My name is Dr. Dianne N. Irving, and I would like to thank the panel for allowing me to testify today as a concerned individual - although five minutes is woefully insufficient time, and although I know that nothing I say will have any impact whatsoever on your deliberations. I am preparing a longer written statement for the record.
I am a former research biochemist, and worked here at NIH/NCI in radiation biology and viral oncology. I subsequently received my Master's and Doctoral degrees in philosophy (with concentrations in the history of philosophy and bioethics) from Georgetown University. As my publications will demonstrate, I am not anti-research or anti-science - indeed scientific research was my first career. I am against unethical research and scientific research fraud, and so, for example, am on the Board of Editors of the journal Accountability in Research. I am also not anti-individuals or anti-families with diseases - indeed, I currently work with the families in NAMI in ethical issues concerning psychiatric research.
My remarks are offered simply as "reality checks". In this short time I want to focus on only two of many of my major concerns - and then mention some suggestions. My major focus is on the ethical (not legal) considerations for scientific research, of which I will only mention three: (1) that the science used to ground and develop the research project is correct science; (2) that the design of the protocol is ethical, and (3) that the scientific goal - no matter how lofty that goal is - as well as the means used in the experiment in order to reach that goal are also ethical.
First, concerning the use of correct science, for over 15 years much of the human embryology stated in arguments about "human personhood" is, for want of a better word, simply fake human embryology. This should be important to you for two reasons. One, the bottom-line ethical requirement for any scientific research is that the science itself is correct - as Dr. Van Blerkom so eloquently pointed out. We do know the correct human embryology - it simply is not being acknowledged or used. Thus to use "fake" human embryology as your starting point in designing, performing and analyzing your experiments renders them scientifically invalid, meaningless and unethical. Two, arguments for so-called "delayed personhood" - fabricated in order to justify theoretically what is in fact unethical - have been grounded precisely on this "fake" human embryology, which has led to equally "fake" conclusions about the moral and legal status of human embryos - in turn having direct implications for your definition of "human subjects of research" and how OPRR regulations should be constructed.
My doctoral dissertation was precisely on whether it is ethical to use surplus IVF human embryos in destructive experimental research - research that is not for the direct benefit of that human embryo. I did, actually, originally sense that I would have argued for "personhood" at 14-days, based primarily on the "embryology" that I was reading in the journals and books. I analyzed 23 representative arguments on "delayed personhood" - using three criteria: (a) is the science used correct; (b) is the philosophy - especially the definition of a "human being" - historically correct or objectively defensible; (c) do the conclusions follow logically from the major and minor premises? To my own amazement I discovered that in all 23 arguments, the science was incorrect, the philosophy was historically incorrect or indefensible, and that none of the conclusions followed logically from their premises.
Of particular concern for our present purposes, this same "fake" human embryology which has been disseminated for so many years - especially by long time members of the American Fertility Society Ethics Committee, and paid consultants of NIH - is once again presently being used in your materials, debates and invited papers - even published in the Washington Post. The purpose of this "fake" human embryology is to designate a "pre-embryo" - i.e., a pre-person - with different ethical and legal rights and protections than "real" persons - precisely so that they can be used in experimental research with few if any regulations. The "philosophy" used to support this conclusion, by the way, would also render the mentally ill, Parkinson's patients, Alzheimer's patients, the comatose, drug addicts, alcoholics, etc. also non-persons - a fact which seems to escape most of those to whom these bizarre and indefensible theories would be applied (including family member advocates). In other words - regardless of your position on abortion or fetal research, the use of fake human embryology is still being condoned and perpetuated, which will lead to invalid scientific experiments; and the conceptual precedents now in place in these debates are easily transferable to millions of adult human beings, yet rarely pointed out to them.
I submit for the record a copy of my 400-page dissertation on this topic, as well as other of my peer-reviewed publications on this and related issues; an obnoxious and arrogant letter sent to me by a journalist of the Washington Post who recently used a chart containing this fake human embryology in his article on this panel; and a written statement from Dr. C. Ward Kischer, a professor of human embryology for over 30 years documenting agreement by him and many deans of human embryology that this Grobstein-McCormick "human embryology" is objectively, scientifically wrong, and that the term "pre-embryo" is objectively and scientifically invalid. I would add that even Clifford Grobstein himself - who is not a human embryologist, but an amphibian embryologist - agreed with me, in front of a scientific conference, that his "embryology" was wrong, but that he was "just trying to be helpful"! Additionally, Keith Moore also agreed that this "embryology" and the use of the term "pre-embryo" was scientifically incorrect and inappropriate.
Aside from the obvious ethical criteria of using correct science as the starting point in any human embryo research, the larger question is the credibility of NIH and the greater scientific community itself. Why have NIH and the scientific community allowed this fake science to go uncorrected in the literature for over 15 years - with no censure, and continued to use scientists and bioethicists who perpetrate this fake science as paid consultants and grantees? Why is there no human embryologist on this panel? Your earlier discussions on "how to define the human embryo" - that on which you are attempting to regulate research - was, from an objective scientific point of view, mortifying and embarrassing. Does NIH - one of the greatest scientific research institutions in the world - mean to have political scientists, sociologists, feminists and bioethicists define scientifically what a human embryo is?
A second ethical requirement of scientific research is that the design of the protocol itself be ethical. For our purposes here, if the very design of the protocol used in human embryo research is unethical - i.e., specifically designed to destroy a living developing human being during the process of experimental research -then the whole experiment is unethical. NIH's credibility in funding research in which the very design of the protocols is unethical is already in question - and I ask that this panel take seriously the real harm caused by all such unethically designed protocols. Grants of millions of tax-payers dollars have been given to researchers whose protocols are specifically designed not for the health and benefit of the patients, but solely for the "advancement of scientific knowledge". For example, some proposals require sham surgeries, and other researchers' protocols required and produced the purposeful inducement of relapses in schizophrenia research -all protocols approved by IRB's (so much for IRB's).
A third ethical requirement is that not only the goal, but the means to achieve that goal, are ethical. And here even the credibility of the existing OPRR regulations themselves are in question. For example, these regulations make "exceptions" for just about everything, if the "information cannot be obtained in any other way" - or "for the sake of scientific knowledge alone". I strongly disagree with such utilitarian "ethics". No human being - human embryos included - should be used in experimental research for someone else's good or for the greater glory of scientific knowledge itself - without their informed consent. This was precisely the legacy of Nuremberg - a legacy which, frankly, realistically no longer exists. Only therapeutic research - for the direct benefit of that human being - is ethically permissible with vulnerable populations of human research subjects - which includes human embryos, fetuses, etc. Given that human embryos are human beings/persons -much as that fact might anger so many of you - it is not only unethical, it is, frankly, sick to use vulnerable human embryos for any one else's "good", or for the glory of scientific knowledge.
These OPRR regulations themselves, then, desperately need an ethical overhaul. Specifically, they should eliminate all such references to "exceptions" for "knowledge which cannot be obtained in any other way" or "for the advancement of scientific knowledge" when referring to vulnerable human research populations. They should also include both the mentally ill and human embryos and fetuses as vulnerable human research subjects. Also in question is NIH's real commitment in really protecting all human subjects used in research. For example, a policy presently exists here which allows cognitively impaired human subjects to give "informed consent" for participation in both therapeutic and experimental research - a policy which is both ethically and legally "irregular". There are other irregularities and concerns about this panel, including the incorrect summary of what the Massachusetts state statutes really state about the use of living versus dead human embryos, fetuses and neonates.
But I want to move on to just mention briefly the second area of concern I have about these proposals which pertains to the field of bioethics, which I think might inappropriately influence the questions before you. As with the "scientific" concerns, I hope no one takes this personally, but it is about time that someone articulate at least a question about the credibility of the field of bioethics itself - especially when there is now and has been historically an intimate - one might almost say incestuous - connection between the fields of bioethics and medical research. I don't expect several of you to be particularly pleased with my comments.
Quite briefly, as I look back on my participation in bioethics (which goes back to 1979), I am beginning to seriously question the credibility of the field of bioethics itself. Similar to Dr. Van Blerkom's comments relative to the lack of real scientific expertise on the part of many involved in the field of IVF, I see a similar lack of real academically meaningful credentials in the field of bioethics. And this concern, by the way, is not unique to me - there is a growing body of literature reflecting the same basic concern. Bioethics "degrees" simply do not reflect the kind of rigorous course work and examinations required of real Ph.D. philosophers. Students come into graduate philosophy programs from sociology, law, medicine, history, literature, etc. - with little or no undergraduate course work in philosophy - especially the history of philosophy, which is usually required for undergraduate freshmen and sophomore philosophy majors. Practically no two "bioethicists"' course work is alike. The result is a very watered-down curriculum leading to watered-down credentials. What is worse is that by far the majority of "bioethicists" in the field in this country do not even have this meager background, but simply take a few courses from a bioethics "think tank" or read a few "bioethics" text books - and voila - a professional "bioethicist"!
There is a very real credibility crisis emerging concerning the de facto expertise of these seemingly self-appointed "bioethics" gurus who are genuinely convinced that they can proclaim to the American people what is "ethical" and what is "unethical". Academically these persons are not real philosophical ethicists. The term "bioethicist" should be changed - to "moral lobbyists" - or whatever more accurately describes their true "expertise" and role. This is not to negate some of the good efforts of so many good people involved.
Unfortunately - just as the really good, ethical scientists will go down with a handful of unethical scientists, so too will these good and ethical people in "bioethics" lose their own credibility in time because of the arrogant and intellectually abusive theories and practices of the unethical ones.
In sum, my concerns about the credibility of this panel and these research proposals centers on the lack of the presence of several nationally recognized human embryologists, its perpetuation of 15 years of "fake" human embryological science, its incestuous relationship over as many years with a tightly controlled "bioethics" super-system, questions about other possible conflicts of interests that need to be raised, and an apparent willingness to disregard even the most basic ethical requirements of any scientific research proposal -most of which deals simply with scientific soundness, accuracy and design. It is all, in my opinion, simply built on a house of cards - and one which is about to crumble.
The consequences are wide-reaching. There really seems to be no real accountability of any one to any one. Blatantly unscientific and unethical experiments are about to be condoned - indeed hailed as "progress" and "beneficence". Yet human harm of epic proportions will be caused by such unethical experiments approved by you. Additionally, true informed consent has virtually been precluded - for aborted women, their pre-born children, the donors of sperm and ova, the researchers who unwittingly perform such experiments - indeed the members of this very panel - since none actually know about or refuse to acknowledge the real and correct human embryology and the implications of that correct human embryology for any meaningful future experiments or regulations. Furthermore, any real "democratic" process - either in these hearings or in the broader American community - is impossible.
Because the research and bioethics "institutions" have for so many years arrogantly refused to acknowledge, deal with or correct such problems, because so much real harm has been, is and will be caused, and because of the sheer arrogance in even considering so seriously and enthusiastically these unethical experiments with such helpless vulnerable human embryos who are human beings and human persons such as those that are being proposed by this panel, with little or no "outside" notice or input, they have finally lost any credibility. I would support a call for Congressional hearings, in order that these fundamental discussions and decisions of life, death and harm can be brought back to the American people where they properly belong. I am certain that the American people in general have no concept of what has taken place recently in the areas of medical research, regulations and bioethics, nor any clue that all of these weird theories and such fraudulent science could and might be applied to them later through "conceptual transfer" (it has happened once before in recent Nazi history). And all this, using their own tax monies!
Congress should close these hearings down immediately, and hold the appropriations of these research funds until such time as the Congress and the American people can be caught up on these issues, and then have them decided by referendum in their state legislatures. Congress should also immediately begin investigations into the following related matters:
In this democracy it is the American people who should be deciding whether or not human beings should be produced for and used in macabre destructive experimental research - not a self-aggrandizing, self-appointed NIH panel which is willing and ready to impose its brand of utilitarian "ethics" on the rest of us - and at our expense.