ELEMENTS OF RESEARCH ETHICS

Renan P. Limjuco, Ph.D.

Chair, UIC-REC
 Social Value
■ relevance of the study to an existing social or health problem
such that the results are expected to bring about a better
understanding of related issues, or contribute to the promotion
of well-being of individuals, their families, and communities.
■ significance of the study, i.e. how the study will help arrive at a
solution.
■ scientific validity, i.e. study design, methodology, and data
collection, overall, should be able to generate information
supportive of the objectives of the study.
■ dissemination plan (appropriateness and applicability) for the
study results shall be included in the protocol.
 Informed Consent
■ a decision of a competent potential participant to be
involved in research after receiving and understanding
relevant information, without having been subjected to
coercion, undue influence, or inducement

■ obtaining informed consent is a process, i.e. respect for

the prospective participants’ dignity and autonomy must
be manifested; researchers shall have the duty to avoid
deception, undue influence, or intimidation
 Informed Consent
■ essential information must be disclosed: 1. name and affiliation of
the researcher; 2. must be understood as an invitation to participate; 3.
reasons for considering the potential participants; 4. voluntariness; 5.
purpose of the research, the procedures to be carried out by the
researcher; 6. expected duration of the individual’s participation; 7. any
foreseeable risks, pain or discomfort, or inconvenience to the individual,
including risks to the health or well-being of the individual’s spouse or
partner; 8. direct benefits; whether money or other forms of material
goods will be provided in return for the individual’s participation; 9.
expected benefits of the research to the community or to society at large,
or contribution to scientific knowledge; 10. respect for the privacy of
research participants and the confidentiality of records in which they are
identified; 11. participants are free to withdraw from the research at any
time without having to give any reason
Vulnerability of Research Participants
■ those who are relatively or absolutely incapable of deciding for
themselves whether or not to participate in a study for reasons
such as physical and mental disabilities, poverty, asymmetric
power relations, and marginalization, among others and who are
at greater risk for some harms.
■ shall not be included in research unless such research: 1. is
necessary to promote the welfare of the population represented;
2. cannot be performed on non-vulnerable persons or groups.
Vulnerability of Research Participants
■ Competent advice and assistance shall be provided to
participants who, by virtue of social, economic, political
or medical disadvantages, are liable to give consent
under duress or without the benefit of adequate
information.
 Risks, Benefits, and Safety
■ the population from which the participants are derived
stand to benefit from the research.
■ there must be a careful assessment of predictable risks,
burdens, and foreseeable benefits to the research
participant or to others.
■ a careful assessment of predictable risks, burdens, and
foreseeable benefits to the research participant or to
others must be done.
■ acceptable positive benefit-risk ratio.
■ researcher/funder/sponsor shall endeavor to ensure
the reasonable availability and accessibility of favorable
research outcomes to the community.
 Privacy and Confidentiality of
Information
■ researchers shall adhere to the principles of
transparency, legitimate purpose, and proportionality in
the collection, retention, and processing of personal
information (Data Privacy Act of 2012).
■ researchers must respect participants’ right to privacy.
Unless required by law, the confidentiality of
information shall at all times be observed.
■ records that link individuals to specific information
shall not be released. This requirement shall be included
in the informed consent form.
 Privacy and Confidentiality of
Information
■ researchers shall refrain from identifying individuals or
groups when release of information about them can
expose them to possible harm or social stigma unless
required by law.
■ where there is some likelihood or opportunity for the
researcher to observe the occurrence of illegal or
harmful behaviors (e.g., child abuse, substance use, self-
harm, or suicide ideation), the researcher shall 1. explicitly
indicate the limits of confidentiality in the informed consent process ; 2.
emphasize the right of the respondent to withdraw from the study or
withdraw his or her data, and to refuse to answer any question
 Privacy and Confidentiality of
Information
3. Prepare a concrete and realistic protocol for reporting and referral in the event
that imminent harm and/or a criminal act is disclosed or discovered in the process
of data collection.
■researchers shall recognize that collecting data using group methods
(e.g., FGDs) has implications for the privacy and confidentiality of
individuals, i.e. ensure that the nature of the study and the questions would
cause minimal harm should confidentiality or anonymity be breached.
■ researcher shall describe his or her data protection plan in the
protocol, including the steps to be taken so that all who have access to
the data can safeguard privacy and confidentiality
 Privacy and Confidentiality of
Information
■ researcher shall provide adequate and clear instructions
to research assistants, transcribers of audio recordings,
or translators of transcriptions.
 Justice
■ there must equitable distribution of both the burdens and
the benefits of participation in research. That is, it should
not be the case that one group in society bears the costs
of research while another group reaps its benefits, i.e. 1.
fair selection in the choice of population, sampling, and assignments; 2.
provision of appropriate care to research participants regardless of their
economic status, gender, race, or creed; 3. just compensation for harms brought
about by participation in the research; 4. reimbursement for lost earnings,
travel costs, and other expenses incurred ; 5. participants may be given a
reasonable and appropriate incentive for inconvenience
■ individuals and communities shall have access to benefits
related to participation in the study.
 Transparency
■ It is imperative for all parties to be transparent about
matters relating to their involvement, i.e. 1. promotes
confidence in the research enterprise, even when privacy and anonymity need to
be preserved about sensitive matters; 2. entails disclosure of research results.
■ researchers must be transparent about aspects of a
study that may have an impact on the rights, health, and
safety of participants, or in respect to information that
may have a bearing on the decision of participants to
give or withhold their informed consent.
 Transparency
■ researchers must disclose information about their
affiliations, financial interests, or other loyalties that may
affect their objectivity and the integrity of their research
output.
■ research participants need to be truthful in declaring
their health conditions, and to be candid in expressing
their concerns about their involvement in research.
Qualification of the Researcher
■ persons engaged in research involving human
participants shall have moral fortitude, scientific
competence, social awareness, cultural sensitivity,
intellectual humility, vigilance, and preparedness in
safety issues.
■ researcher shall have the training, ability, and resources
to conduct the proposed study.
■ researcher shall be knowledgeable of the literature on
the research topic.
 Adequacy of Facilities
■ assurance that the research environment for the specific
issues must be supportive of protocol procedures and
well-being of participants; i.e. library must make accessible
the peer-reviewed journals; equipped laboratory facilities, pool of
experts; data analysts;
 Community Involvement
■ respect for local traditions and culture, community
empowerment, acknowledgement of participation.
■ benefits must be made clear to the individuals and to
communities that they represent
■ research forum for the stakeholders must be possibly
organized for the dissemination of research results
THANK YOU FOR YOUR
ATTENTION.