Scientific and research misconduct may present the most vexing of challenges for the compliance officer. Lines of inquiry that have been supported by human and animal subjects (and sacrifice), as well as significant financial investment, can be wholly discredited and rendered worthless if misconduct has occurred. Careers may be ruined and institutions shamed. Settlements, fines and awards deplete resources and imprisonment may await those who would perpetrate fraud upon the government. Investigators may be excluded from participating in Public Health Service (including National Institutes of Health) and National Science Foundation supported research. In addition, private causes of action from defamation to conversion (theft) may be available to victims.
Most areas of compliance address developing an institution-wide approach to ensuring that behaviors, practices and systems are consistent with laws and regulations. If an electronic medical record has been improperly accessed, providers have programs that will detect such a breach. The fact of the breach and its electronic detection does not have a personality. Conversely, allegations of scientific or research misconduct may arise among colleagues who work together or out of a position of trust (peer review of grant proposals; work overseen by a dissertation advisor). The real or apparent violation takes on a life of its own as those who used to go about their business in peaceful co-existence take sides and prepare for battle. Institutional anxiety runs high as those not directly involved seek to avoid the fall-out.
This chapter will review governing regulations and provide examples of scientific misconduct. A distinction is drawn between scientific misconduct and regulatory misconduct. The latter is conduct inconsistent with regulations and standards that govern the process of research, and that are found, for example, in the Common Rule, the Health Insurance Portability and Accountability Act (HIPAA), and regulations regarding the use of animals. Scientific misconduct may, indeed, include elements of some or all of these, and can be found in other sections of this compendium; however, this chapter will focus on the standards enunciated in 42 CFR Part 93 (Department of Health and Human Services) and 45 CFR Part 689 (National Science Foundation) that address institutional responsibilities regarding “fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research.” The essence of this chapter and its body of rules is to support the integrity of the public investment in “biomedical and behavioral research, research training or activities related to that research …”. It should be noted that compliance with the section is required upon application for support and is not contingent upon success in securing funding.
Institutions that seek Public Health Service (PHS) funding are required to have in place an “assurance.” This assurance certifies that the institution has adopted and implemented policies and procedures to address allegations of fabrication, falsification or plagiarism, including the identification of an appropriate institutional official to carry out the intent of such provisions, a research integrity officer (RIO). Prior to 1996, institutions filed an “initial assurance form;” however, beginning in 1996, signing the face page of a grant application constitutes/is deemed assurance. In addition, there is an annual reporting obligation that describes the status of activities that have taken place during the course of the preceding year. Failure to file a timely annual report could expose the institution to heightened scrutiny, as well as the need to pursue reinstatement of its assurance status in order to become eligible for Public Health Service (PHS) funding.
The regulations are prescriptive regarding the steps that must be taken when an allegation is received or misconduct suspected. The clarity and detail lend themselves to institutions adopting the process outlined 42 CFR Part 93 in applying its provisions to misconduct allegations that are expressed beyond the scope of behavioral or biomedical fields. The PHS approach, then, becomes imbedded and actually may serve to raise the standard of review universally.
Definitions (42 and 45 CFR)
Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
Fabrication is making up data or results and recording or reporting them.
Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.
Research misconduct does not include honest error or differences of opinion.
Requirements for findings of research misconduct
A finding of research misconduct made under either of these sections requires that:
There be a significant departure from accepted practices of the relevant research community; and
The misconduct be committed intentionally, knowingly, or recklessly; and
The allegation be proved by a preponderance of the evidence.
Response to an allegation of misconduct takes on a life of its own. It is logical to consider this process as a series of stages. At the first stage, the “notice” or allegation stage, the RIO or compliance officer (CO) becomes aware of the possibility of misconduct. The method of discovery could be direct, from someone who has specific knowledge of a transgression. The Office of Research Integrity may advise that it has received a report. Such communications can be transmitted through anonymous or confidential “hotlines.” Indirect knowledge could be obtained through an intermediary, such as an administrator in a department, or a non-involved researcher who reports “something she has heard from a lab technician …” In any event, having received such notice, the official is compelled to examine the situation with the information available and to consider advancing the process to the second stage, initiating an inquiry.
Consider the following scenario:
The phone rings… The voice on the other end of the line asks if he can be assured of confidentiality.
You (the compliance official) say, “I will protect your confidentiality as completely as allowed by law.” The caller then declines to identify himself, but says that the pressure to enroll subjects into a clinical trial that he supports is enormous. If patients don’t meet inclusion criteria detailed in the protocol, the staff is “encouraged” to “check those values again,” and reminded that jobs are dependent upon grant support. The caller says that he doesn’t want you to do anything, he just had to tell someone—he does not identify the study or the investigator. Weeks later you receive an anonymous call from a person describing herself as a monitor for a sponsor. She advises you that she believes subject records she has reviewed have been altered to satisfy study inclusion criteria.
The first caller was likely expressing frustration over the stress abundant in a grants-dependent work environment. The second call, however, should lead the listener to begin developing strategies to begin the second stage, or pre-inquiry review. In addition, caution is urged regarding a representation to anyone that their communications can be kept completely confidential. Institutional officials, except for professional ombudsmen or an official appointed to investigate, generally have an “obligation to report” that could be considered a breach of confidentiality. Counsel should be consulted regarding limitations in these matters.
The standard for moving forward states: “An inquiry is warranted if the allegation … (3) is sufficiently credible and specific so that potential evidence of research misconduct may be identified”. Your plan should include the following steps:
Develop a written record of all the facts, including a complete statement from the complainant;
Identify others who may be involved with the challenged conduct;
Identify others who may “be aware” of the situation;
Review relevant grant proposals, protocols, monitoring/ audit records, journal articles;
Assess the course the complainant wishes to follow—review concepts of anonymity and confidentiality as well as institutional policies on research integrity and nonretaliation.
Steps that must be taken to protect the records and evidence over which the (now) respondent has physical control, for example, in the laboratory, will likely produce turmoil and anxiety. Section §93.307 provides substantial detail regarding the kinds of evidence that should be protected, as well as provision of notice to the respondent. The appearance of institutional officials to take custody of the evidence may be the first opportunity for the respondent to be made aware that a misconduct allegation has been lodged. Although the notion of lack of advance notice may seem harsh, this element of surprise could be critical so that there is no opportunity to destroy or remove evidence that must be available throughout the course of the investigation and possibly beyond. Counsel and appropriate institutional officials should be advised of what actions will be taken (they, too, should be reminded of the need for confidentiality). In addition, the researcher’s work will need to be supported until resolution, which will likely include locating new laboratory space (if applicable).
The compliance or integrity officer should remember that he/she must maintain a posture of equipoise—it is her responsibility to manage a process that is fair. The rights of both the complainant and respondent must be protected. He/she should not provide legal advice. Institutional counsel should notify the respondent that retaining his or her own counsel should be considered.
“An inquiry’s purpose is to decide if an allegation warrants an investigation. An investigation is warranted if there is—(1) A reasonable basis for concluding that the allegation falls within the definition of research misconduct … and (2) Preliminary information-gathering and preliminary fact-finding from the inquiry indicates that the allegation may have substance”.
The institution is required to prepare an “inquiry report” to which the respondent is entitled to respond. The respondent’s comments should be attached to the report and be made part of the inquiry record. The regulation directs that the inquiry should be completed within sixty days of its initiation. Upon completion of the inquiry, the respondent must be notified whether an investigation will be undertaken and provided with a copy of the report. Note that the complainant may be notified and may be provided with relevant portions of the report. Though this is not required, anticipate that the complainant will likely be interested—it would be wise to review at the beginning of the process what the institution is able to accommodate. Consider that other laws and regulations may be invoked, such as HIPAA or those that protect the privacy of personnel records.
It may be that the institution determines not to investigate. Perhaps the allegation was found not to have substance. The institution should be prepared to restore the accused to his pre-allegation stature. Records supporting the decision not to investigate are directed to be maintained for seven years. If an investigation is warranted, it must be initiated within thirty days of conclusion of the inquiry and the Office of Research Integrity provided with the report and findings. Section §93.309 outlines the information that must be included in this communication.
After a determination that the allegation likely has substance, the investigation stage begins and should be concluded within one-hundred twenty (120) days. Review of the evidence, examination of witnesses, including experts in the relevant discipline and perhaps forensics, should be thorough and rigorous. Witnesses should have the opportunity to review their statements for accuracy. Again, the regulation, in section §93.310, is prescriptive and detailed. Succeeding sections address the development of the investigation report, requiring that there be a “[s]tatement of findings. For each separate allegation of research misconduct identified during the investigation, provide a finding as to whether research misconduct did or did not occur, and if so—(1) Identify whether the research misconduct was falsification, fabrication, or plagiarism, and if it was intentional, knowing, or in reckless disregard”. The potential “public nature” of this process becomes clear through (4): “Identify whether any publications need correction or retraction.” In addition, all instances of Federal support must be identified.
The institution’s policies and procedures regarding research misconduct must be included with both the inquiry report and the investigation report. For instance, the regulations may not address whether the institution should terminate the respondent’s employment relationship. Rather, the institution’s policies should provide guidance on consequences for engaging in misconduct.
Sections 93.316—93.318 address steps that must be taken to conclude the process, including notifications and opportunity for appeal. Note that ORI may assert itself into the process, provided it has jurisdiction, at any time. Remember, too, that complainants may take their concerns directly to the agency rather than through the institution that is the site of the grievance.
Institutional policies should recognize that consequences of research misconduct extend well beyond those assessed against the person responsible for engaging in the reprehensible behavior. Fines, settlements, exclusion from federal funding (debarment), civil actions for damages and the prospect of imprisonment appear not to be sufficient to discourage some. For an institution, the conduct of an inquiry and/or investigation will represent a significant drain on resources, including time and possibly space, and expert witness fees, for example. Junior researchers, students and colleagues may be unaware of the corrupt premise upon which their futures depend, and could fall. In order for our research to blossom into products, processes and services of benefit to us all, there must be mechanisms in place for anyone to advance a good faith concern about circumstances that jeopardize this objective.
Increasingly, federally funded researchers are required to submit peer reviewed articles and research to depositories so that the public and other researchers may have access to the products of our national research investment. NIH-funded, peer reviewed articles must comply with that agency’s Public Access Policy. Clinical trials, too, must be timely registered or continuation funding may be jeopardized.
Scientific efficacy is demonstrated by the ability of researchers who do not have an interest in a research outcome to achieve the same results as reported by the original team. “Replicability” of research findings is increasingly a subject of concern and will likely be a source for allegations of misconduct. Access to original data is critical in order to prove or disprove a finding or theory. Inability of successor researchers to achieve the same findings or theories may raise questions about the integrity of the data or data analysis. Those who urge rigorous, unbiased review of findings and therapeutic “breakthroughs” support requiring that original data be made available so that it can be tested and scrutinized to ensure that conclusions are correct. In addition, as inquiry becomes more complex, biostatisticians will need to join research teams to ensure analysis is reliable. Though whistleblowers, as identified in the earlier example, may serve as the primary source of misconduct allegations, peer researchers may increasingly lodge challenges if they are able to access and challenge data or data analysis.
Note that the Health and Human Services Office of Research Integrity (ORI) is responsible for oversight of misconduct for Public Health Service Agencies, including the NIH. The National Science Foundation Office of Inspector General is responsible for NSF-funded research. Additionally, all personnel, except for principal investigators, supported through NSF-funded research, are required to be trained in the Responsible Conduct of Research, for which employing institutions are responsible.
Finally, in addition to the above cited regulation, excellent resources are available. The Office of Research Integrity offers an excellent, web-available, Handbook for Institutional Integrity Officers as well as a quarterly newsletter that provides news of investigations.