ETHICS IN

RESEARCH
Prepared by:
MA. TERESA A. MONDERIN,
RN-MAN
Disclaimer…
For ACADEMIC
Purposes Only.
No Copyright infringement
intended in all references,
materials and sources used.
The Author/s reserves the
rights.
 PRINCIPLE OF
BENEFICENCE

“ Above all, do no harm”

1. FREEDOM FROM HARM

Participants are
harmed in a variety
of ways:
- Physical
- Psychological
- Social
- Economic
  Risk reduction while conducting
research by:
done by qualified
people only especially
when handling
technical equipments
& procedure
Start with animals
before proceeding with
humans
Ex: infants in bathing
Be sensitive to
psychological
effects of
research, do
debriefing and
proper referral for
assistance.
2. FREEDOM FROM EXPLOITATION

• Not placing participants at a

disadvantage or expose them to
situation for which they
have not been prepared.

The participants enter

into a special relationship
with the researcher
In qualitative
research, risk of
exploitation is
especially acute.

 Examples:
malicious acts, follow up visit
not properly oriented to the
subjects.
 3. BENEFITS FROM RESEARCH
RISK-BENEFIT RATIO:
 MINIMAL RISK, MAXIMIZE BENEFITS

•MINIMAL RISK:

•risk anticipated to be no greater

than those ordinarily encountered in
daily life or on routine physical or
psychological tests and procedure.
PRINCIPLE OF RESPECT
FOR
HUMAN DIGNITY
1. THE RIGHT TO SELF-DETERMINATION

 Prospective participants have the right to

decide voluntarily whether to participate in a
study, without risking any penalty or
prejudicial treatment
.
 They have the right to

ask questions, to refuse

to give information and
to ask for clarification or
to terminate their
participation
This means freedom from
COERCION of any type
 Implicit or explicit

Threats of penalty
from failing to
participate in a study
or excessive rewards
from agreeing to
participate.
 2. RIGHT TO FULL DISCLOSURE
FULL DISCLOSURE:
the researcher has
fully described the
nature of the study,
the person’s right to
refuse participation,
the researcher’s
responsibilities and
the risk/ratio benefits.
 INFORMED CONSENT.
 Self determination +

Full disclosure
 This is done not only
in the beginning of the
study but even during
the research, either
by debriefing sessions
or written
communications
 3. ISSUE RELATING TO THE PRINCIPLE OF RESPECT

Inability of the individual to make well-informed judgments

about the risk/benefits of participating in the study.
Ex. Children

Full disclosure can lead to two biases:

1. subjects providing inaccurate information
- HAWTHORNE EFFECT
2. representative sample is not recruited.

One way to deal this problem is through

COVERT DATA COLLECTION OR
CONCEALMENT AND DECEPTION
( BENOVOLENT DECEPTION)

 Another issue is collecting of data posted in the

internet
PRINCIPLE
OF
JUSTICE
1. THE RIGHT TO FAIR TREATMENT

 Have the right to fair and equitable treatment

before, during and after their participation in
the study. These includes the following:
•fair and nondiscriminatory selection of
participants such that any risk and
benefits will be equitably shared.
•respect for cultural and
other forms of human
diversity.
•non prejudicial treatment of
those who decline to participate
or who withdraw from the study
after agreeing to participate

•Honoring all agreements

between the researcher and
participants.
•Participants access to the
researcher at any time of the
study for clarification
•Participant access to
any form of assistance
in possible damage
•Debriefing
•courteous and
tactful treatment
at all time.
 2. THE RIGHT TO PRIVACY
Right to expect that any data they provide will be
kept in strictest confidence through anonymity and
other confidentiality procedures.
ANONYMITY:
occurs when even the researchers cannot
link participants to their data.
CONFIDENTIALITY PROCEDURES
- Right to privacy is a more crucial problem in
qualitative research.
-when anonymity will be impossible then researchers
opted for confidentiality procedures.
INFORMED CONSENT
Participants have
adequate information
regarding the research,
are capable of
comprehending the
information, have the
power of free choice,
enabling them to consent
to or decline participation
voluntarily
Involve communicating the following information:
1. Participant status
2. Study goals
3. type of data
4. procedures
5. nature of commitment
6. sponsorship
7. participant selection
8. potential risk
9. potential benefits
10. alternatives
11. compensation
12. confidentiality pledge
13. voluntary consent
14. right to withdraw and withhold information
15. contact information
PROCESS CONSENT: in qualitative
studies, it is viewed as ongoing, transactional
process.
Comprehension of informed consent
 require written and oral form at the level of understanding of
the participants
Testing participants for their comprehension

Documentation of informed consent

allow participants to sign
unless in some situation
short and simplified
readable
 VULNERABLE SUBJECTS
Maybe incapable of giving
fully informed consent maybe at high risk
of intended side
effects because of
their circumstances.
CHILDREN
- parent’s consent and legal guardian
should be taken. ASSENT should be
taken to children at least 7 years old.
- at age 13 years old, developmentally
mature, consent is taken as well
- for those developmentally immature,
legal guardian with best interest
for the child should be the
person to consent.
 SEVERELY ILL OR PHYSICALLY
DISABLED PEOPLE
• - Assess ability to
reason decision in
the participation of
the study
ex. Mechanically
ventilated individuals

for with disabilities, special procedure maybe required

for getting consent.
TERMINALLY ILL
- seldom benefit from
the study, ensure
their health care
and comfort not
compromise and
that there are
special procedures
in taking up
consent for them
 INSTITUTIONALIZED PEOPLE
1. Those in hospital are
potential for being
pressured into participating
or may feel their care will
be jeopardized if they will
not participate since they
are highly dependent on the
care of the heath care
givers. 2. Prisoners may lost their
sphere of autonomy in
making voluntary consent.
PREGNANT WOMEN
- protection for the
mother and the fetus.
- They can participate
only if the purpose of
their research is to
meet the needs of the
pregnant women and
risk to her and the
fetus is very minimal
or there is only
minimal risk to the
fetus.
Philippine National
Health Research
System
an integrated national framework for health
research in the country.
 Republic Act 10532, also known as “Philippine
National Health Research System Act of 2013”
 institutionalization of the PNHRS
 DOST through Philippine Council of Health
Research and Development (DOST-
PCHRD), the DOH through Health Policy
Development and Planning Bureau (DOH-
HPDPB), the CHED and University of the
Philippines Manila-National Institutes of
Health (UPM-NIH) form the PNHRS
implementing agencies, with PCHRD as the
lead Secretariat.
Objectives:
The PNHRS aims to improve the health status, productivity
and the quality of life of Filipinos by:
 Ensuring that health research is linked to the health
system needs;
 Ensuring that investments in health research yield the
most benefit;
 Promoting good governance among health research
organization through efficient, effective, transparent and
ethical health research management system;
 Engaging in national and international partnerships and
networks for health research development; and
 Ensuring sustainability of resources for health research
 NATIONAL ETHICAL GUIDELINES
FOR HEALTH AND HEALTH-RELATED
RESEARCH (2017)
 The Philippine Health Research Ethics Board (PHREB)
launched the 2017 National Ethical Guidelines for Health
and Health-Related Research (NEGHHR) during the 11th
Philippine National Health Research Week held on 24
August 2017 at the Philippine International Convention
Center (PICC).
ELEMENTS OF RESEARCH ETHICS
1. Social Value
2. Informed Consent
3. Vulnerability of Research
Participants
4. Risk, Benefits & Safety
5. Privacy & Confidentiality of
Information
6. Justice
7. Transparency
 1. SOCIAL VALUE
1. The participation of human beings in research can only be justified if
the study has social value. Social value refers to 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 well-being of individuals, their families,
and communities.
2. The significance of the study shall be clearly described in a separate
section of the protocol with an accurate and updated description of the
status of the social or health problem, and how the study will help arrive
at a solution.
3. The study design, methodology, and data collection, overall, should be
able to generate information supportive of the objectives of the study.
Social value can only be realized if the study is scientifically valid.
4. A dissemination plan for the study results shall be included in the
protocol. Dissemination is essential to achieving social value.
5. The Research Ethics Committee (REC) shall determine the
appropriateness and the practicability of the dissemination plan, as well
as the suitability of the recipient(s) of the information.
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 2. INFORMED CONSENT
6. Informed consent 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.
7. Obtaining informed consent is a process that is begun when initial
contact is made with a potential participant and continues
throughout the course of the study. By informing the potential
participants, by repetition and explanation, by answering their
questions as they arise, by ensuring that they understand each
procedure, and by obtaining agreement from them, researchers elicit
their informed consent, and in so doing manifest respect for their
dignity and autonomy.
8. For all research involving humans, the researcher shall obtain the
voluntary informed consent of the prospective research participant. In the
case of an individual who is incapable of giving or who has diminished
capacity to give informed consent, the researcher must exert effort to
obtain his or her assent and the consent of a legally authorized
representative (LAR), in accordance with applicable laws.
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INFORMED CONSENT
9. In obtaining informed consent, sponsors and researchers shall have the
duty to avoid deception, undue influence, or intimidation.
10. Informing the potential participant shall not be simply a ritual recitation
of the contents of a written document. Rather, the researcher shall convey the
information, whether orally, in writing, or other modes of communication, in a
language and manner that suit the individual’s capacity and level of
understanding.
11. The researcher shall ensure that the prospective participant has
adequately understood the information. The researcher shall give each
one the full opportunity to ask questions, and should answer them honestly,
promptly, and completely.

Essential information for participants

12. The researcher shall provide the following information to the potential
research participant, whether orally or in writing, in a language that suits the
participant’s level of understanding:

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 12.1. That the individual is invited to participate in the research which is being
undertaken by the researcher (name of researcher) from the institution (name of
institution);
12.2. The reasons for considering the individual suitable for the study, and that
participation is voluntary;
12.3. That the individual is free to refuse to participate in the research without
penalty or loss of benefits to which he or she is entitled;
12.4. 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;
12.5. The expected duration of the individual’s participation (including number and
duration of visits to the research center and the total time involved) and the
possibility of early termination of the study, or of the individual’s participation in it;
12.6. Any foreseeable risks, pain or discomfort, or inconvenience to the individual
(or others) associated with participation in the research (in both the control and
experimental group), including risks to the health or well-being of the individual’s
spouse or partner;
12.7. The direct benefits, if any, expected to manifest to individuals from
participating in the research;
12.8. Whether money or other forms of material goods will be provided in return for
the individual’s participation and, if so, the kind and amount;

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12.9. The expected benefits of the research to the community or to society at large, or
contribution to scientific knowledge;
12.10. Whether, when, and how, any intervention proven by the research to be safe
and beneficial will be made available to the individuals after they have completed their
participation in the research, and whether they will be expected to pay for them;
12.11. The provisions to ensure respect for the privacy of research participants and
the confidentiality of records in which they are identified, including documentation
through taking of pictures and recording of the interview and that these might be
displayed in publications and conferences or fora;
12.12. Legal or other limits to the researcher’s ability to safeguard confidentiality, and
the possible consequences of breaches of confidentiality;
12.13. The 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 he or she
is entitled;
12.14. The sponsors or funders of the research, the institutional affiliation of the
researchers, and the nature and sources of funding for the research;
12.15. The possible research uses, direct or secondary, of the individual’s medical or
health records, and the possible future use and final disposition of biological
specimens;
12.16. If the specimens collected will not be destroyed, then where, how, and for how
long they are going to be stored;

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12.17. That the research participants have the right to decide about future use,
continued storage, or destruction of collected specimens and/or personal
information;
12.18. 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;
12.19. The extent of the researcher’s responsibility to ensure needed services to
the research participant;
12.20. That treatment and rehabilitation will be provided free of charge for specified
types of research-related injury or for complications associated with the research,
the nature and duration of such care, the name of the medical service or
organization that will provide the treatment and whether there is any uncertainty
regarding funding of such treatment;
12.21. That a PHREB-accredited REC has approved or cleared the research
protocol; and
12.22. The contact information of persons designated to respond to the following:
12.22.1. Queries on the details of the protocol;
12.22.2. Issues relating to the human rights of participants;
12.22.3. Related concerns and grievances; and
12.22.4. Management of research-related injuries.

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Documentation of consent
13. As a general rule, documentation of informed consent includes an actual
signature or thumb mark of the prospective participant on the informed consent
form.
14. When the use of an informed consent form is not feasible or unacceptable to
the prospective participant, a description of the process, attested by a witness, may
be an alternative that needs prior approval of the REC.
Waiver of the informed consent
15. Waiver of individual informed consent is to be regarded as exceptional, and
must be approved by an REC.
16. The informed consent process may be waived in specific research contexts,
such as:
16.1. Archival research involving publicly available documents;
16.2. Research that uses the method of naturalistic observation (often described
as “covert” method) in data collection provided that all of following requirements
are complied with:
16.2.1. Thorough justification for the use of naturalistic observation;
16.2.2. Plan for how the data collected will be used;
16.2.3. Assurance that risks to participants are unlikely; and
16.2.4. Mechanism to ensure confidentiality and anonymity of observed
individuals and their data (e.g., observations are recorded in such a way that the
individuals involved are not identifiable).
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17. Some or all of the elements in the informed consent may be waived or altered
(with prior approval of the REC) if all these conditions are met:
17.1. The research presents no more than minimal risk;
17.2. The waiver or alteration will not adversely affect the rights and welfare
of the participants;
17.3. The research cannot be practicably carried out without the waiver or
alteration; and
17.4. The participants will be provided with additional pertinent information
after their participation (whenever appropriate).

Renewing consent
18. The informed consent of each research participant shall be renewed under the
following conditions:
18.1. If there are any significant changes in the circumstances or procedures
of the research; or
18.2. If new information becomes available that could affect the willingness
of research participants to continue to participate; or
18.3. In long-term studies at pre-determined intervals even if there are no
changes in the design or objectives of the research.

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 3. VULNERABILITY OF
RESEARCH PARTICIPANTS
19. Vulnerable participants shall require special protection because
of certain characteristics or situations that render them as such.
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.
20. Vulnerable groups shall not be included in research unless such
research:
20.1. Is necessary to promote the welfare of the population
represented; and
20.2. Cannot be performed on non-vulnerable persons or groups.

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Vulnerability of Research Participants
21. Researchers, sponsors, or RECs shall not arbitrarily
exclude women of reproductive age from biomedical research.
The potential for becoming pregnant during a study shall not,
in itself, be used as a reason for precluding or limiting women’s
participation in research.

22. 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. Caution
shall be exercised in obtaining informed consent for a research
project if the research participant is in a dependent relationship
with the researcher (e.g., as a research participant) to ensure
that the consent is not given under duress or undue influence.

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 Risks, Benefits, and Safety
23. Research is justified if there is a reasonable likelihood that the
population from which the participants are derived stand to benefit
from the research.

24. All research involving human participants shall be preceded by a

careful assessment of predictable risks, burdens, and foreseeable
benefits to the research participant or to others.

25. Every precaution shall be taken to minimize the negative impact

of the study on the research participant’s wellbeing.
26. Research shall be conducted only if there is an acceptable
positive benefit-risk ratio.

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Vulnerability of Research Participants

27. The researcher/funder/sponsor shall endeavor to ensure

the reasonable availability and accessibility of favorable
research outcomes to the community.

28. When there is ethical and scientific justification to conduct

research with individuals capable of giving informed consent,
the risk from research interventions that do not hold out the
prospect of direct benefit for the individual participant shall be
no more likely and no greater than the risk attached to routine
medical or psychological examination of such persons. Slight
or minor increases above such risk may be permitted when
there is an overriding scientific or medical rationale for such
increases and when the REC has approved them.

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 5. PRIVACY AND CONFIDENTIALITY OF
INFORMATION
29. 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).
30. 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.
31. 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.
32. 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:
32.1. Explicitly indicate the limits of confidentiality in the informed consent
process, such as when the researcher is ethically and legally obligated to
disclose the identity of the respondent to forestall imminent harm to self or
others;
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PRIVACY AND CONFIDENTIALITY OF INFORMATION
32.2. Emphasize the right of the respondent to withdraw from the study
or withdraw his or her data, and to refuse to answer any question; and
32.3. 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.

33. Researchers shall recognize that collecting data using group methods
(e.g., FGDs) has implications for the privacy and confidentiality of individuals.
As it might not be possible for researchers to ensure the confidentiality of
information or the anonymity of research participants, the researcher shall
ensure that the nature of the study and the questions would cause minimal
harm should confidentiality or anonymity be breached.
34. The 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 and the identities of the respondents can safeguard privacy and
confidentiality. For example, the researcher shall provide adequate and clear
instructions to research assistants, transcribers of audio recordings, or
translators of transcriptions.

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 6. JUSTICE
35. In research involving human participants the principle of justice refers primarily to
distributive justice, which requires the 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.
Research should not worsen existing health and social inequities.
35.1. There shall be fair selection in the choice of population, sampling, and
assignments.
35.2. There shall be provision of appropriate care to research participants
regardless of their economic status, gender, race, or creed.
35.3. There shall be just compensation for harms brought about by
participation in the research.
35.4. Research participants shall be reimbursed for lost earnings, travel costs,
and other expenses incurred when taking part in a study. Where there is no prospect
of direct benefit, participants may be given a reasonable and appropriate incentive for
inconvenience. The payments shall not be so large as to induce prospective
participants to consent to participate in the research against their better judgment
(undue inducement).
36. Individuals and communities shall have access to benefits related to participation
in the study.
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 7. TRANSPARENCY
37. Ethical research shall be characterized by transparency. It is imperative
for all parties to be transparent about matters relating to their involvement.
Transparency is not diametrically opposed to privacy. On the contrary,
transparency is an element of ethical research that promotes confidence in
the research enterprise, even when privacy and anonymity need to be
preserved about sensitive matters. The need for transparency also entails
disclosure of research results.
38. 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.
39. Disclosure of research results to research participants shall occur only
when all of the following apply:

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TRANSPARENCY
39.1. The findings are scientifically valid and confirmed;
39.2. The findings have significant implications for the participant’s
well- being; and
39.3. The course of action to ameliorate these concerns is readily
available when research results are disclosed to its participants.

40. 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 output.

41. At the same time, transparency imposes responsibilities on research

participants to be truthful in declaring their health conditions, and to be
candid in expressing their concerns about their involvement in research.

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 REFERENCES
Polit, Denise & Beck, Cheryl, Essentials of Nursing Research, Appraising
Evidence for Nursing Practice, 9th Edition, Wolters Kluwer Health (2018)

Polit, Denise & Beck, Cheryl, Nursing Research, 11th Edition, Wolters Kluwer Law
& Business, (2020)

https://libguides.library.cityu.edu.hk/researchmethods/ethics

https://www.healthresearch.ph/index.php/about-pnhrs

https://ahrecs.com/resources/philippines-national-ethical-guidelines-for-health-and-
health-related-research-phreb-2017/

http://49.231.15.21/deptw13/upload/files/hercF256312041721022781.pdf

https://www.pchrd.dost.gov.ph/index.php/events/6293-phreb-launches-2017-
national-ethical-guidelines-for-health-and-health-related-research