SUPPLEMENTARY INFORMATION:

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case:

Daniel Andrade, Ph.D., University of Oklahoma Health Science Center (OUHSC): Based on evidence obtained during a research misconduct investigation conducted by OUHSC and ORI's oversight review of OUHSC's investigation, ORI found that Daniel Andrade, Ph.D. (Respondent), former Assistant Professor of Research, Department of Obstetrics and Gynecology and Stephenson Cancer Center, OUHSC, engaged in research misconduct under 42 CFR part 93 in research included in two (2) grant applications submitted for PHS funds, specifically DP2 OD030789-01 submitted to OD, NIH, and R21 CA253956-01 submitted to NCI, NIH.

ORI found by a preponderance of the evidence that Respondent intentionally and knowingly falsified and/or fabricated data included in two (2) 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 grant applications are:

• DP2 OD030789-01, “Exosomes as Liquid Biopsies: Biomarkers for Tumor Heterogeneity and Subclonal Evolution,” submitted to OD, NIH, on August 20, 2020
• R21 CA253956-01, “miRNA signatures that predict chemoradiation response and resistance in cervical cancer using patient-derived organoids and their exosomes,” submitted to the NCI, NIH, on November 18, 2019

Specifically, ORI found by a preponderance of the evidence that Respondent engaged in research misconduct by intentionally and knowingly falsifying and/or fabricating:

• Exosome Nanoparticle Tracking Analysis (NTA) data by relabeling data obtained from a cell line as data derived from cancer Patient-Derived Organoids (PDOs) and reporting the falsely relabeled NTA graph to the Principal Investigator (PI), who included it in Figure 2D of grant application DP2 OD030789-01.
• Western blot data by splicing together blot image panels from separate unrelated experiments on different cell lines to depict a composite image of western blot data derived from exosomes of cancer PDOs and reporting the western blot composite image to the PI, who included it in Figure 2E of grant application DP2 OD030789-01.
• Transmission Electron Micrograph (TEM) image data in Figure 3B of his grant application R21 CA253956-01 by falsely reporting that the TEM image was obtained from patient serum when the image was from another source.

On December 8, 2024, based on the information in the administrative record, ORI proposed a three-year period of supervision under 42 CFR § 93.407(a)(7) and a three-year period of prohibition from PHS advisory service under 42 CFR 93.407(a)(9). HHS provided Respondent the opportunity to contest the proposed administrative actions under 42 CFR part 93 by requesting a hearing before an administrative law judge with the HHS Departmental Appeals Board. Respondent did not contest within the prescribed 30-day notice period. Accordingly, the following administrative actions have been implemented:

• Respondent will have his PHS-supported research activities supervised for a period of three (3) years beginning on January 11, 2026 (the “Supervision Period”). During the Supervision Period, prior to his participation in any capacity in PHS-supported research activities, he must submit a plan for supervision of his duties to ORI for approval. He may only participate in PHS-supported research activities if a supervision plan is approved by ORI and he complies with the approved plan. The requirements for Respondent's supervision plan are as follows:

— Committee oversight. The supervision plan must designate a committee of at least two senior researchers at the institution employing Respondent who are familiar with his field of research and are not his supervisor or collaborators to oversee his PHS-supported research activities during the Supervision Period.

Review of primary data. The supervision plan must provide for the committee to review primary data generated by or for Respondent through PHS-supported research activities on a quarterly basis.

Advance reviews. The supervision plan must provide for the committee to conduct advance reviews of any reporting of PHS-supported research activities in which Respondent is or was involved, including reporting in manuscripts, abstracts, progress reports, or applications or proposals for PHS funding, to ensure his contributions are supported by the primary data. The advance reviews must include discussion with Respondent.

Reporting to ORI. The supervision plan must include a requirement for the committee to submit a report to ORI at 6-month intervals. The report must identify any primary data reviewed, the date of review, and the results of the review. The report also must summarize any advance reviews conducted by the committee. Additionally, the report must verify that Respondent is complying with accepted research practices.

• During the Supervision Period, Respondent must ensure that any institution employing him submits, in conjunction with each application for PHS funds, or each report, manuscript, or abstract involving PHS-supported research activities in which Respondent was involved, a certification to ORI and the funding agency that the data provided by Respondent are based on actual experiments and legitimately derived, and that the data, procedures, and methodology are accurately reported.
• If Respondent does not have a supervision plan approved by ORI during the Supervision Period, Respondent must submit a written statement to ORI at the conclusion of the Supervision Period certifying that he has not participated in PHS-supported research activities during the Supervision Period.
• 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 for a period of three (3) years, beginning on January 11, 2026.

91 FR 5774