RESEARCH
ETHICS
THEORY
HND-603
RESEARCH PLANNING AND SCIENTIFIC WRITING
3(3-0)
SEMESTER 7 T H
What is ethics? What is Research?
What exactly is
research Ethics?
ETHICS DEFINED
A discipline dealing with what is proper course of action for man
(Aristotle, cit in Mckeon,1941)
A branch of philosophy that looks at what is good and what is bad
A system of obligation that we have towards others
Also known as moral philosophy, involves, systematising,
defending, and recommending concepts of right and wrong
behaviour
A study of principles guiding the good of the individual within the
context of social interactions and the community
ETHICS DEFINED
Meta Ethics: “is a branch of analytic
philosophy that explores the status,
foundations, and scope of moral values,
properties, and words”
Normative Ethics: addresses the
ETHICS AS A question of ‘What ought to be done?’
THEORETICAL Normative Ethical theorists seek to
ENTERPRISE provide action guides and codes.
Applied Ethics: domain specific
ethics (Business, biomedical,
engineering, etc.)
Generalisability of findings: the
extent to which the sample used in the
research project reflects the broader
population of interest
Univesality and
Scientific Rigour
objectivity (explicit
(truth is accepted if there
Key rules and systematic
is sufficient evidence to
procedures)
support claims made Features of - Research should be
through the research
process. Such claims
Scientific designed in a manner
Research that allows any
have to withstand the
competent researcher to
scrutiny of repeated
conduct a similar study
testing)
and generate the same
findings
Originality of research work: original
ideas backed with appropriate evidence in a
clear, logical and convincing argument that
illustrates critical and analytical thinking.
Research Ethics therefore
are:
1. A code of guidelines on how to conduct
scientific research in a morally acceptable way.
2. Principles and standards that help researchers to
uphold the value and standards of knowledge
construction.
ETHICAL CONSIDERATIONS IN THE RESEARCH
PROCESS
1. Conceptualisation and design of the study
(scientific merit, identify risks and ways to
mitigate the risks)
Ethical
considerations 2. When participants are recruited (the process of
informed consent, right to privacy)
come into play
at five stages of 3. During the intervention or measurement
procedure to which participants are subjected
research (management of risk)
4. In the release of results obtained
(protection of confidentiality and anonimity)
5. After the release of results (ensure that
participants and communities involved in the
research benefit)
ANOTHER WAY OF LOOKING AT RESEARCH ETHICS IS
BY LOOKING AT UNETHICAL RESEARCH CONDUCT
Deception (issues of full disclosure)
Plagiarism
Conducting research that does not have a scientific base (ill-
formed problem statement)
Fabrication or falsification of data
Not respecting the right to privacy
Not respecting the right to anonymity and confidentiality
Not respecting rights of vulnerable groups
• Children
• Mentally handicapped individuals
• The aged
• Prisoners
• Illiterate
• Those with low social status
PRINCIPLES OF ETHICS
DIFFERENCE BETWEEN CLINICAL AND SOCIAL SCIENCE
RESEARCH
Clinical Research Social Science Research
Definition A research study intended to test A systematic recording and
safety, quality, effectiveness of analysis of data that
new and/or existing or old may lead to generaliseable,
medicines, medical devices principles and
and/or treatment options, using theories resulting in prediction and
human participants possibly management of
behaviour and events in society.
Research Invasive and non-invasive Review of literature, review of data,
activities procedures that may include interviews, focus groups,
surgical intervention, removal of observatations, administration of
body tissues/ fluids, survey instruments, or tests etc.
administration of chemical
substances, observation,
administration of questions etc.
Phases or Four phases More or less eight phases
steps (depending on research questions
followed and design of the study)
PHASES OF RESEARCH: CLINICAL VS SOCIAL
CLINICAL TRIALS SOCIAL RESEARCH
PHASE I: A new drug, vaccine or PHASE 1: Problem identification
medical device is tested in a small group
PHASE2: Problem definition
of healthy persons for the very first time.
The aim is to determine the general
safety, the correct dosage and negative PHASE 3: Development of a theoretical
effects. framework
PHASE II: Clinical trials the new drug, PHASE 4: Hypothesis formulation or
vaccine or medical device in a larger literature review
group (several hundred people)
PHASE III : testing to several thousand PHASE 5: Research Design
people
PHASE IV: clinical trials done to several PHASE 6: Data collection
thousand people after the new drug,
vaccine or medical drug has been
registered and licensed for sale by the PHASE 7: Data analysis
Medical Control Council
PHASE 8: Report writing and
dissemination of findings
WHY BE CONCERNED WITH RESEARCH ETHICS?
1. Professional Responsibility
2. To avoid reputational damage
3. Research can be harmful to:
• Participants
• To researchers
• To institutions
• To research communities
INFORMED CONSENT
A consent given by well informed potential participants
about the nature of the research procedure, scientific
purpose,and about the risks and benefits of the study.
Informed consent is given without subjecting the
potential participant to coercion, intimidation or undue
influence
Participant’s understanding of the research aim and
objectives must be addressed by laying out the details
out in the language the participant understands, in a
culturally acceptable way.
STAGES AND PROCESS OF INFORMED
CONSENT
Stages of informed Informed Consent Activities
consent
Before the commencement Assessment of the local culture
of the study Identification of risks and benefits before and
after the study
Pilot testing
At the beginning of the Information is presented with the aid of support
study material to enhance understand of the research
aims and objectives
Risks and benefits of the study are presented
Understanding is assessed
During the study Reinforce key ethical principles
Address issues of concern
KEY ELEMENTS OF INFORMED CONSENT
Description of research aims and objectives
Description of potential risks
Description of expected benefits
Explanation of confidentiality and anonymity of participants
Explanation of participants rights including the fact that
participation is voluntary
Explanation of issues relating to remuneration/compensation for
injuries
HOW TO SUBMIT A PROPOSAL FOR ETHICAL
CLEARANCE
The proposal submitted for ethical approval should
demonstrate that each of the following ethical aspects are
not only addressed, but are discussed in a logical and
cogent fashion:
1. Respect and dignity of participants
2. Privacy and confidentiality
3. Balance of benefits and risks
4. Sampling plan – fair participant selection
5. Competence and capacity of researcher
6. Protocols and procedures followed in dealing with minors,
vulnerable persons (if applicable)
