Findings of Research Misconduct, 69230-69231 [2015-28437]

Download as PDF 69230 Federal Register / Vol. 80, No. 216 / Monday, November 9, 2015 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Dated: November 3, 2015. James Macrae, Acting Administrator. [FR Doc. 2015–28436 Filed 11–6–15; 8:45 am] BILLING CODE 4165–15–P srobinson on DSK5SPTVN1PROD with NOTICES National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy The Health Resources and Services Administration (HRSA) is publishing an updated monetary amount of the average cost of a health insurance policy as it relates to the National Vaccine Injury Compensation Program (VICP). 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In 2015, MEPS–IC, available at www.meps.ahrq.gov, published the annual 2014 average total single premium amount per enrolled employee at private-sector establishments that provide health insurance. The figure published was $5,832. This figure is divided by 12-months to determine the cost per month of $486.00. The $486.00 shall be increased or decreased by the percentage change reported by the most recent KFF/HRET, available at www.kff.org. The percentage increase from 2014 to 2015 was published at 4 percent. By adding this percentage increase, the calculated average monthly cost of a health insurance policy in 2015 is $505.44. Therefore, the Secretary of Health and Human Services announces that the revised average cost of a health insurance policy under the VICP is $505.44 per month. In accordance with § 100.2, the revised amount was effective upon its delivery by the Secretary to the Court. Such notice was delivered to the Court on October 23, 2015. VerDate Sep<11>2014 19:52 Nov 06, 2015 Jkt 238001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct Office of the Secretary, HHS. Notice. AGENCY: ACTION: Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Anil Potti, M.D., Duke University School of Medicine: Based on the reports of investigations conducted by Duke University School of Medicine (Duke) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Anil Potti, former Associate Professor of Medicine, Duke, engaged in research misconduct in research supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grant R01 HL072208 and National Cancer Institute (NCI), NIH, grants R01 CA136530, R01 CA131049, K12 CA100639, R01 CA106520, and U54 CA112952. ORI found that Respondent engaged in research misconduct by including false research data in the following published papers, submitted manuscript, grant application, and the research record as specified in 1–3 below. Specifically, ORI found that: 1. Respondent stated in grant application 1 R01 CA136530–01A1 that 6 out of 33 patients responded positively to dasatinib when only 4 patients were enrolled and none responded and that the 4 CT scans presented in Figure 14 were from the lung cancer study when they were not. 2. Respondent altered data sets to improve the accuracy of predictors for response to treatments in a submitted paper and in the research record by: • Reversing the responder status of 24 out of 133 subjects for the adriamycin predictor in a manuscript submitted to Clinical Cancer Research • switching the cancer recurrence phenotype for 46 out of 89 samples to validate the LMS predictor in a file provided to a colleague in 2008 • changing IC–50 and R-code values for the cisplatin predictor in a data set provided to NCI in 2010 3. Respondent reported predictors and/or their validation by disregarding SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 accepted scientific methodology so that false data were reported in the following: • Blood 107:1391–1396, 2006: Describing a predictor for thrombotic phenotypes • New England Journal of Medicine 355:570–580, 2006: Describing a predictor of lung cancer relapse • Nature Medicine 12:1294–1300, 2006: Describing a predictor for the response to the chemotherapeutic drugs topectan and docetaxol • Journal of Clinical Oncology 25:4350–4357, 2007: Describing a predictor for the response to the chemotherapeutic drug cisplatin • Lancet Oncology 8:1071–1078, 2007: Describing a predictor for the response to the combination of the chemotherapeutic drugs flurouracil, epirubicin, and cyclophosphamide or docetaxol, epirubicin, and docetaxol • Journal of the American Medical Association 299:1574–1587, 2008: Describing a predictor for breast cancer relapse • Public Library Science One 3:e1908, 2008: Describing a predictor for the response to the chemotherapeutic drugs paclitaxel, 5-fluouracil, adriamycin, and cyclophosphamide • Proceedings of the National Academy of Sciences 105:19432–19437, 2008: Describing a predictor of colon cancer recurrence • Clinical Cancer Research 15:7553– 7561, 2009: Describing a predictor for the response to the chemotherapeutic drug cisplatin As a result of Duke’s investigation, the published papers listed above were retracted. Respondent has entered into a Voluntary Settlement Agreement with ORI. Respondent neither admits nor denies ORI’s findings of research misconduct; the settlement is not an admission of liability on the part of the Respondent. The parties entered into the Agreement to conclude this matter without further expenditure of time, finances, or other resources. Respondent has not applied for or engaged in U.S. Public Health Service (PHS)-supported research since 2010. Respondent stated that he has no intention of applying for or engaging in PHS-supported research or otherwise working with PHS. However, the Respondent voluntarily agreed: (1) That if the respondent obtains employment in a research position in which he receives or applies for PHS support within five years of the effective date of the Agreement (September 23, 2015), he shall have his research supervised for a period of five years; E:\FR\FM\09NON1.SGM 09NON1 Federal Register / Vol. 80, No. 216 / Monday, November 9, 2015 / Notices (2) that prior to the submission of an application for PHS support for a research project on which the Respondent’s participation is proposed and prior to Respondent’s participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of Respondent’s duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent’s research contribution; Respondent agreed that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan; (3) that any institution employing him shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHSsupported 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 in the application, report, manuscript, or abstract; and (4) to exclude himself voluntarily 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 period of five years beginning on September 23, 2015. FOR FURTHER INFORMATION CONTACT: Acting Director, Division of Investigative Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453–8200. Applicability Date: The correction notice is applicable for the Findings of Research Misconduct notice published on October 29, 2015. FOR FURTHER INFORMATION CONTACT: Ms. Karen Gorirossi at 240–453–8800. SUPPLEMENTARY INFORMATION: I. Background In FR Doc. 2015–27587 of October 29, 2015 (80 FR 66546), there was a sentence inadvertently omitted from the text of the notice. The error is identified and corrected in the Correction of Errors section below. II. Correction of Errors In FR Doc. 2015–27587 of October 29, 2015 (80 FR 66546), make the following correction: 1. On page 66546, second column, in FR Doc. 2015–27587, last paragraph, line 13, after ‘‘otherwise working with PHS,’’ add ‘‘Respondent neither admits nor denies ORI’s findings of research misconduct; the settlement is not an admission of liability on the part of the Respondent’’ so that the corrected section of the last paragraph in the second column reads: ‘‘Respondent stated that she is not currently involved in U.S. Public Health Service (PHS)-supported research and has no intention of applying for or engaging in PHS-supported research or otherwise working with PHS. Respondent neither admits nor denies ORI’s findings of research misconduct; the settlement is not an admission of liability on the part of the Respondent.’’ Dated: October 30, 2015. Donald Wright, Acting Director, Office of Research Integrity. [FR Doc. 2015–28440 Filed 11–6–15; 8:45 am] BILLING CODE 4150–31–P Donald Wright, Acting Director, Office of Research Integrity. [FR Doc. 2015–28437 Filed 11–6–15; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct; Correction Office of the Secretary, HHS. Correction of notice. srobinson on DSK5SPTVN1PROD with NOTICES AGENCY: ACTION: This document corrects an error that appeared in the notice published in the October 29, 2015, Federal Register entitled ‘‘Findings of Research Misconduct.’’ DATES: Effective Date: November 9, 2015. SUMMARY: VerDate Sep<11>2014 19:52 Nov 06, 2015 Jkt 238001 National Institute of Mental Health; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings 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 PO 00000 Frm 00044 Fmt 4703 Sfmt 9990 69231 applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Mental Health Special Emphasis Panel; Global Mental Health (U19). Date: November 16, 2015. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hotel Monaco, 700 F Street NW., Washington, DC 20001. Contact Person: Karen Gavin-Evans, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Boulevard, Room 6153, MSC 9606, Bethesda, MD 20892, 301–451–2356, gavinevanskm@mail.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: National Institute of Mental Health Special Emphasis Panel; Research Education Programs (R25) for HIV/ AIDS Research. Date: November 20, 2015. Time: 11:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Aileen Schulte, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6140, MSC 9608, Bethesda, MD 20892–9608, 301–443–1225, aschulte@mail.nih.gov. Name of Committee: National Institute of Mental Health Special Emphasis Panel; Mental Health Services Conflicts. Date: November 23, 2015. Time: 1:00 p.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Karen Gavin-Evans, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Boulevard, Room 6153, MSC 9606, Bethesda, MD 20892, 301–451–2356, gavinevanskm@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program No. 93.242, Mental Health Research Grants, National Institutes of Health, HHS) Dated: November 3, 2015. Carolyn A. Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–28385 Filed 11–6–15; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\09NON1.SGM 09NON1

Agencies

[Federal Register Volume 80, Number 216 (Monday, November 9, 2015)]
[Notices]
[Pages 69230-69231]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28437]


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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.

-----------------------------------------------------------------------

SUMMARY: Notice is hereby given that the Office of Research Integrity 
(ORI) has taken final action in the following case:
    Anil Potti, M.D., Duke University School of Medicine: Based on the 
reports of investigations conducted by Duke University School of 
Medicine (Duke) and additional analysis conducted by ORI in its 
oversight review, ORI found that Dr. Anil Potti, former Associate 
Professor of Medicine, Duke, engaged in research misconduct in research 
supported by National Heart, Lung, and Blood Institute (NHLBI), 
National Institutes of Health (NIH), grant R01 HL072208 and National 
Cancer Institute (NCI), NIH, grants R01 CA136530, R01 CA131049, K12 
CA100639, R01 CA106520, and U54 CA112952.
    ORI found that Respondent engaged in research misconduct by 
including false research data in the following published papers, 
submitted manuscript, grant application, and the research record as 
specified in 1-3 below. Specifically, ORI found that:
    1. Respondent stated in grant application 1 R01 CA136530-01A1 that 
6 out of 33 patients responded positively to dasatinib when only 4 
patients were enrolled and none responded and that the 4 CT scans 
presented in Figure 14 were from the lung cancer study when they were 
not.
    2. Respondent altered data sets to improve the accuracy of 
predictors for response to treatments in a submitted paper and in the 
research record by:
     Reversing the responder status of 24 out of 133 subjects 
for the adriamycin predictor in a manuscript submitted to Clinical 
Cancer Research
     switching the cancer recurrence phenotype for 46 out of 89 
samples to validate the LMS predictor in a file provided to a colleague 
in 2008
     changing IC-50 and R-code values for the cisplatin 
predictor in a data set provided to NCI in 2010
    3. Respondent reported predictors and/or their validation by 
disregarding accepted scientific methodology so that false data were 
reported in the following:
     Blood 107:1391-1396, 2006: Describing a predictor for 
thrombotic phenotypes
     New England Journal of Medicine 355:570-580, 2006: 
Describing a predictor of lung cancer relapse
     Nature Medicine 12:1294-1300, 2006: Describing a predictor 
for the response to the chemotherapeutic drugs topectan and docetaxol
     Journal of Clinical Oncology 25:4350-4357, 2007: 
Describing a predictor for the response to the chemotherapeutic drug 
cisplatin
     Lancet Oncology 8:1071-1078, 2007: Describing a predictor 
for the response to the combination of the chemotherapeutic drugs 
flurouracil, epirubicin, and cyclophosphamide or docetaxol, epirubicin, 
and docetaxol
     Journal of the American Medical Association 299:1574-1587, 
2008: Describing a predictor for breast cancer relapse
     Public Library Science One 3:e1908, 2008: Describing a 
predictor for the response to the chemotherapeutic drugs paclitaxel, 5-
fluouracil, adriamycin, and cyclophosphamide
     Proceedings of the National Academy of Sciences 105:19432-
19437, 2008: Describing a predictor of colon cancer recurrence
     Clinical Cancer Research 15:7553-7561, 2009: Describing a 
predictor for the response to the chemotherapeutic drug cisplatin
    As a result of Duke's investigation, the published papers listed 
above were retracted.
    Respondent has entered into a Voluntary Settlement Agreement with 
ORI. Respondent neither admits nor denies ORI's findings of research 
misconduct; the settlement is not an admission of liability on the part 
of the Respondent. The parties entered into the Agreement to conclude 
this matter without further expenditure of time, finances, or other 
resources. Respondent has not applied for or engaged in U.S. Public 
Health Service (PHS)-supported research since 2010. Respondent stated 
that he has no intention of applying for or engaging in PHS-supported 
research or otherwise working with PHS. However, the Respondent 
voluntarily agreed:
    (1) That if the respondent obtains employment in a research 
position in which he receives or applies for PHS support within five 
years of the effective date of the Agreement (September 23, 2015), he 
shall have his research supervised for a period of five years;

[[Page 69231]]

    (2) that prior to the submission of an application for PHS support 
for a research project on which the Respondent's participation is 
proposed and prior to Respondent's participation in any capacity on 
PHS-supported research, Respondent shall ensure that a plan for 
supervision of Respondent's duties is submitted to ORI for approval; 
the supervision plan must be designed to ensure the scientific 
integrity of Respondent's research contribution; Respondent agreed that 
he shall not participate in any PHS-supported research until such a 
supervision plan is submitted to and approved by ORI; Respondent agreed 
to maintain responsibility for compliance with the agreed upon 
supervision plan;
    (3) that any institution employing him shall submit, 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 in the 
application, report, manuscript, or abstract; and
    (4) to exclude himself voluntarily 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 period of five years beginning on September 23, 2015.

FOR FURTHER INFORMATION CONTACT: Acting Director, Division of 
Investigative Oversight, Office of Research Integrity, 1101 Wootton 
Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200.

Donald Wright,
Acting Director, Office of Research Integrity.
[FR Doc. 2015-28437 Filed 11-6-15; 8:45 am]
BILLING CODE 4150-31-P

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