[Congressional Record Volume 148, Number 52 (Wednesday, May 1, 2002)]
[Senate]
[Pages S3631-S3637]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. SPECTER (for himself, Mrs. Feinstein, Mr. Hatch, Mr. 
        Kennedy, Mr. Harkin, Mrs. Boxer, Mr. Durbin, Mr. Miller, Mr. 
        Corzine, Ms. Mikulski, Mrs. Clinton, and Mr. Thurmond):
  S. 2439. A bill to prohibit human cloning while preserving important 
areas of medical research, including stem cell research.
  Mr. SPECTER. Madam President, I have sought recognition to introduce 
legislation to prohibit human cloning while preserving important areas 
of medical research, including stem cell research.
  I introduce this legislation on behalf of Senator Feinstein, Senator 
Kennedy, Senator Hatch, Senator Harkin, Senator Boxer, Senator Durbin, 
Senator Thurmond, Senator Miller, Senator Corzine, Senator Mikulski, 
Senator Clinton--and I do believe there will be other cosponsors 
joining that parade.
  Stem cells offer enormous hope for solving some of the most tragic 
illnesses confronting Americans--and for that matter people worldwide. 
In November of 1998, stem cells burst on the scene, holding this unique 
promise. Stem cells are extracted from embryos, and they may be used to 
replace defective cells in the human body. For example, enormous 
progress has been made on conquering Alzheimer's, conquering 
Parkinson's, on cancer, on heart ailments, and many other illnesses.
  A controversy arose because they came from embryos and embryos can 
produce life. Embryos are characteristically or customarily created for 
in vitro fertilization. Normally, about a dozen are created, maybe 
three or four are used, and the rest are discarded. It is from those 
discarded embryos that the stem cells are extracted. If all of those 
embryos could turn into human life, that would obviously be the very 
best use of those embryos. But there are some 100,000 in storage, and 
it is a practical impossibility for those embryos to be used for human 
life.
  In last year's appropriation bill coming out of the subcommittee of 
Labor, Health, Human Services and Education, where I am the ranking 
member, $1 million was appropriated to promote adoption of embryos. We 
are now working on legislation to give a tax credit for people who use 
the embryos for adoption. But since there are so many of these embryos 
which are not going to be utilized for adoption purposes, and the 
alternatives are either to discard them or to use them, then it makes 
good sense to use them to save lives.
  There is general repugnance against reproductive cloning. The 
legislation which we are introducing now would ban reproductive cloning 
and impose very substantial criminal penalties.
  Unfortunately, the scientists use a term, ``therapeutic cloning,'' 
which has led to confusion and has given a process known as nuclear 
transplantation a bad name. Essentially what nuclear transplantation 
is, it is to take DNA from a cell of a person who has Parkinson's and 
then insert that in a egg of a woman with the DNA removed. Then the 
stem cells which are produced from that egg are compatible with the 
donor's DNA. For example, those stem cells could be used to combat the 
Parkinson's which that individual has.
  The legislation contains very substantial protections to be sure that 
in the course of this nuclear transplantation none of this will be 
implanted in the womb of a woman or otherwise used to produce human 
cloning, reproductive cloning--cloning of a person. There are very 
tough criminal penalties attached.
  To Reiterate, over the past 4 years, the Labor, Health and Human 
Services and Education Appropriations Subcommittee has held 14 hearings 
at which scientists, patients, and ethicists have described the promise 
of stem cell research and nuclear transplantation to produce stem 
cells. A problem arises from the fact that scientists misnamed the 
promising technique of nuclear transplantation to produce stem cells. 
In calling this technique therapeutic cloning, scientists used a word, 
which for many Americans, conjures up grotesque images from bad science 
fiction movies: mad scientists, bubbling test tubes, and row after row 
of zombie-like creatures.
  Most Americans equate the word cloning with human reproductive 
cloning, where a carbon copy of a person is created in a process that 
also gave us Dolly the sheep and CC the cat. By this definition so-
called therapeutic cloning is not really cloning at all. It is a 
process that creates embryonic stem cells genetically matched to a 
patient for the purpose of repairing unhealthy or injured tissue.
  For example, if a patient has heart damage, the genetic material from 
one of his cells could be transplanted into a human egg cell that has 
had its genetic material removed. After a time, stem cells are 
produced, coaxed into becoming heart cells, and transplanted into

[[Page S3632]]

the damaged heart to restore function. Because the cells are an exact 
match of the patient's cells, no rejection would occur. Scientists have 
suggested that this procedure is better termed nuclear transplantation 
to produce stem cells.
  Embryonic stem cells can be coaxed into becoming any of the more than 
200 types of cells in the human body, and therefore may be used to 
treat a vast array of diseases and disorders including heart disease, 
Parkinson's disease, diabetes, paralysis, Alzheimer's disease, and 
severe burns. Scientists at the National Academy of Sciences estimate 
that the combination of nuclear transplantation and stem cell therapies 
could spare the lives of 170,000 Americans each year.
  History shows us the devastating effects of tying the hands of 
scientists for ideological reasons. Galileo was imprisoned for his 
support of Copernicus' theory that the planets revolve around the sun. 
Pope Boniface VIII banned the practice of cadaver dissection in the 
1200's. This set back the understanding of human anatomy and the 
practice of medicine for over 300 years. In the 1800's, the Scottish 
Calvinist Church objected to the use of anesthesia during labor because 
the ``pain of childbirth was God's will.'' Let us not repeat the 
mistakes of history.
  Recently 40 American Nobel laureates stated that:

       legislation [that would ban all cloning] would foreclose 
     the legitimate use of nuclear transplantation . . . and 
     impede progress against some of the most debilitating 
     diseases known to man.

  Former Presidents Ford and Carter have written to President Bush 
stating their opposition to reproductive cloning and their strong 
support for nuclear transplantation to produce stem cells. I believe 
that when the facts are weighed there will be strong bipartisan support 
for such a policy.
  As I said, today, I, along with Senators Feinstein, Kennedy, Hatch, 
Harkin, Boxer, Durbin, Miller, Corzine, Mikulski, Clinton, and Thurmond 
 am introducing a bill which would prohibit human cloning while 
preserving important areas of medical research, including nuclear 
transplantation to produce stem cells.
  Let me review the key provisions of the bill. It would prohibit human 
reproductive cloning by imposing a criminal penalty of up to 10 years 
in prison and a civil penalty of at least one million dollars. It would 
allow medical research into nuclear transplantation to produce stem 
cells, also known as therapeutic cloning, thereby allowing promising 
research towards cures for a vast array of diseases to go forward. It 
would apply strict Federal ethical requirements to all nuclear 
transplantation research. These include informed consent, an ethics 
board review, and protections for the safety and privacy of research 
participants. The legislation imposes a $250,000 civil penalty for 
violation of the ethics requirements.

  I believe that the Senate should act quickly to ban human cloning. In 
the process, we must preserve important areas of medical research, such 
as nuclear transplantation to create stem cells. The bill that I and my 
colleagues have introduced will do that in an ethical and moral way.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2439

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Human Cloning Prohibition 
     Act of 2002''.

     SEC. 2. FINDINGS.

       Congress makes the following findings:
       (1) Human cloning is unsafe, immoral, and unacceptable.
       (2) Federal legislation should be enacted to prohibit 
     anyone from attempting to conduct human cloning, whether 
     using Federal or non-Federal funds.
       (3) To deter human cloning, any attempt to create a human 
     clone should be a felony subject to severe punishment.
       (4) The National Academies (including the National Academy 
     of Sciences and the Institute of Medicine) and the National 
     Bioethics Advisory Commission recommended that any 
     legislative action undertaken to ban human cloning should be 
     careful not to interfere with important areas of scientific 
     research, such as nuclear transplantation to produce stem 
     cells.
       (5) The National Academies found that there are significant 
     differences between human cloning and nuclear 
     transplantation. Specifically, the Academies determined that, 
     unlike human cloning, the creation of embryonic stem cells by 
     nuclear transplantation does not involve implantation of an 
     embryo in a uterus and thus cannot produce a complete, live-
     born animal (that is, a ``clone'').
       (6) The National Academies found that scientific and 
     medical considerations that justify a ban on human cloning 
     are not applicable to nuclear transplantation.
       (7) The National Academies concluded that nuclear 
     transplantation has great potential to increase the 
     understanding and potential treatment of various diseases and 
     debilitating disorders, as well as our fundamental biological 
     knowledge. These diseases and disorders include Lou Gehrig's 
     disease, Parkinson's disease, Alzheimer's disease, spinal-
     cord injury, cancer, cardiovascular diseases, diabetes, 
     rheumatoid arthritis, and many others.
       (8) The National Academies determined that nuclear 
     transplantation research could improve our ability to 
     transplant healthy tissue derived from stem cells into 
     patients with damaged or diseased organs. Such research could 
     greatly reduce the likelihood that a person's body would 
     reject that tissue and also help obviate the need for 
     immunosuppressive drugs, which often have severe and 
     potentially life-threatening side effects.
       (9) Based on these expert conclusions and recommendations 
     and other evidence, nuclear transplantation is a valuable 
     area of research that could potentially save millions of 
     lives and relieve the suffering of countless others, and thus 
     should not be banned.
       (10) The National Academies recommended that nuclear 
     transplantation experiments should be subject to close 
     scrutiny under the Federal procedures and rules concerning 
     human-subjects research.
       (11) Given the need for additional oversight in this area, 
     strict ethical requirements for human subjects research, 
     including informed consent, safety and privacy protections, 
     and review by an ethics board, should be prescribed for all 
     research involving nuclear transplantation, whether using 
     Federal or non-Federal funds.
       (12)(A) Biomedical research and clinical facilities engage 
     in and affect interstate commerce.
       (B) The services provided by clinical facilities move in 
     interstate commerce.
       (C) Patients travel regularly across State lines in order 
     to access clinical facilities.
       (D) Biomedical research and clinical facilities engage 
     scientists, doctors, and others in an interstate market, and 
     contract for research and purchase medical and other supplies 
     in an interstate market.

     SEC. 3. PURPOSES.

       It is the purpose of this Act to prohibit human cloning and 
     to protect important areas of medical research, including 
     stem cell research.

     SEC. 4. PROHIBITION ON HUMAN CLONING.

       (a) In General.--Title 18, United States Code, is amended 
     by inserting after chapter 15, the following:

               ``CHAPTER 16--PROHIBITION ON HUMAN CLONING

``Sec.
``301. Prohibition on human cloning.

     ``Sec. 301. Prohibition on human cloning

       ``(a) Definitions.--In this section:
       ``(1) Human cloning.--The term `human cloning' means 
     implanting or attempting to implant the product of nuclear 
     transplantation into a uterus or the functional equivalent of 
     a uterus.
       ``(2) Human somatic cell.--The term `human somatic cell' 
     means any human cell other than a haploid germ cell.
       ``(3) Nuclear transplantation.--The term `nuclear 
     transplantation' means transferring the nucleus of a human 
     somatic cell into an oocyte from which the nucleus or all 
     chromosomes have been or will be removed or rendered inert.
       ``(4) Nucleus.--The term `nucleus' means the cell structure 
     that houses the chromosomes.
       ``(5) Oocyte.--The term `oocyte' means the female germ 
     cell, the egg.
       ``(b) Prohibitions on Human Cloning.--It shall be unlawful 
     for any person or other legal entity, public or private--
       ``(1) to conduct or attempt to conduct human cloning; or
       ``(2) to ship the product of nuclear transplantation in 
     interstate or foreign commerce for the purpose of human 
     cloning in the United States or elsewhere.
       ``(c) Protection of Research.--Nothing in this section 
     shall be construed to restrict practices not expressly 
     prohibited in this section.
       ``(d) Penalties.--
       ``(1) Criminal penalties.--Whoever intentionally violates 
     paragraph (1) or (2) of subsection (b) shall be fined under 
     this title and imprisoned not more than 10 years.
       ``(2) Civil penalties.--Whoever intentionally violates 
     paragraph (1) or (2) of subsection (b) shall be subject to a 
     civil penalty of $1,000,000 or three times the gross 
     pecuniary gain resulting from the violation, whichever is 
     greater.
       ``(3) Forfeiture.--Any property, real or personal, derived 
     from or used to commit a violation or attempted violation of 
     the provisions of subsection (b), or any property traceable 
     to such property, shall be subject to forfeiture to the 
     United States in accordance with the procedures set forth in 
     chapter 46 of title 18, United States Code.

[[Page S3633]]

       ``(e) Right of Action.--Nothing in this section shall be 
     construed to give any individual or person a private right of 
     action.''.
       (b) Ethical Requirements for Nuclear Transplantation 
     Research.--Part H of title IV of the Public Health Service 
     Act (42 U.S.C. 289 et seq.) is amended by adding at the end 
     the following:

     ``SEC. 498C. ETHICAL REQUIREMENTS FOR NUCLEAR TRANSPLANTATION 
                   RESEARCH, INCLUDING INFORMED CONSENT, 
                   INSTITUTIONAL REVIEW BOARD REVIEW, AND 
                   PROTECTION FOR SAFETY AND PRIVACY.

       ``(a) Definitions.--In this section:
       ``(1) Human somatic cell.--The term `human somatic cell' 
     means any human cell other than a haploid germ cell.
       ``(2) Nuclear transplantation.--The term `nuclear 
     transplantation' means transferring the nucleus of a human 
     somatic cell into an oocyte from which the nucleus or all 
     chromosomes have been or will be removed or rendered inert.
       ``(3) Nucleus.--The term `nucleus' means the cell structure 
     that houses the chromosomes.
       ``(4) Oocyte.--The term `oocyte' means the female germ 
     cell, the egg.
       ``(b) Applicability of Federal Ethical Standards to Nuclear 
     Transplantation Research.--Research involving nuclear 
     transplantation shall be conducted in accordance with 
     subparts A and B of part 46 of title 45, Code of Federal 
     Regulations (as in effect on the date of enactment of the 
     Human Cloning Prohibition Act of 2002).
       ``(c) Civil Penalties.--Whoever intentionally violates 
     subsection (b) shall be subject to a civil penalty in an 
     amount that is appropriate for the violation involved, but 
     not more than $250,000.
       ``(d) Enforcement.--The Secretary of Health and Human 
     Services shall have the exclusive authority to enforce this 
     section.''.

  Mrs. FEINSTEIN. Mr. President, I rise to join my colleagues Senators 
Specter, Kennedy, Hatch, Harkin and Thurmond to introduce legislation 
banning human cloning, but permitting valuable stem cell research to 
continue.
  At the dawn of a new era in medicine, it would be unconscionable for 
Congress to prohibit medical research that offers hope to so many 
people with crippling and often incurable diseases. There is broad 
agreement across our society that human reproductive cloning should be 
prohibited. And our bill bans human reproductive cloning. But there is 
also widescale support to continue research that may yield cures for 
paralysis, cancer, Parkinson's disease, Alzheimer's and so many other 
illnesses. And our bill allows this important research to continue. 
Simply put, nuclear transplantation research has nothing to do with 
cloning humans. Rather, it has everything to do with saving lives and 
alleviating suffering.
  The legislation we are introducing today bans human reproductive 
cloning, that is, creating a whole-body, carbon copy of a human being. 
Such cloning is unsafe, immoral, and unacceptable. Under the bill, 
anyone who even attempts human cloning will be subject to 10 years in 
jail and a minimum $1 million fine. However, the bill does not ban 
somatic cell nuclear transplantation. This is a technique that offers 
enormous potential for providing cures for diseases such as cancer, 
diabetes, cystic fibrosis, and heart disease as well as conditions such 
as spinal cord injuries, liver damage, arthritis, and burns.
  Somatic cell nuclear transportation works like this: 1. The nucleus, 
that is, the DNA, is taken from the body cell of a sick person; 2. It 
is then injected into an unfertilized egg from which the nucleus has 
been removed; and 3. The egg is stimulated to divide and produce stem 
cells. These stem cells can potentially grow into any organ or tissue. 
This ``new'' organ or tissue would have the same DNA as the sick person 
and thus can be implanted without rejection by the person's body. This 
could save the lives of the thousands of people every year waiting for 
an organ or tissue to be donated or who receive a transplant but suffer 
complications from powerful immuno-suppression drugs.

  Today, almost 80,000 Americans are waiting for organ transplants, 
while hundreds of thousands more need tissue transplants. Nuclear 
transplantation research offers many other applications as well. It 
could be used to produce human proteins such as blood clotting factors 
that aid in healing wounds. It could yield information on stem cell 
differentiation, providing valuable information about the mechanism of 
aging and the cause of cancer. It could even be used to find a cure for 
cancer by teaching us how to reprogram cells. However, we must 
acknowledge that nuclear transplantation research, like all scientific 
and medical research involving human diseases and conditions, involves 
complex ethical issues.
  Currently, this research is largely unregulated in the private 
sector. That is why this legislation would impose a number of ethical 
requirements on it, including informed consent, an ethics board review, 
and protections for the safety and privacy of research participants. 
These regulations are found in Subparts A and B of 45 CFR 46 and are 
incorporated in full into the bill we introduce today. Currently, these 
regulations apply to any research done or funded by the federal 
government. Our legislation would extend the regulations to all 
research involving somatic cell nuclear transplantation.
  The bottom line is that these regulations will prevent exploitation 
of women as part of nuclear transplantation research and, more 
generally, require that researchers do this research in an ethical 
manner. These regulations are already routinely applied to government-
funded researchers who do research on human subjects, and they seem to 
have worked well. Moreover, the bill provides that anyone engaging in 
unethical nuclear transplantation research would face up to a $250,000 
fine.
  I ask unanimous consent that a summary of Subparts A and B of 45 CFR 
46 be printed in the Record directly following my remarks.

  The PRESIDING OFFICER. Without objection, it is so ordered.
  (See exhibit 1.)
  Ms. FEINSTEIN. I would also add that I believe that there may be a 
need for even greater oversight over nuclear transplantation research 
than is provided in the bill we introduce today.
  I intend to work with my colleagues to strengthen this legislation 
further before it is enacted. There may well be a need to include 
additional provisions for regulation and oversight. For one thing, I 
believe that we should add the full text of Subparts A and B of 45 CFR 
46 to this legislation to make clear what the bill actually says. And I 
will work with my colleagues to do so. Unfortunately, competing 
legislation goes far beyond such regulation. It would completely ban 
nuclear transplantation--criminalizing scientific research that offers 
the promise of saving the lives of millions and relieving the suffering 
of countless others. In fact, it would even make it a crime for a 
doctor to cure a patient if that cure was developed overseas from 
nuclear transplantation research.
  I strongly oppose such legislation. I believe that passing such a 
sweeping ban would be a huge mistake. As is the case with many medical 
technologies, it is not stem cell research techniques that are the 
problem, but some of their potential applications. The scientific and 
medical evidence is overwhelming that nuclear transplantation offers 
the promise of curing many deadly diseases and debilitating conditions. 
As Professor Irving Weissman, chair of the National Academies' panel on 
cloning, testified before a Judiciary Committee hearing I chaired, 
``[T]here are no scientific or medical reasons [for banning nuclear 
transplantation], and such a ban would certainly close avenues of 
promising scientific and medical research.'' In fact, over 80 major 
organizations and associations have already come out in favor of our 
approach.
  These include the American Medical Association, National Health 
Council, Parkinson's Action Network, Juvenile Diabetes Research 
Foundation, and Federation of American Societies for Experimental 
Biology, which represents over 600,000 medical researchers around the 
country. Moreover, the leading blue-ribbon scientific and medical 
panels that have examined the cloning issue have also supported our 
approach.
  The National Bioethics Advisory Commission, the National Academies' 
Panel on Scientific and Medical Aspects of Human Cloning, and the 
California Advisory Committee on Human Cloning all concluded that we 
should ban human reproductive cloning, but not interfere with important 
areas of scientific research, including nuclear transplantation.
  I have been very moved by the many sick people and their relatives 
that have contacted me and told me that my legislation offers them 
hope. One of the most compelling stories is that of

[[Page S3634]]

Kris Gulden who testified at our hearing on the subject. Ms. Gulden, a 
former veteran police officer, received several awards for her 
outstanding law enforcement work. She also maintained an active 
schedule outside the office, including winning the women's triathalon 
gold medal in August 1996 at the biannual International Police Olympics 
in Salt Lake City. Tragically a car struck Ms. Gulden while she was 
training for the 1998 AIDS Ride, leaving her with a severe spinal cord 
injury. That accident changed her life. Nine days before the accident, 
she was participating in a triathalon in Memphis. Nine days after the 
accident, she was left exhausted just trying to brush her teeth. I'll 
never forget her words: ``In my dreams, I still walk. I run, I play 
basketball, and I wear the uniform of the Alexandria Police Department. 
When the sun rises each morning, it brings reality with it. I rise to 
the sight of a wheelchair, yet I rise with the hope that maybe this 
will be the morning that I can move my legs.''
  In the face of the enormous promise of nuclear transplantation 
research, it is difficult to see why anyone wants to dash the hopes of 
Kris Gulden and the millions of others facing debilitating and painful 
illnesses and ailments. As former Senator Connie Mack has testified 
before the Senate:

       A cell isn't human life if it hasn't been fertilized by a 
     sperm and placed in the womb'' and `[t]he research value of 
     these cells is enormous. They have the potential to form any 
     cell in the body and can reproduce indefinitely. Studies in 
     animals demonstrate that this could lead to cures and 
     treatments for millions of people.

  The legislation we introduce today would ban human reproductive 
cloning and preserve valuable medical research. I urge my colleagues to 
support this bill.
  I would also ask unanimous consent that several letters I have 
received supporting the Specter-Feinstein-Kennedy-Hatch approach to 
cloning be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                          Joint Steering Committee


                                            for Public Policy,

                                      Bethesda, MD, April 9, 2002.
     Hon. Orrin G. Hatch,
     U.S. Senate, Hart Senate Office Building, Washington, DC.
       Dear Senator Hatch: I am writing to seek your help with 
     efforts being made by many disease advocacy groups and by 
     many of us in the scientific community to protect highly 
     valuable scientific research from an overzealous legislative 
     proposal intended to prohibit the cloning of human beings.
       The measure in question, S. 1899, introduced by Senator 
     Brownback and others, would, in effect, establish criminal 
     penalties for three things: (i) attempts to produce a human 
     being by methods that include transfer of a somatic cell 
     nucleus (``nuclear transfer'') and placement of any resulting 
     embryos into a uterus; (ii) the transfer of a human cell 
     nucleus into an egg cell for any purposes; and (iii) the 
     important of any products of nuclear transfer, including 
     those used for medical treatment.
       No scientist of my acquaintance believes that it is 
     currently appropriate or safe, even if it were feasible, to 
     undertake the complex process intended to result in the birth 
     of a cloned human being. For that reason, you are unlikely to 
     hear objections to the first prohibition established by the 
     Brownback bill, even from those who may question whether 
     legislation and criminal penalties are useful instruments for 
     preventing attempts at cloning that might be undertaken by 
     irresponsible individuals.
       The second and third prohibitions, however, are deeply 
     disturbing to many people, including those of use who have 
     given considerable thought to the difficult ethical issues 
     presented by these new technologies. The third prohibition is 
     inappropriately punitive in the more obvious way: it could 
     lead to punishment of seriously ill patients who have gone 
     abroad to seek novel treatments that are unavailable in this 
     country because they are based on nuclear transfer. But the 
     second prohibition is troubling in a more profound way. For 
     the first time in my experience, an American law would create 
     criminal penalties for the use of a highly promising 
     scientific method, regardless of the intent of the 
     investigator, and would threaten to delay development of new 
     therapies for common diseases.
       To appreciate our concerns, it is important to understand 
     the nature of what is called ``nuclear transfer''. Recent 
     studies with experimental animals show that a cell nucleus 
     containing all, but expressing only some, of the genes of an 
     organism can undergo extensive changes, or ``reprogramming'', 
     when moved from one cell environment to another. This means 
     that a nucleus from a highly specialized cell--for example, a 
     skin call--can radically revise the set of genes that it uses 
     when it is put into another cell, such as an egg cell, from 
     which the pre-existing nucleus has been removed. In the new 
     environment of the recipient cell, the genes in the nucleus 
     appear to function as appropriate to that environment.
       Thus, when the recipient cell is an egg, the genes regain 
     the ability to direct the progeny cells, which arise by 
     division, to form nearly any of the many cell type that are 
     found in a mature organism, if the cells are coaxed to do so 
     by appropriate stimuli. This phenomenon has the potential to 
     lead to great things a deeper understanding of human 
     development, important insights into disease mechanism, and 
     the abundant production of normal cells of virtually any 
     type, which could then be used to treat a wide variety of 
     diseases. Moreover, if a parent is the source of the 
     transplanted, reprogrammed nucleus, the normal cells could be 
     used to treat that individual without fear of immune 
     rejection.
       Clearly we have a lot to learn before we can efficiently 
     apply nuclear transfer and reprogramming to medical 
     purposes--most obviously, we need to learn the best recipes 
     to foster reprogramming and development into the various cell 
     types. But studies with certain animal models of disease 
     already show that these strategies can work, and the 
     fundamental discoveries that have emerged from work with 
     nuclear transfer offer legitimate hope for still greater 
     discoveries in the future.
       Unfortunately, the opportunities make such discoveries and 
     develop new therapies may well be denied to American 
     scientists because of any inappropriate equation of the 
     method used in reprogramming cells (nuclear transfer) and the 
     goal of cloning whole organisms. This confusion is based in 
     part on the use of nuclear transfer in an otherwise very 
     different multi-step process that led ultimately to the birth 
     of Dolly the sheep and other cloned animals. Indeed, S. 1899 
     considers transfer of a human somatic cell nucleus into an 
     nucleated human egg for the purpose of reprogramming to be a 
     punishable act of human cloning.
       It is crucial to emphasize how nuclear transfer, the 
     reprogramming step, differs from attempts to generate a full-
     fledged organism. Absent transfer to a uterus, the cells that 
     result from nuclear transfer into an egg cytoplasm will not 
     form the complex and organized collection of cell types that 
     characterize a developing organism. The initial aggregate of 
     fewer than 200 cells, formed after introduction of a nucleus 
     into an egg, lacks the recognizable types of cells that are 
     needed to develop into the organs of a human being, and it 
     is barely visible to the naked eye. Individual cells from 
     this aggregate, however, can be used to develop stem cell 
     lines, to study development of specialized cell types in a 
     Petri dish, and to prepare materials for cell-based 
     therapies.
       Furthermore, in the future, it is possible that cell 
     reprogramming can be carried out in ways that do not involve 
     the use of human egg cells or nuclear transfer itself. The 
     chemicals in the cytoplasm of an egg cell that guide 
     reprogramming have not yet been identified, but when they are 
     it will be possible to use other cells and even simpler 
     defined recipes to reprogram adult cells. Of course, these 
     things will never happen, at least in this country, if the 
     use of nuclear transfer to human eggs is outlawed.
       The Brownback bill that we are worried about today closely 
     resembles a bill (S. 1601) proposed in 1998 by Senator Bond 
     and others. At that time, you helped to derail the passage of 
     that ill-considered measure with an insightful letter to one 
     of the bill's sponsors and a speech on the Senate floor. Many 
     of my colleagues and I believe that the concerns you raised 
     then about the need to ``ban cloning of human beings but do 
     so in a way that allows, to the extent ethically proper, 
     valuable research to continue'' are still valid. For that 
     reason, I hope you will join us in opposing S. 1899.
       Thank you for your consideration of my views on this 
     important legislation. Needless to say, I am prepared to 
     discuss any of the points I have made with you or your staff 
     at any time.
           With best personal regards,

                                                Harold Varmus,

                                   Chair, Joint Steering Committee
      for Public Policy.
                                  ____



                           California Institute of Technology,

                                      Pasadena, CA, April 8, 2002.
     Senator Orrin G. Hatch,
     Hart Office Building,
     Washington, DC.
       Dear Senator Hatch: I am writing in opposition to the 
     Brownback bill on cloning.
       I am a Nobel Laureate who has worked for 40 years in basic 
     biological science and biotechnology. I have seen how a 
     glimmer of an idea can grow to transform a technology, and I 
     have great faith in the ability of basic science to create 
     miraculous treatments for medical conditions.
       The use of nuclear transfer into the embryonic cells for 
     reproductive purposes (so-called reproductive cloning) is a 
     technology that is a long way from being safe enough to be 
     used to create human beings. So, issues of morality aside, I 
     am totally opposed to using cloning technology for human 
     reproduction. All of my colleagues with whom I have talked 
     are equally opposed, but I am aware that there are people 
     threatening to try to carry out the procedure. Thus, I 
     support a legislative ban on reproductive cloning. I hope 
     that any such ban will have a sunset clause so that in 5 
     years the question can be revisited.
       There is another use of somatic cell nuclear transfer into 
     early embryonic cells

[[Page S3635]]

     that is quite different from the process of reproductive 
     cloning. This is often called therapeutic cloning, although 
     that is a terminology that many people find confusing. Such 
     nuclear transfer could be used to produce individual stem 
     cells that may have extraordinary medical value. It is also a 
     valuable technique for probing the causes of genetic 
     diseases. Twice this week, I have heard of new advances that 
     make such a technology increasingly promising. Furthermore, 
     the procedure whereby mouse cells derived by somatic cell 
     nuclear transfer can be used therapeutically has just been 
     described in the journal Cell, erasing any doubt about the 
     feasibility of the method. Thus, it would be a great loss to 
     medical science for somatic cell nuclear transfer for 
     therapeutic use to be legislatively banned.
       I am aware that there are bills in the Senate that would 
     fit the requirements that I have set out. Senator Feinstein 
     of my state along with Senator Kennedy has proposed such a 
     bill as has Senators Specter and Harkin. They make the 
     distinction between banning nuclear transfer for reproductive 
     purposes and continuing to allow nuclear transfer for 
     research and therapeutic purposes. These are bills that I can 
     support.
           Sincerely yours,
                                                  David Baltimore,
     President.
                                  ____

                                      American Association for the


                                       Advancement of Science,

                                Washington, DC, February 28, 2002.
       Dear Senator: The Board of Directors of the American 
     Association for the Advancement of Science (AAAS) recently 
     adopted a policy statement on human cloning. I am enclosing a 
     copy for your attention.
       Citing the serious risks associated with the procedure, the 
     AAAS statement supports a legally enforceable ban on human 
     reproductive cloning. At the same time, however, it backs 
     stem cell research using cells derived with nuclear 
     transplantation techniques, a procedure sometimes called 
     therapeutic or research cloning. Such research offers 
     enormous potential health benefits. However, because it also 
     raises serious ethical, social, and religious concerns, it 
     must be conducted under close scrutiny by the federal 
     government.
       AAAS is the world's largest general scientific society with 
     over 135,000 individual members and 275 affiliated societies 
     representing all fields of science and engineering. Founded 
     in 1848, it is also the publisher of Science magazine and has 
     long been a leader in promoting ethical and responsible 
     science.
           Sincerely,
                                                  Alan I. Leshner,
                                          Chief Executive Officer.
       Enclosure.

                    AAAS Statement on Human Cloning

       The American Association for the Advancement of Science 
     (AAAS) recognizes the intense debates within our society on 
     the issue of human cloning. Since 1997, AAAS has engaged the 
     public and various professional communities in dialogue on 
     the scientific and social issues associated with human 
     cloning and stem cell research. Those experiences form the 
     backdrop for this statement on human cloning.


                        ban reproductive cloning

       AAAS endorses a legally enforceable ban on efforts to 
     implant a human cloned embryo for the purpose of 
     reproduction. The scientific evidence documenting the serious 
     health risks associated with reproductive cloning, as shown 
     through animal studies, make it unconscionable to undertake 
     this procedure. At the same time, we encourage continuing 
     open and inclusive public dialogue, in which the scientific 
     community is an active participant, on the scientific and 
     ethical aspects of human cloning as our understanding of this 
     technology advances.


      support stem cell research (including ``research cloning'')

       AAAS supports stem cell research, including the use of 
     nuclear transplantation techniques (also known as research or 
     therapeutic cloning), in order to realize the enormous 
     potential health benefits this technology offers. Such 
     benefits are likely to be many years away. If they are to be 
     realized at all, however, it will only be through carefully 
     designed research subject to peer review. Because there are 
     religious, ethical, and social concerns raised by the 
     prospect of creating stem cells for research purposes, we 
     believe that research cloning should only proceed under close 
     scrutiny by the federal government over both the public and 
     private sectors.


                     exercise appropriate oversight

       A thorough assessment of existing guidelines and policy, 
     including consideration of possible new regulations specific 
     to this type of research, should be undertaken in light of 
     the concerns surrounding it.
       Adopted by the AAAS Board of Directors, Boston, 
     Massachusetts, February 14, 2002.
                                  ____

                                              The American Society


                                            of Human Genetics,

                                   Bethesda, MD, February 5, 2002.
     Hon. Dianne Feinstein,
     U.S. Senate,
     Washington, DC.
       Dear Senator Feinstein: The American Society of Human 
     Genetics (ASHG) is a society of researchers and professionals 
     in human genetics that represents nearly 8000 scientists, 
     physicians, nurses, genetic counselors, and students actively 
     engaged in genetic discovery, teaching, and application of 
     knowledge of human genetics and the human genome.
       As a major scientific organization whose members have broad 
     expertise and interest in matters related to human genetics, 
     and in the application of genetic knowledge to the well being 
     of people, the Society strives to be extremely thoughtful, 
     thorough and ethical in pondering many of the scientific 
     issues raised in public debate today. As stewards of the 
     field of human genetics elected by the membership of the 
     Society, the Board of Directors of ASHG affirms that basic 
     research and the development of future applications of that 
     research require the ongoing commitment to scientific 
     integrity and social responsibility that has served our 
     organization well for the last 50 years. In other words, 
     scientists must proceed with commitment to rigorous critical 
     evaluation and a heightened sense of responsibility to the 
     patients who entrust their life and health to us.
       In concert with these principles, it is important for you 
     and your colleagues to know that the ASHG concurs 
     wholeheartedly with your bill ``The Human Cloning Prohibition 
     Act'' that bans reproductive human cloning but is finely 
     crafted so as not to prohibit new and evolving techniques 
     that could potentially change the course of human illness as 
     we know it today so that the collective quality of life is 
     enhanced for all of us. Dr. Bert Vogelstein, in his testimony 
     before the Labor Health and Human Services subcommittee on 
     December 4, 2001, so eloquently captured the distinction 
     surrounding two very different medical endeavors--
     regenerative medicine and the cloning of a human--the former 
     being the potential key to the problem of immune rejection, 
     the latter being morally and medically unacceptable.
       In closing, the Senate must be sure that any legislative 
     action only bans cloning to create a human being and does no 
     harm to legitimate biomedical research. Each Senate vote on 
     proposed legislation must make this distinction clear or any 
     ban would have profound negative impact on the advances that 
     have been made thus far in this pioneering and exciting 
     field.
       We congratulate you and your fellow senators for your 
     insight and conviction to advancing the field of biomedical 
     research.
           Sincerely yours,

                                     Dr. P. Michael Conneally,

                                                   ASHG President.

                                        Dr. Joann A. Boughman,

     ASHG Executive Vice President.
                                  ____

                                                   April 12, 2002.

                  Closing Minds to Stem Cell Research

       The United States Senate is about to consider legislation 
     that will determine the fate of a remarkable new form of 
     medical research known colloquially as ``therapeutic 
     cloning''. The research could lead to unprecedented 
     treatments for human disease, but has fallen prey to the 
     confused debate over human stem cell research on the one 
     hand, and the prospects of creating a cloned person on the 
     other--two very different exercises that are now intricately 
     entwined.
       The debate has its roots in the medical potential of human 
     stem cells. All the tissues in our bodies arise from stem 
     cells that are found in the early human embryo. Over the past 
     several years, scientists have learned how to isolate and 
     propagate human stem cells. There is hope that we will 
     eventually be able to use these cells to more effectively 
     treat cancer, diabetes, spinal cord injury, Alzheimer's and 
     Parkinson's diseases, and others. This prospect has inspired 
     great hope among individuals with ailments that had 
     previously seemed incurable.
       Human stem cells can be isolated in several ways. The most 
     visionary approach utilizes a procedure that was first dubbed 
     ``therapeutic cloning'', but should more accurately be termed 
     ``somatic cell nuclear transfer'' or simply ``nuclear 
     transplantation''. To perform nuclear transplantation, 
     scientists replace the genetic material of an unfertilized 
     human egg with that from an adult cell. The egg is then 
     induced to proliferate into a primitive structure known as 
     the ``blastocyst'', from which stem cells can be harvested. 
     Tissue derived from such stem cells would be immunologically 
     compatible with the donor of the genetic material, thus 
     circumventing rejection of the tissue when it is transplanted 
     into the donor in order to renew a failing organ.
       Blastocysts produced by nuclear transplantation can also be 
     implanted into the uterus in order to produce fully developed 
     organisms that are genetically identical to the original 
     donors--``clones'' such as the celebrated sheep Dolly. The 
     prospect of using such ``reproductive cloning'' to create 
     humans is repugnant to most scientists and the general public 
     alike. Consequently, there is widespread support for 
     legislation that would prohibit the production of human 
     clones.
       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

[[Page S3636]]

     than those of two. The U.S. condones the discard of surplus 
     embryos made in fertility clinics. Why should it criminalize 
     the medical use of blastocysts produced by nuclear 
     transplantation? Unfortunately, the term 
     ``therapeutic'' cloning'' was originally used to describe 
     nuclear transplantation, so the procedure is now tarred 
     with the same brush as reproductive cloning. Rarely has 
     semantic inaccuracy been more misleading.
       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.
     Paul Berg, Ph.D.
     J. Michael Bishop, MD.
     Andrew S. Grove, Ph.D.
       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.
                                  ____

                                           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.
                                  ____


 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.''
                                  ____


   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

[[Page S3637]]

     review and approve research involving somatic cell nuclear 
     transplantation. Each IRB must have at least five members.
       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.

                          ____________________