Ethics in Research

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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
Summary
− 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
Summary
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
Summary

• 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
Summary
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
1971
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
Summary 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
Summary 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
Summary 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
Summary 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
Summary

Nazi
Medical
Experiments
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 Objectives
Research
The thing about research
Ethical guidelines
Ethical principles
Other issues
Animal research
Summary

Nazi
Medical
Experiments
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 Objectives
Research
Ethical guidelines
Ethical guidelines
Ethical principles
Other issues

Nuremberg code
Animal research
Summary
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 Ethical principles

Non-maleficence
− Research must not cause harm to the
participants in particular and to people in
general.
Beneficence
− Research should also make a positive
contribution towards the welfare of people.
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 Ethical principles

Autonomy
− Research must respect and protect the rights
and dignity of participants.
Justice
− The benefits and risks of research should be
fairly distributed among people.
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 NON-MALEFICENCE:
Harms that research can
cause

psychological harm

social harm

legal harm

harm to dignity
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 NON-MALEFICENCE:
Deception

non-disclosure of adequate information

giving of incorrect information about the research
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 NON-MALEFICENCE:
Deception

An ethics committee might allow non-disclosure
of all information, provided:
− detailed justification that there is no alternative
means
− harm is “minimal”
− respect of participants’ rights and welfare
− disclosure about aspects that would
affect willingness to participate
− rest of information, especially of risks
involved, are revealed
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− debriefing will be made available

 BENEFICENCE:
Researcher’s responsibility

Ensure that the research is consistent with
− protection of life
− improvement of human existence
− protection and improvement of the
environment
− advancement of the science profession

Give back the results of the research to
the community
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 AUTONOMY:
Informed consent

Consent given by a competent individual who 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:
Voluntariness

Contracts are voidable when consent is
obtained by:
− mistake: substance of or conditions in the
contract
− violence: irresistible force
− intimidation: reasonable fear of imminent
danger
− undue influence: taking improper advantage of
power
− fraud: insidious words or machinations
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 AUTONOMY:
Voluntariness

Non-written consent must be documented

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 are required
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 AUTONOMY:
Voluntariness

A man’s supplemental consent may be
accepted, but in no case may a competent
adult woman be enrolled in research solely
upon the consent of another person. Her
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
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study enrollment
 AUTONOMY:
Voluntariness

inducement: excessive or inappropriate reward or
other overtures to obtain compliance
− payment
− offers of subject credits to students
− promises of leniency to prisoners
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 AUTONOMY:
Contents of the informed
consent

Title, aims and duration of the study

What you will do to the participants and what
their participation will be

Risks in joining the study

Benefits in joining the study, including fees for
participation
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 AUTONOMY:
Contents of the informed
consent

Declaration of the following participant rights:
− Right to refuse consent
− 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
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 AUTONOMY:
Contents of the informed
consent

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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 JUSTICE:
When involving
communities

Understand, appreciate and respect historical,
cultural and social values and beliefs of the
community

Do courtesy calls

Acquire permission from the mayor, barangay
captain, village chief or community leader
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 JUSTICE:
When involving
communities

Ensure that recruited participants and
communities benefit from the conduct and results
of the research

Ensure equal representation of all sectors
(women, indigenous people, prisoners)

Share fairly the benefits and rewards of the
research
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 Summary

Non-maleficence: harms and deception

Beneficence: researcher’s responsibilities

Autonomy: informed consent,
voluntariness

Justice: ensuring moral and cultural
correctness
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 Laud
Humphreys
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 Definitions

Privacy is the right of persons not to share
information about themselves. (Dunn and
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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• Names
• all geographic information
• all elements of dates (except
year), including birth, death,
admission and discharge dates
• Telephone numbers
• Fax numbers
• Email addresses
• Social security numbers
• Medical record numbers
• Health plan beneficiary numbers
• Account numbers
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Identifiers
• Certificate/license numbers
• Vehicle identifiers and serial
numbers including license plate
numbers
• Device identifiers and serial
numbers
• Web URL
• IP address
• Biometric identifiers, including
finger and voice prints
• Full face photographic images
and any comparable images
• Any other unique identifying
number, characteristic or code
From lecture of Dr Vicente Belizario
 Ethically and legally valid
disclosure of health information

De-identified (coded) health information

Publicly available health information, e.g., those
published in research

Mandatory reporting laws
− RA 8504 – Philippine AIDS Prevention and Control
Act of 1998
− RA 3573 – Law on Reporting of Communicable
Diseases (e.g., SARS, dengue)

Judicial and administrative proceedings

Law enforcement activities, e.g., compulsory HIV
testing
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From lecture of Dr Vicente Belizario

 Authorship

“Authorship matters greatly: it is at the centre of academic
life” (R Horton, R Smith)

An “author” is generally considered to be someone who
has made substantive intellectual contributions to a
published study

Can be power-driven

"each author should have participated sufficiently in the
work to take full responsibility for the content."

(International Committee of Medical Journal Editors -
Vancouver Group)
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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"
(workable?)

(International Committee of Medical Journal Editors -
Vancouver Group)
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 Contributors

Those who do not meet the criteria for authorship; listed
in an acknowledgements section and their contribution
should be specified
− Provided purely technical help, writing assistance or general
support
− Financial and material support
− Clinical investigators or participating investigators
− Scientific advisors, reviewers, collected data or cared for study
patients
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 Other issues

Research involving animals
− The dominant ethical position, world-wide, is
that achievement of scientific and medical
goals using 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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 Arguments

The view that animals have moral rights (animal
rights) is a philosophical position proposed by Tom
Regan, who argues that animals are beings with
beliefs, desires and self-consciousness.[146] Such
beings are seen as having inherent value and thus
possessing rights. Regan still sees clear ethical
differences between killing animals and killing
humans, and argues that to save human lives it is
permissible to kill animals. However, some such as
Bernard Rollin have taken his position further and
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argue that any benefits to human beings cannot

outweigh animal suffering, and that human beings
 R.A. 8485 (Animal Welfare
Act of 1998

aims to protect and promote the welfare of all
animals in the Philippines

SECTION 6: It shall be unlawful for any person to
torture any animal, or to neglect to provide adequate
care, sustenance or shelter, or maltreat any animal or
to subject any dog or horse to dogfights or
horsefights, kill or cause or produce to be tortured or
deprived of adequate care sustenance or shelter, or
maltreat or use the same in research or experiments
not expressly authorized by the Committee on
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Animal Welfare.