Latest Newsletter _PDF_ Dec 2009

Document Sample
Latest Newsletter _PDF_ Dec 2009 Powered By Docstoc
					U.S. Department of Health and Human Services • Office of the Secretary • Office of Public Health and Science

volume 18, no. 1                                                         December 2009

   Office of Research Integrity
                                                 n e w s l e t t e r
  in this issue                               Incorporating Ethics into RCR Courses
                                              Sara Vollmer, Ph.D., University of Alabama at Birmingham, and
   Director’s Corner                          Nancy J. Matchett, Ph.D., University of Northern Colorado
   The Costs of Research Misconduct       2
                                              Philosophy departments have been          Today, this situation is changing. A
   ORI Updates
                                              expanding their offerings in applied      number of ethics instructors are using
   2009 Annual Institutional Report on
     Misconduct Activities                3   ethics and ethical decision making        ethical theories in the context of group
   Quest for Research Excellence              for a number of years, yet relatively     discussions, projects, and other assign-
     2010 Conference                      4   little attention has been paid to in-     ments that require individuals to think
   RCR                                        corporating ethical thinking in the       in more principled ways. Rather than
   Incorporating Ethics into RCR              context of Responsible Conduct of         presenting the theories as objects of
      Courses                             1
                                              Research (RCR) instruction. There         study themselves, the theories are
   Proposed Study                         4
                                              has been a sense that the theories of     used to inform concrete decision
   International                              philosophers like Aristotle, Kant,        making about daily choices and ac-
   A View from Europe on European             and Mill are too arcane, too com-         tions. Aided by the availability of
     Research Oversight                   1
   Health Canada Visits OPHS              6
                                              plex, and too hard to apply to be of      RCR video material, we have been
                                              interest to the scientific community.     teaching students to evaluate their
   Case Summaries                         8   So there has been concern that RCR        own choices through the lens of
   Save the Date                              students will be bored or confused        three main ethical frameworks.
   The 2nd World Conference on                and will gain little practical value.     (See Incorporating Ethics, page 5)
     Research Integrity                  12

                                              A View from Europe on European Research Oversight
                                              Xavier Bosch, Dept. of Internal Medicine, Hospital Clínic, Barcelona

                                              Unlike the United States, research        A 2000 European Science Founda-
                                              oversight in Europe appears frag-         tion (ESF) policy paper supported
                                              mented and varies widely from nation      developing transcontinental ap-
                                              to nation. With the exception of          proaches to monitoring research in-
                                              Scandinavia and, to a lesser degree,      tegrity and misconduct, recommend-
                                              Germany, the United Kingdom (UK),         ing national academies and research-
   The ORI Newsletter is published            Croatia, and France, there is little or   funding agencies, universities, and
   quarterly by the Office of Research        no regulation governing scientific mis-   research institutions employing sci-
   Integrity, Office of the Secretary of      conduct. Responses to instances of        entists and the scientists themselves
   Health and Human Services, and
   distributed to applicant or awardee        misconduct in Europe have varied          “to initiate discussions on the most
   institutions and PHS agencies              greatly from country to country and,      appropriate national approach to
   to facilitate pursuit of a common          to date, the European Commission          procedures for investigating allega-
   interest in handling allegations of        (EC), the European Union’s execu-         tions of scientific misconduct” and
   misconduct and promoting integrity
   in PHS-supported research. Please
                                              tive body, has drawn no regulations       urging funding agencies to make eli-
   duplicate and circulate this news-         addressing potential problems aris-       gibility for research grants condi-
   letter freely. An electronic copy is       ing from its multibillion-dollar          tional on having adequate policies
   available on the ORI home page.            framework of research programs.           (See A View from Europe, page 7)

Office of Research Integrity
                                             Director’s Corner
The Costs of Research Misconduct
John Dahlberg, Ph.D., Director, Division of Investigative Oversight (DIO)

ORI regularly receives queries ask-         tions would have deprived more              virtually impossible to estimate
ing for its assessment of the costs as-     worthy applicants of the opportunity        how many laboratories attempt to
sociated with research misconduct           to obtain funding and testified to that     reproduce falsified and fabricated
investigations and of the questioned        effect during the sentencing hearing.       results and how much such efforts
research itself. First, there is the cost   ORI noted that Dr. Poehlman’s mis-          cost scientists in time and re-
to taxpayers who support this office,       conduct had led to a number of costs        sources. Often, these costs are
which is responsible for overseeing         that were significant but could not         borne by graduate students and
both the reviews of misconduct              easily be calculated, if at all.            postdoctoral fellows who can ill-af-
cases, handled by the Division of In-                                                   ford the time wasted on chasing af-
vestigative Oversight (DIO), and the        For example, the University of Ver-         ter irreproducible results.
education and research efforts car-         mont, despite having done an exem-
ried out by the Division of Educa-          plary job of investigating a case of        ORI recently received a perceptive
tion and Integrity (DEI). This cost is      misconduct involving an internation-        letter from Professor Eliane S.
currently about $9 million per year.        ally recognized scientist and having        Azevêdo, Emeritus Professor of
                                            cooperated fully with ORI and the           Medicine, Nucleus of Bioethics,
There is also the cost to cash-strapped     Department of Justice, was unfairly         Faculty of Medicine of Bahia, Fed-
institutions of carrying out inquiries      linked with the misconduct. The hun-        eral University of Bahia, Brazil, who
and investigations into allegations of      dreds of volunteers from the                commented on secondary adverse
research misconduct. ORI does not           Burlington area who had participated        consequences of a large body of re-
track this, but clearly the time and re-    in the rather extensive procedures          search carried out at the University
sources needed for major cases has on       carried out in Dr. Poehlman’s re-           of Alabama at Birmingham that has
occasion reached into the millions.         search protocols were dismayed to           led to 16 retractions of papers by Drs.
                                            hear that his research results had          Judith Thomas and Juan Contreras.
Equally important are the costs result-     been falsified, thereby undermining         ORI recently made findings against
ing from the misconduct itself. Some        the university’s ability to continue to     both researchers, leading to a 10-year
of the relevant cost elements were care-    attract volunteers for its clinical stud-   debarment for Dr. Thomas and a
fully considered by ORI, the National       ies. Also significant was the impact        three-year debarment for Dr.
Institutes of Health (NIH), and court       of the misconduct on the many col-          Contreras.
officials when it became necessary for      laborators and co-authors on the more
the Federal Court in Burlington, Ver-       than 200 published papers authored by       Professor Azevêdo was particularly
mont, to calculate the damages re-          Dr. Poehlman, but not directly in-          concerned about how review articles
sulting from the research misconduct        volved in Dr. Poehlman’s scientific         and meta-analyses can perpetuate
of Dr. Eric Poehlman prior to his sen-      misconduct. A number of young sci-          fraudulent scientific claims even af-
tencing hearing. Dr. Poehlman had           entists and physicians had Dr.              ter the original papers have been re-
pled guilty to criminal and civil charges   Poehlman as a co-author on all or           tracted. For example, she notes (with
arising from a major scientific miscon-     nearly all of their own publications,       minor edits by ORI): “...ORI News-
duct case at the University of Vermont,     leading inevitably to concern and           letter, Vol. 17, No. 4, entitled ‘A Ma-
and ORI was asked to assist in evalu-       mistrust by others of their scientific      jor Case of Misconduct Involving
ating the costs to the injured party,       output and to serious obstacles in          Non-human Primates,’ ... left the
in this case the funding agency, NIH,       finding new research positions.             reader with a disturbing question re-
and to other parties. NIH officials                                                     garding the unrecoverable echo of its
took the lead in evaluating how fal-        Last, there is the cost associated with     bad effect on medical practice. The
sified data in funded grant applica-        falsified publications. It would be         (See Costs, page 3)

volume 18, no. 1                                                       December 2009

                                                ORI Updates
2009 Annual Institutional Report on Misconduct Activities
Robin Parker, ORI, Division of Education and Integrity                                     PRIM&R Honors
                                                                                            Albert Jonsen
In December 2009, ORI will send           by institutions for mailing the ORI
                                                                                        At the 2009 Public Responsibil-
e-mail messages (with a password          Newsletter, the ORI Annual Report,
                                                                                        ity in Medicine and Research
and an IPF number) to officials re-       and other publications; for sending e-
                                                                                        (PRIM&R) Annual Meeting,
sponsible for submitting the 2010         mail messages with updates on con-            Albert Jonsen received the
Annual Report. In order to assure         ferences, programs, and other an-             Lifetime Achievement Award
continuous Public Health Service          nouncements; and for referring                for Excellence in Research
support, the report must be sub-          research misconduct allegations to ap-        Ethics. This award is intended
mitted between January 1, 2010,           propriate officials. Please be sure           to recognize and honor individu-
and March 1, 2010. You may ob-            your mailing address is up-to-date.           als who have made a major and
tain further information from Robin                                                     sustained contribution to the de-
Parker at or         The research misconduct activity data         velopment or dissemination of
(240) 453-8400.                           are reported in the aggregate to the re-      the ethical principles that gov-
                                          search community in the ORI News-             ern research. Al Jonsen is
ORI will automatically acknowledge        letter, the ORI Annual Report, presen-        widely considered to be one of
receipt of the Annual Report. ORI         tations at scientific meetings, special       the pioneers in the research eth-
uses the contact information provided     reports, and the ORI web site.                ics field and was one of the
                                                                                        drafters of the Belmont Report.
Costs (from page 2)
retracted publications, dated from        missed. The retracted publications         and others, also in collaboration with
1997 through 2005, add up to 16. So,      made by single journals will have not      the Neville Laboratory, initially fo-
there was plenty of time to construct     reached review papers and meta-analy-      cused on combining the IT with do-
a school of false ideas in medical sci-   sis data already published.                nor bone marrow infusion (Thomas
ence either through teaching, medi-                                                  et al., 1997). This laboratory, with
cal practice, and review papers or        “As an example, a review by                extensive experience in donor bone
through meta-analysis data.”              Knechtle SJ, published in the Philos       marrow infusion as an adjunct to tol-
                                          Trans R Soc Lond B Biol Sci, 2001,         erance induction....’ Unfortunately,
Dr. Azevêdo continues to point out,       May 29;356(1409):681-9, entitled           the 1997 Thomas et al. has now been
“It is generally accepted that mod-       ‘Treatment with immunotoxin,’ cites        retracted.”
ern medicine must mostly be rooted        four publications from the Thomas
in evidence produced by scientific        Laboratory that have been retracted        Professor Azevêdo certainly makes
publications. Medical professors,         because of false claims: Contreras,        an important note, to which it could
students, and clinicians are con-         J.L., et al., 1998, Transplantation        be added that when papers provid-
stantly seeking new findings in medi-     65,1159-1169; Contreas, J.L., et al.,      ing results on clinical studies are pla-
cine aiming to offer the best for the     1999, Transplantation 68, 215-219;         giarized wholesale, as happens with
patients. Thus, review articles on        Thomas, J.M., et al., 1997, Trans-         some regularity, the risk to having
specific subject and data from meta-      plantation 64, 124-135; and Thomas,        the duplicated data be overrepre-
analysis are preferable sources for       J.M., et al., 1997, Transplantation        sented in meta-analyses is very real
updating medical knowledge. How-          68, 1660-1673. Not only were the           and possibly significant, thus posing
ever, if this precious source of scien-   misleading papers cited, but the re-       a possible additional cost to the sci-
tific information happens to be based     viewer seemed, at the time, im-            entific enterprise and possibly even
on publications that become retracted,    pressed by the Thomas work, so page        having an adverse impact on how
the harm on science will not be dis-      686 states, ‘Studies by J M Thomas         patients are treated.

Office of Research Integrity
                                                ORI Updates
Quest for Research Excellence Conference / Oct. 31-Nov. 4, 2010, Washington, DC
Cynthia Ricard, Ph.D., ORI, Division of Education and Integrity

This conference will explore ways         often is driven by the needs of in-      ful collaborations. The conference
for all members of the research com-      dustry or the needs of the govern-       planners hope that you will leave the
munity to build collaborative and in-     ment. Such multiple directives can       conference inspired and enriched
novative research teams relevant for      be daunting and stressful for re-        with additional research skills and
both bench scientists and social sci-     search groups. Translational re-         that your team will work more ef-
entists. There will be diverse tracks     search, in fact, expects scientists to   fectively and innovatively. Speakers
that will appeal to scientists but also   move beyond their own expertise          and agenda will be made available
to journal editors, research adminis-     and work with different types of sci-    on the ORI web site at http://
trators, and research partners.           entists. True advising and mentoring
                                          require skills beyond our usual sci-
Learn from Nobel laureates and re-                                                 If you have suggestions or recommen-
                                          entific expertise. We depend increas-
searchers who are innovative and                                                   dations for dynamic speakers please
                                          ingly on research teams to solve
collaborative in conducting research                                               contact
                                          complex issues.
in times of crisis.
Collaborations between industry and       At this conference, you will discover
academia are burgeoning. Research         how to form and maintain success-

Abstract: What Do Researchers Do When They Observe or Learn about
Irresponsible Science?
Patricia Keith-Spiegel and Gerald P. Koocher, Simmons College, and Joan Sieber, California State University

A number of surveys reveal that sci-      • What kinds of interventions are at-    • Do researchers who intervene face
entists and advanced students know          tempted, and do differences exist        negative consequences after-
first-hand of scientific misconduct         depending on the type of trans-          ward? If so, what forms do these
and other research wrongdoings. Yet         gression?                                take?
we know little about what research-
                                          • Which intervention strategies          • Do researchers perceive that
ers themselves actually do, if any-
                                            work best and which result in un-        their institutions will proactively
thing, to prevent or correct purpose-
                                            successful or difficult outcomes?        handle incidents reported to
ful or unintentional actions that
                                                                                     them? Do perceptions of institu-
corrupt or misrepresent data. Do they     • Does the social or physical prox-
                                                                                     tional responsibility affect inter-
ignore what they know (or think they        imity of a suspected violator play
                                                                                     vention rate?
know)? Or do they make some at-             a role in a decision to take action?
tempt to intervene, either formally or    • What role does the relative sta-       This project was funded by both the
informally?                                 tus of the suspected violator play     National Institute of Neurological
                                            in the decision to confront or ig-     Disorders and Stroke and the Office
We have responses to our on-line
                                            nore possible instances of mis-        of Research Integrity, Grant No. R01
survey from 2,599 researchers from
                                            conduct?                               NS049573, awarded to Simmons
the 8,000 Principal Investigators
                                                                                   College, Boston.
who were randomly selected from           • Under what conditions do re-
the CRISP database. Our paper will          searchers not intervene? Do they
focus on the following questions:           experience any regrets?
volume 18, no. 1                                                     December 2009

Incorporating Ethics (from page 1)
While viewing a video case study,          Improving ethical thinking has ob-      section of RCR and ethical theory
students are repeatedly asked how          vious implications for the integrity    now promise to enrich this instruc-
they would respond to the situations.      of the research group. We have found    tion. The result will be practical les-
A series of prompts inserted between       that group discussions can help stu-    sons in how mentoring and other
key scenes encourage students to re-       dents understand how the benefit of     forms of interpersonal cooperation
flect on the reasons behind each           the individual relates to the benefit   can help individuals achieve their
character’s choices, as well as on the     of the whole group and how this re-     research goals—while at the same
actions that they themselves might         quires conceptualizing the situation    time enhance the research integrity
choose if placed in a similar situation.   in a way that does not place the in-    of the scientific communities in
Do they (1) try to produce “the great-     dividual and the group in essential     which they work.
est good for the greatest number” of       conflict.
people affected by the situation, view-
ing themselves as simply one person        In our experience, the process of            Research Funding
among many (Mill)? Or do they (2)          comparing and contrasting their               Announcement
adhere to one or more duties that ap-      various beliefs and responses en-             Specifies Focus
ply to the situation, viewing them-        ables students to consider alternate        “Research on Integrity in
selves as an individual agent who is       behaviors and learn new solutions           Collaborative Research”
obligated to do the right thing regard-    to old problems. This heightens their
                                           awareness of their own ethical out-        The format for 2010 research-
less of the consequences to self and
                                           looks while also broadening their          ers who are interested in con-
others (Kant)? Or perhaps they choose
                                           understanding of the cultures and          ducting Research on Research
to (3) act in ways that exemplify the
                                           norms applied by members of other          Integrity (RRI) will use the
best or most admirable character traits,
                                           social groups. This leads to discus-       R21 mechanism. The R21 di-
traits that are shaped by the commu-
                                                                                      rects researchers to focus on
nities in which they grew up and cur-      sions on the place of specific rules
                                                                                      questions in the context of re-
rently participate (Aristotle)?            and values within their research
                                                                                      search collaborations.
                                           group. When combined with good
As the video plays out, students learn     mentoring practices that exemplify         Partnering with ORI this year
to recognize subtly different patterns     research integrity and affirm the          will be the National Center for
of thought and motivation and develop      value of students as members of a          Research Resources (NCRR),
a deeper awareness of the pattern(s)       research community, ethics learning        Fogarty International Center,
that govern their own choices and ac-      can be fully integrated with scien-        National Institute of Biomedi-
tions. The videos also provide oppor-      tific training.                            cal Imaging and Bioengineer-
tunities to practice coordinating indi-                                               ing (NIBIB), and Office for
vidual goals and decisions in a context    That cultivating research integrity        Human Research Protections
in which each person’s success or fail-    requires teaching students how to          (OHRP). NCRR also will pro-
ure is inextricably linked to that of a    achieve individual goals in the group      vide administration at all
larger group. Since the ethics lessons     context is something RCR educators         stages of the grant process,
are brief and presented in the context     have known for at least a decade,          including the review process.
of ongoing scientific research, students   during which time they have been           Deadline for applications is
can see the immediate personal rel-        developing and sharing their cases         April 7, 2010. The announce-
evance, and at the same time, they         at sites like         ment can be found at http://
are being encouraged to think about        and (the
their own choices from a broader           latter also contains video content).       rfa-files/RFA-RR-09-004.html
social and ethical perspective.            New teaching methods at the inter-

Office of Research Integrity
Health Canada Visits the Office of Public Health and Science (OPHS)
Susan Garfinkel, Ph.D., Scientist Investigator, ORI, Division of Investigative Oversight

On October 14, 2009, representa-         also oversees the safety of consumer       tation of the Department and the Min-
tives from Health Canada (HC) vis-       goods, foods, pesticides, and toxic        ister of Health. To continue to foster a
ited the Office of Research Integrity    substances.                                culture of integrity and to address im-
(ORI) to discuss the development of                                                 mediate organizational needs, the
HC’s Scientific Integrity Policy and     In 2006, under the leadership of HC,       Science Policy Directorate is devel-
Procedure for Addressing Allega-         the Canadian Research Integrity            oping a Scientific Integrity Frame-
tions of Scientific Misconduct. Dr.      Committee was formed with the ob-          work for the Department.
Zubin Master, Senior Policy Analyst,     jective of strengthening the research
and Dr. Basanti Ghosh, Manager,          integrity system in Canada. The            The scientific integrity framework
Research Policy, both of the Science     committee concluded that a pan-            when completed will include: (1) a
Policy Directorate, HC, met with         Canadian approach for governing            policy on the ethical conduct of sci-
members of ORI, Office for Human         research integrity was necessary.          ence, (2) a procedure to address al-
Research Protections (OHRP), and         Hence, several ongoing initiatives         legations of scientific misconduct,
the Office of the General Counsel,       were developed to promote re-              and (3) an education and training
Public Health Division, to draw on       search integrity; one focus is an as-      component.
the many years of experience from        sessment by the Council of Cana-
our Offices.                             dian Academies to determine the            Work on the policy is focused on
                                         key research integrity principles,         building from existing policies and
HC is the federal department respon-     procedural mechanisms, and prac-           delineating what is considered ethi-
sible for helping the people of          tices, appropriate in the Canadian         cal conduct of research and the use
Canada maintain and improve their        context, that could be applied             of science in decision making. It also
health. HC has five core roles: leader   across research disciplines at in-         will address the need for a harmo-
and partner, regulator, funder, serv-    stitutions receiving funds from the        nized procedure for addressing al-
ice provider, and information pro-       federal granting councils (http://         legations of scientific misconduct.
vider in order to realize its vision.    w w w. s c i e n c e a d v i c e . c a /   The education and training compo-
                                         research_integrity.html).                  nent will address the training needs
As a regulator, HC is involved in                                                   of the departmental scientific com-
protecting Canadians and facilitat-      In addition, efforts are underway to       munity on scientific integrity and the
ing the provision of products vital      improve the current research integrity     procedures to follow for resolving
to the health and well-being of Ca-      framework, in part through The Tri-        ethical issues that may be encoun-
nadians. HC regulates and approves       Council Policy Statement: Integrity in     tered at work.
the use of health products including     Research and Scholarship (http://
biologics, pharmaceuticals, medical               Two OPHS Offices, ORI and OHRP,
devices, and natural health products.    CRSNG/Policies-Politiques/                 are pleased to continue to collabo-
In this regard, HC’s responsibilities    tpsintegrity-picintegritie_eng.asp).       rate with HC as it models its scien-
are similar to those of the U.S. Food                                               tific integrity framework. Because
and Drug Administration. In addi-        HC realizes that integrity within its      science is now a global enterprise,
tion, HC is also responsible for de-     federal science-based departments          it is more important now, than ever
livering a variety of programs and       and agencies is crucial to deliver its     before, for concurrence of interna-
services in environmental health and     mandate of both helping to ensure          tional research misconduct policies
protection, substance abuse, tobacco     the health and safety of Canadians         and for the international scientific
policy, workplace health, and the        and increasing public trust while          community to foster responsible
safe use of consumer products. HC        maintaining the credibility and repu-      conduct in research.

volume 18, no. 1                                                   December 2009

A View from Europe (from page 1)
for good scientific practice and pro-    guarding good scientific practice       tutions, funding agencies, and
cedures for investigating allegations    (          governments, should decide the
of misconduct (       StewardsOfIntegrity.pdf).               scheme they ultimately choose and
publications/policy-briefings.html).                                             its implementation.
                                         From 1990 to 2005, the number of
Seven years have elapsed without         international collaborations, mea-      The existing legislation also should
consensus for harmonizing policies       sured by co-authorship of refereed      be analyzed. European countries
on research misconduct in Europe.        papers, grew linearly, but the num-     have different judicial traditions
Another ESF report in May 2008,          ber of international addresses grew     that, in most cases, are not adapted
commissioned for the First World         exponentially. The rise in multiple     to cases of scientific misconduct. In
Conference on Research Integrity,        authorships         reflects     the    the absence of appropriate legisla-
intended to “provide a systematic re-    multidisciplinary, collaborative        tion, internal regulations may offer
view of various approaches to pro-       character of modern research. Yet a     consensual solutions through con-
mote research integrity and handle       lack of homogeneity in research         ciliation or arbitration. Possibly, het-
allegations of research misconduct.”     monitoring means that when mis-         erogeneous, influential national and
The information-collection process       conduct allegations appear, authors     European academic societies and
for this report concentrated on pub-     from different countries are being      associations may work out prin-
lic-funding research agencies and        treated differently.                    ciples of good scientific practice for
learned societies.                                                               their area of expertise and make
                                         One way to ensure that all co-authors   them binding on their members. In
Since there is a consensus that re-      are treated fairly would be to estab-   addition, pan-European research-
search institutions are the main guar-   lish a common European policy on        funding bodies, notably the EC and
antors of integrity, it was surprising   scientific dishonesty with uniform      the European Research Council
that universities, research institu-     procedures for violations. Interna-     (ERC), might set up regulatory
tions, and private research-support-     tional cooperation within Europe        mechanisms and compel institutions
ing agencies (e.g., the UK Welcome       (and between Europe and the United      to have research integrity rules and
Trust) were excluded. Although the       States) might also tackle the prob-     procedures for handling allegations of
report stated that countries surveyed    lem of scientists who have commit-      scientific misconduct.
used a wide range of approaches to       ted misconduct relocating to coun-
deal with research integrity and mis-    tries where employers may be            Ultimately, I believe, the bodies that
conduct, there was no discussion of      unaware of their behavior.              make grant decisions need to make
the variability of standards and no                                              them contingent upon the willing-
mention of the number of investiga-      Any future change will require Eu-      ness of institutions to adhere to sci-
tions submitted to existing panels.      ropean countries to adopt current       entific integrity guidelines.
Nevertheless, the report contains        guidance from national or interna-
useful information about countries’      tional organizations as a regulation.
                                                                                     ORI would like to thank
recent efforts to promote research       Thus, countries without either a tra-
integrity guidelines. For instance, in   dition of reporting misconduct or
                                                                                    the following contributors
2004, the Slovak Research and De-        formal systems for investigating al-         to the ORI Newsletter:
velopment Agency pragmatically           legations have the opportunity of ob-      Xavier Bosch, Patricia Keith-
adopted the rigorous recommenda-         serving existing models and choos-         Spiegel, Gerald P. Koocher,
tions of the Deutsche Forschungs-        ing the best one to adopt. Consensus       Nancy J. Matchett, Joan Sieber,
gemeinschaft, Germany’s main             among the sectors involved, the sci-       and Sara Vollmer
research-funding agency, for safe-       entists themselves, research insti-
Office of Research Integrity
                                               Case Summaries
Jennifer N. Arriaga                          the U.S. Public Health Service              Ms. Couvertier has entered into a
Universidad Central Del Caribe               (PHS), including but not limited to         Voluntary Settlement Agreement in
Based on the findings of an investi-         service on any PHS advisory com-            which she has voluntarily agreed, for
gation report by the Universidad             mittee, board, and/or peer review           a period of three (3) years, beginning
Central Del Caribe (UCC) and addi-           committee, or as a consultant.              on September 18, 2009:
tional analysis and information ob-
                                             Norma Couvertier                            (1) to exclude herself from serving in
tained by ORI during its oversight
                                             APT Foundation                              any advisory capacity to the U.S. Pub-
review, ORI found that Jennifer N.
                                                                                         lic Health Service (PHS), including but
Arriaga, former Research Assistant           Based on the report of an investiga-
                                                                                         not limited to service on any PHS ad-
in a clinical trial project entitled Brief   tion conducted by the APT Founda-
                                                                                         visory committee, board, and/or peer
Strategic Family Therapy for Adoles-         tion and additional analysis con-
                                                                                         review committee, or as a consultant;
cent Drug Abusers (BSFT) at UCC,             ducted by ORI in its oversight review,
engaged in research misconduct in            ORI found that Norma Couvertier,            (2) that any institution that submits
research funded by National Institute        former Research Assistant II, APT           an application for PHS support for a
on Drug Abuse (NIDA), National In-           Foundation in New Haven, Connecti-          research project on which the
stitutes of Health (NIH), cooperative        cut, engaged in research misconduct         Respondent’s participation is pro-
agreement U10 DA13720.                       in research supported by National In-       posed, or that uses her in any capac-
                                             stitute of Drug Abuse (NIDA), Na-           ity on PHS-supported research, or
Specifically, ORI found that Ms.             tional Institutes of Health (NIH),
Arriaga knowingly and intentionally                                                      that submits a report of PHS-funded
                                             award R37 DA015969.                         research in which she is involved
engaged in research misconduct by
fabricating 17 interviews and falsi-                                                     must concurrently submit a plan for
                                             Specifically, ORI found that Ms.
fying 10 subject incentive receipts in                                                   supervision of her duties to ORI. The
                                             Couvertier engaged in research mis-
the BSFT. The interview record con-                                                      supervisory plan must be designed to
                                             conduct by falsifying and fabricating
sisted of Timeline Follow Back in-                                                       ensure the integrity of her research
                                             data that were reported on Participant
formation, confidentiality self-report                                                   contribution. Respondent agreed that
                                             Urine Monitoring and Breathalyzer
forms, and urine drug test results.                                                      she will not participate in any PHS-
                                             Result Forms (CRFs) completed by
                                                                                         supported research until such a su-
                                             the Respondent for thirty-two (32) of
The following administrative actions                                                     pervisory plan is approved by ORI.
                                             the enrolled study participants in the
have been implemented for a period
                                             Computer-Based Training in Cogni-
of two (2) years, beginning on Au-                                                       Zhong Bin Deng
                                             tive Behavioral Therapy (CBT4CBT)
gust 18, 2009:                                                                           Medical College of Georgia
                                             research study.
(1) Ms. Arriaga is debarred from eli-                                                    Based on the report of an investiga-
gibility for any contracting or sub-         ORI found that Ms. Couvertier, on 253       tion conducted by the Medical Col-
contracting with any agency of the           occasions, with 32 different study par-     lege of Georgia (MCG), the report
United States Government and from            ticipants, falsified alcohol breathalyzer   of the MCG Adjudication Subcom-
eligibility or involvement in                test results and knowingly and consis-      mittee, additional analysis conducted
nonprocurement programs of the               tently entered a false negative test (in-
United States pursuant to HHS’               dicated by 0.000) rather than identify-
Implementation (2 C.F.R., Part 276 et        ing the result as a missing data                  “Imagination is
seq.) of OMB Guidelines to Agencies          collection (indicated by code 999).
on Governmentwide Debarment and
                                                                                               more important
Suspension (2 C.F.R., Part 180); and         ORI acknowledges Ms. Couvertier’s                than knowledge.”
                                             verbal admissions and willingness to
(2) Ms. Arriaga is prohibited from           cooperate and assist during the APT                  Albert Einstein
serving in any advisory capacity to          Foundation’s investigation.
volume 18, no. 1                                                              December 2009

                                            Case Summaries
by ORI in its oversight review, and         plicates, thus one of the plots is fal-      are accurately reported in the appli-
the Respondent’s written and oral ad-       sified; (3) in row 3, the Aire -/- (liver)   cation or report; and
missions and expressed remorse,             flow cytometry plot [plot 2] and the
ORI found that Dr. Zhong Bin Deng,          Aire +/+ -/- (liver) flow cytometry          (3) to exclude himself from serving in
former postdoctoral fellow at MCG           plot [plot 3] are duplicates, thus           any advisory capacity to the U.S. Pub-
in Augusta, GA, engaged in scien-           one of the plots is falsified; and (4)       lic Health Service (PHS), including but
tific misconduct in research sup-           in row 4, the Aire -/- (thymus) flow         not limited to service on any PHS ad-
ported by National Institute of Al-         cytometry plot [plot 2] and the Aire         visory committee, board, and/or peer
lergy and Infectious Diseases               +/+ +/+ flow cytometry plot [plot            review committee, or as a consultant.
(NIAID), National Institutes of             4] are duplicates, thus one of the           Endnote 1
Health (NIH), grant 2 P01 AI42288.          plots is falsified.
                                                                                         Mi, Q.-S., Deng, Z.-B., Joshi, S.K., Wang,
                                                                                         Z.-Z., Zhou, L., Eckenrode, S., Joshi, R.,
ORI found that Dr. Deng engaged in        Dr. Deng has entered into a Volun-             Ly, D., Yi, B., Delovitch, D.L., & She, J.-
scientific/research misconduct by fal-    tary Settlement Agreement in which             X. “The autoimmune regulator (Aire) con-
sifying research results reported in a    he has voluntarily agreed, for a pe-           trols iNKT cell development and matura-
paper published in Nature Medicine.1      riod of two (2) years, beginning on            tion.” Nature Medicine 12:624-626,
Specifically:                             October 2, 2009:                               2006; hereafter referred to as the “Nature
                                                                                         Medicine paper.”
Figures 1 and 2 in the Nature Medi-       (1) that any institution that submits
cine paper purportedly show that the      an application for PHS support for a
autoimmune regulator Aire controls        research project on which the
                                                                                            The HHS Office of Research Integ-
iNKT cell development and matura-         Respondent’s participation is pro-                rity (ORI) publishes the ORI News-
tion. In Figure 1(a), the Respondent      posed, or that uses him in any capac-             letter to enhance public access to
falsified the Aire +/+ (thymus and        ity on PHS-supported research, or                 its information and resources. In-
liver) flow cytometry plots by sub-       that submits a report of PHS-funded               formation published in the ORI
                                                                                            Newsletter does not constitute of-
stituting Aire +/- (thymus and liver)     research in which he is involved must             ficial HHS policy statements or
flow cytometry plots that were al-        concurrently submit a plan for super-             guidance. Opinions expressed in
tered to disguise their origins and       vision of his duties to ORI; the su-              the ORI Newsletter are solely those
falsified the Aire -/- (bone marrow)      pervisory plan must be designed to                of the author, and do not reflect the
                                                                                            official position of HHS, ORI, or
flow cytometry plot by substituting       ensure the integrity of his research              its employees. HHS and ORI do not
the Aire +/- (bone marrow) flow           contribution; respondent agreed that              endorse opinions, commercial
cytometry plot, also altered to dis-      he will not participate in any PHS-               products, or services that may ap-
guise its origin.                         supported research until such a su-               pear in the ORI Newsletter. Infor-
                                                                                            mation published in the ORI News-
                                          pervisory plan is approved by ORI;                letter is not a substitute for official
• In supplementary Figure 2 of the
                                                                                            policy statements, guidance, appli-
  Nature Medicine paper, the Re-          (2) that any institution employing                cable law, or regulations. The Fed-
  spondent falsified flow cytometry       him submits, in conjunction with                  eral Register and the Code of Fed-
  plots as follows: (1) in row 1, the     each application for PHS funds, or                eral Regulations are the official
  Aire -/- (thymus) flow cytometry        report, manuscript, or abstract in-               sources for policy statements, guid-
                                                                                            ance, and regulations published by
  plot [plot 2] and the Aire +/+ -/-      volving PHS-funded research in                    HHS. Information published in the
  (thymus) flow cytometry plot [plot      which the Respondent is involved, a               ORI Newsletter is not intended to
  3] are duplicates, thus one of the      certification to ORI that the data pro-           provide specific advice. For spe-
  plots is falsified; (2) in row 2, the   vided by the Respondent are based                 cific advice, readers are urged to
                                                                                            consult with responsible officials at
  Aire -/- (spleen) flow cytometry        on actual experiments or are other-
                                                                                            the institution with which they are
  plot [plot 2] and the Aire -/- +/+      wise legitimately derived and that the            affiliated, or seek legal counsel.
  flow cytometry plot [plot 5] are du-    data, procedures, and methodology

Office of Research Integrity
                                          Case Summaries
Nagendra S. Ningaraj, Ph.D.             pretreated with another potassium        pervisory plan must be designed to
Vanderbilt University School of         channel opener, NS1619, and Re-          ensure the scientific integrity of his
Medicine                                spondent falsely stated the minoxidil    research contribution; a copy of the
Based on the reports of an investiga-   pretreatment caused an 8-fold in-        supervisory plan also must be sub-
tion conducted by Vanderbilt Univer-    crease in Gleevec delivery to brain      mitted to ORI by the institution; Re-
sity School of Medicine (VUSM) and      tumors (compared to non-minoxidil        spondent agrees that he will not par-
additional analysis by the Division     pretreated tumors).                      ticipate in any PHS-supported
of Investigative Oversight (DIO),                                                research until such a supervisory plan
                                        3. Respondent further falsified Fig-
ORI, in its oversight review, found                                              is submitted to ORI; and
                                        ure 21 of the 1 U54 CA119421-01
that Nagendra S. Ningaraj, Ph.D.,       grant application by juxtaposing the     (3) Respondent will ensure that any
former Associate Professor of Neu-      reversed MALDI-MS images (ob-            institution employing him submits, in
rological Surgery and Cancer Biol-      tained with minoxidil) with the          conjunction with each application for
ogy, VUSM, engaged in scientific        mass spectral tracings (obtained         PHS funds or any report, manuscript,
misconduct by falsifying MALDI-         with NS1619) in the same figure          or abstract of PHS-funded research
MS images and mass spectral trac-       and by failing to report that the        in which he is involved, a certifica-
ings and associated text in Figure 21   images and spectra in the figure         tion that the data provided by him are
reported in National Cancer Institute   were actually obtained in totally        based on actual experiments or are
(NCI), National Institutes of Health    different experiments, performed         otherwise legitimately derived and
(NIH), grant application 1 U54          on different dates and with differ-      that the data, procedures, and meth-
CA119421-01 and by falsifying           ent K+ agonist pretreatments.            odology are accurately reported in the
MALDI-MS images in a presentation
                                                                                 application or report. Respondent
during the American Association for     Dr. Ningaraj has entered into a Vol-
                                                                                 must ensure that the institution sends
Cancer Research (AACR) meeting          untary Settlement Agreement in
                                                                                 the certification to ORI. The certifi-
held on April 16-20, 2005, which        which he has voluntarily agreed, for
                                                                                 cation shall be submitted no later than
cited support from NCI, NIH, grants     a period of three (3) years, beginning
                                                                                 one month before funding and con-
R25 CA92943 and P50 CA098131.           on August 31, 2009:
                                                                                 currently with any report, manu-
Specifically, ORI found that:           (1) to be prohibited from serving in     script, or abstract.
                                        any advisory capacity to PHS, includ-
1. Respondent reversed the images       ing but not limited to service on any    Ryan M. Wolfort, M.D., Ph.D.
for the control and minoxidil-treated   PHS advisory committee, board, and/      Louisiana State University Health
brains in Figure 21 of the 1 U54        or peer review committee, or as a        Sciences Center-Shreveport
CA119421-01 grant application,          consultant;
claiming that minoxidil increased de-                                            Based on the report of an investiga-
livery of Gleevec to the tumor. Re-     (2) that any institution that submits    tion conducted by Louisiana State Uni-
spondent also reversed the same im-     an application for PHS support for a     versity Health Sciences Center-Shreve-
ages in a presentation during the       research project on which the            port (LSUHSC-S) and additional
AACR meeting in April 2005.             Respondent’s participation is pro-       analysis conducted by ORI in its over-
                                        posed, or which uses him in any ca-      sight review, the U.S. Public Health
2. In Figure 21 of the 1 U54            pacity on PHS-supported research, or     Service (PHS) found that Dr. Ryan M.
CA119421-01 grant application, Re-      that submits a report of PHS-funded      Wolfort, who was a House Officer in
spondent reported mass spectral trac-   research on which he is involved         the Department of Surgery, and a
ings as having been obtained from       must submit a plan for supervision       former graduate student, Department
brain tumors in Gleevec-treated mice    of his duties to the funding agency      of Molecular and Cellular Physiol-
that had been pretreated with           for approval no later than a month       ogy, LSUHSC-S, engaged in research
minoxidil, while in fact they were      before the scheduled funding; the su-    misconduct in the reporting of re-

volume 18, no. 1                                                          December 2009

                                            Case Summaries
search supported by National Heart,       peroxide production by cytochrome            RANTES mediates hypercholester-
Lung, and Blood Institute (NHLBI),        c reduction in papers 1 and 2, for           olemia-induced superoxide production
National Institutes of Health (NIH),      which the underlying spreadsheet data        and endothelial dysfunction.” Arterioscler
                                                                                       Thromb Vasc Biol, Vol. 28 (pages unavail-
grants R01 HL26441 and P01                the Respondent claims were uninten-
                                                                                       able), as Epub 2008, July 17; hereafter
HL55552.                                  tionally misrepresented, massaged,           referred to as “paper 2.” (Identified for
                                          and improperly collated, but for             retraction.)
Respondent’s research misconduct          which Respondent acknowledges that
related to his dissertation research as   the raw data were missing for all three      Wolfort, R.M., Stokes, K.Y., & Granger,
a graduate student, which he under-       papers, admittedly because he inten-         D.N. “Immune cell-mediated endothelial
                                                                                       cell dysfunction during hypercholester-
took at the same time that he also was    tionally erased files and discarded
                                                                                       olemia involves interferon-[gamma] de-
serving as a House Officer at             notebooks.                                   pendent signaling.” Am J Physiol Heart
LSUHSC-S. ORI acknowledges Dr.                                                         Circ Physiol, as Epub 2008, September
                                          Dr. Wolfort has entered into a Vol-
Wolfort’s cooperation with the                                                         5; hereafter referred to as “paper 3.” (Re-
                                          untary Exclusion Agreement in
LSUHSC-S misconduct proceedings.                                                       tracted in Am J Physiol Heart Circ Physiol
                                          which he has voluntarily agreed, for         295(5):H2219, 2008 November.)
                                          a period of two (2) years, beginning
PHS found that Dr. Wolfort engaged                                                     Endnote 2
                                          on July 13, 2009:
in research misconduct by falsifying
                                                                                       Manuscript submitted to the journal Free
and fabricating data reported in three    (1) to exclude himself from any con-         Radicals in Biology and Medicine
publications1 and one manuscript2         tracting or subcontracting with any          (FRBM), by Ryan M. Wolfort, Katherine
that had been submitted for publica-      agency of the United States Govern-          C. Wood, Robert P. Hebbel, and Neil
tion, reviewed, and returned for re-      ment and from eligibility or involve-        Granger, “Mechanisms underlying the
vision. Specifically, Dr. Wolfort fal-    ment in nonprocurement programs of           vasomotor dysfunction in sickle
sified and fabricated data reported in    the United States pursuant to HHS’           transgenic mice,” Ms Number FRBM-D-
research examining the contribution                                                    08-00454.
                                          Implementation (2 C.F.R., Part 276 et
of immune mechanisms to early oxi-        seq.) of OMB Guidelines to Agencies
dative stress and endothelial dysfunc-    on Governmentwide Debarment and                 “Science is an interna-
tion in mice with induced dietary hy-     Suspension (2 C.F.R., Part 180); and            tional endeavor. Wher-
percholesterolemia by:                                                                    ever it is done, it connects
                                          (2) to exclude himself from serving
1. admittedly fabricating tabulations     in any advisory capacity to PHS, in-            us to the scientists, schol-
and the associated statistical analy-     cluding but not limited to service on           ars, and philosophers of
ses of RT-PCR data on Nox-2 mRNA          any PHS advisory committee, board,              the past and the future.
expression in the three publications      and/or peer review committee, or as             Our work as a scientific
and the manuscript; and                   a consultant.                                   community can make hu-
                                                                                          man lives better, healthier,
2. falsifying data and the associated     Endnote 1                                       and longer, and can im-
statistical claims, specifically by (a)   Wolfort, R.M., Stokes, K.Y., & Granger,         prove the economies of
admittedly falsifying the measure-        D.N. “CN4+ T lymphocytes mediate hy-            nations, regions, and the
ments of endothelial function by          percholesterolemia-induced endothelial
                                                                                          world. To be a scientist is
myographic recordings of aortic ring      dysfunction via a NAD(P)H oxidase-de-
                                          pendent mechanism.” Am J Physiol Heart          both a privilege and a
dilation in reaction to vasoactive sub-
                                          Circ Physiol 294:H2619-H2626, 2008;             passion.”
stances in the three papers and manu-
                                          hereafter referred to as “paper 1.” (Iden-
script, (b) admittedly falsifying the     tified for retraction.)
                                                                                          Excellence Everywhere,
measurement of cytokine by                                                                Burroughs Wellcome Fund,
cytometric bead assay in paper 3, and     Wolfort, R.M., Manriquez, R., Stokes,           2009
(c) falsifying the measurement of su-     K.Y., & Granger, D.N. “Platelet-derived

Office of Research Integrity
                                                                                      Office of Research Integrity
                                                                                      1101 Wootton Parkway, Suite 750
                                Save the Date                                         Rockville, Maryland 20852

    THE SECOND WORLD CONFERENCE ON RESEARCH INTEGRITY                                 Office of the Director .... (240) 453-8200
                                                                                      Fax ................................ (301) 443-5351
                Singapore, July 21-24, 2010
                                                    Division of Education
                                                                                      and Integrity .................. (240) 453-8400
   This conference will explore ways         The conference is aimed at leaders and   Fax ................................ (301) 443-5351
   to promote high ethical standards in      key decision makers in research fund-
   conducting research. With the in-         ing organizations (grant agencies and    Assurances Program ..... (240) 453-8400
   creasing numbers of international         research councils).                      Fax ................................ (301) 594-0042
   collaborations, there is likely a
   greater need for consensus and com-       Those interested in attending should     Division of Investigative
   mitment to high standards in design-      register on the conference web site.     Oversight ...................... (240) 453-8800
   ing, conducting, analyzing, and re-       To obtain further information or to      Fax ................................ (301) 594-0043
   porting research. Developing global       propose ideas and topics for discus-
   networks and understanding may            sion, contact the conference co-         Research Integrity
   help to ensure responsible research       chairs: Nick Steneck (nsteneck@          Branch/OGC ................. (301) 443-3466
   and to maintain the public’s confi- and Tony Mayer                Fax ................................ (301) 594-0041
   dence in researchers and their results.   (

Office of the Secretary
Office of Research Integrity
1101 Wootton Pkwy, Suite 750
Rockville MD 20852

Official Business
Penalty for Private Use $300