MODULE 3: Ethics in Nursing Research Week 5
1. Universal ethical principles
INTRODUCTION
This module introduces the researchers, especially
beginning researchers, to some of the more critical
principles and concepts of ethics as they are
applied in health research, which they need to
consider when they write their research proposals.
Research involving human participants is defined as
any social science, biomedical, behavioral, or
epidemiological activity that entails systematic
collection or analysis of data with the intent to
generate new knowledge. Human participants are
said to be involved in research when
1) they are exposed to manipulation,
intervention, observation, or other
interaction with investigators, directly or
indirectly, through alteration of their
environment
2) they become individually identifiable
through the investigator's collection,
preparation, or use of biologic material or
medical or other records.
The principles of research ethics are anchored on
the universal ethical principles of respect for
persons, beneficence, and justice. The
requirements for ethical research can be reflected
in many parts of the research proposal, most
notably in the section on 'Ethical Considerations,'
as well as in the Informed Consent that usually
accompanies research proposals that have human
subjects participation.
LEARNING OUTCOME
By the end of the session, the learner should be
able to:
1. Discuss the universal ethical principles;
2. Explain the different elements of research
ethics;
3. Enumerate significant considerations for
each of these elements.
4. Discuss some essential guidelines in
designing and administering informed
consent forms.
OUTLINE
2. Elements of the research ethics
3. The informed consent
4. Vulnerability of research participants
5. Risks, benefits, and safety
6. Privacy and confidentiality of information
7. Justice
8. Transparency
9. How the quality of research is ensured
10. The research protocol
CONTENT
UNIVERSAL ETHICAL PRINCIPLES
These ethical principles include respect for
persons, beneficence, and justice. These principles,
what they mean, and how they are applied to
research, are discussed in the following
paragraphs.
a. Respect for persons and communities
Respect for persons and communities
has everything to do with respect for
their autonomy and capacity for self-
determination. Respecting their capacity
to decide for themselves is a reflection
of the respect for the dignity of an
individual. Respect for communities, on
the other hand, means respect for the
individuals that make up the community
as well as their culture, beliefs, and
practices. Special attention is given to
individuals and communities, which can
be considered vulnerable.
b. Meaning of Beneficence
Beneficence, the second universal
ethical principle, means concern for the
physical, mental, and social well-being of
the human participants and the
communities where they come from.
The risk-to-benefit ratio of participation
in the research must be favorable. This
means that the investigators are
ethically obliged to maximize the
benefits that will be derived from the
research while at the same time
minimizing the risk that is associated
with participation in the research. This
obligation can be largely attained
1 if the
research design is scientifically sound,
 and the investigators are competent by
their training and experience. The
protection of the participants is the
primary responsibility of the researcher.
Beneficence means non-maleficence,
which means to do no harm.
c. Justice
Justice in research is interpreted as an
ethical obligation of the investigator to
treat each person in accordance with
what is morally right and proper. Justice
in research is defined as 'distributive
justice,' which means the equitable
distribution of both burdens and
benefits of participation in research. This
also means the need for special
protection for vulnerable groups.
"Researchers are expected to refrain
from practices that are likely to worsen
unjust conditions or contribute to new
inequities." (CIOMS, 2008)
ELEMENTS OF THE RESEARCH ETHICS
The elements of research ethics include,
among others, the following — social value;
informed consent; vulnerability of research
participants; risks, benefits, and safety; privacy and
confidentiality of information; justice; and
transparency. Social value in the context of
research means that the participation of human
subjects in research can only be justified if the
study has social value. Social value means the
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 the well-
being of individuals, families, or communities.
a. Since social value is of prime importance in
research, the investigators should
present/discuss the social value of his/her
proposed research in at least in significance
of the study, in the study design and
methodology, and in the dissemination
plan. In the significance of the study, the
investigator should clearly describe the
proposed study's
significance and support his claims with an
accurate and updated description of the
status of the social/health problem and
clearly explain how the proposed study will
help address the problem. The proposed
study design and methodology should be
able to generate information that will
support the objectives of the study. Social
value can be achieved only if the study is
scientifically sound. Dissemination of the
study results is essential to achieving social
value. The study participants and their
communities should be informed about the
findings of the study. Thus, a dissemination
plan for the study results, as well as its
intended audience during this
dissemination, should be included in the
research proposal.
THE INFORMED CONSENT
The fundamental ethical principles and their
provisions are operationalized in informed consent
and the process by which informed consent is
obtained and documented.
a. The Informed Consent (IC) is 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. For
participants who are incapable of giving
his/her consent (or have a diminished
capacity to give informed consent), the
researcher must exert efforts to obtain
his/her assent AND the consent of a legally
authorized representative (LAR), in
accordance with applicable laws.
b. For participants who are incapable of giving
his/her consent (or have a diminished
capacity to give informed consent), the
researcher must exert efforts to obtain
his/her assent AND the consent of a legally
authorized representative (LAR), in
accordance with applicable laws.
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 c. Informing the potential participants shall
not merely be a ritual recitation (or
reading) of the contents of a written
document. Instead, the researcher shall
convey the information, whether orally, or
writing, or other modes of communication,
in a language and manner that suit the
individual's capacity and level of
understanding. (It is generally
recommended to use a language and
present them in such a way that it will be
understood by a Grade 6 student.)
d. The researcher shall ensure that the
prospective participant has adequately
understood the information and that the
researcher shall give each participant the
full opportunity to ask questions, and
should answer them honestly, promptly,
and completely.
Essentially, informed consent is obtained by
informing the potential volunteer, by repetition
and explanation, by answering their questions, by
ensuring that they understand each procedure, and
by obtaining their agreement to participate.
Getting informed consent of the participants shows
the researcher's respect for the participants'
dignity and autonomy. Thus, Informed consent is a
communication process between the researcher
and the research participants that starts even
before the research is initiated and continues
throughout the duration of the study.
The following are the essential information that
should be given to the potential research
participants (as part of the informed consent):
a. That the individual is invited to participate
in a research being undertaken by the
researcher (name of researcher) from the
institution (name of institution). If this is
not made clear to the patients invited to
participate in the research (e.g., clinical
trials) they may think this is part of the
usual care and management of patients
b. Why/how the individual was chosen;
c. That the person is free to refuse to
participate without penalty or loss of
benefits to which he/she is entitled;
d. The purpose of the research, the
procedures to be carried out by the
researcher, and an explanation of how the
research differs from routine medical or
health care;
e. The expected duration of the individual's
participation (including the number and
duration of visits to the research center)
f. Any foreseeable risks, pain or discomfort,
or inconvenience to the individual (or
others) associated with participation in the
research;
g. The direct benefits, if any, to individuals
who participate in the research;
h. Whether money (how much) or other
forms of material goods (what kind), will be
provided in return for the person's
participation;
i. The expected benefits of the research to
the community or to society at large, or
contribution to scientific knowledge (i.e.,
indirect benefits, if any)
j. Whether any intervention found to be safe
and beneficial will be made available (when
and how) to the research participants after
they have completed their participation in
the research and whether they will be
expected to pay for them;
k. The provisions to ensure respect for the
privacy of the research participants and the
confidentiality of records in which they are
identified including documentation of their
participation (e.g., photos, audio recording
and transcripts of interviews);
l. Legal or other limits to the researcher's
ability to safeguard confidentiality, and the
possible consequences of breaches of
confidentiality;
m. That participants are free to withdraw from
the research at any time without having to
give any reason, and without penalty or
loss of benefits to which the person is
entitled;
n. The sponsors of the research, the
institutional affiliation of the researchers,
and the nature and sources of funding for
the research;
o. The possible research uses, direct or
secondary, of the person's medical/health
records, and the possible future use of
biologic specimens; on storage of biologic
specimens (where and for how long, and
final disposition).
p. Whether commercial products may be
developed from biological specimens, and
whether the research participant shall
receive monetary or other benefits from
the development of such products;3
 q. The extent of the researcher's responsibility
to ensure needed services to the research
participants;
r. Whether treatment and rehabilitation will
be provided free of charge for specified
types of research-related injury or
complications associated with the research;
s. That a PHREB-accredited REC has approved
or cleared the research protocol; and the
contact information of persons designated
to respond to respond to the following — i)
queries on the details of the protocol; ii)
issues related to the human rights of
participants; iii) related concerns and
grievances; and iv) management of
research-related injuries.
How is the participant's consent documented?
As a general rule, documentation of informed
consent includes an actual signature or thumbmark
of the potential participant on the informed
consent form. When the use of an IC form is not
feasible or unacceptable to the prospective client,
a description of the process, attested by a witness,
may be an alternative that needs prior approval of
the REC. For instance, it will be difficult, if not
impossible, to get signed informed consent for
study populations that are engaged in illegal
activities like illegal drug use or prostitution.
VULNERABILITY OF RESEARCH
PARTICIPANTS
Vulnerable participants shall require special
protection when they are the study population of
research projects. "Vulnerable participants are
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." (CIOMS,
2008)
Vulnerable groups shall not be included in
research unless such research is necessary to
promote the welfare of the population
represented, and such research cannot be
performed on non-vulnerable persons or groups.
Caution shall be observed in obtaining informed
consent for a research project if the research
participant is in a dependent relationship
(organizations with a hierarchical structure) with
the researcher to ensure that the consent is not
given under duress or undue influence. In general,
vulnerable populations are composed of the
following populations:
a. Children
b. Elderly persons
c. Dependent population (e.g. subsidiary
members of a hierarchical group)
d. Uncomprehending subjects (e.g., mentally
retarded, uneducated or illiterate, senile,
linguistically disadvantaged, inebriated,
unconscious, dying)
e. Mentally or behaviorally disabled
f. Patients in emergency rooms
g. Ethnic/racial minority groups
h. Homeless persons
i. Nomads, refugees or displaced persons,
and persons traumatized by violence
j. Patients with the incurable disease
k. Individuals who are politically powerless
RISKS, BENEFITS, AND SAFETY
Concerning potential risks, benefits, and safety
related to the participants' participation in
research, the following are some essential
guidelines:
a. Research is justified if there is a reasonable
likelihood that the population, from which
the participants are derived, stand to
benefit from the research;
b. All research involving humans shall be
preceded by a careful assessment of
predictable risks, burdens, and foreseeable
benefits to the research participants or to
others.
c. Every precaution shall be taken to minimize
the negative impact of the study on the
research participant's well-being is it
physical or psychological harm.
d. Research should be conducted only if there
is an acceptable positive benefit-risk ratio.
e. The researcher or sponsor/funder shall
endeavor to ensure the reasonable
availability and accesibility of favorable
research outcomes to the community.
f. Where there is ethical and scientific
justification to conduct research with
individuals capable of giving informed
consent, the risks from research
interventions that do not promise the
prospect of direct benefit for the individual
participant, shall be no more likely to occur
and no greater than the Risk attached to
routine medical or psychological
examination of such persons.
g. Slight or minor increases in such risks may
be permitted when there is an overriding
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 scientific or medical rationale for such
increases AND when the REC has approved
them. Related to this, it will be useful to
define the concept of minimal Risk since it
is possible for the research participants to
be subjected to this kind of Risk.
Minimal Risk is a classification of Risk in
research where the probability and
magnitude of harm or discomfort
anticipated in the proposed research are
not greater, in and of themselves, than
those ordinarily encountered in daily life or
during the performance of routine physical
or psychological examinations or tests.
PRIVACY AND CONFIDENTIALITY OF
INFORMATION
a. Researchers shall adhere to the principles
of transparency, legitimate purpose, and
proportionality in the collection, retention,
and processing of personal information
(Data Privacy Act, 2012).
b. Researchers must respect the 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.
c. Researchers shall refrain from identifying
individuals or groups when the release of
information about them can expose them
to possible harm or stigma unless required
by law.
d. For some methods (e.g., FGDs), researchers
cannot ensure the confidentiality of
information or the anonymity of research
participants. In this case, the researchers
shall ensure that the nature of the study
and the questions would cause minimal
harm should confidentiality or anonymity
be breached.
e. 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:
I. Explicitly indicate the limits of
confidentiality in the informed
consent process (issue of disclosure);
II. Emphasize the right of the respondent
to withdraw from the study or
withdraw his/her data, and to refuse
to answer any question; and
III. Prepare a concrete and realistic
protocol for reporting and referral in
the event that imminent harm and/or
criminal act is disclosed or discovered
in the process of data collection.
f. The researcher shall describe his/her data
protection plan in the protocol, including
the steps to be taken so that access to the
data and the identities and privacy of the
respondents can be protected.
JUSTICE
Justice means fairness, impartiality, or
righteousness. In research, however, 'distributive
justice' is of interest. It requires the equitable
distribution of both the burdens and benefits of
participation in research. The other important
requirements for justice to be 'distributive' are:
a. Research should not worsen existing health
and social inequities;
b. Individuals and communities should have
access to benefits related to participation in
the study.
c. There should be the fair selection in the
choice of study populations, sampling, and
assignments;
d. Appropriate care should be given to
participants regardless of their economic
status, gender, race or creed;
e. There shall be just compensation for harms
brought about by participation in research;
f. Research participants should be
reimbursed for lost earnings, travel costs,
and other expenses incurred when taking
part in the study.
g. When there is no prospect for direct
benefit, participants may be given a
reasonable and appropriate incentive for
inconvenience;
h. Payments or incentives should not be too
large to induce eligible participants to
consent to join the study (undue
inducement).
TRANSPARENCY
In an ethical research, the transparency means
that all parties, the sponsors, the researchers and
even the research participants, need to be honest
and truthful in matters related to their
participation in the research. Also important is for
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the researchers to disclose potential conflicts of
interest about matters relating to their
involvement in the research. Transparency in
research is important for the following reasons:
a. It promotes confidence in the research
enterprise even when privacy and
anonymity need to be preserved about
sensitive matters.
b. Also entails disclosure of research results.
c. Researchers must be transparent about
aspects of a study that may have an impact
on the rights, health, and safety of
participants, or with respect to information
that may have a bearing on the decision of
participants to give or withhold their
informed consent.
d. Disclosure of research results to research
participants shall occur only when ALL of
the following situations apply:
I. The findings are scientifically valid
and confirmed;
II. The findings have significant
implications for the participants' well-
being; and
III. The course of action to ameliorate
these concerns is readily available
when research results are disclosed
to its participants.
e. Transparency imposes responsibilities on
researchers to disclose information about
their affiliations, financial interests, or
other loyalties that may affect their
objectivity and the integrity of their
research outputs (i.e., potential conflicts of
interests)
HOW THE QUALITY OF RESEARCH IS
ENSURED
Given the guidelines that are presented above,
how can a researcher ensure that these guidelines
that will protect study participants are adequately
reflected in the research protocol/proposal? The
requirements of an ethical research can be ensured
through the following mechanisms - that the
research proposal is scientifically valid; that the
researchers are qualified and competent; that the
research proposal underwent an ethics review by a
Research Ethics Committee; that the REC is PHREB-
accredited; and that the responsibilities of the
relevant stakeholders are clearly specified.
THE RESEARCH PROTOCOL
The research protocol is the main instrument that
can help ensure that proposed research will be
scientifically valid and ethical sound. In essence the
research protocol shall provide information on how
the safety and welfare of the research participants
will be protected by the investigator and everyone
who will be involved in the research. The proposal
can do this by:
a. Providing guidance for those who will
conduct the study, reference for evaluators
and reviewers, template for validation,
substantiation for intellectual property
claims, and legacy of the proponent; As
such, it should be rigorously
conceptualized, carefully crafted/designed,
and elegantly formulated, and clearly
written.
b. Being sufficiently detailed to serve as
documentation of the study.
c. Justifying the need for the study;
d. Establishing the appropriateness of the
proposed methods to investigate the
research problem;
e. Providing evidence for the feasibility of
doing the proposed study;
f. Defining the recruitment process (where,
who, how);
g. Describing the dissemination plan for
research results and outcomes.
h. Clearly describing the purpose of the study,
the design, the study population, the
methods of data collection and the planned
analysis;
i. Describing all procedures, whether invasive
or not, adequately;
j. Addressing the elements of research ethics
adequately as part of the 'Ethical
Considerations' se
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