When is "not-self" really "self"? International Research Ethics Standards Require Hwang's Team to Retest Its Stem Cells

Dianne N. Irving
Copyright December 6, 2005
Reproduced with Permission

I. Introduction

The world is watching South Korea.

As reported in the article copied below (Jin Hyun-joo , "Hwang's team won't retest its stem cells for validity", The Korea Herald, Dec. 6, 2005, at: http://www.koreaherald.co.kr/SITE/data/html_dir/2005/12/06/200512060023.asp), Hwang and his team in Korea are still refusing to have their spectacular patient-specific "stem cells" retested -- those derived from human embryos cloned from a sick patient's own adult cells. But if Hwang and his team have nothing to hide, then why refuse to retest the cells? After all, the patient advocates who have so successfully been massively organized to pressure legislatures and governments around the world to allow cloning by "nuclear transfer" for "therapies" (which are experimental research therapies) would be delighted to have the scientists' data reaffirmed once and for all before any further patients take part in such therapeutic research. Can you blame them?

Hwang's reluctance to check his data is troublesome. It is still required by the scientific method for a scientist to check and recheck the accuracy of one's own research data - even long before it is "duplicated by other labs around the world". Relatedly, the expert credentials of the scientist in the relevant scientific field the experiment involves and the use of accurate data in an experiment involving human subjects are internationally acknowledged ethical requirements in both the Nuremberg Code and in the Declaration of Helsinki. In both of these international research ethics codes, the scientists performing the research - especially research involving human subjects - must have truly "mastered" the field of science in which they are experimenting (which would include advanced course work, advanced academic degrees and extensive lab and clinical experience) - otherwise, obviously, they don't know what they are talking about or doing. This insistence on true expertise and accurate science are indeed universally accepted research ethical requirements to prevent rogue and (frankly) incompetent scientists from psychologically or physically abusing and harming the human subjects on whom they are experimenting:

Declaration of Helsinki:

Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and on adequate laboratory and, where appropriate, animal experimentation.

Medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given consent.

Nuremberg Code:

The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study, that the anticipated results will justify the performance of the experiment.

The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

No experiment should be conducted, where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects. (emphases added)

Or perhaps Hwang and his team are a bit reluctant because they already know beforehand that it is physically and scientifically impossible that these "stem cells" from cloned human embryos really match the patients into whom they were injected? It is surely no international secret or rocket science that in using the "nuclear transfer" cloning process only the nuclear DNA of the sick patient's cell is transferred; the cell's extra-nuclear mitochondrial DNA in the cytoplasm is not transferred, and thus any "stem cells" derived from this cloned human embryo would not match the patient's genetic material -- thus causing rejection reactions in the patient.1 That is, immunologically the patient's body would see these donor mitochondrial-deficient "stem cells" as "not self" and thus try to get rid of them. Worse, the foreign mitochondrial DNA in the enucleated oocyte used in "nuclear transfer" remains in the resultant cloned human embryo. Thus for yet another reason the "stem cells" derived from this cloned human embryo would not match the patient's genetic material, and thus would be rejected by the patient as "not self". Hard to prove scientifically that "not self" is "self". When even different stearic positions of the same antigens produce significant amounts of different antibodies (and thus cause rejections), it would seem reasonable to expect that the obvious serious genetic differences just described would trigger rejection antibodies in the patients as well. At best these patients would be required to take anti-rejection drugs for a long time.

For the very same reasons it is physically and scientifically impossible for the cloned human embryo produced by any "nuclear transfer" technique to be a "twin" or "genetically identical" to the genetic material in the somatic cell or germ line cell donated by the patient donor. To make such an erroneous claim for "educational purposes" is just as seriously misleading, and could ultimately lead to patients undergoing serious rejection reactions.2 Interestingly, the only way to generate a real genetically identical "twin" is by using the "twinning" or embryo-splitting cloning technique3 (as done routinely now in IVF centers for "infertility treatments"4). Embryo splitting is not nuclear transfer. They are different cloning techniques, producing genetically different cloned human embryos, whose stem cells would not genetically match the patients.

II. Other Critical Requirements of International Research Ethics

As a matter of fact, Hwang's and any stem cell researchers' work might also be analyzed in terms of several other important international ethical requirements in addition, e.g., to those of purportedly obtaining women's oocytes unethically or complicity in a cover-up. A quick look at the international research ethics requirements in the Declaration of Helskini5 and in the Nuremberg Code6 indicates quite a few. For example the fact that patients should understand that the research being performed is not "standard medical care", that the good of the patient involved outweighs that of "society" or "science", that patients must give ethically and legally valid informed consent to participate, as well as various other ethical obligations of others directly complicit in this research. One wonders why the international press doesn't include some of these international research ethics requirements in their investigative reporting about the "ethical" breaches that Hwang and his team or other stem cell researchers are currently being accused of as well? Consider briefly just the following examples:

1. Research is not standard medical treatment

It's worth noting that such patients injected with these "stem cells" for "therapies" are supposedly voluntarily taking part in research - whether purely "experimental" or "therapeutic" -- not "standard medical care". Before a drug or device can be used as standard medical care, it must go through several different phases of clinical trials and then be approved by the FDA (or similar appropriate bodies in other countries). Only then can it be considered as standard medical care. This important distinction between research and standard medical care is carefully explained in the international research ethics code, the Declaration of Helsinki.

The Declaration of Helsinki (1964, 1975, 1983, 1989) divided these activities into three basic categories: (1) standard medical care or treatment; and, (2) research, which itself is further divided into (2a) medical research combined with clinical care (clinical research), usually referred to as "therapeutic research"; and (2b) non-clinical biomedical research, usually referred to as non-therapeutic research. These distinctive kinds of activities are distinguished primarily according to their different aims, goals or purposes - and according to whether or not there is direct medical benefit to a particular patient or not. With reference to defining "research", the Declaration stated:

"The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and prophylactic procedures and the understanding of the aetiology and pathogenesis of disease... In the field of biomedical research a fundamental distinction must be recognized between medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical research, the essential object of which is purely scientific and without implying direct diagnostic or therapeutic value to the person subjected to the research [Intro.]... The physician can combine medical research with professional care, the object being the acquisition of new medical knowledge, only to the extent the medical research is justified by its potential diagnostic or therapeutic value for the patient [Medical research combined with clinical care - clinical research]7 (emphases added)

Note that in the first kind of research - i.e., "clinical research" -- the goals of performing biomedical research to improve diagnostic, therapeutic and prophylactic procedures and the understanding of the aetiology and pathogenesis of disease are referred to as research, not as standard medical care, or as "health care"; and the possible benefits must accrue to the individual patient - not to "others".

Whether for purely experimental purposes or for clinical purposes, research is research - not standard medical care -- and such research with human subjects should be conducted in accord with the international codes of research ethics. Are patients volunteering for human embryonic or adult "stem cell therapies" aware of these facts?

2. No researchers are exempt from international ethical guidelines

No matter if the research is being carried out in a physician's or dentist's office, in a hospital clinic, in a hospice, in a nursing home, in a day care center, etc., any researcher in any locality, state or country is morally bound to follow these international research ethics standards:

Declaration of Helsinki:

Research Investigators should be aware of the ethical, legal and regulatory requirements for research on human subjects in their own countries as well as applicable international requirements. No national ethical, legal or regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in this Declaration. (emphases added)

The research protocol should always contain a statement of the ethical considerations involved and should indicate that there is compliance with the principles enunciated in this Declaration. (emphases added)

3. Patient's good overrules society's or science's good

Regardless of any politically correct utilitarian mantra, the international code of research ethics clearly puts the good and welfare of the patient research subject before that of "science", "society", and one might add organizations, money, fame or other purposes for such research:

Declaration of Helsinki: (emphases added)

In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society.

It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject.

The Declaration of Geneva of the World Medical Association binds the physician with the words, "The health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient."

4. Patient Informed Consent

All human subjects participating in research must give their ethically and legally valid informed consent (or that of a legitimate proxy). The "information" element would include, e.g., that the patient is not just undergoing standard medical care but rather research, that the design of the scientific protocol is ethical, and that the data presented to the patient subject are scientifically accurate and obtained with the highest degree of scientific precision by true scientific experts in the relevant field. The "consent" element would include the absence of pressure from professional colleagues, as well as the absence of undue stress or irrational emotions in the patient research subject (e.g., "I am willing to do anything to be cured", etc.):

Declaration of Helsinki:

In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The subject should be informed of the right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal. After ensuring that the subject has understood the information, the physician should then obtain the subject's freely-given informed consent, preferably in writing. If the consent cannot be obtained in writing ... (emphases added)

When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship with the physician or may consent under duress. In that case the informed consent should be obtained by a well-informed physician who is not engaged in the investigation and who is completely independent of this relationship. (emphases added)

Nuremberg Code:

The voluntary consent of the human subject is absolutely essential.

This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision. This latter element requires that, before the acceptance of an affirmative decision by the experimental subject, there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person, which may possibly come from his participation in the experiment. (emphases added)

The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.

5. Ethical Obligations of Others Involved

The research enterprise involves a host of participants other than just the researcher and the patient research subject. For example, members of review committees, funding organizations, universities, and even journals accepting such studies for publication are directly complicit in such research:

Declaration of Helsinki:

Both authors and publishers have ethical obligations. In publication of the results of research, the investigators are obliged to preserve the accuracy of the results. Negative as well as positive results should be published or otherwise publicly available. Sources of funding, institutional affiliations and any possible conflicts of interest should be declared in the publication. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication. (emphases added)

The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol. This protocol should be submitted for consideration, comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence. This independent committee should be in conformity with the laws and regulations of the country in which the research experiment is performed. The committee has the right to monitor ongoing trials. The researcher has the obligation to provide monitoring information to the committee, especially any serious adverse events. The researcher should also submit to the committee, for review, information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest and incentives for subjects. (emphases added)

III. Conclusion

While finding cures for debilitating and deadly diseases is surely and most definitely a legitimate and valid concern, the world must not lose sight of the means used to attain such lofty medical and research ends. As in all human endeavors so too in that of medical research, the means used as well as the ends must be ethical. The history of research is littered with examples of abuses to human research subjects illegally and unethically used as means to other's ends, and we should not forget them.

In the current almost-mania driven "wild wild west" of the pursuit of stem cell research agendas, we have seen articulated with Hwang's unfortunate situation a clear concern about the possible abuse of women involved - whether illicit pressure brought to bear on female research colleagues to donate their oocytes, or on female citizens who are solicited for oocyte donation. But are women also properly "informed" that the product of nuclear transfer is a cloned human being, their own child - not just a "ball of cells", a "pre-embryo" or some other "pre-embryo substitute"? Are women enticed into donating these "balls of cells" to destructive research without understanding precisely what it is that they are donating? And are they aware that they will eventually be needed as living incubators to verify the scientific methods used in such research, or implanted with these clones for "infertility therapies"?

Are patients - male or female -- undergoing "stem cell therapies" truly informed with the accurate science involved, that nuclear transfer produces a cloned child of theirs who needs to be killed for his/her stem cells in order that the patient might possibly be cured, or that such cells from their cloned children are not their "genetically identical twins" - and thus could cause severe immune rejection reactions in them? Are they really giving ethically and legally valid "informed consent"?

And what about the ethical obligations of all those "others" who are directly involved with stem cell research - e.g., the IRB, HEC or other "review" committees (governmental or private) that approve the research, the organizations or individuals who provide the funding, the university labs and offices that support and house it, the journals that eventually publish these research studies, and the legislators, politicians and scholars - and yes, even the patient advocacy groups - who lobby for such research? What about potential conflicts of interests involved with the researcher and with these "others"?

As the international research ethics codes make crystal clear, ultimately it is the researcher him or herself who bears the greatest ethical burden in these stem cell research experiments. That personal burden cannot be "diluted" with a barrage of committees and organizations. Are these researchers really academically qualified to perform this kind of research experiment? Do they have the required academic degrees, lab and clinical experience? Have adequate animal studies been done beforehand? Have they manipulated or falsified their data, or covered up their activities, thus mis-informing review committees and patients alike? Is the design of their experimental protocol ethical? Are they really concerned first and foremost with the health and welfare of their patients, or are they more interested in winning Nobel Prizes, obtaining research grants, publishing or perishing, becoming rich and famous with their lucrative research patents, holding stock in major sponsoring drug companies or IVF clinics, etc.?

Where are the scientific and medical professions and professionals? And where are those professionals in the international community who make a living writing about, participating in international bodies concerning, and are responsible for the current international research ethics guidelines? Are the only possible ethical violations of Hwang and his team - or of any other stem cell researchers - only two of many women's issues and a cover-up? What about all of the other ethical requirements that have been embedded in those international guidelines for decades?

The silence is deafening.

[Full references follow after the Hwang article copied below.]


The Korea Herald
December 6, 2005
By Jin Hyun-joo

Hwang's team won't retest its stem cells for validity

Scientists on Hwang Woo-suk's team reiterated yesterday that they would not retest the validity of their research on stem cells, saying previous tests conducted by private labs were full of scientific errors.

"Scientific errors in 'PD Notebook' were serious," Kang Sung-keun, Hwang's close associate, told reporters, stating that the genetic information in most of the cells tested was impossible to read.

A news magazine show 'PD Notebook' suggested that the cells may be fraudulent, saying one of the five customized stem cells provided to it by Hwang's team did not match the original somatic cell taken from a patient.

But 'PD Notebook' said the other four cells were impossible to read. Experts alleged the reason the cells were not readable was that they may have been contaminated by fixing fluid containing the cells.

In its paper published in June in Science, Hwang's team said it took somatic cells from patients and put them into donated human eggs to create stem cells tailored for patients.

The comments by Kang came in response to calls in the media for Hwang to verify the stem cells to end the continuing controversy over his work.

"It deals a severe blow to the reliability of Korean science circles given that a media outlet conducts scientific verification. Therefore, we will not respond to the call (by 'PD Notebook') for retests," said Kang. He also said his team will announce its official position soon after gathering opinions.

Another of Hwang's associates also said the authenticity of its patient-specific stem cells will be only proven when it comes up with scientific achievements using the groundbreaking cells. Lee Byeong-chun said, "The cells will be naturally verified after several years when other scientists will reproduce the work and we will come up with follow-up research achievements."

Meanwhile, the stem cell pioneer does not show any sign of returning to work after secluding himself following a news conference Nov. 24. At the conference, he admitted that he used ova donated by his two researchers, an act frowned on by the international scientific community because of the possibility of coercion being used to gain the ova.

'PD Notebook' faced a storm of criticism from the public and politicians for having lied to and blackmailed them in an attempt to extort remarks unfavorable to Hwang. On Sunday, MBC-TV apologized to the public for a coercive interview with members of Hwang's research team and cancelled its plan to air a segment which it had claimed would unveil important flaws in his work.

The main opposition Grand National Party said MBC should implement its pledge to take disciplinary measures against the producers. The web site of the prosecution was also bombarded with messages that the star producers should be investigated.

The program has also come under fire for having aired suspicions that Hwang's team used human eggs from paid donors and its own members. Ardent advocates of Hwang harshly criticized the report for dampening the development of his work aimed at developing therapies for intractable diseases.

A total of 12 advertisements for the program were canceled after supporters of Hwang launched a campaign against those companies.


1 See the Nuremberg Code, U.S. Department of Health and Human Services, Office for the Protection From Research Risks, at: http://www.hhs.gov/ohrp/references/nurcode.htm. [Back]

2 See the Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects, World Medical Association (October 2000), at: http://www.wma.net/e/policy/b3.htm. Unless otherwise noted, reference to this code are from the October 2000 code. [Back]

3  See, e.g., the following scientific and related references in Irving, "Playing God by manipulating man: Facts and frauds of human cloning" (October 4, 2003), at: http://www.mocatholic.org/uploads/IrvingCloning3.pdf; and at, http://www.lifeissues.net/writers/irv/irv_22manipulatingman1.html]:

(1) Tom Strachan and Andrew P. Read, Human Molecular Genetics 2 (2nd ed.) (New York: John Wiley & Sons, Inc., 1999: "Animal clones occur naturally as a result of sexual reproduction. For example, genetically identical twins are clones who happened to have received exactly the same set of genetic instructions from two donor individuals, a mother and a father. A form of animal cloning can also occur as a result of artificial manipulation to bring about a type of asexual reproduction. The genetic manipulation in this case uses nuclear transfer technology: a nucleus is removed from a donor cell then transplanted into an oocyte whose own nucleus has previously been removed. The resulting 'renucleated' oocyte can give rise to an individual who will carry the nuclear genome of only one donor individual, unlike genetically identical twins. The individual providing the donor nucleus and the individual that develops from the 'renucleated' oocyte are usually described as "clones", but it should be noted that they share only the same nuclear DNA; they do not share the same mitochondrial DNA, unlike genetically identical twins." (pp. 508-509).

(2) Congressional website, Cloning Basics: 101: "What is Cloning?" ... It is false to say that cloning solves the transplant rejection problem. Each embryo clone would still contain mitochondrial DNA from the egg donor; the clone is NOT an exact genetic copy of the nucleus donor, and its antigens would therefore provoke immune rejection when transplanted. There would still be the problem of immunological rejection that cloning is said to be indispensable for solving," at http://www.house.gov/weldon/issues/clone_basics.htm.

(3) "Congressman Weldon's Cloning Facts", quoting testimony of Dr. Irving Weissman before the President's Council on Bioethics, "I should say that when you put the nucleus in from a somatic cell, the mitochondria still come from the host" [from the female egg] ... And in mouse studies it is clear that those genetic differences can lead to a mild but certainly effective transplant rejection and so immunosuppression, mild though it is, will be required for that", at http://www.nrlc.org/Killing_Embryos/Weldoncloningfacts022603.html; also at: http://www.traditionalvalues.org/pdf_files/Human_Cloning.pdf.

(4) Transcript of House Hearing introducing Weldon Bill, Cliff Stearns (FL) testimony before Hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, 107th Congress, 1st Session on H.R. 1644 and H.R. 2172 (June 20, 2001, "Seven States' proposals ban the creation of genetically identical individuals, but that leaves another loophole. An egg cell, donated for cloning, has its own mytochondrial DNA, which is different from the mytochondrial DNA of the cell that provided the nucleus. The clone will, therefore, not truly be identical", at: http://energycommerce.house.gov/107/hearings/06202001Hearing291/print.htm.

(5) Senator Sam Brownback, "Some proponents of human cloning claim that an embryo created in this manner will have cells that are a genetic match to the patient being cloned, and thus would not be rejected by the patient's immune system. This claim is overstated at best; in fact there are some scientific reports that show the presence of mitochondrial DNA in the donor egg can trigger an immune-response rejection in the patient being treated, in "A True Complete Ban", National Review Online, Feb. 26, 2003, at: http://www.nationalreview.com/comment/comment-brownback022603.asp.

(6) Leon Kass, "Before one starts arguing the morality of embryo farming, we should know that the whole matter is science fiction. The egg containing my nucleus is not fully my genetic twin. It also contains residual DNA -- mitochondrial DNA -- from the woman who donated the egg. The cloned embryo and all cells derived from it remain partly 'foreign,' enough to cause transplant rejection", in The Chicago Tribune, July 31, 2001, quoted by Dave Andrusko in, "Averting a Catastrophe", at: http://www.nrlc.org/news/2001/NRL08/editA.html.

(7) President's Council on Bioethics, "The technique of cloning ... bring to live birth a cloned animal that is genetically virtually identical (except for the mitochondrial DNA) to the animal that donated the adult cell nucleus", in Human Cloning and Human Dignity: An Ethical Inquiry, "Executive Summary; Fair and Accurate Terminology; Scientific Background", at: http://www.bioethics.gov/reports/cloningreport/execsummary.html.

(8) George Annas, "How could such stem-cell lines be generated? One way is by transferring somatic-cell nuclei into enucleated eggs (nuclear transplantation). When stimulated to divide, the cell can form blastocysts of predefined nuclear genotype (with the mitochondrial DNA coming from the egg)", The New England Journal of Medicine, Volume 346:1576-1579 May 16, 200, "Stem Cells Scientific, Medical, and Political Issues", at: http://www.gardacuore.net/rigenerativa/ARTICOLI/NEJM_Issues.htm. [[emphases added]] [Back]

4 Rev. Dr. Tadeusz Pacholczyk, "Stem Cell Research, Cloning and Human Embryos", posted at Family Research Center, http://downloads.frc.org/16-NOV-05__EF04C54_890303.pdf. [Back]

5 Tom Strachan and Andrew P. Read, Human Molecular Genetics 2 (2nd ed.) (New York: John Wiley & Sons, Inc., 1999: "Animal clones occur naturally as a result of sexual reproduction. For example, genetically identical twins are clones who happened to have received exactly the same set of genetic instructions from two donor individuals, a mother and a father. A form of animal cloning can also occur as a result of artificial manipulation to bring about a type of asexual reproduction. The genetic manipulation in this case uses nuclear transfer technology: a nucleus is removed from a donor cell then transplanted into an oocyte whose own nucleus has previously been removed. The resulting 'renucleated' oocyte can give rise to an individual who will carry the nuclear genome of only one donor individual, unlike genetically identical twins. The individual providing the donor nucleus and the individual that develops from the 'renucleated' oocyte are usually described as "clones", but it should be noted that they share only the same nuclear DNA; they do not share the same mitochondrial DNA, unlike genetically identical twins." (pp. 508-509). [Back]

6  Many IVF providers are strongly promoting the use of twinning cloning techniques, a process they refer to as "embryo multiplication", e.g.: "Because early embryonic cells are totipotent, the possibility of splitting or separating the blastomeres of early preimplantation embryos to increase the number of embryos that are available for IVF treatment of infertility is being discussed Because embryo splitting could lead to two or more embryos with the same genome, the term "cloning" has been used to describe this practice. ... Whereas these ethical concerns raise important issues, neither alone nor together do they offer sufficient reasons for not proceeding with research into embryo splitting and blastomere separation. ... In sum, since embryo splitting has the potential to improve the efficacy of IVF treatments for infertility, research to investigate the technique is ethically acceptable. Persons asked to donate gametes or embryos for such research should be fully informed that research in embryo splitting is intended or planned as a result of their donation. The fears of possible future abuses of the technique are not sufficient to stop valid research in use of embryo splitting as a treatment for infertility. This statement was developed by the American Society for Reproductive Medicine's Ethics Committee and accepted by the Board of Directors on December 8, 1995." See, AMERICAN SOCIETY OF REPRODUCTIVE MEDICINE, at: http://www.asrm.com/Media/Ethics/embsplit.html.

See also: "New Ways to Produce Identical Twins -- A Continuing Controversy": "Now, a new method of actually producing identical twins looms near. Called "blastomere separation" (the separation of a two- to eight-cell blastomere into two identical demi-embryos), it is potentially one method of helping infertile couples have children through in vitro fertilization (IVF). ... The following is excerpted from the medical journal Assisted Reproduction Reviews, May 1994. Dr. Joe B. Massey, who heads an in vitro clinic in Atlanta. Dr. Massey reviews the advances in blastomere separation and discusses the potential indications, benefits, limitations, and ethics of using this method to produce monozygotic twin embryos for IVF patients. The Twins Foundation, by presenting Dr. Massey's material for your information neither advocates nor rejects any such procedures: 'Embryo Multiplication by Blastomere Separation -- One Doctor's Proposal'. [Massey]: In spite of many advances in human in vitro fertilization (IVF), there are still many problems. ... According to Dr. Massey, 'Observations on the potential impact of removing less than half of the cells from the human embryo have been well documented in pre-clinical embryo biopsy studies.' (For more on this story see Research Update Vol. 9, No. 1, 1994)." See, THE TWINS FOUNDATION, at: http://twinsfoundation.com/ru-v9n1-1994.htm.

See also: Professor Dr. Mithhat Erenus, "Embryo Multiplication": "In such cases, patients may benefit from embryo multiplication, as discussed in the study by Massey and co-workers. ... Since each early embryonic cell is totipotent (i.e., has the ability to develop and produce a normal adult), embryo multiplication is technically possible. ... In humans, removal of less than half of the cells from an embryo have been documented. No adverse effects were reported when an eighth to a quarter of the blastomeres were removed from an embryo on day 3 after insemination. ... Further evidence supporting the viability and growth of partial human embryos is provided by cryopreservation. After thawing four-cell embryos, some cells may not survive, leaving one-, two-, or three-cell embryos. These partial embryos survive and go to term, but at a lower rate than whole embryos. ... Based on the results observed in lower order mammals, the critical period of development to ensure success in separating human blastomeres should be at the time of embryonic gene expression, which is reported in humans to be between the four- and eight-cell stages [twinning by "blastomere splitting"]. .... The second potential method of embryo multiplication is blastocyst splitting. ... For couples who have less than three quality embryos for transfer, blastomere separation could be of benefit.." at: http://www.hekim.net/~erenus/20002001/asistedreproduction/micromanipulation/embryo_multiplication.htm. Also, ETHICS COMMITTEE OF THE AMERICAN SOCIETY FOR REPRODUCTIVE MEDICINE, "'Ethical Considerations of Assisted Reproductive Technologies': Originally published as a supplement to the ASRM medical journal (Fertility and Sterility 1994;62:Suppl 1), Ethical Considerations for Assisted Reproductive Technologies covers the American Society for Reproductive Medicine's position on several aspects of reproductive medicine, including: ... the moral and legal status of the preembryo, ... the use of donor sperm, donor oocytes and donor preembryos, ... the cryopreservation of oocytes and preembryos, micro techniques such as: zona drilling, microinjection, blastomere separation (cloning), and assisted hatching." at: http://www.asrm.com/Media/Ethics/ethics94.html. [Back]

7 See Declaration of Helsinki 1989 at: http://www.fda.gov/oc/health/helsinki89.html; Declaration of Helsinki 1983 at: http://www.fda.gov/oc/health/helsinki83.html; Declaration of Helsinki 1975, and 1964 at: http://www.cirp.org/library/ethics/helsinki/. It is quite unfortunate that this critical distinction was dropped from the 2000 Declaration of Helsinki. Consequently, "research" is now being carried out in private physicians' offices - thereby bypassing federal regulations. Unless patients are truly informed, they could easily be misled into thinking that they are undergoing "standard medical care" or "therapies", rather than basic research. [Back]

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