John Ancheff v. Hartford Hospital, et al.

The principal issue in this appeal, taken
from the trial court's judgment on a defendants' verdict
in this medical malpractice action, is whether the trial
court properly excluded from evidence a certain report
of a federal commission regarding the protection of
human subjects of biomedical and behavioral research.1

The plaintiff, John Ancheff,2 appeals3 from the judgment
of the trial court for the defendants, Hartford Hospital
(hospital) and Jonathan Tress,4 rendered following the
jury verdict in their favor. The plaintiff claims that the
trial court improperly: (1) excluded from evidence the
Belmont Report; (2) excluded from evidence a certain
medical consent form; and (3) instructed the jury on
the question of the meaning of medical research. We
affirm the judgment of the trial court.

The plaintiff brought this medical malpractice action
against the hospital for injuries he allegedly had suffered
arising out of an improperly administered program
involving a drug known as Gentamicin. Insofar
as is relevant to the issues on appeal, the plaintiff
claimed that the hospital had improperly: conducted
clinical trials and study procedures regarding Gentamicin;
failed to inform the plaintiff that he was a participant
in such a trial or procedure; failed to obtain his
informed consent for such participation; and failed to
disclose to him the experimental nature of his course
of treatment with the drug. After a trial to the jury, a
verdict was returned in favor of the hospital. The plaintiff
then moved to set aside the verdict, which the trial
court denied. This appeal followed.

The jury reasonably could have found the following
facts. In January, 1993, the plaintiff underwent back
surgery, after which he developed a deep wound infection
reaching his spinal column. He was admitted to
the hospital on February 5, 1993, where Tress was consulted
as a specialist in infectious diseases. Cultures
disclosed the presence of enterococcus, a difficult bacteria
to eradicate. Because Tress suspected enterococcal
osteomyelitis, a potentially life-threatening form of
bone infection, he ordered a course of combined antibiotic
therapy of Gentamicin5 and Unasyn. Gentamicin
has known nephrotoxic and ototoxic6 effects regardless
of how it is administered.

Initially, Tress ordered Gentamicin to be administered
once a day in a dose of 480 milligrams. Pursuant
to an inpatient dosing program previously enacted by
the hospital, the hospital pharmacy increased the daily dosage to 615 milligrams.7 Thereafter, Tress examined
the plaintiff's condition, and determined that the
increased dosage was appropriate. The plaintiff
received this combined dosage of drug therapy for
approximately twelve days in the hospital. During that
time, his kidney clearance and serum levels were monitored
for signs of impaired kidney clearance and drug
accumulation, with negative results during the plaintiff's
stay in the hospital. The plaintiff was discharged
from the hospital on February 24, 1993.

Tress prescribed a course of home intravenous antibiotic
therapy of Gentamicin and Unasyn at the same
levels, in order to eradicate the infection. Although the
infection was successfully treated, on March 17, 1993,
the plaintiff developed side effects from the Gentamicin,
namely, vestibular toxicity, or poisonous effects to
the inner ear, which resulted in the loss of the functioning
of his inner ear, including his sense of balance.
The plaintiff claimed at trial that he suffered total and
permanent destruction of the functioning of his inner
ear due to an excessive administration of Gentamicin.

I

THE BELMONT REPORT

The plaintiff first claims that the trial court improperly
excluded from evidence the Belmont Report. Specifically,
he claims that he sought to establish at trial
that the hospital's program of administering Gentamicin
constituted medical research, and that, therefore, the
hospital was required to have that program reviewed
by an institutional review board and to provide the
plaintiff with a detailed written consent form outlining
the risks, benefits and alternatives, as well as the experimental
nature, of the program.8 The Belmont Report,
he claims, supported this claim. We conclude that, as
the question was presented to the trial court, the court
did not abuse its discretion in excluding the Belmont
Report from evidence.

In order to analyze this claim, it is necessary to
recount, first, the role that the question of medical
research played in the trial. At the heart of the plaintiff's
case, insofar as this appeal is concerned, was his claim
that the hospital's program for administering Gentamicin,
known as the once-daily aminoglycoside regimen,9
constituted engaging in medical research. The hospital
did not challenge the proposition that, if the Gentamicin
program had constituted medical research, such a
review and consent form would have been required.
It vigorously contested, however, the claim that the
program constituted research. The hospital claimed, to
the contrary, that it constituted the implementation of
a program or practice of medical therapy, which, in
turn, was aimed, not at validating an untested theory
or hypothesis, but at using the available literature,
including prior research and clinical data, for the improvement of patient care and safety. Thus, whether
the Gentamicin program constituted medical research,
as claimed by the plaintiff, or the implementation of
a therapeutic program for patient care and safety, as
claimed by the hospital, was litigated as a question
of fact. There was conflicting evidence produced on
the question.

The plaintiff produced the following evidence tending
to prove that the hospital's Gentamicin program constituted
medical research. The hospital's program provided
for a level dose of seven milligrams per kilogram
of body weight (7 mg/kg), a dosage that previously had
not been tested on humans. In 1993, the hospital was
the only one in the country that prescribed that dosage
to entire classes of patients. This dosage departed from
the conventional dosage of 3 mg/kg approved by the
federal Food and Drug Administration. The hospital had
described both the dosage of 7 mg/kg and its method
of administration, namely, one daily injection as
opposed to the conventional administration of three
injections per day, as ‘‘radical.'' In addition, the hospital
administered the drug to a class of patients pursuant
to a ‘‘protocol,'' which meant that, if a physician failed
to prescribe the dosage of 7 mg/kg called for in the
protocol, the hospital pharmacist would change the dosage
automatically.

In publications to the medical community, the hospital
had stated that the Gentamicin program was ‘‘a
radical change from standard aminoglycoside administration
schedules,'' and that ‘‘the [Gentamicin] program
was unlike most other hospital-wide programs because
it was not a conversion to a therapeutic alternative but,
rather, a radical change in both the conventional dosing
and administration of the aminoglycosides.'' Data was
collected by the hospital on each patient apart from
what was kept in the patient's medical record. In addition,
the physicians responsible for enacting the Gentamicin
program at the hospital, namely, Charles
Nightingale, David Nicolau and Richard Quintilliani, lectured
to the medical community on the findings of
the program.

Furthermore, the plaintiff introduced a definition of
research contained in the Code of Federal Regulations
that was applicable to the hospital. That regulation
defined research as ‘‘a systematic investigation, including
research development, testing and evaluation,
designed to develop or contribute to generalizable
knowledge. . . .'' 45 C.F.R. § 46.102 (d); see footnote
15 of this opinion for the full text of this definition.
Finally, the plaintiff's expert witness, Wilmer Leigh
Thompson, a physician, testified that, in his opinion,
the hospital's Gentamicin program constituted medical
research. In the course of rendering his opinion, Thompson,
in effect, gave a definition of research that supported
his opinion that the Gentamicin program constituted research.10
The hospital, to the contrary, offered the following
evidence tending to prove that the Gentamicin program
did not constitute medical research. Before the program
was enacted by the hospital in August, 1992, the physicians
in the hospital's department of infectious diseases,
pharmacy and therapeutics committee,
antiobiotic subcommittee, and medical executive committee
approved it. On the basis of the voluminous
data and known principles of pharmacokinetics,11 these
committees and the physicians on them determined
that the program embodied sound policy for the wellbeing
of patients and did not constitute medical
research.

In addition, the hospital introduced evidence to establish
the following. The Gentamicin program had been
widely studied for many years before the hospital implemented
it, and it was not implemented to test the safety
of Gentamicin. The program was not a clinical trial,
and its implementation did not involve control groups,
randomization or double blinding, which are some hallmarks
of research. There was no motivation to advertise
the drug, to secure funding from a drug company, or
to report findings to the Federal Drug Administration.
The prime considerations in the implementation of the
program were efficacy of outcome and patient safety.
On the basis of the scientific data, the program was
implemented for inpatients at the hospital to maximize
the killing of bacteria and discourage the accumulation
of the drug in the patient's body. It permitted a greater
drug-free interval than the conventional method of
administration, and therefore resulted in less accumulation
of the drug, and was at least as safe and more
effective than multiple daily dosing. In addition, the
hospital presented evidence that the Gentamicin program
is now employed in approximately 80 percent of
the hospitals in the United States.

Finally, the hospital offered the expert testimony of
four witnesses that the Gentamicin program did not
constitute medical research. These witnesses included
David Gilbert, a physician, as well as Nightingale, Nicolau
and Quintilliani. As was the case with Thompson,
each of these expert witnesses gave a definition of
research that supported his opinion that the Gentamicin
program did not constitute research.12

With this background in mind, we turn to the plaintiff's
evidentiary claim regarding the Belmont Report.
The following additional facts, including a summary of
the Belmont Report, are necessary in order to understand
and evaluate this claim.

On July 30, 1992, Nightingale, who was vice president
of research at the hospital, signed an agreement with
the federal Office of Protection from Research Risks,
an agency of the United States Department of Health and Human Services. This agreement was a ‘‘multiple
project assurance,'' which permitted the hospital to conduct
research and to receive federal funding to support
its research programs. This agreement governed ‘‘how
research projects are to be conducted when one or
more organizations are involved in doing that research,''
but it did not define the term ‘‘research.'' In the
agreement, however, under the heading entitled ‘‘Ethical
Principles,'' the hospital agreed to the following:

‘‘This institution [the hospital] is guided by the ethical
principles regarding all research involving humans as
subjects, as set forth in the report of the National Commission
for the Protection of Human Subjects of Biomedical
and Behavioral Research (entitled: Ethical
Principles and Guidelines for the Protection of Human
Subjects of Research [the ‘Belmont Report']), regardless
of whether the research is subject to Federal regulation
or with whom conducted or source of support
(i.e., sponsorship).''

The Belmont Report consists of ten single-spaced
pages. The Belmont Report's introductory passage
points out that, although ‘‘[s]cientific research has produced
substantial social benefits . . . [i]t has also
posed some troubling ethical questions.'' It then refers
to ‘‘reported abuses of human subjects in biomedical
experiments, especially during the Second World War.''
It refers next to the ‘‘Nuremberg War Crimes Trials,''
and to the ‘‘Nuremberg Code . . . drafted as a set of
standards for judging physicians and scientists who had
conducted biomedical experiments on concentration
camp prisoners.'' According to the Belmont Report,
‘‘[t]his code became the prototype of many later codes
intended to assure that research involving human subjects
would be carried out in an ethical manner.'' The
report then states that, because those codes that followed
the Nuremberg Code ‘‘often are inadequate to
cover complex situations,'' and sometimes are conflicting
and ‘‘difficult to interpret or apply,'' the report would
identify (1) ‘‘a distinction between research and practice,''
and (2) three broader principles, or general prescriptive
judgments, that are ‘‘relevant to the ethic of
research involving human subjects,'' namely, respect
for person, beneficence and justice. The report
acknowledged that these ‘‘principles cannot always be
applied so as to resolve beyond dispute ethical problems.
The objective is to provide an analytical framework
that will guide the resolution of ethical problems
arising from research involving human subjects.''

The next part of the Belmont Report, entitled ‘‘Boundaries
Between Practice and Research,'' sought ‘‘to distinguish
between biomedical and behavioral research,
on the one hand, and the practice of accepted therapy
on the other, in order to know what activities ought to
undergo review for the protection of human subjects
of research.'' It acknowledged that the ‘‘distinction
between research and practice is blurred partly because both often occur together (as in research designed to
evaluate a therapy) and partly because notable departures
from standard practice are often called ‘experimental'
when the terms ‘experimental' and ‘research'
are not carefully defined.''

The Belmont Report then stated: ‘‘For the most part,
the term ‘practice' refers to interventions that are
designed solely to enhance the well being of an individual
patient or client and that have a reasonable expectation
of success. The purpose of medical or behavioral
practice is to provide diagnosis, preventive treatment
or therapy to particular individuals. By contrast, the
term ‘research' designates an activity designed to test
an hypothesis, permit conclusions to be drawn, and
thereby to develop or contribute to generalized knowledge
(expressed, for example, in theories, principles,
and statements of relationships). Research is usually
described in a formal protocol that sets forth an objective
and a set of procedures designed to reach that
objective.

‘‘When a clinician departs in a significant way from
standard or accepted practice, the innovation does not,
in and of itself, constitute research. The fact that a
procedure is ‘experimental,' in the sense of new,
untested or different, does not automatically place it
in the category of research. Radically new procedures
of this description should, however, be made the object
of formal research at an early stage in order to determine
whether they are safe and effective. Thus, it is
the responsibility of medical practice committees, for
example, to insist that a major innovation be incorporated
into a formal research project.

‘‘Research and practice may be carried on together
when research is designed to evaluate the safety and
efficacy of a therapy. This need not cause any confusion
regarding whether or not the activity requires review;
the general rule is that if there is any element of research
in an activity, that activity should undergo review for
the protection of human subjects.''

The next three pages of the Belmont Report are
devoted to a discussion under the heading, ‘‘Basic Ethical
Principles.'' This discussion is, in turn, divided into
three parts, entitled ‘‘Respect for Persons,'' ‘‘Beneficence''
and ‘‘Justice.'' It is fair to characterize this discussion
as highly abstract. The discussion refers in quite
philosophical terms to subjects such as: personal autonomy;
self-determination; the ethical considerations
involved in using imprisoned persons as subjects of
research; the Hippocratic maxim of ‘‘do no harm'' and
the Hippocratic oath's requirement that physicians benefit
their patients ‘‘according to their best judgment'';
research involving children as subjects; and various
meanings of the term ‘‘justice,'' such as whether burdens
are to be distributed to each person equally, to
each according to his needs, to each according to his societal contribution, or to each according to merit.

In this connection, the report asserts that, during the
nineteenth and twentieth centuries, the burdens of serving
as subjects of medical research fell largely on ‘‘poor
ward patients,'' and noted that ‘‘the exploitation of
unwilling prisoners as research subjects in Nazi concentration
camps was condemned as a particularly flagrant
injustice.'' The Belmont Report also noted that, ‘‘in the
1940s, the Tuskegee syphilis study used disadvantaged,
rural black men to study the untreated course of a
disease that is by no means confined to that population.''
13 The report concluded this portion by warning
that ‘‘the selection of research subjects needs to be
scrutinized in order to determine whether some classes
(e.g., welfare patients, particular racial and ethnic
minorities, or persons confined to institutions) are
being systematically selected simply because of their
easy availability, their compromised position, or their
manipulability, rather than for reasons directly related
to the problem being studied.''

The final five pages of the Belmont Report, under
the heading, ‘‘Applications,'' are themselves divided into
three categories, entitled ‘‘Informed Consent,'' ‘‘Assessment
of Risks and Benefits'' and ‘‘Selection of Subjects.''
The discussion contained therein is also carried on at
a high level of abstraction. The first category, ‘‘Informed
Consent,'' is further subdivided into abstract discussions
of ‘‘Information,'' ‘‘Comprehension'' and ‘‘Voluntariness.''
The second category, ‘‘Assessment of Risks
and Benefits,'' is further subdivided into a general discussion
under the headings ‘‘The Nature and Scope of
Risks and Benefits'' and ‘‘The Systematic Assessment
of Risks and Benefits.'' The third category, ‘‘Selection
of Subjects,'' focuses on the role of ‘‘the principle of
justice'' in the selection of research subjects, and concludes
with the warning that ‘‘[c]ertain groups, such as
racial minorities, the economically disadvantaged, the
very sick, and the institutionalized may continually be
sought as research subjects, owing to their ready availability
in settings where research is conducted. Given
their dependent status and their frequently compromised
capacity for free consent, they should be protected
against the danger of being involved in research
solely for administrative convenience, or because they
are easy to manipulate as a result of their illness or
socioeconomic condition.''

The trial court addressed the question of the admissibility
of the Belmont Report on several occasions during
the trial proceedings. On the first occasion, the court
addressed the report only indirectly, in response to a
motion in limine, dated May 5, 2000, filed by the hospital
before opening arguments. The hospital alleged that, in
deposition testimony, Thompson had ‘‘testified as to
‘human experimentation' and alleged violations of the
Nuremberg Code, [the] Geneva Convention, Helsinki
Accord, et cetera.'' The hospital moved to ‘‘preclude reference by the plaintiff, his attorneys or witnesses to
such issues as ‘human experimentation,' violations [of]
the Nuremberg Code, the Geneva Convention, Helsinki
Accord, et cetera, and/or making references to the
Tuskegee Study, World War II experimentation, et cetera,''
on the grounds that such references were irrelevant
and unduly prejudicial, and likely to inflame the
jury. The court held argument on the motion on May
15. It is evident from the transcript of this argument
that the court and parties considered the motion in
limine to address both the plaintiff's anticipated opening
argument and his evidence.

In response to the trial court's initial indication that
such references would constitute ‘‘unfair argument,''
the plaintiff's initial position was that all of the references,
with the sole exception of the reference to Nazi
Germany, were relevant to the standard of care. He
represented that he would not use the terms ‘‘Nazi Germany''
or ‘‘human experimentation,'' but he insisted that
he be permitted to refer to the Tuskegee study because
‘‘the foundation of [the] regulations'' about using
humans as subjects of human research was ‘‘the Belmont
Report, and that's where all these regulations
. . . come from,'' and that ‘‘out of Tuskegee came the
Belmont Report.'' The court granted the motion in
limine.

The next instance occurred on May 22, 2000, when,
prior to opening arguments, the trial court and counsel
conferred preliminarily regarding certain documents,
including the Belmont Report, which had been filed by
the plaintiff as proposed exhibits, as to some of which
the hospital objected. In response to the hospital's
objection to the report, including its references to
human experimentation, the Nuremberg Code and the
Tuskegee study, and recalling ‘‘the same issues . . .
which we hashed through the other day,'' the plaintiff
claimed that the Belmont Report was admissible
because ‘‘the standards that I'm going to be claiming
were violated are contained in'' the report, and the
report ‘‘is the best evidence of what [the hospital was]
required to do.'' The plaintiff argued that the Belmont
Report ‘‘is evidence of what the standard of care was
in conducting any research involving humans.'' He contended
further that his expert witnesses would testify
that the hospital was ‘‘required to get, pursuant to [the
report] the informed consent of the [plaintiff] if [it]
wanted to continue with research or include him in the
research,'' and to submit the research to an institutional
review board. He then repeated his claim that the Belmont
Report contained the standards to which the hospital
was to be held in treating the plaintiff, and that it
was ‘‘absolutely essential that [he] be able to introduce
[the report] and show [it] to the jury, [and] explain what
the standards are.''

The plaintiff also asserted that the Belmont Report was admissible because the hospital had represented in
the July 30, 1992 agreement with the federal government
that ‘‘we want to be able to advertise and to reap the
benefits of assuring people that we're going to do
research the right way, and here's the standards that
we're going to live up to in conducting this research,''
that those standards ‘‘define research as this,'' and that
the jury ‘‘should see the standards . . . .'' Although the
court suggested that the plaintiff's own expert could
testify ‘‘what the standard'' was, the plaintiff insisted
that he was also entitled ‘‘to get the standard of care
from the [hospital],'' and to ‘‘explore what the standards
were . . . with the [hospital].'' He contended further
that he would be ‘‘asking the court for an instruction
on violation of the standard of care in conducting what
[he contended was] research,'' which was ‘‘defined in
the [report] as [the hospital] assured the government
[it] would follow. So if [the hospital says] research is
one thing, I should be able to show the jury . . . what
[the report] say[s]. I'm sorry that [it] say[s] human
experimentation, but it's not . . . inflammatory, it's
necessary . . . .'' At the conclusion of this proceeding,
the plaintiff delivered a copy of the Belmont Report to
the court. The court postponed ruling on its admissibility
until the following day.

The next day, May 23, the trial court ruled that the
Belmont Report was inadmissible. The basis of its ruling
was that the report constituted a statement of ethical
principles and guidelines for the protection of human
research subjects, and that, although it distinguished
between practice and research, it did not address the
issue before the jury, namely, the standard of care applicable
to the hospital.

The plaintiff then contended that, on the issue of the
standard of care for informed consent applicable to
the hospital, the treatment by the hospital was in fact
‘‘research and that one of the ways we are going to
establish that is through the . . . report which defines
[research], and it was the standard that the [hospital]
acknowledged as the standard.'' Therefore, he argued,
the Belmont Report was evidence of the applicable
standard of care ‘‘that was embraced by the [hospital].''
The plaintiff then asked the court whether he would
be permitted to pursue the matter further ‘‘with either
my experts or [the hospital's experts].'' The court
responded that he could ‘‘ask them . . . in [his] exploration
of the standard of care . . . what they rely on
in . . . reaching their understanding [of] what the standard
of care is and then it's possible we may get into
this . . . .''14

Subsequently, during the plaintiff's direct examination
of Nightingale, whom the plaintiff had called as his
witness, the plaintiff again offered the Belmont Report,
along with certain federal regulations, which are discussed
in footnote 15 of this opinion, without further elaboration or qualification. The hospital objected to
both the report and the regulations, and the court sustained
the objection to the report and overruled the
objection to the regulations.15

The plaintiff next attempted to offer the Belmont
Report through the direct testimony of Thompson. The
plaintiff represented that Thompson would testify that
one of the bases of his opinion that the hospital violated
the applicable standard of care, ‘‘may or is likely to be
the standards as set forth in the Belmont Report.'' The
court responded: ‘‘The Belmont Report is not getting
in. I've ruled on it several times. Even in this context, it's
not getting in. . . . He can testify about the regulations.
We've resolved that.''

Thereafter, the plaintiff made one final offer of the
Belmont Report, and at the same time asked the court
to reconsider its rulings and to articulate the basis for
its exclusion. The plaintiff repeated his earlier claim
that the report was ‘‘relevant because it is a standard
that was required to be followed by hospitals [that]
assured the government that they would follow the
standard . . . .'' He then read that part of the report
that differentiated between the terms ‘‘practice'' and
‘‘research.'' He then asserted: ‘‘The entirety of the Belmont
Report is relevant. I read that portion because
of the court's concern [at] the time of my argument. I
claim it is absolutely relevant in this case. . . . It's in
evidence that it was assured by the hospital. [Thompson]
. . . will testify that it's a standard that was
required of participants . . . in conducting any
research involving humans. That is the relevance of it
in this case.'' (Emphasis added.)

The court then responded by articulating the basis
of its ruling. The court stated: ‘‘I've read the Belmont
Report. In its summary it states [that it] is a statement
of basic ethical principles and guidelines that should
assist in resolving the ethical problems that surround
the conduct of research with human subjects. It sets
forth principles and guidelines. It refers to the Nuremberg
War Crime trials, Nuremberg Code, judging
physicians, scientists who conducted biomedical experiments
on concentration camp prisoners. It also references
the exploitation of unwilling prison[ers] as
research subjects in Nazi concentration camps was condemned
as a particularly flagrant injustice. In this country
in the 1940s [the] Tuskegee syphilis study used rural
black men to study the untreated course of a disease.
It also talks about justice arrives from social, racial,
sexual and cultural biases, institutionalize[d] in society.
Its prejudicial effect greatly outweighs its very limited
evidentiary value.''

The plaintiff then stated: ‘‘Then, Your Honor, I would
offer the evidence redacted to the portions Your Honor
has cited.'' The court responded: ‘‘That's it. I've rule[d]
on it three times. You can mark it'' as an exhibit for identification. The plaintiff then repeated that, regarding
‘‘each of the court's concerns I would . . . offer it
in redaction.'' The court stated: ‘‘I don't want to hear
another word about it.''

It is clear from the trial court's articulation that the
basis of its ruling16 was that the Belmont Report's probative
value was outweighed by its likely unfair prejudicial
effect. The court acted in accord with § 4-3 of the Connecticut
Code of Evidence, which provides: ‘‘Relevant
evidence may be excluded if its probative value is outweighed
by the danger of unfair prejudice or surprise,
confusion of the issues, or misleading the jury, or by
considerations of undue delay, waste of time or needless
presentation of cumulative evidence.'' In this context,
unfair prejudice is that which ‘‘unduly arouse[s]
the jury's emotions of prejudice, hostility or sympathy;
State v. Wilson, 180 Conn. 481, 490, 429 A.2d 931 (1980);
or tends to have some adverse effect upon [the party
against whom the evidence is offered] beyond tending
to prove the fact or issue that justified its admission
into evidence. State v. Graham, 200 Conn. 9, 12, 509
A.2d 493 (1986), quoting United States v. Figueroa,
618 F.2d 934, 943 (2d Cir. 1980). . . . Section 4-3 also
recognizes the court's authority to exclude relevant evidence
when its probative value is outweighed by factors
such as confusion of the issues or misleading the jury;
Farrell v. St. Vincent's Hospital, [203 Conn. 554, 563,
525 A.2d 954 (1987)] . . . .'' (Citations omitted; internal
quotation marks omitted.) Connecticut Code of Evidence
§ 4-3 (2000), commentary.

In such a case, our scope of review is limited to
determining whether the court clearly abused its discretion.
State v. Wargo, 255 Conn. 113, 123, 763 A.2d 1
(2000). ‘‘We will make every reasonable presumption
in favor of upholding the trial court's ruling, and only
upset it for a manifest abuse of discretion. . . . [Thus,
our] review of such rulings is limited to the questions
of whether the trial court correctly applied the law and
reasonably could have reached the conclusion that it
did.'' (Internal quotation marks omitted.) Id. Applying
this standard, we conclude that the trial court did not
abuse its discretion in excluding the Belmont Report.
We first note that, with two exceptions - one that
we discuss now, and one that we discuss later in this
opinion - throughout the proceedings the plaintiff consistently
offered the entire Belmont Report into evidence.
The first exception was the plaintiff's
representation, in the argument on the motion in limine,
that he would not refer to either ‘‘Nazi Germany'' or
use the term ‘‘human experimentation.''17 We consider
this representation, therefore, as the functional equivalent
of an offer to redact from the report the references
to the ‘‘reported abuses of human subjects in biomedical
experiments, especially during the Second World War,''
and to ‘‘the exploitation of unwilling prisoners as research subjects in Nazi concentration camps . . . .''

See footnote 17 of this opinion.

Thus, we review the
trial court's ruling on the basis on which the question
was presented to it, namely, as an offer of the report
in its entirety, shorn only of those two references.
As our earlier summary of the Belmont Report indicates,
it contained a great deal of material that the
trial court reasonably could have considered as unfairly
prejudicial. First, it purported to be, for the most part,
a statement of basic ethical principles, and not to be a
statement of the legal standard for securing informed
consent. Moreover, it invited the jury, in deciding
whether the hospital's Gentamicin program constituted
research or medical practice, to think about the Nuremberg
War Crimes Trials and the Nuremberg Code, the
substance of which the report did not describe, and
thus, implicitly, to compare the hospital's conduct with
whatever the jurors may have understood those terms
to mean. It also invited the jury to engage in a highly
abstract and philosophical level of inquiry into such
subjects as respect for the autonomy of persons, the
notion of self-determination, the concept of beneficence,
and the various theories of justice. It invited the
jury to think about using children and criminal prisoners
as subjects of medical research. It invited the jury to
think about the meaning of the physician's Hippocratic
oath, which was neither given in full nor explained in
any detail. It invited the jury to compare the hospital's
conduct to the infamous Tuskegee study. It invited the
jury to compare the hospital's conduct regarding the
plaintiff to the complexities of securing informed consent
from vulnerable groups such as racial minorities,
the economically disadvantaged, the very ill, and the
institutionalized. We cannot fault the trial court, as the
plaintiff would have it, for determining that submitting
this material to the jury would unduly arouse its emotions
of prejudice, hostility or sympathy, and would
tend to confuse the issues and mislead the jury.
On the probative side of the scale, the Belmont Report
did contain a definition of research, and an explanation
of the line between practice and research, which the
hospital, by signing the July 30, 1992 agreement, which
in turn incorporated the report by reference, could be
considered to have adopted. Nonetheless, the trial
court, in deciding whether the report was more prejudicial
than probative, was confronted by the plaintiff's
consistent offer of the report as a whole, rather than
with a clear choice of admitting only the probative part
and excluding the rest, which constituted much the
greater portion of the report. We ordinarily leave that
balancing function to the broad discretion of the trial
court, and see no basis for concluding that the court
abused that discretion in this case.

This brings us to the second exception noted previously,
namely, the plaintiff's final offer of redaction. That offer can best be characterized as too little and
too late. It was too little because it left to the trial court
the task of deciding precisely what portions of the ten
single-spaced page report were to be redacted. ‘‘It [was]
not the trial court's responsibility to attempt to separate
the admissible and inadmissible portions of the [Belmont
Report].'' Calcano v. Calcano, 257 Conn. 230, 243,
777 A.2d 633 (2001). It was too late because it came,
not during any of the plaintiff's offers of the report, but
after the court had ruled three times on the report as
offered in an essentially unredacted form, and after the
court had completed delivering its articulation of the
basis of its ruling. We therefore decline to give any
determinative weight to the plaintiff's final offer of
redaction.

II

MEDICAL CONSENT FORM

The plaintiff next claims that the trial court improperly
excluded from evidence a certain medical consent
form used by Gilbert in a research program at his hospital
in Portland, Oregon. Specifically, the plaintiff claims
that that medical consent form ‘‘was strong evidence
relevant to prove that the [h]ospital [in the present case]
was required to get informed consent'' from the plaintiff
‘‘because of the compelling similarities demonstrated
in the consent form between . . . Gilbert's study and
the [hospital's Gentamicin] program . . . .'' We
disagree.

The following facts underpin this claim. Gilbert testified
on direct examination that, beginning in 1988, he
and his colleagues at the hospital in Portland had conducted
a program involving a 5 mg/kg once-daily dose
of Gentamicin and another antibiotic, Timentin, which
is similar to Unasyn, for small groups of patients. This
was done based on the state of knowledge of the drugs
as it existed at the time. From 1988 to 1993, that program
was conducted pursuant to approval of the hospital's
infectious disease and pharmacy committees, but without
review by the hospital's institutional review board.
He described this program as an ‘‘off label use'' of the
drugs involved. In 1993, however, they decided to turn
this program into a formal research project, comparing
two different regimes of dosing - once daily and three
times per day, at different dosages, and involving randomization.
18 At that time, they sought and obtained
permission to do so from the hospital's institutional
review board and drafted a formal written consent form
for the patients to be enrolled in the research project.

On cross-examination, the plaintiff sought to introduce
the medical consent form used by Gilbert. The
court sustained the hospital's objection, ruling that the
form was irrelevant because there was no claim by the
hospital that it had supplied any consent form, and
the dispute in the case was whether the hospital was required to provide a consent form, not what such a
consent form would contain. Therefore, the court ruled,
‘‘[w]hat was contained in [the form] is not relevant
. . . .''

‘‘Upon review of a trial court's decision, we will set
aside an evidentiary ruling only when there has been
a clear abuse of discretion. State v. Provost, 251 Conn.
252, 257, 741 A.2d 295 (1999), cert. denied, 531 U.S. 822,
121 S. Ct. 65, 148 L. Ed. 2d 30 (2000); State v. Thomas,
205 Conn. 279, 283, 533 A.2d 553 (1987). The trial court
has wide discretion in determining the relevancy of
evidence and the scope of cross-examination and
[e]very reasonable presumption should be made in
favor of the correctness of the court's ruling in
determining whether there has been an abuse of discretion.
. . . To establish an abuse of discretion, [the
plaintiff] must show that the restrictions imposed upon
[the] cross-examination were clearly prejudicial. . . .
State v. Casanova, 255 Conn. 581, 591, 767 A.2d 1189
(2001).'' (Internal quotation marks omitted.) State v.
Rolon, 257 Conn. 156, 173, 777 A.2d 604 (2001).19

In the present case, the critical issue was whether
the hospital was required to secure written consent
from the plaintiff because, as he claimed, the Gentamicin
program of medication constituted medical
research. It was not what the contents of any such form
would be. Moreover, the plaintiff was not inhibited in
any way from cross-examining Gilbert regarding his
opinion that the hospital's Gentamicin program here
did not constitute research, or regarding the similarities
and differences, if any, between his program in Oregon
and that of the hospital here, and why his program
constituted research but the hospital's here did not. It
is difficult, therefore, to see why the contents of the
medical consent form used by Gilbert were relevant to
the issues in the case. We conclude that the trial court
did not abuse its discretion in sustaining the hospital's
objection to the form.

III

INSTRUCTION ON MEDICAL RESEARCH

The plaintiff's final claim is that the trial court improperly
instructed the jury on the meaning of the term
medical research. Specifically, the plaintiff claims that
the trial court improperly: (1) declined to follow his
request to charge on the meaning of the term; and (2)
instructed the jury that research ‘‘was that which was
not substantiated by the [medical] literature.'' This
claim is without merit.

In the course of charging the jury on the standard
of care in administering Gentamicin, the court stated:
‘‘What is in dispute is what was the proper dosage
of Gentamicin, was the seven milligrams per kilogram
within the standard of care and an alternative within
the standard of care. ‘‘Also in this dispute, and this is what you'll have to
determine with respect to the research question, what
the state of medicine was in 1993 as to whether such
a dose was experimental or research or substantiated by
medical literature and not something that was research.
‘‘You will have to decide whether the [plaintiff has]
proved that the standard of care was that a health care
provider, a hospital, having the data available in 1993,
the [hospital] would be required to get the institutional
review board approval of this change in dosing regimen
from three times a day one milligram per kilogram to
seven milligrams per kilogram once daily dosing, and
written informed consent from [the plaintiff].''

‘‘Our analysis begins with a well established standard
of review. When reviewing [a] challenged jury instruction
. . . we must adhere to the well settled rule that
a charge to the jury is to be considered in its entirety,
read as a whole, and judged by its total effect rather
than by its individual component parts. . . . [T]he test
of a court's charge is not whether it is as accurate upon
legal principles as the opinions of a court of last resort
but whether it fairly presents the case to the jury in
such a way that injustice is not done to either party
under the established rules of law. . . . As long as [the
instructions] are correct in law, adapted to the issues
and sufficient for the guidance of the jury . . . we will
not view the instructions as improper.'' (Internal quotation
marks omitted.) Godwin v. Danbury Eye Physicians
& Surgeons, P.C., 254 Conn. 131, 142–43, 757
A.2d 516 (2000). We do not critically dissect a jury
instruction. State v. Davis, 255 Conn. 782, 798, 772 A.2d
559 (2001).

The plaintiff submitted a request to charge that
defined medical research in essentially the same language
as that contained in the opening paragraphs of
the Belmont Report. The trial court was correct in
declining to give this instruction because the Belmont
Report properly had been excluded from evidence.
Therefore, there was no basis in the evidence for that
definition. Furthermore, giving any instruction precisely
defining the term medical research as a matter
of law would have been contrary to how the case had
been tried, namely, that the question of whether the
hospital's Gentamicin program constituted medical
research had been presented as a question of fact and,
accordingly, various witnesses had given various definitions
of the term for the jury's consideration.
The plaintiff also took exception to the instruction
as given. He contended that the instruction permitted
the jury to find that what the hospital had done would
not be research ‘‘if the jury finds that there's some
support [for it] in the medical literature . . . .'' He now
claims that, ‘‘[u]nder the [c]ourt's charge, experimentation
or research was that which was not substantiated by the [medical] literature.

This could not have been
further from the truth. In order for a research program
to even pass muster with an Institutional Review Board,
there must be substantiation in the medical literature
for performing the research.'' (Emphasis in original.)
We conclude that the trial court's instruction, viewed
as a whole and not subjected to critical dissection, was
adequately adapted to the issues and sufficient for the
guidance of the jury. It appropriately submitted the
question of whether the Gentamicin program constituted
research to the jury as a matter of fact. There
were, as we have noted, several different versions presented
to the jury of what research involved and did not
involve. The court's passing reference to the medical
literature, which was but one factor in determining
whether a program constituted research, did not, as the
plaintiff suggests, inform the jury that it could not find
that the program constituted research if there was some
support for it in the medical literature.

* * *

Click the case caption above for the full text of the Court's opinion.

The judgment is affirmed.

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