Research Misconduct and Its Federal Regulation: The Origin and History of the Office of Research Integrity—With Personal Views by ORI's Former Associate Director for Investigative Oversight

Abstract

Misconduct in science and research became the subject of significant public attention and Congressional scrutiny beginning in the 1970s and 1980s, which led to public statements, policies, and finally formal federal regulations being promulgated by Government agency officials. The Office of Research Integrity (ORI) in the Department of Health and Human Services was a major and very visible component of this process. This article provides a detailed history of the first two decades of federal research misconduct regulations and of ORI's history (under extremely difficult and unfair challenges), including personal views by the former ORI chief investigator and associate director.

Keywords:

• history of misconduct regulations
• office of inspector general
• office of research integrity
• office of scientific integrity
• research misconduct
• scientific misconduct

Notes

ⁱThe NSF regulation in 1987 defined “misconduct in science and engineering” as “fabrication, falsification, plagiarism, or other serious deviation from accepted practices in proposing, carrying out, or reporting results from activities funded by NSF” as well as “failure to meet other legal requirements governing research” (NSF, 1987). NSF's preamble for its 1987 regulation stated that there was no need for a clause exempting “honest errors or honest differences in judgment or interpretation of data” [found in the parallel 1989 PHS definition] since “ordinary errors, ordinary differences in interpretations or judgments of data, scholarly or political disagreements, personal or professional opinions, or private moral or ethical behavior or views are not, and could never be, considered to be misconduct under this definition.”

ⁱⁱThe author learned that NIH officials knew the HHS Inspector General preferred that OIG handle all HHS investigations centrally, including scientific misconduct ones (as the NSF's OIG did, see above). Kevles (1998) quotes an early OSI official [unnamed, and unknown to the author] in Fall 1992 as saying: “One of the worst things that could happen to this enterprise [OSI] would be for it to become the science cops—for it to be taken over by the office of inspector general and managed and implemented by a bunch of gumshoes who had no experience or understanding or love of science.”

ⁱⁱⁱThe departing NIH Director (James Wyngaarden interview by the NIH Historian, July 1989) stated, “I know Congress has been impatient and, to some extent, unbelieving that science can police itself. But if we don't do it, who will? This is not the kind of enterprise that subjects itself to random audit. That would be destructive of the fabric and fiber of science and the culture of science to move in that direction. As you know, I have in the past year, greatly expanded the office dealing with issues of scientific misconduct [ILO, then OSI] … And we're becoming much more vigorous in investigating those issues … Although, I regret, in a way, the fact that NIH has had to get into a regulatory area, I think it is unavoidable. I think it's irresponsible for us not to do so and to expect some other mechanism to do it.”

^ivHadley held a Ph.D. in clinical psychology. She had been a chief investigator for NIMH in the Stephen Bruening case at the University of Pittsburgh (cited above), which led to his criminal prosecution. As noted by Kevles (1998), she accepted the OSI Deputy Director position in 1988-1989, hoping to become the Director when Kimes returned to NCI. Hadley was a very quick study in OSI, learning to read and speak the very complex research “languages” of immunology and retroviruses. She was also a tireless worker and demanding supervisor, who pushed her staff and herself in working many dozens of misconduct cases all at once (as well as personally handling the frequent Congressional and press information requests). In the author's view, a few times she was too aggressive in trying to pursue scientific misconduct findings, as the decision-maker in OSI cases. (Hadley later turned against OSI, when she left NIH and was detailed to Rep. Dingell's Office; see text below.)

^vPHS ALERT system of records is a Government file listing individuals who were found to have committed scientific misconduct in PHS-sponsored research; it includes persons about whom ORI has received an institutional investigational report finding scientific misconduct by the individual and for whom ORI/PHS has jurisdiction. Disclosures are limited to certain PHS officials who have a need to know for their administrative responsibilities (PHS, 1994).

^viRoger Poisson was a surgeon at the St. Luc's Hospital in Montreal, Canada, doing research under the NCI's National Surgical and Adjuvant Breast and Bowel Cancer Program (NSABP), coordinated by Bernard Fisher at the University of Pittsburgh. Poisson directed his research data managers to falsify the records for breast cancer patients, as human subjects in the lumpectomy versus mastectomy research trial, which were submitted to the University for enrollment of eligible subjects in the clinical trial. When Hadley worked under Rep. Dingell in Spring 1994, she and Rep. Dingell brow-beat ORI officials into investigating Fisher on his NSABP program as well. Fisher was removed as Principal Investigator by NCI during the investigation, but he was later cleared of any research misconduct [he then sued the University (and NCI and ORI) for personal damages, winning a $3 million settlement in 1997]. The Fisher case events triggered by Hadley and Rep. Dingell caused ORI a huge loss in the credibility that ORI, under Dorothy Macfarlane's DIO leadership, had built with federal clinical trial monitors and the clinical research community.

^viiThe Acting ORI Director, J. Michael McGinnis, M.D., a epidemiologist and senior HHS official assigned to ORI, decided in December 1992 to accept an investigation report—which had been rewritten by the staff of the former-OSIR [without involving in the previous six months the former-OSI scientists who had completed the original report and disagreed with the re-wording and findings], to pursue ORI findings against Popovich and Gallo, which were appealed by them to seek DAB hearings.

^viiiAs noted in the ORI Newsletter (ORI, 1993C), the first DAB hearings before DAB staff attorneys (most often, Cecilia Sparks Ford and Judith Ballard) did not go well for ORI and its PHS counsels. DAB attorneys in two 1993 cases (Sharma, http://www.hhs.gov/dab/decisions/dab1431.html and Popovic, http://www.hhs.gov/dab/decisions/dab1446.html) ruled against ORI As a result of those DAB decisions, two other pending DAB hearings on ORI findings were dropped by ORI (Gallo case and Hamosh case). Later, in 1996, the long-standing Imanish-Kari case was lost by ORI at a DAB hearing http://www.hhs.gov/dab/decisions/dab1582.html. However, other respondents withdrew their DAB appeals. In addition, ORI did prevail in several earlier as well as later DAB hearings (see below). Popovic later unsuccessfully sued Hadley and the Government for emotional distress and violation of due process rights in the OSI investigation, under the Federal Torts Claims Act (28 U.S. Code § 1346, 2671) in the U.S. District Court in Maryland [997 Federal Supp. 672 (1998)]. The Court found: “Whatever criticisms may be made of the OSI/ORI/U.S. Congress/”Hadley” investigations, they were not, as a matter of law, intentional or reckless, nor were they extreme and outrageous. In the white hot glare of the international controversy surrounding discovery of the AIDS virus, the record is clear that NIH made an overall reasonable attempt to look into serious allegations of scientific misconduct.” See http://www.leagle.com/xmlResult.aspx?page=4&xmldoc=19981669997FSupp672_11593.xml&docbase=CSLWAR219862006&SizeDisp=7.

^ixThe NSF OIG reports on its misconduct findings in its public Semi-Annual Reports to Congress (http://www.nsf.gov/oig/) without naming the person who committed misconduct or their institution (simply stating, e.g., “a professor at a major northeastern university”). NSF has published the names of persons debarred by NSF from federal funding, but without stating the reason for debarment (some were based on research misconduct findings, but the NSF debarment notices do not so state). One can search for such “exclusions” by name/agency at https://www.sam.gov/portal/public/SAM. It is noteworthy that about 90% of NSF's findings have been for plagiarism-related misconduct, whereas ORI's findings have been over 90% for falsification and fabrication. While NSF OIG officials suggested this difference was due to the attention given to medically-related research (at NIH, for ORI), the author has always believed that this difference may instead be due to an under-reporting of the latter categories to NSF OIG—not to a fundamental difference between physicists, mathematicians, social scientists, and engineers (who mostly plagiarized on NSF funds) versus biomedical scientists (who mostly falsified and fabricated on HHS funds).

^xThe author notes, however, that numerous institutions have retained the “other serious deviations” clause in their institutional research misconduct definition. Officials of one top-tier university considered a report from an institutional investigation committee with an OSD-finding for a faculty member not meeting some undefined “university community standards” of research conduct and mentoring. ORI would not consider such a finding under the federal definition (ORI has not used “OSD” since 1992).

^xiAs noted above, ORI had lost cases at three DAB hearings (Sharma case in 1993, Popovic case in 1993, and Imanishi-Kari case in 1996). However, several respondents found by ORI to have committed falsification, fabrication, or plagiarism withdrew their DAB appeals before any hearing: Raphael Stricker and James Freisheim (ORI, 1993c), Catherine Kerr (ORI, 1994b), and James Gary Linn (ORI, 2010)—as well as Evan Dreyer (ORI, 2000), who withdrew his appeal during a DAB hearing. So ORI findings against them all were published. Furthermore, ORI prevailed at three other DAB hearings in the 1990s, with ORI findings being published: Paul Langlois in 1994: http://www.hhs.gov/dab/decisions/dab1409.html, John Hiserodt in 1994: http://www.hhs.gov/dab/decisions/dab1466.html, and Kimon Angelides in 1999: http://www.hhs.gov/dab/decisions/dab1677.html. Another DAB appeal by a former Michigan State University graduate student, Maie Elkassaby, was withdrawn when ORI and the institution confirmed her acceptance of responsibility in a dispute over research records, and they withdrew their misconduct findings (ORI, 1994a).

^xiiSome institutions have tried to make such findings for reckless misconduct. However, in the author's experience as an expert consultant for seven years, there is a danger in institutions using the “reckless” standard too loosely. For example, the author has seen investigation committees and officials propose or make findings of research misconduct for a professor being a poor mentor—or for failing to do forensic image analysis on figures for publication (when the professors had trusted a graduate student or postdoctoral fellow to publish the same raw-data figure that they had showed to the professor earlier). The author notes that, in the prior decade, two distinguished, nationally-prominent professors had missed such manipulation of images by their graduate students or postdoctoral fellows (until it was detected by others during manuscript review by a journal or after the publication process); these professor were praised for making rapid public retractions of the falsified research publications (ORI findings against Urban under Hood, 1995; ORI findings against Kumar under Hood, 1996; and ORI findings against Hajra under Collins, 1997). No one ever publically accused these professors of being “responsible for the research misconduct” that was committed by their graduate students or postdoctoral fellows.

^xiiiHowever, it became clear in the 1990s (and remains clear in 2013) to the author and other scientists in OSI/ORI who review institutional reports of scientific and research misconduct, that institutional committees and officials are often uncomfortable using such a low standard of proof. Given the serious impact on reputations and careers from allegations and findings of misconduct in science, they appeared to prefer using some level that is closer to a “clear and convincing standard” or to a “beyond a reasonable doubt standard” (generally without so stating in the investigation reports and notification letters to ORI). ORI even found that one major public university in Maryland had formally adopted in the early 1990s a “beyond a shadow of a doubt” standard, which is a literary (not a legal) standard.

^xiv“Research Record” is defined in the 2005 HHS regulations as: “… the record of data or results that embody the facts resulting from scientific inquiry, including but not limited to, research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports, journal articles, and any documents and materials provided to HHS or an institutional official by a respondent in the course of the research misconduct proceeding.” The author has argued in a few of his consulting cases that the mere citation in a biographical sketch for an NIH grant application (or in a curriculum vitae) of a paper containing allegedly falsified results, without referring to the allegedly falsified data or results that constitute the “research record,” should not be a basis for invoking the exception to the six-year time limitation (in order to pursue an issue that arose over six years earlier and thus would fall outside the regulation). For example, asking a professor (who cited papers, published a decade or two ago, in their biographical sketch or curriculum vitae in the past 6 years) to produce research records for the cited postdoctoral work done in another laboratory, where the records were left 15 or 20 year ago—and to defend images that were alleged to have been modified by someone (unnamed) in ways that could not be seen by the naked eye (only detected by sophisticated forensic image analysis available in the last decade)—is very difficult and often extremely unfair to the professor to defend such decade-old papers against new charges of falsification. The author's argument—that the “later reuse” clause be read as being restricted to a later citation of the actual falsified data that constitutes the misconduct-related research record (not merely the citation to the paper's author, title, and journal site)—has not been tested in any appeal, to date in 2013.

^xvSeveral appeals filed with the DAB since 2005 were dismissed by the assigned ALJ under the 2005 HHS research misconduct regulations, without a formal appeal hearing being held (all such cases being decided in favor of ORI's findings and PHS’ proposed administrative actions): (1) Rebecca (Marcus) Uzelmeier in 2007: http://www.hhs.gov/dab/decisions/dab1677.html her debarment-appeal suit in Federal District Court was dismissed in 2008: http://www.gpo.gov//fdsys/pkg/USCOURTSdcd1_07cv00753/pdf/USCOURTSdcd1_07cv007531.pdf, (2) Scott Brodie in 2010: http://www.hhs.gov/dab/decisions/dab1677.html. He was granted the opportunity to pursue a hearing by the ALJ on whether his falsifications were intentional and on the length of the debarment period; his debarment-appeal suit to Federal District Court was dismissed in 2011: http://www.gpo.gov/fdsys/pkg/USCOURTSdcd1_10cv00544/pdf/USCOURTSdcd1_10cv005442.pdf, (3) Philippe Bois in 2011: http://www.hhs.gov/dab/decisions/civildecisions/cr2366a.pdf. His appeal suit for a hearing was upheld on one of two ORI findings in Federal District Court in 2012: www.gpo.gov/fdsys/pkg/USCOURTSdcd1_11cv01563/pdf/USCOURTSdcd1_11cv015630.pdf. However, he settled on an ORI finding in 2013 without any ALJ hearing: http://www.gpo.gov/fdsys/pkg/ FR20130418/pdf/201309134.pdf

^xviAs outlined above, in the eight years under the revised HHS regulation (from June 2005 to date in 2013), the HHS ALJs have granted no formal hearings for such appeals; they have found the appellants have not yet raised issues that would require further adjudication. The author notes that some defense attorneys have expressed the opinion that the revised HHS/ORI regulation has turned the process for appeal of ORI findings—with notice of proposed PHS findings by ORI often after one or several years of review within ORI following an institutional investigation finding—from “scientific debates with ORI” into “legal arguments with ALJs,” making appeals untenable.

1. Another such self-designated “fraud-buster” at NIH was Charles McCutchen, who was the helpful secondary complainant in the Abbs case (see below). McCutchen unsuccessfully sued HHS [McCutchen v. DHHS, 30 F.3d 183 (D.C. Cir. 1994)] to try to get access to the names of all the complainants and the names of all the respondents who were not found guilty of scientific misconduct in the confidential OSI files, to do his own analyses (ORI, 1993a).

2. The Secret Service's glass thin-layer chromatography plates (on which the ink analysis was done, showing the notebook ink was sometimes years newer than the dates on the pages) were demanded in discovery for the HHS hearing process by Imanishi-Kari's lawyer, Bruce Singal, for scientific evaluation by his own expert. He later mailed back the plates loosely packaged, guaranteeing that they would arrive broken back at ORI. Secret Service agents then told ORI they would never again provide such evidence to ORI.

3. Adil Shamoo, Professor of Biochemistry and Molecular Biology at the University of Maryland Baltimore (and Editor of Accountability in Research), proposed random data audits as an alternative to check for the integrity of publicly funded research results, wherein scientist-auditors would match the raw data records with the published research records (Glick and Shamoo, 1993). See also his comment in Nature 439: 784 (2006), with the proposal that he renewed in his talk at the “ORI at 20” Research Integrity Leadership Conference in 2013.

4. ORI makes its own determination, based on institutional investigation reports and additional detailed analysis of the research records, as to whether to pursue institutional findings with ORI findings. However, contrary to Charrow's statement about ORI acting to “reverse” an institutional finding (Charrow, 2010), ORI has never done so and has always made clear that the institution makes its own determinations, which stand under institutional authority (unless the institution should later change them). ORI does not “overturn” an institutional finding; rather, ORI simply declines to pursue some institutional misconduct findings, for various reasons (as Charrow knows from defense cases). As the author learned, a Harvard counsel once told ORI and Harvard colleagues, “We have higher research standards than the Federal Government.”

5. Attorney Robert Charrow wrote a book (Charrow, 2010) that included his observations on research misconduct issues, including this historical incident. In the early 1990s, he labeled the OSI staff as “a bunch of yahoos” [after the primitive legendary creatures in the mud in Gulliver's Travels; see also his critique in the Journal of NIH Research 3: 103--106 (1991)]. ORI staff had a similar affection for him. His book chapter contains several errors of fact about OSI cases, most glaringly his false statement that “he [James Abbs, see case discussion above] terminated the interview when the OSI team refused to permit his attorney to be present.” In fact, the author had told Abbs months earlier that he could bring his attorney, who did indeed attend. [In fact, his attorney demanded (against standard federal investigative processes) that they be allowed to attend OSI's confidential interviews of Abbs’ coauthors and staff, who had witnessed his questioned research and paper. When the NIH counsel and the author rejected that demand, Abbs and his attorney left the interview without answering any of the questions on the issues that the author had told him were to be discussed.] It is noteworthy in this vein that Charrow had been one of the PHS lawyers who wrote the 1989 misconduct regulations and then left the Government for private practice, where he was observed by other PHS counsels as attacking these same regulations and OSI/ORI while serving as a defense attorney. Kevles (1998) quotes Charrow as saying of the ORI: “We created a monster, and now it is time to bury it.” Charrow and his colleagues had little success in trying to do that.

6. As noted in the NAS historical summary (NAS, 2002): “OSI suffered a “scientific backlash” (Hamilton, D.P. 1991. Science 253: 1084–1086) by some scientists and associations that criticized OSI as being too “zealous” (Davis, B., 1991, The Scientist 5: 12) and being staffed by investigators reminiscent of the “Keystone Cops” (Wheeler, D.L., 1991, Chronicle of Higher Education, p. A5). Others suggested that OSI was staffed by “failed scientists” [see quotations in a national news article (Recer, Associated Press, 1991)]. The author personally knows these politically-driven labels were grossly unfair and inappropriate [see text below on the OSI/ORI staff's solid scientific and administrative credentials].

7. OSI's sister office at NIH, the decades-old Office for Protection from Research Risks (OPRR), had similar HHS-wide regulatory authority (over protection of human and animal subjects in PHS research). Later, OPRR's human subjects division was also moved out of NIH to the HHS level, becoming the Office for Human Research Protections (OHRP). It is noteworthy that OHRP makes findings of regulatory violations against institutions, not against individuals; while OPRR and OHRP could have pursued debarment of individuals who abused human subjects (like ORI does for individuals whom ORI found to have committed research misconduct), these other offices have left the possible pursuit of such debarment actions to the individual PHS funding agencies [that rarely has been done, except for financial fraud].

8. In the author's experience at OSI/ORI through the 1990s, the best and most committed of the first RIOs—to the fair and thorough handling of allegations and investigations of research misconduct--included: [EAST COAST] Margaret Dale at Harvard Medical School, Jerome Rosenberg at University of Pittsburgh, Joseph Corless at Duke University Medical Center; Karen Putterman at University of Medicine and Dentistry of New Jersey, and Estelle Fishbein, Julie Gottlieb, and Sheila Garrity at Johns Hopkins University; [MIDWEST] Grainne Martin at University of Iowa, Brenda Russell at University of Illinois Chicago, Todd Guttman and Lynne Olson at Ohio State University, Christina Gunsalus at the University of Illinois Champagne-Urbana, Peter Dunn at Purdue University, Judy Nowak at University of Michigan, and David Wright at Michigan State University; [SOUTH] Thomas Walsh at University of Florida, Leonard Zwelling at M.D. Anderson Cancer Center; and Edward Conradi with Cynthia Karr at Medical University of South Carolina; and [WEST COAST] Paul Friedman and Jerry Schneider at University of California at San Diego, Karl Hittelman at University of California at San Francisco, and Cheryl Cameron at University of Washington.

9. In all these interim years of the 1990s, OSI/ORI had a fine core group of honest, hard-working, and dedicated ORI investigation division members. In addition to the four investigators named above (Dorothy Macfarlane, M.D., and NCI clinical trial auditor; Nancy Davidian, Ph.D., biochemist; Alan Price, Ph.D., biochemist and university associate vice president; and Barbara Williams, Ph.D., geneticist), ORI had: John Dahlberg (Ph.D., virologist/immunologist, now ORI Deputy Director); Kay Fields (Ph.D., molecular biologist); John Krueger (Ph.D., cardiac biophysicist, who developed ORI forensic droplets for image analysis); James Mosimann (Ph.D., statistician, who developed forensic digit analysis for ORI); Samuel Merrill (Ph.D., anatomist); Marshall Narva (Ph.D., psychologist); Peter Abbrecht (M.D./Ph.D., physician and bioengineer); and John Butler (B.A., accountant and data base manager). All had many years of successful university, federal, or corporate research and/or research administration experience (most of the scientists had directed university or federal research laboratories). ORI also had excellent staffers (paralegal Sheila Fleming, data base manager Gary Lipshultz, assurance coordinators Carolyn Bowman and Susan Hart, writer/editor Karen Gorirossi, and administrative assistants Tracy Morgan and Barbara Boyd, as well as several devoted file technicians). Most of these investigators retired in the 2000s. OSI/ORI was ably advised in 1989 and the early 1990s by NIH/PHS counsels: Robert Lanman and Susan Sherman [and by Kendra Dimond, assigned to OSI by Healy], then Debra Parrish, Gail Gibbons, and Peter Poon; followed by Marcus Christ, Stephen Godek, and many other PHS counsels later.

10. See also follow-up article by Steneck (1999).

11. HHS published a Statement of Organization, Functions, and Delegations of Authority for ORI in 2000 (HHS, 2000A). Under that authority: ORI's Director will “(1) Oversee and direct Public Health Service (PHS) research integrity activities on behalf of the Secretary … (2) recommend to the Assistant Secretary for Health for decision, findings of research misconduct and administrative actions in connection with research conducted or supported by the PHS; (3) coordinate the development of research integrity policies designed to ensure that subjects of investigations and whistleblowers are treated fairly, including clear specification of what constitutes misconduct, a fair hearing process, appropriate time limits on pursuing allegations, and specific whistleblower protections; (4) manage the financial resources and provide overall administrative guidance in carrying out the activities; and (5) oversee and direct the research misconduct and integrity activities of the office, including the oversight of research misconduct inquiries and investigations, education and training in the responsible conduct of research, activities designed to promote research integrity and prevent misconduct, and research and evaluation programs.” – and ORI's Division of Investigative Oversight Director will: “(1) review and monitor investigations conducted by applicant and awardee institutions and intramural research programs; (2) evaluate investigations and investigatory findings of awardee and applicant institutions, intramural research programs, and the Office of Inspector General and develop and recommend to the ORI Director, findings of research misconduct and proposal [sic] administrative actions against those who committed misconduct; (3) assist the Office of the General Counsel (OGC) in preparing and presenting cases in hearings before the Research Integrity Adjudications Panel of the DHHS Department Appeals Board; (4) provide information on DHHS policies and procedures, as requested, to individuals who have made an allegation or have been accused of research misconduct; and (5) establish and implement a program of advice and technical assistance to entities that conduct inquiries and investigations, or otherwise respond to allegations of research misconduct.”

12. For additional input to ORI from the institutional officials community, the author recruited as a consultant in the early 2000s, David Wright, an experienced RIO and Professor at Michigan State University (since 2012, he has been ORI's Director). Through the 2000’s, he advised ORI's Division of Investigative Oversight (DIO) on misconduct case strategies and outside activities. Later he was retained as well by ORI's Division of Education and Integrity (DEI) to develop the ORI Boot Camps for RIOs and counsels, as well as to advise on and participate in intramural research on research integrity in ORI with Sandra Titus. In addition, Nicholas Steneck, a Professor at the University of Michigan, was recruited from Michigan to ORI under the Intergovernment Personnel Act in the 2000s, to work on the responsible conduct of research, integrity education, research conferences, and development of related ORI handbooks and publications, with Sandra Titus and Mary Scheetz in DEI.

13. The author and other OSI scientists initiated in 1991 visits with NSF OIG scientists and counsels, and several of them requested a re-visit at ORI in 1993, to discuss as professional colleagues our policies and mutual cases. ORI's scientists and PHS counsels were dismayed by the publication of a non-collegial legal article by NSF OIG counsels and scientists (Herman et al., 1994). It criticized the “scientific dialogue process” at the PHS, while it somehow disregarded that -- while such an idea had been discussed in 1990-1991 by Hallum for OSI -- it been discarded in 1991with publication of OSI's investigative procedures and in 1992 with the initiation of the DAB's due process hearings. The NSF authors claimed in this paper that the ORI/PHS processes might be in violation of the Privacy Act and Administrative Procedures Act, as well as the U.S. Constitution. They inappropriately disclosed the existence of ORI's three massive investigation procedures manuals (ORI had shared these procedural manuals with the NSF in confidence). Nonetheless, ORI staff members ignored this self-serving NSF article (which appeared while Rep. Dingell and Abbs were criticizing ORI, as described above), when ORI scientists and counsels visited NSF OIG in 1995 and 1998, as professional colleagues.

14. Charrow also contrasted the HHS appeals process with the NSF appeals processes: “The NSF system does not provide either an independent or a trial-like review [as does HHS's system]. Rather, the recommendations of the [NSF] OIG are forwarded to the [NSF] deputy director, who reviews the recommendations and may confirm the recommendations or call for additional evidence. The regulations also permit an appeal from the deputy director's decision to the [NSF] director, but there is no indication of what criteria are to be used by the director” (Charrow, 2010). NSF posted debarment regulations at 620.830, 620.835, 620.845, and 620.855 (part of the Government-wide debarment regulations, 2003). NSF OIG noted in 1994: “If the deputy director, who is the debarring official [and who is the adjudicator for NSF] finds that there is a genuine dispute over material facts, the regulations entitle the person to a hearing … with the full panoply of due process protections …” But no respondent in NSF research misconduct cases has ever (to date in 2013) had such a debarment appeal hearing; instead, negotiated settlements are done by NSF (as they are in also most HHS cases).