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records of biomedical research. These records, however, almost exclu-
sively pertain to scientific investigations conducted at hospitals, federal
government-operated laboratories, and educational institutions. (See
Chapters 2, 3, and 5 for examples of major collections in these respective
categories.) Documentation of the functions of specialized biomedical
research units, by contrast, is located in relatively few repositories. In-
stances mainly reflect the academic connections of the principal investiga-
tors; an example is papers of distinguished scientists preserved in univer-
sity archives. Individual prominence has also led to the placement of
relevant collections in certain general repositories, among them the Li-
brary of Congress, the National Library of Medicine, the Smithsonian
Institution, the American Philosophical Library (Philadelphia), and the
State Historical Society of Wisconsin (Madison). The records of the Gen-
eral Education Board of the Rockefeller Foundation in the Rockefeller
Archive Center are important for their coverage of early twentieth-
century foundation support of biomedical research institutions. Rarely
has an independent nonprofit institution in the fields examined here
established its own archives, as is the case with the Cold Spring Harbor
Laboratory. The commitment to archives or discipline history on the part


of specialty profit-making biomedical research enterprises is, at this writ-
ing, an unknown. A patient, persistent, and long-term investigation by a
discipline history group dedicated to biomedical research, along the lines
of the AIP or the Chemical Heritage Foundation, could yield important
information. ^2


1. Various directories of biomedical research organizations follow significantly
different criteria in the selection and arrangement of their listings. The
Encyclopedia of Medical Organizations and Agencies (EMOA), 3rd ed. (Detroit: Gale
Research, 1990), for example, lists more than 2,500 research organizations,
including approximately 700 U.S. government research centers and programs
and approximately 1,800 university-related and other nonprofit institutions
outside of federal agencies. Entries in EMOA are divided into 69 biomedical
specialty areas, all but two of which are the focus of at least one research
center in the United States. The Research Centers Directory (RCD,) 16th ed.
(Detroit: Gale Research, 1991) covers university research centers and other
nonprofit research organizations in both the United States and Canada but
does not list the federal government agencies of either country. "Medical and
Health Sciences," the third of seventeen sections, contains almost 2,000
entries. An additional 1,000 institutions that are devoted to the basic
biomedical and behavioral sciences may be found listed in three other
sections of RCD. Commercial research institutions in the United States, which
do not appear in either of the publications just mentioned, account for about
1,800 of the entries in The Biotechnology Directory (1991 ed., J. Coombs and Y.
R. Alston, New York: Stoclcton Press, 1990).

2. Donald S. Fredrickson, "Biomedical Research in the 1980s," New England
Journal of Medicine 304 ( 1 98 1 ) : 5 1 3 .

3. Biomedical research institutions in these respects are typical of a much larger
web of institutions that cut across government, nonprofit, and industrial
lines. See Louis Galambos and Joseph Pratt, The Rise of the Corporate
Commonwealth: U.S. Business and Public Policy in the Twentieth Century (New
York: Basic Books, 1988), and Louis Galambos, ed.. The New American State:
Bureaucracies and Policies Since World War II (Baltimore: Johns Hopkins
University Press, 1987).

4. Robert Q. Marston, "Influence of NIH Policy Past and Present on the
University Health Education Complex," in H. Hugh Fudenberg and Vijaya L.
Melnick, eds.. Biomedical Scientists and Public Policy (New York: Plenum Press,
1978); Robert J. Glaser, "The Impact of Philanthropy on Medicine and
Health," Perspectives in Biology arid Medicine 36 (1992): 46-56; and George F.
Cahill, "The Role of Foundations in the Future of Medicine," Clinical and
Investigative Medicine 9, no.4 (1986): 273-77.

5. Internal Revenue Code 170A-9(b)(l)(iii).


6. Barbara J. Kirschten, "Obtaining Tax-Exempt Status for Medical Research
Organizations," Tax Management, Estates, Gifts, and Trusts Journal 15 (1990):

7. Internal Revenue Code 170A-9(b)(l)(ii).

8. For official listings and program statements, see The United State Government
Manual (Office of the Federal Register, National Archives and Records
Administration, annual). See also Alice K. Dustira, "The Funding of Basic and
Clinical Biomedical Research," in Roger J. Porter and Thomas E. Malone,
eds.. Biomedical Research: Collaboration and Conflict of Interest (Baltimore: Johns
Hopkins University Press, 1992), 33-56.

9. Arthur Kornberg, For the Love of Enzymes: The Odyssey of a Biochemist
(Cambridge: Harvard University Press, 1989), 1-8, 29-31, 79-83, 121-34.

10. Information drawn in part from an information bulletin, "Mayo Graduate
School of Medicine . . . Postdoctoral Research Fellowship Programs" (Mayo
Clinic and Foundation, Rochester, Minn., 1991).

1 1 . Rosemary Stevens, In Sickness and in Wealth: American Hospitals in the Twentieth
Century (New York: Basic Books, 1989). For more information on academic
health centers, see Joan D. Krizack, "The Context for Documentation
Planning in Academic Health Centers," in Nancy McCall and Lisa A. Mix,
eds.. Designing Archival Programs to Advance Knowledge in the Health Fields
(Baltimore: Johns Hopkins University Press, 1994).

12. Christopher C. Vaughn et al., "The Contribution of Biomedical Sciences and
Technology to U.S. Economic Competitiveness," in Porter and Malone,
Biomedical Research, 57-76.

1 3. Wayne Biddle, "A Patent on Knowledge: Harvard Goes Public," Harper's, July
1981, 22-26, and Bernard D. Reams, University-Industry Research Partnerships
(Westport, Conn.: Quorum Books, 1986), 105.

14. Paul G. Waugaman and Roger J. Porter, "Mechanisms of Interactions
between Industry and the Academic Medical Center," in Porter and Malone,
Biomedical Research, 93-1 18.

15. Reams, University-Industry Research Partnerships, 105-326, devotes extensive
coverage to selected contracts.

16. Waugaman and Porter, "Mechanisms of Interactions," 1 1 1-14.

17. Richard S. Ross, "Academic Research and Industry Relationships," Clinical
and Investigative Medicine 9 (1986): 268-72, and Thomas W. Langfitt et al., eds..
Partners in the Research Enterprise: University-Corporate Relations in Science and
Technology (Philadelphia: University of Pennsylvania Press, 1983).

18. Reams, University-Industry Research Partnerships, 123-24, 146.

19. Joan K[rizack] Haas, Helen Willa Samuels, and Barbara Trippel Simmons,
Appraising the Records of Modern Science and Technology: A Guide (Cambridge:
Massachusetts Institute of Technology, 1985), although not addressing
biomedical research directly, is a substantial guide to understanding the
process and stages of scientific investigations. See especially the Table of
Scientific and Technological Activities and Their Records, 20.

20. Howard H. Hiatt, America 's Health in the Balance: Choice or Chance? (New York:
Harper & Row, 1 987), 1 56-6 1 , and William Paton, Man and Mouse: Animals in


Medical Research (New York: Oxford University Press, 1984), 23-24.
Bioethicists in particular draw distinctions between therapeutic and
nontherapeutic research (or between validated and nonvalidated praaices).
See Thomas A. Mappes and Jane S. Zembaty, Biomedical Ethics, 3rd ed. (New
York: McGraw-Hill, 1991), 204-9. For the concept of clinical research placed
into international perspective, see Jacques Genest, "Modern Concept of the
Organization of Clinical Research," Clinical and Investigative Medicine 9 (1986):

21. Quoted by James B. Wyngaarden in "The Role of Government Support in
Biomedical Research," Clinical and Investigative Medicine 9 (1986): 265-68.

22. Washington University, Division of Biology and Biomedical Sciences, Faculty
Research (catalog), 1992-1993, 1992.

23. For a broad archival survey of industries of the kind involved here, see Bruce
H. Bruemmer and^heldon Hochheiser, The High-Technology Company: A
Historical Research and Archival Guide (Minneapolis: Charles Babbage Institute,
University of Minnesota, 1989).

24. Michael Spector, "The Case of Dr. Gallo," New York Revievi' of Books, 15 Aug.
1991, 52.

25. Robert F. Jones, American Medical Education: Institutions, Programs, and Issues
(Washington, D.C.: Association of American Medical Colleges, 1992), 21.

26. Gerald F. Anderson and Catherine M. Russe, "Biomedical Research and
Technology Development," Health Affairs 6 (1987): 85-92.

27. Jones, American Medical Education, 22.

28. Philip Abelson, "Mechanisms for Evaluating Scientific Information and the
Role of Peer Review," Journal of the American Society for Information Science 41
(1990): 216-22, and Susan Crawford, Loretta Stucki, "Peer Review and the
Changing Research Record," ibid., 223-28.

29. Virginia P. White, Handbook of Research Laboratory Management (Philadelphia:
ISl Press, 1988), 18-20.

30. Carl Frieden and Barbara J. Fox, "Career Choices of Graduates from
Washington University's Medical Scientist Training Program," Academic
Medicine 66, no.3 (1991): 162-64.

31. White, Research Laboratory Management, 46-58.

32. Waneta C. Tuttle et al., "Considerations of Managing Large-Scale Clinical
Tx\a\s," Journal of the Society of Research Administrators 2\, no. 2 (1989): 13-

33. It does not always follow that well-funded investigations use the best
equipment. A National Science Foundation study in the early 1980s revealed
that less than 20 percent of existing apparatus used in academic research in
the biological and medical sciences was state of the art. Many buildings and
laboratory facilities erected in the early days of NIH funding (the late 1940s to
the early 1960s), moreover, urgently need modernization. See E. Jill Hurt,
ed.. Health Policy Agenda for the American People {Chicago: Health Policy Agenda
for the American People, 1987), 2: 1 57.

34. Laurence M. Friedman, Curt D. Furberg, and David L. DeMets, Fundamentals
of Clinical Trials (Littleton, Mass.: PSG, 1985); Stuart F. Spicker, The Use of


Human Beings in Research: With Special Reference to Clinical Trials (Boston:
Kluwer, 1988); and Tuttle et al., "Large-Scale Clinical Trials."

35. Paul Appelbaum, Charles W. Lidz, and Alan Meisel, Informed Consent: Legal
Theory and Clinical Practice (New York: Oxford University Press, 1987), 211-
19; Ruth Faden, Tom L. Beauchamp, and Nancy M. P. King, A History and
Theory of Informed Consent (New York: Oxford University Press, 1 986), 1 5 1-87;
and David J. Rothman, Strangers at the Bedside: A History of How Law and
Bioethics-Transformed Medical Decision Making (New York: Basic Books, 1 99 1 ).

36. David L. Wheeler, "Informed Consent Questioned in Research Using
Humans," Chronicle of Higher Education, 4 Dec. 1991, A 14.

37. Code of Federal Regulations, Title 45, pt. 46, Protection of Human Subjects,
revised March 8, 1983. The portions of the Code that specify how institutional
review boards (IRBs) are to be established and operated include the following:
"Each IRB shall have at least five members, with varying backgrounds to
promote complete and adequate review of research activities commonly
conducted by the institution. The IRB shall be sufficiently qualified through
the experience and expertise of its members, and the diversity of the
members' backgrounds including consideration of the racial and cultural
backgrounds of members and sensitivity to such issues as community
attitudes, to promote respect for its advice and counsel in safeguarding the
rights and welfare of human subjects." A subsequent part of the same seaion
of the regulation indicates that each IRB shall include "at least one member
whose primary concerns are in nonscientific areas (45 CFR 46. 1 07) ." See also
Applebaum et al.. Informed Consent, 219-28.

38. Two institutions at the Washington University Medical Center illustrate
situations of this nature: Barnard Free Skin and Cancer Hospital, a research
hospital in St. Louis that was originally independent, merged with the
university in 1950 and lost its autonomy in patient care four years later, when
it moved to the medical center campus. Barnard now functions as an
endowed research and treatment program of the university medical school
and Barnes Hospital, the center's principal teaching hospital. In 1992,
Mallinckrodt Institute of Radiology, the clinical treatment arm of the
university's radiology department, transferred most of its patient services at
Barnes Hospital to the hospital administration in the interests of simplifying
billing procedures, as required by Medicare and commercial insurers.

39. Archival readers are advised that the research world ineluctably uses the term
manuscript almost exclusively in this context.

40. Arnold S. Relman, "Medical Research, Medical Journals, and the Public
Inieresi," Journal of the Society of Research Administrators 2\, no. 2 (1989): 7-12;
Abelson, "Evaluating Scientific Information"; and Crawford and Slucki,
"Peer Review."

41. White, 1988, 140^7.

42. Joan Warnow-Blewetl, "Saving the Records of Science and Technology: The
Role of a Discipline History Center," Science and Technology Libraries 7 (1987):
29-40; "The Role of a Discipline History Center, Part II: Promoting Archives

NOTES 1 03

and Research in Science and Technology," Science and Technology Libraries 9
(1988-89): 85-102. See also AIP, AIP Study of Multi-Institutional Collaborations:
Phase I: High Energy Physics (New York: AIP, Center for History of Physics,
1992) issues of the AIP History Newsletter, 1989-present, that describe a long-
term study of interinstitutional collaborations in physics and allied sciences.

43. U.S. Department of Health and Human Services, U.S. Department of Energy,
Understanding Our Genetic Inheritance, the U.S. Human Genome Project: The First
Five Years, FY I99I-I995 (Washington, D.C.: Government Printing Office,
1990); and John Beatty and Elizabeth E. Sandager, "Documenting the
Human Genome Project: Challenges and Opportunities," draft report. History
of Science Society, 1992.

44. U.S. Department of Health and Human Services, Understanding Our Genetic
Inheritance, and unpublished communication with David Lipman, NCBI, and
Susan Crawford, Washington University School of Medicine Library.

45. The Chemical Heritage Society publishes a quarterly newsletter. Chemical
Heritage (formerly The Beckman Center for Chemistry News); unpublished
communication with Susan Lindee and Elizabeth E. Sandager, Chemical
Heritage Foundation; Doris Mueller Goldstein, National Reference Center for
Bioethics Literature, Georgetown University, 1990-1991; Elizabeth E.
Sandager, "Report on Los Alamos Exploratory Site Visit," on behalf of the
Chemical Heritage Foundation, unpublished, 1992. Other prominent efforts
to document the human genome project are led and coordinated by Victoria
A. Harden of the NIH Historical office.

46. For a comprehensive account of the "cancer wars," see James T. Patterson,
The Dread Disease: Cancer and Modern American Culture (Cambridge: Harvard
University Press, 1987).

47. The actual total, suggested by EMOA and RCD, would fall between 400 and 500.

48. Brian Jay Yolles, Joseph C. Connors, and Seymour Grufferman, "Obtaining
Access to Data from Government-Sponsored Medical Research," New England
Journal of Medicine 315 (1986): 1669-72.

49. Relman, "Medical Research, Medical Journals, and the Public Interest."

50. Terry E. Hedrick, "Justifications for and Obstacles to Data Sharing," in
Stephen E. Fienberg, Margaret E. Martin, and Miron L. Straf, eds.. Sharing
Research Data (Washington, D.C.: National Academy Press, 1985), 123-47.
See also Jane Williams, "The Importance of Preserving Scientific Data," in
McCall and Mix, eds.. Designing Archival Programs.

51. Joe Shelby Cecil and Eugene Griffin, "The Role of Legal Policies in Data
Sharing," in Fienberg et al.. Sharing Research Data; Cecil and Robert Boruch,
"Compelled Disclosure of Research Data: An Early Warning and Suggestions
for Psychologists," Law and Human Behavior 12 (1988): 181-89; and Yolles
et al., "Obtaining Access to Data."

52. David Bearman and John T. Edsall, eds.. Archival Sources of the History of
Biochemistry and Molecular Biology: A Reference Guide and Report (Boston:
American Academy of Arts and Sciences, 1980), is still the most complete
guide to existing archival collections from biomedical research institutions.



Abelson, Philip. "Mechanisms for Evaluating Scientific Information and the Role
of Peer Review." Journal of the American Society for Information Science 41
(1990): 216-22. Examines the effects of the "publish or perish" syndrome on
research publication and discounts reports of widespread fraud.

American Institute of Physics, Center for History of Physics. AIP Study of Multi-
Institutional Collaborations, Phase I: High-Energy Physics. New York: American
Institute of Physics, 1992. An enormously valuable model for any scientific
discipline history project; divided into reports (no. 1: "Summary and Recom-
mendations"; no. 2: "Documenting Collaborations"; no. 3: "Catalog of Se-
lected Historical Materials") by various authors, principally Joan Warnow-
Blewett (see also below).

Bearman, David, and John T. Edsall, eds. Archival Sources of the History of Biochemis-
try and Molecular Biology: A Reference Guide and Report. Boston: American
Academy of Arts and Sciences, 1980. A classic survey of archival holdings in
key biomedical sciences.

Bruemmer, Bruce H., and Sheldon Hochheiser. The High-Technology Company: A
Historical Research and Archival Guide. Minneapolis: Charles Babbage Institute,
University of Minnesota, 1989. Describes the research function and its activi-
ties in high-technology companies.

Cahill, George F. "The Role of Foundations in the Future of Medicine." Clinical
and Investigative Medicine 9, no. 4 (1986): 273-77. Sees a slow decline in
philanthropic support for biomedical research, made up in part by academic-
private sector contracts.

Frederickson, Donald S. "Biomedical Research in the 1980s." Nevi' England Journal
of Medicine 304 (1981): 509-17. The title notwithstanding, a good short
history of biomedical research before the decade began.

Friedman, Lawrence M., et al. Fundamentals of Clinical Trials, 2nd ed. Littleton,
Mass.: PSG Publishing Co., 1985. A comprehensive and clearly written intro-
duction to a basic methodology.

Fudenberg, H. Hugh, and Vjaya L. Melnick, eds. Biomedical Scientists and Public
Policy. New York: Plenum Press, 1978. A collection of essays on problems and
issues in public funding of research.

Haas, Joan K[rizack], Helen Willa Samuels, and Barbara Trippel Simmons. Ap-
praising the Records of Modern Science and Technology: A Guide. Boston: Massa-
chusetts Institute of Technology, 1 985. An overview of documentation gener-
ated in the various stages of scientific and technological research (although,
with few specific references to biomedicine); well organized and illustrated.

Hedrick, Terry E. "Justifications for and Obstacles to Data Sharing." In Sharing
Research Data, edited by Stephen E. Fienberg, Margaret E. Martin, and Miron
L. Straf. Washington, D.C.: National Academy Press, 1985. Finds little reliable
information about scientific data sharing; advocates careful cost-benefit anal-

Hiatt, Howard H. America's Health in the Balance: Choice or Chance? New York:


Harper & Row, 1987. Chapter 10, "Biomedical Research," advocates taxing
all health-related goods and services to fund scientific investigations.

Institute of Medicine, Division of Health Sciences Policy, Committee on the
Responsible Conduct of Research. The Responsible Conduct of Research in the
Health Sciences. Washington, D.C.: National Academy Press, 1989. Examines
issues related to biomedical research fraud; proposes ways of encouraging
ethical standards without stifling research freedom and creativity.

Langfitt, Thomas W., et al., eds. Partners in the Research Enterprise: University-
Corporate Relations in Science and Technology. Philadelphia: University of Penn-
sylvania Press, 1983. Proceedings of a national conference on university-
corporate relations in science and technology held at the University of Penn-
sylvania in 1982.

Porter, Roger J., and Thomas E. Malone, eds. Biomedical Research: Collaboration and
Conflict of Interest. Baltimore: Johns Hopkins University Press, 1992. Analyzes
problems of biomedical research funding, especially academic-industrial part-
nerships, from a university perspective.

Reams, Bernard D. University-Industry Research Partnerships. Westport, Conn.:
Quorum Books, 1986. An extensive historical and legal analysis, illustrated
by appendices containing the texts of four landmark contracts, three of which
concern biomedical research.

Relman, Arnold S. "Medical Research, Medical Journals, and the Public Interest."
Journal of the Society of Research Administrators 21(1 989) : 7-12. The former
editor of the New England Journal of Medicine discusses the mechanics of
peer-reviewed journals and argues that most substantive findings in biomedi-
cal research are published.

."What Is Clinical Research?" Clinical Research 9, no. 3 (1961): 516-18. A

brief historical review.

Ross, Richard S. "Academic Research and Industry Relationships." Clinical and
Investigative Medicine 9, no. 4 (1986): 269-72. Argues that, overall, academic-
industrial partnerships are worth the risks.

Rothman, David J. Strangers at the Bedside: A History of How Law and Bioethics

Transformed Medical Decision Making. New York: Basic Books, 1991. Chapter 5,
"New Rules for the Laboratory," explores problems in research ethics, espe-
cially involving human subjects, and bureaucratic responses from the NIH
and the Food and Drug Administration.

Strickland, Stephen P. The Story of the NIH Grants Programs. Lanham, Md.: University
Press of America, 1988. A short monograph in eleven chapters, covering
developments from Public Health Service-funded research in the 1 930s to NIH's
growing pains of the later 1960s, with a few cursory glances at events since then.

Swann, John P. Academic Scientists and the Pharmaceutical Industry: Cooperative
Research in Twentieth-Century America. Baltimore: Johns Hopkins University
Press, 1988. Traces cooperative biomedical research partnerships between
universities and industry back to the 1920s; includes classic case studies, such
as the collaboration of the Banting group at the University of Toronto with Eli
Lilly in the discovery of insulin.


Warnow-Blewett, Joan. "Saving the Records of Science and Technology: The Role
of a Discipline History Center." Science and Technology Libraries 7 (1987):
29-40; "The Role of a Discipline History Center, Part II: Promoting Archives
and Research in Science and Technology." Ibid. 9 (1988-89): 85-101. These
articles discuss the development of programs at the Center for the History of
Physics of the American Institute of Physics, especially strategies for selection
and archival placement of key research documentation. (See also citation
under American Institute of Physics.)

Wyngaarden, James B. "The Role of Government Support in Biomedical Re-
search." Clinical and Investigative Medicine 9, no. 4 (1986): 265-68. A brief
sketch of the "panorama of national support for health research and develop-
ment in the United States."


Educational Institutions and
Programs for Health Occupations



A broad range of instructional programs provide students with the requi-
site knowledge, skills and credentials for occupations in the health fields.
Academic preparation for these occupations is designed to instill in stu-
dents specialized knowledge, problem-solving skills, and responsible
modes of professional conduct. The functions of these instructional pro-
grams are, therefore, to provide intellectual, technical, and practical train-
ing of the various disciplines.^ Although the programs focus on tradition
and established standards, they are not immutable. Each generation of

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