Ethical issues (2)

Ethical Issues For Biomedical
Research In India
Dr Anjali Upadhye
Research Coordinator
M.Sc.(Statistics),M.B.A.,PGDTQM,ADCCAA,Ph.D.
ADAMC,ASHTA

What is ethics ?
 The word "ethics" is derived from the Greek word
ethos (character), and
from the Latin word mores (Morals,customs).
Ethos is defined as "the distinguishing character,
sentiment, moral nature, or guiding beliefs of a
person, group, or institution“
Together, they combine to define how individuals
choose to interact with one another

 Definition of Ethics
A set of values or principles and
duties and obligations, based upon
standards of right and wrong that govern
the conduct of members of a particular
group or profession

Ethics in Biomedical Research
Right of the human subject to
understand:
 the nature of research,
 risks & benefits involved
 to agree or not agree to participate.

Ethical Guidelines for Research
on Human Subjects
 “Ethical Guidelines for biomedical research on
human subjects” prepared by
Central Ethics Committee on Human Research
(CECHR)
 Released in the year 2001 by Hon’ble Minister for
Health and Family Welfare, Govt of India
 Guidelines are being drafted for legislation
Available at : www.icmr.nic.in

Early problematic research
• Infected prostitutes and children with
syphilis to test immunity by serum from
syphilitic patients, without consent
(Germany, 1892)

 BCG (TB vaccine) disaster : 77 of
256 children died
(Germany, late 1920s)

• Poor children, especially orphans from
Hebrew Infant Asylum,
To study development of scurvy
(NYC) no orange juice to orphans
(1800s-early 1900s, USA & others)
Susan Lederer :Subjected to Science: Human
Experimentation in America Before the Second World
War 1997.

End point of experiments - DEATH

Research atrocities by Nazis, WWII
In concentration camps (Dachau) and killing camps
(Auschwitz)
□ Immerse prisoners in cold water
until they died – the intent of the research
□ Decompress prisoners in high-altitude chambers
until they died – the intent of the research
□ Inject many prisoners with typhus
many died
Nuremberg Medical Trial, 1946-47
□ tried 23 defendants (20 physicians)
□ convicted 15

War Crimes
Tribunal at
Nuremberg

The Nuremberg Code, Aug. 19, 1947
 10 rules for “Permissible Medical Experiments”:
 voluntary consent, without coercion,
 good science, done by good scientists,
 potential benefits justify experiment,
 harms minimized,
 degree of risk less than potential benefit,
 subjects can end their participation, … [and 4 more]
 http://www.hhs.gov/ohrp/references/nurcode.htm

Nuremberg Code 1949: 10 points
 Voluntary (informed) consent
must be obtained
Investigator’s responsibility was
highlighted

no full disclosure, coercion/ undue pressure, vulnerable subjects

The Declaration of Helsinki 1964
Adopted by the 18th World Medical Assembly
Revised 7 times
Latest version
2013: Seventh revision, 64th Meeting, Fortaleza
32 principles
Para 13: protocols must be submitted to an
Ethics Committee for review, which must be
independent of the investigator, the sponsor
or any other kind of undue influence.

Tuskegee Syphilis Study
American medical research project
conducted by the
U.S. Public Health Service
from 1932 to 1972,
examined the
natural course of untreated syphilis in
black American men…..
……….. illiterate farmers from Macon County in Alabama

US Public Health Service Syphilis Study
 Natural history of untreated syphilis in
405 African American men
impoverished sharecroppers around Tuskegee, AL 1932-72
 Researchers lied to the men
 said they treated them for "bad blood“
 Highly "successful"
 dropout rate only 1% over 40 years

Why was it so “successful”?
 The reason: it was "culturally sensitive"
 paid for funeral,
 African American nurse & some doctors
 Not secret!
 Updated results published about every 5 years

Tuskegee Syphilis Study
Results:
28 direct deaths,
100 cases of disability deaths ,
40 wives infected
19 cases of congenital syphilis

What were the Ethical
issues in this study ?

MILESTONES IN ETHICAL DEVELOPME
 1932–72 Tuskegee experiment on syphilis
 1939–45 Nazi experiments
 1944–74 Human radiation experiments by
U.S. government
 1946 Nuremberg Trial of doctors responsible
for the Nazi experiments
 1947 Nuremberg Code outlining ethical
principles required for research
 1948 United Nations adoption of Universal
Declaration of Human Rights

 1953 NIH policy, the first U.S. federal policy
introducing independent reviewers to
examine research, forerunners of the IRBs
 1963–66 Willowbrook Study, involving hepatitis
research on mentally retarded children, raising
issues access to care, consent, and coercion
 1964 Declaration of Helsinki international
agreement on recommendations for the ethical
conduct of medical research
 1972 Public exposure of Tuskegee syphilis study
 1974 First federal protections for human
research participants

MILESTONES IN ETHICAL DEVELOPMEN
 1979 Belmont Report promoting three
principles for research
 1980 Food and Drug Administration
regulations (CFR 21 (50)
 1982 Council for the International
Organization of Medical Sciences (CIOMS)
publication of the International Ethics
Guidelines for Biomedical Research Involving
Human Subjects
 1985 U.S. Public Health Service Task Force
on Women’s Health issues report
encouraging inclusion of women in research
 1990 Society for Women’s Health Research

 1993 Public exposure of U.S. human radiation
experiments
 1993 NIH Revitalization Act mandating inclusion of
women and minorities in research
 1993 NIH Office of Research on Women’s Health

Ethical issues
 Lack of informed consent,
 Putting subjects and their families to risk,
 Exploitation of vulnerable population,
 Deception,
 Withholding information,
 Denying Treatment (….Penicilin)
 No benefit to subjects
"arguably the most infamous
biomedical research study in U.S. history,"

White House Apology Ceremony – May 16, 1997
Front Row (left to right):
Herman Shaw, Fred Simmons, Charles Pollard, Frederick Moss, Carter Howard.
Back Row (left to right):
Surgeon General David Satcher, President William J. Clinton, Vice-President Albert
Gore.

PRESIDENT CLINTON:
“The United States Government did something that was
wrong, deeply, profoundly, morally wrong. It was
an outrage to our commitment to integrity and
equality for all our citizens.
We can end the silence. We can stop turning our heads
away. We can look at you in the eye and finally say
on behalf of the American people what the United
States Government did was shameful, and I am
sorry.’’

The Belmont Report
Ethical Principles and Guidelines for the
Protection of Human Subjects of Research
The National Commission for the
Protection of Human Subjects of Biomedical and
Behavioral Research
April 18, 1979

U.S. HealthTuskegee Syphilis Study 1932-1972
The Belmont Report 1979
Willowbrook Hepatitis Study
The Declaration of Helsinki 1964
World war II 1939-1945
Nuremberg Medical Trial, 1946-47

The Belmont Report
 Basic ethical principles underlying its proposed regulations ( - and their
application):
 Respect for persons
 Informed Consent
 Beneficence
 Assessment of potential risks [harms] and benefits
 Justice
 Selection of people to be in the research
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

Principle: 1. Respect for Persons
 "Individual autonomy"
 Informed consent
 full information
 full comprehension
 voluntary
 without coercion
 Protect individuals with reduced capacity to exercise
autonomy

Principle: 2. Beneficence
 "Do no harm" - "Do benefit"
 Assessment of risks [harms] and benefits
 Minimize harms to participants
 Use least harmful methods to achieve the scientific end
 Favourable Benefit-to-Risk comparison
 maximize Benefit:-to-Risk ratio
 maximize benefits to participants and society

Principle: 3.Justice
 "Treat individuals fairly"
 Selection of subjects / participants
 Equitable distribution of research harms and benefits
 Equitable selection of subjects / participants within a population
 Equitable selection of population

The Belmont Report: 3 principles summary
 Respect for Persons-
 autonomy of individuals
 Special protection for those with diminished
autonomy
 Beneficence
 maximize the possible benefits
 minimize possible harm
 Justice
 subjects should be selected fairly to ensure that
the benefits and burdens of medical research are
evenly distributed

Some Indian Human Ethics Regulations
1956 : Code of Medical Ethics, MCI
1980 : Policy Statement on Ethical
Considerations involved in research on
Human Subjects (ICMR)
1986 : EPA Act for r-DNA products
2000 : Revised ICMR Ethical guidelines
2001 : Indian GCP Guidelines
2002 : Amendment to Drugs and Cosmetics Act
2007 : Revised ICMR Guidelines

 Revised ICMR Guidelines
in February 1980……
2006
 Statement of General
Principles
 Statement on Specific
Principles
 Guidelines have been
converted into law which is
pending before the Indian
Parliament
Ethical Guidelines for Research
on Human Subjects

Chapter I. Statement of General Principles on
Ethical Considerations
 involving Human Participants
 Background
 General Statement
 Statement of General Principles

Statement of General Principles
I. Principles of essentiality
II. Principles of voluntariness, informed consent
and community agreement
III. Principles of non-exploitation
IV. Principles of privacy and confidentiality

V. Principles of precaution and risk minimisation
VI. Principles of professional competence
VII. Principles of accountability and transparency
VIII. Principles of the maximisation of the public
interest and of distributive justice

IX. Principles of institutional arrangements
X. Principles of public domain
XI. Principles of totality of responsibility
XII.Principles of compliance

Ethical Guidelines for
Biomedical Research (2007)

Expectation
All institutions in the country which carry
out any form of biomedical research
involving human beings should follow
these guidelines in letter and spirit to
protect safety and well being of all
individuals.
Guidelines available at- http://www.icmr.nic.in

Applications
 Voluntary, written, informed consent
 IRB Review

Informed consent
Consent given by a competent individual
Who:
 Has received the necessary information
 Has understood the information
 And having understood the information has
arrived at a decision without having been
under any coercion, undue influence or
inducement or intimidation

Informed consent
 Written informed consent
 Voluntary
 from every subject
 before any study related procedure
 and documented on EC approved form
 adhere to GCP, based on Helsinki Declaration

Who gives the consent?
 1.Subject
if subject unable to give consent ( minor , dementia
etc.) then –
 2.Subject’s legally acceptable representative
-should be informed to the extent compatible with
his/her understanding and consent sought and
documented.

How should the consent
be documented?
Signed and dated by
 Subject / subject’s legally acceptable
representative
 Person conducting the informed consent
discussion
 If subject / subject’s legally acceptable
representative is illiterate, an impartial witness

Informed Consent: Non-English
speaking/Illiterate subject
 Summary and consent in the vernacular
 Written translation
 Thumb impressions allowed

Document Method of Obtaining
Consent:
Video tape
Witness

Informed Consent: Children
 Approval of older children: assent
 Consent from parents/legally
acceptable representative

. . . is not a just a piece of paper.
. . . is not a just a signature.
It is a process by which we . . .
. . . Ensure that our subject’s right to be informed,
and right to consent to research, is protected.
. . . Document our efforts to protect the subject’s
rights to the satisfaction of independent
observers.
Therefore, Informed Consent . . .

 Voluntary, written, informed consent
 IRB Review
Applications

Ethics Committee
Any board, committee or other group
formally designated by an institution to
review,
approve the initiation of and
conduct periodic review of
biomedical research involving
human subjects.

All proposals on
biomedical research involving human
subjects must be cleared
by an
Ethics Committee!

Which studies to submit
to Ethics Committee?

 Pharmaceuticals
 Medical Devices
 Medical Radiation and Imaging
 Surgical Procedures
 Medical Records
 Biological Samples
 Epidemiological, Social and
Psychological Investigations
All Clinical Research!!

Composition of the EC
A reasonable number of members who
collectively have the qualifications and
experience to review and evaluate the
science, medical aspects and ethics of the
proposed trial.

Chairperson : Outsider
Member – Secretary
At least 1 member
 basic medical scientist
 clinician
 legal expert
 social scientist/philosopher/priest
 lay person
Composition of the EC

Ethical committee of SGH
• Dr Shetty Chairman Radiologist KEM
• Dr Ghongane Pharmacology
• Dr Vidya Kelkar. Anaesthesia
• Dr Meenal Jadhav Pathology
• Dr Punpale Forensic Medicine
• Dr Prasad Medicine
• Mr.Masal F.D.A.
• Mrs. Patil Social worker
• Mr. Reddy Retired I. A. S. Officer
• Mrs. Pawar Judge

What does an EC do for
Clinical Research?

Scientific Review
Does this research study
Title
Objectives
Study design
Data collection process
Analytical plan
Have the potential to yield useful information?

Ethical review
Does this research study have adequate concern for
the safety and welfare of subjects ?
Rationale
It is unethical to subject humans to research which is
not scientifically/technically sound and which does
not ensure the safety and welfare of its subjects

Review Proforma
1. Background, Research objectives
2. CV of the investigator
3. Subject recruitment , I/E criteria
4. Research procedures in detail
5. Safety procedures
6. DATA handling
7. Analysis plan
8. Informed consent
9. Cost to subject
10. Plan for publication/sharing of findings
11. Sponsor/conflict of interest
12. Special situations
13. Appendices

What does an EC do for Clinical Research?
 Before the study begins:
 Submission of research proposal
 Review of proposal
 Decision making process
 Issuing an approval
 Record keeping

 During the study:
 Review of amendments ( Protocol )
 Review of Serious Adverse Events
 Protocol deviations
 Progress (study status)
 Record keeping
What does an EC
do for Clinical Research?

 After the study:
 Study report,
 Post trial management
 Publishing
 Record keeping
What does an EC do for
Clinical Research?

Who should deal with the EC?
The chief investigator not the sponsor

Criteria for EC approval of
research proposal?

Criteria for EC Approval of
Research Proposal
 Suitability of Investigator
 Qualifications, Experience
 Supporting Staff, Available Facilities
 Time available

Criteria for EC Approval of
Research Proposal
 Suitability of Protocol
 Objectives of the study
 Scientific efficiency
 Justification: risks/ inconveniences vs. benefits
 Risks & benefits to the trial subject
 Subject safety measures
 Confidentiality of subjects and data
 Regulatory issues

Criteria For Approval
 Equitable Selection of Subjects
 Time Provision - Monitoring the Data
 Confidentiality of subjects and data
 Informed consent process

Special Concerns and Issues
faced in Ethics Committees

 Central Drugs Standard Control
Organization permission for Phase 1-
3 studies
 “new drug” – new indication/new
route of administration/new dosage
form
 Amount of blood to be drawn
 Sending samples abroad
Regulatory Clearances

Challenges
If studies are NOT submitted for review,
then the safeguard of ECs is
meaningless!

OTHER ETHICAL ISSUES
 One should not cheat, falsify data etc.
 One should not plagiarize.

PLAGIARISM
 Plagiarism is taking another’s work and passing it off
as your own.
 In a broad sense we are all guilty of plagiarism many
times each day.
 We often take ideas from others and don’t attribute
them to their original source.
 More often than not we don’t even know the original
source!
 When we talk about the decline and fall of the Roman
Empire or say, “To be or not to be, that is the
question” in normal conversation, we rarely attribute
the words to Gibbon and Shakespeare respectively.

PLAGIARISM IN RESEARCH IS USUALLY QUI
 True plagiarism is, quite bluntly, stealing.
 Sometimes a person just copies text word for
word from a book or article and pretends that
he is the author.
 Or buys an already written paper on the web.
 These are quite deliberate aims to deceive.

PLAGIARISM EXTENDS TO MORE THAN WO
 ONE SHOULD ALWAYS PROVIDE REFERENCES
FOR ANY
□ STATISTICS
□ GRAPHS
□ TABLES
□ NUMBERS, ETC.
THAT ONE WISHES TO USE IN ONE'S OWN
PAPER.
 THUS, IT ISN’T JUST THE WORDS OF ANOTHER
PERSON’S IDEAS THAT ONE SHOULD
REFERENCE.

COPY DIRECT QUOTATIONS EXACTLY
 Make sure that you write it precisely, word-
for-word as in the original.
 Also essential that you enclose the quoted
text in quotation marks.
 Failing to put someone else’s direct text in
quotation marks and crediting the author,
may lead to accusations of plagiarism.

PARAPHRASING IS OFTEN PREFERABLE TO TAKIN
 It’s often preferable to take down the
substance of an author’s idea in your own
words, i.e. to paraphrase.
 The greater part of your paper should be in
your own words with appropriate
documentation of the ideas of others.
 Of course, some direct quotation is fine – but
always with citation.

“PLAGIARISM” SOMETIMES NOT INTENTIONA
 Many instances of plagiarism stem from sloppy
research rather than through a deliberate desire to
cheat.
 Many students during the research process take bad
notes, e.g. they write down someone else’s text
verbatim but forget to include the quotation marks.
 Later when they are writing the actual paper and they
refer to their notes, they fail to remember that the text
is another author’s and not their own.
 A reader who recognizes the original text might think
that the student has cheated. And this may lead to
tough penalties.
 So, the golden rule is to take excellent notes, write
your whole paper yourself and to document your
sources as well and as honestly as possible.

COMMON KNOWLEDGE” AND PLAGIARI
 It is not necessary to document every single
statement.
 One need not give a reference for stating that
President John F. Kennedy was assassinated
in 1963.
 This fact is common knowledge and belongs
in the public domain.
 However, if you are referring to Historian X’s
thesis that Kennedy was killed by a crime
syndicate and not by Lee Harvey Oswald,
proper citation to such a theory is requisite.

106
Ethical principle Ethical rule
Respect for persons Obtain the informed consent of prospective research
subjects
Protect the confidentiality of private information
Beneficence Therapeutic procedures must satisfy clinical equipoise
Risks of non-therapeutic procedures must be (1) minimized
and (2) reasonable in relation to knowledge to be gained
Justice Subject selection procedures must be fair
Compensate subjects harmed as a result of research
participation
Respect for communities Respect communal values, protect and empower social
institutions
Where applicable, abide by the decisions of legitimate
communal authority
ETHICAL PRINCIPLES AND
RULES

Take home message
 There should be a functional Institutional Ethics
Committee in each institute
 These should be constituted as per the ICMR
guidelines
 Research should be conducted following these
Guidelines
 While reporting research, mentioning of ethical
approval is mandatory

Case 1
 A woman enters the emergency room with stomach pain. She
undergoes a CT scan and is diagnosed with an abdominal aortic
aneurysm, a weakening in the wall of the aorta which causes it to stretch
and bulge (this is very similar to what led to John Ritter's death). The
physicians inform her that the only way to fix the problem is surgically,
and that the chances of survival are about 50/50. They also inform her
that time is of the essence, and that should the aneurysm burst, she
would be dead in a few short minutes. The woman is an erotic dancer;
she worries that the surgery will leave a scar that will negatively affect
her work; therefore, she refuses any surgical treatment. Even after much
pressuring from the physicians, she adamantly refuses surgery. Feeling
that the woman is not in her correct state of mind and knowing that time
is of the essence, the surgeons decide to perform the procedure without
consent. They anesthetize her and surgically repair the aneurysm. She
survives, and sues the hospital for millions of dollars.

Questions for Case 1:
 Do you believe that the physician's actions can be
justified in any way?
 Is there anything else that they could have done?
 Is it ever right to take away someone's autonomy?
(Would a court order make the physicians' decisions
ethical?)
 What would you do if you were one of the health care
workers?

Case No 2:
 You are a general practitioner and a mother comes into your
office with her child who is complaining of flu-like symptoms.
Upon entering the room, you ask the boy to remove his shirt
and you notice a pattern of very distinct bruises on the boy's
torso. You ask the mother where the bruises came from,
and she tells you that they are from a procedure she
performed on him known as "cao gio," which is also known
as "coining." The procedure involves rubbing warm oils or
gels on a person's skin with a coin or other flat metal object.
The mother explains that cao gio is used to raise out bad
blood, and improve circulation and healing. When you touch
the boy's back with your stethoscope, he winces in pain
from the bruises. You debate whether or not you should call
Child Protective Services and report the mother.

Questions for Case 2:
 Should we completely discount this treatment as
useless, or could there be something gained from it?
 When should a physician step in to stop a cultural
practice? (If someone answers "when it harms the
child" remind that person that there is some pain in
many of our medical procedures, for example, having
one's tonsils removed)
 Should the physician be concerned about alienating
the mother and other people of her ethnicity from
modern medicine?
 Do you think that the physician should report the
mother?

Case No 3
 A woman was diagnosed with motor neurone disease (the
same
disease that Stephen Hawking has) 5 years ago. This is a
condition that destroys motor nerves, making control of
movement impossible, while the mind is virtually unaffected.
People with motor neurone disease normally die within 4
years of diagnosis from suffocation due to the inability of the
inspiratory muscles to contract. The woman's condition has
steadily declined. She is not expected to live through the
month, and is worried about the pain that she will face in her
final hours. She asks her doctor to give her diamorphine for
pain if she begins to suffocate or choke. This will lessen her
pain, but it will also hasten her death. About a week later, she
falls very ill, and is having trouble breathing.

Questions case 3
 Should the money used to care for this woman be
taken into account when she is being helped? Do you
think that legalizing euthanasia could create conflicts
of interest for the patient/ or the doctor? Will people
feel that they need to end their lives earlier to save
money?
 Ask each student: If you were the physician, what
would you do? Note: if you would pass her off to
another doctor knowing he or she would do it, does
this free you from you ethical obligations?

 Does she have a right to make this choice, especially in
view of the fact that she will be dead in a short while (say
six hours)? Is this choice an extension of her autonomy?
 Is the short amount of time she has to live ethically
relevant? Is there an ethical difference between her dying
in 6 hours and dying in a week? What about a year, and
how do you draw this distinction?
 Is the right for a patient's self-determination powerful
enough to create obligations on the part of others to aid her
so that she can exercise her rights? She clearly cannot kill
herself. She can't move, but should someone be FORCED
to help her, or to find someone to help her?

Case no 4
 There are two types of surrogacy. One type involves a surrogate mother who
uses her own egg and carries the baby for someone else. The other type is
a "gestational surrogacy" in which the mother has no genetic tie to the child
she carries. In the case presented, a gestational surrogate is used.
 A woman, after a bout with uterine cancer had a hysterectomy (surgical
removal of the uterus). Before, its removal, however, she had several eggs
removed for possible fertilization in the future. Now married, the woman
wishes to have a child with her husband. Obviously she cannot bear the
child herself, so the couple utilizes a company to find a surrogate mother for
them. The husband's sperm is used to fertilize one of the wife's eggs, and is
implanted in the surrogate mother. The couple pays all of the woman's
pregnancy-related expenses and an extra $18,000 as compensation for her
surrogacy. After all expenses are taken into account the couple pays the
woman approximately $31,000 and the agency approximately $5,000.
Though the surrogate passed stringent mental testing to ensure she was
competent to carry another couple's child, after carrying the pregnancy to
term, the surrogate says that she has become too attached to "her" child to
give it up to the couple. A legal battle ensues.

Questions case 4?
 In the United States it is illegal to pay a person for non-
replenishable organs. The fear is that money will influence the
poor to harm their bodies for the benefit of the rich. Do you see a
parallel between this case and this law? Can allowing surrogate
mothers to be paid for their troubles allow poorer women to be
oppressed?
 Does paying the surrogate harm her and/or the child's dignity?
 Is it selfish/conceited for this couple to want children of their own
genetic make-up? If yes, does this change if you can "easily"
have a child? (Note: Over 100,000 children in the U.S. are waiting
to be adopted. However, most are older, have several siblings, or
have special needs.)

 On their website, the AMA says "that surrogacy contracts [when the
surrogate uses her own egg], while permissible, should grant the birth
mother the right to void the contract within a reasonable period of time after
the birth of the child. If the contract is voided, custody of the child should be
determined according to the child's best interests." Do you see any problems
with this? (What's a reasonable time? In a way can you steal the surrogate's
child?)
 One of the main arguments against the use of surrogate mothers is that
carrying and giving birth to a child is such an emotional event that it is
impossible to determine if the surrogate will be able to give up the child.
Though adults enter into the contract, the child could ultimately suffer if a
long custody battle ensues (as it could in states where surrogacy contracts
hold no legal value, such as Virginia). With the possibility of such battles, do
you think it is acceptable for parents to use a surrogate mother?
 Do you think that if the surrogate is awarded the baby, this could cause
emotional harm to the child?
 Who do you think should receive the child, and why?

Case No 5
 A married couple wishes to have a child; however, the 32 year old
mother knows that she is a carrier for Huntington's disease (HD).
HD is a genetic disorder that begins showing signs at anywhere
from 35-45 years of age. Its symptoms begin with slow loss of
muscle control and end in loss of speech, large muscle spasms,
disorientation and emotional outbursts. After 15-20 years of
symptoms HD ends in death. HD is a dominant disorder which
means that her child will have a 50% chance of contracting the
disorder. Feeling that risking their baby's health would be
irresponsible, the couple decides to use in vitro fertilization to
fertilize several of the wife's eggs. Several eggs are harvested, and
using special technology, only eggs that do not have the defective
gene are kept to be fertilized. The physician then fertilizes a single
egg, and transfers the embryo to the mother. Approximately 9
months later, the couple gives birth to a boy who does not carry the
gene for the disorder.

Quesstion case 5
 Is this a case of eugenics? "Eugenics" is defined as "the hereditary
improvement of the human race controlled by selective breeding"
(dictionary.com)
 Would it be acceptable for the parents to select for sex as well, or should
they only select an embryo that does not have HD? How would this be
different?
 Is it ethical for this couple to have a baby when the mother could begin
showings signs of HD when the baby is just a few years old?
 With this technology possible, would it be ethical for this couple to have a
child without genetically ensuring it would not have the disease? What if we
did not have this technology, would it be ethical for a known carrier to have
a child? (If not, how far should this carry? a carrier for cystic fibrosis ( which
is recessive)? )
 Weighing everything we have discussed, do you believe the couple acted
ethically?

Case 6
 A mother brings her son into the emergency room
during an asthma attack. Though both of his parents
work, they cannot afford medical insurance for
themselves or him. They also earn too much money
to qualify for state or federal aid. He is treated for his
asthma attack at the hospital and he and his mother
leave. Two weeks later, they return to the hospital in
a virtually identical scenario.

Question case no 6
 Do you think that this boy is receiving adequate care?…Shouldn't he
be able to see a primary care physician before his condition gets so
acute that he must visit the ER?
 Should everyone be entitled to a basic "minimum of health care"…
or to the exact same health care?
 Do you think that health care is a right? If so, are we forced to honor
this right?
 (If students answer "yes" to the above question) Is this right relative
or universal? Does this right exist because of the wealth of the
United States, or is it applicable everywhere? Is health care a
luxury?
 Does having money entitle a person to better health care? (they
may have worked harder for their greater wealth)

Case no 7
 An upper middle class, middle aged, Canadian man
is playing racket ball when he suddenly feels a pop in
his knee. In pain, he makes an appointment with his
general practitioner and is seen the next day. He is
given pain medication, and is referred to an
orthopedic surgeon (he has no choice of who he will
see). After a week wait, he is seen by the orthopedic
surgeon and is told he will need surgery. Two weeks
later surgery is performed on the man's knee. The
physician, who is not very good, does a poor job on
the knee, and the man walks with a slight limp for the
rest of his life. The surgery costs the man no money
directly, however, he pays for it with higher taxes.

Questions case no 7?
 What do you think of this man's experience in comparison to case
1? Which situation seems worse, and why?
 Does it seem like it took too long for him to receive care? (The
physicians will perform surgery on the more urgent patients first
and then on the less serious.)
 What do you think about not being able to choose your own
physician? (Note: In the United States, many insurance companies
limit which physicians you choose.)
 One suggested solution for our current health care woes is that
care for the elderly be decreased/eliminated. For example, people
over the age of 80 will no longer be placed on life support, which
costs approximately $10,000 per day to operate. What do you think
of this?
 What do you think could be a good middle ground solution to this
problem?

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