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

result of impersonal forces
2. Informed Consent
● Christians believe that the impersonal
aspects of the universe were created by the
● Nothing should be done to a person without personal God of Scripture, that God created
a valid informed consent. man in his image. Therefore, the highest
● Can only be obtained if the person is given principle of Christian Ethics;
the correct complete information, he/she ● Love for God and for one another, is also
understands, and he /she voluntarily and distinctively personal. Thus a Christian
freely agrees to the recommendation. understanding of medical ethics will
● Can be given by a proxy emphasize the importance of treating
“patients as persons”, we treat a person, not a
case
3. Beneficence ● 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)
History of Ethics
3. Persuasion vs. coercion vs. manipulation
Public Health Goals
1. Nazi War Crimes of Medical Nature
4. Personal autonomy vs. Community action
2. The Tuskegee Syphilis Study
● e.g. fluoridation of water
3. The Willowbrook Studies
4. The Jewish Chronic Disease Hospital Study
5. Regulation of personal behavior
5. Radiation Tests on Mentally Impaired Boys
● e.g. mandatory condom use in brothels
(Thailand, Nevada)
Nazi War Crimes of Medical Nature
6. Proportionality
● cost versus benefit ● 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 ● The Tuskegee Health Benefit Program was
radiation doses while standing to fill out established to provide these services
forms without their knowledge ● In 1975, wives, widows and offsprings were
● Study in Butch and Wald concentration added to the program.
camp used prisoners for a typhus vaccine ● In 1995, the program was expanded,
study, leading to deaths. including the health as well as medical
benefits.
● The last study participant died in January
Nuremberg Trial
2004 and the last widow receiving the
Tuskegee Health Benefit Program died in
● Post-World War II, exposing Nazi human
January 2009.
experiments.
● There are 11 offspring currently receiving the
● This was horror of experiments, different
medical and health benefits.
human experiments exposed after World
● Now again, till this day, the U.S. government
War II
is still paying millions because of this study.
● Introduction to the Tuskegee syphilis study.

The Willowbrook Studies

The Tuskegee Syphilis Study
● Study on infectious hepatitis and
● Study involved 600 black men (399 with
gamma-globulin's effectiveness.
syphilis, 201 without).
● There were mentally retarded children
● Conducted without informed consent,
housed in Willowbrook State School in
participants told they were treated for "bad
Staten Island, New York.
blood."
● They were intentionally given hepatitis in an
● The researchers told the men that they were
attempt to track the development of the
being treated for bad blood, a local term
viral infection.
used to describe several ailments including
● The study began in 1956 and it lasted for 14
syphilis, anemia and fatigue.
years.
● Subjects didn't receive proper treatment;
● The researchers also wanted to determine
study continued for 40 years.
the effectiveness of gamma-globulin
● In exchange for taking part of the study, the
injection as part of protection against
men received free medical exams, free meals
hepatitis.
and burial insurance.
● They justified that there are deliberate
● Although originally projected to last six
infections and exposures by claiming that
months, the study actually went on for 40
given that there are high rates of infection in
years.
the institution, it was practically inevitable
● In July 1972, an Associated Press story about
that the children would become infected.
the Tuskegee study caused a public outcry
● In other words, the researchers claimed it
that led the Assistant Secretary for Health
was better to be infected under carefully
and Scientific Affairs to appoint an ad hoc
controlled conditions than otherwise.
adversary panel to review the study.
● The panel had nine members from the fields
of medicine, law, religion, labor, education, The Jewish Chronic Disease Hospital Study
health administration and public affairs.
● The men were never given adequate ● In 1963, studies were undertaken at New
treatment for their disease, even when York's Jewish Chronic Disease Hospital to
penicillin became available to drug of choice understand whether the body's inability to
for syphilis in 1947 reject cancer cells was due to cancer or due
● Researchers did not offer it to the subjects. to debilitation.
● The advisory panel found nothing to show ● Previous studies had indicated that healthy
that subjects were given the choice of persons rejected cancer cells promptly
quitting the study. ● The researchers allegedly believed that a
● Even with this new, highly effective debilitated patient would also reject cancer
treatment became widely available. but at a substantial slower rate compared to
● In 1974, a $10 million out of court settlement healthy participants.
was reached. ● They also studied the nature of the human
● As part of the settlement, the U.S. transplant rejection process with injection of
government promised to give lifetime live cancer cells and claimed that consent
medical benefits and burial services to all was taken orally. However, there was no
living participants. documentation.
Public Health Ethics
Lesson 3 | Lecture notes
● Patients were not informed because it would
The Nuremberg Code (1947)
frighten them unnecessarily.

● It is the result of post - World War II trial of

Radiation Tests on Mentally Impaired Boys 23 Nai doctor for crimes against humanity
committed in the name of research
● In Fernald State School in Massachusetts, a ● German doctors performed experiments
study conducted in 19 mentally ill children under the disguise of scientific research in
who were fed with radioactive isotopes Nazi concentration camps where prisoners
through their milk to document its effects. were used without concern for their
● Now this study ran for 10 years from 1946 to welfare and consent.
1956.
● The researchers had no permission from the Principles of Nuremberg Code
kids or their patients ● Informed consent is absolutely essential
● They told the kids that they were part of the - Informed voluntary consent.
science club.
● This was performed for the research on the ● Qualified researchers must use
digestive system. appropriate research designs
● The researchers were from Harvard - Research must be purposeful and
University and Massachusetts Institute of necessary for the benefit of society.
Technology and were supported by Quaker - Research must be based on animal
Oats. studies or other rational justification.
- Avoidance, protection from injury,
unnecessary physical and mental
History of Ethical Research
suffering.
Movement
● There must be a favorable risk/ benefit
ratio
Origins of Medical Ethics - Risks to subjects shall not be greater
than humanitarian importance of
Caraka and Susruta Samhita (400BC) problem.

● In Ashtanga Hridaya ● Participants must be free to stop at any

● earliest recorded medical ethics time
- Investigators must be scientifically
qualified and the subject may (20:04)
terminate the experiment any time.
Hippocrates (600 AD)

● Father of Modern Medicine

● Established a medical school. Declaration of Geneva (1948)
● Developed the Hippocratic Oath
- oath of medical ethics ● This oath was adopted by the World
- formed the basis of the present Medical Association after the atrocities
medical oaths taken by the doctors committed in the name of research in
and students before they begin the World War II by the Nazi concentration
practice of medicine. camps.

Chief Tenets of Hippocratic Oath: Key Concepts in this Declaration

● Honor instructors in medical arts ● Service to humanity
● Pass on the art only to those bound by the ● Respect and gratitude in the practice of
oath the art
● Practice for the benefit of patients ● Conscience and dignity in the practice of
● Do no harm the art
● Give no deadly medicine or substance for ● Attention to health of patient, colleagues
abortion and traditions of art
● Enter homes for the benefit of the sick. ● Practice in accordance with laws of
● Abstain from mischief and corruption. humanity
● Maintain doctor-patient confidentiality ● Respect for human life from conception
● Duty takes precedence over racial,
religious, political or social prejudices
Public Health Ethics
Lesson 3 | Lecture notes
subjects, applying ethical standards in
local circumstances an establishing or
improving ethical review mechanisms.
● Nuremberg → Helsinki → CIOMS
● Informed consent
● Research in developing countries
Declaration of Helsinki
● Protection of vulnerable populations
● Distribution of the burdens and benefits
● World Medical Association (1964, 1975, 1983,
● Role and responsibilities of ethics
1989, 1996, 2002)
committees
● Published as a response to unethical
experiments of Nazis during World War II
and
● Has been revised several times since its The Belmont Report 1987
publication in 1964
● It latest revision in 2002 ● Written by The US National Commission
for the Protection of Human Subjects of
Principles of Declaration of Helsinki Biomedical and Behavioral Research
● “The well-being of the subject should take ● The commission created as a result of the
precedence over the interests of science National Research Act of 1974
and society” ● It was charged with identifying the basic
● Doctors should only act in the patient's best ethical principles that should underlie the
interest. conduct of biomedical and behavioral
● Consent should be in writing research involving human subjects and
● Use caution if participant is in dependent developing guidelines to assure that such
relationship with researcher research is conducted in accordance with
● Health of the patient is the first concern and those principles.
placebo or the use of placebo should be
discussed. Limited use of placebo, Ethical Principles and Guidelines
especially if treatment is available These ethical principles and guidelines for the
● Greater access to benefit once research is protection of human subjects or research are the
concluded following.
● Respect for persons
● Ethics committees have the obligation to ● Beneficence
monitor trials, to disclose to subjects ● Justice
details of funding and conflicts of interest
and publishers may decline studies not
carried out ethically.
● Council for International Organizations of
Basic Principles of Research on
Medical Science guidelines in 1993 and the Human Subjects
latest 2002 are designed to be of use to
countries in defining national policies on
1. Respect for Persons
the ethics of biomedical research
2. Beneficence
involving human subjects, applying ethical
3. Justice
standards in local circumstances an
establishing or improving ethical review
mechanisms. Respect for Persons

● Choices of autonomous individuals should

be respected
Council for International Organizations of
● People incapable of making their own
Medical Science (CIOMS) Guidelines 1993, choices should be protected
2002 ● Voluntary subjects need adequate
information for decision-making
● Council for International Organizations of
Medical Science guidelines in 1993 and the Beneficence
latest 2002 are
● Designed to be of use to countries in
● Participation in research is associated with
defining national policies on the ethics of
a favorable balance of potential benefits
biomedical research involving human
and harms
Public Health Ethics
Lesson 3 | Lecture notes
● Maximize possible benefits, minimize
potential harm
General Principle for Risk and Benefits
Justice
● Risks and benefits to the research
● Participation in research is associated with participant usually carry the most weight.
a favorable balance of potential benefits ● There is absolutely no justification for
and harms inhumane treatment of participants.
● May not exploit or exclude vulnerable ● Risks to participants should always be
individuals who may benefit without good reduced to the maximum extent possible.
reason ● If a significant risk is involved, justification
● The risks must be shared across all groups of the research must be examined with
in society particular care.
● Whenever vulnerable persons are
participants, the need to involve them
must be carefully demonstrated. Informed
Assessment of Benefits and Risks 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 ● What treatment is available and cost
termination) ● Whether payment will be provided for
● Explanation of features of the research participation, and if so, how much (fair
design, such as randomization or placebo payment for time, travel or inconvenience)
● Must not be coercive

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

● 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 ● Community must have a common
health-related culture
● A communication network for the
community must be in place
Two Responsibilities
● Are placebo groups ethical?
● Should placebos reflect international or
● Ensure the research responds to the health
local standards of care?
needs and priorities of the target
● Should participants be assured care
community.
beyond the trials – if so, for how long?
● Ensure any product developed will be
● Should care be provided to the trial
made available to the community
community?
● Should trials be evaluated for scale-up
feasibility before implementation?
Responsiveness to Community Health
Needs
Evaluation of “Opt - Out” / Routine Testing
● It is not sufficient to determine disease
prevalence and that new research is ● HIV is primarily spread by persons who do
needed. not know they are infected
● If successful interventions result from the ● A large proportion of those infected do not
research they must be made available to know their status
the community. ● Testing is associated with stigmatization,
● If this is not done, the research is community rejection and family discord
exploitative. ● Cannot access treatment if don’t know HIV
status
Making a Prior Agreement ● Does routine testing violate human rights?
● Does respecting the right to refuse testing
violate the human rights of others?
● Before the research begins, a plan should
be offered in which the proposed product
is made available to the host nation upon Privacy vs Confidentiality
completion of the study.
● Participants should include ● Privacy is about people and confidentiality
representatives of the nation’s is about data.
government, local authorities, community
members, and NGO groups

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
IRB Considerations Confidentiality Risks
for obtaining the information to constitute
research involving human subjects.
● Confidentiality protections should be
commensurate with the potential risk of
inadvertent disclosure of the information
Are We Redefining Privacy? ● 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
Includes information about behavior that occurs
in a context in which an individual can reasonably ● Restrict access to data (password protect,
expect that no observation or recording is taking lock)
place, and information which has been provided ● If data stored on a computer; maintain on
for specific purposes by an individual and which a standalone computer; no network
the individual can reasonably expect will not be connection
made public (for example, a medical record). ● Use encryption software, if data is
accessed it is unable to be deciphered
● Minimize storage of subject identifiable
IRB Considerations Methods to Protect data on a laptop computer which can be
lost or stolen
Privacy
● Certificates of Confidentiality – protects
data from being subpoenaed
Institutional Review Board (IRB) considerations
● Waiver of Documentation of informed
methods to protect privacy:
consent

● Allow face-to-face interview participants to

provide information in writing or by using
a computer keyboard, instead of orally (e.g., Anonymous
ACASI)
● Use telephone touch tones for responses Data collected from individuals who were not
to sensitive telephone interview questions identified at the time of collection.
● Participants can use headphones and
portable audio player to listen to questions

IRB Considerations Anonymous - Why

Does it Matter?
Confidentiality
Collecting anonymous data or anonymizing data
OHRP IRB Guidebook, Chapter III-D. after collection may serve as most appropriate
● ….pertains to the treatment of information method to protect subjects’ confidentiality
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.”
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?