82 FR 31334 - Findings of Research Misconduct

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 82, Issue 128 (July 6, 2017)

Page Range		31334-31335
FR Document		2017-14075

Federal Register, Volume 82 Issue 128 (Thursday, July 6, 2017)

[Federal Register Volume 82, Number 128 (Thursday, July 6, 2017)]
[Notices]
[Pages 31334-31335]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-14075]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Research Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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    Notice is hereby given that on June 22, 2017, the Department of 
Health and Human Services (HHS) took final action in the following 
case:
    Frank Sauer, Ph.D., University of California, Riverside: Based on 
evidence and findings of an investigation conducted by the University 
of California, Riverside (UCR), the Office of Research Integrity's 
(ORI's) review of UCR's Research Misconduct Investigation Report, the 
Report of Investigation by the National Science Foundation (NSF) Office 
of Inspector General, additional evidence obtained by ORI during its 
oversight review of UCR's investigation, and independent analyses 
conducted as part of ORI's oversight review, ORI found that Dr. Frank 
Sauer, former Associate Professor of Biochemistry, UCR, committed 
research misconduct in research supported by the following National 
Institute of General Medical Sciences (NIGMS), National Institutes of 
Health (NIH) grants:

 R01 GM073776
 R01 GM066204

    Images that were falsified and/or fabricated were presented in the 
following publications and grant applications.
     Gou, D., Rubalcava, M., Sauer, S., Mora-Berm[uacute]dez, 
F., Erdjument-Bromage, H., Tempst, P., Kremmer, E., & Sauer, F. 
``SETDB1 is involved in postembryonic DNA methylation and gene 
silencing in Drosophila.'' PLoS One 5(5):e10581, 2010 (hereafter 
referred to as ``PLoS One 2010'').
     Sanchez-Elsner, T., Gou, D., Kremmer, E., & Sauer, F. 
``Noncoding RNAs of trithorax response elements recruit Drosophila Ash1 
to Ultrabithorax.'' Science 311(5764):1118-1123, 2006 (hereafter 
referred to as ``Science 2006'').
     Maile, T., Kwoczynski, S., Katzenberger, R.J., Wassarman, 
D.A., & Sauer, F. ``TAF1 activates transcription by phosphorylation of 
serine 33 in histone H2B.'' Science 304(5673):1010-

[[Page 31335]]

1014, 2004 (hereafter referred to as ``Science 2004'').
     National Institute on Drug Abuse (NIDA), NIH, grant 
application R21 DA025703-01.
     National Institute of Diabetes and Digestive and Kidney 
Diseases (NIDDK), NIH, grant application R21 DK082631-01.
     NIDDK, NIH, grant application R01 DK082675-01.
     NIGMS, NIH, grant application R01 GM073776-06A1.
     NIGMS, NIH, grant application R01 GM085229-01.
     NIGMS, NIH, grant application R01 GM085303-01.
     NIGMS, NIH, grant application R01 GM085303-01A1.
    ORI found by a preponderance of the evidence that the Respondent 
engaged in research misconduct by intentionally, knowingly, or 
recklessly falsifying and/or fabricating images in seven (7) submitted 
NIH grant application and three (3) published papers by manipulating, 
reusing, and falsely labeling images. Specifically, the Respondent 
falsified and/or fabricated images representing controls or 
experimental results for in vitro interactions between RNA and 
proteins, co-immunoprecipitation (``co-IP'') assays, histone 
methytransferase (``HMT'') or kinase assays and related stained SDS-
PAGE gels, and reverse transcription-polymerase chain reactions (``RT-
PCR'') in the following grant applications and publications.
    1. The image in Figure S4, Science 2006, representing the in vitro 
interactions between RNA and specific proteins, was used in similar 
assays to represent results with other sets of protein-RNA interactions 
in Figure 9, R21 DA025703-01, Figure 9, R21 DK082631-01, and Figure 9, 
R01 DK082675-01, and again in R01 GM085229-01, Figure 11C.
    2. The image in Figure 1A, R01 GM085303-01, representing a co-IP 
assay from the Drosophila cell line S2, was manipulated and used in 
Figure 1B of the same grant application to represent a different co-IP 
assay from Drosophila embryonic extracts.
    3. The image in Figure 8A, R01 GM085303-01A1, representing an SDS-
PAGE gel for an in vitro HMT assay, was used previously in Figure 1d in 
a manuscript submitted to Nature in 2005 to represent an SDS-PAGE gel 
from an unrelated experiment for an ubiquitination assay.
    4. The image in Figure 1E, R01 GM085303-01 and Figure 1D, R01 
GM085303-01A1, representing stained SDS-PAGE for an HMT assay, was used 
in Figure 1b, Nature 419(6909):857-862, 2002, to represent an HMT assay 
with different experimental conditions, and also was used in Figure 1B, 
Science 2004, to represent stained PAGE for an in vitro kinase assay.
    5. The image in Figure 1C, R01 GM085303-01 and Figure 1B, R01 
GM085303-01A1, representing an HMT assay, was manipulated and used to 
represent an HMT assay with different experimental conditions in Figure 
1E, R01 GM085303-01 and Figure 1D, R01 GM085303-01A1, and also was used 
to represent another unrelated HMT assay in Figure 2 (right panel) in 
R01 GM085303-01.
    6. The image in Figure 2 (right panel) in R01 GM085303-01 
representing an HMT assay was used in Figure 1B, PLoS One 2010 to 
represent an HMT assay with different experimental conditions.
    7. The image in Figure 6B, R21 DA025703-01, Figure 11B, R01 
GM085229-01, Figure 6B, R01 DK082675-01, and Figure 6B, R21 DK082631-
01, all representing RT-PCR experiments for transcribed ncRNAs, was 
used in Figure 13, R21 DK082631-01 and Figure 13, R21 DA025703-01 to 
represent RT-PCR experiments for transcription for different ncRNAs.
    8. The image in Figure 10C (right half) in R01 GM073776-06A1, 
representing transcription of endodermal genes from embroid bodies, was 
manipulated and used in Figure 10C (left half) in the same grant 
application to represent the transcription of mesodermal and ectodermal 
genes.
    Science 311(5764):1118-1123, 2006 was retracted in: Science 
344(6187):981, 2014. Science 304(5673):1010-1014, 2004 was retracted 
in: Science 344(6187):981, 2014. Nature 419(6909):857-862, 2002 was 
retracted in Nature 521(7550):110, 2015.
    ORI issued a charge letter enumerating the above findings of 
research misconduct and proposing HHS administrative actions. Dr. Sauer 
subsequently requested a hearing before an Administrative Law Judge 
(ALJ) of the Departmental Appeals Board to dispute these findings. The 
parties filed cross-motions for summary judgment. On May 22, 2017, the 
ALJ recommended to the Assistant Secretary for Health that summary 
judgment be granted in favor of ORI. On June 22, 2017, the ALJ's 
recommended decision became the final agency decision. Thus, the 
research misconduct findings set forth above became effective, and the 
following administrative actions have been implemented, beginning on 
June 22, 2017:
    (1) Dr. Sauer is prohibited 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, 
through July 27, 2020, the end date of his government-wide debarment, 
which was imposed by NSF; and
    (2) ORI will send a notice to PLoS requesting retraction or 
correction of PLoS One 5(5):e10581, 2010 (PMID: 20498723) in accordance 
with 42 CFR 93.411(b).

FOR FURTHER INFORMATION CONTACT: Director, Office of Research 
Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 
453-8200.

Kathryn M. Partin,
Director, Office of Research Integrity.
[FR Doc. 2017-14075 Filed 7-5-17; 8:45 am]
BILLING CODE 4150-31-P

31334 Federal Register / Vol. 82, No. 128 / Thursday, July 6, 2017 / Notices

Collection of Qualitative Research and strategic planning, legislative planning, shape emerging health and human
Assessment. and review of regulations. Integral to services policy issues for HHS
OMB No.: 0990–0421. this role, ASPE will use this mechanism leadership, agencies, and offices. The
Abstract: The Office of the Assistant to conduct qualitative research, end purpose is to obtain broad and
Secretary for Planning and Evaluation evaluation, or assessment, conduct diverse perspectives on public health,
(ASPE) is requesting an extension for analyses, and understand needs, human service, and health care issues to
their generic clearance for purposes of barriers, or facilitators for HHS-related understand emerging issues, promising
conducting qualitative research. ASPE programs. practices by innovative programs or
conducts qualitative research to gain a ASPE is requesting comment on the organizations funded by HHS, or
better understanding of emerging health burden for qualitative research aimed at examining health or human service
and human services policy issues, understanding emerging health and policy issues that have as yet gone
develop future intramural and human services policy issues. The goal unanswered or need further
extramural research projects, and to of developing these activities is to examination. Additionally, ASPE will
ensure HHS leadership, agencies and identify emerging issues and research collect, analyze, and interpret
offices have recent data and information gaps to ensure the successful information gathered through this
to inform program and policy decision- implementation of HHS programs. The generic clearance to identify strengths
making. ASPE is requesting approval for participants may include health and and weaknesses of current programs,
at least four types of qualitative research human services experts; national, state, policies, and services.
which include, but are not limited to: (a) and local health or human services Likely Respondents: Respondents
Interviews, (b) focus groups, (c) representatives; public health, human have typically been stakeholders from
questionnaires, and (d) other qualitative services, or healthcare providers; and the health and human services fields
methods. representatives of other health or human such as state health officers, human
ASPE’s mission is to advise the services organizations. The increase in service professionals, groups that
Secretary of the Department of Health burden from 747 in 2014 to 1,500 represent health or human services
and Human Services on policy respondents in 2017 reflects an increase interests or populations, individual
development in health, disability, in the number of research projects experts in the fields of health, human
human services, data, and science, and conducted over the estimate in 2014. services, science, data, or other relevant
provides advice and analysis on Need and Proposed Use of the professions, and other individuals and
economic policy. ASPE leads special Information: The information collected groups relevant to the work conducted
initiatives, coordinates the Department’s for qualitative policy research and by ASPE and HHS.
evaluation, research and demonstration assessment will be used by ASPE to The total annual burden hours
activities, and manages cross- develop future intramural and estimated for this ICR are summarized
Department planning activities such as extramural research projects and to in the table below.

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
Number of
Number of burden per Total burden
Form name responses per
respondents response hours
respondent (in hours)

Health or Human Services Stakeholder .......................................................... 2,000 1 1 2,000

Total .......................................................................................................... 2,000 1 1 2,000

Terry S. Clark, conducted by the University of following publications and grant
Asst. Information Collection Clearance California, Riverside (UCR), the Office applications.
Officer. of Research Integrity’s (ORI’s) review of • Gou, D., Rubalcava, M., Sauer, S.,
[FR Doc. 2017–14211 Filed 7–5–17; 8:45 am] UCR’s Research Misconduct Mora-Bermúdez, F., Erdjument-
BILLING CODE 4150–05–P Investigation Report, the Report of Bromage, H., Tempst, P., Kremmer, E.,
Investigation by the National Science & Sauer, F. ‘‘SETDB1 is involved in
Foundation (NSF) Office of Inspector postembryonic DNA methylation and
DEPARTMENT OF HEALTH AND General, additional evidence obtained
gene silencing in Drosophila.’’ PLoS
HUMAN SERVICES by ORI during its oversight review of
One 5(5):e10581, 2010 (hereafter
UCR’s investigation, and independent
Office of the Secretary referred to as ‘‘PLoS One 2010’’).
analyses conducted as part of ORI’s
oversight review, ORI found that Dr. • Sanchez-Elsner, T., Gou, D.,
Findings of Research Misconduct Kremmer, E., & Sauer, F. ‘‘Noncoding
Frank Sauer, former Associate Professor
AGENCY: Office of the Secretary, HHS. of Biochemistry, UCR, committed RNAs of trithorax response elements
research misconduct in research recruit Drosophila Ash1 to
ACTION: Notice.
supported by the following National Ultrabithorax.’’ Science
sradovich on DSK3GMQ082PROD with NOTICES

Notice is hereby given that on June Institute of General Medical Sciences 311(5764):1118–1123, 2006 (hereafter
22, 2017, the Department of Health and (NIGMS), National Institutes of Health referred to as ‘‘Science 2006’’).
Human Services (HHS) took final action (NIH) grants: • Maile, T., Kwoczynski, S.,
in the following case: • R01 GM073776 Katzenberger, R.J., Wassarman, D.A., &
Frank Sauer, Ph.D., University of • R01 GM066204 Sauer, F. ‘‘TAF1 activates transcription
California, Riverside: Based on evidence Images that were falsified and/or by phosphorylation of serine 33 in
and findings of an investigation fabricated were presented in the histone H2B.’’ Science 304(5673):1010–

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Federal Register / Vol. 82, No. 128 / Thursday, July 6, 2017 / Notices 31335

1014, 2004 (hereafter referred to as 2002, to represent an HMT assay with any PHS advisory committee, board,
‘‘Science 2004’’). different experimental conditions, and and/or peer review committee, or as a
• National Institute on Drug Abuse also was used in Figure 1B, Science consultant, through July 27, 2020, the
(NIDA), NIH, grant application R21 2004, to represent stained PAGE for an end date of his government-wide
DA025703–01. in vitro kinase assay. debarment, which was imposed by NSF;
• National Institute of Diabetes and 5. The image in Figure 1C, R01 and
Digestive and Kidney Diseases (NIDDK), GM085303–01 and Figure 1B, R01 (2) ORI will send a notice to PLoS
NIH, grant application R21 DK082631– GM085303–01A1, representing an HMT requesting retraction or correction of
01. assay, was manipulated and used to PLoS One 5(5):e10581, 2010 (PMID:
• NIDDK, NIH, grant application R01 represent an HMT assay with different 20498723) in accordance with 42 CFR
DK082675–01. experimental conditions in Figure 1E, 93.411(b).
• NIGMS, NIH, grant application R01 R01 GM085303–01 and Figure 1D, R01 FOR FURTHER INFORMATION CONTACT:
GM073776–06A1. GM085303–01A1, and also was used to Director, Office of Research Integrity,
• NIGMS, NIH, grant application R01 represent another unrelated HMT assay 1101 Wootton Parkway, Suite 750,
GM085229–01. in Figure 2 (right panel) in R01
• NIGMS, NIH, grant application R01 Rockville, MD 20852, (240) 453–8200.
GM085303–01.
GM085303–01. 6. The image in Figure 2 (right panel) Kathryn M. Partin,
• NIGMS, NIH, grant application R01 in R01 GM085303–01 representing an Director, Office of Research Integrity.
GM085303–01A1. HMT assay was used in Figure 1B, PLoS [FR Doc. 2017–14075 Filed 7–5–17; 8:45 am]
ORI found by a preponderance of the One 2010 to represent an HMT assay BILLING CODE 4150–31–P
evidence that the Respondent engaged with different experimental conditions.
in research misconduct by intentionally, 7. The image in Figure 6B, R21
knowingly, or recklessly falsifying and/ DA025703–01, Figure 11B, R01 DEPARTMENT OF HEALTH AND
or fabricating images in seven (7) GM085229–01, Figure 6B, R01 HUMAN SERVICES
submitted NIH grant application and DK082675–01, and Figure 6B, R21
three (3) published papers by DK082631–01, all representing RT–PCR HHS Approval of Entities That Certify
manipulating, reusing, and falsely experiments for transcribed ncRNAs, Medical Review Officers
labeling images. Specifically, the was used in Figure 13, R21 DK082631–
Respondent falsified and/or fabricated AGENCY: Substance Abuse and Mental
01 and Figure 13, R21 DA025703–01 to
images representing controls or Health Services Administration,
represent RT–PCR experiments for
experimental results for in vitro Department of Health and Human
transcription for different ncRNAs.
interactions between RNA and proteins, 8. The image in Figure 10C (right half) Services.
co-immunoprecipitation (‘‘co-IP’’) in R01 GM073776–06A1, representing ACTION: Notice.
assays, histone methytransferase transcription of endodermal genes from SUMMARY: The current version of the
(‘‘HMT’’) or kinase assays and related embroid bodies, was manipulated and Department of Health and Human
stained SDS–PAGE gels, and reverse used in Figure 10C (left half) in the Services (HHS) Mandatory Guidelines
transcription-polymerase chain same grant application to represent the for Federal Workplace Drug Testing
reactions (‘‘RT–PCR’’) in the following transcription of mesodermal and Programs (Mandatory Guidelines),
grant applications and publications. ectodermal genes. effective on October 1, 2010, addresses
1. The image in Figure S4, Science Science 311(5764):1118–1123, 2006 the role and qualifications of Medical
2006, representing the in vitro was retracted in: Science 344(6187):981, Review Officers (MROs) and HHS
interactions between RNA and specific 2014. Science 304(5673):1010–1014, approval of entities that certify MROs.
proteins, was used in similar assays to 2004 was retracted in: Science As required under Section 13.1(b) of the
represent results with other sets of 344(6187):981, 2014. Nature Mandatory Guidelines, this notice
protein-RNA interactions in Figure 9, 419(6909):857–862, 2002 was retracted publishes a list of HHS approved MRO
R21 DA025703–01, Figure 9, R21 in Nature 521(7550):110, 2015. certification entities.
DK082631–01, and Figure 9, R01 ORI issued a charge letter
FOR FURTHER INFORMATION CONTACT:
DK082675–01, and again in R01 enumerating the above findings of
research misconduct and proposing Sean J. Belouin, Pharm.D., CAPT,
GM085229–01, Figure 11C.
2. The image in Figure 1A, R01 HHS administrative actions. Dr. Sauer United States Public Health Service,
GM085303–01, representing a co-IP subsequently requested a hearing before Senior Pharmacology and Regulatory
assay from the Drosophila cell line S2, an Administrative Law Judge (ALJ) of Policy Advisor, Substance Abuse and
was manipulated and used in Figure 1B the Departmental Appeals Board to Mental Health Services Administration,
of the same grant application to dispute these findings. The parties filed 5600 Fishers Lane, Room 16N06D,
represent a different co-IP assay from cross-motions for summary judgment. Rockville, Maryland 20857; Telephone:
Drosophila embryonic extracts. On May 22, 2017, the ALJ recommended (240) 276–2716; Email: sean.belouin@
3. The image in Figure 8A, R01 to the Assistant Secretary for Health that samhsa.hhs.gov.
GM085303–01A1, representing an SDS– summary judgment be granted in favor SUPPLEMENTARY INFORMATION: Subpart
PAGE gel for an in vitro HMT assay, was of ORI. On June 22, 2017, the ALJ’s M-Medical Review Officer (MRO),
used previously in Figure 1d in a recommended decision became the final Section 13.1(b) of the Mandatory
manuscript submitted to Nature in 2005 agency decision. Thus, the research Guidelines, ‘‘Who may serve as an
MRO?’’ states as follows: ‘‘Nationally
sradovich on DSK3GMQ082PROD with NOTICES

to represent an SDS–PAGE gel from an misconduct findings set forth above
unrelated experiment for an became effective, and the following recognized entities that certify MROs or
ubiquitination assay. administrative actions have been subspecialty boards for physicians
4. The image in Figure 1E, R01 implemented, beginning on June 22, performing a review of Federal
GM085303–01 and Figure 1D, R01 2017: employee drug testing results that seek
GM085303–01A1, representing stained (1) Dr. Sauer is prohibited from approval by the Secretary must submit
SDS–PAGE for an HMT assay, was used serving in any advisory capacity to PHS their qualifications and a sample
in Figure 1b, Nature 419(6909):857–862, including, but not limited to, service on examination. Based on an annual

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Document Created: 2017-07-06 01:04:45
Document Modified: 2017-07-06 01:04:45

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200.
FR Citation		82 FR 31334

82 FR 31334 - Findings of Research Misconduct

DEPARTMENT OF HEALTH AND HUMAN SERVICESOffice of the Secretary

Federal Register Volume 82, Issue 128 (July 6, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary