ETHICAL CONSIDERATIONS IN THE
CONDUCT OF HEALTH SCIENCES
RESEARCH
WHAT IS ETHICAL RESEARCH
• A research is ethical when the researcher
• Carry out the research competently, rigorously
and methodologically
• Manage resources with respect and integrity
• Acknowledge fairly those who contribute
guidance and asssitance
• Communicate results accurrately
• Consider the consequences of the research for
the field of study in particular and for the society
in general
FUNDAMENTAL ETHICAL PRINCIPLES
Three Fundamental Ethical
Principles
• Respect for Persons
• Beneficence
• Justice
RIGHTS OF PERSONS
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Right to self determination
Right to privacy
Right to anonymity and confidentiality
Right to fair treatment
Right to protection from discomfort and
harm
RESPECT FOR PERSONS
• Based on the following convictions
• Individuals are autonomous that is they have the
right to self determination.
• This implies that they have the right to
• decide whether or not to participate in a study,
without the risk of penalty or prejudicial treatment.
• Right to withdraw from a study at any time
• Right to refuse to give information
• Right to ask for clarification about purpose of study
DIMINISHED AUTONOMY
Individuals with diminished autonomy cannot decide fro
themselves.
These includes children (minors), mentally ill persons,
unconscious patients and institutionalized persons
Where power relations are present the individual may become
vulnerable for example, prisoners, students whose lecturer is
the researcher
In some communities in Africa, individuals are not regarded as
autonomous
In these conditions special attention will have to be given to
protect the right of these individuals
BENEFICENCE
• The researcher must secure the well being of the
participant. Thus the research must provide
benefits. Any research that does not provide
benefit is unethical
• Who benefits from research?
• The individual and the society
• However the individual participant may not
benefit from the research directly or immediately.
Even benefits to the society may be delayed
NON MALEFICENCE
• The complement of the principles of
beneficence is NON MALEFICENCE which
means the research must first do no harm
• To adhere to this principle the researcher
must protect the participants from all forms of
harm such as the following
• Physical harm
• Psychological harm from stigmatization, discrimination,
stereotyping
• Emotional harm such as anxiety, depression, worry, etc
• Spiritual
• Economic harm e.g insurance policy decline, or
insurance premium raise as a cnsequence of the
research, economic goods boycot etc
• Reputational harm
• Social harm
• Legal harm
• It is noted that research may introduce some
harm in the process of obtaining benefits.
Thus the principle of beneficence and non
maleficence is futher clarified to include the
following
• First benefit
• Then do no harm
• Then minimise harm
• Thus the concept of risk benefit ratio
• What is the cost of the benefit? Can the
benefit be obtained through another methods
that is less costly- RISK-BENEFIT RATIO
• The duty of the researcher is to provide
benefit and minimize harm
PRINCIPLE OF JUSTICE
• The principle of justice refers to participants
right to fair selection and treatment.
• Fairness should be shown in selection of the
study population, selection of the unit of
enquiry.
• Participants should not be selected because it
convenient to do so or because the
investigator wants them to benefit from a
certain treatment
• Justice should also be shown in sharing
benefits of research especially when new
drugs are discovered or the research leads to
some economic benefits
• Agreements for between participants in a
research and the investigator should be
respected. Agreements could be on
compensation, puntuality, incentives, sharing
of information or results etc
OPERATIONALIZING THE PRINCIPLES
• Respect for persons
– Privacy
– Confidentiality
– Anonymity
– Consent
• Beneficence and non maleficence
– Assessing risk/benefit ratio
• Justice
PRIVACY ISSUES
• The investigator must respect the participants
right to privacy
• The participant has the right to determine in
what circumstances research information is
derived from him.
• The participant has the right to determine the
circumstances and extent to which
information related to him is shared or not
with other parties.
CONFIDENTIALITY
• Confidentiality is the process of keeping the
identities of participants in a study secret
• In publishing the report of the study,
investigators must ensure that the identities
of the participants are kept secret.
Anonymity
• The participant who agrees to research has the
right to expect that the information collected
from or about him remain anonymous. To be
anonymous means to be nameless
• To ensure anonymity the following can be done
– Use number or code names for participants
– Keep master list of code names in a safe place
– Destroy the list of real names
Consent issues
• The expression of personal autonomy implies
that the individual freely decides to participate in
a research process. To freely decide the individual
must have the capacity to decide, be provided
the information to decide and be free from every
limitation that hinders that decision. Thus
informed consent has three components
– Information
– Comprehension or understanding of the information
– Choice of the individual (Consent or Dissent)
Information
The information must be clear and documented
• The information could be provided in the
following forms
• Written
• Verbal
• Taped
The choice of method depends on the careful
consideration of the individual participants
characteristics
Content of the information
• Title of the research
• Introduction to the research activities,
researchers title and position, the purpose of the
research, the selection of the paticipants and the
population being studied, how the data will be
collected, the risks involved in the study, the
benefits, assurance of anonymity, confidentiality
and privacy, voluntary nature of the participation,
office of the researcher to answer any questions
from the participants, name of contact peson
• Signature for consent
Assessing risk-benefit ratio
• Risk refers to the potential the the participants
may be harmed during the research.
• All research involves a certain amount of risk.
• Benefits are the positive values that the
research provides for example the the study’s
potential contributions to knowledge, practicl
value to the society and the benefit to the
individual participant
• The general rule is that the risk should not
exceed the potential benefit to be gained by
the study.
RESEARCH INTEGRITY
• The researcher must demonstrate respect for the
scientific community by protecting the integrity of
scientific knowledge.
• The researcher must be competent, rigorous accurrate
and honest
• The researcher must refrain from
• Fabrication, falsification or forgery
• Manipulation of design and methods
• Selective retainment or manipulation of data
• Plagiarism
• Irresponsible collaboration