5/6/ 201 5

Ethics and Mor ality

What are they?
~

Ethics and moral ity ore often used interc

hang eably
- indeed . I hey usually con mean I he some
lhing. and in c asual
conver so lion lhcre isn'l a proble m w ilh
swilch ing bclwe en one and
lheolh cr

Howe ver. there is o d is tinction betw een

them in philos ophy

Ethics and Mor ality

Etymology
8 Mora lity and ethics hove some roots
0 "mores " (Latin): mann er and custo ms
0 "etas " (Greek): custo m and habits
-Robe rt Louden. "Mora lity and Mora l Theor
y"

Ethics and Mor ality

What are they?
it Mora lity

cond uct

is used to refer to what we would coli mora

/

t:: Ethics is used to refer to the forma

l study of mora l cond uct.

Ethics is o lso often calle d mora l philos

ophy.

Ethics and Mor ality

What are they?
,_ Mora lity: first-or der set o f beliefs and
pract ices abou t how to live
a good life.
Praxis

ill" Ethics: o secon d-ord er. conscious re flectio

n on the adeq uacy of
our mora l beliefs.
Theor y

5/6/ 201 5

Activity

Wha t is "Re sea rch Ethics"?

rstan ding and exam ining w hat is
iii! Rese arch Ethics is a w a y o f unde
"
ng
"wro
is
ho!
w
nd
"right " a

wor ds ?
Wh at is you r und ers tan ding of these
~

Res pec t

~ Harm

and e xamining what is "rig ht" and

10 Bioef hics is o w ay o f understa nd ing
rch a nd practice.
what is " wron g" in bio medica l resea

Principles of Res earc h Ethics

Fairness

Res pec t for Persons

Aut ono my
Q

Res pec t for Persons

Is unique a nd free;
;
Has the right and capac ity to decide
nd
Has value a nd d ignify; a

lfi: Ben e fice nce /No n-M alef ic enc e

~

Justice/ Non-Exploita tion

Says tha t ea c h individ ual:

Has the rig ht to inform ed conse nt.

Protection for vulnerable persons

for those whose d ecisio nSpec ial prote c tio ns must b e in p la ce

hed . whether due to
iminis
d
or
ired
impa
is
ity
apac
c
ng
maki
tors
c
fa
l
socia
or
al
p hysic

5/6/2015

Benefic ence/No n-Malefi cence

Benefic ence/No n-Malefi cence

---.,-

'i< Protection of the study particip a nts is the most imporlont responsibility

of the researcher
" Reseorchers must:
Protect the phl"'icol. mental a nd social well-being o l each research
participant;
Minimizes physical and social risks;
Maximize the possible benefits; a nd
Retain the community perspective.

Justice/N on-Explo itation

~

The principle tha t calls for fairness in the conduct of research is the
principle of justice/no n-exploitatio n

iii Research must:

Ensure a fa ir distribution of risks and benefits

- Research should nol be done in a community that is no l likely to benefit
lrom the result

ON BALANCE:
The research should generate
more good than harm: a nd
Risks of research should be
re a sonable in light of the
expected benefits to the
individual and to society.

DISCUSSION QUESTIONS
What ore lhe potential RISKS
o f becoming involved in o
prevention trial?
For part icipants?
For communities?

What ore the p o lentio l BENEFITS

of b ecoming involved in o
prevention trial?
For participants?
For communities?

Conduct equitable recruitment o f resea rc h porticipants: a nd

Provide special p rotection for vulnerable group s.

5/6/2015

Participant Risks vs. Benefits

RISKS
"' Biologic/Physical
~ Social/Emotional
From the product: side etrecls
From HIV/ STI testing
Portner issues
Stigma

EXAMPLE
Par ticipants Have Said t he Benefits of Par ticipating
in Microbicide Trials Include:

BENEFITS
Improved access to hea lth core
q Beller preven tion
~

111<

Risk reduction counseling

STD lrcolmcnl
Condoms

checks is considered t he biggest benefit

4!l Counseling about w omen's bodies, sexuality,

repr oductive t ract infections, STis, and HIV
~

Good relationships w ith study staff

f. Feeling empowered; impr oved communication

Other

fi Access to medical services and regular health

Cosh
Sense or social contribution

w it h male partner s and children

~

Access to study gel; improved sex due to gel

<& Contribut ing to a w omen's health cause: "One

is helped but is also helping others"

___
. . . . .--
--.-~
-

EXAMPLE
Participants Have Said the Risks and Burdens of
Microbicide Trials Include:

,..

HIV testing considered biggest burden

Discomfort during pelvic exam

il-

Lo ng waiting times at clinic

18

Feeling of loss at end of study

Worries about side effect s

Community Burdens and Benefits

~

Risks and Burdens

Possible stigma
Diversion of local health personnel

~ Benefits

Improved health infrast ruct ure

Training
Comm unity education on HIV/research
Preferential access to product if it pr oves
effective

5/6/2015

Question: Will participating in trials increase people's risk of HIV?

it Generally, no...
01. People will become infected during the trial but not because of the trial

Undue

People in both arms should have lower HIV prevalence than people in the
general comm unity

Therapeutic
Misconception
Condoms
pliK<!bog~l

Condoms

mk:robkdc

L._-::-..,---:---' --:--,--:-..,..----- ---'--......1 (ll ~ W(Uk\)

Bf!fore trm l

During Trlal

Important Ethics Concepts

Equipoise

_j l_

Therapeutic Misconception

ill a state of genuine uncertainty or doubt about

whether one intervention or treatment is superior
to anot her

iJ Equipoise is a necessary condition for clinical

research to be morally acceptable

If t he scientific community "knows" that one
treatment is better than another, it would be
considered unethical to withhold it

ill Questions remain, however, about how to decide

when "scientific or clinical consensus" exists about
the relative m erits of different treatments

Q> "Therapeutic m isconception":

the tendency of some research participants to

wrongly assume that whatever drug or
intervention they are offered must work or be
beneficial (or why would it be offered?)

.g; It occurs when the goals of research and those of

t herapy or "health care" become confused in the
participants mind.
ol'> The therapeutic misconception is a major threat to

"informed consent."

5/6/2015

Voluntary Informed Consent

Research description
- (what is being studied, what is the procedure, who is sponsoring the study?)
Sl Risks of participating;
'>I! Benefits of participating;
~ Alternatives to participation, such as other studies or services in t he area;

Voluntary informed consent is the agreement

given by a w ell-informed person w ho:
Ql Has received the necessary information
expressed in spoken words and in writing;

Jr. Has adequately understood the information; and

qt

0 Has made the choice to participate (or not

Jl

Essential Elements for Informed Consent

"t:; Adequat e underst anding includes the difference between research and health

Assurance that information will be kept confidential;

Compensation for time, t ravel or possible harm;

iii Contact s ( whom to contact with questions/concerns); and

participate) without coercion.

Essential Elements for Informed Consent

Voluntary participat ion and withdrawal.

Informed Consent is a Process

-'-

care

ft Informed consent is a process of collaborativ e communica tion and

related concept: " therapeutic misconception "

After t hinking seriously about t he information, the person can arrive at a

decision without being forced, threatened or offered something so valuable
that free choice is impossible

decision making, not the signing of a form

Informed consent requires t hat prospective participants:
Be appropriately informed about t he nature of t he research
Adequately understand t his informat ion and its implications
Voluntarily decide t o participate, without coercion
Explicitly consent t o participate, orally or in writ ing

related concepts: "coercion" and "undue inducement"

5/6/2015

Balancing respect for culture and respect for persons

ACTIVITY

"> concept of " individual autonomy" may be in

confl ict with entrenched cultural norms or
expectations

There are many

women who

'il Example:

may be expected that a woman's husband

has the right and authority to make decisions
regarding her health care
~

are isolated-

through fear of
being found out.

while recognizing loca l value and ethical

plural isms, ethics is also concerned w ith
universal principles of conduct

In some settings it is generally expected that

a woman's husband has the right and
authority to make decisions regarding her
health care
~In

this instance, how should one balance respect for persons

with respect for culture~

~Should

~Arc

sexual partners be involved?

there creative strategies for encourof!ine portncr

engogerl'W?nt!
;What might you recomme nd as an appropriate way to respect
both of these values in this instance~

(Undue) Inducement

ll

How Do You Decide If It's "Undue"?

~ Harmfulness:
~

Informed consent can be undermined by incentives that lead to

"undue pressure", "coercion" or "undue inducement" t o
participate

t1 An inducement may persuade an individual to change his or her

mind about entering a research project , but this in itself is not
enough to make it inappropriate
'i

An "inducement" becomes inappropriate when it causes a person

to assume risks that they would ordinarily view as unacceptable

the nature of the potential risks t o the participant's health

$" Proportionality:
whether the inducement is in proportion to the risks and costs of research

Vulnerability:
whether prospective participants are especially vulnerable to influence

~ Reciprocal Justice:
someone who benefits from the investment and sacrif ice of o thers owes t hem
proportional recompense

(Nuffield Council on Bioethics)

5/6/2015

Who?

Seven Steps for Ethical Research

1.

Ethics Committees
and Review Boards

Priorities: Did the study address a priority issue? Whose?

2. Planning: Was the study well designed to optimize the chances of

generating useful knowledge and protecting subjects?

3 Permission: Was the project reviewed and cleared by t he relevant
institutions? Did t he investigators obtain informed consent?
4 Performance: Was the study conducted in a way that respected the rights
o f the subjects and minimized the risks to them?
5 Processing: Were the results correctly analyzed and interpreted?
6. Publication: Were the results published and dissem ina ted?
7 Programming: Have the findings been translated to policy and action?

What Makes Research Ethical?

*'

Social or scientific va lue

El

Scientific validity

Q;

Fair subject selection

Favorable risk-benefit ratio

Ill

Independent revie w

q\"

Informed consent

Scientific Misconduct
lt

Scientific misconduct
-the violation of the standard codes of scholarly conduct and ethical
behavior in professional scientific research .
the body of principles and practices used by scholars to make t heir claims
about t he world as valid and trustworthy as possible, and to make t hem known
to the scholarly public

Respect for potential and enrolled subjects

Collaborative partnership
(Emanual et al., JAMA, 283, 2ooo)

** moral philosophy: involves systematizing, defending and recommending

concepts of right and wrong conduct
self explanatory, isn't it?

5/6/2015

Research Misconduc t
What is it?
~ The US Department of Health and Human Services defines research misconduct as:

Fabrication, falsification, or plagiarism in proposing, performing, or reviewing

research results.

II

Criteria for Research Misconduc t

NRepresents a significant departure from accepted practices

.;.Has been committed intentionally, or knowingly, or recklessly
'"~<Ca n be pr oven by a pr eponderance of evidence
liOWhat is NOT MISCONDUCT:
:Jhonest, unintentional error

0 Fabrication: making up results and recordine or reporting them

!J Falsification: mon;pulation of research materials, equipment, or processes, or changing or

omitting results such that the research is not occurotely represented in the record.

o Plagiarism: the appropriation of another's ideas, processes, results, or words without giving
prope r credit.

Research Misconduc t

II

Research Misconduc t

Nature 453, 980-982 (19 June 2008)

~ SURVEY

of 2,212 Researchers
Observed 201 instances of misconduct
Examples:
o "A post doc changed the numbers in assays in order to 'improve' the data."
0 "A colleague duplicated results between three different papers but differently labeled data In each
paper.

0 "A coinvestigator on a large, interdisciplinary grant application reported that a postdoctoral

fellow in his laboratory falsified data submitted os preliminary data in the grant AS
principal investigator of the gran t, I submitted supplementary data to correct the

Why does misconduct happen?

"' Publish or Perish Pressure

e: Desire to "get ahead"

.
i1

Per sonal problems

1i Character issues

t Cultural Differences

,,

appUcation.ff

"A colleague used Photoshop to eliminate background bands on a western blol to make the data
look more specific t han t hey w ere.

5/6/ 2015

Ethics Guidelin es: Philippin es

Ethics Guidelin es: Philippin es

t.

Ethical Scientific Practices

All nliplno sc.ientlsts recognize, o.bide by, o.nd intentionally
diuemin.. te the basic ethkal princip'cs articulated in this
document. They ~lso require of all t heir colleagues conduct

Ethical Princi ples

and Guideline s
for Filipino Scien ti st s

Ethical Principles
and Guideline s
for Filipino Scientists

3 Conflict of In terest

<~nd beM... Ior consistent v.'ith these principles. 1hey do not

dcftmd, conceal or justify conduct thot brNchc.s these
principles, not evt"n on the basis o f necessary obedience and
loyalty. TI1ey refuse all forms of scicntifk dishonesty ond
Infringement ot the pr1nclplcs specl fed In t his document

2.

All Filipino scientists serve the scien tific community

and the general publk by providint unbiased
profess ional judg mcnu and s tatements regarding
various issues of public inte rest; these j ud~ments and
s tatements are based o n care ful s<icnti/k studies.
TI>ey avoid all possible cases in which the p rovision of
unbiased judgm ents Is affected in any way that may
favor sclfintcrest and other conflicting inte rests.

Ethical U s~ o f Science in Philippine Societ y

All Filipino scientisU consider sclcntif l< r esear ch ::.san

integral port of o culture of inquiry, and as the source of

innovation, and thus, defend scientific work atainst
inappropriate criticism. They stand determinedly ... gainst t he
unethical and inappropriate use of scientific knowl~dge, and
ensure that scientific knowledge Is used it1 t he service of
national and hum.an deve'opmcnt goals.

~.--

NoUonN Aeadafny of Sceence and Tectmo&ogy

Ph il1pplnos

':_thics Guidelin es: Philippin es

1. 1ntcllectua l Honesty
Filipino sdentists acknowledge the scientific
contributions of predecessors and coUeagu es to the
reseorch question being studied in all written and oral

Ethical Principle s
and Guideline s
for Filipino Scientists

Nal.oonol Aca.domy cf Sc~ttee and Tochnology

Phlhppmos

Ethics Guidelin es: Philippin es

Ethical Principles
and Guideline s
for Filipino Scientists

Al l Fi lipino scientists u ndertake research in such a way

that e nsures that society and a ll its me mbers, the
environment, a nd other basic h uman and cultural values
arc not compromised. Thus, Filipino scientists must
always conside r the benefits of their scientific work vis-avis these potentia l harms. In cases w hen the benefits of
science are deemed to outweigh tl>e potential hann,
ri lipino scie ntists take afl steps to minimize potential
harm and toke steps to m itig ate their neg ative
consequences.

reports o f their research st udy.

Whe n citing findings and resu lts obtained by o ther
scientists, they provide dear references to the
appropriate respective sources, whethe r published or
unpublished. Th ey do not ploglorize ony p4rt of the
reseorch reports of other scientists and resear<h ers,
whether published or unpublished; that is, t hey do not
toke other authors' findings, words, and writings, and
pass them off as their own by not providing appropriate
indications and <itotions of the original sources, whether
published or unpublished.

5- Weig hing the Benefits of Sc.ience vis-avis Potential Harm

NaUoml Ae.demy of SctOOGe and Techno'ogy

Phlt.ppln"'

NatJon.ill AcMemy of Sclence llnd TechnOIO{J)'

Philipplnu

10

5/ 6/ 2015

Ethics Guidelines: Philippines

Ethics Guidelines: Philippines

Ethical Principles
and Guidelines
for Filipino Scientists

Ethical Principl es
and Guidelines
for Filipino Scientists

6. Commitment to Professional Development as Scientists

All Fil ipino scientists are committed to m entoring future

scientists and to developing the scientific knowledge of
their students as well as other stakeholders and end

All Filipino sc tent ists broaden and deepen their scientific

knowled ge and strive to improve personal professional
competency. TI1ey maintain a critiCDtly reflective attitude

towards their own scientific findings and results as w ell as to

result s of colleag ues, a nd are open to discussion and
factual orguments.

7 Development of Students and othC< Stakeholder,;

users of scientific knowledge.

They model the proper know/edge, skills, and principles of
good conduct in science to students and other
stakeholders, as such they consider the conseq uences

~\

and oct appropriately rega rding the possible scientific

misconduct or unethical beha viors o f their students,
co llaborators, and partners in scientifk work.

a'l:i~~l~
. ;~.!'4l! ''
\.

;:,

NntlonM Academy of Sc~e and Thnotogy

Phlhpplno

Ethics Guidelines: Philippines

Ethical Principles
and Guidelines
for Filipino Scientists

N:ataon"l /'eAdemyof Sc.lonce nd Technology

Phlhppln~

11

Some Issues in Genetic Engineering

Random insertion of short gene construct

variable numbers of copies inserted
Insertion sites diffe rent for each individ ual
Regulatory and Public Approvol
Develop food safety da ta
Design reliable environmental safel y measures
Effectiveness & target animal safely dat a

8. Advocacy for Scientific Approaches

All Filipino scientists defend the freedom of scientific

thought, expression, exchanges of opinion and

information. The y refuse to use non-scientifu:
approaches and expressions of ideological, religious, and
political opinions in their work as scientists.

Convince regulatory agencies

Convince producers and custo mers to buy

Environmental concerns about releases

Competition with wild po pulations

Gene introgression effects on wild gene pool
Ecological disruptions d ue t o changes in prey size and other niche requirements

Containment and bio-containme:nt

Eneinec ring approaches are involved & unprove n
Bio<ontainmc nt research still needed
N<'1tlonnl Acndony of Science end Tec hnology
Phll lppin<~ s

11