Comments on the ORI Model Policy

The following comments and opinions were solicited in 1999 on the topic of the Model Policy for Responding to Allegations of Scientific Misconduct, written by Office of Research Integrity (ORI) of the U.S. Public Health Service (PHS). The National Institutes of Health (NIH) is under the PHS.

The contributions were posted as part of the Online Ethics Center Forum and Symposium on Responding to Allegations of Research Misconduct, which took place at Case Western Reserve University on Friday, October 30, 1999.

Charlotte Horton

Robert L. Sprague

Kenneth D. Pimple

Michael C. Loui

Charlotte Horton, Director, Research Administration, Case Western Reserve University

The University does take seriously allegations of misconduct in research:

• Funds allocated for a Compliance Officer

How do we get involved?

• Current policy outlines ORA as the first contact point; however, we are contacted through other means or channels. These include:
  • Through another University administrator or faculty
  • Anonymously
  • Letters or phone calls

• Go over flowcharts
• Preliminary inquiry. Conducted by the Associate Director for Compliance (becomes the Research Integrity Officer (RIO) under our policy. Stress confidentiality and keep all information very close to the vest in case the allegation does not constitute misconduct. If not misconduct, the individual is referred to the appropriate University official for help or further consultation. We provide and review the policy at this point with respondent and the compliant.
• Appointment of committee members and a chair. Recommendation solicited from pertinent Dean. Final decision is the RIO's.
• RIO meets with the committee chair to be sure he/she understands their duties and the policy.
• Respondent informed of the committee composition and he/she has an opportunity to request removal of a member(s). Final decision on removal rests with the RIO.
• With the first meeting of the inquiry, the RIO's role switches to administrative function and she serves as a resource and also provides the charge to the committee which outlines, but not limits, the research areas to be reviewed.
• Packet provided to committee before first meeting.
• We go over the policy with committee at first meeting as well as having a representative from the University Attorney's office to assist in answering any questions the committee may have about the legal ramifications of their involvement. These attorneys do not have any further involvement unless other attorneys are involved.
• We stress to the committee that this is not a legal proceeding.
• We stress confidentiality to the committee, other involved parties, and all witnesses that appear before the committee. We remind them of this at each meeting.
• Almost all correspondence for the committee is hand-delivered to further protect those involved. The only exception is using e-mail to set up committee meetings. The committee decides whom they wish to interview and what materials they wish to review.
• The RIO sets appointments and assists in gathering data.

Sequestering data:

• Decision made to sequester once a decision is made to go forward with a formal inquiry.
• Materials are kept under lock and key in the ORA office.
• Decision is not made at the end of the inquiry stage as to whether or not misconduct occurred.
• All files gathered up at the end and disposed of by RIO.

Difficulties we have encountered implementing the policy.

• Meeting the time limits.
  • Faculty are very busy people. Difficult to line them up for meetings.
  • Usually the committee consists of 5 members and coordinating their teaching and travel schedules can become an impossible mission.
  • An odd number of committee members is strongly recommended to avoid a "hung" panel.
  • Informing and educating the University community that they should come to us first to help ensure confidentiality. The involved parties often already breach confidentiality by the time we formally learn of the allegations.

The Office of Research Integrity, in answer to a question posed by ORA staff stated that there is no statute of limitations on misconduct in research.

• This can impose an immense burden on investigators who must retain their data.

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Robert L. Sprague, Interim Dean, College of Applied Life Studies, University of Illinois

• 1A. The introduction to the policy should contain statements about the importance of being proactive.
• 1B. The policy should apply to all the university's research activities whether funded by the federal government or not.
• 2B. A better definition, or better yet examples, should be given for "apparent" conflict of interest.
• 2D. Again, "with honest belief" is a vague wording. It also implies the ability of committees to judge "intent" which is extremely difficult to impossible.
• 2F. "All" under F is vague. Better wording would be "exhaustive."
• 2K. The Research Integrity Office should be reviewed on a regular basis and a report publicly issued on the performance of the office. Without such a regular review, such offices may perform poorly.
• 3L. How is it possible to security research records when they may be archived in a foreign country if the project involves foreign faculty? Some consideration of this issue should be given in the policy.
• 3N. A more complete listing of how the institution will restore the whistleblower's status should be given. For example, the Michigan whistleblower protection law protects against threats, defamation, harassment, and any change in the terms and conditions of employment.
• 3P. A statement about "honest error" means that committees will have to judge "intent" or the psychological state of mind at the time of the event. Such loose wording in the past has resulted in committees and/or university officials to claim that extensive verbatim copying of words is not plagiarism because the culprit did not "intend" to do it. Such judgments are ridiculous, but they are occurring.
• 4A. The Research Integrity Officer should consult with the Dean of the College where the misconduct occurred, or if the misconduct could possibly involve the Dean, the higher administrative officer.
• 4A. The most important disagreement I have with this policy is the insistence on confidentiality at all levels which certainly raises the suspicions of cover-up to those outside the system. And, in fact, sometimes provides an encouraging mechanism for cover-up. Confidentiality at all levels is not desirable for a number of reasons.
  1. Complete confidentiality does not follow the model of law in America. Most court decisions are open and available to the public even if the accused has been wrongly charged. This is a very important mechanism for making those court decisions have creditability for the general public. I am certainly glad Charlie McCutchen sued the ORI to force them to even make public their guilty decisions. Without that court decision apparently they would have kept the guilty decisions private.
  2. Publicity about cases often brings to light other people who have been harmed by the culprit. The best example in this are that I know about and which I mentioned at the colloquium is Barbara Noel. Noel was raped by Dr. Jules Masserman, a famous psychiatrist on the faculty at Northwestern University who gave his female patients sedative improperly for therapy. When she reported the rape to the police, the police did not believe her. Only after years of struggle when Noel was able to obtain publicity for the story, did a number of other women who also been assaulted by Masserman come forth when they received information that a case was being brought against him.
  3. Information about the resolution of these cases should be made public for general public accountability for the expenditure of millions of tax dollars in research projects. This is the primary reason for the False Claims Act.
  4. Publicity is vital to improve the area through, hopefully, thoughtful research by academic scholars like yourself and others. Without such research and information, we are likely to blindly stumble along either making policy or refusing to adjust policy on the basis of bias or whoever has the loudest trumpet to blow to further their own selfish ends. A good example of such effects is the Imanishi-Kari case.
• 5A. I believe it is fuzzy thinking to state the employees "should report" implied they have a duty to report. Thus, if they do not report for a number of valid reasons, they may in turn be charged. Several universities have attempted to silence whistleblowers by charging them with failures such as failing to report some act or another. In addition, implying such a duty to report often places undo pressure on students and other people low on the academic social power scale.
• 6B. The language about the protection of the whistleblower is not sufficient to ensure protection. For examples, the whistleblower protection statements of Michigan are much more appropriate. The Michigan law protects against threats, defamation, harassment, and any change in the terms and conditions of employment.
• 6B. "Employees should immediately report" is fuzzy language for the reasons given in 5A above.
• 7B. How does the university or other entity secure records if it is a collaborative project with part of the records in a foreign country? Because they are an increasing number of foreign collaborators, this section needs to be revised.
• 8C. Does the whistleblower also have a right to a written objection. There are instances in which the organization proposed a committee composed of members who had major conflicts of interest with the respondent until somebody, like the whistleblower publicly complained. Remember the first NIH committee to investigate the Imanishi-Kari case until Feder and Stewart made the two of the committee members close relationships to Dr. Baltimore publicly known.
• 9E. One of the major problems with past investigations is that, typically, faculty do not know how to conduct a thorough investigation. Thus, some language should be included which states that a staff person with professional experience in investigation should be involved either as permanent staff or consultant. In my knowledge of the Breuning case, the investigator, Mr. James Schriver, rather quickly found that Breuning has engaged in a number of misconduct activities, but in this situation, the NIMH administrator did not want to believe her own staff.
• 9B. The whistleblower should obtain the complete report not a summary. This just opens the door for manipulation of the report for a cover-up.

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Kenneth D. Pimple Ph.D., Research Associate, Poynter Center for the Study of Ethics and American Institutions, Indiana University

I served on Indiana University's Committee on Research Fraud and Misconduct while we were drafting our own policies and procedures; thus I am attuned to some fine details that we discussed in that process. I also served on an inquiry committee (the inquiry did not lead to an investigation) and found that we were well served by having a well-defined policy. (I understand that an inquiry undertaken earlier, before the policy and procedures were in place, was much more difficult for everyone involved.) The policy and procedures we adopted can be found at http://www.indiana.edu/~resrisk/miscond.html.

There has been a great deal of controversy over the definition of misconduct in science; I have made a presentation on the topic, and the text can be found at http://www.indiana.edu/~poynter/tre4-2a.html. I will take the liberty of quoting just one paragraph from that presentation:

To my knowledge, none of the findings of misconduct challenged to date has relied on the "other serious deviations" clause -- and I feel sure that if one had, it would have made the headlines. FASEB would have seen to it. This does not mean that such fears are utterly unfounded, of course, but [Donald E.] Buzzelli's suggestion that the procedures are really more important than the definition rings true to me. Bad procedures cannot be salvaged by a good definition, and an imperfect definition (which is all we can hope for) can be salvaged by well-designed procedures. At times all of the fuss over the definition seems like a smokescreen.

The referenced comment by Buzzelli follows:

"The scientific community has a right to be assured that federal agencies are not going to create misconduct in science cases based on some scientist's perfectly innocent behavior. . . . [T]his assurance should be sought in the procedures that agencies use, more than in definitions." Buzzelli, Donald E. 1993. "Some Considerations in Defining Misconduct in Science." In Ethics, Values, and the Promise of Science: Forum Proceedings, pp.220-224. Research Triangle Park, NC: Sigma Xi, The Scientific Research Society.

All of this is by way of anticipating a debate on the definition of misconduct, of making it clear that I think discussion of this policy is important, and of justifying some rather nit-picky comments on the model policy, which I find overall to be a very good start. Some specific comments:

II. A. Allegation means any written or oral statement or other indication of possible scientific misconduct made to an institutional official.

This is very broad and problematic. See comments on IV. A. below.

II. N. Retaliation means any action that adversely affects the employment or other institutional status of an individual that is taken by an institution or an employee because the individual has in good faith, made an allegation of scientific misconduct or of inadequate institutional response thereto or has cooperated in good faith with an investigation of such allegation.

The wording here is unnecessarily confusing. I would suggest changing it to something like this: "Retaliation means any action that adversely affects the employment or other institutional status of an individual that is taken by an institution or an employee because the individual has made a good-faith allegation of scientific misconduct, a good-faith allegation of inadequate institutional response to scientific misconduct, or has cooperated in good faith with an investigation of such allegation."

II. P. Whistleblower means a person who makes an allegation of scientific misconduct.

It would be better to use a less loaded term than "whistleblower" -- perhaps "initiator" (this is used by IU).

IV. A. Responsibility to Report Misconduct

All employees or individuals associated with [Institution] should report observed, suspected, or apparent misconduct in science to the Research Integrity Officer [Option: also list other officials]. If an individual is unsure whether a suspected incident falls within the definition of scientific misconduct, he or she may call the Research Integrity Officer at [telephone number] to discuss the suspected misconduct informally. If the circumstances described by the individual do not meet the definition of scientific misconduct, the Research Integrity Officer will refer the individual or allegation to other offices or officials with responsibility for resolving the problem.

At any time, an employee may have confidential discussions and consultations about concerns of possible misconduct with the Research Integrity Officer [Option: also list other officials] and will be counseled about appropriate procedures for reporting allegations.

Would such a confidential discussion constitute an allegation of misconduct, as defined in II.A?

V. A. Initiation and Purpose of the Inquiry

Following the preliminary assessment, if the Research Integrity Officer determines that the allegation provides sufficient information to allow specific follow- up, involves PHS support, and falls under the PHS definition of scientific misconduct, he or she will immediately initiate the inquiry process.

The key term to me here is "involves PHS support." Similar qualifiers show up all through the policy. Strictly speaking, this means that misconduct in research that did not receive PHS support (e.g., research funded by NSF) does not have to be investigated under this policy. Practically speaking, however, most universities will have one police/procedure to deal with allegations of misconduct, whatever the funding source. If memory serves (I have not double-checked this) the main differences between PHS and NSF requirements involve the number of days allowed for each step in the process, and the point at which the funding agency has to be notified. These are fairly minor differences that could either be reconciled by NSF and PHS. Or universities could craft a policy designed to meet both requirements, either by using the lower number of days or keeping careful track of the differences between requirements. It is important for practical purposes that NIH and NSF (and other funding agencies) cooperate to maintain similar policies and procedures, if only to keep the administrative burden on universities to a minimum.

Finally, on a fairly nit-picky point (but one which could end up in a lawsuit), the policy should consistently use precise terms such as "calendar days" or "working days" when establishing deadlines, and never use simply "days."

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Michael C. Loui, Associate Dean of the Graduate College and Professor of Electrical and Computer Engineering, University of Illinois at Urbana-Champaign

Dear Colleagues:

I have only recently become the Research Standards Office for my campus, and I have only a few comments. I am influenced by the procedures on my campus. These procedures have served us well since 1991 or so. I recommend strongly that the term "Whistleblower" be replaced by a less inflammatory word such as "Initiator."

I recommend that the model policy require the active involvement and explicit consent of academic administrators, such as the appropriate department head and college dean, to ensure the acceptance of the inquiry and investigation processes. These processes should not be perceived as external to the academic mission of the departments and colleges.

I recommend that the inquiry committee be kept small, with a total of only two or three members.