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Fetal research and antiabortion politics: Holding science hostage.

Revolutionary technical advances in probing, viewing and listening to the pregnant womb, and in culturing and evaluating the products and byproducts of conception, have brought us to the verge of understanding and treating disease processes that have stumped science for decades -- closer, even, to unraveling the secrets of the aging process, and of how cancer begins. Already, human fetal research has resulted in the near elimination of such scourges of childhood as polio, measles, congenital rubella syndrome and Rh disease.

Before development of the new therapeutic techniques made possible by fetal research, just one of these afflictions--Rh blood disease--each year caused 10,000 stillbirths, and severely damaged the brains, bodies or senses of 25,000 babies that were born. The cost-to-benefit ratio alone is staggering: The total amount of money used to support this research is equal to what society is now paying for the lifetime care of just a half-dozen children brain-damaged by Rh disease. (1)

Yet--mainly because of the intrusion of the volatile abortion issue--most fetal research has been halted, at least temporarily, since July 12, 1974, when the National Research Act (P.L. 93-348) was signed into law. That act prohibits the Department of Health, Education and Welfare (DHEW) from conducting or supporting "research in the United States or abroad on a living human fetus, before or after induced abortion...[except] for the purpose of assuring the [fetus's] survival...." This means, in effect, that virtually all research involving the human fetus has been stopped, because:

* most biomedical research is at least partially funded by DHEW;

* the legislation does not define "living," and most tissue used in research is, in the cellular sense, "live";

* most tissue used in fetal research is from products of abortion; and

* a significant portion of the fetal research in utero has involved women undergoing abortions.

Whether the ban will be continued or modified depends upon what recommendations are made to the DHEW Secretary by the 11 members of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, set up under the National Research Act. (*) The Commission is required to make its recommendations to the Secretary by May 1, and he must draft regulations to implement them, or tell Congress why he does not accept the Commission's recommendations.

Prior to the 1973 Supreme Court decisions which declared restrictive state abortion laws unconstitutional, Congress had been evolving legislative guidelines appropriate to protect the subjects of biomedical and behavioral research. Fetal research played no part in these discussions. However, after the Supreme Court decisions, antiabortion congressmen, spurred by "right-to-life" constituents, seized on the fetal research issue as an additional means to express their opposition to abortion. Their method has been to confound citizen and congressional concern over the ethical considerations arising from human research with their personification of the fetus as 'captive' in its mother's womb, and entitled to the same protections as all individuals.

Because of intrusion of the abortion issue, the fate of fetal research is now being debated in an atmosphere of publicity and emotion unprecedented for a scientific subject in modern times.

In this article, we will try to trace how debate on fetal research has become so muddled and embittered, to summarize the past and likely benefits of fetal research, as well as the medical, ethical and legal problems involved, and to examine whether there are possible courses of action under which important fetal research may be undertaken in the future.

Biomedical Research: Resources and Resistances

As stated recently by Philip Handler, President of the National Academy of Sciences:

In the aftermath of World War II, the belief that science-based technology could improve the condition of man went unchallenged, as did the assumption that, one day, we would understand biology sufficiently so that the capability of medicine to cope with the biological ills of man would be greatly enhanced. . . . Concomitantly this nation built an unparalleled scientific enterprise; talent, increasingly well-supported by public funds, gained international leadership in virtually every aspect of the scientific endeavor. (2)

As a result of fiscal constraints, the expansion of biomedical and other research has slowed. It is notable, however, that current expenditures of about $2.5 billion by the National Institutes of Health (NIH) (3) compare to just $52 million allocated by the federal government in 1950. (4) (Even taking inflation into account, this represents a more than 2,800 percent increase over the 25-year period.) During the 1960s, the Kennedy, Johnson and Nixon administrations and the Congress sought to direct the expansion of medical research toward more widespread application of the new basic knowledge which had been gained. Neurosurgery, development of life support systems, organ transplants, and prenatal diagnosis and treatment of diseases and defects affecting the fetus and the newborn infant are among the more spectacular practical attainments resulting from this research expansion. The contributions of fetal research to saving babies' lives and improving the chances of fetal survival and health are especially notew orthy, according to Maurice J. Mahoney, the Yale scientist who directed a study group surveying the extent of such research for the National Commission for the Protection of Human Subjects. Mahoney points out that "the child and the infant for many decades did not benefit proportionately with adults from the advances in medical science," while the fetus benefited even less. (3) He notes that there has been a "quantum jump" in fetal research over the past five years, made possible by the development of endoscopic and ultrasound instruments and coinciding with the increase in fetal material available from legal abortions in this and other countries. (6)

Prior to the liberalization of some state abortion laws in 1970 and the 1973 Supreme Court abortion decisions, investigations involving fetal tissues were dependent upon material derived from spontaneous abortions and stillbirths and from the relatively small number of therapeutic induced abortions. The scarcity of materials for research presented an obvious barrier to large-scale investigations and the advancement of knowledge. It was perhaps inevitable, under these circumstances, that individuals and organizations who oppose legal abortion would view increased fetal research with deep concern, if not outright horror. They believe that fetal research will entrench dependence on abortion and, therefore, regardless of the benefits to humanity of such research, they want it curtailed or stopped. In addition, they are concerned lest medical and biological researchers who might 'benefit' from such experimentation encourage abortions just to get fetal material. (7)

Fetal Research

The study and culture of human fetal cells and tissue is not new. Studies of fetal tissue by Albert B. Sabin and Peter K. Olitsky during the late 1930s began a new epoch in immunological approaches to combating viral diseases. (8) Over the next decade, John F. Enders, Thomas Weller and Frederick C. Robbins made landmark discoveries through utilization of human embryonic tissue that led to prophylaxis against polio, measles and rubella. (9) For virtually eliminating these diseases, they were awarded a Nobel Prize in 1954. As early as 1948, Earl Chapman's work with fetal tissues led to new discoveries about thyroid physiology and to the development of safer therapy for thyroid disease. (10)

During the last 10 years, several thousand studies involving fetal tissues have been conducted, according to the Mahoney study group - many of them "directed at identifying the threatened fetus in utero . . . and devising methods successfully to manage fetal problems." (11) Such studies have involved, among other things, the detection and treatment of fetal illness, abnormalities or damage, and the observation of the effect on the fetus of medicines given the pregnant woman.

It is generally acknowledged that the study of normal fetal growth and development is a fundamental prerequisite for obtaining knowledge about abnormalities and pathologies in the fetus. Most diseases of the newborn begin during fetal development, and many of the difficulties experienced by the fetus during delivery and in the first year of life must be studied at that time. (12) No animal models of most human genetic and metabolic disorders exist. As Alabama University's Charles A. Alford, Jr., has stated: "To provide the maximal medical care for the fetus's protection, we must understand its normal development, the deviations from the norm that lead to disease, and the causes for these deviations. Without this knowledge, the necessary steps toward medical treatment prior to birth, either now or tomorrow, become impossible." (13) In addition, there is no adequate way to assess the safety of drugs which are used to treat pregnant women and their offspring other than to study the efficacy, safety and metaboli sm of these drugs in the groups of women and children for whom they are intended. (14) It has been estimated that 75 percent of all therapeutic agents presently being marketed are not approved for use in infants, children and pregnant women because conclusive evidence of safety and efficacy in this population is not available. Nevertheless, the average woman takes six pharmacological agents during her pregnancy -- many of them self-prescribed. In a very real sense, as one investigator put it, "the human fetus is incubated in a sea of drugs," the effects of which on fetal development "are almost entirely unknown." (15) Legal compliance with the Food, Drug and Cosmetics Act would., therefore, require cautious research on the fetus and pregnant woman if the use of pharmacological agents were to be based on valid scientific data. (16)

Advances based upon culture and evaluation of fetal fluids and tissue have led to clinical procedures aimed specifically at improving the outcome of pregnancy. These are some of the specific areas of health care which have benefited from such research:

* The detection, management and prevention of Rh blood group sensitization has been accomplished by sampling the blood of the pregnant woman and the developing fetus and by giving the fetus total blood transfusions when the woman's and fetus's blood types are. found to be incompatible. More recently, an Rh vaccine has been developed, effectively immunizing against the disease. A study contracted from Battelle Columbus Laboratories by the National Commission for the Protection of Human Subjects estimated that 450,000 stillbirths would have been caused by Rh disease in recent decades if the advances made possible by fetal research had not occurred; in addition, tens of thousands of babies would have been born live but brain-damaged because of Rh sensitization. (17) The Battelle group concluded that the transfusion technique would never have been developed, and the vaccine would have been delayed for 10 years, without human fetal research,. The in utero exchange transfusions alone were credited with saving 200,0 00 lives over a 20-year period. (18)

* Thirty chromosomal, metabolic and other congenital abnormalities, including Down's syndrome (mongolism), cystic fibrosis and Tay-Sachs disease, can be detected before birth by sampling fetal cells from the amniotic fluid in which the fetus floats in the womb. Without human fetal research, this technique could never have been developed and applied, the Battelle study found. (19) Although therapy is not yet available for most of the abnormalities which can be diagnosed, couples who know they carry recessive genes which place their offspring at risk may elect to terminate a pregnancy where the fetus is known to be affected. On the other hand, if the fetus is found to be free of the defect, the parents may continue the pregnancy to term without fear.

* Fetal lung maturity can be assessed by chemical tests of the amniotic fluid. This has resulted in reduction of the incidence of respiratory distress syndrome -- the usually fatal breathing ailment of premature infants -- by permitting identification of the fetus at risk, and administration of corticosteroids into the amniotic fluid of the pregnant woman, thus stimulating fetal lung maturation. (20)

The rate of fatality from pulmonary insufficiency and respiratory distress syndrome, however, remains high; and further studies of normal and abnormal lung maturation are expected to lead to additional improvement in the prevention and management of prematurity. Additional research is also needed concerning the mechanism, as well as the short- and long-term side effects, of steroid therapy.

* Rubella, or German measles, is a comparatively mild disease, but can have devastating effects on the fetus when it strikes the pregnant woman. Congenital rubella syndrome may cause blindness, deafness, mental retardation and other handicaps in the offspring -- if it survives. Fetal research led to development of the rubella vaccine, first marketed in 1969. The number of cases has been reduced, Battelle pointed out, from 47,500 per year in prevaccine days to about 11,800 cases now. (21) And only 25 cases of congenital rubella syndrome were reported in 1973 (the last year for which there are data). (22) Monkey research suggested that the rubella vaccine was safe to give to pregnant women. Only research in humans led to the understanding that such vaccination was as dangerous to the fetus as acquisition by the pregnant woman of the disease itself. Further human fetal research is necessary to find out whether the pregnant woman can still catch the disease from a vaccinated child who is subsequently reinfected, but has no symptoms. (23)

* Through new fetal monitoring techniques and intensive neonatal clinical care, advances have been made in developing means to prevent and treat prematurity, the leading cause of neonatal death and serious neurologic damage such as blindness, mental retardation and cerebral palsy. (24)

* Measurements can be made of hormone levels in the mother's blood or urine. These help to evaluate the health of the fetus, and offer the physician the opportunity to prepare appropriate prenatal therapeutic measures. (25)

In addition, the use of fetal tissue and fluid samples was absolutely essential to the achievement of a number of now standard clinical techniques (26) which have led to important improvements in maternal health. As the President of the Society for Gynecologic Investigation has pointed out, (27) these include: discovery and development of new agents to prevent long and dangerous labor; new anesthesia techniques leading to safer deliveries; means to treat preeclampsia, the sometimes fatal toxic reaction to pregnancy associated with high blood pressure, convulsions and kidney damage; new regimens which have reduced the risk that pregnancy involves for women with heart or metabolic disease; and evaluation of timing of delivery and use of antibiotics to treat premature rupture of amniotic sac membranes.

The Need for Further Fetal Research

After studying the nature and extent of fetal research, and analyzing the ethical considerations involved, the Mahoney group concluded that the benefits of past fetal research have been great, and the need for continued research is even greater. The study group estimated that about 25 percent of fetuses -- more than one million each year -- perish in the womb; another two percent die at or soon after birth; and about three percent of all that are born live have a serious genetic defect. "Fetal disease and disorders provide a massive medical problem and one which must be addressed by an ethical profession. Abandonment of the fetal patient is clearly unethical and abhorrent. . . ." (28)

There are many areas involving human health where future progress is likely to be blocked if research on the human fetus is halted or severely curtailed permanently. For example, pregnancy complicated by diabetes mellitus is dangerous to the fetus and newborn infant; but fetal research is needed to understand the high rates of mortality and morbidity. Such research is also considered likely to increase our knowledge of the factors responsible for the initiation of labor -- and, therefore, our ability to develop a more effective approach to the prevention of premature labor. (29)

Of the more than 100 human recessive genetic defects in which the specific metabolic error has been identified, about 60 can be determined by studies of fetal cells in the amniotic fluid. However, fewer than half of these potentially detectable defects have been successfully identified to date. (30) Antenatal diagnosis of human hemoglobin disorders cannot be made by amniocentesis; but development of procedures utilizing ultrasound and, more recently, the amnioscope and fetoscope to view the fetus in the womb, have resulted in the detection of sickle cell and Cooley's anemia (thalassemia). (31)

In addition to improving diagnostic accuracy, these new developments are adding important information to our store of knowledge about the onset and early pathology of genetic disease, as well as about the normal parameters of fetal biochemistry and development.

Amniography, fetoscopy and sonography have been employed recently to detect neural tube defects, including such serious structural abnormalities as anencephaly (the absence or near-absence of a cranial vault and cerebral hemispheres of the brain) and myelomeningocele (hernia of the spinal cord and surrounding membranes through a defect in the vertebral canal). (32) These techniques have also been successfully applied to the evaluation of fetal gastrointestinal lesions. (33) Use of ultrasound and radiographic aids to determine the respiratory movements and growth and development of the fetus should help in assigning accurate gestational age to the fetus, which may be critical in pregnancies where immaturity is suspected. (34) Further work is also required to determine the long-term effects on the fetus of amniocentesis, ultrasound applications and other diagnostic procedures.

Studies of fetal blood cells in maternal circulation offer great potential for fetal diagnosis through the selective isolation of fetal red and white blood or lymph cells derived from maternal blood or urine. (35) Knowledge of normal function of the heart and blood vessels during fetal development should lead to a greater understanding of congenital heart disease and, possibly, of heart disease manifested later in life. (36) Finally, research in the biochemistry of the developing fetus and of fetal-specific proteins have been mentioned as vital to the study of the aging process as well as the study and detection of certain cancers occurring in adulthood. (37)

Congress Ponders the Ethics of Human Research

By the late 1960s, congressional discussions began to reflect growing concern in scientific and other professional and lay circles over the potential impact on Individuals and society of milestone advances in medical technology involving human research. Serious congressional consideration of these problems began In 1968, when hearings were held on a measure introduced by Senator Walter F. Mondale (D.-Minn.) to establish a National Commission on Health Science and Society. (38) The Mondale measure (39) was intended to establish a short-term forum for the study and evaluation of new and prospective developments in medical research. In seven days of hearings, ethical problems involving heart and kidney transplants, medical devices and genetics research were discussed. Fetal research, however, was not mentioned." (40)

After three years in which no action was taken, the Senate in March 1971 unanimously approved a resolution calling for the establishment of the Mondale-sponsored commission. (41) However, the companion measure in the House of Representatives (42) was not considered during that session, and the legislation died.

Congressional interest in the human experimentation issue continued, however, and was kindled in the summer of 1972 by extensive media publicity about a U.S. Public Health Service study initiated in the 1930s of 400 black men from Tuskegee, Alabama, to determine the long-term effects of syphilis. (The men were not told whether or not they had syphilis and were not offered treatment -- even when an effective means of therapy became available after World War II.) Senator Jacob K. Javits (R.-N.Y.), who had authored landmark patient consent amendments to the Food, Drug and Cosmetics Act in 1962, (43) introduced a bill to provide safeguards for all human subjects of any future experimental research. (44) He recommended that DHEW establish a panel of experts to conduct an in-depth study of the ethical, social and legal implications of the Tuskegee experiments, and to determine the adequacy of existing NIH guidelines to safeguard the rights and welfare of human subjects of research.

Even as the debate in Congress burgeoned, in 1971 the NIH set up, without publicity, a special study group to review and recommend policies for the protection of human subjects in biomedical research. Following the revelations about the Tuskegee syphilis project, an ad hoc DHEW group was organized to investigate and report to Congress.

In November 1972, the Science Policy Division of the Library of Congress reported to a House committee: "Never before have the issues [ethical and medical, involved in biomedical research] been given such wide publicity or discussed so frankly as has been the case in recent months." (45) Although no relevant legislation was enacted in 1972, a coherent dialogue between legislators and scientists was taking shape; and there appeared to be every likelihood that there would be widespread public support for sound approaches to the issues. Notably, during this entire period, fetal research was not the subject of congressional debate.

The Supreme Court Decisions and Congress's Debate on Fetal Research

On January 3, 1973, the very day the new 93rd Congress convened for legislative business, the first of a string of bills designed to establish a commission on medical research on the Mondale model was introduced. (46) A month later, Senator Edward M. Kennedy (D.-Mass.) announced that his Subcommittee on Health would hold hearings on the rights of human subjects of biomedical and behavioral research. Javits, the subcommittee's ranking minority member, reintroduced his measure to strengthen informed consent guidelines and review procedures. He cited psychosurgery, organ transplants and genetic manipulation, as well as sterilization and brainwashing of criminals, as special areas of concern. (47) Senator Hubert H. Humphrey (D.-Minn.) introduced a bill calling for establishment of a national board on human experimentation standards. (48) In addition, Congress awaited a final report on the Tuskegee syphilis experiments from the DHEW ad hoc advisory panel.

When the Senate Health Subcommittee hearings convened on February 21, Kennedy stated: "It is our hope that these hearings will encourage continued support of and advancement of biomedical research ... [and] that they will encourage a closer look at the ethical and moral implications of what we have already done and will soon be able to do." (49) Twelve days of widely publicized hearings were dominated by discussion of informed consent for human experimentation. Testimony was heard on psychosurgery, the use of the poor and prisoners as research subjects, genetic engineering, the use of new surgical techniques, the sterilization of minors and the utilization of approved drugs in untested, unapproved therapies. (50) Fetal research was not specifically discussed.

While the Senate moved toward action to protect human subjects of experimentation, of which research on pregnant women and the fetus was just one minor part, the building concern of right-to-life groups over the Supreme Court's January 22 decisions on abortion was destined to give fetal research an unexpectedly prominent role in the congressional debate. By the early spring of 1973, opposition to the Supreme Court abortion decisions had begun to emerge among a small but vocal segment of Congress. Statements of disapproval were entered in the Congressional Record by several members, (51) and constitutional amendments were introduced in the House. and Senate to reverse the decisions. (52) These resolutions were routinely referred to the appropriate judiciary committees for consideration. Antiabortion congressmen soon sought additional legislative approaches to dramatize their opposition to the Supreme Court abortion decisions. (53) Prohibition of fetal research was perhaps an inevitable target: It fit in with the antiabortionists' position that the fetus was a person from the moment of conception, with a right to life and protection from harm; and the issue promised to provide plenty of the kind of dramatic examples that congressmen seek when arguing for a measure.

Representative Angelo D. RoncaHo (R.-N.Y.), a sponsor of several antiabortion resolutions and bills, was the first to introduce a measure to ban fetal research. Roncallo's bill provided criminal penalties of up to 20 years' imprisonment for carrying out research on a human fetus; and the same bill contained an explicit antiabortion provision banning outright "the killing or hastening the death of a human fetus" in any federally supported program. (54)

On April 12, 1973, the day before the Roncallo bill was introduced, about 200 persons gathered in an auditorium at the National Institutes of Health in Bethesda, Md. to protest any present or future use of live aborted human fetuses for scientific research purposes. The meeting was organized by students of the nearby Stone Ridge Country Day School of the Sacred Heart, a Roman Catholic school for girls, following the first public revelation that the NIH was considering new guidelines for human research, including fetal research. (55) The meeting occurred in an atmosphere heated by the recent Supreme Court abortion decisions. Only days before, the U.S. Catholic Conference had called for an amendment to the Constitution "protecting the life of the unborn." (56) The Stone Ridge protest drew a public pledge from the National Institutes' Deputy Director for Science that the NIH would not fund any research on "living" human fetuses. (57)

By mid-May, Roncallo had rounded up 24 cosponsors for his bill to jail fetal researchers; (58) at the same time, he introduced a measure prohibiting the use of any federal funds to "carry out or assist research on living human fetuses." (59)

On May 31, the House scheduled floor consideration of a major health bill designed to expand the national biomedical and behavioral research training program, but including a provision banning DHEW from conducting or supporting any research "which would violate ethical standards adopted by NIH. . .. (60)

Immediately following introductory comments on the research training measure, Roncallo rose to offer from the floor an amendment which would have prohibited "research in the United States or abroad on a human fetus which is outside the uterus of its mother and which has a beating heart." (61) Roncallo declared:

This is not an antiabortion bill. We are not concerned here with how this live human fetus gets to the operating table. All we say is, if I cannot live, let me die in peace. Do not cut tissue samples while I still have a heartbeat; do not stick tubes in me; do not artificially prolong my life when the decision has already been made that I cannot survive just to watch what happens, only to shut off the machine when we are done and watch me die. (62)

One congressman after another rose to support Roncallo's defense of the fetus, each tying his support to opposition to legal abortion. (*) "...Abortion, as we now know it, cannot be a license for the over-enthusiastic experimentation of research by any person," stated one member. (63) Another said: "I. .. am proud to say that this measure may well be the first breakthrough in this Congress for the most important 'Right to Life' principle. The highest court in our land, which... announces that the taking of a human life by abortion is legal, poses a problem as to the rights of all of us human beings. (64) "Ultimately we must restore the right to life to the unborn child. Today we have an opportunity to take a step in that direction," stated another. (65) Representative Harley O. Staggers (D.-W. Va.), Chairman of the Interstate and Foreign Commerce Committee and floor manager of the bill, and Representative Paul Rogers (D.-Fla.), Chairman of the Subcommittee on Public Health and Environment, with specific juris diction over DHEW-supported research, opposed singling out for condemnation a single research area which had already been declared unethical by official NIH policy. Stating that the bill was intended to halt unethical research of any kind, Rogers noted that the Senate had already begun hearings on the entire range of ethical issues in biomedical research. Recognizing that some members might find it politically difficult to vote against the Roncallo amendment, Rogers went on to state:

Rogers' plea for caution went unheeded. When the roll was called, the Roncallo amendment was passed overwhelmingly by a vote of 354 to 9.

The Senate hearings are not just on research on the fetus, but on all of these ethical problems such as research on prisoners, improper drug use, and on research being conducted on patients without their full knowledge of their risk. A whole range of problems is involved. That is the way the situation should be handled. (66)

After the landslide vote in favor of his "beating heart" amendment, Roncallo continued to use the same tactic--blurring the distinction between fetal research and abortion--to place other restrictions on fetal research. When, a month later, in late June, the House was considering the authorization of FY 1974 appropriations for the National Science Foundation (NSF), Roncallo offered an amendment to ban live fetal research in NSF projects, declaring that society should be "free from vivisection of its own living kind." (67) Although the amendment could have no practical effect, since there had never been an NSF project involving fetal research, the tactic worked. The House passed the Roncallo amendment by a vote of 288 to 73, just one day after adopting an antiabortion rider to the national legal services legislation. The vote was a far cry, however, from the 354-to-9 landslide by which the same body had adopted the beating heart amendment a month before. Some members, apparently, were beginning to react again st the precipitous adoption of such amendments made from the floor. A week later, the Senate without debate adopted the NSF legislation with the Roncall rider attached, (68) and shortly thereafter the bill became law. (69)(*)

The Kennedy Bills

In early June 1973, DHEW's ad hoc advisory committee on the Tuskegee syphilis experiments issued its final report, recommending that Congress establish a permanent body to regulate all federally supported research involving human subjects. (70) Soon thereafter, Kennedy, joined by several of his senatorial colleagues, (+) introduced two major bills regarding biomedical research. The first, the National Research Service Awards Act, (71) unlike its companion research training measure in the House, did not include a Roncallo-type heating heart rider. The second, the Protection of Human Subjects Act, (++) was the culmination of the Health Subcommittee's lengthy investigation of research involving human subjects. (72) The bill called for the creation of a permanent 11-member national commission to carry out a comprehensive review and study of all DHEW-supported research. The commission was, Kennedy said, to be given authority to develop and implement policies and regulations to ensure "that ethical principles becom e the foundation of biomedical and behavioral research involving human subjects," and to provide an open channel of communication with research institutions regarding the protection of human subjects of research. Kennedy added: "It has been our experience that good researchers do not fear, and in fact welcome appropriate oversight of the research process....It will in no way inhibit the growth of our necessary biomedical research activities." (73) Javits, a cosponsor of the bill, pointed to the need for flexible operating procedures adaptable to biomedical research needs. (74)

While Kennedy and his senatorial colleagues pressed forward with their research and training proposals, and Roncall and his House colleagues worked to tighten the noose around the neck of fetal research, DHEW proceeded to work on formulations of revised guidelines for research on human subjects. In July, The New York Times reported that several DHEW staff papers contemplated, as part of these revised guidelines, prohibition of research that prolonged the vital life functions of aborted nonviable fetuses, as well as of experiments on women contemplating abortion if these experiments could injure the fetus. (75) The Times story quoted DHEW Assistant Secretary Henry E. Simmons as promising that draft policies would be promulgated by DHEW within several months, and public comment invited.

In September 1973, the Kennedy bills on research training and protection of human subjects were modified, combined into a single bill and scheduled for floor consideration. Various amendments concerning psychosurgery, confidentiality of records and the makeup of the proposed commission's membership were offered and accepted. At this point, Senator James L. Buckley (R.-N.Y.), backed by seven co-sponsors, (ss) rose to offer a version of Roncallo's beating heart amendment to the Senate bill. Buckley's amendment barred DHEW from the "conduct or support [of] research or experimentation...on a living human fetus or infant, whether before or after induced abortion, unless...for the purpose of ensuring the survival of that fetus or infant." (76)

Pointing to the adoption of a similar amendment in the House, Buckley argued that all fetal research involved with abortions should be banned, whether or not the pregnant woman consented, because "the mother has already consented to the killing of her unborn offspring and [thus] she has already abrogated any right she might otherwise have to consent to any medical procedure to be performed on her child...[and] nothing...requires us to say that these poor children, so callously condemned to die by their mothers, must also become human guinea pigs." (77)

Kennedy acknowledged the complexity of the consent issue, but stated that the Buckley proposal would be likely to impede necessary research on genetic disease, mental retardation and other vital health areas. He added that such provisions should not be drawn up precipitously on the Senate floor, but should be made by a commission that "can get the people dealing with theology, religion, medicine and research to sit down and spend hours and days thinking about these various problems." (78)

Seeking to accommodate their differences, Kennedy suggested an alternative whereby there would be a temporary moratorium on fetal research "before or after induced abortion" until after the proposed commission had developed policies on such research. (79) Buckley refused to accept this solution, because he believed it implied tacit approval of such research. The Kennedy compromise (**) nevertheless passed on a roll call vote, 53 to 35, following which the Senate passed the modified bill. (80)

Due to differences between the House and Senate bills on the duration, composition and responsibilities of the commission, and to opposition from the administration, the measure was not enacted during 1973. It remained stalled in joint conference until June 1974 while conferees sorted out their differences on the commission, and attempted to resolve the conflict between the House-passed prohibition on fetal research and the Senate-passed moratorium. A compromise was finally effected, and a final bill, entitled the National Research Act, emerged. The National Commission for the Protection of Human Subjects was given a two-year term instead of permanent status, but was to be replaced at the end of that time by a permanent council; it was given advisory status, rather than regulatory authority; and the Commission members were to be appointed by the DREW Secretary rather than by the President.

The final bill required the Commission to make a report to the Secretary of DREW by May 1 recommending future department policy on fetal research; until the Commission made its recommendations, studies were prohibited in projects operated or supported by DREW that involved research on the "living human fetus, before or after abortion," unless to assure the survival of that particular fetus. (81) This prohibition, which is still in effect, has resulted in misunderstanding and acrimony among scientists and laymen alike.

DHEW Fetal Research Policies

In the course of the Congress' consideration of the Kennedy bills in 1973, and following adoption of the National Research Act in 1974, DREW issued and continued to publish revisions of its proposed policy on the protection of human subjects. In October 1973, DREW issued guidelines which simply set forth the principle that in all human research any "risks to an individual are outweighed by the potential benefits to him or by the importance of the knowledge to be gained, and that informed consent is to be obtained by methods that are adequate and appropriate. ("82) This was followed in November by the long-awaited detailed recommendations of the special NIH study group. (83) The November study document contained detailed recommendations involving research on children, the abortus, the fetus in the womb, the products of in vitro fertilization, prisoners and the mentally infirm. With regard to the fetus, the study group proposed that "no experimental procedures entailing risk to the fetus be undertaken in antici pation of abortion";(84) "the consent of both parents must be obtained for any research involving the fetus";(85) and "the maintenance of heartbeat or respiration artificially in the abortus for the purpose of research" should be barred," as should procedures to terminate heartbeat or respiration. (87)

In August 1974, following adoption of the National Research Act, DHEW published revised policy guidelines indicating that, of more than 400 letters received concerning its proposed rules on research with children, "the majority... touched on... research with fetuses, abortuses, and pregnant women."(88) The department rejected the contention of a "large number of respondents" that all such research be discontinued if it endangered the fetus, insisting that such a ban "would seriously hamper the development of needed improvements in the health care of the pregnant woman, the fetus, and the newborn."

"Viability" was defined in the proposed rules to be "a function of technological advance." Current technology, the department stated, required that a fetus be able "after either spontaneous or induced delivery to survive.., to the point of independently maintaining heartbeat and respiration." Such a viable fetus would be considered a premature infant."

In an important revision of its earlier proposal, the department stated that it would "permit research to be undertaken from which there will be risk of harm to the [previable or nonviable] fetus if such research is conducted as part of the abortion procedure ... in the expectation that such research may produce new technology which will enable countless premature infants to live who now cannot. ("90)

The department indicated that the broadened proposal was meant to safeguard the pregnant woman's right to change her mind about the abortion, since the research would not begin until the abortion procedure commenced. The earlier proposal to ban artificial maintenance of any of the vital functions of an abortus for research purposes was broadened to say "except where the purpose. . . is to develop new methods for enabling the abortus to survive to the point of viability." The prohibition against experimental procedures which would terminate heartbeat or respiration was continued. (91)

Since the National Research Act forbids DREW involvement in any "live" fetal research before or after abortion until the National Commission has made its recommendations, the proposed DHEW policies have no effect at the present time.

State Laws

Antiabortionist pressure to ban fetal research was not restricted to the federal level. At least 15 states passed laws restricting fetal research following the Supreme Court's 1973 abortion decisions. (92) In most of these states, considerable ambiguity exists as to what constitutes permissible and illegal action. Maine, for example, prohibits all live fetal research, in utero or on the abortus, even, apparently, to preserve fetal life or health. Louisiana, Minnesota and Missouri virtually restrict such research to preserving the life or health of the particular fetus. South Dakota merely requires consent of the pregnant woman. Massachusetts (where Kenneth Edelin was recently convicted of manslaughter as the result of a late abortion he performed, and where four doctors await trial on grave robbing charges for performing autopsies on dead abortuses) is the only state where a law was negotiated (in June 1974) between right-to-life advocates, scientists, legislators and ethicists. The Massachusetts law, as orig inally drafted, prohibited all research on fetuses, alive or dead, inside or outside the womb, which were the subjects of planned abortions. In the final law, research on a dead abortus is permissible with the mother's consent; diagnostic or remedial procedures in utero are permitted to determine or preserve the life or health of the fetus or pregnant woman; and in utero studies are permitted with the mother's consent even if the fetus is subsequently aborted, provided the pregnant woman states that she did not plan an abortion at the time of the study.

This would seem to testify to the possibility of attaining a reasonable fetal research law, providing that the various interested parties sit down and negotiate a compromise. However, the Edelin conviction, the grave robbing indictments, and the very fact that violation of the fetal research law constitutes a felony, have generated an atmosphere in Massachusetts in which it has not been possible to do any experimental fetal research. Many doctors refuse even to do diagnostic amniocentesis, and at least one cancer research project involving use of dead fetal tissue has been dropped because of fears and uncertainties about the law. Ironically, two scientists who helped negotiate the law's compromise language have been unable to continue their research in amnioscopy to diagnose sickle cell and Cooley's anemia. (93)

A total of seven states(*) have restricted research involving the fetus in utero, and 14 states (*) have enacted restrictions on research involving the abortus. The latter laws are especially vague: Nebraska, Kentucky, Louisiana, Montana and Pennsylvania ban research on "live" or "viable" fetuses only; and Indiana, Illinois and Ohio make exceptions only for pathological examination of the aborted fetus. The hasty nature of the bans which have been enacted reflects the political situation in the states with regard to the abortion issue, and parallels the manner in which the Congress handled the issue of fetal research. (94)

What's So Bad About Doing Good?

If fetal research has placed us at the threshold of important new advances in improving the health and well-being of mothers and their offspring, why are so many people trying to stop it? Undoubtedly, part of the present controversy stems from broad, unresolved questions that have arisen only relatively recently concerning all biomedical and behavioral research. These include a lack of agreement about what constitutes research; that is, the inadequacy of current definitions as to what is "experimental" as distinct from "treatment." In addition, a heightened sensitivity to the rights of the patient in both research and routine medical practice has led to consideration of what constitutes adequate disclosure and explanation of the procedure involved.

For example, in discussing recent press reports of spinal taps performed on 43 healthy premature babies without parental knowledge or consent between 1956 and 1965 as part of a research project at two New York hospitals, Robert C. Backus, acting chief of a new Office for Protection from Research Risks at the NIH, pointed out:

Today everyone would regard [such experiments] as unethical. But 10, 15 years ago, that wasn't the case. Doctors quite sincerely believed that they knew what was best and were doing what was best. Now they are more aware that patients have the right to make their own decisions. (95)

The concept of informed, voluntary patient consent was not reflected in federal laws until the early 1960s, when statutes were written to protect individuals participating in drug trials. (96) Now such consent is generally viewed as an essential component of all general clinical and prescribing practices, although it is also recognized that there are practical limitations which make fully informed consent difficult, if not impossible, in many instances. Finally, in our pluralistic society, experts on medical, legal and ethical issues have not arrived at a consensus to define when human life begins, or even what constitutes death. As polio research pioneer Albert B. Sabin remarked recently:"... the real question is not when does life begin or end but rather what marks the beginning and the end of a living human being .... there is a marked difference between human cellular, visceral and biological death." (97)

The question of informed consent is a difficult one, even with regard to adult subjects. Because children differ from adults in their physiologic responses to drugs and to disease, it is necessary to know the nature and extent of these differences, and to understand fully what constitutes normal patterns of growth, metabolism and biochemistry at each stage of development, if children's health is to be improved. Therefore, it is generally agreed that research involving children is necessary for the benefit of society as a whole. The capacity of children to give truly informed consent is limited and, at early ages, impossible. So society has recognized the need for protections to assure that scientific importance is weighed against other values in determining acceptable risk. In the case of research which might involve a risk without clear therapeutic benefit to the individual child, DHEW has proposed that, in addition to informed parental consent, there be a variety of specific institutional review safeguards . For children over the age of seven, consent

of the child would also be obtained. (98) The same types of policy considerations and safeguards which are available to children in research could be extended to fetuses which are intended to be brought to term by the mother and are, therefore, expected to be born as viable, healthy infants.

Many such research problems involving human subjects are further complicated in the case of fetal research. Amniocentesis, for example, a technique which is now in clinical use for fetal diagnosis, is no longer considered experimental. Yet its immediate and long-term safety and efficacy for the fetus is the subject of continued investigation. (+) Obviously, the procedure affects the woman requesting it as well as the fetus; only the woman, however, can provide consent. Although parents or guardians are considered legally competent to give informed consent on behalf of a child for routine therapeutic procedures, it is generally recognized that additional institutional protections must supplement parental consent in experimental procedures which may or may not result in direct therapeutic benefit to that child. In the case of fetal research, some individuals contend that a pregnant woman who is considering an abortion has abrogated her interest in the fetus, and, therefore, her right to consent on its behalf.

A more complex question involves the considerations that should be accorded to a fetus when the pregnant woman plans to terminate her pregnancy by abortion. Monsignor James T. McHugh has argued for the U.S. Catholic Conference that consent of a woman who had decided on abortion "is a mockery [because she has] already decided on the death of the fetus." (99) The government, he insists, must supplant the mother as guardian of the fetus and make sure that no experimental procedures be undertaken unless they are to ensure the survival of the fetus. Others have argued forcefully that the decision to abort does not imply lack of concern for the fetus or, certainly, for future benefits which might be derived for others from such research. (100) The Mahoney study group, in its analysis for the National Commission of ethical issues involved in fetal research, stated: "...the mother may continue to be the best advocate [for the fetus] even in the setting of elective abortion. It is our experience that the mother conti nues to consider the welfare of her fetus during abortion and afterward." (101)

The indictment of four Boston physicians for allegedly performing unauthorized autopsies on aborted fetuses, in violation of an 1814 Massachusetts grave robbing statute, dramatizes the difficulties inherent in the abortion situation and in the consent issue. The doctors were investigating the efficacy of common antibiotics in treating the pregnant woman, and the extent to which these drugs crossed the placental barrier and reached the fetus. In order to avoid any possible risk to a fetus which would be carried to term, the investigators limited their study to women who intended to have an induced abortion. In the prosecutor's interpretation of the case, the defendants did not have legal authority to examine the fetuses used in their study without express consent of each woman, although each woman had given written consent to participation in the study. Express permission for autopsy was not sought since it was not then general hospital practice to obtain consent for postabortion examination of fetal material , and, in fact, if the fetuses had not been employed in the experiment, they would have been routinely discarded. (102)

There is a further consideration involving research which may directly or indirectly infringe upon a woman's decision to have an abortion. Harvard's David G. Nathan, whose research in fetoscopy has resulted in prenatal diagnosis of sickle cell disease and Cooley's anemia, has urged that no research procedure be permitted which might damage the fetus, since such research could seriously affect a pregnant woman's decision about whether to proceed with the abortion. (103) He notes that this situation could only occur if the research procedure were conducted somewhat in advance of the scheduled abortion, during which time the pregnant woman's option to change her mind would be compromised. This view would require that the fetus scheduled for abortion be accorded the same protections as the fetus to be carried to term. As noted earlier, DHEW has proposed in its draft policy that such research be limited to the period after the commencement of the abortion procedure itself. (104) If taken literally, such a proviso would seriously limit the kinds of research which would be permissible, since a suction procedure takes only a few minutes. Few women who have decided on abortion are likely to change their minds--especially if their decision is prompted by knowledge that their fetus is afflicted with a serious hereditary disease. In such cases, since the opportunity to conduct highly valuable research is extremely limited, it may reasonably be argued that it is appropriate to weigh the benefits to society that could result from research on a fetus where abortion is contemplated. These potential benefits are large, according to the Mahoney study group, which recommended: "Experimentation in anticipation of abortion or in process of abortion should not be categorically prohibited but...should be assessed in terms of risk to the fetus as well as risk to the mother." The study group pointed out: "imminent death does not automatically exclude participation of children or adults from medical research." (105)

Research on fetuses or on fetal tissues or organs after spontaneous or induced abortion is complicated by the various definitions of "life" and "viability" which have been propounded by lawyers, scientists, ethicists and politicians. Most persons would agree that once a fetus is capable of independent continued survival outside its mother's womb, it is no longer a fetus, but an Infant, and entitled to all the protections accorded a child. What constitutes such capability--generally referred to as viability--is related to the state of technology and to its availability.

According to a report presented to the National Commission by Richard E. Behrman, chairman of pediatrics at Columbia's College of Physicians and Surgeons, a fetus weighing less than 601 grams and/or of 24 weeks' or less gestational age is not viable even if it shows signs of life outside the mother's womb. The Behrman and Mahoney reports agree that nontherapeutic experimentation should be limited to fetuses that are below the possible limit of viability at any given time. The Behrman report suggests 22 weeks' (106) gestation and the Mahoney report, 20 weeks'. (107) There is little disagreement that research designed to save the life of a viable fetus is desirable -- even though the techniques used to aid the fetus are so new that they must be considered experimental.

A large proportion of fetal research involves examination and culture of fetal cells and tissues, placental material, fetal fluids, and organs obtained from the dead fetus. This type of fetal research is considered the least controversial, since it is acknowledged to be highly valuable and presents no risk to a living fetus. However, the moratorium has halted most such research because of confusion about the definition of fetal death, and because much of the fetal material previously available came from induced abortions. The Mahoney report strongly recommends that the definition of death "focus on the whole organism." It warns that delay in making tissue available would make impossible such important work as examination of brain ultrastructure and metabolism, transplantation of tissues and recovery of some viruses. (108)

Andre E. Hellegers, director of the Kennedy Institute for the Study of Human Reproduction and Bioethics, has observed that the dead aborted fetus may be likened to the dead unclaimed child or adult. (109) The Mahoney report agrees: "We consider that the fetus which is clearly dead after delivery should be viewed as any other dead human being. Legal regulations and ethical constraints on the handling of the deceased human being should be applicable to the dead fetus. These should permit removal of still living tissues or organs for biomedical research and therapy functions." (110) And in a report to the National Commission on legal aspects of fetal research, John P. Wilson, Associate Dean of Boston University Law School, points out that under the Uniform Anatomic Gift Act "a parent may donate the body of a deceased child (including a fetus) for the purposes of research." (111)

Perhaps the most controversial area of fetal research involves the nonviable fetus which displays some signs of life outside the womb. The Mahoney study found very little such research reported or proposed. It pointed out, however, that such research can be very important to fetuses as a class. As an example, It cited efforts to develop an artificial womb by replacing the many functions of the maternal placenta. In such circumstances, the report stated, the previable fetus may be compared to an adult with a disease or physiological derangement which renders that person unable to continue life because a technological solution to the problem does not exist. The impending death of the adult would not deprive that person of certain protections as a possible experimental subject nor would it exclude the individual as a possible subject. The patient would presumably consent, or an advocate would consent, only to those procedures which sought important information, unobtainable in any other way, with minimal risk. These same guidelines should be applied to the previable fetus outside the uterus. (112)

Acknowledging that the prceedural safeguards instituted by NIH to protect subjects of experimentation "have a short history," the Mahoney group observed that our review of fetal research suggests that the system has worked well and that the number of ethically questionable studies is a miniscule part of the whole. Even in those few instances, the projects have been discontinued in this country." Pointing to "... the dangers of a policy resulting from political pressures rather than reasoned ethical consideration of all relevant data," the study group advised that "the final policy recommended by the Commission be one which includes an ample exposition of the many legal, ethical, and medical issues, but which mandates only a vigorous review process rather than specific restrictions." (113)

In light of the sharp disagreements which have surfaced, it remains to be seen whether a strengthened review process will satisfy the Commission or Congress.

Where Do We Go From Here?

The recent adoption of the fetal research issue by right-to-life groups is a logical extension of their belief that the fetus is a 'person', endowed from the moment of conception with basic constitutional rights; it results as well from their perception of the political support which the fetal research issue can bring to their antiabortion drive.

Thus, if a fetus is a person, it must, in the course of research, be accorded the same civil and constitutional protections from harm as living children and adults; that is, whatever controls are imposed upon research involving persons, in the legal sense, must also be applied to fetuses. The point at which right-to-life groups draw the line against fetal research is determined, however, by their opposition to abortion. The failure of right-to-life groups to participate In the broader issues relating to the protection of research subjects, as well as their failure to evidence concern about fetal research during the decade before eruption of the abortion controversy (when the major fetal research developments occurred), underscores the political nature of their present battle against fetal research. For tactical reasons, in the same way that they construe abortion as murder, the antiabortion groups charge fetal research is reckless experimentation, or torture.

There is little evidence that national debate on abortion will become less emotional in the near future. Yet as Columbia's Richard E. Behrman observed recently: "Society's judgments on fetal research should not be dominated by special interest groups organized for the political process." (114) Similarly, the Mahoney study group concluded that "... in a pluralistic democracy there must legitimately exist different views of the human individual and the nature of humanness and personhood." While no person should be pressured into participating In research he or she considers unethical, the study group said, "the view of one segment of our population should not dictate the activities of other large segments of the population as long as fundamental human rights are preserved." (115)

The National Commission held one public hearing on February 14 at which 25 scientists, physicians, civil libertarians, women's rights advocates and right-to-life representatives testified. Not one of the six individuals and organizations, including the U.S. Catholic Conference, who testified against live fetal research actually opposed all such research. Indeed, each of them supported a broad range of experimental fetal research techniques--only if, however, they were to be used exclusively for the therapeutic benefit of the fetus, or involved no possible risk. Acceptance of this position requires the prohibition of all research, regardless of the stringency of the safeguards or its value to society, if it presents any risk to the fetus. Since research involving some risk and promising great social benefit is not categorically barred for children, adoption of such a policy would place the fetus at any stage of development in a privileged position in regard to infants, children and adults. While there was gen eral agreement at the Commission hearing that the researcher who uses fetal material derived from induced abortion should not perform the abortion, there remained considerable disagreement concerning the adequacy of consent by the pregnant woman on behalf of the fetus.

The task before the Commission, and indeed our entire society, is an extremely difficult one. As the National Commission's executive director, Charles Lowe, observed: "We as a nation have tried to avoid legislating moral issues. If we are now set on a course indirectly to 'regulate' ethics, then surely this in itself is a major national experiment." (116)

Whatever the immediate outcome, the future of biomedical research is not necessarily jeopardized because society is talking about it, or because we are assessing where we are and where we should go. Yet the views of risks and benefits of research which have currency with medicine and science do, in fact, stand quite apart from the views held by the general public. Scientists need to give considerably more recognition than they have up to now to the factors that have caused this disparity. Because the public tends to extrapolate from specific if atypical abuses to characterize science as a whole, "it is necessary," points out Harvard surgery professor Francis Moore, "for us to understand how science is perceived." (117) In other words, in a situation where the public has been stirred up by fetal research horror stories --however distorted--of scientists who have decapitated 'babies' for research purposes, it is not enough for the scientists to respond indignantly that their research efforts must not be handcu ffed by political restrictions. The reports from the Behrman and Mahoney groups and from Battelle, although necessarily put together in some haste to meet the Commission's May 1 deadline, are remarkable for their openness, responsiveness, and scientific and community responsibility. It may be hoped that they presage an era when fetal research may be discussed openly and performed ethically. Until and unless that occurs, it is the children who will suffer.

Diana S. Hart is Policy Analyst with The Alan Guttmacher Institute in Washington, D.C. The author acknowledges the research assistance of Sue Sederstrom, Institute intern from Lewis and Clark College.

(*.) John Kenneth Ryan, Chairman of the Department of Obstetrics and Gynecology at Harvard Medical School, is chairman. Other members are: Joseph V. Brady, Professor of Behavioral Biology, School of Medicine, Johns Hopkins University; Robert E. Cooke, Vice Chancellor for Health Sciences, University of Wisconsin; Dorothy S. Height, President, National Council of Negro Women; Albert R. Jonsen, S.J., Adjunct Associate Professor of Bioethics, School of Medicine, University of California; Patricia King, Professor of Law, Georgetown University Law Center; Karen A. Lebacqz, Assistant Professor of Christian Ethics, Pacific School of Religion; David W. Louisell, Professor of Law, University of California at Berkeley; Donald Wayne Seldin, Chairman, Department of Internal Medicine, University of Texas Southwestern Medical School; Eliot Stellar, Provost of the University and Professor of Physiological Psychology, University of Pennsylvania; and Robert H. Turtle, Washington, D.C., attorney.

(*.) Fourteen Congressmen rose to speak in support of the Roncallo amendment: Representatives J. William Stanton (R.-Ohio); Frank E. Denholm (D.-S.) Dak.); John N. Erlenborn (R.Ill.); John W. Wydler (R.-N.Y.); William F. Walsh (R.-N.Y.); H. John Heinz III (R.-Pa.); Hugh L. Carey (D.-N.Y.); Romano L. Mazzoli (D.-Ky.); Bill Frenzel (R.-Minn.); Elwood Hills (R.-Ind.); Gene Snyder (R.-Ky.); Jack F. Kemp (R.-N.Y.); Tennyson Guyer (R.-Ohio); and Lawrence J. Hogan (R.-Md.). (See: Congressional Record, May 31, 1973, pp. H.4167-H.4174.)

(*.) Roncallo succeeded in attaching an identical amendment to the NSF FY 1975 appropriations bill in the House; but the amendment was dropped in conference as "unnecessary." (See: "National Science Foundation, Authorization Act, Conference Report," Congressional Record, Aug. 19, 1974, pp. S.15280-S.15283.)

(+.) Jacob K. Javits (R.-N.Y.); J. Glenn Beall, Jr. (R.-Md.); Alan Cranston (D.-Calif.); Peter H. Dominick (R.-Colo.); William D. Hathaway (D.-Maine); Harold E. Hughes (D.-Iowa); Claiborne Pell (D.-R.I.); Jennings Randolph (D.-W.Va.); Richard S. Schweiker (R.-Pa.); and Harrison Williams (D.-N.J.).

(++.) Cosponsored by javits, Hathaway, Fell and Randolph.

(ss.) The cosponsors were: Mark O. Hatfield (R.-Oreg.); Dewey F. Bartlett (R.-Okla.); Harold E. Hughes (D.-Iowa); Carl T. Curtis (R.-Nebr.); Jesse Helms (R.-N.C.); William V. Roth, Jr. (R.-Del.); and Robert Dole (R.-Kans.).

(**.) Explaining his view of the Senate's adoption of the moratorium on fetal research in a December 2. 1974 speech at Yale University Medical Center, Kennedy said: "I have opposed, and...will always oppose, uninformed legislative attempts to prohibit specific research activities....During the enactment of the National Research Act this past year, amendments were offered...to ban...fetal research....I persuaded my colleagues to...change the ban on fetal research from permanent to temporary....The temporary ban passed narrowly. Had it failed...we would today have a politically Imposed ban on a portion of fetal research in this country."

(*.)Louisiana, Maine, Massachusetts, Minnesota, Missouri, South Dakota and Utah.

(*.) California, Illinois, Indiana, Kentucky, Louisiana, Maine, Massachusetts, Minnesota, Missouri, Montana, Nebraska, Ohio, Pennsylvania and South Dakota.

(+.) The Johns Hopkins University is currently compiling a "National Amniocentesis Registry," under contract with the National Institute of Child Health and Human Development.

References

(1.) Battelle Columbus Laboratories, "Final Report on an Assessment of the Role of Research Involving Living Human Fetuses In Advances in Medical Science and Technology to National Commission for the Protection of Human Subjects," March 14, 1975, P.68 (mimeo).

(2.) P. Handler, "On the state of Man," lecture presented at the Annual Convocation of Markle Scholars, The Homestead, Virginia, Sept. 29, 1974.

(3.) Special Analyses, Budget of the United States Government, FY 1975, U.S. Government Printing Office, Washington, D.C. (GPO), 1974, p. 140.

(4.) Department of Health, Education and Welfare (DHEW), National Institutes of Health Almanac 1974, DHEW Publication No. 74-5, GPO 1974, p. 112.

(5.) M. J. Mahoney, "Report to National Commission for the Protection of Human Subjects," March 14, 1975, p.30 (mimeo).

(6.) M. J. Mahoney, presentation before National Commission for the Protection of Human Subjects, Bethesda, Md., Feb. 15, 1975.

(7.) C. Mooney, testimony for Pregnancy Aid Centers before National Commission for the Protection of Human Subjects, Bethesda, Md., Feb. 14, 1975; and Sen. D. F. Bartlett (R.-Okla.), "The Difficult Issue of Abortion," Congressional Record, Feb. 20, 1975, p. S.2300.

(8.) S. Gard, "1954 Nobel Presentation Speech," Nobel Lectures: Physiology and Medicine, 1942-1962, American Elsevier, New York, 1964, p.443.

(9.) J. F. Enders, "Fetal Experimentation," New England Journal of Medicine, 290:1199, 1974.

(10.) E. Chapman, "Collection of Radioactive Iodine by the Human Fetal Thyroid," Journal of Clinical Endocrinology, 8:717, 1948.

(11.) M. Mahoney, Mar. 14, 1975, op. cit., p.27.

(12.) T. K. Oliver, testimony for the Association of American Medical Colleges before National Commission for the Protection of Human Subjects, Bethesda, Md., Feb, 14, 1975.

(13.) C. A. Alford, Jr., "Experiments and Research with Humans: Values In Conflict," paper presented before the National Academy of Sciences Forum, Washington, D.C. (NAS Forum), Feb. 18, 1975.

(14.) R. B. Jaffe, paper presented before NAS Forum, Feb. 18, 1975.

(15.) M. Mahoney, Mar. 14, 1975, op. cit., p.39.

(16.) S. J. Yaffe, testimony before National Commission for the Protection of Human Subjects, Bethesda, Md., Feb. 14, 1975.

(17.) Battelle Columbus Laboratories, March 14, 1975, op. cit., p. 82.

(18.) Ibid., pp. 1-2.

(19.) Ibid., pp. 52-54.

(20.) G. C. Liggins and R. N. Howie, "A Controlled Trial of Antepartum Glucocorticoid Treatment for Prevention of RDS In Premature Infants," Pediatrics, 50:515, 1972.

(21.) Battelle Columbus Laboratories, 1975, op. cit., p.2.

(22.) Ibid. ,p. 14.

(23.) Ibid., pp. 22-23.

(24.) R. E. Behrman and T. S. Rosen, "Report to National Commission for the Protection of Human Subjects," March 1975, p.38 (mimeo).

(25.) R. B. Jaffe, 1975, op. cit.; and M. J. Mahoney, March 14,1975, op. cit., p. 14.

(26.) J. F. Enders, 1974, op. cit.

(27.) W. L. Herrmann, testimony before National Commission for the Protection of Human Subjects, Bethesda, Md., Feb. 14, 1975.

(28.) M. Mahoney, Mar. 14,1975, op. cit., p.30.

(29.) R. B. Jaffe, 1975, op. cit.

(30.) M. M. Kaback, J. T. Leisti and M. D. Levine, "Prenatal Genetic Diagnosis," in L. Gardner, ed., Endocrine and Genetic Diseases of Childhood, 2nd edition, W. B. Saunders, Philadelphia, 1975 (in press).

(31.) D. G. Nathan, testimony before National Commission for the Protection of Human Subjects, Bethesda, Md., Feb. 14, 1975.

(32.) D. J. H. Brock, A. E. Bolton and J. M. Monaghan, "Prenatal Diagnosis of Anencephaly Through Maternal Serum-Alphafetoprotein Measurement," The Lancet, II:923, 1973; and R. Harris, R. F. Jennison, A. J. Barson, K. M. Laurence, E. Ruoslahti and M. Seppala, "Comparison of Amniotic Fluid and Maternal Serum AlphaFetoprotein Levels in the Early Antenatal Diagnosis of Spina Bifida and Anencephaly, The Lancet, I:429, 1974.

(33.) M. Mahoney, Mar. 14, 1975, op. cit., p.6.

(34.) W. J. Garrett and D. E. Robinson, "Assessment of Fetal Size and Growth Rate by Ultrasonic Echoscopy," Obstetrics and Gynecology, 38:525, 1971; W. J. Garrett, D. Phil and D. E. Robinson, "Fetal Heart Size Measured in Vivo by Ultrasound," Pediatrics, 46:25, 1970; and I. Donald, "New Problems in Sonar Diagnosis in Obstetrics and Gynecology," American Journal of Obstetrics and Gynecology, 118:299,1974.

(35.) J. Walknowska, F. A. Conte and M. M. Grumbach, "Practical and Theoretical Implications of Fetal/Maternal Lymphocyte Transfer," The Lancet, I:1119,1969.

(36.) R. B. Jaffe, 1975, op. cit.

(37.) M. Mahoney, Mar. 14, 1975, op. cit., p.37.

(38.) Subcommittee on Government Research, Committee on Government Operations, U.S. Senate, "Hearings on the National Commission on Health Science and Society," 90th Congress, 2nd Session, March 7,8,21,22,27,28; April 2, 1968.

(39.) S. J. Res. 145, Congressional Record, Feb. 8, 1968, p. S.2607.

(40.) Subcommittee on Government Research, 1968, op. cit.

(41.) S.J. Res. 75, Congressional Record, March 24, 1971, pp. S.7669-S.7678.

(42.) T. S. Foley, H.R. 8279, Congressional Record, May 11, 1971, p. H.14520.

(43.) P.L. 87-781, Oct. 10, 1962.

(44.) J. K. Javits, S.3935, Congressional Record, Aug. 17, 1972, p. S.28651.

(45.) Science Policy Division, Congressional Research Service, Library of Congress, "Genetic Engineering, Evolution of a Technological Issue," report to the Subcommittee on Science, Research and Development, House Committee on Science and Astronautics, Nov. 8, 1972, p.40.

(46.) E. R. Roybal, H.R. 1111, Congressional Record, Jan. 6, 1975, p. H.88.

(47.) J. K. Javits, S.878, Congressional Record, Feb. 15, 1973, pp. S.2250-S.2252.

(48.) H. H. Humphrey, S.394, Congressional Record, Feb. 21, 1973, pp. S.4788-S.4790.

(49.) "Quality of Health Care--Human Experimentation, 1973," hearings before the Subcommittee on Health, Committee on Labor and Public Welfare, U.S. Senate, 93rd Congress, 1st Session, Feb. 21, 1973, p.2.

(50.) Committee on Labor and Public Welfare, U.S. Senate, "Report No. 93-381, National Research Service Awards Act," 93rd Congress, 1st Session, Aug. 3, 1973.

(51. J. L. Buckley, Congressional Record, Feb. 1, 1973, p. S.1862; J. N. Erlenborn, Congressional Record, Feb. 21, 1973, pp. H.933-H.934; and L. J. Hogan, Congressional Record, March 5, 1973, pp. H.1260-H.1263.

(52.) L. J. Hogan, H.J. Res. 261, Congressional Record, Jan. 30, 1973, p. H.585; G. W. White-hurst, H.J. Res. 427, Congressional Record, March 13, 1973, p. H.1717; and J. L. Buckley, S.J. Res 119, Congressional Record, May 31, 1973, p. S.10005.

(53.) M. Heckler, H.R. 4797, Congressional Record, Feb. 27, 1973, p. H.1197; reintroduced as H.R. 5708 and 5709, Congressional Record, March 15, 1973, p. H.1848; reintroduced as H.R. 6445, Congressional Record, April 2, 1973, p. H.2646.

(54.) A. D. Roncallo, H.R. 6849, Congressional Record, April 11, 1973, p. H.2646.

(55.) V. Cohn, "Live Fetus Research Debated," Washington Post, April 10, 1973, p. 1.

(56.) J. T. McHugh, "Catholic Officials Score Proposals on Experimentation with Fetuses," press release, U.S. Catholic Conference, April 10, 1973.

(57.) R. Berliner, quoted in H. M. Schmeck, Jr., "Health Agencies Ponder Research on Human Ethics," The New York Times, April 13, 1973, p. 20.

(58.) A. D. Roncallo et al., H.R. 7725, Congressional Record, May 10, 1973, p. H.3623.

(59.) A. D. Roncallo, H.R. 7850, Congressional Record, May 15, 1973, p. H.3692.

(60.) H.R. 7724, "National Biomedical Research Fellowship, Traineeship, and Training Act of 1973," Congressional Record, May 10, 1973, p. H.3623; and Committee on Interstate and Foreign Commerce, U.S. House of Representatives, "Report No. 93-224 to Accompany H.R. 7724," 93rd on Congress, 1st Session, May 23, 1973, pp. 11-12.

(61.) A. D. Roncallo, Congressional Record, May 31, 1973, pp. H.4166-H.4167.

(62.) Ibid.

(63.) F. E. Denholm, Congressional Record, May 31, 1973, p. H.4167.

(64.) T. Guyer, Congressional Record, May 31, 1973, p. H.4172.

(65.) L. J. Hogan, Congressional Record, May 31, 1973, p. H.4174.

(66.) P. Rogers, Congressional Record, May 31, 1973, p. H.4173.

(67.) A. D. Roncallo, Congressional Record, June 22, 1973, pp. H.5181-H. 5182.

(68.) Congressional Record, June 29, 1973, pp. S.12458-S.12460.

(69.) P.L. 93-96, Aug. 16, 1973.

(70.) DHEW, "Final Report of the Tuskegee Syphilis Study Ad Hoc Advisory Panel," April 28, 1973, pp. 39-42.

(71.) S.2071, Congressional Record, June 26, 1973, p. S.11952.

(72.) S.2072, Congressional Record, June 26, 1973, P. S.11955.

(73.) Ibid., p. S.11953.

(74.) Ibid., p. S.11954.

(75.) H. M. Schmeck, Jr., "Health Agency Report Proposes Limits on Fetal Experiments," The New York Times, July 16, 1973, p. 12.

(76.) J. L. Buckley et al., Congressional Record, Sept. 11, 1973, pp. S.16344-S.16345.

(77.) Ibid., pp. S.16344-S.16348.

(78.) Ibid., pp. S.16348-S.16349.

(79.) Ibid., pp. S.16350-S.16352.

(80.) Ibid.

(81.) U.S. House of Representatives, "Conference Report on H.R. 7724, National Research Act," Report No. 93-1148, June 25, 1974; and P.L. 93-348, July 12, 1974, Sec. 202(b) and Sec. 213.

(82.) Federal Register, 38:27882, Sec. 46.2(b), Oct. 9, 1973.

(83.) Federal Register, 38:31738-31749, Nov. 16, 1973.

(84.) Federal Register, 38:31742, Nov. 16, 1973, III-E.

(85.) Ibid.

(86.) Ibid., p. 31743, IV-A.

(87.) Ibid.

(88.) Federal Register, 39:30619, Aug. 23, 1974.

(89.) Ibid., p.30653.

(90.) Ibid., p. 30651.

(91.) Ibid., p. 30654.

(92.) "A Review of State Abortion Laws Enacted Since January 1973," Family Planning/Population Reporter, 3:93, 1974, Table 5.

(93.) B. J. Culliton, "Fetal Research (III): The Impact of a Massachusetts Law," Science, 187:1175,

(94.) "A Review of State Abortion Laws. . . . .," 1974, op. cit.

(95.) V. Cohn, "Spinal Taps of 43 Babies Are Reported," Washington Post, March 2, 1975, p.1.

(96.) PL 87-781, Oct. 10, 1962.

(97.) A. B. Sabin, "Death Sentence at Birth: Challenges to Science and Society," paper presented at the 1975 Medicolegal Symposium on Life and Death in the 21st Century, sponsored by the American Medical Association and the American Bar Association, Las Vegas, March 14, 1975.

(98.) Federal Register, 38:31738-31742, Nov. 16, 1973.

(99.) J. T. McHugh, testimony for U.S. Catholic Conference before National Commission for the Protection of Human Subjects, Bethesda, Md., Feb. 14, 1975.

(100.) K. J. Katz, National Tay-Sachs Foundation: J. Mears, American Civil Liberties Union; and L. Schiffer, Center for Law and Social Policy: testimony before National Commission for Protection of Human Subjects, Bethesda, Md., Feb. 14, 1975.

(101.) M. Mahoney, Mar. 14, 1975, op. cit., p.36.

(102.) B. J. Culliton, "Grave-Robbing: The Charge Against Four from Boston City Hospital," Science, 186:420,1974.

(103.) D. G. Nathan, 1975, op. cit.

(104.) Federal Register, 39:30651, Aug. 23, 1974.

(105.) M. Mahoney, Mar. 14, 1975, op. cit., p. 34.

(106.) R. E. Behrman and T. S. Rosen, March 1975, op. cit., p.73.

(107.) M. Mahoney, Mar. 14, 1975, op. cit., p.31.

(108.) Ibid.

(109.) A. E. Hellegers, "Fetal Research," testimony before Subcommittee on Health, Committee on Labor and Public Welfare, U.S. Senate, 93rd Congress, 2nd Session, July 19, 1974, p. 104.

(110.) M. Mahoney, Mar. 14, 1975, op. cit., p.31.

(111.) J. P. Wilson, "A Report to the National Commission for the Protection of Human Subjects," March 5, 1975, p. 51.

(112.) M. Mahoney, Mar. 14, 1975, op. cit., p. 35.

(113.) Ibid., p. 36.

(114.) R. E. Behrman, remarks at NAS Forum, Feb. 18, 1975.

(115.) M. Mahoney, Mar. 14, 1975, op. cit., p.33.

(116.) C. Lowe, paper presented at NAS Forum, Feb. 18,1975.

(117.) F. Moore, remarks at NAS Forum, Feb. 18, 1975.
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Author:Hart, Diana S.
Publication:Readings on Induced Abortion, Volume 1: Politics and Policies
Geographic Code:1USA
Date:Jan 1, 2000
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