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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 overonly 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

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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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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 OCR for page 66
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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lo o o of ~ ~ 0 :: ~ a: - ~ 3 0 4 o ~ C) t; SO o o of ~ ' 0 ~ ~ 0a 0 ~ TIC :: aa:~. ~ ~ ED - - 0 ~ =3R ~ Boon 1 ~ ~ 0 0 4 o ~ :z co :~ ~ ~ ~ ~ A: _ ~ 0 ~ 0 lo I: ~ 1 1 ~ 81 JO 0 0 :^ tar ~ ~ Or ~ ~ ~ ~ ~ ~ 1 ~ 0 ~ ~ 0 ~ O 0~ - C - ~ ~ 0 ~ en - .c ~ ~ 1 0 ~ E~ ~ ~ O ~ ~ _ _ :Z ~ `: X~ ~ 0 C) 0 0 ~r ~ ~ ~ ~ ~ 0~0 ~ eC~ 0 ~ 0 O. ~ ~C ~ V H ~ ~ `: ~ U ~ f: ~ ~r ~ :~: :~: .30 ~ Z~ ~ ~ I 0 ~ 3 ~ ~ ~ ~D O - - a: a=:o ~ ~ ~s | :~ - i I c _ c) t) ~ eq ~ ~ 0 ~ O h $: O ~ 0 X ~ ~S ~ I ~S O 0 ~00U, .= 3 :~:~~ ~ ~: :- =~ - 3-. -~ 1 0 a: O V ~ ~ 0 ~ ~ ~ ~ ~ C) U) C: 3 :~ ~ ~ ~ . ~ ~ ' ~ 1 0 co o ~ ~ a~ v Ri O ~ -:^ %_ ,~ k~ _ ~ ~ ~ ~ ~ ~ x: `) X ~ a~ ~ :^ . ~ _ ~t O U~ ~ 1 U ~ 0 ~ ~ ~ 0 ., ~ ~ aa~:0 I ~0 ~ ~ m 0m 1 ~= um ~ ~ ~ 0 ~ - 0 ~ o~ 00 ~ _ a ~ 1 {~ v, I ~ ~ Q 3 S~ O ~ s~ ~ a :: :~ ~ O ~ Q. C) _ `~ - 0 ~ ~ O I: ~ ID ~ U .c ~ 1 ~1 0 Y) c5 ~: O ~J ~ al~ 1 :< ~ t)~1 0 ~S KS C~ 1 o4 0 e m O O eq~ ~ "~ - ~ ~ =-- u, ~ u, O u, ~ ~ ^. ~ ~ ~ s~ R U ~ O 0 ~ =o on . ~ u 0 ~ _ :5 S~ -_ a' :- - `: ~ ~ 5: ~ U ~ 0 ~ ~ 1 ~1 ~ ~ S~ _t 1O ~ ~ 45 ~ _ O =_ - O~ ~ ~= ~ 0Q0 0 0 ~: ~ ~ :~ o~ :~ ~ ~ _ ~ ~ ~ U ~ ~ ~ ~ ~ Q4 - S~ ~ 0 - c: 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 ~ OO~ =: U t~ ^: ~ :' ~ c' ~ 0 a) 0 oo :~: ~ ~ ~ ~ cn U) .. a) a -~_ cn O _ ~n - 75

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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 -

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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

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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 mbrolly ~.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

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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

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~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

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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 OCR for page 66
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

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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-

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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

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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 ofwear, 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