Public comments submitted to the NIH in response to the "Draft Guidelines on Human Stem Cell Research" will be accepted until 11:00 p.m. EST tonight. Comments must be read by the NIH before the guidelines become official so I wanted to have my say. This is what I submitted to them today...
The NIH draft guidelines fail the standards they set for themselves and too quickly dismiss weighty ethical issues at the core of the ESCR (Embryonic Stem Cell Research) debate. The heart of the NIH proposal relies on critical terms that are poorly defined and misleading. In other places, claims come pre-loaded with biased assumptions resulting in non-sequitor, question-begging, and even contradictory logic. I don’t question the motivation behind the push for this research, but point out the fallacious thinking and misstatements of fact by NIH in these draft guidelines. I cite their words from the draft guidelines in bold then present a detailed analysis in the text that follows.
Under “Supplementary Information” the document begins, “The purpose of these draft Guidelines is to … help ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law.”
The very fact they acknowledge ethical concerns is telling. They could be referring to handling of personal medical data, conflicting interests of clinicians, and donor consent agreements as these issues are addressed in other parts of the document. But the overwhelming elephant in the room is the matter pertaining to human embryos. After all, that is the fundamental matter at hand. Despite this, the moral controversy over embryonic research is not even mentioned except by saying bioethicists were consulted.
They also stated the purpose for the research to be “scientifically worthy.” It seems strange that such a project would show concern for scientific worthiness in an area (ESCR) where no medical developments have been made. While this could refer to the taxpayer support or the limited amount of embryos available for research, the guidelines don’t address these concerns anywhere else in the text. Furthermore, no evidence exists to support a probable discovery through ESCR so the NIH limits the likelihood to a logical “possibility” when describing a list of hypothetical cures from pluripotent stem cells harvested from unborn humans. If science has shown ESCR to be anything, it’s that funding such a failed effort is not worthy at all.
Both claims of the NIH to be “ethically responsible” and “scientifically worthy” make the same underlying assumption that ESCR involves value judgments. The most obvious of these is the personhood of human embryos. Put most succinctly by Greg Koukl, “if an embryo is not a human being, then no justification for ESCR is necessary. Experiment as you please. However, if the unborn is a human being, no justification for taking her life is adequate” (Koukl, Gregory. “Responsible Science & ESCR.” Solid Ground. May/June 2009. p3). In America, we don’t justify killing other human beings for the sake of medical research. Sadly, no effort to make this distinction was made anywhere in the draft guidelines. Such groundless ideology is unacceptable considering the ethical risks at stake.
“Long-standing HHS regulations for Protection of Human Subjects, 45 C.F.R. 46, establish safeguards for individuals who are the sources of many human tissues used in research including non-embryonic human adult stem cells and human induced pluripotent stem cells.”
It is apparently important to the NIH to ensure human beings involved with stem cell research are protected. Accordingly, every reasonable effort must be taken to ensure stem cells harvested from human donors do not adversely impact them. To this I agree. However, a question-begging assumption by the NIH arises when we ask them who the donors are. The draft guidelines refer to “donors” as people who give embryos over to research. But pay close attention because there is a clever slight of hand at work here. The HHS regulations to protect donors are intended to mean human donors who themselves have tissue removed from their own bodies for the harvesting of stem cells (i.e. skin, hair, blood, etc). However, ESCR involves not the tissue of an adult “donor” but the tissue belonging to an entirely separate individual - an embryo itself. It’s important to realize we’re talking about two distinct individuals: 1) the embryo, and 2) the donor(s). Categorizing the parents of the embryo as “donors,” misplaces the protections altogether and confuses the issue. In fact, the NIH drafted these guidelines so the person sacrificing their own tissue (the embryo) isn’t defined as the donor at all!
Furthermore, it may not help much even if the NIH considered the embryo as the tissue donor. They claim to work on pre-established protections for human subjects but exclude embryos from those protections anyway. No attempt to justifiably exclude them from human subject protection is given. No argument is offered defining embryos as anything less than human life. It’s just assumed.
Under the US Government’s Code of Federal Regulations Title 45 (Public Welfare) Part 46 (Protection of Human Subjects) Subpart A (Basic HHS Policy for Protection of Human Research Subjects), Section 102 (Definitions), “a human subject is a living individual about whom an investigator (whether professional or student) conducting research obtains:
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.”
Under this definition, there’s no reason to exclude human embryos from protection since they certainly are living individuals meeting the definition in 45 C.F.R. §46.102(f). Perhaps such a categorical loophole was foreseen by the draft writers who inserted the following disclaimer a few paragraphs later:
“Please note that, for NIH funded research using the permitted human embryonic stem cells, the requirements of the Department’s protection of human subjects regulations, 45 C.F.R. 46, may or may not apply, depending on the nature of the research.”
In other words, even if embryos can be categorized as human subjects warranting protection, the NIH leaves room for these protections not to apply anyway.
Under “Scope of Guidelines” it states: “Although human embryonic stem cells are derived from embryos, such stem cells are not themselves human embryos.”
This same phrase was cited earlier in the “Supplementary Information” section so it was hard to ignore it a second time when repeated in the draft guidelines themselves. Perhaps there is no implicit meaning to be taken from this statement. But if that were the case, why mention it? The NIH seems to think it important enough to differentiate between human embryos and their stem cells which are just parts of the whole. They suggest the research only impacts cells taken from the embryo rather than the embryonic human body itself.
But why even make this distinction if the human embryo has no inherent value? I agree that it would be more ethically responsible to harmlessly harvest cells from a living embryo than to kill the embryo entirely, but that assumes the human embryos: 1) have intrinsic human worth, 2) can fully recover, and 3) are permitted to continue living productive lives. The first premise, that embryos have value as human persons is side-stepped completely. The personhood question is simply never addressed. So it’s odd that NIH even attempts to win moral favor here.
How about the other two premises regarding what happens to the embryo’s body? By saying research is done to embryonic stem cells rather than the embryo itself implies that the embryo is unharmed. However, with virtually every instance of ESCR, this is simply not the case. The kinds of experiments these embryos endure at the very least would permanently disable them later in life, prevent implantation/birth, or kill them in the experimentation process. So whether disfigured for life, ripped apart in a lab, left for dead in a Petri dish, or discarded in bio-waste, their destiny was set before the tests ever began. Telling us that the cells are not themselves human embryos is therefore irrelevant and little more than patronizing propaganda.
Lastly, section II-B(7) under the heading “Guidelines for Eligibility of Human Embryonic Stem Cells for Use in Research” lists nine statements researchers are required to disclose to potential “donors” (parents of the embryos). The purpose is to ensure informed consent to those involved. That donation was voluntary, alternative options are available, and profits waived are examples. Other than the previously mentioned misuse of the term “donor,” there is another problem. Absent from the list of required disclosures was any mention of the personhood status of the embryo. Given the consensus in the scientific community of when human life begins, there should at the very least be a statement about this given to the parents. Even the creator of this funding himself, President Barack Obama, is admittedly uncertain when human life begins. Therefore, as long as no morally significant difference exists between an embryo and a newborn baby, this is something the parents donating their embryos should be told.
Until human embryos are given equal protections under the law, or the NIH can show embryos are not human persons, protections for human subjects are meaningless and research that leads to their death is both ethically irresponsible and scientifically unworthy.
Under “Supplementary Information” the document begins, “The purpose of these draft Guidelines is to … help ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law.”
The very fact they acknowledge ethical concerns is telling. They could be referring to handling of personal medical data, conflicting interests of clinicians, and donor consent agreements as these issues are addressed in other parts of the document. But the overwhelming elephant in the room is the matter pertaining to human embryos. After all, that is the fundamental matter at hand. Despite this, the moral controversy over embryonic research is not even mentioned except by saying bioethicists were consulted.
They also stated the purpose for the research to be “scientifically worthy.” It seems strange that such a project would show concern for scientific worthiness in an area (ESCR) where no medical developments have been made. While this could refer to the taxpayer support or the limited amount of embryos available for research, the guidelines don’t address these concerns anywhere else in the text. Furthermore, no evidence exists to support a probable discovery through ESCR so the NIH limits the likelihood to a logical “possibility” when describing a list of hypothetical cures from pluripotent stem cells harvested from unborn humans. If science has shown ESCR to be anything, it’s that funding such a failed effort is not worthy at all.
Both claims of the NIH to be “ethically responsible” and “scientifically worthy” make the same underlying assumption that ESCR involves value judgments. The most obvious of these is the personhood of human embryos. Put most succinctly by Greg Koukl, “if an embryo is not a human being, then no justification for ESCR is necessary. Experiment as you please. However, if the unborn is a human being, no justification for taking her life is adequate” (Koukl, Gregory. “Responsible Science & ESCR.” Solid Ground. May/June 2009. p3). In America, we don’t justify killing other human beings for the sake of medical research. Sadly, no effort to make this distinction was made anywhere in the draft guidelines. Such groundless ideology is unacceptable considering the ethical risks at stake.
“Long-standing HHS regulations for Protection of Human Subjects, 45 C.F.R. 46, establish safeguards for individuals who are the sources of many human tissues used in research including non-embryonic human adult stem cells and human induced pluripotent stem cells.”
It is apparently important to the NIH to ensure human beings involved with stem cell research are protected. Accordingly, every reasonable effort must be taken to ensure stem cells harvested from human donors do not adversely impact them. To this I agree. However, a question-begging assumption by the NIH arises when we ask them who the donors are. The draft guidelines refer to “donors” as people who give embryos over to research. But pay close attention because there is a clever slight of hand at work here. The HHS regulations to protect donors are intended to mean human donors who themselves have tissue removed from their own bodies for the harvesting of stem cells (i.e. skin, hair, blood, etc). However, ESCR involves not the tissue of an adult “donor” but the tissue belonging to an entirely separate individual - an embryo itself. It’s important to realize we’re talking about two distinct individuals: 1) the embryo, and 2) the donor(s). Categorizing the parents of the embryo as “donors,” misplaces the protections altogether and confuses the issue. In fact, the NIH drafted these guidelines so the person sacrificing their own tissue (the embryo) isn’t defined as the donor at all!
Furthermore, it may not help much even if the NIH considered the embryo as the tissue donor. They claim to work on pre-established protections for human subjects but exclude embryos from those protections anyway. No attempt to justifiably exclude them from human subject protection is given. No argument is offered defining embryos as anything less than human life. It’s just assumed.
Under the US Government’s Code of Federal Regulations Title 45 (Public Welfare) Part 46 (Protection of Human Subjects) Subpart A (Basic HHS Policy for Protection of Human Research Subjects), Section 102 (Definitions), “a human subject is a living individual about whom an investigator (whether professional or student) conducting research obtains:
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.”
Under this definition, there’s no reason to exclude human embryos from protection since they certainly are living individuals meeting the definition in 45 C.F.R. §46.102(f). Perhaps such a categorical loophole was foreseen by the draft writers who inserted the following disclaimer a few paragraphs later:
“Please note that, for NIH funded research using the permitted human embryonic stem cells, the requirements of the Department’s protection of human subjects regulations, 45 C.F.R. 46, may or may not apply, depending on the nature of the research.”
In other words, even if embryos can be categorized as human subjects warranting protection, the NIH leaves room for these protections not to apply anyway.
Under “Scope of Guidelines” it states: “Although human embryonic stem cells are derived from embryos, such stem cells are not themselves human embryos.”
This same phrase was cited earlier in the “Supplementary Information” section so it was hard to ignore it a second time when repeated in the draft guidelines themselves. Perhaps there is no implicit meaning to be taken from this statement. But if that were the case, why mention it? The NIH seems to think it important enough to differentiate between human embryos and their stem cells which are just parts of the whole. They suggest the research only impacts cells taken from the embryo rather than the embryonic human body itself.
But why even make this distinction if the human embryo has no inherent value? I agree that it would be more ethically responsible to harmlessly harvest cells from a living embryo than to kill the embryo entirely, but that assumes the human embryos: 1) have intrinsic human worth, 2) can fully recover, and 3) are permitted to continue living productive lives. The first premise, that embryos have value as human persons is side-stepped completely. The personhood question is simply never addressed. So it’s odd that NIH even attempts to win moral favor here.
How about the other two premises regarding what happens to the embryo’s body? By saying research is done to embryonic stem cells rather than the embryo itself implies that the embryo is unharmed. However, with virtually every instance of ESCR, this is simply not the case. The kinds of experiments these embryos endure at the very least would permanently disable them later in life, prevent implantation/birth, or kill them in the experimentation process. So whether disfigured for life, ripped apart in a lab, left for dead in a Petri dish, or discarded in bio-waste, their destiny was set before the tests ever began. Telling us that the cells are not themselves human embryos is therefore irrelevant and little more than patronizing propaganda.
Lastly, section II-B(7) under the heading “Guidelines for Eligibility of Human Embryonic Stem Cells for Use in Research” lists nine statements researchers are required to disclose to potential “donors” (parents of the embryos). The purpose is to ensure informed consent to those involved. That donation was voluntary, alternative options are available, and profits waived are examples. Other than the previously mentioned misuse of the term “donor,” there is another problem. Absent from the list of required disclosures was any mention of the personhood status of the embryo. Given the consensus in the scientific community of when human life begins, there should at the very least be a statement about this given to the parents. Even the creator of this funding himself, President Barack Obama, is admittedly uncertain when human life begins. Therefore, as long as no morally significant difference exists between an embryo and a newborn baby, this is something the parents donating their embryos should be told.
Until human embryos are given equal protections under the law, or the NIH can show embryos are not human persons, protections for human subjects are meaningless and research that leads to their death is both ethically irresponsible and scientifically unworthy.
1 comment:
Great post, I am almost 100% in agreement with you
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