Robert Cushing

Inspirational Quote

Stem Cells-What do you think? Ethical issues? Ideas?

A Market for Human Eggs

            New York State was the first state that legally allowed women to donate their eggs for embryonic cell research.  The women were given $10,000 for their donation and a guarantee that the eggs would be used for research.  This area of research is not without controversy by critics that see this form of research as killing as well as the potential for the exploitation of women, especially poor women, who may not be the ideal candidate for donation. The purpose of this paper is to explore the ethical dilemmas in women that donate eggs to stem cell research or to infertile couples and whether or not they should be compensated for their donation (Stein, 2009).

Background

            The human egg (oocyte) donation has been used for many years.  The women take hormones to hyper-stimulate their ovaries to produce eggs that are harvested by a physician, during a surgical procedure, fertilized in vitro and placed back in the uterus for development. The difference in stem cell research is that the eggs are fertilized in vitro and then the genetic materials (stem cells) are removed for research.  The cells are not allowed to develop into an embryo. Embryonic cell research is considered a promising area in science.  The stem cells have the ability to become any cell that is needed to cure many different diseases and injuries.  According to the Stem Cell Research Foundation (SCRF) stem cell research is showing promise in the treatment of heart disease, arthritis, osteoporosis, cancer, Alzheimer’s disease, juvenile diabetes, and spinal cord injuries (Tong, 2007).

            The ethical dilemma comes into play when the embryonic cells are destroyed when they are only days old.  This is view by the critics as killing.  In Kantian Ethics he believed that Moral rules have no exceptions; killing is always wrong. Critics that consider stem cell research killing have to agree that this does follow Kantian Ethics (Stein, 2009).

            Stem cells can be found in limited numbers in adults and  in newborns’ umbilical cord blood, but most scientists feel that the best source is in the “inner mass of a blastocyst (a stage in the development of a pre-embryo that occurs approximately 4 days after fertilization) or in the gonadal tissue of aborted fetuses” (Tong, 2007, p.221). There are two ways to secure pre-embryos for stem cell research that will be discussed in this essay.  The first is to use the left over embryos from couples that have produced more than it is likely that they will have implanted back into the uterus. Their options are to discard them, put them up for adoptions, keeping them frozen or donate them for research.  The second source of pre-embryos is to advertise and obtain eggs and sperm from random donors.  It is not surprising that stem cell research with embryonic stem cells has some morally and ethical controversy (Tong, 2007). 

            In November 2005 a South Korean scientist,  Woo Hwang, was conducting stem-cell research and started an international debate when it was discovered that the eggs he had acquired were from his junior scientists in his laboratory.  Over a period of three years Hwang worked with over 2000 eggs from 129 different women.  It is not clear the amount that these women received for the donations or if they received any payment at all.  While it is clear that egg donors should be compensated on the basis of time and discomfort the international debate continues on the amount and what expenses will be reimbursed to the donor (Steinbrook, 2006).

The Positives and the Negatives

            Egg donation requires a significant amount of time, as well as discomfort from the medication’s  that can cause hot flashes, vaginal dryness, fatigue, insomnia, body aches, mood swings, breast tenderness, headaches and visual problems.  There is a chance of hyper-stimulation of the ovaries which is usually an unpredictable response to ovulation-induction therapy and it causes a fluid shift causing complication such as ascites, pleural and pericardial effusions.  The risk of venous thromboembolism is increased and there is some concern that the women who receive multiple cycles may have a higher risk of ovarian cancer later in life.  This is based on research in animal because there have not been enough studies on human subjects at this time.    There may be future effects to fertility and the future off-spring of the woman that donates her eggs (Steinbrook, 2006).

The no-compensation policy idea has become the standard for stem cell research across the country and internationally there are drafted guidelines that prohibit “undue inducements”.  The ruling of California’s Proposition 71 “prohibits payment in excess of the amount of reimbursement of direct expenses incurred as a result of the procedure” (Gerber, 2007, p. 220). California’s rules have become the standard for stem cell research retrieval of eggs.  This does not however have any effect on egg donation for in vitro fertilization, only for women who donate their eggs for scientific research.  As a result of this no-compensation ruling the high demand for eggs for embryonic stem cell research has far exceeded the supply and altruism alone may not be enough to meet the demand.  Many states are facing shortages and are contesting the policy of no-compensation.   Women have a choice of donating their eggs to an infertile couple for compensation or donating their eggs to stem cell research for no-compensation (Gerber, 2007).

While we as a society remain uneasy with the sale of eggs, it is an acceptable practice to sell sperm.  Is it because there are only a limited number of eggs that a female produces or because we live in a male dominated society? The procedure is not without discomfort and risk in a female.  There is no risk involved with the donation of sperm and the supply is endless.

People participate in research for many reasons; many of them are self-serving, including securing access to healthcare and furthering the knowledge of a condition that they or a family member may suffer from with the hope that one day there will be a treatment or cure (Johnson, 2006).

            In 1999 Ron Harris held a human egg auction that featured three female models with pictures and descriptions, the bidding started at $15,000.  The high volume of people accessing the site over loaded his server and he had to discontinue his egg auction.  Recruiters look for prospect on college campuses with the promise of $15,000-50,000, depending on your ethnicity, height, IQ, and eye color.  In the United States alone over 75,000 births per year are a result of assisted reproductive technology (Resnik, 2001).  

            There are some benefits for selling human eggs; it helps the donors economically if they use their eggs to help an infertile couple have a child. That couple will have a child and the child will have a life.  There may still be some compensation for time and expenses if eggs are donated to research (Resnik, 2001).   Over all the negative aspects far out weight the positives.  

            Stakeholders are all women that have donated eggs for research.  Infertile couples that desire to have children and the children that will be born from the donated eggs.  As well as all persons receiving treatment as a result of the stem cell research that is being conducted today and in the future.  The list of stakeholders is endless and the possibilities are astounding. 

            After the scandal in South Korea it is uncertain how the research groups will obtain approval and funding for the stem cell research, the number of donors they will be able to obtain, and whether enough women will agree to donate if the only monetary compensation is for their expenses.  There is concern that the only women that will donate will be friends and family of persons with diseases and disabilities, whom have an optimistic point of view that they are helping their family member.  There is extensive publicity and advertising that introduces the idea of egg donation in hope that it could motivate more women to consider donating their eggs to research (Steinbrook, 2006).

Not Ethics But.........

Mace MN510 Lesson Plan Project

Tuskagee Project!

Informed Consent

Informed Consent.

 Robert J. Levine’s article Informed Consent: Some Challenges to the Universal Validity of the Western Model (1991) Beauchamp & Walters (2008) p.132-137.  In this article the author states that “Informed consent holds a central place in the ethical justification of research involving human subjects” (p. 132) In order for it to be informed consent four points need to be made it must be “voluntary”, the patient must be “legally competent’, “informed” and able to “comprehend” what is being advised.  The purpose of research on humans must be used to improve the lives of others, either through improving the ability to diagnose a problem, the use of therapeutic and prophylactic procedures and finally understanding of the disease or the pathogens of disease. Special considerations must be obtained when the research involves the environment and animals. 

The Declaration of Helsinki (1964) http://www.cirp.org/library/ethics/helsinki/ 

Lists the Basic Principles as:

1.      Biomedical research involving human subjects must conform to general accepted scientific principles and should be based on adequate preformed laboratory and animal experimentations and on a thorough knowledge of scientific literature.

2.      The design and performance of each experiment procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted to a specially appointed independent committee for consideration.

3.      Biomedical research involves human subjects should be conducted only by scientifically qualified persons.  The responsibility for the human subject must rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent.

4.      Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objective is in the proportion to the inherent risk to the subject.

5.      Every biomedical research project involves human subjects should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others. Concern for the interest of the subject must always prevail over the interest of science and society.

6.      The right of the research subject to safeguard his or her integrity must always be respected.  Every precaution should be taken to respect the privacy of the subjects and to minimize the impact of the study on the subject’s physical and mental integrity and the personality of the subject.

7.      Physicians should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable.  Physicians should cease any investigation if the hazards are found to outweigh the benefits of the study.

8.      In publication of the results of his or her research, the physician is obligated to preserve the accuracy of the results.  Report of experimentation not in accordance with the principles laid down in the Declaration should not be accepted for publication.

9.      In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potentional hazards of the study and the discomfort it may entail.  He or she should be informed that he or she is at liberty to abstain from participation in the study and that he or she is free to with draw visor her consent to participate at any time.  The physician should then obtain the subject’s freely given informed consent, preferably inheriting.

10.  When obtaining informed consent for the research project the physician should be cautious if the subject is in dependent relationship to him or her or may consent under duress.  In that case the informed consent should be obtained by a physician who isn’t engaged in the investigation and who is completely independent of this official relationship.

11.  In cases of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation.  Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with the national legislation.  Whenever the minor child is in fact able to give consent the minor’s consent must be obtained in addition to the consent of the minor’s legal guardian.

12.  The research protocol should always contain a statement of the ethical consideration involved and should indicate that the principles enunciated in the declaration are complied with.

This document has been cited in the article many times and I felt that it was important to clarify exactly what are the Declaration of Helsinki’s Principles.

            It is felt by the Universalists that this Declaration of Helsinki is a widely excitable universal standard for biomedical research and it is used in many countries.  These are the principles that are used to conduct research universally.

            The Pluralists feel that the Declaration of Helsinki shows a Western view and that it does not guide the investigators to show the respect to others in the world.

            The author came to four ideas to provide informed consent to all people in all nations:

1. All plans to conduct research involving humans subjects should be reviewed and approved by a research ethics committee.
2. Proposals to employ consent procedures that do not conform to the international standard should be justified by the researcher and submitted for review and approved by a national ethics review body.
3. There should be established an international ethics review body to provide advice, consultation and guidance to national ethics review bodies when such is requested.
4. In the case of externally sponsored research: Ethics review should be conducted in the initial country.

This article was a bit confusing to exactly what they were trying to point out.  After I made the reference the Declaration of Helsinki it made more sense to me once I knew what they were talking about.  He needed to make more of a reference to that than he did to Immanuel Kant, who seems to be one of his favorites.  I apologize for the length of this posting but it needed to be clarified. 

Ethics in use everyday

The Washington Post-New York to Pay for Eggs from Stem Cell Research By Rob Stein, Staff Writer, June 26, 2009 New York is the first state to allow women to give their eggs to embryonic stem cell research. The critics are afraid that the women will be exploited. The women will be given $10,000 for their donations of eggs for experiments. “This is a great, appropriate policy,” said Susan Solomon, co-founder of the New York Stem Cell Foundation, a private nonprofit research organization. “This could help us to pursue some critical experiments that we hope will lead to treatments for devastating diseases.” One of the goals to that they want to produce stem cells using the nucleus from the patients cells, the stem cells produced would not be rejected by the host immune system. Laurie Zoloth, a Northwestern University Bioethics, states “Whenever society starts to pay for relationships that are traditionally done with Altruism and generosity with in families, it raises the issue of whether there is anything not for sale.” Jonathan Moreno, a bioethics at University of Pennsylvania States that “In a field that’s already the object of a great deal of controversy, the question is, are we at the point where we really need to go that route in order to do the science?” “I’m not convinced” Embryonic cell research is considered a promising area in biomedical science. Stem cells are able to become any cell that is needed to cure diseases. The controversy comes with the embryonic cells that are destroyed when they are days old, some see this as killing. Women have been reimbursed for donating eggs for infertile couples to have children in vitro; this is really not any different except that they are not allowing the embryos to develop fully. They are taking the genetic material from the nucleus of the eggs and using the stem cells to research cures for disease. There is a lot of bioethical controversy in the stem cell research area of biomedicine. Critics worry that the move could lead to the exploitation of women, especially poor women, who tend not to be in demand for infertility donation. In the Kantian Ethics he believed that Moral rules have no exceptions. Killing is always wrong. Lying is always wrong. The action described by the moral rule is necessary and independent of surrounding circumstances or purposes. The Critics that consider stem cell research killing would agree that this does not follow the Kantian Ethics.

Should sterilization be mandated by the government?

I chose the article by Stephen Jay Gould, 1985, Carrie Buck’s Daughter, p. 256-260. The article points out that bad thing come in threes. Two bad things are just an accident but three is a pattern. This is how Virginia came up with their sterilization laws. The point being that, “Three generations of imbeciles are enough.” Virginia passed the eugenic sterilization laws in 1924. At the time Carrie Buck was 18 years old and committed to an institution for the Epileptics and Feeble-Minded. Carrie herself was an illegitimate child and when entering the institution she was pregnant, and unmarried. Harry Laughlin testified that Emma Buck, Carrie’s mother tested to be seven years and eleven months , Carrie to be nine years on the Stanford-Binet test of IQ. Under these guidelines they were deemed imbeciles. “Generally feeble-mindedness is caused by the inheritance of degenerate qualities; but sometimes it might be caused by environmental factors which are not hereditary. In the case given, the evidence points strongly towards the feeblemindedness and moral delinquency of Carrie Buck being due, primarily to inheritance and not to environment.” Carrie Buck was sterilized. Nothing more was heard of the case until 1980 when Dr. K Ray Nelson began researching the records of the institution where Carrie had been sterilized. He found Carrie alive and well and after being tested my professionals they found her to be neither mentally ill nor retarded. They discovered that while Carrie was in the care of a foster home she was raped by a relative of the foster family and they wanted her institutionalized for sexual immorality and social deviance. Vivian was adopted by the family that had raised Carrie and it was found that she was a perfectly normal, average student. She died at the age of 8 of enteric colitis. The research showed that this famous case was based on falsehoods. There were no imbeciles in the three generations of Bucks. In my practice I have not had to deal with forced sterilization. I know that it was done and I know that it was often a court ordered sterilization for a mentally handicapped person, usually female. Just as a foot note Carries’ sister Doris was also sterilized but was told that she was having her appendix removed. Not until all of this was reopened did she know the truth. I really do not find any weaknesses in this article. It is easy to understand and to the point. It is a sad point in our history that people thought they had to right to pick and choice who could reproduce and who could not, based on facts that were unfounded.

The case of Terri Shiavo

On February 25, 1990 Terri Schiavo suffered a cardiac arrest which resulted in severe brain injury leaving her in an irreversible vegetative state, all food and fluids had to be delivered to her via feeding tube. After years of experimental therapies and treatments Michael Schiavo, her husband, was able to accept the diagnosis and he believed that his wife would not want to be kept alive indefinitely in her condition. “ the right of competent patients to refuse unwanted medical treatment, including artificial hydration and nutrition, is a settled ethical and legal issue in this country—based on the right to bodily integrity” (Quill, 2005, p.1631). The problem in this case was the definition of family and how it is to be decided when members disagree with what is determined to be in the best interest of the patient. Michael wanted the feeding tube removed, her parents did not. It was left up to the courts to decide. After nine years Terri Schiavo was allowed to have her feeding tube removed and she died 13 days later on March 31, 2005 (Quill, 2005). There is an obligation to all patients and families to include in our nursing care the patients’ rights to refuse medical treatment if they feel that it is not in their best interest. As healthcare professionals we may not always agree with their decision but it is not our place to decide what is best for them. It is our place to provide them with the quality healthcare that they rightly deserve, support their decision and advise them of the consequences if they choose to not follow the recommended plan of care. It is unfortunate when it becomes necessary for the courts to become involved in the decision making process, which can take years for the final decisions, endless trips to court, the appeals process and then a final decision. Can you find another historical ethical case that uses the principle of ethics?

The Requirements

The Death with Dignity Act is a citizen’s initiative that has allowed Physician Assisted Suicide (PAS) in Oregon. The patients must be older than 18, be an Oregon resident, be capable of making and communicating health care decisions, have a terminal illness with less than six months to live and voluntarily request the prescriptions. The patient must make one written request and two verbal requests, separated by at least 15 days, to their physician. The physician must consult with another physician to confirm the terminal diagnosis and the poor prognosis, and then determine if the patient is capable of making the decision; refer the patient for counseling if there is any question regarding the patient’s ability to make decisions before the prescriptions are given. The physician must advise the patient on alternative treatment options such as hospice, palliative care, and pain control options. The physician as well as pharmacists must report all prescriptions written and filled to the Health Division (OSHD, 2010). Oregon State Health Department (OSHD) (2010) Physician Assisted Suicide Statistics, Retrieve from: http://www.oregon.gov/DHS/ph/pas/docs/statute.pdf?ga=t.

For those of you that may have questions about the new Health Affordability laws here is a quiz and a site that is full of knowledge, answers and questions, Enjoy! http://healthreform.kff.org/quizzes/health-reform-quiz.aspx

Does the patient have The "Right to Die"?

In 1997, Oregon became the first and only state to legalize the terminal patients Right to Die with Dignity. Since that time, in November 2008, the residents of Washington State have also adopted laws to support the patients’ right to physician assisted suicide. The term Right to Die “is used in a legal context to mean that an individual has a right to refuse medical treatment and the refusal of such treatment will cause death” (Matzo & Sherman, 2006, p. 189). In total, from 1998-2009, 460 residents of Oregon have chosen to ingest a lethal dose of medication to end their life and suffering (Oregon State Health Department, 2010). Does the patient have the right to die? Matzo, M. & Sherman, D. (2006) Palliative Care Nursing: quality at end of life (2nd Ed) New York, Springer Publishing. Oregon State Health Department. (OSHD) (2010) Physician Assisted Suicide Statistics, Retrieve from http://www.oregon.gov/DHS/ph/pas/docs/statute.pdf?ga=t.