Ethics in Research

Alvin Concha, MD
Davao Medical School Foundation
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 Objectives
Research
What we hope to achieve
Ethical guidelines
Ethical principles
Other issues At the end of the session, you will be able to:
Animal research − describe ethical principles in research
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− define informed consent
− enumerate the contents of an informed
consent form
− describe practical issues in participants’
autonomy
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 Objectives
Research
Outline
Ethical guidelines
Ethical principles
Other issues

Why do research
Animal research 
Origins of international guidelines (from
Bottomlines
lecture of Prof Edlyn Jimenez)

Tuskegee videos

Ethical principles

Other issues: privacy, confidentiality,
deception, inducement, authorship

Animal research

Summary
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 Objectives
Research
Research
Ethical guidelines
Ethical principles
 Asking questions
Other issues
 Generating answers through a rigorous process
Animal research
 Communicating the new information
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• Knowledge/information production
• Advancement of medicine through research

What we What we
already already
know know
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 Objectives
Research
Life expectancy over the decades
Ethical guidelines
Ethical principles

The increased longevity of humans over the past century can be
significantly attributed to advances resulting from medical research.
Other issues (http://wisconsinmedicalresearch.com)

Animal research
75 years
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67 years
65 years

Human genome project

Ciprofloxacin 2003
50 years 1987 Angiotensin II vaccine
2008
Synthetic “human” insulin
1982
~30 years Penicillin
Measles vaccine
1963 Anti retroviral for AIDS
1928 1996
Polio vaccine
Syphilis study 1955 AIDS Levoflocacin
1932 Statins
Streptomycin 1981 1993
Arsphenamine 1971
1908 1944
Cefalexin
Lympoma antineoplastic 1970
1940

c.1800 1960 1990 2004 2050

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Sources: http://muse.jhu.edu/login?uri=/journals/human_biology/v075/75.1demerath.html; Disease Control

Priorities in Developing Countries, second edition, 2006, Table 1.1; World Population Prospects: The 2006
Revision, Highlights. New York: United Nations. Table III.1
 Objectives
Research
The thing about research
Ethical guidelines
Ethical principles
Other issues

Research participants may be unduly harmed
Animal research − 1796: Edward Jenner inoculated healthy 8-year-old
Bottomlines James Phipps with cowpox, then 3 months later with
smallpox, and was hailed as the discoverer of
smallpox vaccine
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 Objectives
Research
The thing about research
Ethical guidelines
Ethical principles
Other issues

Research participants may be unduly harmed
Animal research − 1900: Walter Reed infected 22 Spanish immigrants in
Bottomlines Cuba with the agent for yellow fever, paying them
$100 if they survive and $200 if they contract the
disease; first “informed consent”
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 Objectives
Research
The thing about research
Ethical guidelines
Ethical principles
Other issues

Research participants may be unduly harmed
Animal research − 1906: Richard Pearson Strong, then head of the
Bottomlines Philippine Biological Laboratory, inoculated 24 men--
inmates of Manila's Bilibid Prison--with a cholera
vaccine that somehow had been contaminated with
plague organisms; 13 men died.
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Source: Chernin, E. Richard Pearson Strong and the iatrogenic plague disaster in Bilibid Prison, Manila, 1906. Rev Infect Dis. 1989
Nov-Dec;11(6):996-1004.
 Objectives
Research
The thing about research
Ethical guidelines
Ethical principles
Other issues

Research participants may be unduly harmed
Animal research − 1970: Laud Humphreys published Tearoom Trade, a
Bottomlines study on “deviant behavior”; the book described how
he pretended to be a lookout for men who had fellatio
in public restrooms. Humphreys copied their car plate
numbers to get their addresses, and interviewed the
men by pretending to be a market researcher.
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 Objectives
Research
The thing about research
Ethical guidelines
Ethical principles
Other issues
Animal research
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Nazi
Medical
Experiments
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Source: http://www.ushmm.org/wlc/media_ph.php?lang=en&ModuleId=10005168&MediaId=859
 Objectives
Research
The thing about research
Ethical guidelines
Ethical principles
Other issues

Tuskegee Syphilis Study
Animal research
Bottomlines
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 Objectives
Research
Ethical guidelines
Ethical guidelines
Ethical principles
Other issues

Nuremberg code (1947)
Animal research − Principles resulting from the Nuremberg Trials (the
Bottomlines Doctors’ Trial) (1945-49)
− 23 leading German physicians and administrators – for
conspiracy, war crimes, crimes against humanity,
membership in criminal organization
− principles

informed consent (autonomy)

absence of coercion (autonomy)

properly formulated scientific experimentation

beneficence towards experiment participants
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 Objectives
Research
Ethical guidelines
Ethical guidelines
Ethical principles
Other issues

Declaration of Helsinki (1964)
Animal research − By World Medical Association, amended several
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− First significant effort of the medical community to
regulate itself
− Principles

respect for the individual

right to self determination (autonomy)

research should be based on a thorough knowledge of the
scientific background

research must have a reasonable likelihood of benefit to the
population studied (beneficence)

research must be conducted by suitably trained investigators
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using approved protocols, subject to independent ethical

review and oversight by a properly convened committee
 Objectives
Research
Ethical guidelines
Ethical guidelines
Ethical principles
Other issues

CIOMS Guidelines
Animal research − International Ethical Guidelines for
Bottomlines Biomedical Research Involving Human
Subjects
− By the Council for International Organizations
of Medical Sciences
− 1993; revised 2002
− Principles

Respect for persons

Beneficence

Justice
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 Objectives
Research
Ethical guidelines
Ethical guidelines
Ethical principles
Other issues

National Ethical Guidelines
Animal research for Health Research (2006)
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(Philippines)
− Research Ethics Review
Process
− General Ethical Guidelines
for Health Research
− Special Guidelines
− Guidelines on Authorship
and Publication
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 Objectives
Research
Ethical guidelines
Ethical guidelines
Ethical principles 
Special Guidelines
Other issues
− Ethical Guidelines for Clinical Trials on Drugs, Devices, and
Animal research Diagnostics
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− Ethical Guidelines for Herbal Research
− Ethical Guidelines for Complementary and Alternative Medicine
Research
− Ethical Guidelines for Epidemiologic Research
− Ethical Guidelines for Social and Behavioral Research
− Ethical Guidelines for the Conduct of Research on Populations
Traumatized in Emergencies and Disasters
− Ethical Guidelines for HIV/AIDS Research
− Ethical Guidelines for Research on Assisted Reproductive
Technology
− Ethical Guidelines for Genetic Research with a Section on Stem
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Cell Research
− Ethical Guidelines for International Collaborative Research
 Objectives
Research
Ethical principles
Ethical guidelines
Ethical principles
Beneficence
Other issues
− Research should make a positive contribution towards
Animal research
the welfare of people.
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Justice
− The benefits and risks of research should be fairly
distributed among people.
Autonomy
− Research must respect and protect the rights and
dignity of participants.
Non-maleficence
− Research must not cause harm to the participants in
particular and to people in general.
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 NON-MALEFICENCE:
Objectives
Research Harms that research can cause
Ethical guidelines
Ethical principles
Other issues

psychological harm
Animal research 
social harm
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
legal harm

harm to dignity

deception: non-disclosure of adequate
information, or giving of incorrect information
about the research; may be allowed in certain
circumstances
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 AUTONOMY:
Objectives
Research Informed consent
Ethical guidelines
Ethical principles
• Consent given by a
Other issues
Animal research
competent individual who
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has received the necessary
information, who has
adequately understood the
information, and who after
considering the
information, arrived at a
decision without having
been subjected to coercion,
undue influence or
intimidation.
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 AUTONOMY:
Objectives
Research Voluntariness
Ethical guidelines
Ethical principles
Other issues
• Non-written consent
Animal research must be documented
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• For a minor child
(below 18 years),
insane, deaf-mutes or
those who cannot
write, consent of a
legally authorized
representative PLUS
assent of the mentally
competent participant
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are required
 AUTONOMY:
Objectives
Research Voluntariness
Ethical guidelines
Ethical principles 
A man’s supplemental consent may be accepted, but in no
Other issues
case may a competent adult woman be enrolled in
Animal research
research solely upon the consent of another person. Her
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individual consent is always required

If the community consents to participate, individuals may
still refuse to participate; if the community does not
consent, individual members of the community should not
be approached for study enrollment
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 AUTONOMY:
Objectives
Research Contents of informed consent
Ethical guidelines
Ethical principles
Other issues

Title, aims and duration of the study
Animal research 
What you will do to the participants and what
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their participation will be

Risks in joining the study

Benefits in joining the study, including fees for
participation
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 AUTONOMY:
Objectives
Research Contents of informed consent
Ethical guidelines
Ethical principles
Other issues

Declaration of the following participant rights:
Animal research − Right to refuse consent
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− Right to withdraw from the study anytime
− Right to confidentiality of personal
information
− Right to access of information of study results
and anything pertinent to participation

A statement, below which the participant signs
that he or she has understood all the provisions in
the form and has given voluntary consent to join
the study.
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 Objectives
Research
Privacy and confidentiality
Ethical guidelines
Ethical principles
Other issues

Privacy is the right of persons not to share
Animal research information about themselves. (Dunn and
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Chadwick 2004)

Confidentiality is the obligation to keep
private information that has been collected
from being shared with others. (Dunn and
Chadwick 2004)
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 Objectives
Research
Identifiers
Ethical guidelines
Ethical principles
• Names • Certificate/license numbers
Other issues • •
all geographic information Vehicle identifiers and serial
Animal research • all elements of dates (except numbers including license plate
Bottomlines year), including birth, death, numbers
admission and discharge dates • Device identifiers and serial
• Telephone numbers numbers
• Fax numbers • Web URL
• Email addresses • IP address
• Social security numbers • Biometric identifiers, including
• Medical record numbers finger and voice prints
• Full face photographic images
• Health plan beneficiary numbers
and any comparable images
• Account numbers
• Any other unique identifying
number, characteristic or code
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From lecture of Dr Vicente Belizario

 Objectives
Research
Authorship
Ethical guidelines
Ethical principles 
“Authorship matters greatly: it is at the centre of academic
Other issues
life” (R Horton, R Smith)
Animal research
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
Basis for authorship
− Substantial contributions to
A. Conception and design, or analysis and interpretation of data
B. Drafting the article or revising it critically for important intellectual
content
C. Final approval of the version to be published
− "conditions (A), (B), and (C) must all be met"

(International Committee of Medical Journal Editors - Vancouver
Group)
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 Objectives
Research
Animal research
Ethical guidelines
Ethical principles
Other issues

The dominant ethical position, world-wide, is that
Animal research
achievement of scientific and medical goals using
Bottomlines
animal testing is desirable, provided that animal
suffering and use is minimized.

The British government has additionally required that
the cost to animals in an experiment be weighed
against the gain in knowledge.
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 Objectives
Research
Arguments against animal research
Ethical guidelines
Ethical principles 
Tom Regan: animals have moral rights; animals are
Other issues
beings with beliefs, desires and self-consciousness
Animal research
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
Bernard Rollin: any benefits to human beings cannot
outweigh animal suffering, and that human beings have no
moral right to use an individual animal in ways that do not
benefit that individual

Peter Singer: there is no convincing reason to include a
being's species in considerations of whether their
suffering is important in utilitarian moral considerations
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 Objectives R.A. 8485 (Animal Welfare Act of
Research 1998)
Ethical guidelines
Ethical principles
Other issues

aims to protect and promote the welfare of all
animals in the Philippines
Animal research
Bottomlines 
SECTION 6: It shall be unlawful for any person
to… use (any animal) in research or experiments
not expressly authorized by the Committee on
Animal Welfare.

The killing of any animal other than cattle, pigs,
goats, sheep, poultry, rabbits, carabaos, horses,
deer and crocodiles is likewise hereby declared
unlawful except in the following instances:

… 6. When the animal is killed after it has been
used in authorized research or experiments…
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 Objectives
Research
Bottomlines
Ethical guidelines
Ethical principles
Other issues

Research is very important but it can be harmful
Animal research to participants
Bottomlines 
Research processes must be ethically regulated

There are international, national and local
guidelines that follow widely-accepted ethical
principles; these guidelines can be used for
reference in designing research methods

Screening by Ethics Review Boards allows proper
weighing of risks and benefits of certain research
procedures; risks may not always be avoided, but
they can be managed
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Thank you!