Rules and Regulations. Notice

Agency: Office of the Secretary, HHS
Action: Notice
Citation: FR Doc. 2026-08675

Summary

Findings of research misconduct have been made against Ariel Fernandez, Ph.D. (also known as Ariel Fernandez Stigliano), former Karl F. Hasselmann Chaired Professor of Engineering, Department of Bioengineering, Rice University. Dr. Fernandez engaged in research misconduct under 42 CFR part 93 in research supported by U.S. Public Health Service (PHS) funds, specifically National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grant R01 GM072614. Administrative actions, including debarment for a period of fifteen (15) years, were implemented and are detailed below.

Supplementary Information

Notice is hereby given that the Office of Research Integrity (ORI) and the Suspension and Debarment Official (SDO) have taken final action in the following case: Ariel Fernandez, Ph.D., Rice University (Rice): Based on evidence and findings of an investigation conducted by Rice, ORI's oversight review of Rice's investigation, and additional evidence obtained and analysis conducted by ORI during its oversight review, ORI found that Dr. Ariel Fernandez (Respondent), former Karl F. Hasselmann Chaired Professor of Engineering, Department of Bioengineering, Rice, engaged in research misconduct under 42 CFR part 93 1 in research supported by PHS funds, specifically NIGMS, NIH, grant R01 GM072614. 1 In 2024, HHS revised 42 CFR part 93. 89 FR 76280 (Sept. 17, 2024). The revised Part 93 applies to allegations received on or after January 1, 2026. Id. at 76289. Thus, the version of Part 93 in effect prior to the revision applies to this research misconduct proceeding. That prior version of Part 93 was promulgated in 2005 and is available at 70 FR 28370 (May 17, 2005). Citations to Part 93 within this document refer to Part 93 as set forth in the 2005 Federal Register notice, which is available at https://www.federalregister.gov/documents/2005/05/17/05-9643/public-health-service-policies-on-research-misconduct. ORI found by a preponderance of the evidence that Respondent intentionally, knowingly, or recklessly fabricated and/or falsified the synthesis of six (6) novel chemical compounds; figures of Western blots and confocal microscopy images by copying, manipulating, and relabeling images; and the results of spectrophotometric kinetic assays, high-throughput kinase screening, cell proliferation assays, adsorption/desorption assays, and ATP production assays in twelve (12) PHS-supported papers, four (4) PHS-supported submitted, unpublished manuscripts, one (1) PHS-supported presentation, and three (3) PHS grant applications submitted for PHS funds. ORI found that these acts constitute a significant departure from accepted practices of the relevant research community. The affected published and unpublished papers, grant applications, and presentation are: • Structure 2005;13:1829-36. doi: 10.1016/j.str.2005.08.018 (hereafter referred to as “ Struct 05”). Notice of addendum and supporting information: Structure 2006;14:947. doi: 10.1016/j.str.2006.05.006 (“ Struct 05 Addendum”). • Proc. Natl. Acad. Sci. USA 2006;103:323-8. doi: 10.1073/pnas.0509351102 (hereafter referred to as “ PNAS 06”). Retraction in: Proc. Natl. Acad. Sci. USA 2006;103:4329. doi: 10.1073/pnas.0601034103. • J. Med. Chem. 2006;49:3092-100. doi: 10.1021/jm060163j (hereafter referred to as “ JMC 06”). • Biomol. Eng. 2006;23:307-15. doi: 10.1016/j.bioeng.2006.09.004 (hereafter referred to as “ BioE 06”). • Cancer Res. 2007;67:4028-33. doi: 10.1158/0008-5472.CAN-07-0345 (hereafter referred to as “CR07”). Correction in: Cancer Res. 2013;73:6375. doi: 10.1158/0008-5472.CAN-13-2601. • Front. Biosci. 2007;12:3617-27. doi: 10.2741/2338 (hereafter referred to as “ FBS 07”). • J. Phys. Chem. B 2007;111:13987-92. doi: 10.1021/jp074479u (hereafter referred to as “ JPCB 07”). • Mol. Pharm. 2008;5:430-7. doi: 10.1021/mp700148h (hereafter referred to as “ MP 08”). —Supporting information was made available online at the time MP 08 was published (hereafter referred to as “ MP 08 Original Supporting Information”). —In July 2008, MP 08 Original Supporting Information was replaced with revised supporting information (hereafter referred to as “ MP 08 Revised Supporting Information”). —A notice of the MP 08 Revised Supporting Information was published at Mol Pharm 2008;5:680. doi: 10.1021/mp8000777. In December 2009, an addendum to the MP 08 Revised Supporting Information was published (hereafter referred to as “ MP 08 Addendum to Supporting Information”). A notice of the addendum was published at Mol Pharm 2010;7:306. doi: 10.1021/mp9002893. An acknowledgement addendum was published in March 2010 at Mol Pharm 2010;7:1877. doi: 10.1021/mp100057w. • J. Med. Chem. 2008;51:4890-8. doi: 10.1021/jm800453a (hereafter referred to as “ JMC 08”). • ACS Nano 2008;2:61-8. doi: 10.1021/nn700239j (hereafter referred to as “ NANO 08”). Correction in: ACS Nano 2012;6:6525. doi: 10.1021/nn302352t. • Drug Discov. Today 2009;14:1-5. doi: 10.1016/j.drudis.2008.10.008 (hereafter referred to as “ DDT 09”). • Trends Pharmacol. Sci. 2009;30:403-10. doi: 10.1016/ j.tips.2009.06.001 (hereafter referred to as “ TiPS 09”). • Engineering drug selectivity through a packing-based kinase classifier. Original manuscript submitted to Journal of Molecular Biology in 2006 (hereafter referred to as “ JMB sub06”). • Editors of anticancer kinase inhibitors for side-effect removal. Original manuscript submitted to Cancer Research in 2009 (hereafter referred to as “ CR sub09”). • Editors of anticancer kinase inhibitors for side-effect removal. Original manuscript submitted to Nature Biotechnology in 2009 (hereafter referred to as “ NBT sub09”). • Selective antagonism of anticancer drugs for side-effect removal. Original manuscript submitted to Trends in Pharmacological Sciences in 2009 (hereafter referred to as “ TiPS sub09”). • Selectivity filter for drug discovery: Evolutionary insights into the control and personalization of drug specificity. PowerPoint presentation at the Morgridge Institute for Research (hereafter referred to as the “Morgridge PowerPoint”). • X02 RR023858-01, “Molecular theranostic engineering,” submitted to the National Center for Research Resources, NIH on April 14, 2006, unfunded. • R01 CA138431-01, “Kinome-wide atlas of specificity-promoting features for anticancer drug therapy,” submitted to the National Cancer Institute, NIH, on May 8, 2008, unfunded. • R01 LM010169-01, “Bioinformatics platform to control drug cross reactivity,” submitted to the National Library of Medicine, NIH, on December 18, 2008, unfunded. Specifically, ORI found by a preponderance of the evidence that Respondent engaged in research misconduct by intentionally, knowingly, or recklessly fabricating and/or falsifying: • the syntheses of six (6) novel chemical compounds reported in: MP 08, MP 08 Original Supporting Information, MP 08 Revised Supporting Information, MP 08 Addendum to Supporting Information (“Entropy Jolt”); NBT sub09, NBT sub09 supplementary materials (“ NBT sub09 Supp. Mat.”), CR sub09, CR sub09 supplementary materials (“ CR sub09 Supp. Mat.”), TiPS sub09, TiPS 09 (“SUDE”); Struct 05, Struct 05 Addendum, PNAS 06, JMB sub06 supporting materials (“ JMB sub06 Supp. Mat.”). (“Wrapper 1”); JMB sub06, JMB sub06 Supp. Mat., PNAS 06 (“Wrapper 2”); JMC 06, JMB sub06, JMB sub06 Supp. Mat., FBS 07, JMC 08, JMC 08 supporting information (“ JMC 08 Supp. Info.”) (“Compound 9”); and JMC 08, JMC 08 Supp. Info. (“Compound 10”) • figures of Western blots by copying previously published images and altering and/or relabeling those images in twenty-four (24) figures reported in three (3) manuscripts submitted by Respondent and two (2) figures reported in one (1) PowerPoint presentation by Respondent: Figures 2b, 2c, 2e, 2f, 2g, 3d, and 3f and Supplemental Figures 1, 2, and 3 in NBT sub09; Figures 3B, 3C, 4A, 4B, 4C, 5B, 5C, 6A, 6B, and 6D in CR sub09; Figures 4 and 5 in TiPS sub09; and the figures in Slides 15 and 31 of the Morgridge PowerPoint presentation • the results of spectrophotometric kinetic assays reported in Figure 5c of BioE 06, Figure 9 of FBS 07, Figure 6 of JMC 06, Figure 8 of MP 08, Figures 5E and 6B of PNAS 06, and Figure 4D of Struct 05; Figures 3d and 4c of unpublished manuscript JMB sub06; and Figures 6 and 9 of NIH grant application X02 RR023858-01 • the results of high-throughput kinase screening reported in: MP 08 (Figure 9 and associated text); JMC 08 (Figures 4 and 7 and associated text and tables); DDT 09 (text description), unpublished manuscript CR sub09 and CR sub09 Supp. Mat. (Figure S2 (A-C) and associated text); and two NIH grant applications R01 CA138431-01 and R01 LM010169-01 (Figure 8 and associated text in both applications) • results of cell proliferation and other experiments involving SUDE and WBZ_4, including Figure 3 reported in TiPS 09 • Figure 3b of NANO 08, Figure 2h of NBT sub09, and Supplemental Figure S3 of CR sub09 by copying and manipulating confocal microscopy images from other papers and relabeling them to report falsely different experiments • the results of adsorption/desorption assays reported in Figure 2b of NANO 08 and Figure 3 of JPCB 07 • the results of cell proliferation assays involving the compound SUDE reported in Figure 5a of CR sub09, Figure 3e of NBT sub09, and Figure 3 of TiPS sub09 • the results of ATP production assays involving the compound SUDE reported in Figure 5d (bottom graph) of CR sub09 and Figure 3g (bottom graph) of NBT sub09 • images of Western blots in Figure 10 of MP 08 and in Figure 4B of CR 07 ORI issued a charge letter enumerating the above findings of research misconduct and proposing HHS administrative actions of a fifteen-year ban on PHS advisory services and correction of Respondent's research record. Based on the information in the administrative record, and as part of the charge letter, the HHS SDO proposed a fifteen-year period of debarment under 2 CFR 180.800(d)—“Any other cause that is so serious or compelling in nature that it affects your present responsibility” to protect the Federal Government's interest. Respondent requested a hearing before an administrative law judge (ALJ) with the Departmental Appeals Board to contest the research misconduct findings and proposed administrative actions under 42 CFR part 93, including the proposed debarment. ORI filed a motion for summary judgment, which Respondent opposed, and Respondent filed a cross motion for summary judgment. On May 22, 2025, the ALJ issued a recommended decision to the Acting Assistant Secretary for Health (ASH) granting summary judgment in favor of HHS. The Acting ASH opted not to review the ALJ decision, and ORI's research misconduct findings therefore became final under 42 CFR 93.523. The decision constituted findings of fact to the HHS Debarring Official in accordance with 2 CFR 180.845(c). On March 25, 2026, the HHS SDO issued a final notice of debarment. Accordingly, the following administrative actions have been implemented: (1) For a period of fifteen (15) years, beginning on March 25, 2026, Respondent is debarred from participating in “covered transactions” as defined in 2 CFR 180.200 and procurement transactions covered under the Federal Acquisition Regulation (48 CFR chapter 1). (2) For a period of fifteen (15) years, beginning on June 22, 2025, Respondent is prohibited from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant. (3) ORI will send a notice to the pertinent journals of the following eleven (11) papers that require retraction and/or correction, in accordance with 42 CFR 93.407(a)(1) and 93.411(b): • Structure 2005;13:1829-36 • J. Med. Chem. 2006;49:3092-100 • Biomol. Eng. 2006;23:307-15 • Cancer Res. 2007;67:4028-33 • Front. Biosci. 2007;12:3617-27 • J. Phys. Chem. B 2007;111:13987-92 • Mol. Pharm. 2008;5:430-7 • J. Med. Chem. 2008;51:4890-8 • ACS Nano 2008;2:61-8 • Drug Discov. Today 2009;14:1-5 • Trends Pharmacol. Sci. 2009;30:403-10 Dated: April 30, 2026. Sheila R. Garrity, Director, Office of Research Integrity, Office of the Assistant Secretary for Health. [FR Doc. 2026-08675 Filed 5-4-26; 8:45 am]