82 FR 28078 - Findings of Research Misconduct
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 82, Issue 117 (June 20, 2017)
Office of the Secretary
Federal Register Volume 82, Issue 117 (June 20, 2017)
| Page Range | 28078-28079 | |
| FR Document | 2017-12744 |
[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)] [Notices] [Pages 28078-28079] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12744] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct AGENCY: Office of the Secretary, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Brandi M. Baughman, Ph.D., National Institutes of Health (NIH): Based on Respondent's admission and analysis conducted by ORI, ORI found that Dr. Brandi M. Baughman, former Intramural Research Training Awardee, National Institute of Environmental and Health Sciences (NIEHS), NIH, engaged in research misconduct in research supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH, grant R01 DK101645 and the NIEHS, NIH, Postdoctoral Intramural Research Training Award (IRTA). ORI found that falsified and/or fabricated data were included in eleven (11) figures in PLoS One 11(10):e0164378, 2016 (hereafter referred to as ``PLoS One 2016''). ORI found that Respondent falsified and/or fabricated data and text published in PLoS One 2016, in Figures 2, 3, 4, 5, 6, 8, S1, S2, S3, S4, and S5, by claiming that a screening strategy of the kinase focused libraries, PKIS and 5K, was performed, when original data do not exist to support the claims. Respondent also claimed that three (3) inhibitory compounds for the inositol phosphate kinase, PPIP5K, were identified from the 5K library, when these compounds, UNC10112646, UNC10225354, and UNC10225498, were not part of the data set for the 5K library. Specifically, Respondent falsified and/or fabricated the characterization of the inhibitor compounds in:Figures 2 and 3 results for Z'-factor, %CV, signal:background ratio, and a 10-point dose response titration experiment for inhibitor UNC10225354 claims in the text of PLoS One 2016 that eight molecules from the PKIS library and fifteen molecules from the 5K library inhibited PPIP5K activity by >50% Figure 4D results for the inhibition by UNC10112646, UNC10225354, and UNC10225498, in dose response assays against the kinase domain of PPIP5K Figures 5A and 5B results for isothermal titration calorimetry (ITC) assays for quantifying intermolecular interactions between PPIP5K and the inhibitors, UNC1011264 and UNC10225498, and Figure S5 for UNC10225354 Figure 6 results for the analysis of the mechanisms of inhibition of PPIP5K by UNC10112646 and UNC10225498 Figures 8A and 8B results for high performance liquid chromatography (HPLC) analysis for the effects of UNC10112646 or UNC10225498 on PPIP5K activity and IP6K activity Figures S1-S4 for experimental results further characterizing UNC10112646, UNC10225498, and other inhibitors, when the results were not supported by the experimental records. As a result of Respondent's admission, NIH recommended that the PLoS One 2016 paper be retracted. Dr. Baughman has entered into a Voluntary Settlement Agreement with ORI, in which she voluntarily agreed: (1) To have her research supervised for a period of three (3) years beginning on May 17, 2017; Respondent agreed to ensure that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which Respondent's participation is proposed and prior to Respondent's participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of Respondent's duties is submitted to ORI for approval; the supervision plan must be designed to [[Page 28079]] ensure the scientific integrity of Respondent's research contribution; Respondent agreed that she will not participate in any PHS-supported research until a plan for supervision is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan; (2) that for a period of three (3) years beginning on May 17, 2017, any institution employing her shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; (3) 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 a period of three (3) years, beginning on May 17, 2017; and (4) as a condition of the Agreement, to the retraction or correction of PLoS One 11(10):e0164378d, 2016 (PMID: 27736936). 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. 2017-12744 Filed 6-19-17; 8:45 am] BILLING CODE 4150-31-P
![28078 Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices
• An indication of whether the electronic submission process by hours per registrant (‘‘average burden
facility compounds from bulk drug submitting a written request to FDA per response’’ in table 1, row 1). We
substances, and if so, whether it explaining why the use of electronic expect to receive no more than one
compounds sterile or nonsterile drugs means is not reasonable. waiver request from the electronic
from bulk drug substances. This information collection supports submission process annually (‘‘number
Registration information should be the Agency guidance discussed above. of respondents’’ and ‘‘total annual
submitted to FDA electronically using We estimate that approximately 62 responses’’ in table 1, row 2), and that
the Structured Product Labeling (SPL) outsourcing facilities (‘‘number of each request should take approximately
format and in accordance with section respondents’’ and ‘‘total annual
1 hour to prepare and submit to us
IV of the FDA guidance entitled responses’’ in table 1, row 1) will
(‘‘average burden per response’’ in table
‘‘Providing Regulatory Submissions in annually submit to FDA registration
Electronic Format—Drug Establishment information using the SPL format as 1, row 2).
Registration and Drug Listing.’’ Under specified in the guidance, and that FDA estimates the burden of this
the final guidance, outsourcing facilities preparing and submitting this collection of information as follows:
may request a waiver from the SPL information will take approximately 4.5
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Compounding Average
Number of responses Total annual
outsourcing burden per Total hours
respondents per responses
facility response
respondent
Electronic Submission of Registration Information Using
SPL Format ...................................................................... 62 1 62 4.5 279
Waiver Request From Electronic Submission of Registra-
tion Information ................................................................. 1 1 1 1 1
Total .............................................................................. ........................ ........................ ........................ ........................ 280
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 15, 2017. (11) figures in PLoS One interactions between PPIP5K and the
Anna K. Abram, 11(10):e0164378, 2016 (hereafter inhibitors, UNC1011264 and
Deputy Commissioner for Policy, Planning referred to as ‘‘PLoS One 2016’’). UNC10225498, and Figure S5 for
Legislation, and Analysis. ORI found that Respondent falsified UNC10225354
[FR Doc. 2017–12838 Filed 6–19–17; 8:45 am] and/or fabricated data and text • Figure 6 results for the analysis of
BILLING CODE 4164–01–P published in PLoS One 2016, in Figures the mechanisms of inhibition of PPIP5K
2, 3, 4, 5, 6, 8, S1, S2, S3, S4, and S5, by UNC10112646 and UNC10225498
by claiming that a screening strategy of • Figures 8A and 8B results for high
DEPARTMENT OF HEALTH AND the kinase focused libraries, PKIS and performance liquid chromatography
HUMAN SERVICES 5K, was performed, when original data (HPLC) analysis for the effects of
do not exist to support the claims. UNC10112646 or UNC10225498 on
Office of the Secretary Respondent also claimed that three (3) PPIP5K activity and IP6K activity
inhibitory compounds for the inositol • Figures S1–S4 for experimental
Findings of Research Misconduct phosphate kinase, PPIP5K, were results further characterizing
AGENCY: Office of the Secretary, HHS. identified from the 5K library, when UNC10112646, UNC10225498, and
ACTION: Notice. these compounds, UNC10112646, other inhibitors, when the results were
UNC10225354, and UNC10225498, were not supported by the experimental
SUMMARY: Notice is hereby given that not part of the data set for the 5K records.
the Office of Research Integrity (ORI) library. Specifically, Respondent As a result of Respondent’s
has taken final action in the following falsified and/or fabricated the admission, NIH recommended that the
case: characterization of the inhibitor PLoS One 2016 paper be retracted.
Brandi M. Baughman, Ph.D., National compounds in: Dr. Baughman has entered into a
Institutes of Health (NIH): Based on • Figures 2 and 3 results for Z’-factor, Voluntary Settlement Agreement with
Respondent’s admission and analysis %CV, signal:background ratio, and a 10- ORI, in which she voluntarily agreed:
conducted by ORI, ORI found that Dr. point dose response titration experiment (1) To have her research supervised
Brandi M. Baughman, former Intramural for inhibitor UNC10225354 for a period of three (3) years beginning
Research Training Awardee, National • claims in the text of PLoS One 2016 on May 17, 2017; Respondent agreed to
Institute of Environmental and Health that eight molecules from the PKIS ensure that prior to the submission of an
Sciences (NIEHS), NIH, engaged in library and fifteen molecules from the application for U.S. Public Health
research misconduct in research 5K library inhibited PPIP5K activity by Service (PHS) support for a research
>50% project on which Respondent’s
sradovich on DSK3GMQ082PROD with NOTICES
supported by National Institute of
Diabetes and Digestive and Kidney • Figure 4D results for the inhibition participation is proposed and prior to
Diseases (NIDDK), NIH, grant R01 by UNC10112646, UNC10225354, and Respondent’s participation in any
DK101645 and the NIEHS, NIH, UNC10225498, in dose response assays capacity on PHS-supported research,
Postdoctoral Intramural Research against the kinase domain of PPIP5K Respondent shall ensure that a plan for
Training Award (IRTA). • Figures 5A and 5B results for supervision of Respondent’s duties is
ORI found that falsified and/or isothermal titration calorimetry (ITC) submitted to ORI for approval; the
fabricated data were included in eleven assays for quantifying intermolecular supervision plan must be designed to
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![Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices 28079
ensure the scientific integrity of promote research integrity and prevent to PHS funded institutions. The
Respondent’s research contribution; research misconduct. program has a robust and unique
Respondent agreed that she will not Amount of Award: $135,763 in process for assessment and data
participate in any PHS-supported Federal Fiscal Year (FFY) 2017 funds analysis.
research until a plan for supervision is and estimated $135,665 in FFY 2018 Legislative Authority: Sec. 301 of the
submitted to and approved by ORI; funds subject to the enactment of Public Health Service Act, 42 U.S.C. 241
Respondent agreed to maintain appropriations and availability of funds. FOR FURTHER INFORMATION CONTACT:
responsibility for compliance with the Project Period: July 1, 2017—June 30, Kathryn Partin at kathryn.partin@
agreed upon supervision plan; 2019. hhs.gov or by telephone at 240–453–
(2) that for a period of three (3) years SUMMARY: The Office of Research 8200.
beginning on May 17, 2017, any Integrity (ORI) announces the award of
a single-source, grant in response to an Dated: June 13, 2017.
institution employing her shall submit, Kathryn M. Partin,
in conjunction with each application for unsolicited proposal from Washington
University, St. Louis, Missouri. The Director of the Office of Research Integrity.
PHS funds, or report, manuscript, or
abstract involving PHS-supported proposal submitted was not solicited [FR Doc. 2017–12747 Filed 6–19–17; 8:45 am]
research in which Respondent is either formally or informally by any BILLING CODE P
involved, a certification to ORI that the federal government official.
data provided by Respondent are based ORI performed an objective review of
the unsolicited proposal from DEPARTMENT OF HEALTH AND
on actual experiments or are otherwise
Washington University to expand and HUMAN SERVICES
legitimately derived and that the data,
procedures, and methodology are evaluate the Professionalism and
Integrity in Research Program (PI National Institutes of Health
accurately reported in the application,
report, manuscript, or abstract; Program), the only remediation program
Center for Scientific Review; Notice of
(3) to exclude herself from serving in for researchers who violate expectations
Closed Meetings
any advisory capacity to PHS including, for the responsible conduct of research.
but not limited to, service on any PHS Based on an external and internal Pursuant to section 10(d) of the
advisory committee, board, and/or peer review of the proposal, ORI determined Federal Advisory Committee Act, as
review committee, or as a consultant for that it has merit. amended (5 U.S.C. App.), notice is
There is a strategic importance of hereby given of the following meetings.
a period of three (3) years, beginning on
access to this type of training. Research The meetings will be closed to the
May 17, 2017; and
misconduct involving Public Health public in accordance with the
(4) as a condition of the Agreement,
Service (PHS) support is contrary to the provisions set forth in sections
to the retraction or correction of PLoS
interests of PHS and the federal 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
One 11(10):e0164378d, 2016 (PMID:
government, the health and safety of the as amended. The grant applications and
27736936).
public, the integrity of research, and the the discussions could disclose
FOR FURTHER INFORMATION CONTACT: conservation of public funds. confidential trade secrets or commercial
Director, Office of Research Integrity, Participants in the PI Program will property such as patentable material,
1101 Wootton Parkway, Suite 750, demonstrate better research compliance and personal information concerning
Rockville, MD 20852, (240) 453–8200. and integrity outcomes, such as individuals associated with the grant
Kathryn M. Partin, developing better, more ethical research applications, the disclosure of which
practices. These outcomes will promote would constitute a clearly unwarranted
Director, Office of Research Integrity.
research integrity and help prevent invasion of personal privacy.
[FR Doc. 2017–12744 Filed 6–19–17; 8:45 am]
future research misconduct. Name of Committee: Center for Scientific
BILLING CODE 4150–31–P This award is being made non- Review Special Emphasis Panel; PAR16–136:
competitively because there is no Using the NIMH Research Domain Criteria
current, pending, or planned funding (RDoC) Approach to Understand Psychosis.
DEPARTMENT OF HEALTH AND opportunity announcement under Date: July 5, 2017.
HUMAN SERVICES which this proposal could be competed. Time: 9:00 a.m. to 5:00 p.m.
ORI has identified three additional key Agenda: To review and evaluate grant
[CFDA Number: 93.085] applications.
reasons to support rationale for
Place: National Institutes of Health, 6701
Office of Research Integrity; Awards awarding this unsolicited proposal:
Rockledge Drive, Bethesda, MD 20892
Unsolicited Proposal for the 1. ORI’s federal regulation directs us (Telephone Conference Call).
Professionalism and Integrity in to focus on remediation of Respondents Contact Person: Julius Cinque, MS,
Research Program who have been found to commit Scientific Review Officer, Center for
research misconduct, and the PI Scientific Review, National Institutes of
AGENCY: Office of Research Integrity, Program permits a pathway for that Health, 6701 Rockledge Drive, Room 5186,
Office of the Assistant Secretary for remediation after any sanctions have MSC 7846, Bethesda, MD 20892, (301) 435–
Health, Department of Health and been completed. 1252, cinquej@csr.nih.gov.
Human Services. 2. Washington University is uniquely Name of Committee: AIDS and Related
ACTION: Notice of Award of a single- positioned to provide this type of Research Integrated Review Group;
source unsolicited grant to Washington training. As the only remediation Behavioral and Social Consequences of HIV/
AIDS Study Section.
sradovich on DSK3GMQ082PROD with NOTICES
University in St. Louis, Missouri. program for researchers, the grantee has
developed a comprehensive and Date: July 13–14, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Recipient: Washington University, St. intensive program that will improve Agenda: To review and evaluate grant
Louis, Missouri. research compliance and integrity applications.
Purpose of the Award: Grant to outcomes. Place: Ritz-Carlton Hotel, 1700 Tysons
provide remediation training through 3. With this experience, Washington Boulevard, McLean, VA 22102.
the Professionalism and Integrity in University is well known in the research Contact Person: Mark P Rubert, Ph.D.,
Research Program (PI Program) to community and is an important service Scientific Review Officer, Center for
VerDate Sep<11>2014 18:01 Jun 19, 2017 Jkt 241001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\20JNN1.SGM 20JNN1](https://thefederalregister.org/doc/82_FR_28195/page/2.svg)
Document Created: 2017-06-20 02:21:19
Document Modified: 2017-06-20 02:21:19
| 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 28078 |
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