Findings of Research Misconduct, 80729-80733 [2023-25603]

Download as PDF Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices SUPPLEMENTARY INFORMATION: I. Background This public meeting is intended to facilitate improvements in the treatment of rare diseases and conditions, consistent with the requirements under section 3202 of the Food and Drug Omnibus Reform Act of 2022 (FDORA). Section 3202 of FDORA requires FDA to conduct a number of activities related to improving the treatment of rare diseases and conditions, including the convening of one or more public meetings to address increasing and improving engagement with rare disease patients, rare disease patient groups, and experts on small population studies, in order to improve the understanding of patient burden, treatment options, and the side effects of treatments (see section 3202(d)(2) of FDORA). II. Topics for Discussion at the Public Meeting The purpose of this public meeting is to highlight and build upon existing actionable approaches for engaging patients, patient groups, and related experts when developing necessary evidence for rare disease drug approvals. The meeting will address approaches to increasing and improving engagement with rare disease patients, groups representing such patients, rare disease experts, and experts on small population studies, to improve the understanding of how to best understand patients’ experiences living with a rare disease and how to incorporate those experiences and priorities throughout the drug development process. This includes understanding patient perspectives on the burden of their condition and any existing treatment options, as well as how their current health status and risk of disease progression may impact willingness to accept risks from treatment side effects. Meeting updates, the agenda, and background materials (if any) will also be made available at https://duke.is/4/ 7yuu prior to the meeting. ddrumheller on DSK120RN23PROD with NOTICES1 III. Participating in the Public Meeting Registration: To register for the public meeting, please visit the following website: https://duke.is/4/7yuu. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Registration will end at 11:59 p.m. Eastern Time on December 13, 2023. Registration is free and persons interested in attending this public meeting must register to receive a link VerDate Sep<11>2014 17:42 Nov 17, 2023 Jkt 262001 to the meeting. Registrants will receive a confirmation email after they register. If you need special accommodations due to a disability, please contact Margolisevents@duke.edu no later than November 30, 2023. Please note, closed captioning will be available automatically. Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://duke.is/4/7yuu. The transcript will also be available at https:// www.regulations.gov and may be viewed at the Dockets Management Staff (see ADDRESSES). Dated: November 14, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–25500 Filed 11–17–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Advisory Committee on Blood and Tissue Safety and Availability Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: The U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a virtual meeting. The meeting will be open to the public via webcast. The committee will discuss and vote on recommendations related to surge capacity for blood and blood products. DATES: The meeting will take place virtually on January 11, 2024 from approximately 9:00 a.m.—5:00 p.m. Eastern Time (ET). Meeting times are tentative and subject to change. The confirmed times and agenda items for the meeting will be posted on the ACBTSA web page at https:// www.hhs.gov/oidp/advisory-committee/ blood-tissue-safety-availability/ meetings/2024-01-11/ when this information becomes available. FOR FURTHER INFORMATION CONTACT: James Berger, Designated Federal Officer for the ACBTSA; Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, Department of Health and Human Services, Tower Building, 1101 Wootton Parkway, Rockville, MD, 20852. Email: ACBTSA@hhs.gov. Phone: 202–795– 7608. SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 80729 On the day of the meeting, please go to https:// www.hhs.gov/live/ to view the meeting. The public will have an opportunity to present their views to the ACBTSA by submitting a written public comment. Comments should be pertinent to the meeting discussion. Persons who wish to provide written public comment should review instructions at https://www.hhs.gov/ oidp/advisory-committee/blood-tissuesafety-availability/meetings/2024-01-11/ index.html and respond by midnight January 3, 2024, ET. Written public comments will be accessible to the public on the ACBTSA web page prior to the meeting. Background and Authority: The ACBTSA is a discretionary Federal advisory committee and is governed by the provisions of the Federal Advisory Committee Act (FACA), Public Law 92– 463, as amended (5 U.S.C. app), which sets forth standards for the formation and use of advisory committees. The ACBTSA functions to provide advice to the Secretary through the Assistant Secretary for Health on a range of policy issues to include: (1) Identification of public health issues through surveillance of blood and tissue safety issues with national survey and data tools; (2) identification of public health issues that affect availability of blood, blood products, and tissues; (3) broad public health, ethical, and legal issues related to the safety of blood, blood products, and tissues; (4) the impact of various economic factors (e.g., product cost and supply) on safety and availability of blood, blood products, and tissues; (5) risk communications related to blood transfusion and tissue transplantation; and (6) identification of infectious disease transmission issues for blood, organs, blood stem cells and tissues. The Committee has met regularly since its establishment in 1997. SUPPLEMENTARY INFORMATION: Dated: November 2, 2023. James J. Berger, Designated Federal Officer, Advisory Committee on Blood and Tissue Safety and Availability, Office of Infectious Disease and HIV/AIDS Policy. [FR Doc. 2023–25572 Filed 11–17–23; 8:45 am] BILLING CODE 4150–28–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct AGENCY: E:\FR\FM\20NON1.SGM Office of the Secretary, HHS. 20NON1 80730 ACTION: Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices Notice. Findings of research misconduct have been made against Sarah Elizabeth Martin (Respondent), who was formerly a Graduate Teaching Assistant, Department of Biological Sciences, Auburn University (AU). Respondent engaged in research misconduct in research included in a grant application submitted for U.S. Public Health Service (PHS) funds, specifically R21 AI159361–01 submitted to the National Institute of Allergy and Infectious Disease (NIAID), National Institutes of Health (NIH), and in research supported by NIAID, NIH, grant R21 AI159361–01. The administrative actions, including debarment for a period of three (3) years followed by supervision for a period of two (2) years, were implemented beginning on November 3, 2023, 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: Sarah Elizabeth Martin, Auburn University: Based on the report of an investigation conducted by AU and additional analysis conducted by ORI in its oversight review, ORI found that Sarah Elizabeth Martin, who was formerly a Graduate Teaching Assistant, Department of Biological Sciences, AU, engaged in research misconduct in research included in a grant application submitted for PHS funds, specifically R21 AI159361–01 submitted to NIAID, NIH, and in research supported by NIAID, NIH, grant R21 AI159361–01. ORI found that Respondent engaged in research misconduct by intentionally or knowingly falsifying and/or fabricating experimental data and results obtained under different experimental conditions that were included in one (1) grant application, one (1) published paper, one (1) submitted manuscript, and six (6) presentations as follows: • R21 AI159361–01, ‘‘The interplay between m6A and viral lncRNA during KSHV replication,’’ submitted to NIAID, NIH, on July 15, 2020, Funded Period: March 4, 2021–February 28, 2023. • The m6A landscape of polyadenylated nuclear (PAN) RNA and its related methylome in the context of KSHV replication. RNA. 2021 Sep;27(9):1102–1125. doi: 10.1261/ rna.078777.121 (hereafter referred to as ‘‘RNA 2021’’). Retraction in RNA. 2022 ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:42 Nov 17, 2023 Jkt 262001 Feb;28(2):274. doi: 10.1261/ rna.079042.121. • Determination of m6A frequency utilizing 4SedTTP–RT Ligation Assisted PCR (SLAP) in viral and cellular long non-coding RNAs. Manuscript submitted to RNA in 2021 (hereafter referred to as ‘‘RNA ms’’). • The dynamic status of N6methyladenosine modifications of polyadenylated nuclear (PAN) RNA lncRNA and its methylome throughout KSHV replication. Presented at The RNA Institute Mini Symposium, Albany, NY, March 3, 2021 (hereafter referred to as ‘‘RNA Mini 2021’’). • Elucidating the N6Methyladenosine Landscape of Viral LncRNA in the Context of Kaposi’s Sarcoma-Associated Herpesvirus Replication. Poster presented at the NIH/NCI 2021 RNA Biology Symposium, Frederick, MD, April 14, 2021 (hereafter referred to as ‘‘NCI Poster 2021’’). • The m6A epitranscriptomic landscape of polyadenylated nuclear (PAN) RNA.’’ Presented at The KSHV 2021 Virtual Meeting, June 21, 2021 (hereafter referred to as ‘‘KSHV Virtual 2021’’). • The epitranscriptomic landscape of viral long non-coding RNA. Presented at the Noncoding RNA World: From Mechanism to Therapy, Virtual, July 21, 2021 (hereafter referred to as ‘‘RNA World 2021’’). • The m6A landscape of polyadenylated nuclear RNA and its related methylome in the context of KSHV replication. Presented at the American Society for Virology Annual Meeting, Virtual, July 19, 2021 (hereafter referred to as ‘‘Virology Virtual 2021’’). • The Dynamics of N6methladenosine Landscape of PAN RNA during the KSHV Replication. Presented at the 45th Annual International Herpesviruses Workshop, Virtual, August 2, 2021 (hereafter referred to as ‘‘IHW Virtual 2021’’). Additionally, data falsification and/or fabrication were identified in four (4) research records sequestered from Respondent’s laboratory files, specifically: • A_response.pptx • B_response.pptx • Response_B_clarified.pptx • Intermediate.pptx Specifically, ORI finds that Respondent intentionally or knowingly falsified and/or fabricated: • Native PAGE blots representing 4SedTTP–RT Ligation Assisted PCR (SLAP) analysis for m6A detection on PAN RNA and MALAT1 RNA standards PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 in Figure 2a and 2d, respectively, of RNA ms by relabeling and reusing the Native PAGE blot representing SLAP analysis for m6A detection limit on PAN RNA standard in Figure 3A of RNA 2021. • calibration curve for detection of m6A modification at nt position 54 on PAN RNA by SLAP analysis in Figure 2b of RNA ms by relabeling and reusing the calibration curve for detection of m6A modification at nt position 63 on PAN RNA by SLAP analysis in Figure 3B of RNA 2021. • Native PAGE blot representing SLAP analysis of PAN RNA at unmodified adenosine position 366nt in Figure 3a of RNA ms by relabeling the amplicon size from 103nt in Figure 3C of RNA 2021 to 106nt in Figure 3a of RNA ms. • Figure 3a and Figure 4a of RNA ms and Figure 3C of RNA 2021 by relabeling and reusing the bands and Native PAGE blots to represent SLAP analysis at unmodified adenosine on RNA molecule, specifically: —in Figure 3a of RNA ms and Figure 3C of RNA 2021, the same band is used in lanes 1 and 5, from the left, of 410nt sample Native PAGE blot to represent SLAP analysis of PAN RNA at unmodified adenosine position under different experimental conditions. Relabeling and reuse of the same band also occurred in lanes 3 and 7, from the left, of Figure 4a of RNA ms to represent SLAP analysis of MALAT1 RNA under different experimental conditions. —Native PAGE blot representing SLAP analysis of PAN RNA at nt position 410 in Figure 3a of RNA ms and Figure 3C of RNA 2021 is identical to lanes 3–9 portion of the Native PAGE blot representing SLAP analysis of MALAT1 RNA at nt position 2674 in Figure 4a of RNA ms. • Native PAGE panels in Figure 3b of RNA ms by relabeling and reusing lanes 1, 4, 6 and 9 of 18nt panel in Figure 3C of RNA 2021 representing amplicon sizes of 183nt for m6A and 106nt for A as lanes 1–4, respectively, for 18nt Replicate 1 panel in Figure 3b of RNA ms representing amplification sizes 202nt for m6A and 160nt for A • Native PAGE panels in Figure 3b of RNA ms by relabeling and reusing bands under different experimental conditions, specifically: —Replicate 1 18nt 48 hpi +4SedTTP group ‘‘202nt, m6A’’ band is identical to Replicate 2 18nt 48 hpi +4SedTTP group ‘‘202nt, m6A’’ band —Replicate 2 18nt 0 hpi –4SedTTP group ‘‘160nt, A’’ band is identical to E:\FR\FM\20NON1.SGM 20NON1 ddrumheller on DSK120RN23PROD with NOTICES1 Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices Replicate 2 203nt 0 hpi –4SedTTP group ‘‘103nt, A’’ band —Replicate 2 203nt 0 hpi +4SedTTP group ‘‘103nt, A’’ band is identical to Replicate 2 1041nt 48 hpi +4SedTTP group ‘‘75nt, m6A’’ band • Figure 4a of RNA ms by using identical bands in lanes 3 and 7, from the left, of the Native PAGE blot representing two different experimental conditions • Figure 4b of RNA ms by using identical bands to represent the m6A modifications on different samples, specifically: —lanes presented for replicate 1 of nt position 2515 are identical to lanes for replicate 1 at nt position 2698 —lanes presented in 0¥, 48¥ and 48+ samples in replicate 2 of nt position 2515 are identical to lanes for 0¥, 48¥ and 48+ samples, respectively, in replicate 2 of nt position 2698 —lane for 0¥ sample in replicate 3 of nt position 2515 is identical to lane for 0¥ sample in replicate 3 of nt position 2698 —lane for 0¥ sample in replicate 1 of nt position 2515 is identical to lane for 48¥ sample in replicate 3 of nt position 2698 —lanes for 0+ sample in replicate 1 of nt position 2515, 48+ sample in replicate 3 of nt position 2515, and 0+ samples in replicate 1 of nt position 2698 are identical —lanes for 48+ sample in replicate 1 of nt position 2515, 0+ sample in replicate 2 of nt position 2515, 48+ sample in replicate 1 of nt position 2698, and 0+ and 48+ samples in replicate 3 of nt position 2698 are identical —lanes for 0¥ sample in replicate 2 of nt position 2515, 48¥ sample in replicate 3 of nt position 2515, and 0¥ sample in replicate 2 of nt position 2698 are identical —lanes for 48¥ sample in replicate 2 of nt position 2515, 0¥ sample in replicate 3 of nt position 2515, 48¥ sample in replicate 2 of nt position 2698, and 0¥ samples in replicate 3 of nt position 2698 are identical —lane for 0+ sample in replicate 3 of nt position 2515 is identical to lane for 0+ sample in replicate 2 of nt position 2698 • two original gel images on slides 7– 8 of A_response.pptx provided in support of nt position 2515 panels in Figure 4b of RNA ms • two original gel images on slides 9– 10 of A_response.pptx provided in support of nt position 2698 panels in Figure 4b of RNA ms • Native PAGE panels in Figure 3C of RNA 2021 by relabeling and reusing VerDate Sep<11>2014 17:42 Nov 17, 2023 Jkt 262001 bands under different experimental conditions, specifically: —18nt 48–72 hpi +4SedTTP ‘‘183nt m6A’’ bands share a same source image with 203nt 48–72 hpi +4SedTTP ‘‘61nt m6A’’ bands, respectively —672nt ‘‘98nt A’’ sample share a same source bands panel with 1048nt ‘‘95nt A’’ sample, except for bands in two lanes corresponding to 8–24 hpi ¥4SedTTP samples —In 1041nt panel, ‘‘101nt A’’ 72 hpi ¥4SedTTP and 0 hpi +4SedTTP bands share a same source image with +4SedTTP 8 hpi and +4SedTTP 24 hpi bands, respectively • Western blot panels for Total Lysate group in Figure 5A of R21 AI159361–01, Figure 4D in RNA 2021, Figure [B] on slide 2 in RNA Mini 2021, Figure 4D in NCI Poster 2021, Figure d on slide 10 in KSHV Virtual 2021, Figure d on slide 10 in RNA World 2021, and Figure 4D in IHW Virtual 2021, specifically: —bands for METTL3 0hr, FTO 0hr, and HNRNPC 0hr share a same source image —bands for METTL3 8hr, FTO 8hr and 72hr, HNRNPC 8hr, 48hr and 72hr, and b-actin 72hr share a same source image —24hr time point bands for METTL3, FTO, SND1, and HNRNPC share a same source image —bands for METTL3 48hr, FTO 48hr, SND1 48hr, b-actin 8hr and 48hr share a same source image —bands for METTL3 72hr, SND1 72hr, and b-actin 0 and 24hr share a same source image • Western blot panels for PAN Proteins (FA) (also named as RAP–FA Crosslink) group in Figure 5A in R21 AI159361–01, Figure 4D in RNA 2021, Figure [B] on slide 2 in RNA Mini 2021, Figure 4D in NCI Poster 2021, Figure d on slide 10 in KSHV Virtual 2021, Figure d on slide 10 in RNA World 2021, and Figure 4D in IHW Virtual 2021, specifically: —bands for 8–72hr time points in SND1 and FTO panels share a same source image —0–24hr panel areas for HNRNPC and YTHDF2 share a same source image —blank panel for METTL3 and b-actin panels share a same source image • original Western blot images provided in B_response.pptx to support the Western blot panels presented in Figure 4D in RNA 2021, Figure 5A in R21 AI159361–01, Figure [B] on slide 2 in RNA Mini 2021, Figure 4D in NCI Poster 2021, Figure d on slide 10 in KSHV Virtual 2021, Figure d on slide 10 in RNA World 2021, and Figure 4D in IHW Virtual 2021, specifically: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 80731 —RMB15 Western blot images for bio reps 1 and 2 share a same source image, with areas pasted over to make the two images appear different from each other. RBM15 bands for Total Lysate and RAP–FA Crosslink sample groups have been pasted over the base image on both the gels. The Total Lysate group bands between the two gel images share a same source image. —The two METTL3 Western blot images share a same source image, with areas pasted over to make the two images appear different from one another. METTL3 bands for the Total Lysate and empty areas corresponding to RAP–FA crosslink sample groups have been pasted over the base image. The Total Lysate group bands in two Western blot images share a same source image, although vertical positioning of T2 and T3 with respect to T0 and T1 is changed to make the panels appear different from one another. T0 and T1 bands share same source image with T2 and T3 bands, respectively, on the two Western blot images. —SND1 Western blot images for bio reps 1 and 2 share a same source image, with areas pasted over to make the two images appear different from one another. RAP–FA Crosslink T1– T4 bands share a same source image between the two gels. Bands are shifted vertically to give the impression that the two gels are different from each other. The Total Lysate T0–T3 main darker bands share a same source image between the two Western blot images. The bands are merged with background and additional band patterns to make the two images appear different from one another. —HNRNPC Western blot images for bio reps 1 and 2 share a same source image, with areas pasted over to make the two images appear different from one another. The Total Lysate bands on the two images share the same source image. Further, Total Lysate T0 and T1 bands share same source image with T2 and T3 bands, respectively. The HNPNRC bio rep 2 Western blot share a same source image with RMB15 bio rep 2 Western blot. In the HNPNRC bio rep 2 image, the 26 kDa bands have been pasted over to make the gel image appear different from the RMB15 bio rep 2 image. Further, the same ladder image has been modified to appear different between the two gels. —YTHDF2 Western blot images for all the three replicate gels share the same background image, with areas pasted over to make the three images appear different from one another. The Total E:\FR\FM\20NON1.SGM 20NON1 ddrumheller on DSK120RN23PROD with NOTICES1 80732 Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices Lysate group bands on the Western blot 1 and 3 share a same source image. The Total Lysate bands on Western blot 2 share a same source image with METTL3 Total Lysate bio rep 1 (∼53kDa) bands, HNRNPC Total Lysate bio rep 2 (26kDa) bands, and SND1 bio rep 2 RAP–FA crosslink (between 125 and 82 kDa) bands. —FTO Western blot images for all the three replicate gels share the same background image, with areas pasted over to make the three images appear different from one another. On the FTO bio rep 3 Western blot image, RFA–FA Crosslink T3–T4 bands, Total Lysate T0–T1 bands, and Total Lysate T2–T3 band, respectively, are identical. —b-actin Western blot image for the two replicate gels share the same source image, with areas pasted over to make the blot images appear different from one another. On the second replicate blot image, the Total Lysate T0–T1 bands are identical to Total Lysate T2–T3 bands, respectively. The Total Lysate T0–T3 bands on b-Actin Western blot replicate 2 image are identical to FTO Western blot replicate 3 Total Lysate T0–T3 bands, respectively. —all the original unedited Western blot images for RMB15, METTL3, SND1, HNRNPC, YTHDF2, FTO and b-actin share the same source background image that have been modified to appear different from one another • Native PAGE data by relabeling and reusing several identical bands to represent m6A modifications at different nt positions on the PAN RNA samples in Figure 5E in RNA 2021, Figure [D] in RNA Mini 2021, Figure 5B in NCI Poster 2021, slide 12 in KSHV Virtual 2021, slide 6 in Virology Virtual 2021, slide 12 in RNA World 2021, and Figure 5B in IHW Virtual 2021, specifically: —band in lane 1 corresponding to 0 hpi ¥4Sed sample of RBM15 KD 18nt panel, after flipping horizontally, share a same source image with band in lane 1 of METTL3 KD 1041nt, RBM15KD 1041nt and FTO KD 18nt samples —bands for 0 hpi ¥4Sed, 48 hpi ¥4Sed, 0 hpi +4Sed and 48 hpi +4Sed samples in RBM15 KD 1041nt, METTL3 KD 1041nt and FTO KD 18nt blots are identical —RBM15 KD 18nt 0 hpi +4Sed and 48 hpi +4Sed bands are identical to METTL3 KD 1048nt 0 hpi ¥4Sed and 48 hpi ¥4Sed bands, respectively, and to horizontally flipped FTO KD 203nt 48 hpi ¥4Sed and 0 hpi +4Sed bands, respectively —FTO KD 1041nt 0 hpi ¥4Sed and 48 hpi ¥4Sed bands share a same source VerDate Sep<11>2014 17:42 Nov 17, 2023 Jkt 262001 image with RBM15 KD 203nt 0 hpi ¥4Sed and 48 hpi ¥4Sed bands, respectively —RBM15 KD 1048nt 0 hpi ¥4Sed and 48 hpi ¥4Sed bands are identical to RMB15 0 hpi +4Sed and 48 hpi +4Sed bands, respectively, and to the copy pasted bands on the lanes 10–11 (from the left) and 5–6 (from the left) of gel images on slides 11 and 12 of the intermediate.pptx • confocal micrographs by using identical images either with or without modifications to present PAN RNA colocalization experiments in Figure 7 of RNA 2021, slide 11 of KSHV Virtual 2021, slide 6 of Virology Virtual 2021, and slide 11 of RNA World 2021, specifically: —Replicate 2 and Enlarged-2 of RBM15 at 72 hpi are identical to Replicate 2 and Enlarged-2 of METTL3 72 hpi, respectively —Replicate 1 of RBM15 48 hpi is rotated 90 degrees clockwise to present Replicate 2 of RBM15 24 hpi —RBM15 24 hpi Enlarged 2 image is a further zoomed area of RBM15 48 hpi Enlarged 1 image • confocal micrographs by using identical images to present PAN RNA colocalization experiments under different experimental conditions in Supplementary Figures 10a–b of RNA 2021, specifically: —T3 panel representing staining for RBM15, DAPI, PAN and Combined samples in Supplementary Figure 10a is identical to T2 panel representing staining for METTL3, DAPI, PAN, and Combined samples, respectively. The same images also appear in 48 hpi panel in Figure 7A of RNA 2021, slide 11 of KSHV Virtual 2021, slide 6 of Virology Virtual 2021, and slide 11 of RNA World 2021, representing staining for RBM15, DAPI, PAN and Combined samples, respectively —T4 replicate 2 (Rep 2) in RMB15 staining composite in Supplementary Figure 10a is identical to T4 replicate 2 (Rep 2) in METTL3 staining composite in Supplementary Figure 10b. The same image appeared as RMB15 T4(2) image in Figure 9B of R21 AI159361–01 • images of Native PAGE gel images in intermediate.pptx by adding transparency adjusted images of individual bands, empty areas, and/or ladders, to make the gel images appear different from the baseline images. Additionally: —baseline gel image on slide 6 of intermediate.pptx was used to falsify and/or fabricate original gel-2 image for 2698nt sample on slides 9–10 of A-response.pptx PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 —baseline gel image on slide 7 of intermediate.pptx was used to falsify and/or fabricate one of the two original gel images on slide 7 of Aresponse.pptx —part of falsified and/or fabricated bands on slide 12 of intermediate.pptx were incorporated in RBM15 KD original bottom gel image on slide 15 of B-response.pptx • original gel images and Western blot images in A_response.pptx, B_ response.pptx and Response_B_ clarified.pptx provided to the RNA journal, specifically: —the right-side gel image for SLAP analysis at nt position 2698 on slide 9 of A-response.pptx is a fabricated and/or falsified gel image that shares an identical baseline image with the gel image on slide 1 of intermediate.pptx —bands in lanes 6–8 of the bottom METTL3 KD gel image on slide 14 of B_response.pptx and bands in lanes 9–7 of the bottom RBM15 KD gel image on slide 15 of B_response.pptx are, respectively, identical —bands in lanes 9–11 of the bottom METTL3 KD gel image on slide 14 of B_response.pptx and bands in lanes 5–3 of the bottom RBM15 KD gel image on slide 15 of B_response.pptx are, respectively, identical —bands in lanes 7–9 of the left-side FTO KD gel image on slide 13 of B_ response.pptx and bands in lanes 9– 7 of the bottom RBM15 KD gel image on slide 15 of B_response.pptx are, respectively, identical —bands in lanes 10–13 of the left-side FTO KD gel image on slide 13 of B_ response.pptx and bands in lanes 5– 2 of the bottom RBM15 KD original gel image on slide 15 of B_ response.pptx are, respectively, identical —overall, one replicate gel for each of the three experimental groups (FTO KD, RBM15 KD, and METTL3 KD) provided as original unaltered image in support of Figure 5E of RNA 2021 share two panels containing a total of 7 bands from a same source image. Respondent entered into a Voluntary Exclusion Agreement (Agreement) and voluntarily agreed to the following: (1) Respondent will exclude herself voluntarily for a period of three (3) years, beginning on November 3, 2023 (the ‘‘Exclusion Period’’), from any contracting or subcontracting with any agency of the United States Government and from eligibility for or involvement in nonprocurement or procurement transactions referred to as ‘‘covered transactions’’ in 2 CFR parts 180 and 376 (collectively the ‘‘Debarment E:\FR\FM\20NON1.SGM 20NON1 ddrumheller on DSK120RN23PROD with NOTICES1 Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices Regulations’’). At the conclusion of the Exclusion Period, Respondent agrees to have her research supervised for a period of two (2) years (the ‘‘Supervision Period’’). During 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) During the Exclusion Period, Respondent will not apply for, permit her name to be used on an application for, receive, or be supported by funds of the United States Government and its agencies made available through contracts, subcontracts, or covered transactions. (3) During the Supervision Period, the requirements for Respondent’s supervision plan are as follows: i. A committee of 2–3 senior faculty members at the institution including Respondent’s supervisor or collaborators will provide oversight and guidance. 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. (4) During the Supervision Period, Respondent will ensure that any institution employing her 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 that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, VerDate Sep<11>2014 17:42 Nov 17, 2023 Jkt 262001 procedures, and methodology are accurately reported and not plagiarized in the application, report, manuscript, or abstract. (5) If no supervision plan is provided to ORI, Respondent will provide certification to ORI at the conclusion of the Supervision Period that her participation was not proposed on a research project for which an application for PHS support was submitted and that she has not participated in any capacity in PHSsupported research. (6) During the Exclusion and Supervision Periods, Respondent will exclude herself voluntarily from serving in any advisory or consultant capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee. Dated: November 15, 2023. Sheila Garrity, Director, Office of Research Integrity, Office of the Assistant Secretary for Health. [FR Doc. 2023–25603 Filed 11–17–23; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; SEP–3: NCI Clinical and Translational Cancer Research. Date: February 21–22, 2024. Time: 9:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W612, Rockville, Maryland 20850, (Virtual Meeting). Contact Person: Prashant Sharma, Ph.D., Scientific Review Officer, Special Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W612, Rockville, PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 80733 Maryland 20850, 240–275–6351, prashant.sharma@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: November 15, 2023. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–25619 Filed 11–17–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG–2023–0830] National Merchant Mariner Medical Advisory Committee; December 2023 Virtual Meeting United States Coast Guard, Department of Homeland Security. ACTION: Notice of open Federal advisory committee virtual meeting. AGENCY: The National Merchant Mariner Medical Advisory Committee (Committee) will conduct a virtual meeting to discuss matters relating to medical certification determinations for issuance of licenses, certificates of registry, and merchant mariners’ documents, medical standards, and guidelines for the physical qualifications of operators of commercial vessels, medical examiner education, and medical research. The virtual meeting will be open to the public. SUMMARY: Meeting: The Committee will meet virtually on Tuesday, December 19, 2023, from noon until 3:00 p.m. Eastern Standard Time, (EST). The virtual meeting may adjourn early if the Committee has completed its business. Comments and supporting documentation: To ensure your comments are received by Committee members before the virtual meeting, submit your written comments no later than December 12, 2023. ADDRESSES: To join the virtual meeting or to request special accommodations, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section no later than 1 p.m. EST on December 12, 2023, to obtain the needed information. DATES: E:\FR\FM\20NON1.SGM 20NON1

Agencies

[Federal Register Volume 88, Number 222 (Monday, November 20, 2023)]
[Notices]
[Pages 80729-80733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25603]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Research Misconduct

AGENCY: Office of the Secretary, HHS.

[[Page 80730]]


ACTION: Notice.

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SUMMARY: Findings of research misconduct have been made against Sarah 
Elizabeth Martin (Respondent), who was formerly a Graduate Teaching 
Assistant, Department of Biological Sciences, Auburn University (AU). 
Respondent engaged in research misconduct in research included in a 
grant application submitted for U.S. Public Health Service (PHS) funds, 
specifically R21 AI159361-01 submitted to the National Institute of 
Allergy and Infectious Disease (NIAID), National Institutes of Health 
(NIH), and in research supported by NIAID, NIH, grant R21 AI159361-01. 
The administrative actions, including debarment for a period of three 
(3) years followed by supervision for a period of two (2) years, were 
implemented beginning on November 3, 2023, 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:
    Sarah Elizabeth Martin, Auburn University: Based on the report of 
an investigation conducted by AU and additional analysis conducted by 
ORI in its oversight review, ORI found that Sarah Elizabeth Martin, who 
was formerly a Graduate Teaching Assistant, Department of Biological 
Sciences, AU, engaged in research misconduct in research included in a 
grant application submitted for PHS funds, specifically R21 AI159361-01 
submitted to NIAID, NIH, and in research supported by NIAID, NIH, grant 
R21 AI159361-01.
    ORI found that Respondent engaged in research misconduct by 
intentionally or knowingly falsifying and/or fabricating experimental 
data and results obtained under different experimental conditions that 
were included in one (1) grant application, one (1) published paper, 
one (1) submitted manuscript, and six (6) presentations as follows:
     R21 AI159361-01, ``The interplay between m\6\A and viral 
lncRNA during KSHV replication,'' submitted to NIAID, NIH, on July 15, 
2020, Funded Period: March 4, 2021-February 28, 2023.
     The m\6\A landscape of polyadenylated nuclear (PAN) RNA 
and its related methylome in the context of KSHV replication. RNA. 2021 
Sep;27(9):1102-1125. doi: 10.1261/rna.078777.121 (hereafter referred to 
as ``RNA 2021''). Retraction in RNA. 2022 Feb;28(2):274. doi: 10.1261/
rna.079042.121.
     Determination of m\6\A frequency utilizing 4SedTTP-RT 
Ligation Assisted PCR (SLAP) in viral and cellular long non-coding 
RNAs. Manuscript submitted to RNA in 2021 (hereafter referred to as 
``RNA ms'').
     The dynamic status of N6-methyladenosine modifications of 
polyadenylated nuclear (PAN) RNA lncRNA and its methylome throughout 
KSHV replication. Presented at The RNA Institute Mini Symposium, 
Albany, NY, March 3, 2021 (hereafter referred to as ``RNA Mini 2021'').
     Elucidating the N6-Methyladenosine Landscape of Viral 
LncRNA in the Context of Kaposi's Sarcoma-Associated Herpesvirus 
Replication. Poster presented at the NIH/NCI 2021 RNA Biology 
Symposium, Frederick, MD, April 14, 2021 (hereafter referred to as 
``NCI Poster 2021'').
     The m\6\A epitranscriptomic landscape of polyadenylated 
nuclear (PAN) RNA.'' Presented at The KSHV 2021 Virtual Meeting, June 
21, 2021 (hereafter referred to as ``KSHV Virtual 2021'').
     The epitranscriptomic landscape of viral long non-coding 
RNA. Presented at the Noncoding RNA World: From Mechanism to Therapy, 
Virtual, July 21, 2021 (hereafter referred to as ``RNA World 2021'').
     The m\6\A landscape of polyadenylated nuclear RNA and its 
related methylome in the context of KSHV replication. Presented at the 
American Society for Virology Annual Meeting, Virtual, July 19, 2021 
(hereafter referred to as ``Virology Virtual 2021'').
     The Dynamics of N6-methladenosine Landscape of PAN RNA 
during the KSHV Replication. Presented at the 45th Annual International 
Herpesviruses Workshop, Virtual, August 2, 2021 (hereafter referred to 
as ``IHW Virtual 2021'').
    Additionally, data falsification and/or fabrication were identified 
in four (4) research records sequestered from Respondent's laboratory 
files, specifically:

 A_response.pptx
 B_response.pptx
 Response_B_clarified.pptx
 Intermediate.pptx
    Specifically, ORI finds that Respondent intentionally or knowingly 
falsified and/or fabricated:
     Native PAGE blots representing 4SedTTP-RT Ligation 
Assisted PCR (SLAP) analysis for m\6\A detection on PAN RNA and MALAT1 
RNA standards in Figure 2a and 2d, respectively, of RNA ms by 
relabeling and reusing the Native PAGE blot representing SLAP analysis 
for m\6\A detection limit on PAN RNA standard in Figure 3A of RNA 2021.
     calibration curve for detection of m\6\A modification at 
nt position 54 on PAN RNA by SLAP analysis in Figure 2b of RNA ms by 
relabeling and reusing the calibration curve for detection of m\6\A 
modification at nt position 63 on PAN RNA by SLAP analysis in Figure 3B 
of RNA 2021.
     Native PAGE blot representing SLAP analysis of PAN RNA at 
unmodified adenosine position 366nt in Figure 3a of RNA ms by 
relabeling the amplicon size from 103nt in Figure 3C of RNA 2021 to 
106nt in Figure 3a of RNA ms.
     Figure 3a and Figure 4a of RNA ms and Figure 3C of RNA 
2021 by relabeling and reusing the bands and Native PAGE blots to 
represent SLAP analysis at unmodified adenosine on RNA molecule, 
specifically:

--in Figure 3a of RNA ms and Figure 3C of RNA 2021, the same band is 
used in lanes 1 and 5, from the left, of 410nt sample Native PAGE blot 
to represent SLAP analysis of PAN RNA at unmodified adenosine position 
under different experimental conditions. Relabeling and reuse of the 
same band also occurred in lanes 3 and 7, from the left, of Figure 4a 
of RNA ms to represent SLAP analysis of MALAT1 RNA under different 
experimental conditions.
--Native PAGE blot representing SLAP analysis of PAN RNA at nt position 
410 in Figure 3a of RNA ms and Figure 3C of RNA 2021 is identical to 
lanes 3-9 portion of the Native PAGE blot representing SLAP analysis of 
MALAT1 RNA at nt position 2674 in Figure 4a of RNA ms.

     Native PAGE panels in Figure 3b of RNA ms by relabeling 
and reusing lanes 1, 4, 6 and 9 of 18nt panel in Figure 3C of RNA 2021 
representing amplicon sizes of 183nt for m\6\A and 106nt for A as lanes 
1-4, respectively, for 18nt Replicate 1 panel in Figure 3b of RNA ms 
representing amplification sizes 202nt for m6A and 160nt for A
     Native PAGE panels in Figure 3b of RNA ms by relabeling 
and reusing bands under different experimental conditions, 
specifically:

--Replicate 1 18nt 48 hpi +4SedTTP group ``202nt, m\6\A'' band is 
identical to Replicate 2 18nt 48 hpi +4SedTTP group ``202nt, m6A'' band
--Replicate 2 18nt 0 hpi -4SedTTP group ``160nt, A'' band is identical 
to

[[Page 80731]]

Replicate 2 203nt 0 hpi -4SedTTP group ``103nt, A'' band
--Replicate 2 203nt 0 hpi +4SedTTP group ``103nt, A'' band is identical 
to Replicate 2 1041nt 48 hpi +4SedTTP group ``75nt, m6A'' band

     Figure 4a of RNA ms by using identical bands in lanes 3 
and 7, from the left, of the Native PAGE blot representing two 
different experimental conditions
     Figure 4b of RNA ms by using identical bands to represent 
the m\6\A modifications on different samples, specifically:

--lanes presented for replicate 1 of nt position 2515 are identical to 
lanes for replicate 1 at nt position 2698
--lanes presented in 0-, 48- and 48+ samples in replicate 2 of nt 
position 2515 are identical to lanes for 0-, 48- and 48+ samples, 
respectively, in replicate 2 of nt position 2698
--lane for 0- sample in replicate 3 of nt position 2515 is identical to 
lane for 0- sample in replicate 3 of nt position 2698
--lane for 0- sample in replicate 1 of nt position 2515 is identical to 
lane for 48- sample in replicate 3 of nt position 2698
--lanes for 0+ sample in replicate 1 of nt position 2515, 48+ sample in 
replicate 3 of nt position 2515, and 0+ samples in replicate 1 of nt 
position 2698 are identical
--lanes for 48+ sample in replicate 1 of nt position 2515, 0+ sample in 
replicate 2 of nt position 2515, 48+ sample in replicate 1 of nt 
position 2698, and 0+ and 48+ samples in replicate 3 of nt position 
2698 are identical
--lanes for 0- sample in replicate 2 of nt position 2515, 48- sample in 
replicate 3 of nt position 2515, and 0- sample in replicate 2 of nt 
position 2698 are identical
--lanes for 48- sample in replicate 2 of nt position 2515, 0- sample in 
replicate 3 of nt position 2515, 48- sample in replicate 2 of nt 
position 2698, and 0- samples in replicate 3 of nt position 2698 are 
identical
--lane for 0+ sample in replicate 3 of nt position 2515 is identical to 
lane for 0+ sample in replicate 2 of nt position 2698

     two original gel images on slides 7-8 of A_response.pptx 
provided in support of nt position 2515 panels in Figure 4b of RNA ms
     two original gel images on slides 9-10 of A_response.pptx 
provided in support of nt position 2698 panels in Figure 4b of RNA ms
     Native PAGE panels in Figure 3C of RNA 2021 by relabeling 
and reusing bands under different experimental conditions, 
specifically:

--18nt 48-72 hpi +4SedTTP ``183nt m\6\A'' bands share a same source 
image with 203nt 48-72 hpi +4SedTTP ``61nt m\6\A'' bands, respectively
--672nt ``98nt A'' sample share a same source bands panel with 1048nt 
``95nt A'' sample, except for bands in two lanes corresponding to 8-24 
hpi -4SedTTP samples
--In 1041nt panel, ``101nt A'' 72 hpi -4SedTTP and 0 hpi +4SedTTP bands 
share a same source image with +4SedTTP 8 hpi and +4SedTTP 24 hpi 
bands, respectively

     Western blot panels for Total Lysate group in Figure 5A of 
R21 AI159361-01, Figure 4D in RNA 2021, Figure [B] on slide 2 in RNA 
Mini 2021, Figure 4D in NCI Poster 2021, Figure d on slide 10 in KSHV 
Virtual 2021, Figure d on slide 10 in RNA World 2021, and Figure 4D in 
IHW Virtual 2021, specifically:

--bands for METTL3 0hr, FTO 0hr, and HNRNPC 0hr share a same source 
image
--bands for METTL3 8hr, FTO 8hr and 72hr, HNRNPC 8hr, 48hr and 72hr, 
and [beta]-actin 72hr share a same source image
--24hr time point bands for METTL3, FTO, SND1, and HNRNPC share a same 
source image
--bands for METTL3 48hr, FTO 48hr, SND1 48hr, [beta]-actin 8hr and 48hr 
share a same source image
--bands for METTL3 72hr, SND1 72hr, and [beta]-actin 0 and 24hr share a 
same source image

     Western blot panels for PAN Proteins (FA) (also named as 
RAP-FA Crosslink) group in Figure 5A in R21 AI159361-01, Figure 4D in 
RNA 2021, Figure [B] on slide 2 in RNA Mini 2021, Figure 4D in NCI 
Poster 2021, Figure d on slide 10 in KSHV Virtual 2021, Figure d on 
slide 10 in RNA World 2021, and Figure 4D in IHW Virtual 2021, 
specifically:

--bands for 8-72hr time points in SND1 and FTO panels share a same 
source image
--0-24hr panel areas for HNRNPC and YTHDF2 share a same source image
--blank panel for METTL3 and [beta]-actin panels share a same source 
image

     original Western blot images provided in B_response.pptx 
to support the Western blot panels presented in Figure 4D in RNA 2021, 
Figure 5A in R21 AI159361-01, Figure [B] on slide 2 in RNA Mini 2021, 
Figure 4D in NCI Poster 2021, Figure d on slide 10 in KSHV Virtual 
2021, Figure d on slide 10 in RNA World 2021, and Figure 4D in IHW 
Virtual 2021, specifically:

--RMB15 Western blot images for bio reps 1 and 2 share a same source 
image, with areas pasted over to make the two images appear different 
from each other. RBM15 bands for Total Lysate and RAP-FA Crosslink 
sample groups have been pasted over the base image on both the gels. 
The Total Lysate group bands between the two gel images share a same 
source image.
--The two METTL3 Western blot images share a same source image, with 
areas pasted over to make the two images appear different from one 
another. METTL3 bands for the Total Lysate and empty areas 
corresponding to RAP-FA crosslink sample groups have been pasted over 
the base image. The Total Lysate group bands in two Western blot images 
share a same source image, although vertical positioning of T2 and T3 
with respect to T0 and T1 is changed to make the panels appear 
different from one another. T0 and T1 bands share same source image 
with T2 and T3 bands, respectively, on the two Western blot images.
--SND1 Western blot images for bio reps 1 and 2 share a same source 
image, with areas pasted over to make the two images appear different 
from one another. RAP-FA Crosslink T1-T4 bands share a same source 
image between the two gels. Bands are shifted vertically to give the 
impression that the two gels are different from each other. The Total 
Lysate T0-T3 main darker bands share a same source image between the 
two Western blot images. The bands are merged with background and 
additional band patterns to make the two images appear different from 
one another.
--HNRNPC Western blot images for bio reps 1 and 2 share a same source 
image, with areas pasted over to make the two images appear different 
from one another. The Total Lysate bands on the two images share the 
same source image. Further, Total Lysate T0 and T1 bands share same 
source image with T2 and T3 bands, respectively. The HNPNRC bio rep 2 
Western blot share a same source image with RMB15 bio rep 2 Western 
blot. In the HNPNRC bio rep 2 image, the 26 kDa bands have been pasted 
over to make the gel image appear different from the RMB15 bio rep 2 
image. Further, the same ladder image has been modified to appear 
different between the two gels.
--YTHDF2 Western blot images for all the three replicate gels share the 
same background image, with areas pasted over to make the three images 
appear different from one another. The Total

[[Page 80732]]

Lysate group bands on the Western blot 1 and 3 share a same source 
image. The Total Lysate bands on Western blot 2 share a same source 
image with METTL3 Total Lysate bio rep 1 (~53kDa) bands, HNRNPC Total 
Lysate bio rep 2 (26kDa) bands, and SND1 bio rep 2 RAP-FA crosslink 
(between 125 and 82 kDa) bands.
--FTO Western blot images for all the three replicate gels share the 
same background image, with areas pasted over to make the three images 
appear different from one another. On the FTO bio rep 3 Western blot 
image, RFA-FA Crosslink T3-T4 bands, Total Lysate T0-T1 bands, and 
Total Lysate T2-T3 band, respectively, are identical.
--[beta]-actin Western blot image for the two replicate gels share the 
same source image, with areas pasted over to make the blot images 
appear different from one another. On the second replicate blot image, 
the Total Lysate T0-T1 bands are identical to Total Lysate T2-T3 bands, 
respectively. The Total Lysate T0-T3 bands on [beta]-Actin Western blot 
replicate 2 image are identical to FTO Western blot replicate 3 Total 
Lysate T0-T3 bands, respectively.
--all the original unedited Western blot images for RMB15, METTL3, 
SND1, HNRNPC, YTHDF2, FTO and [beta]-actin share the same source 
background image that have been modified to appear different from one 
another

     Native PAGE data by relabeling and reusing several 
identical bands to represent m\6\A modifications at different nt 
positions on the PAN RNA samples in Figure 5E in RNA 2021, Figure [D] 
in RNA Mini 2021, Figure 5B in NCI Poster 2021, slide 12 in KSHV 
Virtual 2021, slide 6 in Virology Virtual 2021, slide 12 in RNA World 
2021, and Figure 5B in IHW Virtual 2021, specifically:

--band in lane 1 corresponding to 0 hpi -4Sed sample of RBM15 KD 18nt 
panel, after flipping horizontally, share a same source image with band 
in lane 1 of METTL3 KD 1041nt, RBM15KD 1041nt and FTO KD 18nt samples
--bands for 0 hpi -4Sed, 48 hpi -4Sed, 0 hpi +4Sed and 48 hpi +4Sed 
samples in RBM15 KD 1041nt, METTL3 KD 1041nt and FTO KD 18nt blots are 
identical
--RBM15 KD 18nt 0 hpi +4Sed and 48 hpi +4Sed bands are identical to 
METTL3 KD 1048nt 0 hpi -4Sed and 48 hpi -4Sed bands, respectively, and 
to horizontally flipped FTO KD 203nt 48 hpi -4Sed and 0 hpi +4Sed 
bands, respectively
--FTO KD 1041nt 0 hpi -4Sed and 48 hpi -4Sed bands share a same source 
image with RBM15 KD 203nt 0 hpi -4Sed and 48 hpi -4Sed bands, 
respectively
--RBM15 KD 1048nt 0 hpi -4Sed and 48 hpi -4Sed bands are identical to 
RMB15 0 hpi +4Sed and 48 hpi +4Sed bands, respectively, and to the copy 
pasted bands on the lanes 10-11 (from the left) and 5-6 (from the left) 
of gel images on slides 11 and 12 of the intermediate.pptx

     confocal micrographs by using identical images either with 
or without modifications to present PAN RNA colocalization experiments 
in Figure 7 of RNA 2021, slide 11 of KSHV Virtual 2021, slide 6 of 
Virology Virtual 2021, and slide 11 of RNA World 2021, specifically:

--Replicate 2 and Enlarged-2 of RBM15 at 72 hpi are identical to 
Replicate 2 and Enlarged-2 of METTL3 72 hpi, respectively
--Replicate 1 of RBM15 48 hpi is rotated 90 degrees clockwise to 
present Replicate 2 of RBM15 24 hpi
--RBM15 24 hpi Enlarged 2 image is a further zoomed area of RBM15 48 
hpi Enlarged 1 image

     confocal micrographs by using identical images to present 
PAN RNA colocalization experiments under different experimental 
conditions in Supplementary Figures 10a-b of RNA 2021, specifically:

--T3 panel representing staining for RBM15, DAPI, PAN and Combined 
samples in Supplementary Figure 10a is identical to T2 panel 
representing staining for METTL3, DAPI, PAN, and Combined samples, 
respectively. The same images also appear in 48 hpi panel in Figure 7A 
of RNA 2021, slide 11 of KSHV Virtual 2021, slide 6 of Virology Virtual 
2021, and slide 11 of RNA World 2021, representing staining for RBM15, 
DAPI, PAN and Combined samples, respectively
--T4 replicate 2 (Rep 2) in RMB15 staining composite in Supplementary 
Figure 10a is identical to T4 replicate 2 (Rep 2) in METTL3 staining 
composite in Supplementary Figure 10b. The same image appeared as RMB15 
T4(2) image in Figure 9B of R21 AI159361-01

     images of Native PAGE gel images in intermediate.pptx by 
adding transparency adjusted images of individual bands, empty areas, 
and/or ladders, to make the gel images appear different from the 
baseline images. Additionally:

--baseline gel image on slide 6 of intermediate.pptx was used to 
falsify and/or fabricate original gel-2 image for 2698nt sample on 
slides 9-10 of A-response.pptx
--baseline gel image on slide 7 of intermediate.pptx was used to 
falsify and/or fabricate one of the two original gel images on slide 7 
of A-response.pptx
--part of falsified and/or fabricated bands on slide 12 of 
intermediate.pptx were incorporated in RBM15 KD original bottom gel 
image on slide 15 of B-response.pptx

     original gel images and Western blot images in 
A_response.pptx, B_response.pptx and Response_B_clarified.pptx provided 
to the RNA journal, specifically:

--the right-side gel image for SLAP analysis at nt position 2698 on 
slide 9 of A-response.pptx is a fabricated and/or falsified gel image 
that shares an identical baseline image with the gel image on slide 1 
of intermediate.pptx
--bands in lanes 6-8 of the bottom METTL3 KD gel image on slide 14 of 
B_response.pptx and bands in lanes 9-7 of the bottom RBM15 KD gel image 
on slide 15 of B_response.pptx are, respectively, identical
--bands in lanes 9-11 of the bottom METTL3 KD gel image on slide 14 of 
B_response.pptx and bands in lanes 5-3 of the bottom RBM15 KD gel image 
on slide 15 of B_response.pptx are, respectively, identical
--bands in lanes 7-9 of the left-side FTO KD gel image on slide 13 of 
B_response.pptx and bands in lanes 9-7 of the bottom RBM15 KD gel image 
on slide 15 of B_response.pptx are, respectively, identical
--bands in lanes 10-13 of the left-side FTO KD gel image on slide 13 of 
B_response.pptx and bands in lanes 5-2 of the bottom RBM15 KD original 
gel image on slide 15 of B_response.pptx are, respectively, identical
--overall, one replicate gel for each of the three experimental groups 
(FTO KD, RBM15 KD, and METTL3 KD) provided as original unaltered image 
in support of Figure 5E of RNA 2021 share two panels containing a total 
of 7 bands from a same source image.

    Respondent entered into a Voluntary Exclusion Agreement (Agreement) 
and voluntarily agreed to the following:
    (1) Respondent will exclude herself voluntarily for a period of 
three (3) years, beginning on November 3, 2023 (the ``Exclusion 
Period''), from any contracting or subcontracting with any agency of 
the United States Government and from eligibility for or involvement in 
nonprocurement or procurement transactions referred to as ``covered 
transactions'' in 2 CFR parts 180 and 376 (collectively the ``Debarment

[[Page 80733]]

Regulations''). At the conclusion of the Exclusion Period, Respondent 
agrees to have her research supervised for a period of two (2) years 
(the ``Supervision Period''). During 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) During the Exclusion Period, Respondent will not apply for, 
permit her name to be used on an application for, receive, or be 
supported by funds of the United States Government and its agencies 
made available through contracts, subcontracts, or covered 
transactions.
    (3) During the Supervision Period, the requirements for 
Respondent's supervision plan are as follows:
    i. A committee of 2-3 senior faculty members at the institution 
including Respondent's supervisor or collaborators will provide 
oversight and guidance. 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.
    (4) During the Supervision Period, Respondent will ensure that any 
institution employing her 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 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 and not plagiarized 
in the application, report, manuscript, or abstract.
    (5) If no supervision plan is provided to ORI, Respondent will 
provide certification to ORI at the conclusion of the Supervision 
Period that her participation was not proposed on a research project 
for which an application for PHS support was submitted and that she has 
not participated in any capacity in PHS-supported research.
    (6) During the Exclusion and Supervision Periods, Respondent will 
exclude herself voluntarily from serving in any advisory or consultant 
capacity to PHS including, but not limited to, service on any PHS 
advisory committee, board, and/or peer review committee.

    Dated: November 15, 2023.
Sheila Garrity,
Director, Office of Research Integrity, Office of the Assistant 
Secretary for Health.
[FR Doc. 2023-25603 Filed 11-17-23; 8:45 am]
BILLING CODE 4150-31-P
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