News Release

AAAS urges US to give scientists a voice in research misconduct cases

Peer-Reviewed Publication

American Association for the Advancement of Science (AAAS)

WASHINGTON, DC – Under new rules on research misconduct, proposed by the US Department of Health and Human Services (DHHS), "scientists would have no voice," officials at AAAS, the world's largest general science society said today.

In a letter to Chris Pascal, director of the Office of Research Integrity (ORI), AAAS CEO Alan I. Leshner, executive publisher of the journal Science, said scientists contribute a critical level of objectivity, balance and technical expertise to research misconduct proceedings.

"Research misconduct allegations can damage the public's trust in the scientific process and the promise that science holds to improve all our lives," Leshner said. "Responsible scientists thus have an obligation to help investigate such cases in a technically rigorous, objective and timely manner. Under the current process, scientists play an important role in hearing and assessing allegations of research misconduct, and AAAS believes that this input is imperative."

The AAAS letter was a response to proposed new research misconduct rules issued in April 2004 by the DHHS (http://ori.hhs.gov/). While AAAS generally supports the new recommendations, it considers disbanding the current appeals board in favor of a single judge for hearing and deciding all violations as imprudent. It is highly unlikely that any judge hearing the case will be sufficiently versed in the science that lies at the core of the misconduct findings.

"Eliminating the Departmental Appeals Board in favor of a single administrative law judge disenfranchises scientists from the appeals process," said Mark Frankel, director of the program on Scientific Freedom, Responsibility and Law at AAAS. "By doing so, the proposed regulations risk losing credibility within the research community. We have urged the government to require the judge to appoint an expert with no ties to the case under review in order to assist in the evaluation of the highly technical matters presented on appeal."

AAAS is uniquely positioned among scientific societies to understand the implications of dealing with technical matters in legal proceedings. Through the Court Appointed Science Experts project (CASE), AAAS identifies scientists to help federal judges understand evidence presented in court. Use of a single administrative law judge would likely function more effectively with the assistance of a scientist working as a court expert.

"In the federal court system, independent court appointed experts, who have no loyalties to either side of the dispute, are in a position to offer an opinion that is more balanced than the parties' experts. AAAS has assisted numerous federal judges with identifying qualified experts, and their use has demonstrated the added value they bring to the judicial proceedings," wrote Alan I. Leshner, AAAS chief executive officer, in the letter to ORI.

The Court Appointed Scientific Experts Project (CASE) was launched in 1998 and is managed by AAAS staff. For more information on this program, please visit http://case.aaas.org .

The association has convened meetings on research misconduct and research integrity, simulated sessions with research administrators that offered insights for responding to allegations of misconduct, and educated hundreds of scientists with a series of integrity in scientific research videos (http://www.aaas.org/spp/video).

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MEDIA NOTE: The AAAS response to ORI about the proposed rule change on research misconduct is attached. To receive a copy of the letter, reporters may call the Office of Public Programs at 202-326-6440.

The American Association for the Advancement of Science (AAAS) is the world's largest general scientific society, and publisher of the journal, Science (www.sciencemag.org). AAAS was founded in 1848, and serves some 265 affiliated societies and academies of science, serving 10 million individuals. Science has the largest paid circulation of any peer-reviewed general science journal in the world, with an estimated total readership of one million. The non-profit AAAS (www.aaas.org) is open to all and fulfills its mission to "advance science and serve society" through initiatives in science policy; international programs; science education; and more. For the latest research news, log onto EurekAlert!, www.eurekalert.org, the premier science-news Web site, a service of AAAS.

AAAS is the world's largest general scientific society, dedicated to "Advancing science · Serving society."

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June 15, 2004

Chris B. Pascal, J.D.
Director, Office of Research Integrity
1011 Wootten Parkway, Suite 750
Rockville, MD 20852

Re: Notice of Proposed Rulemaking on Research Misconduct, April 16, 2004

Dear Mr. Pascal:

On behalf of the American Association for the Advancement of Science (AAAS), the world's largest multidisciplinary scientific society, I am writing in response to the Notice of Proposed Rulemaking on Research Misconduct issued by the Department of Health and Human Services (Federal Register, April 16, 2004, pp. 20777-20803). We appreciate the opportunity to share with you our reactions to what is a significant matter for the research community. Since the mid-1980s, AAAS, many of whose members are PHS grantees, has been in the vanguard of scientific organizations in recognizing the importance of research integrity for science and its relationship with the larger public.

We have convened a number of meetings, some in collaboration with ORI or its predecessor within DHHS, and some with the National Science Foundation, on the topics of research misconduct and research integrity. Our practicums have served the educational needs of hundreds of research administrators and scientists, who have consistently described the experience as giving them useful practical insights for responding to allegations of research misconduct at their institutions. Our videos on integrity in scientific research, funded in large part by ORI and NIH, are used in hundreds of colleges, universities, and other research institutions worldwide. Science, the flagship journal of AAAS, have been out in front of other scientific publications in reporting on research misconduct issues. Given the extent of the Association's involvement in these matters, we offer the following comments in response to the proposed rule, in the hope that it will assist DHHS in making appropriate revisions.

1. AAAS generally supports the proposed rule.

At the outset, we want to make clear our general support for the proposed rule. The Department has made great strides over the past several years to listen carefully to the concerns of the research community and to be responsive. ORI staff have been in the forefront of that effort, and they deserve considerable credit for constructing a proposal that is much improved over the current set of regulations.

For the most part, the rule's provisions reflect current practices by ORI and the research community that have served the interests of both science and the public well since OSTP issued its common federal policies and procedures on research misconduct in December 2000. One of the strengths of the DHHS proposal is its incorporation of the OSTP definition of research misconduct and its relevant policies and procedures.

We also believe that it makes sense to expand DHHS's jurisdiction to contracts and to apply the new regulations to all PHS funded research or training regardless of whether the respondent was a recipient of PHS funding. The latter rightly places the emphasis on the alleged act and its impact, rather than on the funding status of the alleged perpetrator. Expanding the "requirements for findings of research misconduct" to include "reckless" behavior by the respondent is also an improvement, given the vagaries of attempting to judge one's intent. We support codifying practices that promote coordination among the federal agencies in responding to allegations of research misconduct that affect more than one funding agency. Not only is it likely to generate greater efficiencies within government, but it should also be less burdensome to researchers and their institutions, which otherwise might have to deal with two or more concurrent agency investigations involving similar, if not identical, incidents.

2. AAAS agrees that, absent allegations of plagiarism, research misconduct regulations are not the proper framework for resolving authorship disputes.

ORI specifically requests comment on its preference for omitting from the applicability of the rule disputes over authorship, absent a clear allegation of plagiarism. We agree with that position. Intellectual property disputes are, in many cases, at the core of disagreements over authorship or some form of credit for work done. Such disputes should be resolved within the context of institutional intellectual property policies and/or existing intellectual property law, not research misconduct regulations.

3. We support the rule's more detailed delineation of the rights and responsibilities of parties involved in misconduct proceedings, but clarification is needed regarding the selection and use of an outside entity for assisting a "small institution."

We support ORI's efforts to provide greater detail regarding the responsibilities of research institutions in applying the government's misconduct policies and procedures. We believe that most of the changes will have a salutary effect on preserving the rights of the parties involved in the misconduct proceedings as well as drawing clearer lines of accountability. However, there is insufficient detail about the responsibilities of ORI, the institution, and any outside entity when a "small institution" requires assistance from the latter (Section 93.306, Using a consortium or other entity for research misconduct proceedings.) While the rule states that the entity "must be qualified by practice and experience to conduct research misconduct hearings," there is no mention of what kinds of practice and experience would qualify an outside entity, how possible conflicts of interest on the part of an outside entity would be handled and what might be a disqualifying conflict, whose responsibility it is to make a determination of whether an entity is qualified or in non-compliance under the rule, and what ORI's authority is vis-à-vis the institution's authority to select an outside entity to conduct the proceedings. Does ORI or the institution have the "final word" on the selection of the outside entity? No clear guidance is provided on this matter, either in this Section or in Section 93.400, General statement of ORI authority.

4. The rule should clarify what sanctions are available to impose on persons violating its confidentiality provisions.

Section 93.108, Confidentiality, stresses the importance of ensuring, "to the extent possible," the confidentiality of records or of a person's identity during the misconduct proceedings. It is not clear, however, what, if any, sanctions can be taken, either by ORI or the institution, against someone for breaching such confidentiality. If those involved "must" maintain confidentiality, what are the possible sanctions if they do not?

5. Clarification is needed of the roles played by institutions and ORI in preventing researchers from continuing their research in the event of misconduct allegations.

Section 93.305, Responsibility for maintenance and custody of research records and evidence, states that the institution has "a continuing obligation" to maintain custody of all records associated with the misconduct proceedings, but that, where appropriate, it make available to the respondent copies of or supervised access to the original materials. The commentary preceding the actual rule declares that ORI does not intend to "limit an institution's control over its employees and the research conducted under its auspices." It goes on to state that the respondent has no right to continue the research in the face of "reasonable institutional objections." It would be useful to provide some examples of what would constitute "reasonable" objections by an institution and to indicate what, if any, role ORI would have in reviewing such objections.

6. Coverage of the rule should be clearly stated throughout the document.

There are several places in the proposed rule where mention is made of "research" with respect to what is covered, but not to "training programs." If the intent is for the proposal to apply to both research and research training, it might be best to make that clear throughout the document.

7. AAAS has several concerns about revisions in the appeals process.

Our final set of comments focus on Subpart E, Opportunity to Contest PHS Findings of Research Misconduct and HHS Administrative Actions. While we support efforts to provide a clear, fair, efficient, and timely appeals process, we nevertheless have serious concerns about the proposed switch from the current Departmental Appeals Board (DAB) panel to a single Administrative Law Judge (ALJ) for hearing and judging all appeals. Before raising our specific concerns, we have a couple of general comments that should provide context for the points to follow.

A. Eliminating the DAB panel in favor of a single ALJ represents a significant change in the role of scientists in the appeals process.

Under the current appeals process, scientists have a role to play in the hearing and in the making of a decision regarding guilt or innocence. Given the technical nature of the subject matter, which can vary from case to case, it makes good sense for scientists to be involved in the process. (We are aware that not every research misconduct case coming before the DAB has included a scientist on the panel.) Although the new proposal provides for opportunities for participation by scientists, it is to a much lesser extent, as we interpret it, since they would have no vote in the recommendation that goes forward from the ALJ. Because the proposed change would "disenfranchise" scientists in the appeals process, we believe it is very important to scrutinize carefully how the expertise needed in evaluating the technical aspects of the case will be integrated into the proposed shift to a single ALJ.

B. AAAS's experience with court appointed experts offers insights into how the ALJ model might function.

Our second general comment relates to the AAAS experience with helping federal judges identify and use scientists and health care professionals as court appointed experts. That experience has informed our views on Subpart E in a way that is available to few other scientific organizations. The Court Appointed Scientific Experts Project, or CASE, was launched in 1998, and is managed by staff in the AAAS Program on Scientific Freedom, Responsibility and Law. Details about the project can be found at http://www.aaas.org/spp/case/case.htm. Under the Federal Rules of Evidence, judges can appoint their own experts to assist them in understanding the evidence presented by the parties (FRE 706). While the parties in the litigation are free to employ their own scientific experts, it is clear from our experience that experts for the parties tend to become advocates for their "side" and do not always offer a balanced account of the scientific issues before the court. Independent court appointed experts, who have no loyalties to either side of the dispute, are in a position to offer an opinion that is more balanced than the parties' experts. AAAS has assisted numerous federal judges with identifying qualified experts, and their use has demonstrated the added value they bring to the judicial proceedings. Based on our experience with CASE, we have several issues to raise about Subpart E.

  • The criteria for rejecting an ALJ's recommendation should be stated explicitly for both the DHHS debarring official and the DHHS Assistant Secretary for Health.

    In Section 93.500, General policy, provisions (d) & (e) describe the authority of the DHHS Assistant Secretary for Health and the DHHS debarring official to reject the ALJ's ruling "in whole or in part." Provision (e) makes clear that the debarring official may reject the ALJ's rulings "only after specifically determining them to be arbitrary, capricious, or clearly erroneous." These criteria seem reasonable to us, but we wonder why there are no similar criteria given in provision (d). We suggest that clear language be added listing the criteria for rejection of the ALJ's ruling by the Assistant Secretary for Health.

  • The ALJ should be required to retain outside expertise in all appeals involving research misconduct.

    Section 93.502, Hearing process, states that the ALJ "may retain one or more persons with appropriate scientific or technical expertise to assist the ALJ in evaluating scientific issues related to the PHS findings of research misconduct. At the request of either party, the ALJ must retain such an expert." We support the intent of this provision, but believe that it does not go far enough. Given the complexity of these types of cases, where the technical issue is likely to be very narrow, if not arcane, we recommend that the regulation require the ALJ to appoint an expert(s) in every appeal. We believe that this will not only increase the possibility that the scientific issues in the case are properly considered, but also that the process will be more credible in the eyes of the research community.

  • The rule should provide specific guidelines to assist ALJs in retaining appropriate expertise.

    Having expressed our support for ALJs having access to appropriate expertise, we acknowledge that this leads to other issues. Our experience in the CASE project has taught us that judges often do not know what kind of expert they need or where to find the right expert. These are reasons federal judges seek the assistance of CASE. There are no obvious procedures in the proposed rule to provide that type of assistance to ALJs. If the ALJ were to look for an expert through the resources of DHHS, that would certainly appear to be conflict of interest, in that the Department (ORI) is a party to the litigation. So while we support providing the ALJs with access to scientific expertise, we believe the regulations fall short by not providing some guidance for finding appropriate expertise. Finding the right expert(s) is critical to the entire process. We are aware of the procedures available to Special Masters in vaccine injury compensation cases that are referenced in the proposed rule. In speaking by telephone (May 28, 2004) with the Chief Special Master for that program, we learned that in creating the Special Master position for the vaccine program, Congress wanted them to be proactive in finding information that would help resolve disputes over scientific questions, including recruiting expert advice independent of the parties to the dispute. Although the procedures used by the Special Masters, according to the Chief of the program, are ad hoc, they are nevertheless instructive, and we urge the Department to consider them in developing guidance for ALJs for inclusion in the regulation. Of course, the CASE project could also assist ALJs in recruiting appropriate experts.

  • Guidance is needed to help ALJs assess an expert's qualifications.

    The proposed rule addresses how ALJ's are supposed to assess a potential expert's conflict of interest (Section 93.502 (c) and (d)). It does not address vetting for the expert's qualifications. The Chief of Special Masters for the vaccine program noted that there is no formal vetting process for experts' credentials. The Federal Rules of Evidence describe what qualifies an expert to give an authoritative opinion, but since the proposed rule indicates that the ALJs are not fully bound by those rules of evidence (93.519 (b) ), it is not clear on what basis the ALJ will determine an expert's qualifications for purposes of a research misconduct hearing. Nor is it clear whether the parties will have the right to challenge the qualifications of the expert appointed by the ALJ. The rule should provide more explicit guidance on these matters.

  • In fairness to all parties, the role of appointed experts should be formalized.

    The upfront material that precedes the proposed regulation acknowledges the significance of a proposed change in the expert's role by stating that "Substituting a single ALJ for the current three-person panel would alter, to some extent, the role of the scientist in the proceeding" (p. 20783). We believe that understates the nature of the change that is being proposed. Although the prefatory material compares the proposed change to "developments in the Federal judicial system in which judges may select their own outside experts….", that is where the comparison ends. In the proposed regulation, "the ALJ would consult informally with the scientific expert,…rather than following the more formal procedures" of the Federal Rules of Evidence (p. 20784). The proposal continues, "we do not contemplate that the ALJ's expert advisor would provide testimony for the record,…." These latter distinctions with the Federal Rules of Evidence may "simplify the process" (p. 20783), but we question whether they would ultimately provide for a "fair and impartial hearing" and "assure that a complete and accurate record of the proceeding is properly made" (Section 93.506 (a)). We find this particularly troublesome, given that the Department has recognized that members of the research community and participants in the hearing process have "commented that the current informal hearing procedures…lack the consistency and clarity provided by binding rules of procedure for other types of cases" (p. 20783). We do not believe that making the role of the independent expert informal is an adequate response to concerns raised about the current DAB panel. We also believe that such an informal role, as described in the proposed rule, can potentially taint the hearing process and its credibility with the parties, perhaps increasing the likelihood of further appeals to the federal courts.

  • AAAS believes that the opinion proffered by an ALJ appointed expert should be transparent to all parties and officials within DHHS.

    The proposed regulation is unclear on what access the parties will have to the opinions given by the ALJ appointed expert. Will the parties be able to challenge the accuracy or rigor of those opinions? How can the parties be expected to prepare their cases and respond to questions or stipulations by the ALJ if they have no access to what opinion the ALJ is receiving from the independent expert? How can a "complete and accurate record of the proceeding" be "properly made" (Section 93.506 (a) if the opinion of the independent expert is treated informally and out of view of the parties? To what extent will the Assistant Secretary for Health or the DHHS debarring official have access to the independent expert's opinion? Is it possible for them to judge fairly the recommendations from the ALJ without knowing how the latter used the expert's opinion? Given all of the detailed procedures proposed for the parties' experts, we find it troubling that similar details germane to the role of the ALJ appointed expert are not included.

    In light of these concerns regarding the role of the independent expert, we believe that the expert should be available for questioning by the parties. The vaccine program referred to earlier provides that experts appointed by a Special Master must be open to cross-examination by both parties. Ex parte communication must also be addressed. The rules governing the use of medical experts (ME) in hearings convened by the Social Security Administration state that "The ALJ must avoid any off-the-record discussion with the ME. If such a discussion occurs, the ALJ must summarize the discussion on the record at the hearing or enter a written summary of it into the record as an exhibit" ( Social Security Administration, Office of Hearings and Appeals Litigation Law Manual, Volume 1, Division 2, Chapter 5, Section 32: Medical Experts) Further, those rules provide that "If a claimant raises an objection about an ME's opinion, the ALJ must rule on the objection and discuss any ruling in the decision" (ibid.). This is a model that we believe should apply to research misconduct as well. It favors openness, fairness and a complete and accurate record.

    We hope that these comments prove helpful to DHHS as it considers revising the initial proposal. As we noted earlier, the proposal represents an improvement over the existing regulations, but still falls short of what we believe is needed to make it an effective, fair and credible response to research misconduct. Should you or your colleagues wish to discuss these matters further, please contact Dr. Mark S. Frankel, Director of the Program on Scientific Freedom, Responsibility and Law (phone: 202.326.6793; email: mfrankel@aaas.org).

    Sincerely,

    Alan I. Leshner


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