WALTER SISULU UNIVERSITY POLICIES AND PROCEDURES
TITLE: RESEARCH ETHICS POLICY (DRAFT)
POLICY NUMBER
DATE
EFFECTIVE DATE
APPROVED BY
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NO OF PAGES
REFER QUESTIONS TO: DIRECTOR RESEARCH DEVELOPMENT
Table of contents
Abbreviations and acronyms……………………………………………………………….………………2
1.
Preamble…………………………………………………………………………………….…………..3
2.
Principles and objectives………………………………………………………………………..…3
2.1
Principles…………………………………………………………………..…………………..3
2.2
Objectives…………………………………………………………………….……………....3
3.
Definitions and explanations…………………………………………………….…………………4
4.
Research ethical values………………………………………………………………………………7
4.1
The researcher and WSU………………………………………………………..……….7
4.2
The researcher and research participants…………………………..…………….7
4.3
The researcher and the research community………………………….…………7
4.4
The researcher and the sponsors/clients of research…..……………………8
4.5
The researcher and society……………………………………………….…………...8
4.6
The researcher and the environment………………………………….……………8
5.
Groupings of research ethics…………………………………………..…………………………8
5.1
Biomedical research ethics…………………………………….………..……………..9
5.2
Animal and plant ethics…………………………………………….…………………...9
5.3
Humanities and social sciences ethics…………………………..……………...10
5.4
Other specialised research ethics…………………………….…………………...10
6.
Research policy implementation and management……………………………………11
6.1
Research ethics policy implementation…………………………………….…….11
6.2
Research ethics committees …………………………………………………….…..11
6.2.1 University Research Ethics Committee……………………………..….11
6.2.2 Faculty Research Ethics Committee……………………………………..12
6.3
Implementation at school and department levels………………………......13
6.4
Benchmarking of research ethics outputs………………………………….……..13
Research Ethics form………………………………………………………………………………………..….14
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Abbreviations and acronyms
DVC: AA&R
Deputy Vice-Chancellor: Academic Affairs & Research
FREC
Faculty Research Ethics Committee
FRMC
Faculty Research Mentoring Committee
FHDC
Faculty Higher Degrees Committee
REP
Research Ethics Policy
UREC
University Research Ethics Committee
WSU
Walter Sisulu University
1.
PREAMBLE
Researchers are imperatively compelled to have ethical clearance of their projects. The
policy is designed to take into consideration accountability, dignity, intellectual honesty,
integrity, leadership, objectivity, and respect of individuals. It creates awareness in the
conduct of research activities thereby compelling researchers of their ethical obligations
and responsibilities. It also serves as an enabling document to regulate ethical issues of
research conducted by staff, students, research affiliates and associates of WSU.
Research activities of ethical concerns at WSU are biomedical, animal and plant,
humanities and social sciences, education, business, management and law. It is believed
that ethical concerns addressed in the policy, may withstand national and international
scrutiny.
2.
PRINCIPLES AND OBJECTIVES
2.1
PRINCIPLES

The Research Ethics Policy (REP) of WSU is developed from the principle of
internationally accepted ethical guidelines and code of good practice for the
different categories of researchers including staff and students;

The policy is to encourage the application of ethical principles and guidelines in
the conduct of quality research in an enabling environment;

The policy seeks to implement a research agenda and policies that take into
consideration ethical issues with strategic focus on and alignment with local,
regional and national priorities;
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2.2
Subject to prior approval by the Deputy Vice-Chancellor: Academic Affairs &
Research (DVC:AA&R), staff may engage in private research projects or
consultancies with external organizations provided ethical issues are considered.
OBJECTIVES

To decide the processes for the establishment, operation and review of ethical
policy and ethical procedures applied to research conducted by staff, students,
research affiliates and associates of WSU;

To maintain and monitor co-operative relationships with respect to ethical issues
between the research entities of the University and its faculties as research
activities are executed by staff, students, research affiliates and associates of
WSU;
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This WSU Research Ethics Policy is developed from the WSU vision and mission on
research; the WSU Research Policy; the WSU Higher Degrees Policy; the CHE’s A Good
Practice Guide for Quality Management of Research; Research Ethics Policies of selected
universities of South Africa including Universities of Kwazulu Natal, Cape Town, Pretoria
and South Africa, and University of Southampton, England; and the World Medical
Association Declaration of Helsinki regarding ethical issues of medical research.

To identify the strengths, weaknesses, threats and opportunities affecting ethical
issues of research at WSU and facilitate the effective promotion of both general
and specific research activities based on good ethical code of conduct and
practice;

To elaborate and explain ethical issues to researchers in all fields and disciplines
in order to enhance WSU’s efforts to become a developmental research
institution of national and international repute;

To facilitate the dissemination of research findings carried out under good ethical
code of conduct and practice through publications in peer-reviewed journals,
books and other scholarly recognised outlets.
3.
DEFINITIONS AND EXPLANATIONS

Collegial obligation: WSU must have working environment that is conducive
and allows colleagues of researchers to be able to constructively criticize
research findings. The institutional atmosphere must therefore be such that
there is transparency and impartiality which advance quality research
undertakings.

Fabrication of research findings: This is the creation or production of data
not generated from the research. The fabricated data is intended to be declared
as part of research results and findings which constitute the research record.
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
Falsification of results: This is the malpractice of altering or changing
research materials, equipment, or processes, or the cooking/doctoring of
research data with intent of projecting false research findings. Researchers must
not publish data which they know to be false or has been deliberately falsified.

Human related research: This is research that involves the participation of
humans which could be physical invasive or non invasive, active or passive.
Participation could also be indirect by granting access to data or human tissue;
or on behalf of others.

Intellectual Property: This is property derived from the intellect. They cover
artistic and commercial creation of mind and deal with copyrights and patents. A
University Intellectual Property Policy will guide researchers in the
implementation of Intellectual Property Rights and Protection.

Plagiarism: This is academic dishonesty manifested as the appropriation or
claiming of another person’s or institution’s research record without
acknowledging, proclaiming recognition or giving credit to whom the intellectual
property belongs. Researchers must not knowingly represent published or
unpublished work of another person.

Misuse and abuse of research funds: Research funds should be used for the
particular activity indicated in an approved proposal or project document for
which money has been allocated. If for some reasons funds for one activity
should be used for another activity, permission should be sought from the DVC:
AA&R through the Director of Research Development following appropriate
institutional channels. Failure to seek such permission would result in the
researcher being sanctioned by WSU.
Any researcher who misapplies research funds would be required to refund the
amount with interest. As part of the process of monitoring the use of research
funds, auditing could be carried out at any time.

Non acknowledgement of support for research: This is the failure to give
oral or documented recognition where applicable of sources of support for a
research undertaking.

Non declaration of conflict of interest: In the undertaking of a research,
there may be a conflict of interest. This is a situation whereby the personal
interests of the researcher are positioned ahead of the university’s interests.
Conflict of interest is when the researcher has material interest such as finance;
career or any other that may be have an ethical bearing in the execution of the
research activities. Failure to declare conflict of interest is considered as research
misconduct.

Non suppression of research: certain research topics may be controversial. If
such research complies with scholarly quality and respects all ethical concerns,
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UREC must ensure that such work is not suppressed. The researcher (s) must
not be denied the opportunity of carrying out the research.

Posthumus reputation: There is need to apply caution when conducting
research with the dead. The reputation of the individual, though dead, must be
guarded, and all ethical concerns respected.

Research confidentiality: Respect for the privacy of individuals must be
adhered to when designing and performing research. Researchers should refrain
from disseminating information and research findings that could harm
individuals. Anonymity and caution are called for when dealing with research
materials which are personal, sensitive, and could cause harm to individuals or
society.

Research data: This is primary or secondary information generated or accessed
for use in a given research undertaking. Data could be very personal and
sensitive. It is therefore very important for researchers to apply special control
measures in the handling of data.

Research disputes: This deals with disputes of co-researchers. Researchers
working in a team are encouraged to solve their disputes among themselves. If
they are not able to resolve the dispute, the matter should be referred to
appropriate higher authorities for mediation.

Research ethics: It addresses values, principles and norms that regulate
research activities. Respect for good and positive doings, and deliberate
avoidance of malicious or bad doings while conducting research activities.

Research misconduct: Research misconduct will be considered where there is
demonstrated evidence of fabrication, falsification, or plagiarism related to
research records; misuse and abuse, and non acknowledgement of research
funds; and non declaration of conflict of interest in a research undertaking.

Research record: This constitutes all documented and oral information or
knowledge generated from a research undertaking. Correspondences, proposals,
field and laboratory records, questionnaires, reports, abstracts, dissertations,
theses, articles, proceedings, and special publications among others; that do
relate to the research undertaking.

Research safety: The conduct of research activities ensuring that all safety
procedures are adhered to. This is in compliance with the South Africa
Occupational Health and Safety Act No. 85 of 1993. A University Research Safety
Policy developed will guide researchers in the implementation of research safety.

Scientific integrity: Research activities carried out must adhere to standards
and guidelines that promote scientific integrity.
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4
RESEARCH ETHICAL VALUES
WSU subscribes to ethical values in the relationship between the researcher and: WSU,
Research Community, Research Participants, Research Sponsors/Clients, Society and the
Environment.
4.1
THE RESEARCHER AND WSU
The researcher must ensure that research conducted by him/her or with associates,
employees, or students of WSU conforms to ethical values, respecting the ethical
principles advanced to in this policy.
4.2
THE RESEARCHER AND RESEARCH PARTICIPANTS
The researcher should also inform participants, where appropriate, about all aspects of
the research, especially its aims and implications in order to influence their willingness to
participate. The researcher should first reach a clear and fair arrangement with the
participants of his/her study before involving or engaging them in such a process. All in
all, s/he should obtain the consent of the participants.
The researcher should not regard the pursuit of knowledge as the supreme goal at the
expense of the personal, social and cultural values of the participants.
The researcher should emphasize to participants at the outset their volunteer status and
their right to withdraw, whether or not payment or other inducement is offered.
The researcher should respect the privacy and psychological well-being of participants,
especially with regard to non-volunteers, based on observation or on records (some of
which may be confidential). S/he should honour all guarantees of privacy, confidentiality
and anonymity and should not coerce or humiliate participants.
The researcher should obtain permission from the parents and/or guardians of infants
and children participants before involving them in his/her research. The researcher
should also exercise caution when discussing results of such research with parents,
guardians, or teachers of the children since evaluative statements may carry unintended
weight.
The researcher should be responsible, considerate and should do nothing to injure,
harm, or disturb the participants from whom s/he collects information. Reports on
his/her findings may be subject to public scrutiny.
4.3
THE RESEARCHER AND THE RESEARCH COMMUNITY
The researcher should endeavour to conduct his/her research in a scientifically and
scholarly manner. The researcher (or team of researchers) should accept responsibility
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for the design, methodology and execution of the research, plan it in order to optimize
the validity of the findings, report the limitations of the findings, and indicate, where
applicable, possible alternative interpretations.
The researcher should recognize and acknowledge the right of fellow researchers to
select from a variety of paradigms, methods and techniques.
In the communication of his/her findings, the researcher should subscribe to the
principles of honesty, comprehensiveness and exposure to public scrutiny.
The researcher should not misuse his/her position as a researcher for personal gain.
4.4
THE RESEARCHER AND THE SPONSORS/CLIENTS OF RESEARCH
The researcher has the right to demand from the sponsor/client of his/her research
clearly set out conditions and terms of the research or service, after which an explicit
agreement or contract may be drawn between the two parties.
The researcher should accept the right of the sponsor/client to request information on
the conduct of his/her research or service at any stage in the course of the research.
However s/he should not tolerate interference by sponsors or clients that may
jeopardize the scientific integrity of the research or prejudice the interest of the research
participants.
The researcher may not provide the sponsor/client with information that may reveal the
identity of individual participants in the research without permission from such
participants.
The researcher should negotiate the possibility of publication of his/her research findings
in scientific journals with the sponsors or clients of the research.
4.5
THE RESEARCHER AND SOCIETY
WSU is committed to research that will make a significant contribution directly and
indirectly to the welfare and quality of life of South Africans and people from other
nations resident in South Africa.
WSU prohibits all forms of inequality and injustice in society and, through its research
and other forms of service, will seek to contribute to the improvement in the lives of
disadvantaged and deprived South Africans.
4.6
THE RESEARCHER AND THE ENVIRONMENT
The researcher must maintain the highest standards of safety in procedure, equipment,
and premises.
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The researcher should evaluate the potential impact of his/her research on the
environment, and declare that possible impact. The components of the environment will
include different types of buildings and construction sites, mining and industrial settings,
soils, water bodies (ponds and lakes, streams, rivers, subsurface waters), and
atmosphere. Strict control in the conduct of research will aid in addressing
environmental monitoring and control, environmental pollution and waste management.
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GROUPINGS OF RESEARCH ETHICS
Researchers must accept ethical and scientific responsibility for the research they
conduct or manage and must ensure that research proposals are channeled through the
appropriate office at WSU. Specialist subject areas which call for ethical approval and
monitoring of research activities include the following: Biomedical Research Ethics,
Animal and Plant Research Ethics, Humanities and Social Sciences Research Ethics,
Business, Management and Law Research Ethics, Education a Research Ethics nd other
specialised Research Ethics.
5.1
BIOMEDICAL RESEARCH ETHICS
This covers biomedical research activities that involve human subjects including
cadavers, human body parts and human body fluids. The proposals must have ethical
approval by the UREC. Applications for the approval must be channeled through the
appropriate research ethics committee including that of the Faculty of Health Sciences
before consideration by the UREC. Ethical clearance is also required where human
subjects including cadavers, human body parts and human body fluids are also used for
teaching and exhibition.
5.2
ANIMAL AND PLANT RESEARCH ETHICS
WSU is committed to ensuring complete ethical and humane use and careful
responsibility in the handling of animals and plants for research. Research activities that
involve any type of animals (including domestic animals, pets, amphibians, reptiles,
mammals, aves, fish and crustaceans, insects, anthropods, among others) and plants
are of ethical concerns. Proposals for such research activities from staff and students
must have ethical approval by the UREC. Ethical clearance is also required where
animals are also used for teaching and exhibition.
Under the guidance of the DVC: AA&R, policy and procedures dealing with all aspects
for care and use of animals and plants for research and teaching be developed with
respect to ethical concerns.

The UREC shall establish, review guidelines for use of animals and plants in
research and teaching.
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5.3
Scrutinise procedures and protocols involving the use of animals and plants for
research and teaching.
Maintain ethical standards in the handling of animals and plants for research and
teaching.
Ensure that WSU ethical standards for handling and use of animals and plants for
research and teaching are in conformity with national and relevant international
ethical standards for the management of animals for research and teaching.
Guidelines shall be set to address animal euthanasia, tumor induction, use of
analgesia, genetically modified animals, blood and tissue collection, aspects of
cloning, animal monitoring, transportation and storage, animal breeding, and any
other relevant procedure or technique dealing with animals for research and
teaching.
Facilitate seminars and workshops dealing with ethical issues in the use of
animals and plants for research and teaching.
Stop or terminate the use of an animal or plant in research activities that deviate
from approved proposal and protocol.
Order euthanasia to be carried out if unbearable pain is brought to an animal
through research activities.
Order the closure of an animal facility or plant facility that does not comply with
ethical standards.
HUMANITIES AND SOCIAL SCIENCES RESEARCH ETHICS
This covers non biomedical research activities in the humanities and social sciences that
involve human subjects including cadavers, human body parts and human body fluids.
The proposals must have ethical approval by the UREC. Applications for the approval
must be channelled through the appropriate research ethics committee before
consideration by the UREC. Where questionnaires are involved, they should be subjected
to ethical clearance as well.
Under the guidance of the DVC: AA&R, the UREC must:
5.4

Ensure the implementation of policy and procedures dealing with ethical issues in
respect of human and social sciences.

Ensure that researchers show respect and allow for the preservation of cultural
artefacts, texts, archive, remains and monuments dealing with the past.

When working with different cultures, UREC must ensure that researcher(s) have
adequate knowledge and respect for tradition and local authorities.

Researchers must respect the private interests of private businesses and special
groups and institutions that are not interested in a research activity.
OTHER SPECIALISED RESEARCH ETHICS
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This covers research activities that involve hazardous biological, chemical, and geological
materials. It also refers to the conducting of research in hazardous environments. Safety
considerations are of prime importance especially when dealing with radiation materials.
The proposals must have ethical approval by the UREC. Ethical clearance is also required
where hazardous biological, chemical, and geological materials are also used for
teaching and exhibition.
Hazardous biological, chemical, and geological materials can cause harm to individuals,
animals and the environment.
The DVC: AA&R through UREC must:

Ensure that staff and students engaged in research activities dealing with
hazardous, toxic and ionizing radioactive materials have understanding of ethical
issues, guidelines, and good code of conduct in performing such research.

Ensure that hazardous, toxic and ionizing radioactive materials are avoided as
much as possible in the execution of research activities; but only used where
there is no suitable alternative.

Ensure that research activities involving hazardous, toxic, ionizing (x-rays,
gamma rays, alpha and beta particles) and non ionizing (micro waves, radio
waves, ultra violet rays) radiations have very limited exposure of radiation
materials to staff, students, the university community, and the biophysical
environment.

Ensure that staff and students engaged in research activities dealing with
hazardous, toxic and ionizing radioactive materials have adequate knowledge of
appropriate accident and emergency procedures.
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RESEARCH POLICY IMPLEMENTATION AND MANAGEMENT
6.1
RESEARCH POLICY IMPLEMENTATION
The WSU Senate Research Ethics Committee will manage research ethics affairs at the
institutional level.
The DVC:AA&R will provide strategic leadership on research ethics at WSU.
The Director: Research Development will be responsible for the development and
implementation of an institutional research ethics strategy and an annual strategic
functional research ethics plan. In addition, the Director of Research will liaise with key
internal or external stakeholders such as the Senate Research Ethics Committee, the
Departments of Health, Science and Technology, Education, Agriculture at the level of
vision, mission, policy and strategy for research development in the University.
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At the decentralised level, there will be similar Faculty Research Ethics Committees in
each of the four Faculties or University-wide Centres. In addition to the above, WSU has
its Research Committee, Research Mentoring Committee as well as Higher Degrees
Committee.
6.2
RESEARCH ETHICS COMMITTEES
6.2.1 University Research Ethics Committee (UREC)
The UREC shall have the following members:
 Deputy Vice-Chancellor: Academic Affairs & Research - Chair
 Deputy Vice-Chancellor (PQA and Development)
 Director: Research Development-Convener
 Director: Postgraduate Unit
 Director: Quality Assurance
 Research Ethics Committee Coordinator of each Faculty
Based on the type of research and research topic, additional members will as indicated
below be added:
- Representatives from Professional Councils;
- Representatives from the Clinical Sciences;
- Any other relevant person on ad hoc basis.
The scope of the UREC shall include the following:
 The DVC: AA&R or at his discretion, the Director of WSU Research Development
or another person shall serve as the chair;
 The UREC shall meet regularly to address pertinent issues;
 The specific dates of meeting of the UREC are incorporated into the University
Almanac for transparency of dates of meetings and avoidance of clashes of
meetings for members;
 The UREC shall accept research proposals from the Director: Research
Development submitted through the Chairs of FHDCs;
 Chairs of the FREC, FRMC and FHDCs may be co-opted as members of the
UREC;
 The UREC shall draw up strategic functional and implementation plans for every
academic year;
 Copies of the strategic functional plan will be forwarded to the WSU Research
Development;
 The UREC shall submit quarterly reports of its activities to the WSU Research
Office and Postgraduate Unit.
6.2.2 Faculty Research Ethics Committee (FREC)
This committee shall be responsible for the development and implementation of
research ethics at the faculty. The committee’s substantive and procedural functions will
be in accordance with the WSU Research Ethics Policy. Its activities among others will
include the following:


Each Faculty shall have a research ethics committee;
The Faculty shall appoint an active researcher and academic as its convener and
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6.3
chair;
Each Faculty shall have a research ethics policy;
The FREP shall be consistent with the University Research Ethics Policy;
The FREC shall meet regularly to address pertinent issues;
The specific dates of meeting of the faculty ethics committee must be
incorporated into the Faculty Almanac for transparency of dates of meetings and
to avoid clashes of meetings for members;
The FREC shall accept research proposals from the Faculty Research Ethics
Coordinator;
The Faculty Research Chair Coordinator shall be a member of the FREC;
The Agenda and minutes of the FREC shall be documented and records kept
thereof;
Preferably, a person with training in research ethics or an active researcher will
be the Chair of the FREC;
At least two members from the FHDC will be members of the FREC;
The chair of the FRMC will be a member of the FREC;
The FREC shall work harmoniously with the FRMC, FHDC, UHDC and the WSU
Research Office;
Each FREC shall draw up a strategic functional and implementation plan for every
academic year;
Copies of the strategic functional plan shall be forwarded to the respective
Executive Dean, with copies to the Director: Research Development ;
Each FREC shall submit quarterly reports of its activities to the respective
Executive Dean, with copies to the Director: Research Development.
IMPLEMENTATION AT SCHOOL AND DEPARTMENT LEVELS
The Directors of Schools and Heads
implementation of the research ethics
respectively. In case staff and students
ethical concerns, they may contact their
the Director of Research Development.
6.4
of Department will be responsible for the
policy at the School and Department levels
are not sure of how to proceed on issues of
Heads of Departments, Directors of Schools or
BENCHMARKING OF RESEARCH ETHICS OUTPUTS
This will be in accordance with the requirements specified in the WSU Research Ethics
Policy.
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DIRECTORATE OF RESEARCH DEVELOPMENT
RESEARCH ETHICS FORM (DRAFT)
This form has eight sections. Applicants must complete section one and at least one of
the other six sections and the administrative section where applicable. The appropriate
recommendations, signatures and dates should be obtained before submission to the
Directorate of Research Development.
SECTION ONE: GENERAL
1.1
Name of Principal Researcher:……………………………………………………..
Department:…………………………………………………………………………
Faculty:……………………………………………………………………………..
Title and Qualifications…………………………………………………………….
Office Tel:………………………………..Cell………………………………….…
Fax:………………………………………Email:…………………………………..
1.2
Name(s) of Co- Researcher(s):……………………………………………………..
Department:…………………………………………………………………………
Faculty:………………………………………………………………….………….
Title and Qualifications……………………………………………………………..
Office Tel:………………………………..Cell……………………………………
Fax:………………………………………Email:………………………………….
Name(s) of Co- Researcher(s):……………………………………………………..
Department:…………………………………………………………………………
Faculty:………………………………………………………………….………….
Title and Qualifications……………………………………………………………..
Office Tel:………………………………..Cell……………………………………
Fax:………………………………………Email:………………………………….
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Project Details
1.3
Full title and Abstract of the Project:
1.4
Research Problem
1.5
Research Objectives
1.6
Research Methodology
1.7
Expected Significance of Study
1.8
Other relevant Project Information
1.9
Proposed duration of Project (give start and end dates):
1.10
Place of Fieldwork:
1.11
Experimental Site:
General Ethical Concerns
1.12 Is this a degree oriented research? If yes, give names and titles of supervisor(s),
Departments and telephone contacts
1.13
If researcher does not posses a doctorate degree, give names and titles of
mentor(s), Departments and telephone contacts
1.14
Where confidentiality is required in the research project, explain how it will be
ensured and guaranteed?
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1.15
Explain how the findings of the research project will be disseminated taking into
consideration recognition of ethical concerns?
1.16
It is required that consent is sought if human subjects are involved. Explain
whether consent will be verbal or written. Attach a copy of the consent
statement which will be applied to this study.
1.17
It is required that researchers declare any conflict of interest. Explain any conflict
of interest (who, and how, and extent of conflict of interest). Failure to disclose
any conflict of interest may result to disciplinary action.
1.18
Explain any physical, biological, chemical, safety, psychological or any related
concerns/harm this research project can cause in its execution.
1.19
Is this a collaborative research with other institutions? If yes, give names, titles,
qualifications, email addresses and telephone numbers of collaborators. Will
additional ethical clearance be required from institutions of collaborators?
1.20
Will there be recorded media (audio, video or other – specify) involved in the
execution of the research project? If yes, explain.
1.21
How will the research be funded? If human subjects are participants, have costs
for transportation, feeding, and honoraria been factored into the budget?
Explain.
SECTION TWO: BIOMEDICAL RESEARCH ETHICS
2.1
Indicate type of research: Basic research/ applied research/ clinical/medical
equipment trial/experimental/epidemiological/ observational/ psychological/other
– specify
2.2
Explain statistical concerns for sampling and statistical techniques to be used
2.3
Indicate which of the following procedures will be used for data gathering?
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Structured interview/ Questionnaire administration/Review of existing records/
medical examination/urine and analysis/fecal samples and analysis/ body fluids
and
analysis/blood
sampling
and
analysis/biopsy/
plant
components/experimental animals/other (specify)
2.4
Indicate which type of human subjects are included in the research: humans in
existing data/healthy persons/patients/individuals who are sick (or ill)/males/
females/ pregnant persons/professional/ prisoners/fetuses/ cadavers/ other
types of human material (specify)
2.5
Explain how samples and specimens will be disposed of.
2.6
Are there any financial benefits given to the researchers by pharmaceutical
companies? If so, please indicate and explain how this does not affect research
objectives.
2.7
Indicate and explain what types of risks are involved in the execution of the
project and steps to be taken to reduce the risks? The risks should include pain,
discomfort, stress and strain, accidents and other complications
2.8
Are the methods used tested, recognized and established? If no, how were the
methods derived?
2.9
Is there a pilot study phase of the project? If yes, does it take into consideration
the anticipated risks and how they can be reduced?
2.10
Will there be need for interim analyses? If yes, explain.
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SECTION THREE: ANIMAL AND PLANT RESEARCH ETHICS
3.1
Indicate type of research: Basic research/ applied research/ diagnostic
procedures/animal biology/animal production/animal management/environmental
study/ production of biological products/ psychological/other – specify
3.2
Which of the following procedures will be performed on the animal in the
execution of the project? Observations with interferences/conscious &
unconscious
intervention/physiological
challenges/surgical/invasive
intervention/genetically modified animal/ death/other (specify)
3.3
Why must animal(s)/plant(s) be used in the research? Is there no alternative
method that can be used to carry out the same project?
3.4
Which animal(s)/plant(s) will be employed for the research project?
3.5
Explain why the choice of the animal(s)/plant(s)
3.6.
The use of animals/plants in research should be minimized as much as possible.
Can the animals/plants or animal material be used for another research project?
What will be the fate of the animal(s)/plant(s) at the end of the project? Will the
animal(s) be euthanised? If so give generic name(s) of drug, the dosage and the
route of its administration.
3.7
What is the number of animal(s)/plant(s) to be used in the research project? Is
that the most minimum? Explain how the number can be further cut down.
3.8
From where will the animal(s)/plant(s) be obtained and how will the
transportation to research site be carried out?
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3.9
Where and how will the animals be housed during the execution of the research
project? How many animals will be put in one cage or pen? Is the housing site
quarantined? If plants, where and how will they be grown/kept during the
execution of the project?
3.10
What diet will the animal(s) be put on? What will be the
chemicals/fertilizers/manure used for the plant(s) during the experiments? Is
there any special care required? If so explain.
3.11
Who and how will the animal(s)/plant(s) be monitored after work hours, during
weekends, public holiday and vacation?
SECTION FOUR: HUMAN AND SOCIAL SCIENCES RESEARCH ETHICS
4.1
What type of research is this?
4.2
Are the interviews structured or otherwise? Explain the type of questionnaire
being administered (open ended questions or otherwise).
4.3
Describe the rationale and reason for choosing the study population
4.4
What is the purpose of the study? (Is it a pilot study or a full study?) Is this
study going to generate new knowledge or will confirm existing knowledge?
4.5
Describe how recruitment will be conducted taking into consideration social and
cultural aspects, screening measures and authorization.
4.6
Which processes will be used in obtaining informed consents, and why are these
processes chosen over others?
4.7
What methods will be used for non disclosure of sensitive data/information, and
what risks are associated therein?
4.8
What are the direct and indirect benefits to participants of the study?
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4.9
Explain how the study complies with legislation and individual rights to privacy
4.10
Is there any conflict of interest? If so, how is it accommodated without
compromise in the conducting of the research?
SECTION FIVE: BUSINESS, MANAGEMENT AND LAW RESEARCH ETHICS
5.1
What type of research is this?
5.1
Will information be collected from corporations and companies or other agencies
about individuals without their direct consent? If so, how will the information be
sought and why will individual consent not be sought?
6.3
If recorded media (audio, video or other) will be used in the execution of the
research project, specify where the materials will be retained after the study; for
how long will they be retained; and how they will they eventually be disposed of.
SECTION SIX: EDUCATION RESEARCH ETHICS
6.1
What type of research is this?
6.2
Will information be collected from institutions such as universities, schools,
employers, government and related, or other agencies about individuals without
their direct consent? If so, how will the information be sought and why will
individual consent not be sought?
6.3
If recorded media (audio, video or other) will be used in the execution of the
research project, specify where the materials will be retained after the study; for
how long will they be retained; and how they will they eventually be disposed of.
6.4
Will children be engaged in the research? If so which age grouping? Will the
children be those in the care of a local authority, orphanage, foster home, or
living with their parents? Please explain.
6.5
Does the research focus on participants with special educational needs?
Physically or mentally ill? Vulnerable in other ways? Racial or ethnic minority?
Please explain.
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6.6
Does the research advance knowledge in Education?
SECTION SEVEN: OTHER SPECIALIZED RESEARCH ETHICS
7.1
Which of the following health and safety hazards to other animals, humans and
or environment will be introduced during the execution of the research project?
Teratogens/carcinogens/anaesthetic gases/genetically modified organisms/
biological / chemical / radioactive /geological hazards/other (specify)
7.2
If plant or animal, is it an endangered/exotic species?
7.3
Do you have understanding of ethical issues, guidelines, and good code of
conduct in performing research that deals with hazardous, toxic and ionizing
radioactive materials/exotic or endangered species? Explain your understanding
in relation to the study you intend to undertake, if applicable.
7.4
Why did you choose to conduct research using hazardous, toxic and ionizing
radioactive materials/ exotic or endangered species? Could you not have avoided
using the materials? If not, explain why?
7.5
What measures will you take to ensure that only the most minimum quantities of
materials are used through out the experiments? Such measures should include
keeping a logbook.
7.6
How would you control exposure of hazardous, toxic, ionizing and non ionizing
radiations to staff, students, university community, and the biophysical
environment?
7.7
Do you have adequate knowledge of appropriate accident and emergency
procedures in place during the conduct of the research activities?
7.8
Explain how you will dispose of the wastes that will be generated during the
research activities.
7.9
Will appropriate warning signs be displayed where necessary? If yes, which
signs, and if no why not?
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SECTION EIGHT: ADMINISTRATIVE SECTION
I, ……………………………….confirm that the information provided in this form to the best
of my knowledge is accurate, and that the project will be executed in accordance with
the University Research Ethics Policy, the University Mentoring Policy, and the University
Research Policy.
Signature of (Principal) Researcher:
Date:
Faculty Research Ethics Committee
1.
Name of Faculty Research Committee Chair:
Recommended/Not recommended (delete where applicable)
If not recommended, why?
Date:
Signature:
2.
Name of Executive Dean of Faculty:
Recommended/Not recommended (delete where applicable)
If not recommended, why?
Date:
Signature:
University Research Ethics Committee
UREC recommendation(s), date of consideration and Signatures of Director: Research
Development and Chair of UREC:
1.
Recommended/Not recommended (delete where applicable)
If not recommended, why?
Date:
Signature of Director: Research Development:
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2.
Recommended/Not recommended (delete where applicable)
If not recommended, why?
Date:
Signature of Chair:
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