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Handling Misconduct - Appeals
ORI Summary Of Angelides Decision,
DAB Decision No. 1677,
February 5, 1999, and Related Civil Suit
In a decision dated February 5, 1999, a Research Integrity Adjudications Panel of the HHS Departmental Appeals Board (DAB or Board) ruled that Kimon J. Angelides, Ph.D. had engaged in scientific misconduct by intentionally falsifying data in five (5) grant applications submitted to the National Institutes of Health (NIH) seeking a total of $4 million in research funds. In its decision, the DAB affirmed the recommendation of the Office of Research Integrity that Dr. Angelides be debarred from eligibility for Federal grants, contracts or cooperative agreements with the Federal government for a period of five (5) years. He also is prohibited from serving on any Public Health Service advisory committee, board, and/or peer review committee, or as a consultant for five years and the five scientific papers that contain falsified data are to be retracted.
The Angelides matter has had a tortuous history, which is outlined in the 169 page decision issued by the DAB. The allegations of scientific misconduct surfaced while Dr. Angelides was a scientist at the Baylor College of Medicine (BCM). The initial concerns about Dr. Angelides' work were raised by his Department chairman who noticed inconsistencies in grant applications submitted by Dr. Angelides. As required by BCM and Federal procedures for addressing allegations of scientific misconduct, a preliminary inquiry was held. This preliminary BCM inquiry found insufficient evidence to proceed to an investigation. However, additional questions soon came to light. A second inquiry was conducted and a full investigation was engaged. The BCM investigation was extremely thorough. Reams of data were sequestered and analyzed and numerous witnesses were interviewed. During the course of the second inquiry and investigation, Dr. Angelides conceded that elements of his grant applications were false. Although his explanations shifted from time to time, he attempted to deflect responsibility for many of the falsifications by accusing two members of his laboratory (a graduate student and a postdoctoral fellow) of deceiving him by providing the falsified data. Other false information, particularly those appearing in the published papers, he claimed to be matters of data interpretation or simple errors.
At the conclusion of the investigation, the BCM investigation committee found that Dr. Angelides was solely responsible for the numerous data falsifications in the grant applications and published papers. Dr. Angelides was afforded the right to appeal the investigation committee's findings to an appellate committee, and he did so. He was consulted regarding the appointment of scientists to the appellate committee, and Dr. Angelides specifically nominated one of the leading members of that committee. The appellate committee reviewed the matter and unanimously affirmed the investigative findings. Dr. Angelides was subsequently dismissed from
BCM.
As a result of his dismissal, Dr. Angelides filed suit against BCM, individual committee members and various witnesses in Texas state court. Among other things, Dr. Angelides raised charges of wrongful termination, defamation, and contractual interference. BCM removed the case to Federal district court by alleging that the case raised questions of Federal law. Once in Federal court, the defendants moved to dismiss the case by arguing that, because they were acting on behalf of the United States in investigating misconduct, they should be entitled to the same immunity from suit that the Federal government would enjoy when conducting such investigations. The district court not only denied the defendants' motion, but it reconsidered its own jurisdiction and remanded the case back to state court, ruling that because the Federal claims were raised only as a defense, the court lacked subject matter jurisdiction. The court also rejected the immunity defense raised by the BCM defendants. BCM appealed to the U.S. Court of Appeals for the Fifth Circuit, and the United States filed and amicus curiae brief before that court. The U.S. argued that BCM and its officials should be privileged from certain suits (such as defamation) when carrying out duties mandated by Federal law. However, the Court of Appeals dismissed the appeal without ruling on the issues of immunity or privilege. It held that BCM was essentially appealing a remand order, which is not subject to appeal. Nonetheless, it also ruled that because the district court had remanded the case back to state court, the district court should not have ruled on the issue of immunity. The Court of Appeals left that issue open to a ruling by the state court. The state court did not rule on this issue and the lawsuit was subsequently settled and dismissed (see below). Thus, the issue of immunity for participants in scientific misconduct inquiries at institutions remains to be addressed.
At the same time Dr. Angelides was bringing his case before the state and Federal courts, ORI was conducting a detailed oversight review of the BCM misconduct findings. On March 10, 1997, ORI issued a seventy-two (72) page detailed explanation of its misconduct findings. Based on the seriousness of the charges, ORI recommended a five-year debarment and other administrative actions. On April 8, 1997, Dr. Angelides appealed those charges to the HHS Departmental Appeals Board.
At the DAB's initial status conference, counsel for Dr. Angelides noted that his client was currently under criminal investigation by the Office of the United States Attorney in Houston and requested that the DAB proceedings be stayed until the conclusion of the criminal investigation. This request was granted. Several months later, Dr. Angelides' counsel informed the Board that the criminal matter was concluded and Dr. Angelides would not be prosecuted criminally. At this time, Dr. Angelides requested that the matter again be continued until after the conclusion of the civil suit he was pursuing in the Texas state court. He also indicated that he wanted the opportunity to brief several legal points before proceeding to the merits of the case. A briefing schedule was established and towards the end of December 1997, the Board ruled against Dr. Angelides on his request to stay the case and on his legal challenges. The Board established schedules for the exchange of exhibits and witness lists and moved the case forward on the merits.
A de novo hearing on the merits took place in Houston, Texas between March 30 and April 9, 1998. This hearing was a full trial-type evidentiary hearing. ORI is required to prove each of its charges by a preponderance of the evidence. The Board decision would be based upon only the evidence produced for the hearing. However, in a change from earlier misconduct cases, the Board ordered that the direct testimony of most of the witnesses should be submitted in writing in advance of the hearing. Only Dr. Angelides and a handful of his fact witnesses were exempt from providing written direct testimony. All witnesses were required to be available for cross examination, either in person or, where all parties agreed, by telephone. Testimony from forty (40) witnesses was elicited, twenty-four (24) volumes of exhibits were submitted and 2,100 pages of transcripts were generated. Upon the conclusion of the hearing, a schedule for the submission of post-hearing briefs was established. Several such briefs were submitted through the summer and late fall of 1998. On February 10, 1999, the DAB decision was made public and found Dr. Angelides guilty of scientific misconduct. On the following day, Dr. Angelides' civil trial against BCM and several others, which had commenced two weeks earlier, was settled. As part of the settlement, Dr. Angelides dropped his state court suit and agreed not to contest or appeal the DAB's decision.
The Board's decision is extensive, finding against Dr. Angelides on all of the charges brought by ORI and agreeing with ORI's recommendation for a five-year debarment and other administrative sanctions. The decision provides a lengthy analysis of each of Dr. Angelides' arguments and explains why those arguments are not credible. Because of the length of the DAB decision, ORI will not endeavor an in-depth analysis of the decision herein. The decision is available on this web site and may prove to be a valuable resource in evaluating future allegations of misconduct. However, the reader should be cautioned that each misconduct case must be evaluated on its own individual facts. What may have been true in the Angelides matter may not necessarily hold true under another set of circumstances. Therefore, individuals and institutions should not automatically apply rationales from the Board's Angelides decision to other factual scenarios. Nonetheless, there are several points that surface in this decision that ORI wishes to note.
The facts in the case revealed that a substantial percentage of the data reported by Dr. Angelides in his NIH grant applications were falsified. The facts additionally revealed that the bulk of the data contributed by Dr. Angelides for the five papers at issue were also falsified. That the grants and papers contained falsified data was all but indisputable. However, Dr. Angelides was not the hands-on experimentalist responsible for conducting the experiments reported in the grants or papers. Rather, Dr. Angelides was the laboratory chief who developed projects, oversaw the work, supervised and administered the lab and obtained funding through the submission of grants. The members of the laboratory similarly testified that Dr. Angelides prepared the grants alone and that he did not provide copies of the grants, particularly those at issue in this case, to others in the lab for review. Moreover, the facts revealed the five papers at issue were submitted after the experimentalists that actually generated the data used in the papers had left the laboratory. Dr. Angelides prepared the figures for the papers, sent those figures to his coauthors at another institution for use in the papers, and never shared drafts of the papers with the experimentalists prior to publication.
Dr. Angelides' defense was that the other members of his laboratory were responsible for the falsifications. For example, he claimed that a graduate student and a postdoctoral fellow had each falsified the data in the grant applications. He also argued that the data in the papers were matters of interpretation and that the experimentalist who conducted the experiments had either falsified or misinterpreted the data. However, each of the lab members denied any involvement in the falsifications. They indicated that they were unaware that their data had been falsely presented by Dr. Angelides until they were shown the data during the BCM investigation. The laboratory records of the experimentalists were always consistent with their testimony, and all lab members during this time period testified that Dr. Angelides was fully aware of the true nature of their experimental results. In its decision the DAB noted that "although testimony presented to the Panel was often conflicting, the conflict was between Dr. Angelides and all of his colleagues, whose testimony was consistent with each other."
DAB Decision No. 1677, at 3 (February 5, 1999).
Dr. Angelides' explanation that he blindly relied upon data provided to him by his lab members was squarely rejected by the Panel. The facts revealed that he was fully aware of the actual results. However, Dr. Angelides simply chose to ignore them in an effort to show that substantial research progress had been made when, in fact, the experiments had little or no success or had not even been conducted. For example, with respect to some of the falsified data in the grant applications, the Panel stated that: "[w]hile a principal investigator must indeed place some reliance on laboratory members to provide and interpret their data, the situation found by the Panel here is one where the principal investigator, faced with persistent and frustrating failure by a laboratory member to achieve anticipated results, nevertheless chose to report success." Id. at 34. Later in the decision, the Panel noted that:
Dr. Angelides indisputably wrote and signed as principle investigator each of the grants at issue here. In doing so, he undertook responsibility for the accuracy of the information in them. Dr. Angelides did not dispute, and ample testimony supported, the standard in the scientific community that a principal investigator may not report results in a grant application for which he lacks a good faith belief in the legitimacy and interpretation of the data . . . .
Id. at 57 (citations omitted); see also id.at 73, 122, 169.
Dr. Angelides' practice of preparing grants without consulting the experimentalists in the lab and of submitting data for the papers at issue without consulting the individual who generated the data was a significant factor in assigning responsibility for the falsifications to Dr. Angelides. With respect to the grants, the Panel noted that:
Dr. Angelides generally prepared his grant applications without review by other laboratory members whose data were presented in them. Where a laboratory member's data were presented but the presentation was not reviewed by the actual experimentalist, the Panel concluded that Dr. Angelides bore a greater responsibility to show a reasonable basis for his presentation of those data, given that he had chosen to dispense with the check on accuracy that would be provided by the experimentalist's review.
Id. at 38. With respect to the published papers, the Panel found that:
Dr. Angelides's own expert witness testified that, if a manuscript is prepared after a student has left a laboratory, the standard procedure would be to contact the experimentalist to review and interpret the primary data and participate in the preparation of the manuscript. They agreed that the standards in the scientific community, then as now, required a good faith effort to ensure accurate reporting of others' data. In fact, Dr. Angelides himself agreed that he had an obligation to consult his students and resolve any questions about molecular weight or tissue source. Other scientists agreed that the interpretation of data should be verified with the person who conducted the experiment if the data are not labeled clearly enough to preclude error . . . . Dr. Angelides had the primary responsibility for the accuracy of the data, since in each case he provided them for publication without seeking the review and input of the actual experimentalists.
Id. at 113 (citations omitted); see also id. at 73, 111, 136.
Dr. Angelides also argued that the falsified data were not important to the overall conclusions of the papers or to the funding decision for the grant applications. Therefore, he suggested that the false statements should not be considered to be misconduct. The Panel noted that this argument was flawed both legally and factually. As a legal matter, the Panel noted that Dr. Angelides failed to provide any authority to suggest that intentional reporting of a false statement:
[I]s immunized from consideration as scientific misconduct merely because it is not integral or requisite to the grant application or paper at issue. Such a proposition would permit a scientist, with impunity, to knowingly make false claims that overstate the capabilities or achievements of a laboratory, as compared to others that may also be seeking funding in a very competitive funding environment, so long as the misrepresentations in a particular grant were not about the grant's central project or so long as the scientist could suggest alternative approaches making the falsified data "optional." The integrity of the funding process, which depends on accurate and honest information, could be undermined . . . . Hence, any statement included in a grant application that portrays to the reviewers the capacities or accomplishments of the researcher or laboratory as further advanced than they are in reality, or presents a more favorable picture of the likelihood of success than the true facts would suggest, can therefore be considered as material to the funding decision, whether or not it was "necessary" to the presentation of the research proposal. At the same time, it is evident as a general proposition that the more favorable and the more significant the false statement is, all other things being equal, the greater the likelihood that the misrepresentation is
intentional .
Id. at 65; see also id. at 35, 93, 141.
Accordingly, the decision suggests that the significance of a false statement is just one element to be reviewed in determining whether falsely reported data was included in a grant application or paper knowingly, or whether it was simply a result of honest error. 42 C.F.R. § 50.102. However, there may be many ways to look at whether a statement is significant. DAB Decision at 65. In the instant case, the evidence clearly demonstrated that Dr. Angelides intentionally falsified the data for the grants and papers and there was also materiality to those statements "even under the kind of criteria Dr. Angelides appeared to apply." Id. at 66. The facts revealed that Dr. Angelides engaged in "intentional and conscious fraud." Id. at 4. He "unfairly sought to advantage himself in seeking competitive funding and opportunities for publication that might otherwise have gone to other researchers who consistently presented their work honestly."
Id.
An additional factor commented upon by the Panel in its decision concerned Dr. Angelides' refusal to fully cooperate with the BCM investigative committee. The Panel suggested that respondents, such as Dr. Angelides, have an obligation as members of the scientific community to ensure that questions regarding scientific integrity are fully resolved. Dr. Angelides' refusal to respond to many of the investigative committee's questions "is inconsistent with Dr. Angelides's responsibility as a scientist to cooperate in ensuring scientific integrity, particularly since by that time he had raised allegations of scientific misconduct against [others] . . . ."
Id. at 169.
The resolution of the Angelides matter was a direct result of painstaking efforts on the part of scientists at the Baylor College of Medicine. The time and effort of the former members of the Angelides laboratory, the members of the Baylor investigative and appellate committees, together with the BCM legal and administrative staff, made it possible to untangle the systematic pattern of data falsifications engaged in by Dr. Angelides over the years. They are to be commended by all who value the integrity of the research process. The prevention and investigation of scientific misconduct is a cooperative effort between ORI and research institutions across the country. Without diligent efforts, such as those demonstrated by the Baylor scientific community, the systems established by Congress to protect Public Health Service funds from fraud would be ineffective.
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