Findings of Scientific Misconduct, 31955-31957 [E9-15910]
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Federal Register / Vol. 74, No. 127 / Monday, July 6, 2009 / Notices
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[FR Doc. E9–15932 Filed 7–2–09; 8:45 am]
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Board of Governors of the Federal Reserve
System, June 30, 2009.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E9–15776 Filed 7–2–09; 8:45 am]
BILLING CODE 6210–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Scientific Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
SUMMARY: Notice is hereby given that
the Office of Research Integrity (ORI)
and the Assistant Secretary for Health
have taken final action in the following
case:
Judith M. Thomas, PhD, University of
Alabama at Birmingham: Based on a
finding of scientific misconduct made
by the University of Alabama at
Birmingham (UAB) on January 24, 2008,
a report of the UAB Investigation
Committee, dated November 21, 2007,
and additional analysis conducted by
ORI during its oversight review, the U.S.
Public Health Service (PHS) found that
Dr. Judith M. Thomas, former Professor
of Surgery, UAB, engaged in scientific
misconduct in research supported by
National Institute of Allergy and
Infectious Diseases (NIAID), National
Institutes of Health (NIH), grants R01
AI22293, R01 AI39793, and U19
AI056542, National Institute of Diabetes
and Digestive and Kidney Diseases
(NIDDK), NIH, grant U19 DK57958, and
NIH/Novartis Cooperative Research and
Development Agreement 96–MH–01/
NIHITC–0697.
The objective of the research was to
test the effectiveness of different agents,
such as Immunotoxin FN18–CRM9 or
15-deoxyspergualin (15-DSG),
administered around the time of renal
transplantation in non-human primates,
in preventing rejection of the
transplanted kidney. To determine
whether or not the transplanted kidney
was functioning (able to sustain life)
after the immunomodulating therapy,
the animals were to have both of their
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31955
native kidneys removed at or shortly
after the time of transplant, so that their
survival would depend solely on the
viability of the transplanted kidney. It
was postulated that the use of
immunomodulating agents would
increase tolerance of the host animal to
the grafted kidney and thus eliminate
the necessity for chronic administration
of immunosuppressive medications
commonly required to prevent rejection
in renal transplant recipients. Failure to
remove both native kidneys would
render it impossible to assess the
effectiveness of the immunomodulating
treatment, and could give totally
misleading results, suggesting that the
treatment worked while in fact survival
was due entirely to the remaining native
kidney.
PHS found that Respondent engaged
in scientific misconduct by falsifying
reports of research results in NIHsupported experiments with non-human
primate (NHP) renal allograft recipients
in 15 publications and in progress
reports in two NIH research grant
applications. Specifically, PHS found
that:
1. Respondent falsely reported in 15
publications that NHP renal allograft
recipients had received bilateral
nephrectomies of their native kidneys,
while in fact many of the animals
retained an intrinsic kidney.
Specifically:
A. Respondent falsely reported in
eight publications 1 that at least 32
specific NHPs in a renal
allotransplantation study had received
bilateral nephrectomies, while in fact an
intrinsic kidney was left in place in
each animal, and generally, in seven
additional publications,2 Respondent
falsely reported that all long term
surviving NHP renal allograft recipients
had received bilateral nephrectomies of
their native kidneys. The publications
referenced are listed separately in the
endnotes.
2. In seven publications,3 Respondent
falsely reported immunomodulating
treatments given to NHP renal allograft
recipients by not reporting the
administration of donor bone marrow to
seven recipients and not reporting
administration of cyclosporine A to four
recipients. She also falsely reported (by
overstating by 15%) dosages of the
immunomodulating agents that were
given and/or duration by overstating the
exceptionalbriefer duration of
immunomodulating treatment given to
four recipients and cited in at least eight
publications.4
3. In progress reports for NIH research
awards R01 AI39793 and U19 DK57958,
Respondent falsely claimed that long
term surviving (LTS) NHP renal
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Federal Register / Vol. 74, No. 127 / Monday, July 6, 2009 / Notices
allotransplantation recipients had
received bilateral nephrectomies and
falsely reported the immunomodulating
therapies received by the graft
recipients. Specifically:
A. In the progress report in
application 5 R01 AI39793–04,
submitted in approximately May 1999,
Respondent repeated falsified claims of
successful LTS NHP allografts by citing
two publications (Transplantation
68:1660–1673, 1999 and
Transplantation 68:215–219, 1999) that
reported LTS in renal allograft
recipients that were falsely reported to
have had bilateral intrinsic
nephrectomies, while laboratory records
showed that at the most four of these
animals had bilateral nephrectomies.
B. In the progress report in
application 5 U19 DK57958–02
submitted in approximately May 2000,
Respondent falsely reported that 10/13
LTS NHP renal allograft recipients had
received bilateral nephrectomies of their
native kidneys and falsified the
immunomodulating treatment received
by four of the animals by failing to
report the administration of
cyclosporine A (CSA) or donor bone
marrow.
For the same award, in a progress
report submitted in approximately May
2002, Respondent falsely reported that
all of the 16 animals in the rhesus Ktx
(kidney transplant) series had bilateral
nephrectomies of their native kidneys,
but in fact at least nine of the animals
did not have the requisite bilateral
nephrectomies.
In a competing renewal application 2
U19 DK057958–05, submitted on about
03/10/2003, Respondent reported that
14 Ktx long term survivors did not have
an intrinsic kidney, while in fact at least
11 of those animals had a remaining
intrinsic kidney.
Both Dr. Thomas and PHS are
desirous of concluding this matter
without further expense of time and
other resources, and the parties have
entered into a Voluntary Exclusion
Agreement to settle the matter. Dr.
Thomas accepted responsibility for the
reporting described above, but denied
that she intentionally committed
research misconduct. The settlement is
not an admission of liability on the part
of the Respondent.
Dr. Thomas has entered into a
Voluntary Exclusion Agreement in
which she has voluntarily agreed, for a
period of ten (10) years, beginning on
May 5, 2009:
(1) To exclude herself voluntarily
from any contracting or subcontracting
with any agency of the United States
Government and from eligibility or
involvement in nonprocurement
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programs of the United States
Government referred to as ‘‘covered
transactions’’ and defined by 2 CFR
parts 180 and 376; and
(2) To exclude herself from serving in
any advisory capacity to PHS, including
but not limited to service on any PHS
advisory committee, board, and/or peer
review committee, or as a consultant.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative
Oversight, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8800.
John E. Dahlberg,
Director, Division of Investigative Oversight,
Office of Research Integrity.
Endnotes
1.
Asiedu, C.K., Dong, S.S., Lobashevsky, A.,
Jenkins, S.M., & Thomas, J.M. ‘‘Tolerance
induced by anti-CD3 immunotoxin plus
15-deoxyspergualin associates with donorspecific indirect pathway
unresponsiveness.’’ Cell Immunol.
223(2):103–112, June 2003. (Retraction
required by UAB.)
Hutchings, A., Wu, J., Asiedu, C., Hubbard,
W., Eckhoff, D., Contreras, J., Thomas, F.T.,
Neville, D., & Thomas, J.M. ‘‘The immune
decision toward allograft tolerance in nonhuman primates requires early inhibition
of innate immunity and induction of
immune regulation.’’ Transpl Immunol.
11(3–4):335–344, July-September 2003.
(Retraction required by UAB.)
Lobashevsky, A.L., Jiang, X.L., & Thomas,
J.M. ‘‘Allele-specific in situ analysis of
microchimerism by fluorescence resonance
energy transfer (FRET) in nonhuman
primate tissues.’’ Hum Immunol.
63(2):108–120, February 2002. (Retraction
required by UAB.)
Thomas, J.M., Eckhoff, D.E., Contreras, J.L.,
Lobashevsky, A.L., Hubbard, W.J., Moore,
J.K., Cook, W.J., Thomas, F.T., & Neville,
D.M. Jr. ‘‘Durable donor-specific T and B
cell tolerance in rhesus macaques induced
with peritransplantation anti-CD3
immunotoxin and deoxyspergualin:
Absence of chronic allograft nephropathy.’’
Transplantation 69(12):2497–2503, June
27, 2000. (Retracted.)
Thomas, J.M., Contreras, J.L., Jiang, X.L.,
Eckhoff, D.E., Wang, P.X., Hubbard, W.J.,
Lobashevsky, A.L., Wang, W., Asiedu, C.,
Stavrou, S., Cook, W.J., Robbin, M.L.,
Thomas, F.T., & Neville, D.M. Jr.
‘‘Peritransplant tolerance induction in
macaques: Early events reflecting the
unique synergy between immunotoxin and
deoxyspergualin.’’ Transplantation
68(11):1660–1673, December 15, 1999.
(Retracted.)
Contreras, J.L., Eckhoff, D.E., Cartner, S.,
Frenette, L., Thomas, F.T., Robbin, M.L.,
Neville, D.M. Jr., & Thomas, J.M.
‘‘Tolerability and side effects of anti-CD3immunotoxin in preclinical testing in
kidney and pancreatic islet transplant
recipients.’’ Transplantation 68(2):215–
219, July 27, 1999. (Retracted.)
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Contreras, J.L., Wang, P.X., Eckhoff, D.E.,
Lobashevsky, A.L., Asiedu, C., Frenette, L.,
Robbin, M.L., Hubbard, W.J., Cartner, S.,
Nadler, S., Cook, W.J., Sharff, J., Shiloach,
J., Thomas, F.T., Neville, D.M. Jr., &
Thomas, J.M. ‘‘Peritransplant tolerance
induction with anti-CD3-immunotoxin: A
matter of proinflammatory cytokine
control.’’ Transplantation 65(9):1159–1169,
May 15, 1998. (Retracted.)
Asiedu, C.K., Goodwin, K.J., Balgansuren, G.,
Jenkins, S.M., Le Bas-Bernardet, S., Jargal,
U., Neville, D.M Jr., & Thomas, J.M.
‘‘Elevated T regulatory cells in long-term
stable transplant tolerance in rhesus
macaques induced by anti-CD3
immunotoxin and deoxyspergualin.’’ J
Immunol. 175(12):8060–8068, December 5,
2005. (Retracted.)
2.
Thomas, J.M., Hubbard, W.J., Sooudi, S.K., &
Thomas, F.T. ‘‘STEALTH matters: A novel
paradigm of durable primate allograft
tolerance.’’ Immunol Rev. 183:223–233,
October 2001. Review. (Retracted.)
Thomas, F., Ray, P., & Thomas, J.M.
‘‘Immunological tolerance as an adjunct to
allogeneic tissue grafting.’’ Microsurgery
20(8):435–440, 2000. (Retraction required
by UAB.)
Hutchings, A., & Thomas, J.M.
‘‘Transplantation: Tolerance.’’ Current
Opinion in Investigational Drugs 4(5):530–
535, 2003. (Retraction required by UAB.)
Hubbard, W.J., Eckhoff, D., Contreras, J.L.,
Thomas, F.T., Hutchings, A., & Thomas,
J.M. ‘‘STEALTH on the preclinical path to
tolerance.’’ Graft 5(6):322–330, 2002.
(Retraction required by UAB—Journal has
ceased publication.)
Hutchings, A., Hubbard, W.J., Thomas, F.T.,
& Thomas, J.M. ‘‘STEALTH in
transplantation tolerance.’’ Immunologic
Res. 26:143–152, 2002. (Retracted.)
Thomas, J.M., Asiedu, C., George, J.F.,
Hubbard, W.J., & Thomas, F.T. ‘‘Preclinical
bridge to clinical tolerance.’’ Current
Opinion in Organ Transplantation 6:95–
101, 2001. (Retraction required by UAB.)
Hubbard, W.J., Contreras, J.V., Eckhoff, D.E.,
Thomas, F.T., Neville, D.M., & Thomas,
J.M. ‘‘Immunotoxins and tolerance
induction in primates.’’ Current Opinion in
Organ Transplantation 5:29–34, 2000.
(Retracted.)
3.
Asiedu, C.K., Dong, S.S., Lobashevsky, A.,
Jenkins, S.M., & Thomas, J.M. ‘‘Tolerance
induced by anti-CD3 immunotoxin plus 5deoxyspergualin associates with donorspecific indirect pathway
unresponsiveness.’’ Cell Immunol.
223(2):103–112, June 2003. (Retraction
required by UAB.)
Hutchings, A., Wu, J., Asiedu, C., Hubbard,
W., Eckhoff, D., Contreras, J., Thomas, F.T.,
Neville, D., Thomas, J.M. ‘‘The immune
decision toward allograft tolerance in nonhuman primates requires early inhibition
of innate immunity and induction of
immune regulation.’’ Transpl Immunol.
11(3–4):335–344, July-September, 2003.
(Retraction required by UAB.)
Thomas, J.M., Eckhoff, D.E., Contreras, J.L.,
Lobashevsky, A.L., Hubbard, W.J., Moore,
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Federal Register / Vol. 74, No. 127 / Monday, July 6, 2009 / Notices
J.K., Cook, W.J., Thomas, F.T., & Neville,
D.M. Jr. ‘‘Durable donor-specific T and B
cell tolerance in rhesus macaques induced
with peritransplantation anti-CD3
immunotoxin and deoxyspergualin:
Absence of chronic allograft nephropathy.’’
Transplantation 69(12):2497–2503, June
27, 2000. (Retracted.)
Thomas, J.M., Contreras, J.L., Jiang, X.L.,
Eckhoff, D.E., Wang, P.X., Hubbard, W.J.,
Lobashevsky, A.L., Wang, W., Asiedu, C.,
Stavrou, S., Cook, W.J., Robbin, M.L.,
Thomas, F.T., & Neville, D.M. Jr.
‘‘Peritransplant tolerance induction in
macaques: Early events reflecting the
unique synergy between immunotoxin and
deoxyspergualin.’’ Transplantation
68(11):1660–1673, December 15, 1999.
(Retracted.)
Contreras, J.L., Eckhoff, D.E., Cartner, S.,
Frenette, L., Thomas, F.T., Robbin, M.L.,
Neville, D.M. Jr., & Thomas, J.M.
‘‘Tolerability and side effects of anti-CD3immunotoxin in preclinical testing in
kidney and pancreatic islet transplant
recipients.’’ Transplantation 68(2):215–
219, July 27, 1999. (Retracted.)
Contreras, J.L., Wang, P.X., Eckhoff, D.E.,
Lobashevsky, A.L., Asiedu, C., Frenette, L.,
Robbin, M.L., Hubbard, W.J., Cartner, S.,
Nadler, S., Cook, W.J., Sharff, J., Shiloach,
J., Thomas, F.T., Neville, D.M. Jr., &
Thomas, J.M. ‘‘Peritransplant tolerance
induction with anti-CD3-immunotoxin: A
matter of proinflammatory cytokine
control.’’ Transplantation 65(9):1159–1169,
May 15, 1998. (Retracted.)
Asiedu, C.K., Goodwin, K.J., Balgansuren, G.,
Jenkins, S.M., Le Bas-Bernardet, S., Jargal,
U., Neville, D.M. Jr. & Thomas, J.M.
‘‘Elevated T regulatory cells in long-term
stable transplant tolerance in rhesus
macaques induced by anti-CD3
immunotoxin and deoxyspergualin.’’ J
Immunol. 175(12):8060–8068, December 5,
2005. (Retracted.)
4.
Includes those cited in Endnote 3 plus:
Thomas, J.M., Neville, D.M., Contreras, J.L.,
Eckhoff, D.E., Meng, G., Lobashevsky, A.L.,
Wang, P.X., Huang, Z.Q., Verbanac, K.M.,
Haisch, C.E., & Thomas, F.T. ‘‘Preclinical
studies of allograft tolerance in rhesus
monkeys: A novel anti-CD3-immunotoxin
given peritransplant with donor marrow
induces operational tolerance to kidney
allografts.’’ Transplantation 64(1):124–135,
July 15, 1997.
[FR Doc. E9–15910 Filed 7–2–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Secretary’s Advisory Committee on
Human Research Protections
AGENCY: Office of Public Health and
Science, Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
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SUMMARY: Pursuant to Section 10(a) of
the Federal Advisory Committee Act,
U.S.C. Appendix 2, notice is hereby
given that the Secretary’s Advisory
Committee on Human Research
Protections (SACHRP) will hold its
twentieth meeting. The meeting will be
open to the public.
DATE: The meeting will be held on
Tuesday, July 21, 2009 from 8:30 a.m.
until 5 p.m. and Wednesday, July 22,
2009 from 8:30 a.m. until 5 p.m.
ADDRESSES: The Sheraton National
Hotel, 900 South Orme Street,
Arlington, Virginia 22204. Phone: 703–
521–1900.
FOR FURTHER INFORMATION CONTACT: Jerry
Menikoff, M.D., J.D., Director, Office for
Human Research Protections (OHRP), or
Julia Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; 240–453–8141; fax:
240–453–6909; e-mail address:
sachrp@osophs.dhhs.gov.
Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services and the
Assistant Secretary for Health on issues
and topics pertaining to or associated
with the protection of human research
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On July 21, 2009, the Committee will
discuss a summary of comments from
the recent OHRP-issued advance notice
of proposed rulemaking on institutional
review board (IRB) accountability, as
well as hear a summary of Clinical and
Translational Science Awards pediatric
research issues. SACHRP will also
spend time focusing on long-range
future planning regarding new
subcommittees and areas of focus. The
day will conclude with a panel
discussion addressing the question of
how to evaluate IRB effectiveness.
On July 22, 2009, the Committee will
hear a report from the Subpart A
Subcommittee focusing on issues
surrounding consent for future use of
specimens or data. This subcommittee
was established by SACHRP at its
October 4–5, 2006 meeting and is
charged with developing
recommendations for consideration by
SACHRP about the application of
Subpart A of 45 CFR part 46 in the
current research environment. SACHRP
will then hear a presentation of the
recent National Academy of Sciences
report entitled ‘‘Conflict of Interest in
Medical Research, Education and
SUPPLEMENTARY INFORMATION:
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31957
Practice,’’ followed by a panel
discussion.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend the meeting and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the designated contact persons.
Members of the public will have the
opportunity to provide comments on
both days of the meeting. Public
comment will be limited to five minutes
per speaker. Any members of the public
who wish to have printed materials
distributed to SACHRP members for this
scheduled meeting should submit
materials to the Executive Director,
SACHRP, prior to the close of business
Friday, July 17, 2009. Information about
SACHRP and the draft meeting agenda
will be posted on the SACHRP Web site
at: https://www.hhs.gov/ohrp/sachrp/
index.html.
Dated: June 29, 2009.
Jerry Menikoff,
Director, Office for Human Research
Protections Executive Secretary, Secretary’s
Advisory Committee on Human Research
Protections.
[FR Doc. E9–15783 Filed 7–2–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
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Meeting of the National Vaccine
Advisory Committee
AGENCY: Department of Health and
Human Services, Office of the Secretary,
Office of Public Health and Science.
ACTION: Notice of meetings via
conference call.
SUMMARY: As stipulated by the Federal
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Department of Health and Human
Services (HHS) is hereby giving notice
that the National Vaccine Advisory
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DATES: The meetings will be held on
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]]>Agencies
[Federal Register Volume 74, Number 127 (Monday, July 6, 2009)]
[Notices]
[Pages 31955-31957]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-15910]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Findings of Scientific Misconduct
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Notice is hereby given that the Office of Research Integrity
(ORI) and the Assistant Secretary for Health have taken final action in
the following case:
Judith M. Thomas, PhD, University of Alabama at Birmingham: Based
on a finding of scientific misconduct made by the University of Alabama
at Birmingham (UAB) on January 24, 2008, a report of the UAB
Investigation Committee, dated November 21, 2007, and additional
analysis conducted by ORI during its oversight review, the U.S. Public
Health Service (PHS) found that Dr. Judith M. Thomas, former Professor
of Surgery, UAB, engaged in scientific misconduct in research supported
by National Institute of Allergy and Infectious Diseases (NIAID),
National Institutes of Health (NIH), grants R01 AI22293, R01 AI39793,
and U19 AI056542, National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK), NIH, grant U19 DK57958, and NIH/Novartis
Cooperative Research and Development Agreement 96-MH-01/NIHITC-0697.
The objective of the research was to test the effectiveness of
different agents, such as Immunotoxin FN18-CRM9 or 15-deoxyspergualin
(15-DSG), administered around the time of renal transplantation in non-
human primates, in preventing rejection of the transplanted kidney. To
determine whether or not the transplanted kidney was functioning (able
to sustain life) after the immunomodulating therapy, the animals were
to have both of their native kidneys removed at or shortly after the
time of transplant, so that their survival would depend solely on the
viability of the transplanted kidney. It was postulated that the use of
immunomodulating agents would increase tolerance of the host animal to
the grafted kidney and thus eliminate the necessity for chronic
administration of immunosuppressive medications commonly required to
prevent rejection in renal transplant recipients. Failure to remove
both native kidneys would render it impossible to assess the
effectiveness of the immunomodulating treatment, and could give totally
misleading results, suggesting that the treatment worked while in fact
survival was due entirely to the remaining native kidney.
PHS found that Respondent engaged in scientific misconduct by
falsifying reports of research results in NIH-supported experiments
with non-human primate (NHP) renal allograft recipients in 15
publications and in progress reports in two NIH research grant
applications. Specifically, PHS found that:
1. Respondent falsely reported in 15 publications that NHP renal
allograft recipients had received bilateral nephrectomies of their
native kidneys, while in fact many of the animals retained an intrinsic
kidney. Specifically:
A. Respondent falsely reported in eight publications \1\ that at
least 32 specific NHPs in a renal allotransplantation study had
received bilateral nephrectomies, while in fact an intrinsic kidney was
left in place in each animal, and generally, in seven additional
publications,\2\ Respondent falsely reported that all long term
surviving NHP renal allograft recipients had received bilateral
nephrectomies of their native kidneys. The publications referenced are
listed separately in the endnotes.
2. In seven publications,\3\ Respondent falsely reported
immunomodulating treatments given to NHP renal allograft recipients by
not reporting the administration of donor bone marrow to seven
recipients and not reporting administration of cyclosporine A to four
recipients. She also falsely reported (by overstating by 15%) dosages
of the immunomodulating agents that were given and/or duration by
overstating the exceptionalbriefer duration of immunomodulating
treatment given to four recipients and cited in at least eight
publications.\4\
3. In progress reports for NIH research awards R01 AI39793 and U19
DK57958, Respondent falsely claimed that long term surviving (LTS) NHP
renal
[[Page 31956]]
allotransplantation recipients had received bilateral nephrectomies and
falsely reported the immunomodulating therapies received by the graft
recipients. Specifically:
A. In the progress report in application 5 R01 AI39793-04,
submitted in approximately May 1999, Respondent repeated falsified
claims of successful LTS NHP allografts by citing two publications
(Transplantation 68:1660-1673, 1999 and Transplantation 68:215-219,
1999) that reported LTS in renal allograft recipients that were falsely
reported to have had bilateral intrinsic nephrectomies, while
laboratory records showed that at the most four of these animals had
bilateral nephrectomies.
B. In the progress report in application 5 U19 DK57958-02 submitted
in approximately May 2000, Respondent falsely reported that 10/13 LTS
NHP renal allograft recipients had received bilateral nephrectomies of
their native kidneys and falsified the immunomodulating treatment
received by four of the animals by failing to report the administration
of cyclosporine A (CSA) or donor bone marrow.
For the same award, in a progress report submitted in approximately
May 2002, Respondent falsely reported that all of the 16 animals in the
rhesus Ktx (kidney transplant) series had bilateral nephrectomies of
their native kidneys, but in fact at least nine of the animals did not
have the requisite bilateral nephrectomies.
In a competing renewal application 2 U19 DK057958-05, submitted on
about 03/10/2003, Respondent reported that 14 Ktx long term survivors
did not have an intrinsic kidney, while in fact at least 11 of those
animals had a remaining intrinsic kidney.
Both Dr. Thomas and PHS are desirous of concluding this matter
without further expense of time and other resources, and the parties
have entered into a Voluntary Exclusion Agreement to settle the matter.
Dr. Thomas accepted responsibility for the reporting described above,
but denied that she intentionally committed research misconduct. The
settlement is not an admission of liability on the part of the
Respondent.
Dr. Thomas has entered into a Voluntary Exclusion Agreement in
which she has voluntarily agreed, for a period of ten (10) years,
beginning on May 5, 2009:
(1) To exclude herself voluntarily from any contracting or
subcontracting with any agency of the United States Government and from
eligibility or involvement in nonprocurement programs of the United
States Government referred to as ``covered transactions'' and defined
by 2 CFR parts 180 and 376; and
(2) To exclude herself from serving in any advisory capacity to
PHS, including but not limited to service on any PHS advisory
committee, board, and/or peer review committee, or as a consultant.
FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative
Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite
750, Rockville, MD 20852, (240) 453-8800.
John E. Dahlberg,
Director, Division of Investigative Oversight, Office of Research
Integrity.
Endnotes
1.
Asiedu, C.K., Dong, S.S., Lobashevsky, A., Jenkins, S.M., & Thomas,
J.M. ``Tolerance induced by anti-CD3 immunotoxin plus 15-
deoxyspergualin associates with donor-specific indirect pathway
unresponsiveness.'' Cell Immunol. 223(2):103-112, June 2003.
(Retraction required by UAB.)
Hutchings, A., Wu, J., Asiedu, C., Hubbard, W., Eckhoff, D.,
Contreras, J., Thomas, F.T., Neville, D., & Thomas, J.M. ``The
immune decision toward allograft tolerance in non-human primates
requires early inhibition of innate immunity and induction of immune
regulation.'' Transpl Immunol. 11(3-4):335-344, July-September 2003.
(Retraction required by UAB.)
Lobashevsky, A.L., Jiang, X.L., & Thomas, J.M. ``Allele-specific in
situ analysis of microchimerism by fluorescence resonance energy
transfer (FRET) in nonhuman primate tissues.'' Hum Immunol.
63(2):108-120, February 2002. (Retraction required by UAB.)
Thomas, J.M., Eckhoff, D.E., Contreras, J.L., Lobashevsky, A.L.,
Hubbard, W.J., Moore, J.K., Cook, W.J., Thomas, F.T., & Neville,
D.M. Jr. ``Durable donor-specific T and B cell tolerance in rhesus
macaques induced with peritransplantation anti-CD3 immunotoxin and
deoxyspergualin: Absence of chronic allograft nephropathy.''
Transplantation 69(12):2497-2503, June 27, 2000. (Retracted.)
Thomas, J.M., Contreras, J.L., Jiang, X.L., Eckhoff, D.E., Wang,
P.X., Hubbard, W.J., Lobashevsky, A.L., Wang, W., Asiedu, C.,
Stavrou, S., Cook, W.J., Robbin, M.L., Thomas, F.T., & Neville, D.M.
Jr. ``Peritransplant tolerance induction in macaques: Early events
reflecting the unique synergy between immunotoxin and
deoxyspergualin.'' Transplantation 68(11):1660-1673, December 15,
1999. (Retracted.)
Contreras, J.L., Eckhoff, D.E., Cartner, S., Frenette, L., Thomas,
F.T., Robbin, M.L., Neville, D.M. Jr., & Thomas, J.M. ``Tolerability
and side effects of anti-CD3-immunotoxin in preclinical testing in
kidney and pancreatic islet transplant recipients.'' Transplantation
68(2):215-219, July 27, 1999. (Retracted.)
Contreras, J.L., Wang, P.X., Eckhoff, D.E., Lobashevsky, A.L.,
Asiedu, C., Frenette, L., Robbin, M.L., Hubbard, W.J., Cartner, S.,
Nadler, S., Cook, W.J., Sharff, J., Shiloach, J., Thomas, F.T.,
Neville, D.M. Jr., & Thomas, J.M. ``Peritransplant tolerance
induction with anti-CD3-immunotoxin: A matter of proinflammatory
cytokine control.'' Transplantation 65(9):1159-1169, May 15, 1998.
(Retracted.)
Asiedu, C.K., Goodwin, K.J., Balgansuren, G., Jenkins, S.M., Le Bas-
Bernardet, S., Jargal, U., Neville, D.M Jr., & Thomas, J.M.
``Elevated T regulatory cells in long-term stable transplant
tolerance in rhesus macaques induced by anti-CD3 immunotoxin and
deoxyspergualin.'' J Immunol. 175(12):8060-8068, December 5, 2005.
(Retracted.)
2.
Thomas, J.M., Hubbard, W.J., Sooudi, S.K., & Thomas, F.T. ``STEALTH
matters: A novel paradigm of durable primate allograft tolerance.''
Immunol Rev. 183:223-233, October 2001. Review. (Retracted.)
Thomas, F., Ray, P., & Thomas, J.M. ``Immunological tolerance as an
adjunct to allogeneic tissue grafting.'' Microsurgery 20(8):435-440,
2000. (Retraction required by UAB.)
Hutchings, A., & Thomas, J.M. ``Transplantation: Tolerance.''
Current Opinion in Investigational Drugs 4(5):530-535, 2003.
(Retraction required by UAB.)
Hubbard, W.J., Eckhoff, D., Contreras, J.L., Thomas, F.T.,
Hutchings, A., & Thomas, J.M. ``STEALTH on the preclinical path to
tolerance.'' Graft 5(6):322-330, 2002. (Retraction required by UAB--
Journal has ceased publication.)
Hutchings, A., Hubbard, W.J., Thomas, F.T., & Thomas, J.M. ``STEALTH
in transplantation tolerance.'' Immunologic Res. 26:143-152, 2002.
(Retracted.)
Thomas, J.M., Asiedu, C., George, J.F., Hubbard, W.J., & Thomas,
F.T. ``Preclinical bridge to clinical tolerance.'' Current Opinion
in Organ Transplantation 6:95-101, 2001. (Retraction required by
UAB.)
Hubbard, W.J., Contreras, J.V., Eckhoff, D.E., Thomas, F.T.,
Neville, D.M., & Thomas, J.M. ``Immunotoxins and tolerance induction
in primates.'' Current Opinion in Organ Transplantation 5:29-34,
2000. (Retracted.)
3.
Asiedu, C.K., Dong, S.S., Lobashevsky, A., Jenkins, S.M., & Thomas,
J.M. ``Tolerance induced by anti-CD3 immunotoxin plus 5-
deoxyspergualin associates with donor-specific indirect pathway
unresponsiveness.'' Cell Immunol. 223(2):103-112, June 2003.
(Retraction required by UAB.)
Hutchings, A., Wu, J., Asiedu, C., Hubbard, W., Eckhoff, D.,
Contreras, J., Thomas, F.T., Neville, D., Thomas, J.M. ``The immune
decision toward allograft tolerance in non-human primates requires
early inhibition of innate immunity and induction of immune
regulation.'' Transpl Immunol. 11(3-4):335-344, July-September,
2003. (Retraction required by UAB.)
Thomas, J.M., Eckhoff, D.E., Contreras, J.L., Lobashevsky, A.L.,
Hubbard, W.J., Moore,
[[Page 31957]]
J.K., Cook, W.J., Thomas, F.T., & Neville, D.M. Jr. ``Durable donor-
specific T and B cell tolerance in rhesus macaques induced with
peritransplantation anti-CD3 immunotoxin and deoxyspergualin:
Absence of chronic allograft nephropathy.'' Transplantation
69(12):2497-2503, June 27, 2000. (Retracted.)
Thomas, J.M., Contreras, J.L., Jiang, X.L., Eckhoff, D.E., Wang,
P.X., Hubbard, W.J., Lobashevsky, A.L., Wang, W., Asiedu, C.,
Stavrou, S., Cook, W.J., Robbin, M.L., Thomas, F.T., & Neville, D.M.
Jr. ``Peritransplant tolerance induction in macaques: Early events
reflecting the unique synergy between immunotoxin and
deoxyspergualin.'' Transplantation 68(11):1660-1673, December 15,
1999. (Retracted.)
Contreras, J.L., Eckhoff, D.E., Cartner, S., Frenette, L., Thomas,
F.T., Robbin, M.L., Neville, D.M. Jr., & Thomas, J.M. ``Tolerability
and side effects of anti-CD3-immunotoxin in preclinical testing in
kidney and pancreatic islet transplant recipients.'' Transplantation
68(2):215-219, July 27, 1999. (Retracted.)
Contreras, J.L., Wang, P.X., Eckhoff, D.E., Lobashevsky, A.L.,
Asiedu, C., Frenette, L., Robbin, M.L., Hubbard, W.J., Cartner, S.,
Nadler, S., Cook, W.J., Sharff, J., Shiloach, J., Thomas, F.T.,
Neville, D.M. Jr., & Thomas, J.M. ``Peritransplant tolerance
induction with anti-CD3-immunotoxin: A matter of proinflammatory
cytokine control.'' Transplantation 65(9):1159-1169, May 15, 1998.
(Retracted.)
Asiedu, C.K., Goodwin, K.J., Balgansuren, G., Jenkins, S.M., Le Bas-
Bernardet, S., Jargal, U., Neville, D.M. Jr. & Thomas, J.M.
``Elevated T regulatory cells in long-term stable transplant
tolerance in rhesus macaques induced by anti-CD3 immunotoxin and
deoxyspergualin.'' J Immunol. 175(12):8060-8068, December 5, 2005.
(Retracted.)
4.
Includes those cited in Endnote 3 plus:
Thomas, J.M., Neville, D.M., Contreras, J.L., Eckhoff, D.E., Meng,
G., Lobashevsky, A.L., Wang, P.X., Huang, Z.Q., Verbanac, K.M.,
Haisch, C.E., & Thomas, F.T. ``Preclinical studies of allograft
tolerance in rhesus monkeys: A novel anti-CD3-immunotoxin given
peritransplant with donor marrow induces operational tolerance to
kidney allografts.'' Transplantation 64(1):124-135, July 15, 1997.
[FR Doc. E9-15910 Filed 7-2-09; 8:45 am]
BILLING CODE 4150-31-P
