Dr. Paul F. Langlois, DAB No. 1409 (1993)
Department of Health and Human Services (H.H.S.)
Departmental Appeals Board
DAB Decision
DR. PAUL F. LANGLOIS
Docket No. A-93-30
Decision No. 1409
May 6, 1993
RECOMMENDED DECISION ON THE PROPOSED DEBARMENT
The Deputy Assistant Secretary for Grants and Acquisition
Management
(Debarring Official) of the Department of Health and Human
Services issued a
proposal to debar Paul F. Langlois, D.N.Sc. (Respondent)
prospectively for a
period of three years from eligibility for, or
involvement in, nonprocurement
transactions (grants) of the federal
government and from contracting with any
federal government agency. The
proposal to debar was based on findings by the
Public Health Service (PHS)
Office of Research Integrity (ORI). ORI found that
Respondent had fabricated
data in the conduct of research and that his actions
constituted serious
scientific misconduct. The scientific misconduct involved
research conducted
by Respondent while he had a research fellowship with the
National Institute
of Allergy and Infectious Disease, of the National
Institutes of Health
(NIH). The Debarring Official determined that this
scientific misconduct
constituted a cause for debarment of a serious and
compelling nature and
affected Respondent's present responsibility as a
recipient of federal
funds.
Respondent appealed and a Research Integrity
Adjudications Panel (Panel) was
appointed. See 57 Fed. Reg. 53,1 25 (November
6, 1992). Respondent contested
only the length of the debarment. Based on the
record before us and the reasons explained below, we
recommend that
Respondent be debarred for three years effective from the date of the Debarring
Official's final decision.
I. Regulatory
Authority
Administrative debarment from grants and contracts is
provided for by
regulation. See 45 C.F.R. Part 76; 48 C.F.R. Subpart 9.4; and
48 C. F.R.
Subpart 309.4. By means of an administrative debarment,
individuals or entities are excluded from
eligibility for grant and contract
awards from the federal government for a specified period of time.
Administrative debarments are discretionary actions taken to protect the
interests of the public and the
government and are not punitive. Gonzalez v.
Freeman, 334 F.2d 570 (D.C.
Cir. 1964); 45 C.F.R. Sec. 76.115 and 48 C.F.R.
Sec. 9.402(a) and (b).
The causes for debarment are enumerated in the
regulations at 45 C.F.R. Sec.
76.305 and 48 C.F.R. Sec. 9.406-2.
Federal policy requires the award of grants and contracts only to
responsible parties. Debarment is not mandatory upon a determination that a
cause for debarment exists.
A determination to debar is made after
consideration of "the seriousness of the . . . acts or omissions
and any
mitigating factors." 45 C.F.R. Sec. 76.300 and 48 C.F.R. Sec. 9.406-4(a). The
term of a
debarment is for "a period commensurate with the seriousness of
the cause," but generally does not
exceed three years. The regulations
applicable to grants provide for a term longer than three years
"(w)here
circumstances warrant" (45 C.F.R. Sec. 76.320(a)) and both regulations provide
that an existing
debarment may be extended if necessary to protect the
public interest (45 C.F.R. Sec. 76.320(b) and 48
C.F.R. Sec.
9.406-4(b)).
II. Factual Background
Our
description of the factual background is taken from the ORI Report. [FN1]
Respondent stated that
he concurred "with the eight page report."
Respondent's letter dated November 16, 1992. Thus, we regard
the factual
allegations in the ORI Report as established.
Beginning in
January 1988, Respondent was a research fellow at the NationalInstitute of
Allergy and
Infectious Diseases, NIH. He worked in the laboratory of Dr.
Michael Frank, Chief, Laboratory of
Clinical Investigation. During his
fellowship, Respondent received financial support from an NIH
Intramural
Research Training Award.
Besides participating in a number of
other experiments in the laboratory,
Respondent had sole responsibility for a
project involving the use of mammalian red cells as a model for
studying the
role of complement in clearance of bacteria from the blood. [FN2] The project
involved
experiments which looked at the effect of Complement 1 (C1)
inhibitor on the binding complex of C1r,
C1s, and C1q to red cells
sensitized with antibody. ORI Report at 2.
Dr. Frank found
Respondent's findings surprising. According to the ORI
Report, Dr. Frank
stated that it is well known that an intermediate, termed
EAC1, is formed
upon addition of C1 to sheep erythrocytes previously sensitized with rabbit
antibody. C1
can be dissociated from this intermediate by C1 inhibitor.
After dissociation, the cell still contains
antibody on its surface along
with a portion of the C1 molecule (C1q). The remainder of the C1 molecule
is
found in the supernatant in association with a covalently bound complex of two
molecules of C1
inhibitor, one molecule of C1r and one molecule of C1s. ORI
Report at 2. During the course of his
project, Respondent was able to repeat
this result with sheep erythrocytes, but he reported that when he
used
guinea pig erythrocytes, the C1 inhibitor bound to the surface of the guinea pig
cells in the
presence of C1. He also reported finding similar binding to C1
on the surface of parainfluenza virus.
According to Dr. Frank, Respondent's
findings were potentially important. ORI Report at 3.
The report
also indicates, however, that Dr. Frank became concerned with
Respondent's
data; although Respondent repeatedly presented Dr. Frank with data related to
the C1
inhibitor binding studies, the data were always in the form of
computer printouts, highly processed
graphical representations
and
tabulations. Moreover, Respondent evaded Dr. Frank's requests for the raw
data
supporting the processed data. ORI Report at 3. As a result, Dr. Frank
did not
submit any of Respondent's data for publication. In June 1990, Dr.
Frank asked
another member of his laboratory to repeat some of Respondent's
C1 inhibitor
binding experiments. This person as well as others in the
laboratory were
unable to achieve the same results as Respondent. Another
request was made to
Respondent for the raw data and Respondent did not
provide it. ORI Report at 3. Later, Dr. Frank asked
other
laboratory personnel to repeat Respondent's
experiments with the following
results: when Respondent was not involved in the
conduct of the
experiments, the experiments had negative results; and
when
Respondent participated or reagents prepared by him were used, the
experiments
showed positive, but anomalous results. A study of these results
indicated that radioactive
antibody had
been added to the reagents or to
the
experimental samples, thus resulting in
false positive results. ORI Report
at 3 and 4.
Respondent was confronted on
September 11, 1990 by the NIH Director of
Intramural Research with concerns
about Respondent's fabrication and
falsification of data on the C1 inhibitor
experiments. At this meeting,
Respondent admitted to this misconduct and was
suspended from all laboratory
activities and placed on administrative leave.
On September 19, 1990, NIH
authorized an investigation into Respondent's
activities.
Even though Respondent admitted his misconduct with
respect to the C1
inhibitor experiments, it was determined that an
investigation was needed to
determine the full extent of the possible
misconduct since Respondent had
participated in a number of other experiments
in the laboratory. Respondent,
however, refused to cooperate or to
participate in the investigation.
Specifically, there were suspicions about
the data from two other projects
conducted primarily by others in the
laboratory with the participation of
Respondent. As a result, the
investigation also examined the data from a
project on the biological
activity of a newly discovered and novel plasma
protein on which Respondent
had prepared all the critical reagents. The
experimental results were a major
research finding. However, Dr. Frank was
concerned; although the researcher
primarily responsible for conducting the
experiment desired to do the
experiments from start to finish, Respondent had
insisted on making the
necessary reagents for her. ORI Report at 5.
Similarly, suspicions
were raised about another set of experiments that
involved the demonstration
of Sgp fragments in joint fluid collected from
patients experiencing acute
episodes of joint inflammation, because Respondent
prepared the fluids for
assay for the experiments and because the original
samples of joint fluid
disappeared from the laboratory after the decision was
made to repeat these
assays. Dr. Frank suspected the authenticity of the data
from these
experiments due to Respondent's role in these projects; he feared
that if
Respondent had chosen to manipulate the reagents, internally consistent but
nevertheless false
and misleading hard data could have been produced. As a
result, Dr. Frank did not believe he could
depend on the results of the
experiments. ORI Report at 5 and 6.
Based on the foregoing
information and the results of the
investigation, ORI found two separate
acts of scientific misconduct:
(1) Respondent
committed scientific misconduct by reporting
fabricated data on the binding of
C1
inhibitor to guinea pig erythrocytes. He presented to
his supervisor computer printouts of charts
and data for which no
primary
data existed. The experiments to support such processed data were
never
performed. Respondent admitted that such data did not
exist.
(2) Respondent committed scientific
misconduct by falsifying experimental
results. He substituted radiolabelled
antibody to guinea pig erythrocytes for
radiolabelled C1 inhibitor in
experiments conducted by other members of the
laboratory to verify his
previous results. Respondent admitted to doctoring
the materials used in
these experiments in order to show a result consistent
with his previous
fabricated results.
ORI Report, Addendum.
Respondent concurred with the findings in the ORI Report and the
proposed
three-year prohibition from serving on PHS Advisory Committees,
Boards, or peer review groups.
Respondent did not appeal the ORI findings and the
administrative actions
prohibiting him from serving on PHS
Advisory
Committees, Boards or
peer review groups. Thus, those determinations
became final on October 20, 1992. The
Debarring
Official proposed debarment based on the
determination that the findings of scientific misconduct
indicate
a lack of care and judgment that seriously
and directly affects Respondent's
present responsibility to participate in nonprocurement transactions of
the federal government and
to receive federal
contracts. See 45 C.F.R.
Sec. 76.305(d) and 48
C.F.R. Sec. 9.406-2(c).
Respondent contested only the
term of the debarment. Summary of
Preliminary Conference dated
January 5,
1993 and Transcript of February 8, 1993 oral
argument at 4.
III. The proposed three-year term of debarment is
warranted by the
circumstances of this case.
We
determine that the proposed three-year term of debarment is warranted
because
of the seriousness of Respondent's misconduct and because the
mitigating
factors advanced by Respondent present no compelling reason to
conclude that
a period of debarment of less than three years
would
adequately protect the
public interest. The policy underlying debarment
is that the government should conduct business
only with responsible contractors and grantees.
"Responsibility" is a term of art; the Federal
Acquisition Regulations
define responsibility in terms of whether a prospective contractor possesses the
requisite present capacity, competence, record of satisfactory performance
on other awards, honesty and
integrity, and ethics to satisfactorily perform
under an award of federal funds. See generally 48 C.F.R.
Sec. 9.104-1 et
seq. Debarment, a discretionary action, allows the government to
effectuate this
policy of doing business only with responsible parties. 48
C.F.R. Sec. 9.402(a) and 45 C.F.R. Sec.
76.115. Debarment is "designed to
insure the integrity of government contracts in the immediate present
and
into the future." Shane Meat Co., Inc. v. United States Dep't of Defense, 800
F.2d 334 (3rd Cir.
1986). [FN3] The serious nature of debarment requires
that it be
imposed only in the public interest for the government's
protection; it is not
penal in nature. See 48, C.F. R. Sec. 9.402(b) and 45
C.F.R. Sec. 76.115(b).
The applicable regulations provide that
the term of the debarment shall be
for a period commensurate with the
seriousness of the cause. The regulations
further provide that generally,
debarment should not exceed three years, but
may if the circumstances
warrant. 48 C.F.R. Sec. 9.406-4(a); 45 C.F.R. Sec. 76.320(a). In
determining
the length of a term of debarment where the cause for debarment
is established, as it is here, the
regulations require us to consider "the
seriousness of the . . . acts or omissions and any mitigating
factors." 45
C.F.R. Sec. 76.300 and 48 C.F.R. Sec. 9.406-1(a). Therefore, we must also
determine whether
any mitigating factors alleged by a respondent indicate
present responsibility, indicate that the
conduct is not likely to recur, or
are sufficient to show that a lesser period of debarment will
adequately
protect the government interests.
Respondent's appeal concerned only the length of the debarment
term necessary to protect the
government's interest. Respondent seeks to
have a debarment imposed effective as of September 1990, the
time he left
NIH, rather than as of the date of the Debarring Official's decision. By
admitting the
cause for debarment and that some period of debarment was
necessary, Respondent admitted that his
misconduct reflected a lack of
responsibility in the conduct of federally supported research.
Respondent advanced the following mitigating factors for the
Panel's
consideration in recommending the appropriate debarment
term:
1. Respondent has not received PHS research
funds since leaving NIH in
September,
1990;
2. He realized that he committed grave
misconduct and has learned not to
commit such an
offense in the future; and
3. He was in the early
stages of his career and wishes to pursue research
again in the future at the earliest allowed time.
The parties
agreed that an evidentiary hearing was not required and that
factual
development with regard to these factors was not necessary. ORI
ultimately
questioned the accuracy of Respondent's assertions, but did not
offer proof
to the contrary. We do not here reach the issue of whether
respondent's
assertions are reliable evidence of all the underlying facts
since, even
accepting his assertions as true, we conclude that they present no
basis for
reducing the proposed term of debarment.
Below, we first discuss
the seriousness of Respondent's misconduct and then
discuss each mitigating
factor and why we conclude that the mitigating factors
advanced by the
Respondent present no compelling reason for a period of
debarment of less
than three years from the date of the Debarring Official's
final
decision.
A. Respondent's admitted scientific
misconduct was extremely serious.
Respondent's admitted scientific misconduct
was a serious breach of trust.
His conduct reflected a fundamental lack of
responsibility by one who assumed a high degree of
responsibility to the government. The scientific
misconduct here strikes at the heart of the system
of scientific research and progress in
scientific inquiry. The scientific community functions on
trust
and openness;
once that trust is breached, the harm from incidents of
fabrication
and falsification of data is far greater
than simply discrediting the work
known to be false or
fabricated. Here, all the research in which
Respondent had been involved in Dr. Frank's
laboratory
from 1988 to 1990 was regarded as tainted. Respondent's
misconduct adversely affected not only the other
members of the laboratory
whose research was directly affected by Respondent's conduct, but also the
scientific community and the public, whose personal safety
was
potentially compromised and endangered. Thus, we consider
Respondent's
scientific misconduct to be extremely serious. In recommending a
period of
debarment, we must consider the strong public interest in
protecting the
integrity of the scientific research process and preventing
the potential for
abuses of federal funds.
B. The
fact that Respondent has not received federal funds since
September, 1990 is
not a basis for reducing the proposed term of debarment.
Respondent advanced
as a mitigating factor that he had not received PHS
research funds since he
left NIH in September 1990. With regard to this factor, Respondent asserted:
If I did not feel remorse, I would have continued to
seek funding until the time that the
committee forced me from
receiving PHS funds. The self-imposed debarment from receiving PHS
monies was
very difficult for me since I thoroughly enjoy
research, but it was a true heart felt sign that I was
indeed sorry
for having upset the lives of the researchers I worked with at
NIH.
Letter dated March 16, 1993.
Respondent
asserted that since he voluntarily left federally funded research
in 1990,
the debarment term should run from that time. Notwithstanding
Respondent's argument, we see
no basis to infer remorse or contrition from
the mere fact that Respondent had not received or sought
PHS research funds
since September 1990. Rather, the record undercuts his assertion that this
factor
demonstrates remorse. For example, Respondent was confronted on
September 11, 1990 by the NIH Director
of Intramural Research with concerns
about Respondent's fabrication and falsification of data on the C1
inhibitor
experiments. At this meeting, Respondent admitted to this misconduct and was
suspended from
all laboratory activities and placed on administrative leave.
On September 19, 1990, NIH authorized an
investigation into Respondent's
activities. While Respondent may have left NIH, as he alleged,
voluntarily
in September, 1990, he left at a time when his conduct had been called into
question and the
investigation into the extent of any misconduct was getting
under way. Moreover, Respondent refused
ORI's subsequent request to
cooperate in the investigation. Respondent's refusal to cooperate
necessarily had a substantial adverse impact on the government's efforts to
determine the extent to
which Respondent had falsified or fabricated
research. Under these circumstances, this factor provides
no assurance that
the government's interests have been adequately protected since September of
1990.
Therefore, this factor should not be taken into account in setting the
length of the debarment term.
C. Respondent's
statements that he realized the gravity of his misconduct
and has learned not
to commit such an offense in the future is not a basis
for reducing the
proposed term of debarment. Respondent stated that he realized he committed
grave
misconduct and has learned not to commit such an offense in the
future. In response to the Panel's
question as to whether he had taken any
ethics courses or other training in his field after leaving NIH,
Respondent
stated that at Dr. Frank's suggestion he had consulted with a psychologist.
Transcript at 19;
Letters dated February 26, 1993 and March 16,
1993.
Respondent has merely stated that he has realized his
error and learned not
to commit such an offense in the future -- without
demonstrating anything more. Considering the
seriousness of his misconduct
here and the far-reaching
consequences of his actions, Respondent's own
subjective beliefs are simply not enough to demonstrate
the honesty,
integrity and trustworthiness necessary for a recipient of federal research
funds. This
factor does not demonstrate affirmative steps taken in an effort
to ameliorate the harm or to prevent
future misconduct.
Respondent's consultation with a psychologist is inadequate in and of itself to
establish that Respondent is rehabilitated and can now be considered honest
and trustworthy. In the
absence of any such evidence, we have no reason to
conclude that Respondent is now any more responsible
than he was at the time
of the misconduct, and we conclude that the possibility exists that Respondent
might commit similar conduct again. Therefore, this factor
should not be taken into account in setting
the debarment
term.
D. Inexperience is not a basis for reducing
the proposed term of debarment.
Respondent stated that he was in
the early stages of his career and wished to pursue research again
in the
future at the earliest possible time. Respondent did not show that due to
inexperience he was
unaware that his conduct constituted serious scientific
misconduct. Essentially, Respondent would like
to wish away his conduct on
the basis of inexperience and pretend it did not occur so that he could
pursue his chosen career again. However, what the Respondent fails to
recognize in advancing this factor
is that the government's interest in
sound scientific research techniques is placed in serious jeopardy
regardless of when in a researcher's career scientific misconduct occurs.
This factor is not evidence of
present responsibility or that the misconduct
would not recur. Therefore, this factor should not be
taken into
account in setting the debarment term.
E. A
prospective three-year debarment is necessary to protect the
government's interests.
In light of the seriousness of the
admitted scientific misconduct, we
consider the factors presented by
Respondent to present no compelling reason to reduce the debarment
term
proposed. The mitigating factors advanced by Respondent do not support a
conclusion that the
three-year debarment should
begin as of September
1990. It is fundamental to scientific research that
experimental results must
be trustworthy. The government has an obligation to
award its limited federal
research funds only to those that it determines will
use those funds
responsibly. Given Respondent's actions, which undercut the
trustworthiness,
honesty, and integrity of the nature of scientific research,
we conclude that
there is no lesser sanction than a prospective three-year
debarment that
would adequately protect the public interest. Accordingly, we
find the
proposed three-year term reasonable and necessary to protect the
government's
interests in light of the serious scientific misconduct engaged in by
Respondent.
IV. Conclusion
Based on the foregoing, we recommend to the Debarring Official
that
Respondent, Paul F. Langlois, D.N.Sc., be debarred for a period of three
years
from the date of the Debarring Official's final decision.
Judith A. Ballard
M. Terry Johnson
Cecilia Sparks Ford
Presiding Board Member
FN1. On June 8, 1992, PHS announced the reorganization of its
research
integrity program. See 57 Fed. Reg. 24,262 (June 8, 1992).
Under this
reorganization, ORI was created and assimilated the
responsibilities of the
Office of Scientific Integrity (OSI) and the
Office of Scientific Integrity
Review. OSI had investigated Respondent
and prepared a report prior to the
reorganization; the OSI report was
reviewed, amended, and accepted by ORI. We,
therefore, refer to that
report as the ORI Report.
FN2. The complement system is a component of the immune system and
represents a mechanism not only
for direct killing of certain
foreign cells, but also for
identifying foreign cells for clearance by
the reticuloendothelial system and
for attack by other components of
the immune system. ORI Report at 1.
FN3. Debarment also extends to nonprocurement transactions such as
grants,
cooperative agreements, scholarships, fellowships, and loans.
In this decision
we refer to these nonprocurement transactions as
grants. See 45 C.F.R Sec.
76.110.