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.