Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Office of the Secretary

# AGENCY:

Office of the Secretary, HHS.

# ACTION:

Notice.

# 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                               ( print page 76122)                            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                           ( print page 76123)                        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