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But the use of nuclear transplantation to obtain stem cells is another matter. At the time stem cells would be isolated from blastocysts produced by nuclear transplantation, the structures are no larger than the head of a small pin, of the order of 100-150 cells, and have no distinctive tissues--in particular, no neural tissue. Moreover, they have been obtained artificially, without even the intervention of fertilization, and will not be used to produce cloned individuals. They are biologically akin to the very early embryos produced in fertility clinics by fertilization in test tubes, except that they contain the genes of only one individual rather
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The Senate will be offered two very different legislative approaches to nuclear transplantation. One approach, sponsored by Senator Sam Brownback, would prohibit both reproductive cloning and nuclear transplantation itself. The other approach, sponsored in two similar forms by Senators Dianne Feinstein and Edward Kennedy, and by Senators Tom Harkin and Arlen Specter, would ban reproductive cloning , but permit research with nuclear transplantation to go forward. Also in the wings is a proposed moratorium on nuclear transplantation as an alternative to full fledged prohibition, but this has yet to take legislative form.
The Brownback bill is an onerous piece of legislation. It would criminalize a form of medical research that is intended to explore the prospects for stem cell therapies, not to create cloned persons; importation of treatments developed in other nations by the use of nuclear transplantation; even the receipt of such therapies abroad. It holds out the prospect of a U.S. diabetic returning from Great Britian--where the production of stem cells by nuclear transplantation is authorized--with a pancrease restored through the agency of nuclear transplantation and finding herself a felon.
The proposed moratorium is not a satisfactory alternative. It raises the specter of interminable discussion and political machinations, perhaps stalling research on nuclear transplantation indefinitely. The proponents of a moratorium argue that ``the widespread creation of clonal embryos would increase the risk that a human clone would be born, and would further open the door to eugenic procedures.'' But nuclear transplantation itself is in no way a ``eugenic procedure''. And any legislative prohibition of reproductive cloning automatically forbids the use of nuclear transplantation for that purpose.
Congress should unite around legislation that would prohibit reproductive cloning , but permit research on nuclear transplantation to go forward under suitable regulations and oversight. The makings of such legislation are already before the Senate, in the form of the Feinstein-Kennedy and Specter-Harkin bills. Legislation fashioned from these bills could offer a forthright, progressive and humane solution to the impasse over nuclear transplantation. The U.S. public deserves no less.
Dr. Berg is Emeritus Professor in the Department of Biochemistry at Stanford University and a Nobel laureate in chemistry. Dr. Bishop is Chancellor at the University of California, San Francisco, and a Nobel laureate in Physiology or Medicine. Dr. Grove is a cofounder and presently chairman of Intel Corp., and a cancer survivor.
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ASSOCIATION OF AMERICAN
UNIVERSITIES,
Washington, DC, April 25, 2002.
Hon. DIANNE
FEINSTEIN,
U.S. Senate,
Washington, DC.
DEAR SENATOR FEINSTEIN: I am writing to let you know that the Association of American Universities has now adopted a position on human cloning , which is attached. The AAU represents 61 leading public and private research universities in the United States and two in Canada.
Our university membership adopted this statement unanimously, and we look forward to working with you to enact legislation consistent with it, which would include the legislation you have introduced on this topic, S. 1758.
Your leadership in the fight to ensure that appropriate restrictions against human reproductive cloning are enacted, while allowing important research on nuclear transplantation to produce stem cells to continue, is most appreciated.
Cordially,
Nils Hasselmo,
President.
Enclosure.
AAU Statement on Human Cloning
The Association of American Universities has a long history of supporting academic and scientific freedom. It also recognizes the importance of conducting research consistent with ethical, legal, and safety requirements.
AAU strongly opposes human reproductive cloning , and supports legislation to ban this practice. The National Academy of Sciences (NAS) has concluded that cloning procedures are currently not safe for humans and that no responsible scientists or physicians are likely to undertake to clone a human . We generally do not support legislation to limit fields of research, but since some organizations have announced an intention to clone humans, we concur with the NAS that a legal ban is more likely to deter any attempt to close a human than would any voluntary system or moratorium. The ban should be reconsidered at five-year intervals, based on current scientific knowledge.
In contrast to human reproductive cloning , AAU continues to support both basic and applied stem cell research. AAU therefore supports nuclear transplantation to produce stem cells, also known as somatic cell nuclear transfer, as nonreproductive cloning , and as therapeutic cloning . AAU concurs with the NAS that nuclear transplantation to produce stem cells has considerable potential for advancing our fundamental knowledge and developing new medical therapies to treat debilitating diseases. Continuing the investigation of stem cells produced by nuclear transplantation is the only way to assure that the value of this nascent technology is realized. Before applications to humans should be considered, we need further study of cells derived from the process of nuclear transplantation, subject to federal safeguards. This research should proceed in parallel with other types of stem cell research, including human embryonic and adult stem cell research.
Adopted by the AAU Membership on April 23, 2002.
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Patient Stories From California Supporting Specter-Feinstein Approach on Cloning
FROM STEFANIE SONICO IN CATHEDRAL CITY, CA
``I totally and completely support stem cell research in hopes that it will lead to a cure for juvenile diabetes and other such devastating diseases. My son developed juvenile diabetes at 20 months old and is now 16 years old. Without stem cell research, his future is frightening. He does not need to look forward to kidney failure, eye damage, heart disease and stroke, and death 15 years before his time. He needs to believe that the United States of America, a free country, supports research, done by renowned scientists, to find a cure for diabetes. He needs to believe that the United States will not imprison scientists for their knowledge and their skill. I am a Christian that believes that we have an obligation to use our God-given brains and skills to better mankind. The research I support involves a cell in a petri dish that will produce cells to cure a disease like diabetes and that is called therapeutic cloning . My son and the millions of children like him, need the research and the results that will come from therapeutic cloning . Thank you.''
FROM LISBETH DERMODY IN MONTEREY, CA
``My son sustained a spinal cord injury 4 years ago and is now a quadriplegic; my husband developed the first symptoms of Parkinson's Disease 10 years ago and is now deteriorating and experiencing Parkinson's dementia. Stem cell therapy is our best hope that these two brilliant and productive men may expect some improvement in their lives and an alleviation of the psychological and physical suffering they endure every hour of every day. I urge defeat of the Brownback Bill; I urge support of intelligent and humane research that will help my loved ones.''
FROM HELLEN MUELLER, MODESTO, CA
``I am a type 2 diabetic with severe neuropathy. Recently, I had surgery for thyroid cancer and have lost the use of my parathyroids. I look to science particularly the science of cloning for help in treating my ailments. Life has become difficult as I am in pain much of the time. Even normal activities are limited for me. I would like to live the years I have left relatively pain-free, diabetes free too.
My husband has terrible knees. He suffers from degenerative cartilage and arthritis as does my sister. It would be wonderful if they could be helped by SCNT [somatic cell nuclear transplantation]. My husband is still able to work; however he pays a great price in the pain that he suffers. Only by using a large amount of pain killers is he able to get thru a work day. My sister is very incapacitated by her problems.
My sister's husband has had by-pass surgery which resulted in cognitive problems. Stem cell research, cloning , etc seem to be the only hope on the horizon.
In 1990 I lost a husband to ALS [Amyotropic Lateral Sclerosis or Lou Gehrig's disease]. Today I understand scientists are very hopeful that stem cell research will lead to a cure for this killer. He was gone one year after diagnosis. I was left without a husband, my son without a father. What a miracle it would be if this could be avoided for other people.''
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Summary of Human Subject Regulations as Incorporated Into Specter-Feinstein Legislation
GENERAL RESEARCH PROVISIONS
Types of Research Covered
Would cover ALL research involving somatic cell nuclear transplantation, regardless of who performs it or whether it is funded by the government.
Assurance and Certification Procedure
The institution conducting the research must: Submit a statement of ``written assurance'' outlining the procedures by which the institution will abide by federal regulations, and certify that the research has been reviewed and approved by an institutional review board (IRB) (see below for definition of IRB).
Penalities
HHS may require that the project be terminated or suspended if it finds an institution has failed to comply with federal regulations
HHS may also require the institution to pay a civil penalty of up to $250,000.
DEFINITIONS AND REQUIREMENTS
Institutional Review Board (IRB)
Research institutions must establish (or hire outside) Institutional Review Boards to
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In order to approve this research involving human subjects, the IRB must determine that all of the following requirements are satisfied: Risks to subjects are minimized and are reasonable in relation to any anticipated benefits and importance of the knowledge expected; selection of subjects equitable; informed consent is sought and appropriately documented from each subject; when appropriate, the research plan makes adequate provision for monitoring and protecting the data collected, to ensure the safety and privacy of subjects; and when some of the subjects are likely to be vulnerable to undue influence (such as mentally disabled or disadvantaged persons), additional safeguards must be included in the study to protect the rights and welfare of these subjects.
The IRB has the authority to suspend or terminate approval of research that fails to meet these requirements, or that has been associated with unexpected serious harm to subjects.
Informed Consent
No investigator may use a human subject in research unless the investigator has obtained the legally effective informed consent of the subject.
An investigator can seek consent only under circumstances that minimize the possibility of undue influence.
No informed consent, whether oral for written, may include any language through which the subject waives his legal rights, or the investigator is released from liability for negligence.
Basic elements of informed consent: The following information must be provided to each subject: A statement that the study involves research, an explanation of the purposes of the research, the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; a description of any reasonably foreseeable risks or discomforts to the subjects; a description of any benefits to the subject or to others which may reasonably be expected from the research; a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; for research involving more than minimal risk, an explanation as to whether the subject will be compensated, and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; an explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled.
Additional Protections for Pregnant Women and
Fetuses
General Restrictions: Research on fetuses and pregnant women cannot be undertaken, unless: Appropriate studies on animals and nonpregnant individuals have been completed; the risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means; any risk is the least possible for achieving the objectives of the research; if the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means, only the mother's consent is needed; if the research holds out the prospect of direct benefit solely to the fetus then the consent of both the pregnant woman and the father must be obtained, except that the father's consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest; individuals engaged in the activity will have no part in (i) any decisions as to the timing, method, and procedures used to terminate the pregnancy, and (ii) determining the viability of the fetus at the termination of the pregnancy; and no inducements, monetary or otherwise, may be offered to terminate pregnancy for purposes of the activity.
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