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Ethical issues (2)

The document discusses ethical issues in biomedical research in India. It begins by defining ethics and outlining some key historical events that shaped modern research ethics like the Nuremberg trials and Tuskegee Syphilis study. It then describes India's regulatory guidelines for research ethics, including obtaining informed consent and having proposals reviewed by an ethics committee. The document emphasizes that all clinical research involving humans must follow strict ethical protocols to protect participants.

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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
Run up to the present
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.
"Medical experiments"
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
MILESTONES IN ETHICAL DEVELOPME  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
MILESTONES IN ETHICAL DEVELOPME  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
Indian scenario?
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 Statement of General Principles
IX. Principles of institutional arrangements X. Principles of public domain XI. Principles of totality of responsibility XII.Principles of compliance Statement of General Principles
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?
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?
Thank you

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Ethical issues (2)

  • 1.
    Ethical Issues ForBiomedical Research In India Dr Anjali Upadhye Research Coordinator M.Sc.(Statistics),M.B.A.,PGDTQM,ADCCAA,Ph.D. ADAMC,ASHTA
  • 2.
    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
  • 3.
     Definition ofEthics 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
  • 4.
    Ethics in BiomedicalResearch Right of the human subject to understand:  the nature of research,  risks & benefits involved  to agree or not agree to participate.
  • 5.
    Ethical Guidelines forResearch 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
  • 6.
    Run up tothe present
  • 7.
    Early problematic research •Infected prostitutes and children with syphilis to test immunity by serum from syphilitic patients, without consent (Germany, 1892)
  • 8.
     BCG (TBvaccine) disaster : 77 of 256 children died (Germany, late 1920s)
  • 9.
    • 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.
  • 10.
  • 11.
    End point ofexperiments - DEATH
  • 12.
    Research atrocities byNazis, 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
  • 13.
  • 14.
    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
  • 15.
    Nuremberg Code 1949:10 points  Voluntary (informed) consent must be obtained Investigator’s responsibility was highlighted
  • 16.
    no full disclosure,coercion/ undue pressure, vulnerable subjects
  • 18.
    The Declaration ofHelsinki 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.
  • 19.
    Tuskegee Syphilis Study Americanmedical 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
  • 20.
    US Public HealthService 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
  • 21.
    Why was itso “successful”?  The reason: it was "culturally sensitive"  paid for funeral,  African American nurse & some doctors  Not secret!  Updated results published about every 5 years
  • 22.
    Tuskegee Syphilis Study Results: 28direct deaths, 100 cases of disability deaths , 40 wives infected 19 cases of congenital syphilis
  • 23.
    What were theEthical issues in this study ?
  • 25.
    MILESTONES IN ETHICALDEVELOPME  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
  • 26.
    MILESTONES IN ETHICALDEVELOPME  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
  • 27.
    MILESTONES IN ETHICALDEVELOPMEN  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
  • 28.
    MILESTONES IN ETHICALDEVELOPME  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
  • 29.
    Ethical issues  Lackof 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,"
  • 30.
    White House ApologyCeremony – 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.
  • 31.
    PRESIDENT CLINTON: “The UnitedStates 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.’’
  • 32.
    The Belmont Report EthicalPrinciples 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
  • 33.
    U.S. HealthTuskegee SyphilisStudy 1932-1972 The Belmont Report 1979 Willowbrook Hepatitis Study The Declaration of Helsinki 1964 World war II 1939-1945 Nuremberg Medical Trial, 1946-47
  • 34.
    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
  • 35.
    Principle: 1. Respectfor Persons  "Individual autonomy"  Informed consent  full information  full comprehension  voluntary  without coercion  Protect individuals with reduced capacity to exercise autonomy
  • 36.
    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
  • 37.
    Principle: 3.Justice  "Treatindividuals fairly"  Selection of subjects / participants  Equitable distribution of research harms and benefits  Equitable selection of subjects / participants within a population  Equitable selection of population
  • 38.
    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
  • 39.
  • 40.
    Some Indian HumanEthics 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
  • 41.
     Revised ICMRGuidelines 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
  • 42.
    Chapter I. Statementof General Principles on Ethical Considerations  involving Human Participants  Background  General Statement  Statement of General Principles
  • 43.
    Statement of GeneralPrinciples I. Principles of essentiality II. Principles of voluntariness, informed consent and community agreement III. Principles of non-exploitation IV. Principles of privacy and confidentiality
  • 44.
    V. Principles ofprecaution 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 Statement of General Principles
  • 45.
    IX. Principles ofinstitutional arrangements X. Principles of public domain XI. Principles of totality of responsibility XII.Principles of compliance Statement of General Principles
  • 46.
  • 47.
    Expectation All institutions inthe 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
  • 49.
    Applications  Voluntary, written,informed consent  IRB Review
  • 50.
    Informed consent Consent givenby 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
  • 51.
    Informed consent  Writteninformed consent  Voluntary  from every subject  before any study related procedure  and documented on EC approved form  adhere to GCP, based on Helsinki Declaration
  • 52.
    Who gives theconsent?  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.
  • 53.
    How should theconsent 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
  • 54.
    Informed Consent: Non-English speaking/Illiteratesubject  Summary and consent in the vernacular  Written translation  Thumb impressions allowed
  • 55.
    Document Method ofObtaining Consent: Video tape Witness
  • 56.
    Informed Consent: Children Approval of older children: assent  Consent from parents/legally acceptable representative
  • 57.
    . . .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 . . .
  • 58.
     Voluntary, written,informed consent  IRB Review Applications
  • 59.
    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.
  • 60.
    All proposals on biomedicalresearch involving human subjects must be cleared by an Ethics Committee!
  • 61.
    Which studies tosubmit to Ethics Committee?
  • 62.
     Pharmaceuticals  MedicalDevices  Medical Radiation and Imaging  Surgical Procedures  Medical Records  Biological Samples  Epidemiological, Social and Psychological Investigations All Clinical Research!!
  • 63.
  • 64.
    Composition of theEC 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.
  • 65.
    Chairperson : Outsider Member– Secretary At least 1 member  basic medical scientist  clinician  legal expert  social scientist/philosopher/priest  lay person Composition of the EC
  • 66.
    Ethical committee ofSGH • 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
  • 67.
    What does anEC do for Clinical Research?
  • 68.
    Scientific Review Does thisresearch study Title Objectives Study design Data collection process Analytical plan Have the potential to yield useful information?
  • 69.
    Ethical review Does thisresearch 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
  • 70.
    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
  • 71.
    What does anEC do for Clinical Research?  Before the study begins:  Submission of research proposal  Review of proposal  Decision making process  Issuing an approval  Record keeping
  • 72.
     During thestudy:  Review of amendments ( Protocol )  Review of Serious Adverse Events  Protocol deviations  Progress (study status)  Record keeping What does an EC do for Clinical Research?
  • 73.
     After thestudy:  Study report,  Post trial management  Publishing  Record keeping What does an EC do for Clinical Research?
  • 74.
    Who should dealwith the EC? The chief investigator not the sponsor
  • 75.
    Criteria for ECapproval of research proposal?
  • 76.
    Criteria for ECApproval of Research Proposal  Suitability of Investigator  Qualifications, Experience  Supporting Staff, Available Facilities  Time available
  • 77.
    Criteria for ECApproval 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
  • 78.
    Criteria For Approval Equitable Selection of Subjects  Time Provision - Monitoring the Data  Confidentiality of subjects and data  Informed consent process
  • 79.
    Special Concerns andIssues faced in Ethics Committees
  • 80.
     Central DrugsStandard 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
  • 81.
    Challenges If studies areNOT submitted for review, then the safeguard of ECs is meaningless!
  • 83.
    OTHER ETHICAL ISSUES One should not cheat, falsify data etc.  One should not plagiarize.
  • 84.
    PLAGIARISM  Plagiarism istaking 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.
  • 85.
    PLAGIARISM IN RESEARCHIS 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.
  • 86.
    PLAGIARISM EXTENDS TOMORE 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.
  • 87.
    COPY DIRECT QUOTATIONSEXACTLY  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.
  • 88.
    PARAPHRASING IS OFTENPREFERABLE 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.
  • 89.
    “PLAGIARISM” SOMETIMES NOTINTENTIONA  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.
  • 90.
    COMMON KNOWLEDGE” ANDPLAGIARI  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.
  • 91.
    106 Ethical principle Ethicalrule 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
  • 92.
    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
  • 93.
    Case 1  Awoman 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.
  • 94.
    Questions for Case1:  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?
  • 95.
    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.
  • 96.
    Questions for Case2:  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?
  • 97.
    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.
  • 98.
    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?
  • 99.
     Does shehave 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?
  • 100.
    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.
  • 101.
    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.)
  • 102.
     On theirwebsite, 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?
  • 103.
    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.
  • 104.
    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?
  • 105.
    Case 6  Amother 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.
  • 106.
    Question case no6  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)
  • 107.
    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.
  • 108.
    Questions case no7?  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?
  • 109.