Promoting Integrity in Research
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Handling Misconduct - Inquiry IssuesORI Responses to Issues Arising from Inquiries and InvestigationsPage Bookmarks A variety of important issues have arisen in the
course of inquiries and investigations conducted by extramural
institutions into allegations of research misconduct. The Office of Research Integrity (ORI) presents its position
on 24 significant issues. For areas of conduct not covered by
the PHS definition of research misconduct, the statutory mandate
and regulations do not replace the authority of extramural institutions
to establish their own professional norms on the responsible
conduct of research.
More specific information on why individuals have been debarred
may be found in summaries published by ORI in the Federal Register,
the ORI Newsletter and in the NIH Guide for Grants and Contracts. Data presented in manuscripts or theses or given to a mentor or lab chief as representing the results of experiments; (16) Avoiding Conflicts of Interest - In responding to allegations, institutions need to select committee members and experts who are free from bias and have no real or apparent conflicts of interest either with the parties involved or the subject matter. Consequently, these individuals should be free of professional, financial, personal, or other substantial ties to the accused and the complainant. Generally, it is the responsibility of the institution's Research Integrity Officer (RIO) to select committee members who have the necessary expertise to evaluate the evidence and issues related to the allegations. The RIO needs to notify the respondent of the proposed committee membership and the respondent should have the opportunity to submit a written objection to any appointed member of the investigation committee or expert based on bias or conflict. The RIO then determines whether the challenged member or expert should be replaced with a qualified substitute. The institution may use either outside researchers or its own scientists as experts but should not select persons who are directly responsible for the laboratory or research project where the misconduct is alleged to have occurred. These individuals have conflicts of interest as mentors, co-authors, and/or supervisors of the respondent that may compromise their objectivity in reviewing the allegations. For more details on this issue, see ORI Newsletter, Vol. 6, No. 3, p. 6. (17) Needed Corrections in Cases - Institutions need to consider all the forms of research reporting that must be corrected or retracted after a finding of research misconduct. In addition to correcting or retracting any scientific publications containing fabricated or falsified data, in some cases, nucleotide sequences submitted to a national database may need to be retracted as well. (18) "Gag" Provisions Are Contrary to Responsibilities & Laws - ORI's position is that "gag" provisions in institutional settlement agreements are contrary to the institution's responsibilities to report misconduct under the Public Health Service (PHS) Act, 42 U.S.C. § 289b, and the regulatory complainant protection provision, Section 93.300(d) of the Public Health Service Policies on Research Misconduct. The PHS research misconduct policies require institutions to notify ORI of the outcome of misconduct investigations and, under certain circumstances, of alleged misconduct before concluding an investigation. Contracting to conceal misconduct would violate the institution's obligation to disclose misconduct to ORI. Furthermore, courts have held that similar "gag" provisions violate complainant protection laws. See e.g., Connecticut Light & Power v. U.S. Dept. of Labor, 85 F.3d 89 (2d Cir. 1996); EEOC v. Cosmair, Inc., 821 F.2d 1085, 1089 (5th Cir. 1987). (19) PHS Funding Jurisdiction in Research Misconduct Cases Explained - An important preliminary issue in research misconduct cases is whether there is Public Health Service (PHS) funding jurisdiction that would allow ORI to exercise its oversight responsibilities. Although there are many possible funding and misconduct scenarios, the general principles discussed below may provide valuable guidance for institutions and individuals alike. In most cases the PHS funding agency is the National Institutes of Health, but it may be any of the seven other PHS agencies: Center for Disease Control and Prevention, Food and Drug Administration, Substance Abuse and Mental Health Services Administration, Health Resources and Services Administration, Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, and the Indian Health Service. Under the PHS Policies on Research Misconduct, ORI's authority extends to "PHS supported biomedical or behavioral extramural or intramural research; PHS supported biomedical or behavioral extramural or intramural research training programs; PHS supported extramural or intramural activities that are related to biomedical or behavioral research or research training, such as the operation of tissue and data banks or the dissemination of research information; plagiarism of research records produced in the course of PHS supported research, research training or activities related to that research or research training. This includes any research proposed, performed, reviewed, or reported, or any research record generated from that research, regardless of whether an application or proposal for PHS funds resulted in a grant, contract, cooperative agreement, or other form of PHS support. This part does not supersede or establish an alternative to any existing regulations or procedures for handling fiscal improprieties, the ethical treatment of human or animal subjects, criminal matters, personnel actions against Federal employees, or actions taken under the HHS debarment and suspension regulations at 45 CFR part 76 and 48 CFR subparts 9.4 and 309.4. This part does not prohibit or otherwise limit how institutions handle allegations of misconduct that do not fall within this part's definition of research misconduct or that do not involve PHS support." Section 93.102.
Another closely related issue is who makes the decision on PHS funding jurisdiction. Initially, the institution has the responsibility to make an independent determination of PHS funding jurisdiction that does not rely solely on the representations of either the respondent or the complainant. While complainants are often in a good position to provide helpful information to the institution regarding the existence of PHS funding, and should always make an effort to assist in the determination, they are not required to prove this issue. However, a respondent who affirmatively claims that the subject matter of the alleged research misconduct does not involve any PHS funding should be required to establish this claim. An institution's decision regarding PHS jurisdiction, however, is not determinative of the issue nor is it binding on ORI. As part of ORI's responsibility for determining whether an institution is complying with its assurance, ORI may request, and the institution is obligated to provide, reasonable evidence that PHS funding jurisdiction is or is not involved in any particular case. ORI is authorized to and does review the institution's conclusion regarding the involvement of PHS support. Section 93.400(a)(2). Any party or institution with questions about a PHS funding issue may contact ORI's Division of Investigative Oversight for further assistance. (20) When Institutions Mistakenly Report "Admissions" to ORI - ORI has found that failure to follow an appropriate investigation process led to reaching incorrect conclusions in two different cases. In one case, institutional officials informed ORI that they were closing the case because the respondent had made an "admission" of research misconduct. In another case, officials said they were closing the case because a former employee was probably responsible for the alleged misconduct. In these cases, initial conclusions by research staff, principal investigators (PIs), and/or institutional officials that the respondents had made "admissions" or were "responsible for misconduct" were largely undocumented and ultimately were found to be unsupportable. In each case, ORI asked the institutions to provide a more formal investigative process to address the questions raised during ORI's oversight review. To concur with an institution's finding of research misconduct, that is based on an "admission," ORI not only needs a well-documented (preferably written or transcribed) admission containing language such as "I falsified results" or "I admit to research misconduct," but also sufficient substantive evidence to support the admission. In addition, the PHS regulation requires that the respondent be notified of the allegations and findings and be allowed to respond to them, or to waive that opportunity under the institution's policies for investigations. Section 93.312 Case 1 A research manager for a behavioral research study found discrepancies in records by a staff interviewer. The manager checked with a few of the research subjects, who said they did not remember getting any calls in the past year. When the principal investigator (PI) confronted the interviewer, he denied any wrongdoing and subsequently resigned without explanation. The institutional officials then notified ORI that the interviewer had "committed" research misconduct. As part of it's oversight process, however, ORI required the institution to notify the respondent of the proposed findings and offer him the opportunity for an interview with an inquiry committee. During the respondent's interview, he again denied any falsification of data, stating that he had called the subjects from home, as allowed by the protocol. The respondent told the committee that he had resigned simply because he thought the PI no longer trusted him. The committee ultimately found there was insufficient documentary evidence to warrant an investigation or a finding of research misconduct. Case 2 An institution investigated allegations that a PI had falsified research records in a clinical trial. The committee exonerated the PI, but its report found the nurse coordinator to be the most likely person responsible for the discrepancies (possible falsifications) between the primary records and those sent to the trial's data coordinating center. However, the institution had closed the case without contacting the nurse coordinator, who had left the institution. ORI required the institution to open a new investigation with the nurse coordinator as respondent in this case. While the nurse coordinator was not available for an interview, she provided written comments. After interviewing several witnesses and reviewing the records, the new investigation committee found one change in the data was not significant. For the other discrepancies, the committee found insufficient evidence that the respondent had changed the records. Thus, the institution made no finding of misconduct in this case. (21) Inquiry Versus Investigation Stages in Research Misconduct Cases - When examining allegations of research misconduct, institutions have an obligation to conduct an initial inquiry, and, if warranted, a thorough investigation in accordance with PHS Policies on Research Misconduct. 42 C.F.R. Part 93. This article discusses some procedural and substantive considerations in examining allegations of research misconduct in inquiries and investigations. After receiving a good faith allegation of research misconduct, an institution will usually open an inquiry to gather general information and make initial findings of fact to determine whether the allegation has substance and there is sufficient evidence to warrant an investigation. Sometimes, however, when there is sufficient evidence already at hand, for example as the result of an audit of a clinical trial, the institution may move directly to the investigation stage. If the inquiry uncovers evidence of "fabrication, falsification or plagiarism," an investigation is warranted. Section 93.307 (d). In general, absent full admissions, inquiries should not be used to make findings on whether research misconduct in fact occurred. On occasion, ORI receives an inquiry report in which either the committee has conducted the equivalent of an investigation and made specific findings, or which is obviously the result of a negotiated agreement. These reports may violate the PHS regulation and cause substantial difficulties for ORI's oversight. Findings made at the inquiry stage are all too frequently incomplete because the record has not been fully developed, and negotiated agreements violate the PHS regulation, if made without advance notice to ORI. Both instances may deprive ORI of the facts necessary to determine whether there has been an adverse effect on the PHS sponsored research, and the institution may be required to reopen its case and initiate an investigation. Instead of short circuiting the process, once an institution has determined that there is some evidence of possible misconduct, a thorough investigation should be conducted in accordance with the requirements explained in Section 93.310. Only after this process is complete should the investigation committee turn to an analysis of whether the charges have been proven by a preponderance of the evidence. Even if the record is relatively complete at the inquiry stage, the PHS regulation gives respondents the opportunity to have a full investigation unless they admit misconduct and waive the investigation. This multiple stage process has also been endorsed by the Federal Office of Science and Technology Policy which has stated that the investigation is "the formal examination and evaluation of the relevant facts leading either to dismissal of the case or a recommendation for a finding of research misconduct or other appropriate remedies." Federal Policy on Research Misconduct, 65 Fed. Reg. 76260-76263 (December 6, 2000). (22) Concerns about Using Set-up Experiments in Institutional Investigations - Several investigation reports transmitted to ORI from research institutions in recent years have included descriptions of experiments that were set up to try to detect additional fabrication or falsification of research results by the respondents. The set-up experiments (S-UEs) were arranged by complainants or institutional officials. Setting up experiments or asking respondents to repeat the experiments resulted in misconduct findings in the first three case examples given here. However, in other cases, the S-UEs failed to include safeguards, so the results were not useful in supporting an ORI finding of research misconduct. Furthermore, "repeating" the originally-claimed results in an experiment does not alone disprove an allegation that the original work was fabricated. Most findings of research misconduct are not based on the implementation of S-UEs and S-UEs are not necessary to confirm research misconduct. The results of S-UEs will not be useful in confirming misconduct unless adequate safeguards are imposed to monitor the situation and document any evidence. Case #1 An M.D./Ph.D. graduate student was suspected of fabricating data on experiments over several years. When asked to return to the laboratory to repeat the work on blinded samples, the student repeated the results in the presence of a coworker. However, when the laboratory director evaluated the materials used in the repeat experiments, the director found changes indicating the student had surreptitiously determined the contents of the "blinded" tubes before doing the new experiments. The student admitted doing so when challenged, and ORI obtained a debarment of the respondent from receiving Federal funds. Case #2 A postdoctoral fellow was observed pipetting material into labeled scintillation vials before conducting an experiment. The complainant secretly counted the vials and found they had been "spiked" with radioactive material. The respondent apparently was conducting the research with unlabeled cells and discarding them. The complainant went to the laboratory director, who set up experiments with animals deliberately mis-identified as being transgenic, but the fellow got the results that he had predicted if they were transgenic. The institution found research misconduct in this case and retracted four papers. Based on the institution's report, ORI obtained a debarment agreement. Case #3 The institution found substantial evidence of falsification of data by a graduate student who had finished a doctoral thesis. The officials delayed awarding the degree, but allowed the student a year to try to repeat the allegedly falsified results in another laboratory. ORI informed the institution that getting the expected results would not constitute proof that the original experiments were actually done, since the student might have correctly predicted the results without actually conducting the original experiments. But the institution insisted that the student have the opportunity to repeat the protocol. However, the student ultimately was unable to do so (there was evidence the student had changed the labels on the new materials, too). ORI found sufficient evidence of multiple falsifications in the student's original research to warrant debarment. Case #4 A group of postdoctoral and graduate students had individually raised concerns about some of the work that their professor did to complete the assays and report the results of the experiments that the students had initiated. So the students set up several experiments in which the biological samples were non-positive controls, but they told the professor that they were actual test samples. The professor got results that were consistent with those predicted by his theoretical model, but were impossible to achieve based on the actual samples. Unfortunately, the students did not inform the chairman, dean, or counsel in advance, and they could not prove later what the samples had contained. Although the evidence of other falsifications by the professor was sufficient for ORI to get a debarment agreement, ORI was not able to use the results of the S-UE to confirm research misconduct. Case #5 A professor and a senior scientist suspected that a graduate student had spiked biological samples before testing, to guarantee achieving the predicted results. They notified university officials, and they arranged for the student to return to their laboratory to conduct controlled, blinded experiments under their close supervision. However, because they learned later that the student could have had overnight access to the room with the "blinded" samples, the student could have tested and decoded the samples before the supervised runs. In the end, the institution found that the evidence was insufficient to conclude that the student had committed research misconduct, and ORI agreed. Case #6 A postdoctoral fellow was accused of manipulating instruments to get results that were "almost perfect" in physiological experiments on patient tissues. The laboratory chief set up experiments in which water was substituted for the biological agent in the solution that he planned for the fellow to use. When the new results came out as expected, he accused the fellow of falsifying all the results, and the fellow left the laboratory without responding. However, the investigation committee found that none of the new stock solution, made up to a standard volume, appeared to have been used. The fellow's notebooks indicated that a new vial of agent had been prepared, and the fellow testified that this new solution had been used for the repeat experiments. The institution found insufficient evidence of misconduct, and ORI agreed. ORI concludes from these examples that set-up experiments have sometimes been problematic, especially when the members of the laboratory conducting the S-UEs have not sufficiently documented the evidence or informed institutional officials who could independently monitor or confirm the actions. However, in other cases, the S-UEs have been used successfully to confirm suspicions about research misconduct and to obtain an admission from the respondent. (23) Assessing Research Misconduct Allegations Involving Clinical Research An allegation of wrongdoing in research involving human subjects must be assessed to determine under which Public Health Service (PHS) regulation or policy it should be handled. For ORI, the question is whether it is an allegation of research misconduct that falls under the PHS definition in Section 93.103. The following are examples of falsification and fabrication that have formed the basis for PHS findings of research misconduct in clinical research. Generally, these incidents occurred in the context of conducting clinical esearch or reporting data (internally or externally), publishing data or results, or including data or research records in grant applications or progress reports. Falsification
Fabrication
The PHS research misconduct regulation does not supersede or create an alternative to the established procedures for resolving fiscal improprieties or criminal violations, or cases of the abuse of animal and human subjects. In the absence of evidence of falsification or fabrication of the research record as described above, the following problems would be forwarded to the appropriate agency, such as the Food and Drug Administration ( FDA) and/or the HHS Office for Human Research Protections (OHRP):
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This page last was updated on March 27, 2007U.S. Department of Health and Human Services Office of Research Integrity 1101 Wootton Parkway Suite 750 Rockville, MD 20852 Directions to ORI Office Questions/suggestions about this web page? Contact ORI |