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                                                              Mark S. Frankel


                              THE PUBLIC POLICY DIMENSIONS OF
       ARTIFICIAL INSEMINATION AND HUMAN-SEMEN CRYOBANKING




                                                              December 1973




                          Program of Policy Studies in Science and Technology
                                            The George Washington University
                                                              Washington, D.C.


                                                          Monograph No. 18


         & S A - C R - 1 39352) II
        IMENSIONS OF ARTIF-                  IBSEN         >* AND
       HDBAB-SEflEN C E i O B A N K I N G   (G           -jhiriqton
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           THE PUBLIC POLICY DIMENSIONS OF
ARTIFICIAL INSEMINATION AND HUMAN-SEMEN   CRYOBANKING




                         by

                  Mark S. Frankel




                   December 1973




 PROGRAM OF POLICY STUDIES IN SCIENCE AND TECHNOLOGY
          The George Washington University
                  Washington, D.C.
 established under NASA Research Grant NGL 09
                                            )-l0M)30

                   Monograph No. 18
                                  11




                          ABOUT THE AUTHOR


     Mark S. Frankel is currently assistant to the Director of
the Graduate Program in Science, Technology, and Public Policy
at The George Washington University, where he is a Research Associate
with the Program of Policy Studies in Science and Technology and
an Instructor of Political Science.
     In addition to this monograph, Mr. Frankel is the author of
The Public Health Service Guidelines Governing Research. Involving
Human Subjects: An Analysis of the Policii-Making Process (NTIS N 72-24093)
and Genetic Technology:   Promises and Problems (NTIS N 73-72427).
                                  m




                               PREFACE


     This paper reports the results of an exploratory study into
the status of human-semen cryobanking in the United States, focusing
primarily on the practices and policies which govern the daily
operations of semen banks. The rapid emergence of human-semen
banks throughout the country has prompted one long-time observer
of human-semen cryobanking to refer to an evolving semen-bank
"industry."!   As is frequently the case with new technologies, the
social and legal processes of society have not kept pace with the
development and implementation of semen cryobanking. A survey
of public policy relating to human-semen cryobanking clearly
indicates the absence of pertinent regulatory policy. Even more
disconcerting is the fact that the information necessary for
formulating and implementing such policy is either incomplete
or unavailable.
     While the technology of human-semen cryobanking has emerged
relatively slowly, its momentum in recent years has increased
considerably. Its therapeutic and contraceptive capabilities



        Ij.K. Sherman, "Synopsis of the Use of Frozen Semen Since
1964: State of the Art of Human Semen Bankingj" Fertility and
Sterility, 24:397-412, May 1973.
                                 IV




are potentially enormous. Yet, like all other technologies, its
application, particularly on a commercial basis, may also produce
unanticipated and undesired results. How we as a society ultimately
use this technology and the knowledge gained from its application
will determine the nature of its consequences.
     This paper suggests that the potential impact of human-semen
cryobanking may be of greater magnitude and more far ranging than one
might initially suspect.2 Admittedly, this study is, in terms of
both the data collected and the questions it raises, exploratory,
and suggestions for further research are raised throughout the text.
While it is too early to speak with certainty about the broad
public-policy dimensions of human-semen cryobanking, it is hoped
that this effort will provide an informative base for undertaking
additional inquiry which can be more focused and more precise.
     My preparation of this paper benefited from the generous
help of many people. Dr. Louis H. Mayo, Professor of Law and
Director of the Program of Policy Studies in Science and Technology,
provided the initial encouragement for the paper. John M. Logsdon,
Director of George Washington University's Graduate Program in
Science, Technology and Public Policy created a hospitable working
environment for me and generated many helpful suggestions regarding


        2
         Some of the issues discussed herein, may, of course, apply
to the use of fresh semen as well. The introduction of cryogenic
techniques, however, does add a new dimension to the impact of
artificial insemination.        •-.••.
an earlier draft of this manuscript. Others who read earlier
versions of the manuscript and whose comments were very helpful
in preparing the final paper include Vary Coates, Lawrence DeLong,
Fletcher Derrick, Audrey Hassanein, Sal Leto, Joseph Margolin, Richard
Restak, J.K. Sherman, Jerome Silbert, and Emil Steinberger.    I am also
grateful for the cooperation of all the semen-bank directors
who responded so fully to my questionnaire survey.   Finally, I
wish to thank Cecil Jacobson, Marlene Leaf, Marcia Smith and Linda
Yelton for their assistance in the research, writing and preparation
of this study.   The preparation of this paper was partially supported
by NSF Grant GS-34902. As is customary, I accept full responsibility
 \

for the paper's content.

                                                         J
                                              M. S. F.
                                              November 1973
                                 vn




                            CONTENTS



INTRODUCTION     ---     ...........          -   .....    -      .....    1
FREEZING HUMAN SEMEN: SUMMARY OF THE STATE-OF-THE-ART
  AND ITS APPLICATION  ----     .......    -     ..........                 4
DATA SOURCES    ---     ........        ----      ......        -----       8
HUMAN-SEMEN CRYOBANKING: PRACTICES AND POLICIES           .....     ---     9
   I. Some Immediate Public-Policy Issues --- —            —      -___io
       A.   Techniques of Human-Semen Cryobanking -- — - - - - 1 0
       B.   Donor Compensation - - - — — - - — _ _ _ _ _ _ i 2
       C.   Donor Selection - - - — - - — _ _ _ _ - - _ _ _ _ i 7
       D.   Informed Consent -- — — -- — -- — - - - - 2 5
       E.   Family Planning Programs — — — _ _ _ _ _ _ _ _ 33
       F.   The Economics of Human-Semen Cryobanking - - - - - - 35
  II. Some Long-Term Public-Policy Issues
       A. Supply and Demand          ------------------         39
       B. Delivery a n d Utilization - - — _ _ _ _ — - _ — 4 0
       C. Population Planning and Policy --- — — - - - - 4 1
          (i) Adoption — - - — - - — - - — _ _ _ _ _ _ 4 1
          (ii) Sex Predetermination and the Sex Ratio - - - - 43
          (iii) Genetic Implications - - - - - - - - - - - - - 4 6
THE PUBLIC-POLICY STATUS OF HUMAN-SEMEN CRYOBANKING            ......      48
   I. Current Public Policy        ........       -----        .....       49
  II. Filling, the Policy Void         -----------        ------          -52
 III. Public Policy and Artificial Insemination       --------55
INTRODUCTION

     In recent years, the number of human-semen cryobanks throughout
the United States has increased rapidly. While in 1969 there were
fewer than ten such banks in the country, by September 1973 the number
had grown to seventeen, including three major commercial banks with
a combined total of eight branch offices.   The potential significance
of this rapid growth is underscored by Sherman, who suggests that it
"may very well determine the future of frozen human semen and to some
extent advances in human reproduction." 2
     Traditionally, the purpose of freezing semen has been over-
whelmingly for the treatment of infertility. The recent growth of
frozen-semen banking, however, has been attributed to two sources.
First, with the heightened popularity of vasectomy as a means of birth
control, many men have sought some type of "fertility insurance" by
freezing their semen for possible later use. Since the number of
vasectomies reached 750,000 in 1971 and 650,000 in 1972,4 that



      IA recent report of the Panel on Human Artificial Insemination of the
British Medical Association has predicted an increase in the use of frozen human
semen in England as well. "Annual Report of Council: Appendices.
Appendix V: Report of Panel on Human Artificial Insemination," British
Medical Journal (Supplement), 2:3-5, April 7, 1973.
      2j. K. Sherman, "Synopsis of the Use of Frozen Semen Since 1964:
State of the Art of Human Semen Banking," Fertility and Sterility,
Vol. 24, May 1973, p. 407.
     3lbid. p. 17.
      4Memorandum from the Association for Voluntary Sterilization, Inc.,
March 1973.
part of the population seeking the services of a semen bank may become
.      5
larger. The second reason given for the expanding number of commercial
semen banks is the increase in demand by infertile couples, who represent
about 15-20 percent of all marriages in the United States, for semen to be
used for artificial insemination.6   Since one of the more important advan-
tages of frozen semen is that in the case of a husband's infertility, which
accounts for approximately 40-50 percent of all infertility among married
couples, a third-party's (often referred to as a "donor" 7) semen may be
used for insemination independent of time and place, this increase in
demand has directly influenced the volume of business of commercial semen
banks. The ability to freeze and preserve human semen by cryogenic methods
has several other potential uses: to collect and centrifuge oligospermic
(deficient sperm count) specimens from the husband for eventual insemina-
tion in concentrated form; to collect the semen specimens required to
develop techniques to separate male-and female-producing sperm so that



        More systematic research will have to be done to acquire better
data and insight into the probability of this occurrence. At the moment,
the evidence is quite mixed. Both Genetic Labs and Idant report a decline
in vasectomy-related business during the past year. Furthermore,
Dr. Edward T. Tyler, Director of the Tyler Clinic in Los Angeles, reports
that "where semen storage is offered free prior to vasectomy, less than 1
percent of patients are interested in it." See his "The Clinical Use of
Frozen Semen Banks," Fertility and Sterlity, Vol. 24, May 1973, p. 414.
Yet, Robert R. Quinlan, Jr., the Director of the Chartered International
Cryobank, which stores semen primarily for those persons contemplating a
vasectomy, reports a "substantial increase" in the volume of business
during the past few months. Private Communication, October 17, 1973.
      6
         R. A. Ersek, Medical Director of Genetic Laboratories, Inc.,
Private Communication, 1973; J. A. Silbert, Director of Laboratories of
Idant Corp., interview with this author, New York City, November 17, 1972.
       'In this study, the term "donor" is generally used to refer both
to those who receive compensation for giving their semen as well as to
those who give it without compensation.
couples might predetermine the sex of their child; for selective breeding
and genetic variability; for "fertility insurance" for men who, because of
exposure to radiation or certain medical procedures, may become sterile;
and for the study of normal physiology.
    This growth in human-semen cryobanking and its potential biological
and social significance for both individuals and society appear to merit
and investigation into the operating practices and policies of frozen-semen
banks. The research reported in this paper was undertaken to achieve the
following purposes:
     1. Collect background data relating to the nature and extent of
human-semen cryobanking in the United States.
     2. Determine the scope and nature of the operating practices and
policies of existing frozen-semen banks.
     3. Determine the scope and substance of public policy pertaining
to human-semen cryobanking.
    4. Identify a variety of immediate and long-term policy-related
issues concerning the techniques and policies of frozen-semen banks
and specify additional data necessary for making a more informative
assessment of their potential significance.
FREEZING HUMAN SEMEN: SUMMARY OF THE STATE-OF-THE-ART AND ITS APPLICATION

                                        Q
    Spallanzani's observations in 1776 were probable the first to report
the effects of freezing temperatures on human sperm, and the concept of
                                                         9
frozen-semen banks was introduced in 1866 by Mantegazza.    It was not
until 1949, however, with the discovery of the cryoprotective action of
glycerol on spermatozoa     that the stage was set for the practical imple-
mentation of frozen-semen banking. Four years later, Sherman and Bunge,
using dry ice for freezing and storing semen, reported the first successful
human pregnancy resulting from insemination with frozen human semen.
Approximately 25 births resulting from frozen human semen were reported
by investigators in 'Japan and the United States over the next nine years J2
The use of dry ice, however, did not provide a practicable technique; the
recovery of motility and of fertilizing capacity of semen stored at -80° C


           8
         L. Spallanzani, Opuscoli di Fisca. Animal e. e Vegetabile.
Opuscolo II. Osservazini, e Sperienze Intorno ai Vermicelli Spermatici
dell 'Uomo e degli Animal i. Modena,1776.
           Q
         P. Mantegazza, "Fisiologia sullo sperma umano," Rendic reale
Instit Lomb, 3:183-86, 1866.
      10
         C. Pcilge. A. U. Smith and A. S. Parkes, "Revival of Spermatozoa
After Vitrification and Dehydration at Low Temperatures," Nature,
164:666, 1949.
           . G. Bunge and J. K. Sherman, "Fertilizing Capacity of Frozen
Human Spermatozoa," Nature. 172:767-768, 1953.
       12
           Sherman, op. cit., supra, n. 2 at 2.
            13                             14
was poor.          Subsequently, Sherman        developed a technique for freez-
ing and storing human semen using liquid nitrogen at a temperature of
-196°C. Using the Sherman technique, Perloff, Steinberger, and Sherman1^
reported four normal births and, in a synopsis of research on frozen human
semen, Sherman confidently concluded that "We now have available, therefore,
a simple, efficient, and clinically proved method for frozen storage of
human spermatozoa, suitable for immediate, but planned, application."
     Since 1964, a number of investigators, ' have also reported concep-
tions resulting from the use of frozen semen stored in liquid nitrogen at
-196.5°C.        The fertilizing capacity of frozen semen, however, has generall
been found to be less than that of fresh semen. Behrman and Sawada



       13
        R. 6. Bunge, "Further Observations on Freezing Human Spermatozoa,"
The Journal of Urology, 83:192-193, 1960.
       14
         J. K. Sherman, "Improved Methods of Preservation of Human Sperma-
tozoa by Freezing and Freeze-Drying," Fertility and Sterility. 14:49-64,
1963.                                  ~
         W. H. Perloff, E. Steinberger and J. K. Sherman, "Conception with
Human Spermatozoa Frozen by Nitrogen Vapor Technique, Fertility and
Sterility. 15:501-04, July-August 1964.
         J. K. Sherman, "Research on Frozen Human Semen: Past, Present,
and Future," Fertility and Sterility. Vol. 15, September-October 1964,
p. 490.
       17
         S. J. Behrman and Y. Sawada, "Heterologous and Homologous
 Inseminations with Human Semen Frozen and Stored in Liquid-Nitrogen
Refrigerator," Fertility and Sterility. 17:457-466, July-August 1966;
S. J. Behrman and D. R. Ackerman, "Freeze Preservation of Human Sperm,"
American Journal of Obstetrics and Gvnecologv. 103:654-661, March 1,
1969; 6. W. Matheson, L. Carlborg, and C. Gemzell, "Frozen Human Semen
for Artificial Insemination," American Journal of Obstetrics and Gynecology.
104:495-501, 1969; E. SteinbeTger and D. Smith,"Artificial Insemination
with Fresh or Frozen Semen: A Comparative Study," The Journal of the
American Medical Association,223:778-783, February 12, 1973; J. Friberg
and u. uemzell, ""Inseminations of human sperm after freezing in liquid
nitrogen vapors with glycerol or glycerol-egg-yoke-citrate as protective
media," American Journal of Obstetrics and Gynecologv. 116:330-34,
June 1, 1973.
report that frequency of pregnancies resulting from insemination with
frozen semen "remains approximately 2/3 of that expected when fresh
semen is utilized. 1       And in a recent study, Steinberger and Smith^
reported a higher conception rate when fresh semen was used--73% versus
                       20
61% with frozen semen.    All the data demonstrate, however, that semen
frozen and stored at -196.5°c can retain enough of its fertilizing
capacity to make pregnancy possible.
     Sherman 21 reports over 500 normal births resulting from the clinical
use of frozen semen.      He also reports 5 abnormal births and 41 spontaneous
abortions; both of these figures are less than the average frequency in
the general population. While these results do not provide evidence of a
reduction in birth defects or spontaneous abortions due to the use of
frozen semen, they do suggest that the use of such semen does not increase
the incidence of defects in pregnancy or in the progeny.        In another study
concerning the offspring resulting from artificial insemination with frozen
                    22
semen, investigators found the physical and intellectual development of
such children in no way inferior to that of the control group resulting
from natural impregnation.


       IO
            Behrman and Sawada, op. cit., supra, n. 17 at 463.
       IQ
       1=7
             Steinberger and Smith, op. cit..   supra, n. 17.
       on
          Another investigator, however, using semen stored at-198°C,
has reported a success rate comparable to that obtained with, fresh semen.
See Tyler, op. cit., supra, n. 5 at 416.
       21
          Sherman, op. cit.. supra, n. 2 at 403.
       22
        R. Y. lizuka, Y. Sawada, N. Nishina, and M. Ohi, "The Physical and
Mental Development of Children Born Following Artificial Insemination,"
International Journal of Fertility. 13:24-32, January-March, 1968. Fifty-
tour children were observed, 40 of whom were two and a half years of age.
Nine of the children were conceived after insemination with semen which had
been frozen to, stored at, and thawed from -79 C.
     Despite these apparent successes, a number of challenges to
human-semen cryobanking have recently surfaced.   Both the American Public
Health Association and the National Medical Committee of Planned Parent-
hood-World Population have questioned the unrestricted use in clinical
practice of semen frozen for more than three years. The American Public
Health Association contends that "the biologic potency and genetic adequacy
of human sperm which has been frozen and stored over a protracted period
of time and then thawed remains to be established."23 This view has been
challenged by Sherman, who has reported three successful conceptions (out
of three attempts) with human semen stored for ten years. It should be
emphasized, however, that the total number of reported pregnancies result-
ing from inseminations with frozen semen stored longer than six months is
relatively small. Thus, one should be cautious in assessing the long-
term cryopreservation capacity of human semen. The National Medical
Committee has also challenged the practice of providing "fertility
insurance" to men contemplating a vasectomy.   Because of what it considers
to be the highly experimental nature of human-semen banking, the Committee
argues that "the promise of fertility insurance to be achieved by storing
semen may be misleading. Moreover, it may lead to the persuasion of
                                                                  pr
immature or poorly motivated individuals to undergo vasectomy."


       0-3
        °APHA Recommended Program Guide for Voluntary Sterilization,
approved by the Executive Board of the APHA on June 16, 1972, p. 3.
       24J. K. Sherman, "Long-Term Cryopreservation of Motility and
Fertility of Human Spermatozoa," Cryobioloqy. 9:332,1972.
       25National Medical Committee of Planned Parenthood-World Population,
Statement Concerning Human Semen Cryobanking, 1972, p. 1.
Since vasectomy should be considered an irreversible operation, this
constitutes a serious challenge.
     These publicly expressed doubts suggest that there might be a need
for greater public accountability on the part of human-semen cryobanks.
They also underscore the need to assure that individual and societal
interests, however they may eventually be defined, are adequately pro-
tected. However, before either the urgency or the extent of such a need
can be determined and before such accountability can be properly defined,
it is necessary first to assess the status of human-semen cryobanking in
this country. In order to achieve this, research was undertaken to collect
information pertaining to the operating practices and policies of human-
semen cryobanks.   While the evolving relationship between frozen-semen
banking and artificial insemination will produce direct consequences for
those using these technologies, it will be the practices and policies under
which frozen semen is collected, stored, and utilized that will help shape
the nature of those consequences for users as well as for the larger
community.


DATA SOURCES

     The initial research task was to identify the human-semen cryobanks-
commercial and non-commercial--now operating in the United States. Each
of the 50 State Departments of Public Health and the Department of Human
Resources of the District of Columbia were asked to supply information
regarding the status of: (1) any commercial or non-commercial human-semen
cryobanks operating within their jurisdiction, and (2) any laws/codes per-
taining to the establishment, operation, and promotional activities of
such banks. Responses were received from 49 states and the District of
Columbia (only North Carolina did not respond). As a result of this
investigation, a list of active frozen human-semen banks was compiled
(Table 1).
     A questionnaire was then constructed which included queries
relevant to the substantive concerns of this study. These items
related to background data regarding the banks' origins, some of the
techniques employed in freezing and storing semen, and the practices and
policies which govern the day-to-day activities of the banks.    Question-
naires were then sent to all the banks listed in Table 1; there was a
response rate of 100%, with the home office of each commercial semen
bank responding for all of its branch offices.


HUMAN-SEMEN CRYOBANKING:    PRACTICES AND POLICIES

     The first frozen human-semen bank was established by Bunge and
Sherman of the University of Iowa in 1953.    It was not until 1970 that
the first commercial frozen-semen bank was established in St. Paul,
Minnesota. Now there are nine non-commercial banks and three major
commercial banks with eight branch offices located throughout the
country.    The majority of non-commercial banks are situated in a
university hospital or clinic, while most of the commercial bank     offices
are located in private laboratories, usually in a private medical office
building.
                                                    10
                                                  TABLE 1
                           FEOZEN-SEHEN BANKS IN THE UNITED STATES*


          The Chartered International                       Genetic Labs, Inc.**
               Cryobank                                     2233 N. Hamline Avenue
          Seven-Ten Bush                                    Minneapolis-St. Paul, Minnesota 55113
          San Francisco, California 94108
                                                            Genetic Labs, Inc.
          Clinic for the Study of Fertility                 3333 West Peterson
          University of Oregon Medical School               Chicago, Illinois 60645
          Portland, Oregon 97201
                                                            Genetic Labs, Inc.
          The Fertility Institute*                          10521 Wilshire Blvd.
          111 'North Wabash Avenue                          Los Angeles, California 90024
          Chicago, Illinios 60602
                                                            Genetic Labs, Inc.
          Frozen Semen Bank*                                2999 Regent Street
          Department of"Obstetrics & Gynecology             Huntmont Properties
          GWU Clinic- Room 735                              Berkeley, California 94705
          Washington, D.C. 20037
                                                            IDANT**
          Frozen Semen Bank                                 645 Madison Avenue
          Department of Anatomy                             New York, New York 10022
          University of Arkansas Medical Center
          Little Rock, Arkansas 72201                       IDANT
                                                            2355 East Stadium Blvd.
          Frozen Semen Bank*                                Ann Arbor, Michigan 48104
          Department of Obstetrics & Gynecology
          University of Michigan                            IDANT
          Ann Arbor, Michigan 48104                         5925 Forest Lane
                                                            Dallas. Texas 75230
          Frozen Semen Bank*
          Department of Urology                             The Tyler Clinic**
          University of Iowa Hospitals                      321 Westwood Blvd.
          Iowa City, Iowa 52240                             Los Ang«les, California    90024

          Frozen Semen Bank*                                Washington Fertility Study Center*
          University of Texas Medical School                2600 Virginia Avenue, N.W.
          102 Jesse H. Jones Library Bldg.                  Washington, D.C. 20037
          Houston, Texas 77025

                  *As of November 1973. The following banks are planning to open new
          offices in late 1973 or early 1974: The Chartered International Cryobank in
          Los Angeles, Sacramento and San Jose; The International Cryogenic System in
          Palo Alto, California; Genetic Labs is negotiating to open an office in
          New York City; a non-conmercial bank will be opening in Columbus, Ohio.
                  "Home Office
                  *Non-commercial semen banks

                  **According to its director, this clinic operates on both a commercial
          and a non-commercial level. For the purposes of this study, it is considered
          a non-commercial bank.




    I. Some Immediate Public-Policy Issues
       A. Techniques of Human-Semen Cryobanking: Of importance in
any study of the policies and practices of semen banks are the tech-
niques used for freezing and storing human semen. Any variation in
these techniques may, to a certain degree, affect the ultimate quality
of the semen sample and its fertilizing capacity, and thus may have
important consequences for prospective depositers and recipients and
                                      11

their potential offspring.    There is general agreement that liquid
                                                            OC
nitrogen at -196°C is superior to other freezing systems.        While
liquid nitrogen is the preferred technique among most of the semen
banks surveyed, one bank reports using refrigeration at -85°C. j^e
issue of the freezing technique is of obvious import since the suc-
cesses achieved from using frozen semen, as measured by the rates of
conception, "have to some extent depended on the freeze technique
used..."    An important research question, then, is what method is
most effective for freezing semen in a way which is consistent with
high fertilizing potential?
     Techniques for the storage of semen raise a similar question. Each
of the large commercial banks—The Chartered International Cryobank,
Genetic Laboratories, and Idant—use different storage methods. The
International Cryobank uses plastic ampules; Genetic Labs seals the
semen in glass ampules; and Idant uses plastic straws. Is there a
superior method for storing semen? Dr. Jerome Silbert, Director of
Laboratories at Idant, contends that "the survival rate during the
freezing process has been shown to be somewhat greater with straws than
with ampules because the configuration which the semen has maintained



         D. R. Ackerman, "Damage to Human Spermatozoa During Storage
at Warming Temperatures," International Journal of Fertility, 13:220-25,
July-September 1968; Sherman, op. cit., supra, n. 14.
       "H. Pederson and P. E. Lebech, "Ultrastructural Changes in the
Human Spermatozoan After Freezing for Artificial Insemination," Fertility
and Sterility, Vol. 22, February 1971, p. 125.
                                      12


permits it to freeze more uniformly." 28    There has been relatively
little comparative research, however, regarding these different methods
of storage. Furthermore, little research has been undertaken regarding
the most efficient and safest storage technique for packaging and ship-
ping frozen semen. Whether or not uniform standards for freezing and
storing techniques should be developed will depend largely upon continued
scientific and medical research.
     As an approach toward developing minimum standards of practice, data
should be collected pertaining to: (a) the methods used by semen banks
for freezing and storing semen;    (b) the methods and criteria employed for
determining the quality and fertilizing capacity of frozen semen; (c) the
number of conceptions/pregnancies resulting from the use of frozen semen
and the degree to which these results are associated with the different
techniques employed; and (d) the results of follow-up studies on children
born as a result of frozen semen, including both their physical and mental
development. With the recent growth of human-semen banking it may not be
too soon to begin to consider some preliminary guidelines.
        B. Donor Compensation:     One of the more important advantages of
frozen-semen is that in the case of a husband's infertility a third-party's
semen may be used for insemination independent of time and place. A pool
of frozen semen would also facilitate the selection of donors with regard
to such factors as physical and genetic characteristics.  There have been
reports of a recent increase in the demand for donor insemination. 29


       Gilbert, op. cit., supra, n. 6.
       29
        R. A. Ersek, Medical Director of Genetic Laboratories, Inc.,
Private Communication, 1973; Silbert, op. cit., supra, n. 6.
                                 -   13



All of the banks surveyed, with one exception, are involved in storing
semen from donors for insemination (The Chartered International Cryo-
bank stores semen only of those persons contemplating vasectomy and from
those with oligospermia). Those banks involved with donor insemination
report that they rely primarily on paid donors, with compensation being
in the range of $10 to $35 per specimen.
     With an increase in frozen-semen banks, particularly commercial
enterprises, the country may witness an increasing commercialization of
semen-donor relationships. This tendency toward commercialization      raises
several questions regarding the long-term impact on social values. If
semen is treated in practice as a commodity to be bought and sold, what •
will be the impact on prospective donors of blood, already heavily
dependent on paid donors,    eyes, or kidneys? Will they also become just
other "commodities" in the market place? And will this eventually lead to
the day when a "semen market" promises "eugenically desirable semen" to the
highest bidder? The fundamental issue is whether semen donations for the
purpose of artificial insemination are commercial transactions or a pro-
fessional service. The manner in which society confronts and resolves this
issue might well have profound consequences for the way it values the "gift


       30
         The Department of Health, Education, and Welfare recently announced
an effort to implement a new national blood policy, which would eventually
result in an all-volunteer donor system. At this time, however, the Depart-
ment apparently has no established guidelines regarding the content of such
a policy. See Constance Holden, "Blood Bankers Pressured to Unite,"
Science, 1821146, October:. 13, 1973.
                                         14

           31
of giving," and the value it accords to the integrity of bodily parts
and, indeed, to life itself.
        There are more immediate concerns, as well, regarding the use of
paid semen donors. These can perhaps be best illustrated by demonstrat-
ing the problems which have arisen from the use of paid blood donors.
There is suspicion among some that economic considerations are polluting
the blood supply. The Center for Disease Control in Atlanta estimates
that some 3500 deaths a year are caused by hepatitis resulting from blood
transfusions.       This infected blood tends to come from certain types of
paid donors, such as alcoholics, drug addicts and prisoners.       Statistics
indicate that the rate of hepatitis in the blood of paid donors is about
30 cases per 1000, while the. rate among volunteer donors is 3 cases per
        oo
1000.         There are no comparable statistics regarding human-semen cryo-
banking which, when compared with blood banking, is still in its infancy.
Also, paid donors constitute an overwhelming majority of those who donate
semen, leaving only a small number of volunteer donors with whom to draw
any statistical comparisons. There are the additional difficulties of
trying to link a donor's semen quality to any subsequent injuries or
defects.


       31An interesting and informative discussion on the psychodynamics
of "giving" can be found in Richard Titmuss, The Gift Relationship:
From Human Blood to Social Policy (Pantheon: New York, 1971) and
Marianne Neisser, "The sense of self expressed through giving and receiv-
ing, "Social Casework, 54:294-301, May 1973.
         32
        constance Holden, "Blood Banking: Money is at Root of System's
Evil," Science. 175:1344-1348, March 24, 1972.
                                    15

     It is conceivable, however, that some of the problems which have
resulted from using paid blood donors may find their way into human-
semen cryobanking. For example, how likely is it that a donor with a
drug habit, using drugs that may cause permanent chromosomal damage,
will seek remuneration for his semen as a way of maintaining his habit?
Syphilis and gonorrhoea are infectious diseases which can be deleterious
to both the recipient and fetus. As the commercialization of semen
donations increases is it likely that those who have contracted either
syphilis or gonorrhoea will constitute a significant proportion of paid
semen donors?   It is crucial to recognize the potential scope of this
problem. At this time, all of the semen banks surveyed report that they
rely primarily on medical students for donors. Whether or not this group
will continue, under the pressures of commercialization, to be a readily
available and desirable source in the future remains to be seen. 33 It is
important, therefore, that, if semen banking becomes increasingly depend-
ent on the paid'or professional donor, society acquire vital information
on the social characteristics of those who sell their semen.     It should



         1t is unlikely that the need for donor semen for therapeutic
insemination will ever be as great as the medical need for blood and
blood products. However, while the overall magnitude of the problem may
be less, the seriousness of the consequences for those directly involved
will be just as great. And, in addition to the possible immediate con-
sequences, the potential harm to future generations must also be considered.

       •^France's Kremlin-Biceter Hospital, a leader in research into male
sterility and artificial insemination, requires that all donors give their
sperm free. This has resulted in a donor population inclined more toward
          socio-economic levels of society. See Paul Majendie, "An
the upper 1
Adulterous Bank," Washington Post, June 10, 1973, p. H9. One might
legitimately ask, therefore, from which segments of society will a highly
commercialized semen-banking industry draw its donors? And what will be
the consequences?
                                       16


be noted here, and will be discussed more fully later, that there
exist a number of medical procedures for minimizing these potential prob-
lems.      It is important, however, to emphasize the need to make these
precautionary measures required procedure.
        It might be useful to consider alternative or complementary pro-
grams to one which relies so heavily upon paid donors. To what extent
can and should a program of voluntary donors become an integral part of
human-semen cryobanking? From what groups within society would such
donors be drawn? What factors might tend to inhibit the free flow of
donors? There will certainly be legal and moral questions involved in
the assessment of any such program and it will be important to evaluate
its possible short- and long-term effects. Another possible program
would be to institute semen donor credits, whereby a person (perhaps a
friend or relative) is able to donate his semen so that another person
may receive credit for a "free" specimen (the "free" specimen would not
necessarily be that of the friend or relative, since this would raise its
own psychological and genetic problems).
     No matter which alternative or complementary program is Instituted,
it is unlikely that society will be able to do without paid donors. An
all-volunteer system would produce surpluses of some types of semen and
shortages of others. To obtain sufficient quantities of semen at the
required times and in the necessary places and with the desired qualities
will certainly require donor compensation. An important question, then,
is whether the medical.profession, which now determines who may give and
not give semen and who may receive it, should also be given the power to
determine the system by which semen donations are made. As noted earlier,
                                    17


the problems which may arise transcend the medical profession and its
specific clientele, reaching into the basic social and economic fiber
of society.
     C. Donor Selection:   Regardless of whether donors volunteer or
are paid, their selection is undoubtedly the most crucial public-policy
issue concerning human-semen cryobanking and donor insemination. Among
all the banks surveyed, donor selection is done by the physician scheduled
to perform the insemination. In the case of commercial banks, the physi-
cian will initiate the request for a donor from a "donor pool" which has
been established by the commercial bank. The methods for donor selection
vary widely. For example, while all the banks attempt to match the dontir
and recipient with respect to their physical characteristics, only about
one third report using some type of "intelligence matching." Some require
that the donor be married, that he be of proven fertility, and that his
marriage is stable. Others, however, assign little importance to these
criteria. While all the banks report taking routine medical and genetic
histories of potential donors, their standards differ greatly. Some
banks require blood tests, while others do not. Some banks perform
screening tests and chromosome analyses for possible genetic defects of
the donor, but some do not. And even when such tests and analyses are
performed, the decision about which tests to perform will"vary from bank
to bank. While a complete semen analysis is considered to be essential
for evaluating semen quality,    there is some lack of agreement among
the banks as to what constitutes such a thorough analysis. Some report


       3
         §John MacLeod, "Human Male Infertility," Obstetrical and
Gynecological Survey, 26:335-351, 1971.
                                    18


conducting tests for sperm count, volume, motility and morphology, while
others report also examining the viscosity of the semen and conducting a
liye-dead assay as an objective check of the motility evaluation. The
critical point of this discussion is that among the banks included in this
survey, the standards and criteria for donor selection vary widely, thus
creating a situation in which there is no>uniform minimum standard of
practice upon which prospective parents and the community can rely.     Before
examining the problems which can arise from this situation, some considera-
tion needs to be given to the responsibility for donor selection.
     The responsibility for selecting a,suitable donor has in the past
rested with the physician. To a great extent he maintains that respon-
sibility today. However, with the emergence of commercial semen banks,
there is now an intermediary in the selection process. The physician who
requests semen from a commercial bank has, at least implicitly, accepted
the original selection criteria employed by that bank. An important
question, then, is this: What will be the effect of commercial banks on
the physician-donor-recipient relationship? Moreover, what should be the
nature and limits of responsibility—moral and legal—within the context
of this changing relationship? There are those who oppose this commercial
"intrusion" into the existing physician-donor-recipient relationship,
believing firmly that "it is the responsibility of the physician who
performs the artificial insemination to be personally involved in select-
ing the donor, knowing the donor, and keeping the entire process in total
confidentiality."?6



           . Steinberger, Private Communication, November 1972.
                                       19




     What, then, should society and the law require of the physician
or the semen bank in its investigation of the suitability of a pro-
spective donor?   In any newly developing field of medical care such
as human-semen cryobanking, there is bound to be a high level of
consumer ignorance and uncertainty.    Under such circumstances, the
patient often has no choice but to trust the medical profession and
others who provide his medical care.        Furthermore, the patient establishes
this fiduciary relationship with the realization that he and his family
may have to bear the biological, social, and economic consequences that
may result from any misplaced trust.        It is obvious, then, that the
social and legal questions at issue with regard to the responsibility for
donor selection are of such magnitude that they may require a more active
role on the part of society and its public institutions.
     The need for a more stringent and uniform set of medical and genetic
tests of prospective donors is particularly acute, for the potential
social and economic costs extend far beyond the individual donor and
recipient. They embrace the potential offspring, the medical profession
                                         i

and a society already concerned with its future population growth. Two examples
illustrate the problems which might arise. Sickle-cell anemia is a recessive
genetic disease which is accompanied by severe pain and for which there is no
cure. When both parents are carriers of the trait there is a 25% risk
that their child will manifest the disease. Each child will also have a
                                      20


25% chance of not inheriting the gene; and there is also a 50/50
chance that the child will receive only a single defective gene and
thus become a carrier of the genetic trait like both parents. Should
this child later marry another carrier, the couple will assume the same
risk as his parents of transmitting the disease to the next generation.
Thus, in the case of artificial insemination, if the semen of a donor
who is a carrier of the sickle-cell trait is used to impregnate another
carrier of the trait, then they become subject to the risks cited above.
There is, however, a simple screening test for the sickle-cell trait
                                            37
which requires only a small sample of blood. The failure on the part
of physicians or semen banks to implement such screening tests might well
have profound consequences not only for the individuals involved, but for
society's gene pool as well.38
     The second example concerns the report of the transmission of
                                       39
gonorrhoea by artificial insemination.    A donor's fresh semen was used
for four inseminations. He was examined carefully on the first three
occasions, including a blood test for syphilis, but was not examined
prior to the fourth insemination, following which the inseminated female


       37
          R. M. Nalbandian, B. M. Nichols, A. E. Heustis, e£. a]_. ,
 "An Automated Mass Screening Program for Sickle Cell Disease," The
Journal of the American Medical Association, 218:1680-1682, December 13,
T97T
       38
         In addition to sickle-cell anemia, there are at least 60 other
recessive genetic diseases which can be detected through screening. See
my monograph, Genetic Technology: Promises and Problems (The Program of
Policy Studies in Science and Technology, The George Washington University,
Washington, D. C., March 1973), especially pp. 12-15.
            . J. Fiumara, "Transmission of Gonorrhoea by Artificial
Insemi nati on , " British Journal of Veneral Disease. 48 : 308-09 ,
August 1972.
                                     21


contracted gonorrhoea. This case demonstrates the necessity for a
careful examination at each collection of semen.   The use of frozen
rather than fresh semen should provide ample time in which to carry out
the examination.
     While written medical and genetic histories are routine procedure
at all of the semen banks surveyed, these two examples stress the
importance of supplementing these histories with appropriate tests. If
not, there remains the possibility that some "problems" will not be dis-
covered.   Furthermore, the results of a medical history depend heavily on
the knowledge and truthfulness of the donor. A physician who does not
follow-up the history with proper medical tests relies, therefore, on the
donor's knowledge and on his willingness to impart his knowledge truthfully.
However, a donor may not know he is a carrier of a transmittable disease;
and reliance upon the honesty of the donor also has its pitfalls. It
would be useful to know the extent to which donors are honest in providing
their histories, and whether or not the level of honesty varies with the
objectives which motivate the donor to give. While a history of gonorrhoea
or syphilis is sufficient grounds for the rejection of a donor, there is
always the dreaded and not entirely unrealistic possibility that a person
who sells his semen to supplement his income not only is more likely to
have such a history, but might well be willing to suppress it.


       ^Returning to the example of blood donors, it has been repeatedly
demonstrated "that paid donors—especially poor donors badly in need of
money—are, on the average and compared with voluntary donors, relatives
and friends, more reluctant and less likely to reveal a full medical
history and to provide information about recent contacts with infectious
disease, recent inoculations and about their diets, drinking and drug
habits that would disqualify them as donors." Richard Titmuss, op. cit.,
supra, n. 31 at 151. By a parity of reasoning, therefore, the payment
and selection of semen donors without the proper follow-up medical and
genetic tests suggests the taking of highly unethical risks from which
the inseminated female, her husband and their potential child might prove
the victims.
                                     22


Thus, procedures used for selecting and screening donors will remain
the key factor in controlling the transmission of infectious and genetic
diseases.   In the absence of such procedures, the subsequent biological
condition of the recipients of the semen and their offspring remains the
ultimate test of the biologic and genetic adequacy of the donated semen.
In effect, to borrow a phrase from Titmuss, "the patient is the laboratory
for testing the quality of 'the gift.1"41 Certainly those persons using
a donor's semen are entitled to expect the application of proper standards.
     There are additional questions regarding the development and imple-
mentation of more rigorous tests for donor selection. While there is an
obvious need to design appropriate standards, there may be certain
limitations on their ultimate implementation. For example, there are at
least 60 recessive diseases susceptible to screening tests. Should semen
banks be required to test for all these diseases?   If not, which tests
should be required? What criteria should be used for making such choices?
The simplicity and cost of the test? The disease's prevalence in the
general population? The risk of occurrence?    Can a balance be achieved
among these factors? And who should absorb the financial burden of the
tests? There is yet another problem: the majority of genetic diseases


       41
        Ibid., p. 143.
                                     23


cannot now be detected by screening tests. Under these circumstances,
how can society maximize the safety and well-being of prospective
                                         42
recipients and their potential offspring?^ At the very least, thorough
medical and genetic histories should be established as minimum-level
requirements for donor selection.
     A caveat should be entered here against the construction of overly
rigid and strict standards, particularly in light of the limited evidence
presently in hand regarding the efficacy of human-semen cryobanking.     Any
set of standards must be flexible enough to take into account new advances
in medical science and technology.   What is clear, however, is that a
greater public interest would be served by a more rational and orderly
approach to the development of donor selection criteria.   There is a need,
therefore, for an investigation into both the feasibility and the desira-
                    \

bility of developing and implementing such criteria. While such a program
of standards will involve sensitive ethical and social policy questions,
such as those pertaining to confidentiality, informed consent, and the
possible inclusion of criteria for eugenic purposes, there can be little
disagreement that an assessment of the impact of such criteria is an
essential task for policy-making.

     Donor selection also raises two other issues. There has been little
systematic research into the consequences of "donor rejection." What is



      ^2 There is also the problem of identifying those diseases, such as
cancer and some types of mental illness, for which a genetic causal link
is believed to exist, but for which verification remains incomplete.
                                     24


the psychological impact upon an individual who has been told that he
is not an "acceptable" donor?43 What are the proper ethical and medical
guidelines for deciding what to tell the rejected donor and how to
tell him? To what extent are physicians and semen-bank personnel sensitive
to the needs of such an individual and trained to serve him effectively?
With a growing demand for donors for therapeutic insemination, these
questions will undoubtedly gain in importance.
     Finally, all of the banks surveyed report that they maintain strict
anonymity of the donor. Such anonymity is necessary in order to protect
against undesired transfers of affection on the part of both recipient and
future offspring 44   or extortion.4*5 There may be justification, however,
for instituting public policy to assure confidentiality in donor-recipient
transactions regarding both the anonymity of those involved and the release
of information.


     43
        The work of psychiatrist Z. Stephen Bohn may be useful in this
regard. On the basis of his professional experience, he suggests that
"the feeling of inadequacy, persists in the individual's mind...they may
for the first time, become acutely aware of their deficiency and the
latent developing neurosis may become overt and full blown. They begin
to wonder what kind of woman will accept their inadequacies. They begin
to consciously wonder what other people will think about them and say
about them and a sense of deep inferiority develops. This, in some
instances, can lead to a paranoid personality...They become maladjusted...
and they experience difficulty in obtaining the degree of emotional
maturity which is so necessary to carry out their responsibilities pertain-
ing to marriage and to society in general." See his article, "Artificial
Insemination: Psychologic and Psychiatric Evaluation," University of
Detroit Law Journal, 34:397-403, 1957. This excerpt is taken from
pp. 400-401.
     44
        Charles T. Gerber, "Medical Progress in Artificial Insemination,"
Illinois Medical Journal, 134:755-760, December 1968; Bernard Rubin,
"Psychological Aspects of Human Artificial Insemination," Archives of
General Psychiatry, 13:121-32, August 1965.
     45
        Milton Golin, "Paternity by Proxy," The New Phvsician.il:425-29.
December 1962.
                                  25


       D. Informed Consent: All the banks were asked if consent forms
were used for accepting and maintaining frozen semen and from whom such
forms were required. All three commercial semen banks, none of which
perform the actual insemination, report having "storage agreements"
for persons seeking to store their semen. In all three cases, a signed
agreement is required from the semen depositor. Of the non-commercial
banks, only one requires consent forms from the donor and his wife
as well as the recipient and her husband. Two require consent forms
from both the husband and the wife seeking the insemination, while two
of the banks require consent forms from the husband only. And three
of the banks replied that no consent forms were required (one bank
did not respond directly to this question). None of the banks reported
that they required consent forms from any other individuals. In light
of the uncertainty of success with the use of frozen semen in any one
specific case, the potential risks involved, and the highly emotional
atmosphere and the ambiguous legal status surrounding artificial
insemination, it would appear to be both essential and desirable to
examine informed consent as it might relate to human-semen cryobanking.
     Properly executed consent becomes an issue in human-semen banking
as it applies to: (1) the process of collecting, storing and using
semen for therapeutic purposes;   (2) the use of frozen semen for purposes
of population control; (3) frozen semen used for scientific research;
and (4) the disposal of semen after an individual's death or the failure
to maintain storage payments.
     The emotional and social impact that donor insemination can have
on the individuals involved and its ambiguous legal status are sufficient
                                   26


reasons for instituting appropriate procedures for obtaining informed
consent. Furthermore, there are still many medical "unknowns" relative
to the use of frozen semen, including questions concerning its efficacy
and genetic consequences.   Moreover, the fact that infectious diseases
may be transmitted is even more reason to make certain that those in-
volved are made fully aware of the potential consequences and that their
consent be obtained. Questions arise, however, concerning from whom
such consent should be required, who should request it, and what should
be the nature and substance of the consent.
     As a minimum requirement, informed consent in human-semen banking
should include: (1) an understanding by donors and recipients that there
is no "guarantee" that frozen semen will be useable at a later date
and that pregnancy will result from its use; (2) the fact that there
may be adverse medical and/or genetic consequences;   (3) the couple's
agreement never to seek to learn the identity of any donor and an
agreement from the donor and his wife not to seek to learn the identity
of any recipient of the donor's semen; (4) a donor's expressed willingness
to undergo a thorough medical and genetic history and subsequent medical
tests; (5) an understanding on the part of the donor's wife that her
husband's semen will be used for purposes of artificial insemination in
a woman other than herself, with the result that her husband may become
the father of a child of which she is not the mother; and (6) information
about the degree of knowledge presently available pertaining to human-
semen cryobanking. In addition, the agreement entered into by the
recipient(s) should include no exculpatory language through which
the recipient(s) is made to waive or to appear to waive, any of his
legal rights, or to release the physician or semen bank and its agents
                                  27


from liability for negligence. Because the bargaining positions of the
physician/semen bank and the donor and recipient are inherently unequal,
it is doubtful that a broadly worded waiver of any recourse against
the physician/semen bank for any fault for which it might be legally
responsible would be acceptable to the courts.
     Beyond these suggestions for achieving a minimum level of informed
consent, other questions emerge. For example, should a separate
consent form be required for each semen specimen, or will all specimens
maintained by the semen bank during the life of the donor be covered?
Should consent forms enumerate the specific medical tests that will
be performed to determine the health status of the donor and the quality
of his semen? As the semen-bank survey indicates, the tests performed
to determine the acceptability of a donor vary from bank to bank and
even individual banks do not necessarily perform the same tests for
each donor. There may be justification, therefore, for informing both
the donor and the recipient of all tests performed.   There is also a
question of what should be considered the proper amount of information
regarding the scientific status of frozen-semen banking that should
be imparted to a prospective recipient. And is the recipient entitled
to know if the semen comes from a volunteer or a paid donor? There
is also the question of who should request the consent.   In the past,
that responsibility has rested with the physician who was to perform
the insemination. Does the emergence of semen banks, however, create



             use Of exculpatory clauses in consent documents has been
considered contrary to public policy. See Tunkl vs. Regents of University
of California. 60 Cal. 2d 92, 32 Cal. Rptr. 33, 383 P. 2d 441 (1963),
Annot., 6 A.L.R. 3d 693 (1966).
                                     28


a shift in this responsibility? Should the request for consent come
from the physician who requested the use of the frozen semen and who
may be required to share legal responsibility for its use or from
the semen bank, which has had the more direct contact with the donor?
     There is a growing recognition of a relationship between the
interest in vasectomy, the storage of frozen semen, the growth of
commercial frozen-semen banks and population control.     Sherman suggests
that "The promise of future fertility in frozen storage may encourage
voluntary submission to vasectomy in proposed attempts at regulation
of the numbers of progeny produced."^' As noted earlier (supra, p. 7),
however, the promise of fertility insurance by freezing semen "may
be misleading" and might cause "immature or poorly motivated individuals
to undergo vasectomy."     Since many men may use frozen-semen banking
as a means of trying to overcome their anxiety over the irreversability
of vasectomy, there is the danger that the promise that not all possibility
of fatherhood is lost with a vasectomy will 1 be used to take advantage
of basic human emotions.     If an individual concerned about his future
fertility feels that he must bank his sperm, then perhaps he should
reexamine his reasons for a vasectomy rather than rush into it and rely
on the semen bank as an escape clause.^ Artificial insemination with


       47
        Sherman, op. cit. , supra, n. 2 at 406.
              is particularly important since there is a growing body
of literature which suggests that vasectomies are not always benign and
may increase sexual and psychological problems, especially among those
not emotionally prepared for the operation. See Helen Wolfers, "Psycho-
logical Aspects of Vasectomy," British Medical Journal, 4:297-300,
October 31, 1970.
                                   29


frozen semen is not always successful and thus a man is deluding himself
if he believes that he can deposit his semen, have it frozen, and then
return a few years later and be certain of having children. ,It is
therefore essential that all men (and their wives) be made fully aware
of the scientific knowledge regarding human-semen cryobanking as well
as the procedures and possible consequences of vasectomy.   Such
information should include the caution that there is no "guarantee"
that semen specimens will be useable at a later date. This information
should be communicated in a manner conducive to its comprehension by
those involved.
     In addition to storing semen for therapeutic purposes and for those
planning to undergo vasectomy, many, if not all, banks are using it
to conduct fertility research. In at least one case, the contract agreement
of a commercial bank includes a clause permitting it to "use small
portions of the Specimen to test the number and motility of spermatozoa
for any purpose whatsoever, including research or statistical purposes."
This therapeutic-contraceptive-research role of frozen semen raises
an immediate ethical question regarding the possible conflict of interest
of an investigator who is involved in fertility research and who, at
the same time, is counseling couples on the therapeutic or contraceptive
potential of banking semen.   Ethical medical research requires a balancing
of two important values. As physician or counselor, the researcher should
value highly humane therapeutic treatment.   As a research scientist, he
values increased scientific success through scientific inquiry. While
very often these two values are satisfactorily balanced, sometimes
emphasis on one value may preclude the achievement of the other. For
example, an overly ambitious investigator may, in promoting his research
                                       30


as well as his own scientific recognition, perform his physician/
researcher responsibilities without proper regard for the integrity of
 his   patient/subject.     In a recent study of the biomedical research
 community involved in human experimentation, Bernard Barber and his
colleagues report that
              the pressures of having to establish oneself
              in a competitive scientific community seem to
              have the effect of making those researchers
              engaged in studies with human subjects who feel the
              pressures most acutely less sensitive to the issue
              of informed consent and more willing to engage in 49
              studies with less favorable risks-benefits ratios.
This ethical dilemma will undoubtedly be present in a growing semen-
bank industry which will not only offer the possibility of therapeutic
and contraceptive help, but will also "create a most desirable spin-off
to research development in human reproduction."5^
       The importance of recognizing this problem is clearly underscored
 by the warning that the promise of fertility insurance through the
 storage of semen may persuade some immature or poorly motivated
 individuals to undergo vasectomy.      It may be necessary, therefore,
 to implement screening programs for vasectomy applicants, since
preexisting instability may be a contraindication to the operation.



       49e. Barber, J. Lally, J. Makarushka, and D. Sullivan, Research
on Human Subjects: Problems of Social Control in Medical Experimentation
(New York:Russell Sage Foundation, 1973), p. 76.
         50
          Sherman, op. cit., supra,' n. 2 at 407.
                                  31


It is imperative, however, that those seeking to store their semen
in a frozen-semen bank, for whatever purpose, be informed of the research
for which their semen may be used and the possible consequences of that
research.   It should be made clear that their semen will be used for
no other research purposes without their written consent.    The impor-
tance of this becomes clear when one examines the storage agreements
of the three major commercial semen cryobanks. All three banks provide
for the termination of their storage agreements upon either the death
of the donor or the failure to maintain storage payments, either by
the donor or his designated representative. Unless the donor has
specifically requested that his semen be destroyed upon his death, his
semen, as noted in the storage agreement he has signed, may be
"destroyed," used "in advancement of medical science," or "in any other
practicable manner," or for any purpose that the bank "deems fit."
Except for the circumstances under which the semen is destroyed, there
is little concrete information provided to the donor concerning the
possible uses of his semen. The uses cited above are all open to a
wide latitude of interpretation, with the result that the donor is
more likely to be confused than "informed."
     It might be useful at this juncture to illustrate what might
result from this situation. While it may be relatively "harmless"



              suggestion, of course, is contrary to existing policy
pertaining to the donation of blood. Once his blood is donated, the
individual is neither told nor given any discretion regarding its
distribution.
                                     32


as well as agreeable to the donor for his semen to be used in research
pertaining to the motility.of spermatozoa, the situation is quite
different if his semen, in the name of scientific research and without
his consent, is used to cause pregnancy by means of artificial insemination
in a woman other than his wife. Yet, only one of the three commercial
banks has a statement in its storage agreement which prohibits explicitly
the use of any specimen "without the client's written consent, for the
purpose of causing pregnancy by means of artificial insemination."
                                     52
Furthermore, it has been suggested        that the semen might be used for
research relating to in vitro fertilization, the fertilization1 outside
the body of the female of human egg by human sperm. It is doubtful
that many of those persons who contemplate banking their sperm are
aware of this possibility; present storage agreements and consent
forms do little to increase their awareness. It is imperative to
raise the question here, however, of the ethical propriety of using
donor semen without properly executed informed consent for experimen-
tation relating to in vitro fertilization.^
     From these concerns, one can articulate additional policy questions:
What provisions should be made regarding the disposal of a man's semen


       5
       ^Silbert, op. cit., supra, n. 6.
       53
         The ethical, social, and legal issues which apply to research
pertaining to in vitro fertilization have been discussed elsewhere. See
R.6. Edwards, and D.J. Sharpe, "Social Values and Research in Human
Embryology," Nature, 231:87-91, May 14, 1971; and Paul Ramsey, "Shall
We 'Reproduce1? I. The Medical Ethics of In Vitro Fertilization.
II. Rejoinders and Future Forecast," The Journal of the American
Medical Association, 220:1346-1350 and 1480-85, June 5 and 12, 1972.
                                     33


upon his death or his failure to maintain storage payments? Should
his semen become the property of the semen bank? His wife? His heirs?
What interest does the community have in the ultimate disposal of his
semen? And finally, are existing medical ethical practices and govern-
ment research guidelines54 adequate mechanisms for balancing the thera-
peutic and contraceptive needs "of the individual with the objectives
of promoting scientific research and protecting the individual as a
research subject?
      E. Family Planning Programs:    Of importance here is the role
now played by semen banking in family planning programs and the role
that it might assume in the future. To what extent are infertile couples
and men contemplating vasectomy aware of the availability of semen
banking as an alternative for family planning? What relationship now
exists between semen banks and family planning programs?   How are
decisions made regarding which couples will "qualify" for artificial
insemination? There are those experienced with the procedure who would
agree that it "should be offered only if the marriage appears stable
and if the couple are mature individuals who will understand all of the
emotional ramifications of such an act."55 Should there be additional
criteria? And how qualified are physicians to make such judgments?


        54
          DHEW Grants Administration Manual Chapter 1-40, The Institutional
Guide to PHEW Policy on Protection of Human Subjects, U.S. Department
of Health, Education, and Welfare (Washington, D.C.: U.S. Government
Printing Office, 1971), DHEW Publication No. (NIH) 72-102. This policy
is how undergoing revision.
        55
          S.A. Fish, "Continuing Problems of Artificial Insemination,"
Postgraduate Medicine, 38:415-20, October 1965, p. 418.
                                   34


Kleegman has noted that "few physicians have the psychological training
to accept this great responsibility; they need help in the choice
of [a] couple, ..."56 It is important, therefore, to learn the extent
to which fertility and genetic counseling services are available to
those planning to use frozen semen for therapeutic insemination.
     Another policy issue involves the providing of frozen semen for
the insemination of unmarried women. A number of semen banks surveyed
reported receiving inquiries from unmarried women—in many cases from
lesbians—who wanted to be inseminated with frozen semen in order to
fulfill their desire for children. What special ethical, legal and
social issues does this situation create? Is the existing practice
of "single-parent adoptions"   a comparable and adequate model for
resolving these issues? Do the issues change character, however, if the



        ^Sophia J. Kleegman, "Practical and Ethical Aspects of Artificial
Insemination," in Hugo G. Bergel (Ed.), Advances in Sex Research (Harper
and Row Inc.: New York, 1963), p. 118.
         'Though policies in most adoption agencies provide a preference
for a married couple to adopt, no state has legislation that prohibits
adoption of a child by single (unmarried, widowed) adults. For more on
"single-parent adoptions," see Ethel Branham, "One Parent Adoptions,"
Children, 17: 103-07, May-June, 1970 and "More Adoptions by Single
Persons," Family Financial Planning, September 17, 1970, p. 1.
                                   35



requests for frozen semen come from an admitted lesbian? 8 What might
be the consequences for a child growing up in this particular home
environment?   What is society's responsibility to such a child? And
is this situation a matter of such legitimate social concern that it
would justify societal intervention? Obviously, this is an area which
will require more thoughtful discussion.
     If frozen-semen banking assumes a larger role in family planning,
it may be necessary to reassess the role of the physician in selecting
couples for therapeutic insemination. An increase in semen banking
portends clear biological and social consequences for a greater part of
the population than a single couple and their offspring. The respon-
sibility for selecting couples, therfore, becomes a social as well
as a medical decision. A critical policy question, then, is whether
physicians should retain their sole responsibility for such decision-
making or, rather, should the decision-making domain be enlarged to
include other sectors of society which may more accurately reflect the
community's social mores?
     F. The Economics of Human-Semen Cryobanking: The economics
of human-semen cryobanking also raises several policy issues. Questions
concerning the costs of semen-bank services, the ability of the population
to pay for these services, and the role of private medical and liability



          In a legal context, of relevance here may be a case now
being appealed to the California Supreme Court. A mother of four
children has asked the Court to rule that she cannot be deprived of
her children because she is a lesbian. See "Calif. Lesbian Seeks
Custody of Children," The Washington Post, October 4, 1973, p. Dl.
                                       36


insurance will increase in importance as semen cryobanks become more
widespread. Underlying these questions, however, are two others:
How does one assess the economic value of potential life? And what
are the moral implications of making such as assessment?
     The person who wishes his semen stored in a frozen-semen bank
will ordinarily have to pay a number of fees. These fees will vary,
depending not only upon whether the individual uses a commercial or
non-commercial bank, but also upon which individual bank he ultimately
chooses.        Among the non-commercial banks surveyed, freezing and
storage fees range from $20 to $55 for the initial processing and the
first year of storage £o no cost at all, as reported by one of the banks.
A fifteen dollar per year fee for storage renewal was quoted by a number
of the banks. Among commercial banks, prices also vary widely. One bank
charges $55 for an initial deposit and $15 per year for storage.         Another
charges $40 for an initial deposit and the first year's storage and
$15 per year storage renewal fee. Yet another bank charges $80 for
an initial deposit and 6 months storage; thereafter, the storage fee
is $18.per year.
     These costs, and their inconsistency, raise questions pertaining
to the manner by which they are determined and the ability of persons
to pay them. Specifically, what factors are considered by the banks
in determining their fees? Can the cost differences       be linked to


           59
          The following fee schedules do not reflect similar amounts
of processing. Rather, the number of ejaculates that will be processed
initially for the given fee will vary among the banks.
                                   37


the different techniques used? If so, would uniform standards for
freezing and storing semen effectively remove these differences? How
do the different bank fees paid to semen donors affect the eventual
costs that the consumer must bear? Do present pricing policies
discriminate against consumers from different economic sectors of
society? To what extent does the financial condition of a couple
prevent it from seeking the services of a semen bank? Unfortunately,
no consistent nationwide data exist on the economics of semen banking.
It is essential, therefore, that a systematic study be done of the costs
involved in semen banking and the impact of those costs on consumers.
While it may be neither feasible nor desirable to establish a single
set of uniform pricing policies, it is probable that the donor, the
recipient, and the semen bank will all benefit from a more coordinated
approach to determining costs.
    The relatively high and varying costs of semen banking brings
clearly into focus the need for health insurance to help absorb the
financial burdens placed upon the consumer. The extent to which
private insurance companies are prepared to provide reimbursement
for the costs of testing, freezing and storing semen is not known.
One bank reports that some health insurance policies cover charges
for semen analysis if it is of "medical necessity." What constitutes
such "necessity," of course, is open to wide interpretation and how
one could "prove" it creates additional problems. With regard to
genetic testing, most insurance companies do not recognize cytogenetics
as a legitimate area for coverage and those that do often provide
                                    38


a reimbursement schedule far below what is needed.    The role now
played by private insurance companies in helping to absorb the costs
of semen banking is probably small relative to the need. An increase in
the availability of and demand for semen banking suggests that they
should assume a much larger role.
     All the semen banks surveyed were asked if they had liability
insurance in the event of damage to semen under their care. Only
two banks—both commercial--responded affirmatively. One bank noted
that the amounts are treated as confidential, while the other reported
that its liability is limited to $1,000 per ampule of semen stored.
What the real need is and will be for such liability coverage and how
a "proper"amount for such coverage is to be determined are more than
economic questions. As noted at the beginning of this section, questions
concerning the economic value of potential life and the implications of
determining such a value will challenge society's social and moral
standards.

     II. Some Long-Term Public-Policy Issues
     As noted earlier, this paper and its survey data constitute
an exploratory study into the policies and practices of human-semen
cryobanking, merely scratching the surface with respect to the kinds
of data that need to be collected. This section presents an agenda
of some long-term public-policy issues of human-semen cryobanking


        60
         Carlo Valenti, "Valenti Speaks Out on...,"   Laboratory
Management, 10:23, October 1972.
                                    39


which could be the basis for more focused study. The purpose here
is not to be exhaustive, but rather to give some direction to future
research.
        A. Supply and Demand: At the present time, there is no
organization or agency, either public or private, that has accurate,
up-to-date information concerning the extent of demand for semen-
banking or the supply capability of semen banks. On the demand side,
who are the people now using semen-bank facilities? How do they dis-
tribute with respect to education, religion, socio-economic status,
age and ethnic background? What reasons do these people give for using
semen-banks?   Personal values play an important role in determining
demand. More study is needed, therefore, of public attitudes and values
(which in turn affect legal responses) toward artificial insemination,
frozen-semen banking, vasectomy, and the procreative processes generally.
Similar data is required from physicians, including whether or not their
attitudes vary according to their professional training. How will
new innovations in the study and treatment of infertility affect the
demand for frozen semen? What will be the impact on demand of the
application of practical techniques for predetermining sex? And how
will the increased use of contraception and new liberalized abortion
laws, which will probably reduce (though not eliminate) the number
of unwanted children, affect the demand for frozen semen? With
respect to supply, a comprehensive national survey of semen banks
would provide data regarding the amount of frozen-semen collected,
stored, and used in this country, the number and location of all semen-
bank facilities, private as well as commercial, and the research cap-
abilities of these banks. Also needed are data concerning donor
                                   40


availability. How do semen banks attract donors? What proportion
of donors are paid/volunteer? What factors motivate donors to give
their semen? Do they vary according to their education, socio-economic
status, age, religion or ethnic background? An important result of
such study should be an improved data base for projecting future
needs and capabilities.
        B. Delivery and Utilization: A major public-policy objective
will be to determine how the benefits of human-semen cryobanking can
be distributed equitably and effectively to the population. Studies
are needed to assess the innovation process by which new techniques
are adopted by semen banks and passed on to the consumer.   What
processes of distribution are now used, including internal adminis-
trative and management techniques? What is the impact of various
pricing policies on the distribution and utilization of semen-bank
facilities? How familiar are physicians with the current availability
of frozen-semen banking and its clinical applications? Similar data
should be collected with respect to the general population, including
information indicating how such knowledge is acquired. More information
is needed regarding the primary and support personnel of frozen-semen
banks. What are their responsibilities? What is the nature of
their educational background and professional training? What kinds of
training are required and how can such training be most effectively
obtained? To what extent are fertility and genetic counselors members
of the "semen-bank team"? In the case of commercial banks, are consul-
tants employed in any advisory capacity? Answers to these questions
are critical if standards pertaining to the qualifications of semen-
bank personnel are to be established.
                                   41


        C. Population Planning and Policy: There are undoubtedly
those who, in view of national concern with an already abundant population,
would question the wisdom of any policy which might act to "institu-
tionalize" the practice of frozen-semen banking for therapeutic purposes.
This raises the familiar problem of balancing societal benefits and
individual needs, a dilemma that will be applicable to a variety of
other population concerns if human-semen cryobanking assumes a broader
role in population planning and policy.
             (i) Adoption: What will be the impact on adoption policies
and practices if infertile couples find frozen-semen banking and arti-
ficial insemination a more acceptable alternative for having their
family? Studies indicate that "reproductive failure is statistically
the commonest and emotionally the most compelling" reason for adoption.6^
As a way of alleviating such reproductive failure, will couples turn
more to frozen-semen banking and artificial insemination? Farris
and Garrison62 found that all the couples(38) they studied desired
a second child by donor insemination. And in his study of 1200



        ^Michael Humphrey, The Hostage Seekers (Humanities Press:
New York, 1969) p. 130.
        CO
           Edmond Farris, and Mortimer Garrison, Jr., "Emotional Impact
of Successful Donor Insemination: A report on 38 couples," Obstetrics
and Gynecology, 3:19-20, January 1954.
                                      42

                                      CO
infertile couples in Norway, L/vset        found that of the 395 who replied
to a survey, 374 were strongly in favor of insemination and 215 preferred
it to adoption. Of the many reasons for this, it appears that artificial
insemination, more than adoption, can satisfy a woman's psychological
drive directed toward bearing children.        Adoption, then, can never be
regarded as a fully adequate substitute for maternity.       In formulating
public policy, what consideration should be given to the welfare of
the "hard-to-place" child for whom it has been virtually impossible
to find a home, even without the additional competitive pressures
exerted by an increase in demand for frozen-semen banking? Will there
be subsequent pressures to alter adoption policies? The difficulties
in placing some "adoptable children" have been sufficiently documented 65
and warrant additional consideration in light of semen banking's
emerging capability. It may well not be in society's best interest to
strive toward one hundred percent fertility in married couples.


        63
          J. L^vset, "Artificial Insemination: Attitudes of Patients
in Norway," Fertility and Sterility. 2:415-429, 1951.
        64Rubin, op. cit., supra n. 44.
        6
          Ursula M. Gallagher, "Problems and Progress in Adoption,"
U.S. Department of Health, Education, and Welfare, Office of Child
Development, Children's Bureau, 1971. To illustrate further the extent
of these difficulties, Congressional committees are considering a bill
that would provide subsidies for couples who adopt hard-to-place children.
The bill would make payments to families who want to adopt such children
but who would be prevented from doing so because of the cost of caring
for the children. See "Adoption Subsidy," The Washington Post,
September 14, 1973, p. C3.
                                        43


             (ii) Sex Predetermination and the Sex Ratio: If techniques
for identifying and separating X-and Y-bearing human sperm can be
developed,66 then the availability of frozen-semen banking will facilitate
the ability of couples to choose the sex of their children (one can
visualize a clever entrepreneur opening up a semen bank for this purpose).
What might be the consequences of such a decision? The freedom to
predetermine sex might reduce family size, since many couples continue
to have more children in hoping to satisfy their desire for a child of
the other sex.       Such freedom may be a mixed blessing, however.
                     CO
Some investigators        have found that sex predetermination would mean a
heavily imbalanced sex ratio in favor of boys. Other studies, however,


        66
          P. Barlow, and C.G. Vosa, "The Y Chromosome in Human Spermatozoa,"
Nature. 226:961, 1970; R.A. Beatty, "Phenotype of Spermatozoa in
Relation to Genetic Content," Sex Ratio at Birth—Prospects for Control.
A Symposium published by the American Society of Animal Science, 1971.
        67
         Jeanne E. Clare and Clyde V. Kiser, "Social and Psycho-
logical Factors Affecting Fertility: XIV. Preference for Children
of Given Sex in Relation to Fertility," Mil bank Memorial Fund Quarterly,
29:440-92, October 1951.
        CO
          Simon Dinitz, Russell Dynes, and Alfred Clarke, "Preference
for Male or Female Children: Traditional or Affectional?", Marriage
and Family Living. 16:128-130, May 1954.
                                      44


found little evidence to support any overwhelming preference for male
children.       Clearly, additional study of such sex preferences is
required,    for an imbalanced sex ratio, in the absence of some
form of social control, may produce profound social and economic
consequences.     For example, Etzioni contends that "interracial and
interclass tensions are likely to be intensified because some groups,



        69$uzanne Keller and Siegwart Lindberg, "When Parents Can
Choose—Which Sex Will It Be?", The Futurist, 6:193-196, October 1972.
Studies of other societies strongly suggest that sex preferences may
be an even more critical factor in determining fertility patterns
than in American society. In many societies the desire for more children
in closely correlated with the number of living sons. For example,
in their study of India, May and Heer found that son survivorship is
commonly given as a motive for having a large family. Couples have
many children in order to be sure that they will have at least one
son who will survive them to their old age. David May and David
Heer, "Son Survivorship Motivation and Family Size in India: A
Computer Simulation," Population Studies. 22:199-210, 1968.
        70
          Unfortunately, many of the speculations about the potential
effects of sex predetermination are based on studies of the expressed
preferences of largely unmarried college students. As Sociologist
Gale Largey suggests, "a far more adequate basis would be the preferences
of married couples," since..."the decision to use sex control, and the
further decision to select children of a particular sex will necessarily
be a joint or couple decision." See her article, "Sex Control, Sex
Preferences, and the Future of the Family," Social Biology, Vol. 19,
December 1972, p. 383, n. 4. It is important, however, to obtain
information pertaining to such sex preferences prior to the time when
a couple starts their family. Otherwise, ex post facto statements of
sex preferences by parents may simply be rationalizations with respect
to the actual sex of their children. See Edward Pohlman, "Statistical
Evidence of Rationalization: Preference for Sex of Child," Psychological
Reports, Vol. 20, 1967, p. 1180.
     Also important for assessing the relationship between artificial
insemination and sex predetermination is information regarding how
those persons initially favoring sex predetermination would react to
choosing the sex of their child by use of artificial insemination.
Unfortunately, most pertinent studies do not explore this relationship
in their attitudinal surveys. One exception to this is a study by
Markle and Nam in which they report that "Many of those in favor of sex
predetermination did not like the idea of using artificial insemination
techniques to choose the sex of their future children, however. Fully
50% defected from their favorable opinion; 17% changed to "no," while
33% moved to a "not sure" position. Gerald E. Markle and Charles B.
Nam, "Sex Predetermination: Its Impact on Fertility," Social Biology,
Vol. 18, March 1971, p. 81.
                                     45


lower classes and minorities specifically, seem to be more male
oriented from the rest of society. Hence while the sex imbalance in
a society-wide average may be only a few percentage points, that of
some groups is likely to be much higher."71        This, according to Etzioni
will lead to lower class males seeking girls in higher status groups
in which they also will be scarce.         Nimkoff has predicted profound
changes in familial relationships as a result of an imbalanced sex
ratio. 72 It has also been suggested that the use of sex predeter- .
mination may generate changes in birth order patterns and "since the
position in the birth order has an affect on both physical and personality
traits of developing offspring, the consequences of the first-born
being all boys and the second-born all girls might well be reflected
                                           7*3
in behavioral shifts of the population.1         Society may eventually
have to consider controls governing the use of techniques for sex
predetermi nati on.74



          Amitai Etzioni, "Sex Control, Science, and Society," Science,
Vol. 161, September 13, 1968, p.. 1109.
        72Meyer F. Nimkoff, "Technology, Biology, and The Changing
Family," The American Journal of Sociology, 57:20-26, July 1951.
        73
          Philip Handler (Ed.), Biology and the Future of Man (Oxford
University Press: New York, 1970), p7 922.        '..       ~
        74A question worth exploring in this regard is whether .an
initial imbalance in.the sex ratio might be corrected "naturally."
In other words, is it reasonable to assume, as most studies of the
subject do, that sex preferences will remain constant? Or would an
initial overabundance of one sex lead to an increase in demand for the
other sex? Unfortunately, there is no data at present which would
indicate if or how people would adjust their actual or ideal family
if there were an excess of male children.
                                    46


             (iii) Genetic Implications: In addition to the possibility
of transmitting genetic diseases through donor insemination, there may
also be other long-term genetic consequences as a result of semen
banking. For example, semen specimens from different donors vary
considerably in their ability to withstand the process of freezing,
storing, and thawing. Thus, those donors whose semen exhibits a
greater degree of freezability will father a greater proportion of
progeny than would be expected with respect to their normal history
of fertility. The inevitable result of "this type of discrepancy in
fertility as introduced by freeze preservation treatment will decidedly
bias the number of offspring attributable to given donors.1      And,
in fact, there are reports in the literature of five donors being
"responsible for 90 pregnancies, one donor siring 35, and another
22.li/6 -[his disproportionate use of donors will increase the
coefficient of inbreeding    and probably reduce genetic variability


        75
          S.J. Behrman, and D.R. Ackerman, "Freeze Preservation of
Human Sperm," American Journal of Obstetrics and Gynecology,
Vol. 103, March 1, 1969, D. 659.
          John 0. Hamon, "Results in Artificial Insemination," The
Journal of Urology, Vol. 72, September 1954, p. 560.
        77jhis might lead to an increase in the incidence of recessive
genetic diseases among the population. For example, a first cousin
marriage brings together 1/8 of the total recessive genes carried by
both individuals. Studies have demonstrated that the progeny of first-
cousin marriages experience a higher-than-normal mortality and mal-
formation rate. Anne McLaren, "Biological Aspects of A.I.D.," in
G.E.W. Wolstenholme and D.W. Fitzsimons (Eds.), Law and Ethics of
A.I.D. and Embryo Transfer, Ciba Foundation Symposium 17 (new series);
(Associated Scientific Publishers: Amsterdam, 1973), p. 7.
                                     47


in the population.7R It may be necessary, therefore, for society
to consider restrictions on the use of any particular donors for
frequent therapeutic insemination.
     Frozen-semen banking will also provide man with a method for
influencing the genetic quality of his species.   By carefully selecting
donors with regard to their genetic qualities and then freezing and
storing their semen, semen banks might be used to make available a
wide range of genetic material for selection independent of time.
The most vocal proponent of this idea was the late biologist Herman
Muller, who suggested that donors be chosen who are the "most truly
outstanding and eminently worthy personalities known."''9   There is,
of course, the very serious problem of determining those human qualities
that are to be considered "desirable," especially with regard to future
generations who will live in different physical and social environments.
There is also the possibility that recessive genes, perhaps carrying
undesirable traits, in the semen of a frequently-used donor could
inadvertently proliferate throughout the population.   Thus, future
generations might experience increased doses of these harmful genes,
manifested in such diseases as sickle-sell anemia and tay-sachs.     On
the positive side, however, a couple in which both partners carry
complementary recessive genes can prevent the birth of a potentially



          D.R. Ackerman, "Biological Consequences of Population
Control," International Journal of Fertility. 17:131-141, 1972.
        79
          H.J. Muller, "Human Evolution by Voluntary Choice of
Germ Plasm," Science, Vol. 134, September 8, 1961, p. 646.
                                   48


afflicted*child (at least with respect to the disease traits that they
carry) by substituting the husband's semen with that of a donor
known to be free of such recessive genes. Similar use of a donor's
semen would especially be indicated in the case of a husband who is
thought or known to be a carrier of a dominant gene, such as Huntington's
chorea, whereby each potential child would have a 50 percent chance
of being affected. There are also other important questions: Will
the availability of this "service" promote an unhealthy preoccupation
with "good genes"? To what extent will such a program of "germinal
choice" affect the manner in which society views children who are born
through more traditional means? And what will be the social and
psychological effect on those children born as a result of germinal
choice? Will there be a need for public policy to determine how
the "best" donors are to be distributed among semen banks? Advancing
semen-bank technology has brought man closer to realizing the imple-
mentation of such genetic programs and serious attention needs to be
directed toward their possible consequences.


THE PUBLIC-POLICY STATUS OF HUMAN-SEMEN CRYOBANKING

     Human-semen cryobanking has yet to come under the serious purview
of any public policy-making body. The promotional and operational
activities of semen banks are, with some minor exceptions-, determined
entirely by the persons operating them. In the survey of the 50
State Departments of Public Health and the Department of Human Resources
of the District of Columbia, there was not one report of any existing
code/statute which applies directly to the establishment, operation or
                                    49


promotional activities of human-semen cryobanks.   Perhaps the most
distressing result of the survey was the observation that many of the
Public Health Departments had little or no knowledge regarding the
existence of semen banks in their state. A typical reply came from
a legal advisor to one of the state's Public Health Departments:
"Since this Department has no authority to regulate the establishment
and operation of sperm banks, we do not have any knowledge as to
whether any sperm banks have been established in the state."
     I. Current Public Policy
       There is some proposed or existing legislation, however, which
may be applicable to human-semen cryobanking. For example, the State
Assembly Health Committee of New York in 1972 drafted a tentative
semen-bank bill — "An Act to ammend the public health law, in relation
to the ownership and operation of semen banks"--for consideration in
the 1973 legislative session.   The bill, however, was never introduced
in the 1973 session. Because the Health Committee has retained the bill
for future study and since it represents the only venture into this
policy area by a state legislature, it might be useful to explore its
substance briefly. The bill is concerned primarily with: (1) the collection,
processing, and storage of human semen;   (2) permits for operating a
semen bank; t (3) rules and regulations; (4) enforcement; and
(5) penalties. The bill delineates who may obtain a permit, how it
may be obtained, and the duration for which it is valid.   Furthermore,
such permits may be "revoked, suspended, limited or annulled" by the
state's Department of Public Health, which is given the authority and
manpower to enforce the regulations. Perhaps the most important section
                                   50


of the bill is its "rules and regulations" (s. 591), which give the
Commissioner of Public Health the power to adopt and amend rules
"to effectuate the provisions and purposes" of the bill. The specific
provisions refer to the: (1) physical facilities and sanitary standards;
(2) qualifications of semen-bank personnel; (3) acceptance requirements
for semen donors;   (4) procedures for identifying and examining semen
samples; (5) procedures and standards for the maintenance of the
reproductive capability of frozen semen; (6) contracts and agreements
for services provided by the semen banks; and (7) content of the
advertisements and promotional materials published or distributed by
semen banks. While the bill covers most of the important policy areas
referred to in this paper, its wording is vague and there is a conspicuous
absence of any legislative guidance. As noted throughout this paper, there
are numerous policy areas for which more precise standards can be
formulated.
                                                                on
       The City of New York amended its Sanitary Code in 1947        to
impose restrictions on the use of donors for artificial insemination.
Among its requirements are that a donor be given a complete physical
examination; that donors found to be suffering from specific conditions
may not be used; that the blood of the donor and recipient be typed
with respect to the RH factor; and that the physician performing the


        80
         New York City, New York, Health Code art. 21 (1959);
formerly New York City, New York, Sanitary Code 112.
                                      51


insemination perpare records showing compliance with these requirements.
While the amendment can be applied to frozen-semen banks, it is unclear
with respect to the medical and genetics tests to be performed and the
precautions that should be instituted regarding informed consent and
the confidentiality of information.
       In some of the states, the regulation of semen banks is accomplished
through rules governing the "minimum standards for clinical labora-
        01
tories."01 There are, however, both procedural and substantive problems
with applying these standards to semen banks. Procedurally, semen
banks are not always automatically covered by such regulations. In
at least one case, a state and the director of the semen bank "arbitrarily
decided that they [the bank] would work under the regulations of a
clinical laboratory."   While the specific circumstances surrounding
these negotiations between the state and the bank are unknown to this
author, one must seriously question the desirability for the public
interest of such arbitrary policy-making. In a more substantive vein,
while there are usually rules pertaining to the qualifications of the
immediate staff of the semen bank, there are little or no regulations
concerning the qualifications of those providing ancilliary services,
such as genetic and fertility counseling. There are no guidelines
pertaining to informed consent and, in fact, the regulations often
do not apply to the research activities of the laboratories. And



          At least eighteen states, however, are without any regulations
pertaining to independent clinical laboratories. State Laboratory
Regulations in the U.S., Center for Disease Control. Department of
Health, Education, and Welfare, .December 1972.
                                      52


since semen banking was not a primary target of the regulations when
they were drafted, there are no standards which apply directly to the
freezing and storing techniques of cryobanking.
         Finally, at least one state noted that human-semen banks would
be subject to any laws in their state "relating to the conduct of
a business, just like any other business association." This seems a
rather incredible remark considering that the end result of the.
"business association" under study here may be the creation of human
life.
        II. Filling the Policy Void
         From this limited survey of state practices, then, it is apparent
that there are few statutes designed to regulate the activities of
human-semen cryobanks.    It would be useful, therefore, to conduct a
more detailed study of any statutes, standards, or practices that might
                                                              ;

apply to semen banks—directly or tangentially--at all policy-making
levels, including national, state and local policy-making bodies and
professional associations. Such a study, covering all aspects of
human-semen banking, would provide useful information necessary for
planning, designing, and implementing appropriate standards for the
operation of semen cryobanks.    The potential problem areas highlighted
throughout this paper demonstrate the need for some type of licensing
or regulatory action applicable to semen banking. Furthermore, while
those now operating semen banks appear to be responsible and sincere
in their concern for the public interest (all three commercial banks,
for example, have voiced their support for some type of regulations
and standards), there is no guarantee that less scrupulous operators
                                    53


will not eventually enter the business. At the present time, prac-
tically anyone with sufficient funds, some liquid nitrogen, and the
proper equipment can open a semen bank.
       A critical question arises, however, concerning the proper
policy-making body for promulgating such regulations. The survey
responses from the semen banks included suggestions which can be
grouped into three broad categories:     (1) federal-level policy-making
bodies, such as the Department of Health, Education and Welfare or,
                                                     \
more specifically, the Food and Drug Administration; (2) public
institutions at the state level; and (3) professional associations.
It would certainly be timely and appropriate to investigate the
feasibility and desirability of these, or other, institutional alternatives.
       No matter which alternative is chosen, there .will be a plethora
of policy-related questions requiring further study. For example,
what is the public-policy status of human-semen cryobanking in
other countries? A comparative study of worldwide policies and prac-
tices pertaining to semen banking should provide valuable information
to policy-makers.   How will related public and social policies affect
the utilization of frozen-semen banks? Specifically, what will be
the impact of laws affecting illegitimacy? Marriage? Adoption?
Sterilization? Contraception?    What should be the role of government
                                   54


in the development and application of semen-bank technology? 82 Since
frozen semen may give man a method of inducing conception in old age
and long after his death, what changes, if any, would be required
concerning the laws of inheritance? Should human-semen banking be
properly regarded as a medical procedure?     If so, should it be
governed only by those laws applying to medical practice generally?
To what extent should a physician or a semen bank be held liable for
errors of judgment in selecting donors?     For the failure to perform
certain medical and genetic tests?83 Should semen be defined as a



              government, of course, is already involved in the
subsidization of birth control. The Department of Health, Education,
and Welfare estimates that nearly four million women received birth-
control aid at government expense in the 1972-73 fiscal year. By
1975, costs for the program are expected to reach 400 million dollars.
U.S. News and World Report. September 10, 1973, pp. 33-35. Federal
agencies also make funds available to pay for the care of those
persons who undergo voluntary sterilization. For example, the Bureau
of Community Health Services of the Department of Health, Education,
and Welfare, through its Family Planning Services program, provides
funds for the voluntary sterilization of both males and females.
To what extent, then, should such a program also be obligated to provide
semen storage for those who undergo vasectomy?
        83
          0f interest here is "an increasing recognition by the courts
of the right of an infant plaintiff to compensatory damages if injured
during any stage of gestational life if the defects were caused by
a negligent third party," See Blair L. Sadler, "The Law and The Unborn
Child: A Brief Review of Emerging Problems," in Maureen Harris (Ed.).
Early Diagnosis of Human Genetic Defects: Scientific and Ethical
Considerations. Fogarty International Center Proceedings, No. 6, 1972
(Department of Health, Education, and Welfare Publication No.
(NIH) 72-75), p. 218.
                                 55


                                                                       oa
service or as a product? And how will the decision affect liability?
Should limits be placed on the content and scope of advertisements and
promotional materials published and distributed by semen banks? What
might be the effect of a "high-powered" advertisement campaign by semen
banks on the reproductive attitudes and behavior of persons seeking
infertility treatment or "fertility insurance" for vasectomy?
     III. Public Policy and Artificial Insemination
      As a concluding note to this discussion, it is appropriate to
comment briefly on existing public policy concerning artificial
insemination. Because of an inhibitory social and moral climate,
artificial insemination has been shrouded in a cloak of secrecy. As
a result, information essential for formulating public policy often
is not available. Furthermore, the legal status of those involved
with the procedure remains ambiguous and has been slow to evolve.85
Until the rights of the persons involved are clarified by public policy,
the physician who performs the insemination, the husband, the wife,
the potential offspring, and the donor are all in an unsatisfactory
position with regard to the law. For example, the child born as a
result of donor insemination is not the biologic offspring of the
husband and is, therefore, technically illegitimate in the overwhelming
majority of the states. Only Georgia, Kansas, and Oklahoma have statutes


       84
          For a relevant summary discussion of liability with the
use of blood, human tissues and organs, see William J. Curran,
"Constitutionality of Exemption Laws on Guarantee of Purity for
Blood Transfusions and Tissue and Organ Transplants," The New
England Journal of Medicine, 288:457-459, March 1, 1973.
      85
        David A. Sergeant, "The Legal Status of Artificial Insemination;
A Need for Policy Formulation," Drake Law Review, 19:409-440, May 1970.
                                   56


legitimizing the child born through artificial insemination. An increase
in frozen-semen banking, therefore, means an increase in the number of
legally illegitimate children born in the United States. Obviously, then,
to establish public policy for semen banks requires concomitant public
                                    Rfi
policy for artificial insemination.
       This study has been a modest attempt to collect information
pertaining to the status of human-semen cryobanking in the United
States. Despite its limited scope, however, the study has attempted to
highlight some familiar as well as emerging policy issues pertaining
to human-semen cryobanking. Heretofore, many of these crucial issues
have hardly been noted, let alone seriously considered. Yet the sudden
and rapid emergence of commercial human-semen banks makes it imperative
for society to begin to examine the many policy questions which are
surfacing.




             relevance here is the recent Report of Panel on Human
Artificial Insemination of the British Medical Association. The
Report recommended that donor insemination be made generally available
within the British National Health Service. Op. cit., supra, n. 1.
Page Intentionally Left Blank

                     +• 5%
STANDARD TITLE PAGE          1. Report No.                                     3. Recipient's Catalog No.
FOR TECHNICAL REPORTS           GWPS-MON       18
4. Title and Subtitle                                                          5- Report Date
     THE PUBLIC POLICY DIMENSIONS OF ARTIFICIAL          INSEMINATION             December 1973
     AND HUMAN-SEMEN CRYOBANKING                                               6. Performing Organization Code

7. Author(s)                                                                   8- Performing Organization Kept.
               MARK S. FRANKEL                                                    No.
9. Performing Organization Name and Address                                    10. Project/Task/Work Unit No.

     Program of Policy Studies in Science and Technology                       11. Contract/Grant No.
     The George Washington University
     Washington, D.C. 20006                                                     NASA NGL 09-010-030
12. Sponsoring Agency Name and Address                                         13. Type of Report & Period
                                                                                   Covered
     National Aeronautics and Space Administration
     400 Maryland Avenue, S.W.                                                 14. Sponsoring Agency Code
     Washington, D.C.
15. Supplementary Notes


16. Abstracts

        The author explores a variety of public-policy issues raised by the use of
     artificial insemination and human-semen cryobanking. Of particular importance
     are those issues which result from the commercialization of semen banking.
        The author's analysis is supplemented by survey research data of the status
     of human-semen cryobanking in the United States. A survey of the 50 State
     Departments of Public Health and the Department of Human Resources of the District
     of Columbia was undertaken in order to acquire information regarding the status
     of: (1) commercial or non-commercial human-semen cryobanks operating within their
     jurisdiction; and (2) laws/codes pertaining to the establishment, operation, and
     promotional activities of such banks. A survey of human-semen cryobanks was also
     conducted in order to obtain information regarding the practices and policies
     which govsern the day-to-da,y activities of the banks.
17. Key Words and Document Analysis. 17o. Descriptors

     Biology            0600
     Medicine           0600
     Cryogenics         2013
     Germ Cells         0616 0603
     Reproduction (biology)                  0603 0616



17b. Identifiers/Open-Ended Terms

     Artificial Insemination
     Semen Cryobanking


17c. COSATI Field/Group
18. Distribution Statement                                     19. Security Class (This     21. No. of Pages
                                                                   Report)                         65
    Releasable to public without limitation. Initial                  UNCLASSIFIED
    distribution from Program of Policy Studies; all           20. Security Class (This     22. Price
                                                                   Page
    subsequent copies from NTIS                                       UNCLASSIFIED
FORM CFSTI-35 (4-70)                                                                        USCOMM-DC 65002-P7O

				
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