Public Health Ethics

Lesson 3 | Lecture notes

Law vs Ethics
Ethics
Law Ethics
According to Webster’s Ninth New
Collegiate Dictionary Refers to a systematic It is a branch of moral
● The discipline of dealing with what is good body of rules that philosophy that guides
and bad, with moral duty and obligation. governs the whole people about the basic
society and the actions human conduct.
● A set of moral principles or values.
of its individual
● The principle of conduct governing an members
individual or group
Set of rules and Set of guidance
regulations
● Ethics is a derivative of a Greek word ethos,
Government Individual, legal,
meaning customs, conduct, or character.
professional norms
● It is concerned with the kinds of values and
morals an individual or society ascribes as Expressed and They are abstract
desirable or appropriate published in writing
● Focuses on the virtuousness of an individual
and their motives. Violation of law is not There is no
● Ethics is the science of morality. It deals with permissible which punishment for
may result in violation of ethics
the right or wrong of any activity. Thus, ethics
punishment
is the principle of right conduct. (imprisonment or fine
or both)

Law is created to Ethics are made to

Dictionary of Epidemiology, 4th edition maintain social order help people to decide
and peace in the what is right or wrong
● The branch of philosophy that deals with
society and provide and how to act
distinctions between right and wrong – with protection to all
the moral consequences of human actions. citizens

Rule
● A statement that tells you what is or is not
allowed in a particular game, situation, etc.
● It is a statement that tells you what is allowed
or what will happen within a particular
system, such as a language or a science.
● A piece of advice about the best way to do
something
Law
● These are rules and regulations that are set
by the authorities or government and are
must be followed otherwise penalties and
punishments may be the consequences
● Code of conduct for the people in a specific
area.
● It explains and illustrates people for what is
allowed to do and what is not allowed to do.
● Laws can be made and changed by
authorities according to demand and need
for maintaining specific conditions in the
society.
● Laws are a must for any country, workplace,
or even in a community.
Bioethics
● Study of ethical dilemmas brought about by
advances in biology and medicine
● Bioethics is concerned with the ethical
questions that arise in the relationships
among life sciences, biotechnology, medicine,
politics, law, and philosophy.
● It is the ethics of life sciences.
● It is a systematic study of human conduct in
the area of life science and healthcare in the
light of moral values and principles.
Why is Bioethics Important?
● It helps govern the clinicians or healthcare
providers' obligation to the sick and to the
society with the help of moral principles.
● The moral principles will serve to make
better healthcare workers and safeguard
the welfare of patients as the healthcare
workers have to adhere to a code of ethics
and to set specific standards of conduct.
● Bioethics has addressed a broad swatch of
human inquiries ranging from debates
over the boundaries of life such as abortion
and euthanasia, surrogacy, the allocation
Public Health Ethics
Lesson 3 | Lecture notes
of scarce healthcare resources such as
organ donation and healthcare rationing
to the right to refuse medical care for
religious or cultural reasons.
● To do good
● It states that healthcare providers should
contribute to the welfare of others or
promote health.

Importance of Bioethics
4. Non - Maleficence
1. Makes health providers sensitive to ethical
problems in medical practice ● Do no harm
2. Makes them know and understand ● It is to serve what is best for the patient and
bioethical principles which guide them to exert due care so that no harm is inflicted on
resolve bio-ethical problems w/c they may him.
later encounter in their profession.
3. Helps to develop mature reasoning and to
act in accordance with principles, moral 5. Justice
judgment therefore developing a
compassionate attitude towards the patient. ● Equality
● Problems arise in determining who are equal,
Bioethical Principles in what way they are equal and to what they
are equal.
1. autonomy ● This could be applied in the issues that arise
2. informed consent in a distribution of scarce resources.
3. beneficence Macroallocation and microallocation.
4. non-maleficence
5. justice 6. Truth telling
6. truth telling
7. confidentiality ● An essential component of informed consent
8. personhood and involves giving information in
9. stewardship and accountability understandable terms and ensuring proper
10. totality understanding of the information
11. cooperation
12. double effect

7. Confidentiality
1. Autonomy
● An essential element in maintaining a good
● The right to be a fully informed participant in
patient-doctor relationship.
all aspects of medical decision making, and
● Based on the principles of respect for person,
the right to refuse unwanted, recommended
privacy, and trust.
and lifesaving medical care.
● What the healthcare provider knows of his
● The respect of persons is observed through
patient, he cannot tell others.
free and informed consent
● When unable to make decisions, a proxy may
8. Personhood
do it according to the patient’s best interest.

● The personal aspects of the universe are the

2. Informed Consent
● Nothing should be done to a person without
a valid informed consent.
● Can only be obtained if the person is given
the correct complete information, he/she
understands, and he /she voluntarily and
freely agrees to the recommendation.
● Can be given by a proxy
3. Beneficence
result of impersonal forces
● Christians believe that the impersonal
aspects of the universe were created by the
personal God of Scripture, that God created
man in his image. Therefore, the highest
principle of Christian Ethics;
● Love for God and for one another, is also
distinctively personal. Thus a Christian
understanding of medical ethics will
emphasize the importance of treating
“patients as persons”, we treat a person, not a
case
● Therefore, the highest principle of a Christian
ethic is love for God and for one another.
Public Health Ethics
Lesson 3 | Lecture notes
Public Health Ethics
9. Stewardship
● Public health ethics are principles and
values that guide actions to promote
Steward
health and prevent injury and disease
A person who manages others property; one who among the population
administers anything as the agent of another ● Public health ethics should be
distinguished from biomedical ethics.
Dominion Biomedical ethics often stress (8:13) the
The power or right of governing or controlling importance of individual interests of
patients, while public health ethics
Accountability emphasizes (8:19) partnership, citizenship,
and community.
Being accountable, liable or answerable to
whatever is done.
Structured Approaches of Public Health
Ethics
10. Totality
Some scholars have structured public health
● The whole is more than the parts and the ethics in 3 ways:
part exist and function for the good of the
whole 1. Professional ethics are concerned with
● When the condition of the part threatens the ethical dimensions of professionalism.
whole, then it can be sacrificed. 2. Applied ethics relate to dynamics of the
public health enterprise itself.
3. Advocacy ethics are informed by the single
11. Double Effect overriding value of a healthy community

● An action results in 2 effects (good and bad)

this principle is applied. Disagreements among Scholars
● 4 conditions to be met for the act to be
ethical:
Scholars and practitioners disagree on each of 3
1. Is not intrinsically evil
forms of public health ethics:
2. Good effect is the one intended
3. Good effect must not result from
1. A code of ethics could clarify the field and
the evil effect
provide guidance regarding ethical
4. Evil effect must be proportional to
dilemmas.
the good effect
2. Some suggest that no single public health
profession exists.
12. Cooperation 3. It is difficult to find a single set of values
that relates to all public health
● Care of a patient often involves more than professionals.
one health care provider.
● Conflicts arise when the providers disagree as
to the best action or when the proposed
action violates one’s conscience
Why Study Ethics in Philippines
1. Many issues of conflict between good of
the individual and good of society.
Ethics 2. Immunization, chlorination, fluoridation
3. Food fortification
● Medical ethics - Patient Centered 4. HIV/AIDS, MDRTB, DOTs vs DOTS Plus
● Public health ethics - community or 5. Aging and Chronic Diseases
population-centered 6. Genetically modified foods
● Research ethics - Subject centered 7. Technology and Resource Allocation
8. Stem Cell Research
9. The Case for Action
Public Health Ethics
Lesson 3 | Lecture notes
Principles of Ethical Practices of Conflicting Public Health Goals
Public Health

Adapted from PH Leadership Society, 2002

● PH should address the causes of disease
and requirements for health
● PH must respect the rights of individuals
● PH should seek input from communities
● PH should strive for health for all
● PH should base policies on evidence
● PH should obtain community consent for
Now there are conflicting public health goals. Is it
implementation of policies/interventions
to protect the infected individual versus the
● PH should respond to health problems in a
uninfected?
timely manner
● PH must respect diverse values, beliefs and
cultures Justification of Research in Humans
● PH programs should enhance the physical
and social environment ● Impossible to reach important conclusions
● PH should protect the confidentiality of without studying human
individuals and communities whenever ○ Human physiologic studies, because
possible animal responses often are not the
● PH must assure the professional same
competence of their employees ○ Epidemiological studies, because They
● PH should engage in collaborations that depend on human susceptibilities and
build public trust and are effective human interactions
○ Drugs for treating humans because
animal experiments don’t always
Public Health Action predict human responses

● If you’re going to treat certain kinds of

1. The Laundry of Human Rights!
humans, then you must perform studies
● Incarceration of infectious individuals e.g.
with them, for example Children, mentally
typhoid
impaired, ethnic groups, elderly, women,
● Quarantine of contacts (China H1N1)
men and pregnant women

2. Right to privacy vs. Mandatory disease reporting

● (STDs, HIV)
3. Persuasion vs. coercion vs. manipulation
Public Health Goals
4. Personal autonomy vs. Community action
● e.g. fluoridation of water
5. Regulation of personal behavior
● e.g. mandatory condom use in brothels
(Thailand, Nevada)
6. Proportionality
● cost versus benefit
History of Ethics
1. Nazi War Crimes of Medical Nature
2. The Tuskegee Syphilis Study
3. The Willowbrook Studies
4. The Jewish Chronic Disease Hospital Study
5. Radiation Tests on Mentally Impaired Boys
Nazi War Crimes of Medical Nature
● Nazis sterilized large populations secretly to
ensure Aryan race supremacy
● They use sterilization methods for women
which includes:
1. dried plant juice in flour and was
fed to general population
2. Intrauterine injections of silver
nitrite given to women without
consent during routine physical
exams
Public Health Ethics
Lesson 3 | Lecture notes
● For Men, they were exposed to sterilizing
radiation doses while standing to fill out
forms without their knowledge
● Study in Butch and Wald concentration
camp used prisoners for a typhus vaccine
study, leading to deaths.
Nuremberg Trial
● Post-World War II, exposing Nazi human
experiments.
● This was horror of experiments, different
human experiments exposed after World
War II
● Introduction to the Tuskegee syphilis study.
The Tuskegee Syphilis Study
● Study involved 600 black men (399 with
syphilis, 201 without).
● Conducted without informed consent,
participants told they were treated for "bad
blood."
● The researchers told the men that they were
being treated for bad blood, a local term
used to describe several ailments including
syphilis, anemia and fatigue.
● Subjects didn't receive proper treatment;
study continued for 40 years.
● In exchange for taking part of the study, the
men received free medical exams, free meals
and burial insurance.
● Although originally projected to last six
months, the study actually went on for 40
years.
● In July 1972, an Associated Press story about
the Tuskegee study caused a public outcry
that led the Assistant Secretary for Health
and Scientific Affairs to appoint an ad hoc
adversary panel to review the study.
● The panel had nine members from the fields
of medicine, law, religion, labor, education,
health administration and public affairs.
● The men were never given adequate
treatment for their disease, even when
penicillin became available to drug of choice
for syphilis in 1947
● Researchers did not offer it to the subjects.
● The advisory panel found nothing to show
that subjects were given the choice of
quitting the study.
● Even with this new, highly effective
treatment became widely available.
● In 1974, a $10 million out of court settlement
was reached.
● As part of the settlement, the U.S.
government promised to give lifetime
medical benefits and burial services to all
living participants.
● The Tuskegee Health Benefit Program was
established to provide these services
● In 1975, wives, widows and offsprings were
added to the program.
● In 1995, the program was expanded,
including the health as well as medical
benefits.
● The last study participant died in January
2004 and the last widow receiving the
Tuskegee Health Benefit Program died in
January 2009.
● There are 11 offspring currently receiving the
medical and health benefits.
● Now again, till this day, the U.S. government
is still paying millions because of this study.
The Willowbrook Studies
● Study on infectious hepatitis and
gamma-globulin's effectiveness.
● There were mentally retarded children
housed in Willowbrook State School in
Staten Island, New York.
● They were intentionally given hepatitis in an
attempt to track the development of the
viral infection.
● The study began in 1956 and it lasted for 14
years.
● The researchers also wanted to determine
the effectiveness of gamma-globulin
injection as part of protection against
hepatitis.
● They justified that there are deliberate
infections and exposures by claiming that
given that there are high rates of infection in
the institution, it was practically inevitable
that the children would become infected.
● In other words, the researchers claimed it
was better to be infected under carefully
controlled conditions than otherwise.
The Jewish Chronic Disease Hospital Study
● In 1963, studies were undertaken at New
York's Jewish Chronic Disease Hospital to
understand whether the body's inability to
reject cancer cells was due to cancer or due
to debilitation.
● Previous studies had indicated that healthy
persons rejected cancer cells promptly
● The researchers allegedly believed that a
debilitated patient would also reject cancer
but at a substantial slower rate compared to
healthy participants.
● They also studied the nature of the human
transplant rejection process with injection of
live cancer cells and claimed that consent
was taken orally. However, there was no
documentation.
Public Health Ethics
Lesson 3 | Lecture notes
● Patients were not informed because it would
frighten them unnecessarily.
Radiation Tests on Mentally Impaired Boys
● In Fernald State School in Massachusetts, a
study conducted in 19 mentally ill children
who were fed with radioactive isotopes
through their milk to document its effects.
● Now this study ran for 10 years from 1946 to
1956.
● The researchers had no permission from the
kids or their patients
● They told the kids that they were part of the
science club.
● This was performed for the research on the
digestive system.
● The researchers were from Harvard
University and Massachusetts Institute of
Technology and were supported by Quaker
Oats.
History of Ethical Research
Movement
Origins of Medical Ethics
Caraka and Susruta Samhita (400BC)
● In Ashtanga Hridaya
● earliest recorded medical ethics
Hippocrates (600 AD)
● Father of Modern Medicine
● Established a medical school.
● Developed the Hippocratic Oath
- oath of medical ethics
- formed the basis of the present
medical oaths taken by the doctors
and students before they begin the
practice of medicine.
Chief Tenets of Hippocratic Oath:
● Honor instructors in medical arts
● Pass on the art only to those bound by the
oath
● Practice for the benefit of patients
● Do no harm
● Give no deadly medicine or substance for
abortion
● Enter homes for the benefit of the sick.
● Abstain from mischief and corruption.
● Maintain doctor-patient confidentiality
The Nuremberg Code (1947)
● It is the result of post - World War II trial of
23 Nai doctor for crimes against humanity
committed in the name of research
● German doctors performed experiments
under the disguise of scientific research in
Nazi concentration camps where prisoners
were used without concern for their
welfare and consent.
Principles of Nuremberg Code
● Informed consent is absolutely essential
- Informed voluntary consent.
● Qualified researchers must use
appropriate research designs
- Research must be purposeful and
necessary for the benefit of society.
- Research must be based on animal
studies or other rational justification.
- Avoidance, protection from injury,
unnecessary physical and mental
suffering.
● There must be a favorable risk/ benefit
ratio
- Risks to subjects shall not be greater
than humanitarian importance of
problem.
● Participants must be free to stop at any
time
- Investigators must be scientifically
qualified and the subject may (20:04)
terminate the experiment any time.
Declaration of Geneva (1948)
● This oath was adopted by the World
Medical Association after the atrocities
committed in the name of research in
World War II by the Nazi concentration
camps.
Key Concepts in this Declaration
● Service to humanity
● Respect and gratitude in the practice of
the art
● Conscience and dignity in the practice of
the art
● Attention to health of patient, colleagues
and traditions of art
● Practice in accordance with laws of
humanity
● Respect for human life from conception
● Duty takes precedence over racial,
religious, political or social prejudices
Public Health Ethics
Lesson 3 | Lecture notes
Declaration of Helsinki
● World Medical Association (1964, 1975, 1983,
1989, 1996, 2002)
● Published as a response to unethical
experiments of Nazis during World War II
and
● Has been revised several times since its
publication in 1964
● It latest revision in 2002
Principles of Declaration of Helsinki
● “The well-being of the subject should take
precedence over the interests of science
and society”
● Doctors should only act in the patient's best
interest.
● Consent should be in writing
● Use caution if participant is in dependent
relationship with researcher
● Health of the patient is the first concern and
placebo or the use of placebo should be
discussed. Limited use of placebo,
especially if treatment is available
● Greater access to benefit once research is
concluded
● Ethics committees have the obligation to
monitor trials, to disclose to subjects
details of funding and conflicts of interest
and publishers may decline studies not
carried out ethically.
● Council for International Organizations of
Medical Science guidelines in 1993 and the
latest 2002 are designed to be of use to
countries in defining national policies on
the ethics of biomedical research
involving human subjects, applying ethical
standards in local circumstances an
establishing or improving ethical review
mechanisms.
Council for International Organizations of
Medical Science (CIOMS) Guidelines 1993,
2002
● Council for International Organizations of
Medical Science guidelines in 1993 and the
latest 2002 are
● Designed to be of use to countries in
defining national policies on the ethics of
biomedical research involving human
subjects, applying ethical standards in
local circumstances an establishing or
improving ethical review mechanisms.
● Nuremberg → Helsinki → CIOMS
● Informed consent
● Research in developing countries
● Protection of vulnerable populations
● Distribution of the burdens and benefits
● Role and responsibilities of ethics
committees
The Belmont Report 1987
● Written by The US National Commission
for the Protection of Human Subjects of
Biomedical and Behavioral Research
● The commission created as a result of the
National Research Act of 1974
● It was charged with identifying the basic
ethical principles that should underlie the
conduct of biomedical and behavioral
research involving human subjects and
developing guidelines to assure that such
research is conducted in accordance with
those principles.
Ethical Principles and Guidelines
These ethical principles and guidelines for the
protection of human subjects or research are the
following.
● Respect for persons
● Beneficence
● Justice
Basic Principles of Research on
Human Subjects
1. Respect for Persons
2. Beneficence
3. Justice
Respect for Persons
● Choices of autonomous individuals should
be respected
● People incapable of making their own
choices should be protected
● Voluntary subjects need adequate
information for decision-making
Beneficence
● Participation in research is associated with
a favorable balance of potential benefits
and harms
Public Health Ethics
Lesson 3 | Lecture notes
● Maximize possible benefits, minimize
potential harm
Justice
● Participation in research is associated with
a favorable balance of potential benefits
and harms
● May not exploit or exclude vulnerable
individuals who may benefit without good
reason
● The risks must be shared across all groups
in society
Assessment of Benefits and Risks
General Principle for Risk and Benefits
● Risks and benefits to the research
participant usually carry the most weight.
● There is absolutely no justification for
inhumane treatment of participants.
● Risks to participants should always be
reduced to the maximum extent possible.
● If a significant risk is involved, justification
of the research must be examined with
particular care.
● Whenever vulnerable persons are
participants, the need to involve them
must be carefully demonstrated. Informed
consent is consent

Assure that Benefits Outweigh Risks

Informed Consent
● Research must be justified based on a
favorable benefit/risk assessment for the
Consent given by a competent individual who:
research participant.
● has received the necessary information
● Benefits must outweigh risks
● has adequately understood the
● This is similar to the principle of
information
beneficence or “do no harm.” Researchers
● after considering the information, has
must protect participants from harm and
arrived at a decision without having been
maximize their well-being
subjected to coercion, undue influence or
inducement, or Intimidation”
Risk Vs Benefits

● Give subject sufficient opportunity to

Risk Benefits consider the decision
● Minimize possibility of coercion or undue
● A risk refers to a ● A benefit refers to a
harm or likelihood positive value that influence
of a harm. accrues to the
● The degree of participant and or Informed Consent as a Process
severity of a to the society.
possible harm may
be unclear. Informed consent is a communication process:
● Between the researcher and the
participant
● Before the research → End of the study
Different Types of Risks and Benefits - It starts before the research is
initiated and continues throughout
1. Physical (pain or injury) the duration,
2. Psychological
3. Social
4. Economic
5. Legal Essential Elements of Informed Consent

Risks or benefits of research may apply to

individual participants, families, groups or Description of Research
organizations, communities or nations.
● That it is a research study
● Objectives of the study
● Expected responsibilities of participant ■
Procedures involved
Public Health Ethics
Lesson 3 | Lecture notes
● Study duration (and possibility of early
termination)
● Explanation of features of the research
design, such as randomization or placebo
● What treatment is available and cost
● Whether payment will be provided for
participation, and if so, how much (fair
payment for time, travel or inconvenience)
● Must not be coercive

Description of Risks
● Includes physical, social, and psychological
risks
● Anticipated or foreseeable risks, pain or
discomfort, or inconvenience to the
individual (or others) associated with the
research
● Includes risks to health or well-being of
subject’s spouse, partner, and/or family
● Culturally appropriate
Description of Benefit
Participant of Contact
● Provide contact for research-related
questions
● Provide contact for concerns about rights
as a participant
● Contacts must be realistic and viable
Voluntary Participation
● Absolutely voluntary
● Right to discontinue at any time
● No penalty for refusal

● Benefit to subject or others reasonably

Informed Consent: Language
expected to result from the research”
(Common Rule)
● Be understandable to subject or
● This can include direct medical benefit to
representative (test for comprehension)
participants and expected benefits of the
● Language Must NOT:
research to the community or larger
- Waive subject’s rights
society, or contributions to scientific
- Release investigator, sponsor, or
knowledge
institution from liability
● Whether, when, and how any products or
interventions proven by the research to be
safe and effective will be made available to
subjects once research is ended, and Factors Influencing Voluntary
whether they will be expected to pay for
them
Consent

Confidentiality ● Vulnerability to incentives

● Impact of community pressure (e.g.,
routine community testing)
● Provisions that will be made to ensure
● Perceived power of investigators
respect for privacy of subjects and
● Inability to understand research
confidentiality of records in which subjects
requirements
are identified
● Limits of confidentiality: what persons or
organizations may have access to the Research in Populations and
information, and possible consequences of
breaches of confidentiality
Communities with Limited Resources
● When appropriate, policies about
disclosure of results of genetic tests; e.g.,
certificate of confidentiality Ethical Requirements for International
● Special cultural circumstances
Public Health Research
Compensation
● Social or scientific value
● Scientific validity
● Available compensation in case of
● Fair subject selection
research-related injury, and whether there
● Favorable risk-benefit ratio
is any uncertainty about funding; whether
● Independent review
there is compensation for death or
● Informed consent
disability
Public Health Ethics
Lesson 3 | Lecture notes
● Respect for potential and enrolled subjects
Two Responsibilities
● Ensure the research responds to the health
needs and priorities of the target
community.
● Ensure any product developed will be
made available to the community
Responsiveness to Community Health
Needs
Evaluation of “Opt - Out” / Routine Testing
● It is not sufficient to determine disease
prevalence and that new research is
needed.
● If successful interventions result from the
research they must be made available to
the community.
● If this is not done, the research is
exploitative.
Making a Prior Agreement
● Before the research begins, a plan should
be offered in which the proposed product
is made available to the host nation upon
completion of the study.
● Participants should include
representatives of the nation’s
government, local authorities, community
members, and NGO groups
● Community must have a common
health-related culture
● A communication network for the
community must be in place
● Are placebo groups ethical?
● Should placebos reflect international or
local standards of care?
● Should participants be assured care
beyond the trials – if so, for how long?
● Should care be provided to the trial
community?
● Should trials be evaluated for scale-up
feasibility before implementation?
● HIV is primarily spread by persons who do
not know they are infected
● A large proportion of those infected do not
know their status
● Testing is associated with stigmatization,
community rejection and family discord
● Cannot access treatment if don’t know HIV
status
● Does routine testing violate human rights?
● Does respecting the right to refuse testing
violate the human rights of others?
Privacy vs Confidentiality
● Privacy is about people and confidentiality
is about data.

Privacy
Comprehensiveness of The Agreement
Merriam-Webster Dictionary
● The agreement should include payments,
● the quality or state of being apart from
royalties, distribution costs, subsidies,
company or observation : seclusion
technology, and intellectual property.
● freedom from unauthorized intrusion
● In some cases, international organizations,
(one's right to privacy)
public and private, may also be included in
the discussions.
Private Information

The Ethics of Conducting Research in ● Includes information about behavior that

occurs in a context in which an individual
Developing Countries
can reasonably expect that no observation
or recording is taking place, and
● When, if ever, should investigators use the
information which has been provided for
standards of care/ethics of developing
specific purposes by an individual and
countries vs. developed countries (e.g.,
which the individual can reasonably
Tanzania drug trials)
expect will not be made public (for
● Are investigators responsible for the health
example, a medical record).
of their participants?
● Private information must be individually
● Community must have legitimate,
identifiable.
empowered spokesperson
Public Health Ethics
Lesson 3 | Lecture notes
● Example, the identity of the subject is or
may readily be asserted by the investigator
or associated with the information in order
for obtaining the information to constitute
research involving human subjects.
Are We Redefining Privacy?
Includes information about behavior that occurs
in a context in which an individual can reasonably
expect that no observation or recording is taking
place, and information which has been provided
for specific purposes by an individual and which
the individual can reasonably expect will not be
made public (for example, a medical record).
IRB Considerations Methods to Protect
Privacy
Institutional Review Board (IRB) considerations
methods to protect privacy:
● Allow face-to-face interview participants to
provide information in writing or by using
a computer keyboard, instead of orally (e.g.,
ACASI)
● Use telephone touch tones for responses
to sensitive telephone interview questions
● Participants can use headphones and
portable audio player to listen to questions
Confidentiality
OHRP IRB Guidebook, Chapter III-D.
● ….pertains to the treatment of information
that an individual has disclosed in a
relationship of trust and with the
expectation that it will not be divulged to
others in ways that are inconsistent with
the understanding of the original
disclosure without permission.”
IRB Considerations Confidentiality Risks
● Confidentiality protections should be
commensurate with the potential risk of
inadvertent disclosure of the information
● A breach of confidentiality of sensitive
research data may pose risk of:
- Social stigmatization or
discrimination
- Damage to financial standing,
employability or reputation
- Prosecution for criminal behavior
● Sensitive data may be subject to subpoena
if not protected by a Certificate of
Confidentiality
IRB Considerations Methods to Maintain
Confidentiality
● Restrict access to data (password protect,
lock)
● If data stored on a computer; maintain on
a standalone computer; no network
connection
● Use encryption software, if data is
accessed it is unable to be deciphered
● Minimize storage of subject identifiable
data on a laptop computer which can be
lost or stolen
● Certificates of Confidentiality – protects
data from being subpoenaed
● Waiver of Documentation of informed
consent
Anonymous
Data collected from individuals who were not
identified at the time of collection.
IRB Considerations Anonymous - Why
Does it Matter?
Collecting anonymous data or anonymizing data
after collection may serve as most appropriate
method to protect subjects’ confidentiality
Public Health Ethics
Lesson 3 | Lecture notes
● What responsibility does the investigator
have for sex workers who become
Three Case Studies infected?

1. Clinical Trial to Prevent Maternal/Child

Transmission of HIV
- Clinical Trial to Prevent A Trial of Prophylactic Tenofovir Use
Maternal/Child HIV Transmission:
Ethical Issues ● Intervention group = sex workers – daily
2. Pre-exposure Prophylaxis tenofovir
- Pre-exposure Prophylaxis: Ethical ● Placebo = no medication
Issues ● Counseling and condoms to avoid HIV
3. A Trial of Prophylactic Tenofovir Use infection provided
● Outcome variable = HIV infection rate
● Approved by IRBs in UCSF and NCHADS
Clinical Trial to Prevent Maternal/Child ● Infected sex workers receive two years of
Transmission of HIV treatment with tenofovir
● Trial proceeding in other developing
● Without treatment, 30+% of infants born to countries
HIV-infected mothers will be infected
● Long-term treatment used in rich
countries costs several thousand dollars
per mother
● Poor countries cannot afford long-term
treatment
● Can short-term treatment reduce
transmission?

Ethical Issue

● Is a trial of short-term treatment ethical

when it is known that long-term treatment
is effective?
● Is it ethical to have a control group?
● What should the control group receive?
● What are the ethical responsibilities of the
investigator towards participants,
particularly in the control group?

Pre-exposure Prophylaxis

● 90% of sex workers become HIV-infected

within the first year of work
● Many clients reluctant to wear condoms
● No female-controlled microbicide available
● Tenofovir is cheap, effective and not known
to have many side effects
● Is a clinical trial of prophylactic tenofovir
ethical?

Ethical Issue

● Is a clinical trial in poorly educated sex

workers in a developing country
exploitation?
● Should there be a control group?
● What should the control group receive, if
anything?