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research organization affiliated with ten sponsoring universities but gov-
erned by its own board. It boasts a research staff numbering in the
hundreds, some of whom are active in fields only tangentially related to
the human health sciences. The laboratory has long been among the
leading centers of work in genetics and molecular biology in the United
States. Cancer investigations are another important part of its program.

Founded in 1888, the Marine Biological Laboratory is among the most
venerable of the private independent research institutions. Despite the
name, the laboratory is not exclusively devoted to the study of marine life
but is renowned for research conducted on cell biology, neurobiology, and
other areas with a human focus. The laboratory is particularly well known
for its summer institute, where scientists in biomedical and related disci-
plines from around the world lease space to further their research projects.
In addition to the arrangement with Boston University's Marine Program,
the laboratory also houses a year-round research program of the Univer-
sity of Pennsylvania.

Some independent biomedical research institutions have small staffs
and limited research budgets. Their programs may, nevertheless, be far-
reaching and ambitious. The Center for Human Genetics, a nonprofit
laboratory in Bar Harbor, Maine, for example, has only one permanent
staff scientist. The center investigates genetic approaches to understanding
and treating a variety of birth defects and congenital debilities. The Center



TYPES OF BIOMEDICAL RESEARCH INSTITUTIONS 8 1



for the Study of Anorexia and Bulimia is a nonprofit division of tfie
Institute for Contemporary Psycfiotherapy in New York City and conducts
studies on the prevalence, demography, etiology, and treatment of these
eating disorders. Its operation is funded almost completely by clinic
income. One of the best known centers for research in human sexuality is
the Masters and Johnson Institute, in St. Louis. Its program includes the
study of conceptive, contraceptive, and human sexual physiology, psy-
chology, and endocrinology.

Some independent research units specialize in fields and treatments
traditionally eschewed by major medical centers. The Acupuncture Re-
search Institute, for example, is a private, nonprofit research organization
in Monterey Park, California, devoted to the ancient Chinese healing art.
It sponsors clinical conferences and seminars at the Queen of Angels
Hollywood Presbyterian Medical Center and at Los Angeles International
University. Another example is the Laban/Bartenieff Institute of Move-
ment Studies, Inc., in New York City, which investigates applications of a
form of physical therapy with roots outside any of the natural sciences.
Rudolf Laban (1879-1958), an Austrian dancer and choreographer, for-
mulated a series of principles for the understanding of body movement
that were applied to therapy by a disciple, Irmgard Bartenieff (1900-
1981). The institute claims that these principles have applications to
psychotherapy, fitness, and sports training.

BIOMEDICAL RESEARCH AND DEVELOPMENT COMPANIES OR
DIVISIONS OF COMPANIES

All profit-making enterprises in biomedical fields necessarily engage to
some degree in research. Although the health industries in the United
States are the subject of Chapter 7, many varieties of specialty research
units within the commercial sector of the contemporary health care
system will be discussed here. The similarities and close ties that exist
between them and nonprofit institutions are noteworthy. Advanced work
in the fields of cellular or molecular biology and genetics, for example,
relies on intimate professional contacts between investigators, on one
side, and suppliers of apparatus, drugs, and reagents, who are themselves
scientists, on the other. ^^

Life Technologies, Inc., of Gaithersburg, Maryland, is typical of many
small research and development companies that have emerged to supply
NIH laboratories and extramural scientific institutions with instruments
and materials relating to DNA technology and advanced clinical diagnos-
tics. The company conducts its own research in areas such as restriction
enzymes, eukaryotic transcription systems, and hepatitis B hybridization.



82 BIOMEDICAL RESEARCH FACILITIES



Synergen, Inc., of Boulder, Colorado, is an example of a firm oriented
toward fields outside the health professions (e.g., applications of microor-
ganisms in enhanced oil recovery) that has discovered applications of its
research to clinical medicine (e.g., the treatment of lung disease). Some
companies have been established by nonprofit institutions to exploit the
commercial potential of biomedical research. A prominent example is
Salk Institute Biotechnology Industrial Associates, Inc., of San Diego,
which conducts research under contract with several larger firms, among
them Phillips Petroleum, in selected areas of cell biology and genetics.



RESEARCH PARTNERSHIPS BETWEEN COMMERCIAL COMPANIES AND
NONPROFIT INSTITUTIONS

Recent decades have witnessed extraordinary developments in partner-
ships between commercial companies and nonprofit institutions. A trend-
setting event in this area was the $23 million contract awarded to Harvard
Medical School by the Monsanto Company in 1974 to fund cancer
research. ^^ The essence of this and subsequent agreements, distinguishing
them from totally commercial research ventures, is that industrial firms
agreed to underwrite investigatory programs using the facilities and staffs
of nonprofit institutions in return for a share in the rights to lucrative
discoveries.^"^

Major partnerships might have developed before the 1970s had there
not been a perception on the part of industry that if nonprofit organiza-
tions were recipients of federal grants or contracts and private money, all
rights to discoveries would fall in the public domain. A lawsuit that has
become known as the Gator- Ade case led to an important clarification of
this matter. A University of Florida researcher discovered a formula for a
soft drink demonstrably beneficial to athletes. After the university de-
clined to file for a patent, the scientist contracted in 1 969 with the Stokley
Van Camp Company to produce the beverage. Gator- Ade proved profita-
ble, whereupon the university belatedly filed suit to claim all royalties.
The case, settled out of court, inspired the passage of Public Law 96-5 1 7 in
1980, giving nonprofit institutions and small businesses the right to retain
title to inventions resulting from government grants and contracts. The
legislation has opened the door to scores of joint agreements between
nonprofit research organizations and small commercial biotechnology
firms.

The 1980s witnessed the advent of several multi-million-dollar con-
tracts between academic medical centers and large chemical or pharma-
ceutical companies which are noteworthy.'^ Massachusetts General Hos-
pital, the largest Boston teaching hospital associated with Harvard Univer-



FUNCTIONS AND ACTIVITIES OF BIOMEDICAL RESEARCH INSTITUTIONS 83



sity, was foremost among institutions of its kind to establish industrial
partnerships. The German chemical firm Hoechst AG signed a contract
with Massachusetts General in 1980 to create a $68 million molecular
biology center. In 1989, the hospital announced an $85 million contract
with Shiseido Co., Ltd., of Japan to support a center for research on skin
and skin diseases. In the following year, a $36.8 million agreement was
reached between the hospital and the pharmaceutical giant Bristol-Myers
Squibb to establish a cardiovascular research unit.

Among universities with large research-oriented medical centers,
Washington University in St. Louis set precedents for attracting huge
corporate contracts. In 1981 the university agreed with Mallinckrodt, also
of St. Louis, to undertake a $3.8 million research project focusing on
hybridomas, artificially created cells that produce antibodies useful in the
treatment of a variety of diseases. The following year, the university
joined with another St. Louis chemical firm, Monsanto, to study cellular
communications, particularly proteins and peptides that affect the im-
mune system. Originally calling for $23.5 million in corporate support,
subsequent renewals of the pact have augmented the total committed to
nearly $100 million, earning it the distinction of being to date the most
extensive research collaboration ever funded between an American com-
pany and an American university. ^^

Agreements such as these have aroused considerable controversy.
Critics warned that the profit motive and the restrictions placed by the
contracts on dissemination of findings and the rights to discoveries could
corrupt academic medicine beyond redemption. ^^ Spokespersons for the
parties involved have responded by praising their agreements as model
collaborative programs, contending that the rights, licenses, and royalties
that academic investigators reserve for their corporate sponsors constitute
a reasonable price for underwriting their work.^^ There is reason to expect
that major academic-industrial partnerships will continue and expand in
the future.



FUNCTIONS AND ACTIVITIES OF BIOMEDICAL RESEARCH
INSTITUTIONS

Most early medical researchers in the United States were physicians who
worked in relative isolation to discover new treatments or new knowl-
edge of the human body. William Beaumont (1785-1853), to cite a
well-known example of a pioneer investigator, conducted experiments on
digestive physiology in his home on an isolated army post in the 1820s,
focusing his attention on a single patient. To observe here that



84 BIOMEDICAL RESEARCH FACILITIES



Beaumont's world disappeared long ago is an understatement. The stark
differences between biomedical research then and now underscore why
today few research programs are possible without elaborate planning and
support. The activities outlined here apply equally to investigations in
hospitals, educational institutions, and programs of independent research
institutions.

The functions and activities of biomedical research units are compli-
cated and diverse. Nevertheless, they can be classified into a relatively few
basic categories. The range of activities composing the research function is
unquestionably central; patient care and education are secondary func-
tions. Not only the core function but also certain activities composing the
institutional administration function deserve archival scrutiny. Before
experimentation begins, efforts must be organized to secure funding and
recruit personnel. All during the operating lifetime of the unit, work is
performed not only by a scientific elite but also by employees who acquire
and manage the equipment, facilities, and materials. The training of junior staff
members and students may be objectives requiring substantial attention
and expenditures. Activities such as these represent more than a string of
peripheral events, for they are the background to the research process in
which investigations are proposed and justified, and results dissemi-
nated.^^

BASIC, CLINICAL, AND APPLIED BIOMEDICAL RESEARCH

Biomedical research is typically dedicated to the pursuit of basic scientific
or clinical knowledge. Rephrasing the definition with which this chapter
began, the difference between basic and clinical research is the difference
between studies of the functions and composition of the human body, on
one hand, and investigations in medicine or other modes of therapeutic
treatment, on the other. Some observers would see this difference as a
health sciences version of the dichotomy common to all intellectual
endeavors — distinguishing fundamental work from applied. Others dis-
cern nuances between the concepts of clinical and applied research and
between therapeutic and nontherapeutic investigation. Merely having
patients tested, we are reminded, is not enough to make the project
practical or useful. ^°

Many distinctions between basic and clinical sciences are more theo-
retical than real. An ever-expanding and overlapping array of research
subfields encompasses all areas of biomedical research. The basic biomedi-
cal sciences may still be known in part by academic names such as
anatomy, biochemistry, genetics, microbiology, pharmacology, and physi-
ology, all of which are subjects in the classic medical education curricu-



FUNCTIONS AND ACTIVITIES OF BIOMEDICAL RESEARCH INSTITUTIONS 85



lum. The identity of clinical sciences is reinforced by counterparts among
common hospital services (e.g., internal medicine, surgery, anesthesiol-
ogy, obstetrics/gynecology, ophthalmology, otolaryngology, neurology,
psychiatry, and radiology). But beneath the intellectual matrix corre-
sponding to the services and departments of clinical and educational
institutions there is much overlap and constant change.

The 1980s and 1990s have witnessed increasing concentration on
molecular and cell biological research engaged in by scientists of various
departmental affiliations. Contemporary biomedicine is now conducted
and expressed, as Kornberg phrased it, "in a common language of chemis-
try."^^ The three following examples illustrate crossovers from basic to
clinical research. Certain projects to discover new treatments for epilepsy
draw on the expertise of biochemists and pharmacologists in testing
anticonvulsion agents; work on growth inhibitory factors by immunolo-
gists and zoologists has contributed to the effectiveness of agents inhibit-
ing the rejection of transplanted organs; and studies of how molecules are
distributed among distinctive cell regions have proved to have important
applications to understanding the functions of photoreceptors in the
human retina, and to yield new forms of treatment to restore impaired
vision. 2^

Applied research programs in engineering and physics continually
produce advances in testing and diagnostic equipment, which offer broad
applications for biomedical programs. Radiology and surgery are among
the fields that most frequently benefit from new technology, such as
magnetic resonance imaging, positron emission tomography, and video-
guided laparoscopic surgery. New synthetic materials for implants and
prostheses are frequently introduced from chemical and engineering
laboratories outside biomedicine. Every discipline of biomedical research
has profited from technologies as various as electron microscopy, chemi-
cal microbalances and microsensors, lasers, and microchips, to name but a
few. Many innovations open up new avenues for diagnostic and thera-
peutic investigations at the same time that they themselves are undergo-
ing further testing and refinement. ^^

In all of biomedical research, and particularly among institutions in
the nonprofit sector, collaboration regularly extends beyond institutional
walls. The science writer Michael Spector described the interaction suc-
cinctly: "Researchers for the NIH, universities, and private businesses
routinely join together in their attempts to develop a drug, for example, or
to understand the nature of a scientific problem. Groups form and dissolve
constantly, based on scientific predilection and research needs. ILeading
scientists] benefit tremendously from these new protean arrange-
ments."^"* Biomedical scientists may aspire to unique credit for major



86 BIOMEDICAL RESEARCH FACILITIES



discoveries but generally acknowledge their dependence on colleagues.
Meetings of professional societies, the review process for grant applica-
tions and for publication of findings, and improved technologies in medi-
cal informatics all encourage collaboration.

RESEARCH FUNCTION: FUNDING

In the 1960s and 1970s, the federal government accounted for about 60
percent of biomedical research funding, and industry accounted for 25 to
30 percent. These relative proportions of funding changed in the 1980s as
industry increased its funding, especially in the areas of biotechnology and
pharmaceutical research. Of the $22.6 billion spent on biomedical re-
search in 1990, roughly 46 percent was funded by industry, 44 percent by
the federal government, and 10 percent by private nonprofit foundations
and other sources. ^^ Industry and the federal government tend to fund
different types of biomedical research. Whereas industry tends to focus on
funding applied research in private laboratories, the federal government
concentrates its funding on basic biomedical research projects in academic
institutions and federal laboratories. As funding resources dwindle, how-
ever, governmental funding priorities may shift toward applied research.

Securing research funding requires the detailed communication of
methods, objectives, and costs involved in the proposed investigations.
Projects that are unsponsored — that is, projects that are supported by the
internal revenues of an organization — must at very least be justified and
budgeted to a degree sufficient to satisfy the scrutiny of the sponsoring
medical center's overall management. Major governmental grants or
contracts require lengthy applications, followed by periodic reports, au-
dits, and other communications to funding agencies. Support from private
foundations may require less paperwork than the NIH or other federal
grant endowments, but they, too, entail extensive administrative prepara-
tions and oversight. Commercial ventures generally involve, in addition,
extensive legal arrangements.^^

Association with a larger organization can provide a research unit
with crucial assistance in maintaining its program over time. Institutional
links help to establish and promote the credentials of research programs
and expedite financial operations. Universities and hospitals, for example,
routinely negotiate blanket agreements with funding agencies covering all
their research subsidiaries. As a result, the number of staff directly in-
volved with grants administration and employed within the individual
research units is minimized. Despite controversy over "excessive" admin-
istrative overhead charged at certain institutions (as in the widely publi-
cized case of Stanford University), basic formulas for determining indirect



FUNCTIONS AND ACTIVITIES OF BIOMEDICAL RESEARCH INSTITUTIONS 87



costs incurred by extramural research units have been followed for dec-
ades. Many large research centers have established committees to monitor
the situation and avoid possible abuses.

Competition for funding can be fierce among colleagues at competing
institutions or even at the same institution. In the 1980s, the chance of
being funded by the NIH decreased from 32 percent to 24 percent of
submitted applications, for three reasons: (1) each grant cost more, (2)
project awards covered a longer period of time, and (3) the number of
high-quality applications increased. ^^

Senior scientists play a significant role in regulating the system
through participation in various aspects of the peer review process.
Through study sections, the formal panels summoned to advise the NIH,
or through less formal advisory work on behalf of foundations, partici-
pants help determine who receives funding. This is generally a rigorous,
time-consuming, and often contentious process. ^^

STAFFING OF BIOMEDICAL RESEARCH INSTITUTIONS

Recruitment of qualified personnel is another basic activity through
which a biomedical research program is organized and justified. The
process may start with the selection of an individual to head the unit.
Normally, the director is a senior scientist, perhaps the individual who
pioneered or first achieved major successes in the chosen field of investi-
gations. A unit has an enormous advantage if it is headed by someone
knowledgeable in all aspects of operations, who is known and respected
by colleagues throughout the discipline, and who commands the trust of
the institution's backers. There is, however, no foregone conclusion that
the most productive investigators available would be willing to assume
executive command. Many capable scientists are philosophically opposed
to devoting precious time and energy to administrative duties and take
pains to eschew such appointments. The direction of large research organ-
izations may, therefore, be entrusted to individuals who have chosen
managerial or entrepreneurial goals over direct involvement in scientific
discovery. 2^

Formal academic training is obviously a basic consideration in the
recruitment of the scientific staff. A doctoral degree has long been the
basic credential for employment and advancement as a full professional in
biomedical research institutions. Clinical research units may require in-
vestigators to have an M.D. degree. For work in one of the basic sciences,
a Ph.D. or Sc.D. degree in a relevant discipline may be preferred. Recog-
nizing the importance of both tracks of graduate education to careers in
advanced biomedical research, many institutions seek candidates with



88 BIOMEDICAL RESEARCH FACILITIES



combined doctorates, particularly graduates of a recognized university
Medical Science Training Program, sponsored by funds from the NIH.^°
Still more significant, fiowever, is tfie reputation of the university where
an individual studied, the reputation of advisors and mentors, and
whether significant scientific experience was acquired through postdoc-
toral fellowships or residencies.^^

The work of visiting and part-time professional staff is a significant
factor at many biomedical research institutions. Researchers in these
categories are often as numerous as the regular, full-time investigators. At
academic medical centers, this may result from joint staff appointments to
hospital services and teaching departments. Independent institutions
have traditionally attracted the participation of visiting researchers during
the summer, when professorial scientists are relieved of their teaching
responsibilities at academic medical centers.

Various numbers of technicians, clerical staff, and other, less skilled
workers are ranked below the professional investigators in the chain of
command. Technicians may range from individuals knowledgeable and
experienced enough to perform complicated assignments to untrained
laboratory assistants hired to wash glassware and clean animal cages.
Hiring, supervision, and other aspects of personnel management are
major responsibilities of institutional administrations, just as in any organ-
ization, but in the case of research units employee performance evalua-
tions are likely to focus on scientific contributions and specialized judg-
ments that are unique to the field.

Despite obvious differences among employee classifications, it is im-
portant to observe that hierarchical ranking may not be as rigid at bio-
medical research units as in most health care delivery facilities and schools.
Research units can be as pragmatic as industrial firms in rewarding and
promoting talented individuals. Investigative experience, particularly a rec-
ord of productive contributions to publishable discoveries, is what ulti-
mately counts the most in establishing a research career. It is very common
in biomedical science for research teams to recognize the contributions of
junior members, and in many instances technicians have been promoted to
professional status in recognition of expertise acquired on the job.

The risk of job instability due to dependence on grant or contract
support is problematic for all employees of biomedical research institu-
tions. A sudden demand for qualified personnel created when grant
money becomes available may be followed by layoffs when grants lapse.
Professional investigators as well as technicians are sometimes inconven-
ienced by short-term positions, but the former presumably have a
stronger commitment to their work and ultimately a greater chance of
gaining permanent employment.'^



FUNCTIONS AND ACTIVITIES OF BIOMEDICAL RESEARCH INSTITUTIONS 89



MANAGING LABORATORIES AND OTHER RESEARCH SETTINGS

Laboratories are the most typical settings for biomedical research. Their
size, the types of equipment used, and the number of personnel employed
vary to such a degree that little generalization is possible. Many kinds of
analysis require close physical proximity to clinical examination rooms or
operating rooms, and therefore the laboratories must be situated within a
hospital or medical center. In other fields of research, investigations focus
on nonliving substances, microorganisms, or laboratory animals that can
be acquired and manipulated without connection to clinical activity.


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Online LibraryJoan D KrizackDocumentation planning for the U.S. health care system → online text (page 10 of 26)