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.