC approval should be sought from each institution unless responsibility has been formally delegated to one AREC.
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When responsibility has been formally delegated to another institution, the investigator should notify the AREC in writing at his/her own institution that there is approval elsewhere for a project.
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AREC may be approached by individuals, or organisations, which do not have direct access to an institutional AREC, yet require AREC approval before proceeding to use animals for scientific purposes.
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The AREC shall decide, on an individual case basis, whether it is prepared to assess the proposal and oversee the project. In such cases proposals for noninstitutional applicants shall clearly address the points below, in addition to all
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information normally required by the AREC. This arrangement should enable the institution to withdraw from the agreement if the non-institutional applicant fails to comply with directions of the AREC.
3.3 Faculty Research Ethics Committee (FREC)
Each Faculty must establish through their ordinary Faculty Board meetings a Faculty
Research Ethics Committee (FREC). The FREC is to be established to function in accordance with the policy framework of the UFH Senate Committee for Research
Ethics. The FREC is a subcommittee of the Faculty Research and Higher Degrees
(RHDC] committee. It is responsible for the implementation of the UFH Research
Ethics and Research Code of Conduct
Where there are research projects or class projects which use human subjects in clinical research and or human subjects in the Social Sciences and Humanities such a Faculty must establish a Faculty Research Ethics Committee (FREC)
The Faculty of Science and Agriculture should use the AREC to deal with all the research ethics matters in that Faculty
3.3.1 Membership of the Faculty’s Research Ethics Committee:
The FREC to be elected by the relevant Faculty shall consist of:
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The Dean or his/her designate;
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At least two departmental staff members active in investigations involving human subjects;
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At least two departmental staff members active in investigations involving research into Social Sciences and Humanities
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Such ad hoc members as may be named by the committee to deal with particular protocols, including student members where appropriate.
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Membership of the FREC will be for a three year term, but members may be reelected for one additional three year term of office.
3.3.2 Functions and Responsibilities

The FREC reports to the UREC and make recommendations regarding the issuing or non-issuing of the research clearance certificate for a particular research project

The FREC will review protocols submitted for University research projects by researchers in order to ensure that, in their use of human subjects as well as research into the Social Sciences and Humanities, such projects will meet the ethical standards adopted by the University. Only the fully completed protocol forms to be submitted to the UREC. See relevant protocols as Annexures 1, 2 and 3

The FREC may recommend approval of the protocol to the UREC. Alternatively, the FREC may suggest amendments, in consultation with the project supervisor, particularly where a discrepancy is perceived between the protocol and the Ethical
Guidelines. The Committee may require a project to be monitored in such a manner as deemed appropriate.
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The FREC will refer the matter to the UREC where:
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the project supervisor is unable to agree to the alterations suggested by the FREC, and where the project supervisor wishes the decision of that Committee to be reviewed;
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a minority of the FREC wishes to register dissent from the approval of a protocol given by that FREC.
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The FREC will retain on file, for the UREC, a copy of each protocol reviewed by it, with amendments if any, and a record of the decision taken by the FREC immediately after the review is completed. If ad hoc members were consulted in the course of making the decision, that fact should be noted.
The FREC will investigate, and attempt to satisfy, objections concerning ethical standards in any on-going or completed project which is subject to review by the
FREC. Where a dispute cannot be resolved, the FREC will refer the matter to the
UREC
3.3.3 Master ’s and Doctoral Research
It is the prerogative of departmental Research and Higher Degrees Committees (or in the absence thereof, the departmental representative on the Faculty RHDC and the departmental chairperson) to scrutinise master ’s and doctoral students’ research proposals for ethical considerations. Based on this scrutiny, the committee responsible for higher degrees will determine which proposals need to be accompanied by a completed 'Research Ethics Protocol' form before submitting these proposals to the Faculty RHDC. The representative of the FREC on both the Faculty
Higher Degrees Committees will, in consultation with the other members of the
RHDCs, determine whether a particular research proposal:

 conforms to ethical requirements, or needs to be referred to the Faculty RHDC for further scrutiny.
In cases where specific documentation / letters of ethical clearance are required (e.g. in order for a student to gain access to respondents), such cases can be referred to the chair of the FRHDC Committee, via the office of the supervisor / promoter. The following documentation need to be submitted:
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A cover letter
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The research proposal as stipulated by the Postgraduate Research Guide
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A completed 'Research Ethics Protocol' form
3.3.4 Honours Research Projects
In the case of honours individual and/or group research projects, the function of monitoring the ethical standing of research proposals and granting ethical clearance is delegated to the relevant department. The department will determine which honours research proposals need to be referred to the Faculty RHDC for further scrutiny. In such cases the following documentation must be submitted to the office chair of the FRHDC:
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
A cover letter
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A research proposal as stipulated by the Postgraduate Research Guide
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A completed 'Research Ethics Protocol' form
In cases where specific documentation/letters of ethical clearance are required (e.g. in order to gain access to respondents), such cases can be referred to the chair of the
Faculty RHDC, via the office of the supervisor / honours course coordinator. The following needs to be submitted:
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A cover letter
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The research proposal as stipulated by the Postgraduate Research Guide
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A completed 'Research Ethics Protocol' form
3.1.5 Research Projects: Members of Staff
All staff members embarking on a specific research project are expected, in the spirit of academic integrity and social justice, to ensure that the standard practice of ethical professionalism will be upheld. Staff members must adhere to guidelines and procedures regarding ethical professionalism stipulated by their relevant departments.
In cases where specific documentation / letters of ethical clearance are required (e.g. in order to gain access to respondents), members of staff need to submit the following documentation to the office chair of the Faculty RHDC:

A cover letter
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A fully motivated research proposal
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A completed 'Research Ethics Protocol' form
4 RIGHTS AND RESPONSIBILITIES OF THE UFH
4.1 The University shall endeavour to consistently respect the autonomy and academic freedom of researchers.
4.2 The University shall create and maintain an enabling an environment within which researchers based at the institution may conduct ethically sound research. For that purpose, the University shall provide the resources necessary for the effective implementation of this Code, including senior management oversight through the
GMRDC as well as administrative and other infrastructural support for such Research
Ethics Committees as may be required/established in accordance with the provisions of this Code.
4.3 The University shall use its best endeavours to ensure that all laboratory facilities and other physical resources used or made available for research at the University meet applicable accreditation requirements and/or are generally suitable for the conduct of effective and ethical research in a safe and healthy environment.
5 RIGHTS AND RESPONSIBILITIES OF RESEARCHERS
This section should also be read in conjunction with the University’s Plagiarism
Policy
5.1
Researchers have a fundamental right to academic freedom and freedom of scientific / academic research.
5.2
Researchers are required to show commitment to high standards of ethical and professional conduct. In that regard, they have a duty to ensure that their work
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enhances the reputation and goodwill of the University. Accordingly, researchers must refrain from all forms of dishonesty, including but not limited to:
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Falsification of data
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Fabrication
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Plagiarism
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Misuse of research funds, and
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Any other form of dishonesty which undermines the integrity of the research and which may bring the UFH into disrepute.
5.3
Researchers must ensure that they only undertake research work that conforms to accepted ethical standards in the relevant discipline and falls within their fields of expertise/competence.
5.4 It is the responsibility of every research project leader to ensure the safety of all those associated with the research and that the design of the project takes account of relevant ethical guidelines, including the requirements of this Code. However, it is the responsibility of every researcher to conduct research in compliance with the provisions of this Code.
5.5
Researchers shall conduct their research and related activities in a manner consistent with section 24 of the Bill of Rights of the Constitution of South Africa which requires that research should not produce an environment that is harmful to human health or well-being. Instead, researchers must seek the protection of the environment for the benefit of present and future generations.
5.6
Where collaborative or team research is being conducted, the research project leader or principal investigator is obliged to ensure that members of the research team are aware of the provision of this Code and of any other applicable norms governing the conduct of research.
5.7 Where the researcher is a student conducting the particular research for academic credit, the Supervisor shall be responsible for informing the student of her/his obligations in respect of the ethical conduct of research and ensuring that the student’s research is conducted in accordance with the provision of this Code.
5.8 Where data of a confidential nature are obtained in the course of research, confidentiality must be observed and researchers must refrain from using such data for their own personal advantage or that of a third party. Although secrecy may be necessary for a limited period in the case of contract research or non-contractual research that is under consideration for patent protection, research results and methods should however be open to scrutiny by colleagues within the institution and, through appropriate publication, by the profession at large.
5.1.1 Data Storage and Retention
5.1.1.1 Data (including electronic data) must be recorded in a durable and appropriately referenced form. Data management should comply with relevant privacy protocols, such as the Australian Standard on personal privacy protection.
5.1.1.2 Data must be held for sufficient time to allow reference. For data that is published this may be for as long as interest and discussion persists following publication. It is recommended that the minimum period for retention is at least five years from the date of publication but for specific types of research, such as clinical research, 15 years may be more appropriate.
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5.1.1.3 Wherever possible, original data must be retained in the department or research unit in which they were generated. Individual researchers should be able to hold copies of the data for their own use. However, retention solely by the individual researcher provides little protection to the researcher or the University in the event of an allegation of falsification of data. When the data are obtained from limited access databases, or via a contractual arrangement, the location of the original data must be identified, or key information regarding the database from which it was collected and this must be retained by the researcher or research unit. In all cases, prior to the publication of research findings a Location of Data Form must be completed.
5.1.1.4 Data related to publications must be available for discussion with other researchers. Where confidentiality provisions apply (for example, where the researchers or the University have given undertakings to third parties, such as the subjects of the research), it is desirable for data to be kept in a way that reference to them by third parties can occur without breaching such confidentiality.
5.1.1.5 Confidentiality agreements will be developed to protect intellectual property rights (see UFH Intellectual Property Policy) belonging to the University, or to pass on obligations of confidence to others in relation to confidential information received by the University. Where such agreements limit free publication and discussion, limitations and restrictions must be explicitly agreed.
5.1.1.6 It is the obligation of the researcher to enquire whether confidentiality agreements apply and of the Head of Department or the research unit to inform researchers of their obligations with respect to these provisions. All confidentiality agreements should be made known at an early stage to the Executive Dean:
Research & Development
5.1.1.7 Researchers must be responsible for ensuring appropriate security of any confidential material, including that held in electronic media. Where computing systems are accessible through networks, particular attention to security of confidential data is required. Security and confidentiality must be assured in a way that copes with multiple researchers and the departure of individual researchers.
5. 1.2 Authorship
5.1.2.1 Minimum requirement for authorship is substantial participation, where all the following conditions are met:

Conception and design, or analysis and interpretation of data;

Drafting the article or revising it critically for important intellectual content;

Final approval of the version to be published
5.1.2.2 Participation solely in the acquisition of funding or the collection of data does not justify authorship. General supervision of the research group is not sufficient for authorship. Any part of an article critical to its main conclusion must be the responsibility of at least one author. An author's role in a research output must be sufficient for that person to take responsibility for at least that part of the output in that person's area of expertise. No person who is an author, consistent with this definition, must be excluded as an author without their permission in writing.
5.1.2.3 Research students can be authors and own the copyright of their thesis, in accordance with the relevant Regulation of the UFH Intellectual Property Regulations.
5.1.2.4 Authorship of a research output is a matter that should be discussed between researchers at an early stage in a research project, and reviewed whenever there are changes in participation. If there are conflicts arising through disputes about authorship then the Executive Dean: Research & Development should be notified and will decide on what course of action.
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5.1.2.5 When there is more than one co-author of a research output, one co-author
(by agreement amongst the authors) should be nominated as executive author for the whole research output, and should take responsibility for record-keeping regarding the research output.
5.1.2.6 Where the research is published, including electronically, one author will be given principal status with the responsibility for signing a Statement of Authorship form ensuring that all co-authors are in agreement with their inclusion and that no person entitled to authorship as defined in clause 3.1 above has been excluded.
5.1.2.7 The authors must ensure that others who have contributed to the work are recognised in the research output. Courtesy demands that individuals and organisations providing facilities should also be acknowledged.
5.1.3 Publication
5.1.3.1 Publication of multiple papers based on the same set(s) or subset(s) of data is not acceptable, except where there is full cross-referencing within the papers (for example, in a series of closely related work, or where a complete work grew out of a preliminary publication and this is fully acknowledged). An author who submits substantially similar work to more than one publisher must disclose this to the publishers at the time of submission.
5.1.3.2 The University believes that peer assessment of research outcomes is important in the validation of research. Wherever possible the University expects researchers to submit their research for peer review.
5.1.3.3 The University recognises the importance of research being communicated to the public media. Ideally this should occur after peer appraisal. Where research is reported in the public media prior to peer review the reporting should be based on the research data and findings.
5.1.3.4 Publications must include information on the sources of financial support for the research. Financial sponsorship that carries an embargo on such naming of a sponsor should be avoided.
5.1.3.5 Publications involving either a student enrolled with the University, or a
University staff member must acknowledge the work was carried out at the University by using the University by-line.
5.1.3.6 Deliberate inclusion of inaccurate or misleading information relating to research activity in curriculum vitae, grant applications, job applications or public statements, or the failure to provide relevant information, is a form of research misconduct. Accuracy is essential in describing the state of publication (in preparation, submitted, accepted), research funding (applied for, granted, funding period), and awards conferred, and where any of these relate to more than one researcher.
5.1.3.7 All reasonable steps must be taken to ensure that published reports, statistics and public statements about research activities and performance are complete, accurate and unambiguous.
5.1.4 Supervision of Students/Research Trainees
Reference should be made to the University of Fort Hare’s Postgraduate Guide as approved by the University’s Senate: March 2009
5.1.4.1The Head of Department or academic unit should ensure that supervision of each research student/trainee (including Honours, Master ’s and Doctoral students, and junior postdoctoral staff) is assigned to specific, responsible and appropriately
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qualified senior research leaders(s), and that the ratio of research students/trainees to supervisors is low enough to ensure effective intellectual interaction and effective oversight of the research at all times.
5.1.4.2 Supervisors or Heads of Departments or academic units should provide each research student/trainee with written material on applicable government and institutional guidelines for the conduct of research, including those covering ethical requirements for studies on human and animal studies, requirements for confidentiality, and occupational health and safety matters.
5.1.4.3 Supervisors should be obliged to provide guidance in all matters of good research practice. This includes discussing with the student, at the outset, relevant issues of research conduct and ethics, and intellectual property, and referring any problems/queries to the Head of Department for consideration.
5.1.4.4 Supervisors must ensure, as far as possible, the validity of research data obtained by a student under his/her supervision.
5.1.5 Disclosure of Potential Conflicts of Interest
5.1.5.1 Disclosure of any potential conflict of interest is essential for the responsible conduct of research. Researchers have an obligation to disclose any affiliation with, or financial involvement in, any organisation or entity with a direct interest in the subject matter or materials of researchers. A conflict of interest may also arise if any organisation or entity with a direct interest in the subject matter provides direct benefits to the researchers such as sponsorship of the investigation, or indirect benefits such as the provision of materials or facilities or the support of individuals such as provision of travel or accommodation expenses to attend conferences.
5.1.5.2 Other examples of conflict of interest include where a researcher (or their spouse or dependent) has a financial interest (equity, directorship, consultant) in the funding agency or in an agency being paid from the grant funds, or where the terms of a new grant from a funding agency require disclosure of project data from a related project and the terms of the related project grant prevent that disclosure.
5.1.5.3 When a conflict of interest arises at the time of reporting or proposing research, and this conflict of interest has the potential to influence research and investigations, publication and media reports, grant applications, and applications for appointment and promotion, the researcher must disclose the details "in confidence" to the Executive Dean: Research & Development. The latter will then decide whether a conflict of interest exists and if so, what further action should be taken. That action will include consultation with the researcher and may also involve consultation with the funding agency or other parties to ensure that the conflict of interest does not compromise the research, or the University's interests. In some circumstances, it may be necessary to reject or terminate a research project, or to disclose the conflict of interest to the editors of journals or the readers of published work arising from the research.
6. PROCEDURES FOR DEALING WITH ALLEGATIONS OF RESEARCH
MISCONDUCT
This section should also be read in conjunction with t he University’s
Plagiarism Policy
6.1 Definition of Research Misconduct
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"Misconduct" or "scientific / academic misconduct" is taken here to mean fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It includes the misleading ascription or credit of authorship including the listing of authors without their permission, attributing work to others who have not in fact contributed to the research, and the lack of appropriate acknowledgement of work primarily produced by a research student/trainee or associate. It does not include honest errors or honest differences in interpretation or judgments of data.
Examples of research misconduct include but are not limited to the following:

Misappropriation.
A researcher or reviewer shall not intentionally or recklessly:

Engage in plagiarism, which shall be understood to mean the presentation of the documentation words or ideas of another as his or her own, without appropriate attribution for the medium of presentation;

Make use of any information in breach of any duty of confidentiality associated with the review of any manuscript or grant application;

Intentionally omit reference to the relevant published work of others for the purpose of inferring personal discovery of new information.

Interference.
A researcher or reviewer shall not intentionally and without authorisation take or seize or materially damage any research-related property of another, including, but not limited to the apparatus, reagents, biological materials, writings, data, hardware, software, or any other substance or device used or produced in the conduct of research.

Misrepresentation.
A researcher or reviewer shall not with intent to deceive, or in reckless disregard for the truth:

State or present a material or significant falsehood;

Omit a fact so that what is stated or presented as a whole states or presents a material or significant falsehood.
6.2 Protection of Interested Parties
6.2.1 Executive Deans and Heads of Departments should be available to advise on integrity in research. Their task should be to give confidential advice to staff and to research students/trainees, about what constitutes research misconduct, the rights and responsibilities of a potential complainant, and the procedures for dealing with allegations of research misconduct within the University.
6.2.2 Allegations of research misconduct require very careful handling. When an allegation is made, the protection of all interested parties is essential. These interested parties include:

The person bringing the allegation;

The person against whom the allegation is made;

Staff, students and trainees working with persons making an allegation, or with persons against whom an allegation is made;

Journals and other media reporting research subject to suspected, alleged, or demonstrated research misconduct;

Funding bodies supporting persons or research involved;

The public
6.3 The Investigation
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Procedures involving the investigation of misconduct or serious misconduct shall for:

Academic teaching and research staff, be dealt with in accordance with the current
UFH Academic Staff Agreement;

Other general staff, be dealt with in accordance with UFH Human Resources
Guidelines on Handling Unsatisfactory Job Performance and Unsatisfactory Job-
Related Behaviour: General Staff;

Students, be dealt with in accordance with the Statute and the Regulations for
Student Conduct and Discipline in the University Prospectus.
7. PROTECTION OF RIGHTS AND DIGNITY IN HUMAN / MEDICAL CLINICAL
RESEARCH AND HUMAN EXPERIMENTATION
7.1 Introduction
Research involving humans as subjects is important for the advancement of knowledge in the sphere of human welfare.
The general conduct of biomedical studies is guided by statements of internationally recognized principles of human rights, including the Nuremberg Code and the World
Medical Association's Declaration of Helsinki, as revised (Helsinki IV). These principles also underlie the Proposed International Guidelines for Biomedical
Research Involving Human Subjects, issued by the Council for International
Organizations of Medical Sciences (CIOMS) in 1982. These and similar national codes are based on the model of clinical medicine, and often address interests of
"patients" or individual "subjects". Epidemiological research concerns groups of people, and the above codes do not adequately cover its special features. Proposals for epidemiological studies should be reviewed independently on ethical grounds.
The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best current interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.
7.2 Principles for all human / medical research
These principles enshrined by the WMA include:
7.2.1The design and performance of each research study involving human subjects must be clearly described in a research protocol. See Annexure 1
7.2.2 The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins. This committee must be independent of the researcher, the sponsor and any other undue influence. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in the Helsinki Declaration. The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No change to the protocol may be made without consideration and approval by the committee. Medical research involving human subjects must be conducted
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only by individuals with the appropriate scientific training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional. The responsibility for the protection of research subjects must always rest with the physician, researcher or other health care professional and never the research subjects, even though they have given consent.
7.2.3 Medical research involving a disadvantaged or vulnerable population or community is only justified if the research is responsive to the health needs and priorities of this population or community and if there is a reasonable likelihood that this population or community stands to benefit from the results of the research.
7.2.4 Every medical research study involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and communities involved in the research in comparison with foreseeable benefits to them and to other individuals or communities affected by the condition under investigation.
7.2.5 Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.
7.2.6 Participation by competent individuals as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no competent individual may be enrolled in a research study unless he or she freely agrees.
7.2.7 Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information and to minimize the impact of the study on their physical, mental and social integrity.
7.2.8 In medical research involving competent human subjects, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal
7.2.9 Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information. After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freelygiven informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.
7.2.10 Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research population. In such circumstances the physician or researcher should seek informed consent from the legally authorized representative.
If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research
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ethics committee. Consent to remain in the research should be obtained as soon as possible from the subject or a legally authorized representative.
7.2.11 At the conclusion of the study, patients entered into the study are entitled to be informed about the outcome of the study and to share any benefits that result from it, for example, access to interventions identified as beneficial in the study or to other appropriate care or benefits.
8. PROTECTION OF RIGHTS AND DIGNITY IN ANIMAL CLINICAL RESEARCH
AND EXPERIMENTATION
8.1 Introduction
This section of the document will cover basic assessment of experimental animal health and welfare, ethical consideration for the use of animals in scientific research as well as implementing assessment techniques for pain management and humane endpoints. This part of the document is governed by the South African National
Standard (SANS 10386:200X ISBN 0-626- Edition 1, 2002) Code. The code encompasses all aspects of the care and use of, or interaction with, animals for scientific purposes in medicine, biology, agriculture, veterinary and other animal sciences, industry and teaching. It includes their use in research, teaching, field trials, product testing, diagnosis, the production of biological products and environmental studies. See Website: sabs.co.za for full document
The purpose of this Code is to ensure the ethical and humane care of animals used for scientific purposes, including teaching. Its aims are to:

Emphasise the responsibilities of investigators, teachers and institutions using animals

Ensure that the welfare of animals is always considered

Ensure that the use of animals is justified

Prevent or minimize pain or distress where possible for each animal used in scientific and teaching activities

Ensure minimum uniform national standards of animal care and use

Minimise the number of animals used in projects in such a way that it will not jeopardise the validity of the study, and

Promote the development and use of techniques which refine, reduce or replace animal use in scientific and teaching activities.

The Code establishes Animal Research Ethics Committees (AREC) to verify that the case for animal use is justified and to ensure adherence to the principles of
Replacement, Reduction and Refinement (the 3 R’s)
When animals are used, the researchers involved have an obligation to safeguard their welfare and minimise discomfort. This will also generally be beneficial for both the animal and the experimental outcome. The ability of an animal to cope with the environmental and exert controls over its life seems to be critical for animal welfare.
The overriding ethical and legal constraints on invasive, potentially harmful and exploitative studies on humans regrettably necessitate a limited use of animal subjects, provided that this does not cause unnecessary suffering in the form of deprivation, fear, stress, distress and pain which may endure. Such conditions are
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addressed by refinement strategies to ameliorate them as far as it is possible to do so.
Animal experiments should only be performed when no alternative is available and when the benefit of the experiment outweighs the suffering of the animal. When animals are used, there is a legal and moral obligation to safeguard welfare and minimise discomfort, since this is generally beneficial for both the animal and the experimental outcome. Discomfort and stress both before, and during the experiment can lead to non-specific effects, thus jeopardising results. Where possible, they should be anticipated, and in the event of any observed adverse reaction, animal studies should be terminated at the earliest time so as to avoid unnecessary discomfort or suffering.
8.2 Principles for animal research
8.2.1 Animal users and institutional managements should strive for the best regulation of laboratory animal use at both an institutional and statutory level. They should see that animal welfare regulations and operational codes and practices are properly adhered to.
8.2.2 The availability to the public of regularly updated and good-quality information on what animal experiments are undertaken and why they are undertaken is vital to create circumstances in which the issue of animal experimentation can be productively discussed and debated.
8.2.3 It must be recognised that the ethical imperative of the 'replacement' component of the three Rs principles is a primary challenge in every animal use procedure, and forms a critical part of the analysis in the ethical review process.
8.2.4 Sensitivity and respect for the sentience of non-human animals demands that they should be treated as organisms fully worthy of moral concern, under the stewardship of institutions and their staff.
8.2.5 Animal users should respect the interests of animals and not subject animals to intentions and motives which are not directly concerned with a research or teaching project, its objectives and its methodology.
8.2.6 Animal care staff, researchers and educators must be both professionally and personally qualified.
8.2.7 Researchers and educators who use laboratory animals and the staff who procure, breed and care for them are considered to be personally responsible for the proper care and use of these animals. They should uphold professional standards in accordance with their academic training and their professions.
8.2.8 Integrity should be promoted by honesty and fairness. In particular, researchers, educators, animal care personnel and Ethics Committee for Research on Animals
(ECRA) members should be honest about their own limitations, competence, belief systems, values and needs, and be prepared to respect views contrary to their own.
8.2.9 Sensitivity in animal experimentation requires balancing scientific or teaching interests with general values and norms supporting the interests and welfare of the animal subjects.
8.2.10 Special care should be taken not to treat animals as mere objects. Research objectives shall always be subordinate to the humane treatment of animals.
8.2.11 Researchers must apply safety rules and guidelines for the preservation and protection of the health and welfare of laboratory animals when hazardous substances, micro-organisms or parasites are being worked with in experimental situations.
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8.2.12 The responsible researcher, educator and animal care staff are to be appropriately qualified and experienced and to have facilities to ensure that all procedures conducted on laboratory animals will be undertaken with due discretion and precautions to protect the welfare of the animals.
8.2.13 Adequate preliminary studies of the literature pertaining to the proposed work should be undertaken to define as far as possible the risks inherent in the animal studies.
8.2.14 The users of laboratory animals have a responsibility to their professions, to the animals which they use, and to the public to ensure that an animal experiment is likely to yield information worth knowing, and that such information is well supported by valid experimental data and analysis of that data.
9. SCOPE
The Policy on Research Ethics with respect to the use of Human and Animal Subjects at the UFH as well as research into the Social Sciences and Humanities shall apply to the use of such subjects in all University research and class projects. In addition, the policy shall apply to research involving the use of University facilities by outside persons/agencies operating under an agreement with the University.
9.1 Definitions and interpretation
9.1.1 Class Project
A classroom demonstration/practical laboratory exercise or a research project assigned by the instructor as part of the learning-teaching plan of a course is defined as a class project. Thesis research does not fall within this category, but within the category of University research projects. In this connection ensuring that the Ethical
Guidelines of the University are complied with is normally a responsibility of the
Department concerned, although a Department may request review of a particular proposed class project by the Ethical Standards Committee.
9.1.2 University Research Project
All research projects carried out by postgraduate students and/or Staff of UFH, or by outside agencies but using UFH-facilities fall within this category.
9.1.3 Project Supervisor and Research Assistant
The project supervisor is a staff member who is carrying out an independent research project, or who is supervising a graduate or undergraduate student engaged in a research project, or who is the lecturer supervising a class project/practical. Students or other persons authorised by the project supervisor to carry out the project are research assistants.
9.1.4 Protocol
The description of the project to be submitted to the FREC and the UREC is called the protocol. (See Annexure 1 and 2 for a copy of the protocol forms to be completed
9.2 POLICY
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9.2.1 The Policy, Procedures and Ethical Guidelines adopted by the University are binding upon all University researchers and lecturers. Primary responsibility for ensuring that these policies and procedures are adhered to rests with the Project
Supervisor.
9.2.2 The University research projects of concern here are those deemed to involve the use of human and animal subjects as well as research into the Social Sciences and Humanities
9.2.3 Where class projects involve the use of human subjects as described the projects must conform to the relevant Ethical Guidelines adopted by the University. It is recognised, however, that certain learning-teaching activities involving human subjects are so proliferated and of such an innocuous nature that the lecturer has no option but to exercise his professional discretion in determining whether a formal approval by the University would be required. Where such lecturers have any doubt about the capability of the project to meet the standard Guidelines, they should consult their FREC or the UREC to determine if the project should obtain formal approval. It is incumbent upon lecturers to make student investigators aware of the
Policy, Procedures and Ethical Guidelines for use of human subjects in academic affairs, and to ascertain that the students involved are competent to maintain the standards.
9.2.4 Nothing in this policy document should be interpreted as relieving a University researcher, lecturer or research assistant of any obligations acquired as a result of membership of a professional association. However, adherence to a professional code of ethics does not in itself override the obligation to observe the procedures set out here, where they normally would apply.
9.2.5 The committees established to implement this policy have discretion in applying the Ethical Guidelines where exceptional circumstances or common sense dictate, provided that the basic principles underlying the policy are not compromised.
References
1. Cameroon Bioethics Initiative. CAMBIN ethical review committee standard operating procedures, 2008.
2. Canadian Council for Animal Care. Guidelines on animal use proto-col review
1997. Downloaded on 06/05/2002.
3. House of Lords Session 2001- 02. Select Committee on Animals in Scientific
Procedures, Volume I Report.
4. Remfry J. Ethical Aspects of Animal Experimentation. In: Tuffery AA, ed.
Laboratory Animals: An Introduction for New Experimenters. New York: John Wiley &
Sons, 1987.
5. South African Medical Research Council. Guide to Ethical Considerations in
Medical Research. Parowvallei, Cape Town: South Africa Medical Research Council,
1979.
6. South African Medical Research Council. Ethical Considerations in Medical
Research. Parowvallei, Cape Town: South African Medical Research Council, 1987.
7. South African Medical Research Council. Guidelines on Ethics for Medical
Research. Parowvallei, Cape Town: South African Medical Research Council, 1993.
8. World Medical Association declaration of Helsinki. Ethical principles for medical research involving human subjects. Adopted by the 15 th WMA General Assembly,
Helsinki, Finland, June 1964, and amended by the 59 th WMA General Assembly,
Seoul, 2008
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SOURCES:
1. Guidelines on Ethics for Medical Research, SA Medical Research Council (1993)
2. Handbook for the use of Animals in Neuroscience Research, Society for
Neuroscience (USA
3. SANS10386:200X ISBN 0-626- Edition 1, 2002
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