[Federal Register Volume 89, Number 180 (Tuesday, September 17, 2024)]
[Notices]
[Pages 76121-76123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21016]


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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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SUMMARY: Findings of research misconduct have been made against 
Arunoday K. Bhan, Ph.D. (Respondent), who was formerly a Research 
Fellow, Department of Pediatrics, Boston Children's Hospital (BCH), 
Harvard

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Medical School (HMS), and a former Staff Scientist, Department of 
Surgery, City of Hope Medical Center (COH). Respondent engaged in 
research misconduct in research supported by U.S. Public Health Service 
(PHS) funds, specifically National Heart, Lung, and Blood Institute 
(NHLBI), National Institutes of Health (NIH), grant T32 HL066987. The 
questioned research was included in two grant applications submitted 
for PHS funds, specifically R03 CA270990-01 and R21 CA272364-01 
submitted to the National Cancer Institute (NCI), NIH. The 
administrative actions, including supervision for a period of four (4) 
years, were implemented beginning on August 21, 2024, and are detailed 
below.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that the Office of 
Research Integrity (ORI) has taken final action in the following case:
    Arunoday K. Bhan, Ph.D., Boston Children's Hospital, Harvard 
Medical School and City of Hope Medical Center: Based on the report of 
an investigation conducted by HMS and COH and additional analysis 
conducted by ORI in its oversight review, ORI found that Dr. Arunoday 
K. Bhan (Respondent), former Research Fellow, Department of Pediatrics, 
BCH, HMS, and a former Staff Scientist, Department of Surgery, COH, 
engaged in research misconduct in research supported by PHS funds, 
specifically NHLBI, NIH, grant T32 HL066987. The questioned research 
was included in two (2) grant applications submitted for PHS funds, 
specifically R03 CA270990-01 and R21 CA272364-01 submitted to the 
National Cancer Institute (NCI), NIH.
    ORI found that Respondent engaged in research misconduct by 
intentionally and knowingly falsifying, fabricating, and/or 
plagiarizing data in the following one (1) published paper and two (2) 
grant applications:
     Human induced pluripotent stem cell-derived platelets 
loaded with lapatinib effectively target HER2+ breast cancer metastasis 
to the brain. Sci Rep. 2021 Oct 15;11(1):16866. doi: 10.1038/s41598-
021-96351-2 (hereafter referred to as Sci Rep. 2021). Retraction in: 
Sci Rep. 2024 Mar 12;14(1):5972. doi: 10.1038/s41598-024-56291-z.
     R03 CA270990-01, ``Human induced pluripotent stem cell 
derived platelets and platelet derived extracellular vesicles mediated 
delivery of chemotherapeutics for breast to brain metastasis 
treatment,'' submitted to NCI, NIH, on June 15, 2021 (hereafter 
referred to as R03 CA270990-01).
     R21 CA272364-01, ``Off-the-shelf engineered human induced 
pluripotent stem cell derived platelets mediated delivery of HER2 
inhibitors for HER2+ Breast to brain metastasis tumors immunotherapy,'' 
submitted to NCI, NIH, on September 29, 2021 (hereafter referred to as 
R21 CA272364-01).
    Specifically, ORI found that Respondent intentionally and knowingly 
falsified, fabricated, and/or plagiarized:
     Figure 2D of Sci Rep. 2021, Figure 4A of R03 CA270990-01, 
and Figure 4A of R21 CA272364-01 by relabeling the transmission 
electron microscopy (TEM) image as Lapatinib-loaded platelet derived 
from the commercially available human induced pluripotent stem cell 
(hiPSC) line DF-19-9-7T when it was actually from a non-drug loaded 
platelet derived from a human donor sample, without appropriate 
citation to the researcher who generated the image
     Supplementary Figure SIB of Sci Rep. 2021 by relabeling 
the fluorescence microcopy images as from a culture of the hiPSC line 
DF-19-9-7T when these were actually from a derivative of the hiPSC line 
1157 .2, without appropriate citation to the researcher who generated 
the image
     Supplementary Figure SlE of Sci Rep. 2021 by relabeling 
the TEM image as from a megakaryocyte on day 6 of maturation obtained 
directly by differentiation of the hiPSC line DF-19-9-7T when it was 
actually from an immortalized megakaryocyte cell line (four days after 
doxycycline-withdrawal induction of differentiation) previously derived 
from hiPSC line 1156
     Supplementary Figure S1C of Sci Rep. 2021 by relabeling 
the karyotype image as from the hiPSC line DF-19-9-7T when it was 
actually from the hiPSC line 1156, without appropriate citation to the 
researcher who generated the image
    Respondent entered into a Voluntary Settlement Agreement 
(Agreement) and voluntarily agreed to the following:
    (1) Respondent will have his research supervised for a period of 
four (4) years beginning with the effective date of the Agreement (the 
``Supervision Period''). Prior to the submission of an application for 
PHS support for a research project on which Respondent's participation 
is proposed and prior to Respondent's participation in any capacity in 
PHS-supported research, Respondent will submit a plan for supervision 
of Respondent's duties to ORI for approval. The supervision plan must 
be designed to ensure the integrity of Respondent's research. 
Respondent will not participate in any PHS-supported research until 
such a supervision plan is approved by ORI. Respondent will comply with 
the agreed-upon supervision plan.
    (2) The requirements for Respondent's supervision plan are as 
follows:
    i. A committee of 2-3 senior faculty members at the institution who 
are familiar with Respondent's field of research, but not including 
Respondent's supervisor or collaborators, will provide oversight and 
guidance for a period of four (4) years from the effective date of the 
Agreement. The committee will review primary data from Respondent's 
laboratory on a quarterly basis and submit a report to ORI at six (6) 
month intervals setting forth the committee meeting dates and 
Respondent's compliance with appropriate research standards and 
confirming the integrity of Respondent's research.
    ii. The committee will conduct an advance review of each 
application for PHS funds, or report, manuscript, or abstract involving 
PHS-supported research in which Respondent is involved. The review will 
include a discussion with Respondent of the primary data represented in 
those documents and will include a certification to ORI that the data 
presented in the proposed application, report, manuscript, or abstract 
are supported by the research record.
    (3) During the Supervision Period, Respondent will ensure that any 
institution employing him submits, 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 and the PHS funding agency 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.
    (4) If no supervision plan is provided to ORI, Respondent will 
provide certification to ORI at the conclusion of the Supervision 
Period that his participation was not proposed on a research project 
for which an application for PHS support was submitted and that he has 
not participated in any capacity in PHS-supported research.
    (5) During the Supervision Period, Respondent will exclude himself 
voluntarily from serving in any advisory or consultant capacity to PHS 
including, but not limited to, service on any PHS

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advisory committee, board, and/or peer review committee.

    Dated: September 10, 2024.
Sheila Garrity,
Director, Office of Research Integrity, Office of the Assistant 
Secretary for Health.
[FR Doc. 2024-21016 Filed 9-16-24; 8:45 am]
BILLING CODE 4150-31-P