RESEARC SBP3002 2023/2024

H ETHICS DR. HASNI IDAYU SAIDI

hasniidayu@upm.edu.my
is Photo by Unknown Author is licensed under CC BY-N
LEARNING OUTCOME
Students should be able to:
• Recognize the ethical rules and terms.
• Describe the needs of ethical approval.
• Explain the principle of ethics in research.

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Ethics
• Rules for distinguishing between right and
wrong.
• “Do unto others as you would have them do
unto you” – Golden Rule
• “First of all, do no harm” – Hippocratic Oath
• “ ou Shall not kill…” – e Ten
Commandments
• Norms for conduct that distinguish between
acceptable and unacceptable behaviour.
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Research Ethics
• Set of ethical guidelines that guide us on
how scienti c research should be conducted
and disseminated.
• Govern the standards of conduct for
scienti c researchers – guideline for
responsibly conducting the research.

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Objectives of Research Ethics
•welfare.
To guard/protect subjects, their rights and
•manner
To makethatsureassists
that research
welfares is
of directed in a
persons/groups/civilization.
•schemes
To inspect
for pa
their icular research
ethical events
reliability – and
issues
such as
privacy the
and controlling
the risk,
progression protection
of informed of
consent.
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MAJOR IDEAS
•conduct
It is the his/her
personalworkresponsibility
so as to of each
enhance researcher
science and to
human welfare i.e. in an ethical manner.
•researchers
Ethical principles
through were
whatdeveloped
can to
become help guide
complex and
di cult issues in our research pursuits.
•quality
Eve one ’s life is a ected by the aims, success, and
of scienti c research.
•carEssential
out for
the researchers
ethical to understand,
obligations and for respect,
students and
of
research to learn about those ethical obligations.
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WHEN do we need to
consider ethical issues?
• When we engage subjects in research, we
subject them to conditions that we select
and/or control i.e. we make decisions about
our use of living organisms in our research 
we are responsible for the safety and welfare
of those subjects.

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WHAT should we do as
researcher?
• Examine the research plans for potential
ethical issues.
• Take steps to correct them.
• Do so prior to contacting any subjects.
• e proposed research plan must su ive
ethical evaluation.
• ONLY when the plan can stand up to ethical
challenges does the investigator proceed with
the data collection.
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ETHICAL PRINCIPLES
• Minimize risks to subjects.
• Constantly evolving.

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• Questions that we
should ask and
answer about our
protocols prior to
formal review by
ethics committee.

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Ethical principles for
ANIMAL research
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MAJOR CONCERNS
• Animals are captive pa icipants; not
capable of providing informed consent.
• Research on animals is generally more
invasive than on humans, and animals often
incur more serious risks than human.
• More responsibility on the researchers;
ensure that animals in the research are treated
humanely.
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 e 3Rs Principles
• Reduction
• Re nement
• Replacement
• e 3Rs | NC3Rs
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Reduction
• application of methods that allow a reduced
number of animals to be used in a protocol.
• Can be achieved by detailed planning of the
experiments.
• Use of animals presenting the same/similar
genetic background – ensures low uctuation
of data, reduces the number of animals used
in a study.

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Re nement
• application of methods that avoid animal
su ering.
• E.g. use of anaesthesia and analgesic
regiments for pain relief, use of non-invasive
techniques, housing conditions provide
comfo able and safe environment, training
animal to cooperate with procedures.

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Replacement
• Substitution of animals with other models.
• E.g. microorganisms, inve ebrates, cell
cultures, organs/cellular fractions.

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ARRIVE
• Animal Research: Repo ing of In Vivo
Experiments.
• Home | ARRIVE Guidelines

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Ethical Guidelines
•agencies
Most scienti
have c societies
their own or government
policy statements in
the use of animal pa icipants.
• Guidelines covers
•Appropriate selection of animals
•Adequate and humane housing
•Preoperative and postoperative care
•discomfo
Concern about
as in icting
possible as little pain and
•thate the
needproposed
to have asresearch
much conis dence
both as
necessapossible
and
well designed.
SBP3002 2023/2024 18
Regulations
•ofUPM Code of Practice for the
Animals for Scienti c Purposes Care and Use
•Use
Malaysian
of Code
Animals forof Practice
Scienti c for the
Purposes Care and
(MyCode)
•Standards
Laws, Regulations,
for Animal Guidelines
Care and and
Use for
Scienti c
Singapore, Purposes in
ailand, the Countries
Indonesia, of
Malaysia, and
India https://doi.org/10.1093/ilar/ilw038
SBP3002 2023/2024 19
WHAT should we do as
researcher?
•using
Proceed in much the
human pa icipants.same way as those
•issuesoroughly review the ethical animal-use
raised by their planned research.
•conduct
Assumeoffulltheresponsibility
research. for the ethical
•committee
Submit research to local lab animal
for evaluation and approval. care
SBP3002 2023/2024 20
Ethical principles for
human research
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Source: Research Ethics: De nition, Principles and Advantages - Public Health Notes
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Core Principles of Biomedical
Research Ethics
• Respect for persons
• Bene cence
• Distributive justice

Reference: Jakobsen, 2020

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Respect for persons
• Emphasizes voluntariness.
• Autonomy: only the individual (or legal
guardian) is authorized to make the decision
about whether to volunteer to pa icipate in a
research study.
• Each potential pa icipant must be fully
informed about the bene ts and burdens of
the study, the procedures involved, and the
plans for the use of the data collected.
SBP3002 2023/2024 24
Respect for persons
•research
Choosingquestion,
an appropriate source
or vice-versa. population for the
•protocol
Developing a scienti cally valid and rigorous
that will answer the research question. study
•possible.
Making research procedures as minimally invasive as
•recruit
Using pa
a nondiscriminato
icipants. process to sample and
•toRecruiting the correct number of pa icipants
have adequate statistical power for the study. required
•informed
Con rming that all pa icipants understand
consent materials and process. the
•information.
Maintaining the con dentiality of all shared
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Bene cence
•of benee study
tingshould do
individual good – high likelihood
pa icipants/communities;
necessity for and the impo Able
anceto justify
of the the
research project.
•study
Oftenshould
paireddowith
no nonmale
harm; cence
minimize – the
potential
harms to pa icipants; ensure
balance between risks and bene ts. acceptable
•appears
E.g. discontinuation
to be dangerous of inte
or so ention
bene when
cial it
that
itthewould
inte be unethical
ention to thenot to immediately
individuals assigned o er
to
the control group; provide
local counselling seSBP3002ices. information about
2023/2024 26
Distributive justice
•equitable.
Ensure bene ts and burdens of research are
•asVulnerable
the source populations
of should
population for not be
research selected
targeting
the general
unfairly population
burden a because
disadvantaged that might
population
group.
•happened
Memberstoof beunderstudied
sampled at populations
random for who
a study
offromthepageneral population
icipation unless should
there is not
a be excluded
defensible
reason for why exclusion is necessa .
•resultse source population must
of the research study. have access to the
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Incentives and Coercion
•anConsider
inducement the ethical
to implications
potential pa of o
icipants ering
to
encourage them to enrol in a study.
•E.Incentives
g . –
reimbursing to increase
pa pa
icipants icipation
for travel, rate.
free
treatment for some
examined by the study. types of conditions
•requests
Coercionthat– could
make include
it di social
cult not pressure
to agree or
to
enrol
generousin a study; can
incentives; be instigated
minimized by by
being
transparent
gained). (what will be gained and not be
SBP3002 2023/2024 28
INFORMED CONSENT
• Understood consent.
•research
Statement
to – essential
potential information
research pa about
icipants the
so
that they
whether can
to make
enroll in a
a thoughtful
study; Mustdecision
use about
clear,
simple language.
•adequate
Process –time
reading
to the statement,
consider, answer allowing
any questions,
willing to sign the form.
•informed
All pa icipants
consent – be given
statement a copy
that of the
includes
contact info, can contact
after data collection. researchers during and
• Documentation – printed/electronic.
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Con dentiality
•toProtection
researchers.of personal information provided
•orAllpassword-protected.
records should be stored in locked room
•notNames
be and
includedother
in personal
data les identi
that ers should
contain
sensitive personal
identi cation number. info – use unique study
•have
Onlyaccess
essential research
to the le. personnel should
•with
Destroy
the identifying
rules about records
how longin compliance
documentation
of informed consent must be stored.
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Privacy
• assurance that individuals get to choose
what information they reveal about
themselves.
• Rights to refuse to allow personal info to be
shared with researchers.
• Have option of meeting researchers in a
place where no one outside the research team
will be able to obse e/overhear.
• Identities of pa icipants should not be
disclosed to unauthorized persons.
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Sensitive Issues
•paInfoicipant
that could materially damage a
if it was made known to public.
•practices/preferences,
E.g. drug/alcohol abuse, sexual
psychiatric illnesses,
immigration status, genetic disorders,
pa icipation in illegal activities, etc
•canWaiver
be of the
requested need
– to document
permission notconsent
to collect
written documentation of consent.
•identity
Ce i cateof pa of con dentiality
icipants from – protects
being subjectthe
to
cou orders or legal demands for info.
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Cultural Considerations
• A research protocol must be appropriate to
the culture(s) of the expected study
pa icipants.
• Adapt the informed consent process to local
custom.
• e instruments and data collection process
must also be culturally appropriate.

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Vulnerable Populations
•might
Peoplebewho
at have
elevated restricted
risk of autonomy
harm from or
research pa icipation.
• E.g. Children, prisoners, comatose patients.
•population.
Defend why research must focus on this
•process
Take extra
is care
fair, to ensure
potential pa that the
icipants selection
understand
and are fullythat pa
informed icipation
about is
the volunta
possible ,
bene ts and risks.
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Institutional review
boards (IRB)
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INSTITUTIONAL REVIEW
BOARDS (IRB)
•large
Research
– peers, members
universities, of
research the community
institutes, at
hospitals,
school systems.
•meet
Review and approve proposals
ethical guidelines. to see if they
•problems.
External viewpoint to reduce potential ethical
•assist
Adviseresearchers
researchers,
in suggest
clarifyingimprovements,
and solving and
potential ethical issues.
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IRB in UPM
• Ethic Committee for Research Involving
Human Subject (JKEUPM)
• Institutional Animal Care and Use
Committee (IACUC)

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WHAT should we do as
researcher?
•riskJudge
it research
poses to paof its value
icipants, to science,
whether the
potential
bene
adequate ts outweigh those
safeguards haverisks,
beenand whether
included to
minimize the risks.
•potential
Should risks
bene to pa
ts, theicipants
ethical outweigh
researcher must
redesign or discontinue the project.
•develop
Researcher has an
well-designed ethical responsibility
projects and to
execute
them with care.
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Other regulations
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Biosafety and Biosecurity
• Biosafety Guidelines for Contained Use
Activity of Living Modi ed Organism (LMO)
• Jawatankuasa Institusi Biokeselamatan dan
Biosekuriti UPM (IBBC)

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RESEARCH
MISCONDUCTS
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Research Misconduct
• Fabricating, falsifying, or plagiarizing the
proposing, pe orming, reviewing, or
repo ing of research results.

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RESEARCH MISCONDUCT
• Fabrication – invention of data/information.
•scienti
Falsi cation – alteration
c experiment. of the obse ed result of a
•and
Plagiarism –
unpublishedunreferenced
ideas, use
includingof others
research’ published
grant
applications, submission under
complete paper, Self-plagiarism “new” authorship of a

•conducting
Ethics and research
Consent –onfailure to
humans get ethical
without approval,
informed
consent
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RESEARCH MISCONDUCT
•are
Datamissing,
Presentation
ignoring and Analysis
outliers – not
without admitting
declaring that
it, some
not data
including
data on side e ects in a clinical trial
•disclosing
Authorshipa –congiftictauthorship, not
of interest attributing other authors, not
•answer
Redundant/Duplicate
a Publication – using same data set to
“di erent” question, publish same a icle in di erent
journals of di erent languages.
•more
Shotgunning – simultaneous
than one journal. submission of a manuscript to
•series
Salami-slicing – dividing the results of a research project
of a icles to maximize the number of publications. into a
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From Gilbe and Denison,
2003

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Additional Readings
• e COPE Repo 1999: Committee on
Publication Ethics (COPE) Guidelines on good
publication practice.
• Research Misconduct – review paper by
Gilbe and Denison, 2003 https:
//doi.org/10.1016/S0009-9260(03)00176-4
• Research Misconduct: e Search for a
Remedy by Donald S. Kornfeld, 2012

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RESPONSIBLE
CONDUCT OF
RESEARCH
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Responsible Conduct of
Research (RCR)
• Foster good research practices.
• Reducing research misconduct.
•(What,
Responsible Conduct of Research
Why, and Does it Work?) Education
•Conduct
e Malaysian
in Code
Research of Responsible
https:
//accountancy. u
Sharing/Booklet_itm.e du.my/images/e-
e_Malaysian_Code_of_Res
ponsible_Conduct_in_Research.pdf
•Research
Introduction
(USA)to the Responsible Conduct of
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REFERENCES
•research
Jacobsen,methods:
K. H. (2021).
A Introduction
practical guide to
(3rdhealth
ed.) .
Jones & Ba lett Learning.
•methods
Graziano,a process
A. M. & Raulin,
of inquiM. L.
(7th(2010).
ed.). Research
Pearson
Education, Inc.
•statistics
Jackson,aS.critical
L. (2012). Research
thinking methods
approach (4th and
ed.).
Cengage Learning.
•Advantages
Research Ethics: De nition, Principles
- Public Health Notes and
•- What Is Ethics in Research & Why Is
by David B. Resnik, J.D., Ph.D. (nih.gov) It Impo ant?
• (PDF) Ethics in research (researchgate.net)
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