In order to put potential issues and solutions into the appropriate context, members identified the objectives that must be achieved if a program of research integrity is to be considered effective. It is the workgroup’s view that the protections intended by the federal regulations and the objectives of a program of research integrity are to:

• Establish comprehensive programs that educate and sensitize all members of the research community to the issues of research integrity, that assure the integrity of science, and that ultimately reinforce the public trust in science.
• Assure an inquiry and investigation process that balances the rights of both the accused and the accuser with the objective of fairly and swiftly assessing and adjudicating the allegations. This adjudicatory process should draw on the procedural strengths of the legal system without that system dominating what is essentially an academic decision-making process often involving complex scientific issues.
• Assure an inquiry and an investigative process that minimizes the inherent tensions and loss of morale that inevitably result from allegations of scientific misconduct and the subsequent proceedings.
• Strike the appropriate balance between the primary role and responsibility of the research institution to respond to allegations of scientific misconduct and the responsibility of ORI to provide meaningful oversight consistent with the statute. This balance must be such that it allows the research institution to act collaboratively with its scientists to resolve issues.
• Develop a partnership and a trust between the research institutions and the ORI that will allow them to work collaboratively in pursuit of their common goal of promoting research integrity.

The group concluded that a credible policy has to achieve these protections. A loss of credibility will, in the long-term, be detrimental to science and to society’s trust of stewardship by research institutions. Any change to reduce regulatory burden should be consistent with the achievement of these objectives.

Following the development of the objectives that a credible research integrity program must achieve, the members identified those issues that were of concern. This list included issues related to the legislation, the regulations and the inconsistency between the agencies on some aspects of the regulations, the interpretation of the regulations, and practices at the research institution that resulted from the interpretation or over-interpretation of the regulations. It should be noted that the purpose of the workgroup was not necessarily to come to consensus. While there was general agreement on the issues and the proposed solutions, there was not necessarily unanimity on each.

• The regulations as currently written effectively require a duplication of effort on the part of the research institution and ORI; in doing so, they compromise the legitimate role of the institution to have primary responsibility for conducting and adjudicating allegations of scientific misconduct. The members of the workgroup concluded that current wording in the regulations, and the current method of reviewing the institution’s actions by ORI, effectively provides the institution with the initial, not the primary, responsibility for conducting investigations and adjudicating allegations of scientific misconduct. Paragraph 50.104(a)(6) of the regulations, state that "While the primary responsibility for the conduct of investigations and inquiries lies with the institutions, the Department reserves the right to perform its own investigation at any time prior to, during, or following an institution’s investigation." Furthermore, when the institution completes its investigation and makes its finding, ORI reviews the case to determine that it has been conducted "…in a timely manner and with sufficient objectivity, thoroughness, and competence." According to the regulations, ORI may request clarifications and additional facts, and has the unqualified authority to conduct another investigation and/or overturn the findings of the institution. In the members’ experience, this re-review forces institutions to emphasize process over substance, lengthens final resolution of the case often to the detriment of the participants, and creates an adversarial relationship between the institution and ORI.

  In addition, members also questioned whether reviewing the facts of individual cases (in contrast to the process employed) by ORI staff was the most efficient way for it to carry out its legislative mandate to provide institutional oversight. Other models based on system evaluation and promoting education and best practices might offer a potential alternative and increase overall effectiveness and efficiency.

• Dividing the case rigidly into "assessment", "inquiry", and "investigation" phases limits flexibility and may be inconsistent with the natural progression of the case. There are three identified phases to a case. The first is the assessment phase, which is identified in the ORI model policy but not formally acknowledged in the regulations. Once the official decides that an allegation merits further action, the inquiry stage begins and, as noted above, the regulation and the model policy are prescriptive regarding the purpose of this phase, the time periods, and the content of the written report that is required. The purpose of the inquiry phase is not to reach a judgment on a finding of misconduct but to decide whether an investigation is warranted. If it proceeds to the investigation phase, the regulations and the model procedures are again prescriptive on the requirements for the investigation phase.

  The members observed, however, that cases often do not proceed as uniformly as is implied by the regulations. While some cases may proceed in defined stages, the line between "assessment", "inquiry" and "investigation" is not always precise. For example, in some cases, particularly those that are less complex, inquiry and investigation are essentially completed at the same time. Some of the consequences of this inflexibility include:

  • The requirement to continue into the investigation stage even if the individual has admitted misconduct in the assessment or inquiry phase.
  • Confusion among the members as to whether a new committee should be established for the investigation stage, which would require repeating some of the same activities conducted in the inquiry phase.
  • The additional pressure placed on the institution to resist moving to the investigation phase unless there is overwhelming evidence of misconduct because the requirement to notify ORI at that point is seen by the accused as a major break in confidentiality.

  The experience of the members is that these inflexible categories lead to inefficiencies and to a lengthening of the proceedings. Flexibility that acknowledges the diversity in types of cases and that would allow a more natural flow would ultimately yield a more efficient process, and allow the institution to better manage the tensions that arise as part of the proceedings.

• Legal mechanisms are available to pursue redress in research misconduct cases which serve as a disincentive to the institutional investigation of allegations of scientific misconduct. Members expressed concern that legal avenues could be pursued that paradoxically may act as disincentives to both institutions and individuals who are participating in good faith in responding to allegations of scientific misconduct. Specifically mentioned were the use of Qui Tam suits under the False Claims Act. In such cases, an individual may file to recover government funds that were misused; if successful, treble damages may be awarded. Extending this to scientific misconduct, an individual might file against the research institution to recover research grant funds that were misused through scientific misconduct, e.g., where the data were falsified. The Department of Justice (DoJ) may join such a suit and use the institution’s investigation files to substantiate the act of misconduct in order to recover treble damages from the institution itself. Thus, as the DoJ may use these evidence files, developed by the institution, against it, vigorous pursuit of evidence by the institution is perversely discouraged.

  Also of concern is the possibility that participation on inquiry and investigation panels may expose panel members and investigators to personal legal action. Unless immunized and/or indemnified in some way by the institution or the Federal government, and by the State in the case of State institutions, panel members are at potential risk for legal costs in defending themselves in the case of a civil suit, and either settlement costs or verdict costs depending on the outcome. Such legal actions obviously could act as a disadvantage to the ability to recruit faculty members to serve on such panels.

• Insufficient effort is being devoted at both the Federal and institutional levels to conduct formal education programs in research integrity. The members concluded that all segments of the research community would benefit from formal training in issues related to research integrity and the responsible conduct of research. While commending the usefulness of the workshops and other proactive efforts currently being conducted by ORI, a significant potential exists to expand these efforts as well as the efforts being conducted at institutions.

• A better dialogue must be established between the institutions and ORI. Members noted that there is not always a sense of trust between the institutions and ORI. They observed that they often feel uncomfortable asking ORI staff a question about a specific case out of concern that ORI might unnecessarily insert itself in the investigation or that a call in the assessment phase, for example, will trigger the initiation of the official inquiry stage. Much of this arises from the "second-guessing" role described above where ORI must re-review all of the actions taken by the institution and is structured and staffed accordingly. This tension prevents the institutions from drawing on the experience and resources of the ORI, prevents ORI from achieving its goal of working collaboratively with the institution, and ultimately results in a less than optimal process.