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OCR for page 66
C~IZE:R 3
P~I1= 10 = 5 IN ~ Vow ~rILIZAlION
AND ~0 It's
Since the birth of Rise In in Ballard in 1978, in vitro
fertilization with embryo r - la~ has became an established method of
treatment for Rain types of infertility that do nok resooTx] to
alternative methods of treatment. ~ 1988, 169 ~ that offered IVF~
were identified in the United Seats:. P~?r~iable Ire for IVAN exists
despite sane dill:, such as a higher rate of ectopic pry
than firs with retinal conoaption, high Its ($6,700 at ye of the
nation's oldest pr~3rmns (Jones, 1989) that are often not rein bar
third-party payers, prepaid treatment time, arm ur~xrta~n results. Data
fern 41 clinics that report to ye American Fert;1it~r Society indicate
the Sac rate is iTr~r~ina.
~ ,~ .,
a__ ~ In 19851 14.1 percent of stimulation
cycles resulted in clinical pregnancies. In 1986 this figure rose to 16.9
pendant (Fertility and Sterility, 1988a). However, ye proportion of
wren entering treatment who a Main a live birth is far 1 over—only 8.9
percent of oocybe retrievals ended ~ live birth (Journal of the American
M~di~1 Association, 1988a). Moreover, some women start treatment, but
for a variety of reasons fail to reach the stage of egg retrieval.
Improvements in the surreal rate of IVFET: are probably not the result of
significant changes in the methods of ovarian stimulation or laboratory
procedures. Rather, improvement may be attributed to a *erline in the
average age of women undergoing rVFET, increasing experience of clinician
and laboratory personnel, and more rigorcus-criteria for selection of
patients (Van Blerkom, 1989~.
. ,
Why are the odes for sum--==ful human rVFET so low? me answer lies
in part in the state of knowledge of reproductive and develop mental
pros. mere are a large nor of unanswered lions wham
resolution weld have major impacts on the sue== of BUFFET. Sare of the
mast basic questions include: HI does one iderltify a viable embryo?
- :_ ~ _, , _ _ ~ , ~ , ~ HI many
embryos should be transferred? Why do sore brays fail ~ r~ntirme to
develop after apparently nosy develc - ant? Rat are the physiological
effE - s of hormonal treatments? Rat are the factors that control cxxVi:e
Rat are the effects of cr~rqor~vat~on or gametm; arm ~ryos~~
maturation? What ready dare of ovarian follicles and Rat are
the uraniums of implantation? C)ne of ye Ned important factors that
limits the success of medially ~~=is~ ~x~rx~ion pry ~= the
natural frequency of em arc] embryo wastage. Ibe fit reliable arc]
r~pra3uc~ble estimates of ir~r~t devel~ntal failure ~ gar - ~==
indicate that abet 20 to 25 pedant of Idiotically nature human - as
c~cainec] after hyperstim~ation have genetic abnormalities, abut 7
percent of spermatozoa are genetically abnormal, arm about 10 to 15
pellet of unfertilized wee; main ~lasmlc acerrarlo~= or
pathologies. In addition, the vast majority of human embryos c~rivect
- 6—
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Frau fertilization in viva or In vitro wil 1 ret bevels? to a blas~sb.
D~rel~rental failure during cleavage is fairly typical. Even embryos
that do develop to the blasts stage can ac~nta~n a~r~lities in cell
structure or namer that are not coamis~ with Exx;ti~lantation
devel ~ rent (bligh ~ 1 amen, for exaIrple). C~liectively, develc ~ ntal
failure in the early stages of embryonic development appears to be the
normal situation for the human species.
The state of clinical practice of [VFET today is limited by lack of
knowledge of some of the basic reproductive biology involved. The reason
for this is, at least in part, due to the many ethical questions raised by
research in pursuit of the needed information. Difficulties An resolving
these issues have caused the research to be deprived of federal funding.
-This chapter first reviews the uncial and ethical barriers to
progress in research, and then f~s=-~- an the scientific barriers. Brief
note is made some of the ethical issues that are r~;~ by the practice of
in vitro fertilization, and the history of federal involvement in
considerations of human fetal research is described. Some nations have
examined the ethical questions and have issued guidelines or regulations.
These will be described. Finally, the major science barriers that have
slowed progress ~ human and animal practice of rVFET will be noted.
Ethir?~1 art Social Issues
Some of the ethical or social issues that arise from the various
forms of assisted conception are unrelated to decisions akcut the progress
of research. Examples of these are questions about The protection of the
rights of gamete donors, gestational parents, and social parents;
decisions on the fate of oona~i, embryos, arm feted; the oral sums
of human potential; the chip of cry~preserved embryos who parents
have divorce or died; the Confidentiality of sperm donors; arm questions
of the right of a dhilc] born of Icy IS oon~ion to knew his
or her complete parentage. Other fi~t^1 questions revolve art
c::onc~s of the right of an ir~ivi~ to ran uce, the He of gametes
and embryos, and whether infers Chard be Refire as a ~i~.
Sare ethical questions have a did bearing on redry, arm have
had important oons~ences for ache furring of ~sear~. 1~ major
questions foous on ache shade= of the Frye at each stage of its
development. How the embryo is Carded dictate Cat is m:,rally
amble to do to it. lee implications for what may be done with an
embryo differ a ~ ending to when human life is Fraught to begin, whether
any biological material containing the potential for human life is
oonsidered to be sacrosanct, and other such questions.
The determination of the Coral static of the embryo drives such
decisions as what level of risk to the embryo is acceptable in the
practice of IVFET and research; whether it is possible to "discard"
~67—
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er~ryo6, even when placement ~ a uterus diminish the prC~ilit~r of
Caller OIibry06 SllrViVirlg; nether it is permissible to cereal ~nb~yo6 for
relearn I, and up to hat stage of develc~nt of the embryo
sold rewarms be allied, and Its hat risk to its nosh develc~rent.
At ore end of this Putnam of It is the position taken by the
P=nan Catholic azure, him holds that life begins with the Ion of ho
haploid games== to form a diploid zygote. he Vatican's Ion on
Pit for Than Life states that "fawn the first ant of its mists
until birth . . . no morel distinction is consi~betw~n zygotes,
pr ~ ryos, embryos or fetuses" (cited in Fertility arxt Sterility,
1988b). Therefore, the absolute sanctity accorded to post-natal human
life begins with the zygote. This concept makes it impossible to
spare embryos or Our them for research purpcees. At the other end of the
spectrum is the position that an embryo is merely biological material like
any other group of living cells. The cg--ial value that might be attached
to that material rats fran the exudations or aspirations of ours.
me ^0 hold this view also rue that a large Rime of nz~tu~ly
conceived embryos fail to develop after implantation, thus disdain
exces; embryos create by IVFET can be viewed as a parallel preens
(Office of Technology Assessment, 1988~.
Midway between these ho positions is cone that holds that "the hman
embryo is entitled to profuse resect; but this resect does not
warily e~a~ the full legal am Oral rights attrih~ to a
person" (Department of Health, Education, and Welfare, 1979~. his is the
position t ~ n In 1979 by the Ethics Advisory Board established in the
Department of Health Education and Welfare (DHEW) to advise the Secretary
on matters concerning embryo research, and to review specific research
proposals. Holding this position, the board concluded that research
involving IVFET was acceptable on embryos up to ~4 days after
fertilization. Other constraints on such research included that it should
be designs to improve ache safety an' efficacy of IVORY, and that the
information cad rut be Obtained by ather mans.
The Fec3Pwal Gov=~.ent and Embryo Arch
(~1~C otherwise need, this discussion ~ derived freon a spry of
fetal research issues t7y~cheAssociatian of Ar~ricanM~ical Colleges
(1988) ) .
As mentioned earlier' the Ethics Advisory Board was charters ~ 1977
to review applications for federal support of r~a~. Tnis ~~—
from growing cordon about fetal or embryo research, whim in torn so
foxy a concern abort federal fulgid of research i~olvir~ human
subjects. Polity oor~xrnir~ rearm on human subjects tract been slowly
evolving since the 1960s. A sty grew was cornea at NIT to develop
guidelines, and a National Advisory admission on Health Science and
Society was pry by Senator Welts Bale in 1968 to examine
velc~nts in m~ica~ Bead. Is cc~nmission was not established,
—68—
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but Me it freon Me effort helped But in play Me later Nautical
Commission for Me ~e~ion of Eon Subjects. F~llc~ring reports of the
infants Tuskegee syphilis experi~s, row r~ cat Is
establish a ~t body to regulate federally furry ~ using
human subjects.
In ache lg70s ~ abortion issue ~ lit to ~ ;~m of embryo
z~. After ~ Roe v. Me decision made 1E,gal Abortion udder
McCann specific c~itior~s, ccooern ~velc~ ~t wren weld be
pi into having abortions art Me Me of abort Oryx; and
feh].~ might occur. Many shade Cat had ~i~ ~~ r
Oh abortion stables pry separate l - Relation to ban such
zetas. In 1974, the federal gave Heat Me National Commission
for the Protection of Human Subjects (P.L. 93-348~. Until this commission
Sport ~ is, r~ can the living fete was p~ibi~ ~~=
ideas ~~ to help ~t fetus survive. This Commission did not consider
the topic of Weary on the embryo or liver. The Omission hatter
ted establishing an Ethics Advisory Board (EAB) to redries requests
for conduct of e Mayo arm Iv ~ r ~ earth. Witha ~ such review, r ~ ts
could not be processed. In 1975, DHEW issued regulations heck on the
findings of the commission. mese regulations prohibited federally funded
research unless the risk to the embryo was no greater than l 'those
ordinarily enccuntered in day y life or during the performance of routine
physical or psychological examinations or tests," or for therapeutic
purposes (cited in Association of American Medico Colleges, 1988~.
The EAB met for the first time in 1978. In 1980, the Secretary of
Health and Human Services allowed the EAB charter to expire and, without
explanation, failed to renew it. muss,- federal funding of embryo and
rVFET research was, in effect, prohibited. As a result, embryo research
has relied on private funding from patient care revenues, pharmaceutical
companies, and university budgets. It is estimated that, were the EAB -
active today, it would receive more than 100 grant applications (Office of
Technology Assessment, 1988). In addition, the federal government has
lacked a means for controlling the direction of, or practices used in,
such research. AS was noted in 1979, "Departmental involvement might help
to resolve questions of risk and avoid abuse by encauraging well~;igned
research }A alified scientists. Such involvement might also help to
shape the use of the pry thrash Ovulation and by example."
(Do artment of Heal th relocation and Welfare, 1979) . Is c~ortlmity has
been 1~ for a nastier of years.
In 198S, two Everett ~ in relation to the future of embryo
rewash. Congas created a Bi~l;~1 Ethics Edward. This board,
~ of Myers of cones, six senators art six representatives, is
to equine the protection of human subjects in biaredira~ Starch.
~69—
OCR for page 70
Inflow in its brief are st~ies of ~e- ethical implications of embryo
A. E'y 1987, the 12 ~r~si~al Embers of we board had been
avoid. the Card established a 14 Ember Biblical Ethics Advisory
Gritty ~ of scientists, E~ysiciarm, clergy, arm others. After
Berths of Sock over is Cat mainly f ~ can anoint
criers cat bortion arm our ethics in to ~ with ciefiniti~ of human
life, the advisory Remittee was runt (American logical As, 3987) . Ibe
firm mewing did rut take place until SO 1988, arx] the Ate for
;s~i~ of a report on fetal relearn had pawn (Capmn, 1989~.
A~ointir~ the leaders arm ~ of this Bi`~;~1 Ethics Board
arm we Biomedical Ethics Advisory Remittee has On fraught with delays,
as has the initiation of the activities of these bodies. date funning
Is rut assure. Alexarxle:r Capmn, Taiwan of the Bi~;~1 Ethics
Advisory Committee rates Cat "age can be hopeful, bit not curtain that
[these groups] will be able to fulfill their statutory EX~S."
(Capron, 1989) Nether prugr=;s in enabling embryo r~ to pled
will be mace is ppen to Cabot In today's political Orient.
In addition to the c~ressior~al grows there has been activity In
the executive arm of goverr~t. The Parent of Health are Human
Service= interns to reactivate the EAB that expire in 1980. In 5
1988, notice of a draft Gary was Public in the Visional
P~rd. me 60 - ay can't period has eland arm a find revised clearer
. .
IS pellCl~.
me EAB, if reactivated' will develop specific guidelines to review
PI research plurals. It seems likely that the guides ines will be
influenoed by the broader policy fort be ache oc~ngressional groups.
Septic arm Foreign Decisions on Embryo Orb
me two professional societies in the United States that represent
the p ysicians most involved in human IVFET have considered ethical
questions about the practice of [VFET and embryo research. m e American
College of Obstetricians and Gynecologists (ACOG) inches an Pinion that
DUET is a clinically applicable procedure that can be practiced if
. . . . . . . . ~
Certain Utahans are assured and the etnl~a I I: are C~;lae~
(American College of C~tetriciar~; and Gynecologists, 1984). In years
later the ACING Nit tee on Ethics (Anerican collie of ~etricians and
Neologists, 1986) issued a statement that Pledged the ethical
issues that were posed by the creation of erdaryo6 outside a uterus,
-70-
.
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Representative terms from entire chapter:
human life
foa~sirg particularly can the Helena ~ by surplus "rbry=; and ~
ac~tab; 1 ity of ~ using early human embryos. be ALEX; Remittee
r~ standards to guide - 0 redry, including that hen Frye
Fold be Ale only if ~ embryos weld no'c provide ~ net
kn~l~. It a:Iso I_ haywire r~r~ on Frye Cat had
reader ~ age of 14 days. the. African Fertility Society (AFS) also
issue1 a report ~ 1986. Isis ~ row; eight technologies that the
AFS Ethics remittee fc~ ethically actable, including heroic IVAN,
use of donor eggs, and ~ ~~ of frozen sperm. Six EN were
fared sui~cable for clinical ~i~7~rtic~n, including Me use of Wizen
eggs, and Arcs =~ embryos up to 14 days (Fertility are Sterility,
1986~. A year later, after cansidera~cior~ of we Vatican's Dstr~bioa, for
Human Life ~ its Origin are on the Dignity of F~ati~, issued by the
C~or~r~ation for Me Marine of Fai=, the AFS issued art report.
~is-r~ort stated that pr~sive do of r~ are due with
pr~;ive develc~rent of Ares, and that experin~ation can be
justified and is r~q~ if the human condition is to be infrared
(Fertility and Sterility, 1988b).
Despite public debate of the issues, statements issued by religious
are pruf~=ional green, are other evidence of public irlter~t, the
Ant of the Miter! Seats, singe 1979, has not followed the lead of
a number of nations that have pys~matically Amid issues relate to
human IvFUr. However, state states relevant to embryo ~ exist.
0n~r-five states restrict embryo Award, are 19 of Me have language
that could be interpret as prohibiting scan "pr~srbryo" Art
(Office of Ethnology As~nt, 1988~. Inten~ticmally, scare
goven~nts have issued nobles or regulations to Nil either the
clinical practice, level of i, or both. Any Walls, Direr of
Bioethics at the Key Institute of E=ics, Geo~eta~n University, has
reviews statements on the red Curative technologies made by
comity; in Aver countries (Walters, 1987~. He Ares ~at, since 1979,
at let 85 statements have been pry by o~nmitt~ representir~ at
let 25 countries. Walers feed his analyst oar Me reports list In
Figure 1. His analysis of issues In human embryo Art An; that for
Australian United= fat r~ on early (preimplantation) embryos to
be ethically unamiable. Eleven committees airiest at let sane kids
of early ergo 1~. Six of these acoapt such Prearm only on
er~ryos left curer freon clinic activities. Five
In sum, numerous groups have wrestled with questions related to the
ethical problems of human embryo or fetal research. Some have heck their
conclusions on religious tenets, some on an interpretation of scientific
knowledge, some on a mixture of both. It should not be surprising that
there are substantial differences in the conclusions drawn by these
grumps. Hover, to the extent that each has laid Ant the foundations of
its ar~ts, Me debate fit the adoptability of - - ryo Has
been awarded.
-72-
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O 3 ~ ~ ~ ~ ~ ~ 0 ~: ~ ~ ~: U]
_ ~ a: E~ O O
_
- 3 ~ ~ <:
S~ 0 ~ ~ ~ ~ ~
_ s~ ~ _ ~ ~ ~n ~ ~ _
: O ~5 :~ ~ _ ~ ~ 3
~ tn ~e ~ ~ `~ - 1 1 ~ ~
dU ~ ~ _ ~ t— ~ H ~ _. ~ - 1 ~t I ~ ~ (1)
_ ~ 0O = - ~ 1 0 I ~ 0-^
~2 3~=— ~ 0 ~ O—O~ =: U
t~ ^: ~ :' ~ c' ~ 0 a) 0
oo :~: ~ ~ ~ ~ cn
U)
..
a) a
-~_
cn O
_ ~n
- 75
Figure 1 (continued)
1~: SIXTEEN SIDED ~ ~1~
ON 1~ NEW REE~WC~VE T~LOGTF~: 1979-1987
A. U.S., lit of Hoff, Education, and Welfare (HEW), Ethics
Advisory irk, HEW Support of Resort Involving amen In Vitro
Fertilization and Embryo Transfer (May 4, 1979)
B. Victoria, Australia, Chronic to' consider We Social, Ethical arc
Meal Issues Arising from In Vitro Ferti ~ ization
Interim Report (= Waller I) (~r 1982)
Issues Paper on Donor Gametes (= Waller II)
1.
2.
3. Report on Donor Ga~tes arc In Vitro Fertilization
(April 1983)
(= Waller III) (August 1983)
4. Report on the Disposition of Embryo Produced by In Vitro
Fertilization (= Waller IV) (August 1984)
South Australia, Report of the working Party on In Vitro
Fertilization and Artificial Insemination by Donor (Jannary 1984
D. Queensland, Australia, Report of the Special Committee Appointed by
the Oueensland Government to Enquire into the Laws Relating to
Artificial Insemination IN Vitro Fertilization and Other Related
,
Matters (= Demack Queensland, report) (March l, 1984)
E. Council for Science and Society (United Kingdom), Working Party,
Lean Creation: Entire Aspects of the New T - hniqu-= (May 1984)
F. Unideal Ki~dc~n, r~rt~t of H=~1 th! an Social Liter, Report of
He Committee of Quit into Human Fertilization are E)Tdoryology
(= Warno~, United Ki~dc~m) (July 1984)
G. Tasmania, Australia, Committee to Investigate Artificial Conception
are Related Matters
1.
2.
Interim Report (= Tasmania I) (l~r 1984)
Final Report (= Tasmania II) (June 1985)
H. Curio, law Reform admission, Pert on Human Artificial
R~pr~uction arc Related Matters (tiled June 13, 1985)
I. Aria, Funnily Law Gerbil
1. Interim Report (= F~nilv low Ail I) (;rulv 19841
2.
Cleating Children:
_ ~ ~ AL ~
A Uniform Abroad to the law and
Practice of Reproductive I~nol~y In Australia
(= Easily Iaw council II) (July 1985)
76 -
Page 2 (Figure 1 continued)
J. Federal Republic of Germany, PdrrLsber for i~#~3rnch and Technology and
Justice Minister, Working Group, ~ Vitro Fertilization, Genome
Analysis, and Gene Therapy (= Eenda, German Federal Republic)
(November 1985)
K.
L.
Spain, Congress of Deputies, General Secretariat, Special Commission
for the Study of Human In Vitro Fertilization and Artificial
Insem mation, Report (April 10, 1986)
American Fertility Society, Ethics Committee, Ethical Considerations
of the New P~uctive ~nolocries (S~b~ 19861
M. tern Australia, C=r~nittee to Entire Who We Social, Legal art
Ethical Issues Relating ~ ~ llitru Fertilization and Its Supervision
1. Interim Report (= Western Australia I) (A - ust 1984)
2. Report (= Western Australia II) (Octc~er 1986)
N. Netherlands, Health Cbuncil, Committee on In Vitro Fertilization and
Artificial Insemination by Donor
1. Inter ~ Report on In Vitro Fertilization (= Dubch Hearth
Cbuncil I) (October 10, 1984)
2. Report on Artificial Reprc~uction, with Special Reference to
In Vitro Fertilization, Artificial Insemination with Donor
Sperm, and Surrc gate Mother hood (= Dutch Health Cbuncil II)
(October 16, 1986)
O. France, National Consultative Committee on Ethics
1. Report on Ethical Ed; Palates to ]~hnicues of
Artl~lcla' Reprmuctlon (= National Ethics Committee I)
(October 23, 1984)
2. Report on Plead Evolving dean E)Tbry~ ~ Vitro and
Their Use for Magical art Scientific is (= National
Ethics Cc~nitt~ II) (l~r 15, 1986)
P. New &0h Wales, Australia, Iaw P~efonn Admission
1. Sur~gate~*herhood: Australian Public Opinion (=New
SaIth Wales I) (May 1987)
Artificial Oonoaption, Discussion Paps 2: In Vitro
Fertilization (= New SaIth Wales II) (July 1987)
- 77
Other Barriers to Scientific Progress
The research agenda developed by the Institute of Medicine, Board on
Agriculture committee (bloc Chapter 4) identifies many areas ~ which
further research would make major contributions to Em pro cements ~
medically accosted conception in humans and animals. As noted in Chapter
1, improving the application of medically Resisted conception would
benefit society in several ways, including my possible the
privation of sane endanger Species, as well as pravidir~ sane relief
freon infertility arm making proration of =3at arm ILL Ire eoca~ni~al.
ELLIS, however, he }>Ben played by a mar of factors, most of which
stem fry m the g ~ rally controversial rapture of ~ ts surround ~
issues in reproduction, and specific controversies related to elements
important to reproductive research zygotes and embryos.
As a prerequisite to developing recommendations to advance the
science base of medically assisted conception, the committee first
examined the impediments. In addition to the ethical considerations
referred to marker, the following barriers deserve particular emphasis:
1) deficiencies in the scientific base of this area of reproductive
biology; 2) the resources available for research in this area of science;
3) lack of mechanisms for communication within the reproductive research
community among basic scientists, clinicians, and animal husbandry
scientists; 4) four of abuses of reproductive technologies; 5) a relative
lack of sympathy and understanding of the problems being experienced by
infertile couples; 6) lack of a cohesive public interest group favoring
such research, in contrast to well organized opposition; 7) limited health
insurance coverage of IVFET serving=; 8) limited sources of research
materials for experiments relating to human beings and to animals; and 9)
the present dilemma of cur society oonocrnIng how to handle our ethical
sagre~ts.
Almost none of these factors is independent of the others; rather a
causal relationship is often found. Some of the barriers identified may
be amenable to policy Intervention. The following sections briefly review
the impact of the major barriers to progress and how they have come to be
. · .
~ sauce.
Deficiencies in the Science REAP
The papers presented at the committee's workshop and the research
agenda developed frill that workshop (Poe Chapters 2 and 4) indicate
deficiencies in the scientific underpinnings of reproductive biology, and
identify many areas in which further research efforts would make major
oontributions to iIrprove~ts in m—brolly ~.Ccist~ cation. me
deficiencies are on three levels: basic science knot - ge; knowledge
needed to improve the technologies being use for medical ly Waist
Monition, such as cryobiology; and knowledge reed to improve bath
human and animal clinical practice of IVFET. As explained in detail in
—78—
Chapter 2, deficiencies ~ all three levels limit bath the quality and
efficiency of the practice of Ivory.
Plead did tc~ard improve Me retie of focxI~r~ucing
animals suck as came Is often ahead of research In We area of humn
r~?r~uction. As a ret, the use of In vim Sperm ca~ci~catic~n,
artificial insemination with frozen seen, transfer of frozen embryos,
Fixate harvesting fern Mad animals (the Icarus effete, and the
Splitting of the dividing ells of the early embryo into Are than me
ir~ivi*ual animal, are routinely used in animal hurry. A me of
factors have ally Focally assist canoaption to pry at a faster
pace in animals than in hung: r~z~ unwire food~r~ir~ animus he
been stipulated by an em economic return can Me ~ invesbrent,
a larger Voltaire of eateries is available for sty, and r~r~ has ret
been subject to as many ethical Dines. The lamer ~ factors rem
~ greater vole of material available for study are fewer ethical
constraints - - derive fee. a difference in He esteem a`-~rd~ to animals
are humans by many Doers of society. Me economic value of Inter, which
acts as a Spur to progress In the animal area, Is to same, although lesser
extent, parallels in human IVFET. mat there is an econc~nic value to
Iv~r for humans is indicated by the fact that clinicians can Large, are
people are willing to pay, quite ~antial fed for the pro. His
has enabled a Eanall Dent of Dash to be cons n the Hence of
federal help.
PI ~
~xi~tely $115 million annually ~ pent on ~ In human
reps ~ Active pr ~ . The major sources of private fulgid (the Ford,
Rockefeller, and A.W. Mellon foundations, and the Population Council) in
1985 together contributed $2.8 million to research related to reproductive
processes. This includes grants to investigate mare and female
infertility, fertilization, zygote transport, reimplantation development
and implantation, and reproductive endocrinology (National Institutes of
Health, 1988~. Federal agencies are the pr ~ ipal support for research.
In 1986 they provided $109 ~ llion for research in reproductive processes
(National Institutes of Health, undated).
the National Institute of Child Health and Human Development (NICHD)
of the National Institutes of Health provides the major portion of federal
support of human reproductive research. Approximately $100 million per
year, one third of the budget of NICHD, is spent in the reproductive
sciences br ~ h of NICHD on contracts and grants to academic centers and
to the NIH centers for reproductive biology. In addition, the
Contraceptive Development Branch, which uses mainly contract meCharjE~5 to
support contraceptive technologies, contributes to basic reproductive
research. Federal funds for research redating to agricultural animal
reproduction are available from the U.S. Department of Agriculture.
—79—
~i~ for - tic r~ in human r~pr~ucti~re biology is
undoubtedly Gained by the lack of veal and f~.~ advocate Get;
Hat have been for for scare d; sub as cancer and heart disease.
Iadki~ such a constit~y, a major in in federal support is
~likely. Yet, as the r~r~ agerx3a in chapter 4 Gusts, Optional
invest ~ Rive biology can exam: to be repaid In
i~pr~v0~nts In Be r~p~:ive health of the nation.
Iadk of Fornication ~ R~r~rs
Dis~=cion with the scientists arx] clinicians at the ~ni~ee's
workshop revoted an ~ of available Panic for c~nications
awry ~ individuals involved Iffy variants aspects of Rae In
relive biology basic, clinical, animal sciences, etc. Also
revealed was a desire for greater ca~nication to allow
~;-feri:ilization of ideas arx] develc~ of ongoir~ relationships
among. investigators E~rsuir~ similar approaches to problem.
Diffi~ll~r in establi~hi~ communications is sometimes caused bar the
locale of irIvestigators art the way science is organized. R~=iC
scientists are freauen~Y ~.D.s In basic skiers dots such as
.
. · _ _. · . ~ ~ ~ · ~ · ~ ~ ·
anarchy or physiology. Hey open use and motels tor their sped arm
have lime or no contact with patients. Clinicians have an M.D. cord
with s ~ eat red iciency training arm are generally ha ~ In clinical
departments such as obstetrics and gynecology. hey are frequently
heavily involved with patient care. S2me researchers working in animal
sciences have veterinarian degrees, others have ba.cic science degrees, and
frequently work in departments related to animal sciences or agricultural
practir== and do with animals of economic importance.
m e excitement and stimulation experienced by the individuals
attending this IOM workshop, which encouraged interaction with individuals
from differing backgrounds, underscored how infrequently meaningful
interactions among these communities occur, and how use fur this
interaction could be.
Societal Concerns
m e fear of abuses of reproductive technologies, the seeming lack of
cietal sympathy and understanding of the problems experienced by
infertile couples, and the lack of a cohesive public interest support
group are to scone extent relay pea.
—80—
Fears of at; of Me new repressive trilogies are legitimate
corxxrre in a society that has not consistently In an ability to
anchor Me ethical implication of scientific progress. Nor has this
society established deliberative bodies that might Assure the public
that abdications of repressive science w;11 be Trolled in ways
sensitive ~ the delicate Away ~ preservir~ echo Utahans and
imploring He Khan Addition.
His ~ not to imply that Ens abaft ~ I of new reproductive
trilogies can be easily quieted by the cn3~tioa, of del iterative or
regulatory bakes. Rather, that to dste the U.S. has not grapple with
He in as sane Ear nations have
pie such as IVFET, likely to benefit a very limit renumber of
pe - le. will be f~ praised ~ a cx~;t~nscials health senri~:
vire~ment.
That these is no single Motive public interest gasp pressir~ for
heightened rearm in the area of r~pr~uctive biology knight be partially
explained by the car'?lex religious arm ethical issues involved with
certain types of rewarm, by the lack of a cohesive ~ unity,
by few' of at; in ~ area of relive theology, by a la' public
awareness of ache size of ~ nation's infert;1i~ pickles arx] me c-~lex
effect of infertility on individuals art couples, or a ~binatic~n of
these art ather factors.
Sates; of Rearm Material
The c~nmi~ee's word provided Barry exhale examples of
Retard In which information abut reproductive physiolc~y deliver] fives,
anion Gels has In useful ~ ur~star~i~ hymn physiology.
Jnst~, however, were also pro in which the human pro have
market differences fun those educing bar animal Is, and to me
forward in und~stdrdi~ the human p~ysiol~y ryes the-use of human
tissue. An exile of this is irnrestigation of masons for the
develc~rental failure of human erdbryc~, art cryop~vation of hen Is
and zygote;. Preservation of human tissue by freezing altos excel=
zygote; t:o be thawed for use at a layer Ire. At present, we do rot kocm
all ache possible n~ative cons of freezing and thawing of the
human tissue, nor do we knew the ~imm Editions urger which these
pry ~ uld be Morse. However, cry~preservation he Get into
clinical practice despite these Antics. Is he ~ in part
because of the dilemma cat by excel= mbryos. Di~rdi~ In is
unamenable ~ scam. Therefore cry~reservation has ~ an a~3b~e
Option.
In addition, abet gh Pacific primates me good~els for scare
aspens of human reproductive E~ys;iology, there are only a limits dumber
of Grays of desirable Ties ~ captivity arx] many of Gem are
presently being use for AIR; rheas. To botanize the use of each
primate, it would be helpful to develop noninvasive pr ~ r ~ for st - ;
such as oocyte harvesting. Such a procedure would also be of great
importance to patients.
The committee believes that restrictions on the amount of material
available for research ~~=- is slowing the rate of progress in developing a
scientific base for rVFET and the technological advances that would make
it more efficient. These limitations are the result of a concern that
hen material be used with proper respect, art that the use of animals
for research pur~ses be strolled to ensure that they are not ahoy.
—82—
There exist ways, however, of enlarging the amount of avail able research
material while preserving a pro per consideration for thee. issues. Making
available material from organs that have been surgically removed would
increase the supply of human tissue. For instance, when an organ such as
the ovary is removed for medic reasons, it Fight be made available for
harvesting oocytes and eggs.
In sum, as dispose In many places in this report, ethical, and
social As underlie mart of the barriers deco progress In repr~cive
research arm the clinic-1 ~E~licatic~n of new trilogies. Isc:ik of
Zanies for resolving sup di~gr~nts has inhibited progress In the
necessary Ate that must prance the <3evelo`~; of policies. It is
q ing that Congress has established the Bic ~ Scat Ethics Edwards,
and that the executive branch of government is taking steps to reactivate
the Ethics Advisory Board. If these bodies become functional the nation
will have taken steeps to establish entities to handle difficult issues in
reproductive biology.
-83-
REFEEDS
Pererican Collie of obstetricians arm Gyr~ologists. 1986.
Ethical Issues In Ran In Vitro Fercilization arm Embryo Placement.
See on Ethics. ACING niece Opinion Namer 47. in,
D.C.
African college of obstetricians arm pyr~Dlogists. 1984. H man
In Vitro Fertilization arm Embryo Placement. niece on
pyr~ologic ~ctioe. niece Statement. Ship, D.C.
American Helical News. 1987. Ethics Sal Embers Are Nap. Aug 14.
Association of American t5edi~=l Colleges. 1988. Fetal ~rdl
arm Fecal -Tissue ~sear=. Wa~i~, D.C.: Association of
American Medic'a1 =11~;. June.
Capron, Alter Organ. 1989. Bioethics on the ~sional Nigeria.
Askings Center Port. Mail pp. 22-23
Deparbrentof Health, Eclucationar~Welfare. 1979. HEW S~rtof
r~ Involving span In Vitro Fertilization and E:rrbryo Transfer.
Pert and Conclusions. May 4. Washington, D.C.: U.S. Gaven~ment
Pr~ntirg Office.
Fertility and Sterility. 1986. Ethiopia Considerations of the New
P~pr~uctive Technologies. me Ethics remittee of The American
Fertility Society. 46(3 S~1 1): IS-94S
Fertility and Sterility. 1988a. In vitro fertilizatiork~br~ro
transfer m the Uninstall:: 198S and 1986 results fern the
National IVF/ET P~gistry. 49(2):212-215.
Fertility and Sterility. 1988b. Ethical considerations of the row
r~pr~uctive trilogies. By the Ethics ~rnitt~ (1986-7) of the
American Fertility Society in light of Instruction on the ~ t for
Human life in its Origin and on the Dignity of Prc creation issued by
the Congregation for the DocUrine of the Faith. Feb;49(2 Suppl
l):IS-7S
Jones, Howard W. Jr. 1989. Eastern Virginia Medical School.
Personal Communication, January 23.
Journal of the American Medical Association. 1988. IVF Registry
Notes Mbre Centers, More Births, Slightly Improved Odds.
259(13):1920-1921.
National Institutes of Health. 1988. Inventory and Analysis of
Private Agency Ration Rearm. 1984 and 1985. U.S. ~t
of Health are Human Septic, Public Health Services, National
i~e5 of Health. June.
—84—
Notional Institutes of Heals. Urx3ated. Marjory arm Analysis of Federal
Pc~ati~ Pleat. Fiscal your 1986. U.S. Dot of Hdal1:h arx]
wren Serving, Public malth Service, N~tic~3al Institutes of Health.
Offioe of Technology Ass~b. 1988. Infertility: ~in~1 arm
- Social Choir. 0 - ~ BP 48. must. Wa~i~t=, D.C.: Offioe of
Phonology Am.
Van Blerk~n, Jonathan. 1989. Professor of—wear, cellular' and
D~rel~tal Biology, University of Amoral at BcAIlcler. Coronal
Fornication, January.
Walt~s, by. 1987. Ethic'; arm New P - restive Technologies:
An ~rnati~ Privies of C~nit~cee StatE~s. Hastings Center
P - art. June:3-9
—85—
