80 FR 69230 - Findings of Research Misconduct
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 80, Issue 216 (November 9, 2015)
Office of the Secretary
Federal Register Volume 80, Issue 216 (November 9, 2015)
| Page Range | 69230-69231 | |
| FR Document | 2015-28437 |
[Federal Register Volume 80, Number 216 (Monday, November 9, 2015)] [Notices] [Pages 69230-69231] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-28437] ----------------------------------------------------------------------- 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
![69230 Federal Register / Vol. 80, No. 216 / Monday, November 9, 2015 / Notices
DEPARTMENT OF HEALTH AND Dated: November 3, 2015. accepted scientific methodology so that
HUMAN SERVICES James Macrae, false data were reported in the
Acting Administrator. following:
Health Resources and Services [FR Doc. 2015–28436 Filed 11–6–15; 8:45 am] • Blood 107:1391–1396, 2006:
Administration BILLING CODE 4165–15–P Describing a predictor for thrombotic
phenotypes
National Vaccine Injury Compensation • New England Journal of Medicine
Program: Revised Amount of the DEPARTMENT OF HEALTH AND 355:570–580, 2006: Describing a
Average Cost of a Health Insurance HUMAN SERVICES predictor of lung cancer relapse
Policy • Nature Medicine 12:1294–1300,
The Health Resources and Services Office of the Secretary 2006: Describing a predictor for the
Administration (HRSA) is publishing an response to the chemotherapeutic drugs
Findings of Research Misconduct
updated monetary amount of the topectan and docetaxol
average cost of a health insurance policy AGENCY: Office of the Secretary, HHS. • Journal of Clinical Oncology
as it relates to the National Vaccine ACTION: Notice. 25:4350–4357, 2007: Describing a
Injury Compensation Program (VICP). predictor for the response to the
Section 100.2 of the VICP’s SUMMARY: Notice is hereby given that chemotherapeutic drug cisplatin
implementing regulation (42 CFR part the Office of Research Integrity (ORI) • Lancet Oncology 8:1071–1078,
100) states that the revised amount of has taken final action in the following 2007: Describing a predictor for the
the average cost of a health insurance case: response to the combination of the
Anil Potti, M.D., Duke University chemotherapeutic drugs flurouracil,
policy, as determined by the Secretary
School of Medicine: Based on the epirubicin, and cyclophosphamide or
of Health and Human Services, is
reports of investigations conducted by docetaxol, epirubicin, and docetaxol
effective upon its delivery to the United
Duke University School of Medicine • Journal of the American Medical
States Court of Federal Claims (the
(Duke) and additional analysis Association 299:1574–1587, 2008:
Court), and will be published
conducted by ORI in its oversight Describing a predictor for breast cancer
periodically in a notice in the Federal
review, ORI found that Dr. Anil Potti, relapse
Register. This figure is calculated using
former Associate Professor of Medicine, • Public Library Science One 3:e1908,
the most recent Medical Expenditure
Duke, engaged in research misconduct 2008: Describing a predictor for the
Panel Survey-Insurance Component
in research supported by National Heart, response to the chemotherapeutic drugs
(MEPS–IC) data available as the baseline
Lung, and Blood Institute (NHLBI), paclitaxel, 5-fluouracil, adriamycin, and
for the average monthly cost of a health
National Institutes of Health (NIH), cyclophosphamide
insurance policy. This baseline is
grant R01 HL072208 and National • Proceedings of the National
adjusted by the annual percentage
Cancer Institute (NCI), NIH, grants R01 Academy of Sciences 105:19432–19437,
increase/decrease obtained from the
CA136530, R01 CA131049, K12 2008: Describing a predictor of colon
most recent annual Kaiser Family
CA100639, R01 CA106520, and U54 cancer recurrence
Foundation and Health Research and
CA112952. • Clinical Cancer Research 15:7553–
Educational Trust (KFF/HRET) ORI found that Respondent engaged
Employer Health Benefits survey or 7561, 2009: Describing a predictor for
in research misconduct by including
other authoritative source that may be the response to the chemotherapeutic
false research data in the following
more accurate or appropriate. drug cisplatin
published papers, submitted
In 2015, MEPS–IC, available at As a result of Duke’s investigation, the
manuscript, grant application, and the
www.meps.ahrq.gov, published the published papers listed above were
research record as specified in 1–3
annual 2014 average total single retracted.
below. Specifically, ORI found that:
premium amount per enrolled employee 1. Respondent stated in grant Respondent has entered into a
at private-sector establishments that application 1 R01 CA136530–01A1 that Voluntary Settlement Agreement with
provide health insurance. The figure 6 out of 33 patients responded ORI. Respondent neither admits nor
published was $5,832. This figure is positively to dasatinib when only 4 denies ORI’s findings of research
divided by 12-months to determine the patients were enrolled and none misconduct; the settlement is not an
cost per month of $486.00. The $486.00 responded and that the 4 CT scans admission of liability on the part of the
shall be increased or decreased by the presented in Figure 14 were from the Respondent. The parties entered into
percentage change reported by the most lung cancer study when they were not. the Agreement to conclude this matter
recent KFF/HRET, available at 2. Respondent altered data sets to without further expenditure of time,
www.kff.org. The percentage increase improve the accuracy of predictors for finances, or other resources. Respondent
from 2014 to 2015 was published at 4 response to treatments in a submitted has not applied for or engaged in U.S.
percent. By adding this percentage paper and in the research record by: Public Health Service (PHS)-supported
increase, the calculated average monthly • Reversing the responder status of 24 research since 2010. Respondent stated
cost of a health insurance policy in 2015 out of 133 subjects for the adriamycin that he has no intention of applying for
is $505.44. predictor in a manuscript submitted to or engaging in PHS-supported research
Therefore, the Secretary of Health and Clinical Cancer Research or otherwise working with PHS.
Human Services announces that the • switching the cancer recurrence However, the Respondent voluntarily
revised average cost of a health agreed:
srobinson on DSK5SPTVN1PROD with NOTICES
phenotype for 46 out of 89 samples to
insurance policy under the VICP is validate the LMS predictor in a file (1) That if the respondent obtains
$505.44 per month. In accordance with provided to a colleague in 2008 employment in a research position in
§ 100.2, the revised amount was • changing IC–50 and R-code values which he receives or applies for PHS
effective upon its delivery by the for the cisplatin predictor in a data set support within five years of the effective
Secretary to the Court. Such notice was provided to NCI in 2010 date of the Agreement (September 23,
delivered to the Court on October 23, 3. Respondent reported predictors 2015), he shall have his research
2015. and/or their validation by disregarding supervised for a period of five years;
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![Federal Register / Vol. 80, No. 216 / Monday, November 9, 2015 / Notices 69231
(2) that prior to the submission of an Applicability Date: The correction applications, the disclosure of which
application for PHS support for a notice is applicable for the Findings of would constitute a clearly unwarranted
research project on which the Research Misconduct notice published invasion of personal privacy.
Respondent’s participation is proposed on October 29, 2015. Name of Committee: National Institute of
and prior to Respondent’s participation FOR FURTHER INFORMATION CONTACT: Ms. Mental Health Special Emphasis Panel;
in any capacity on PHS-supported Karen Gorirossi at 240–453–8800. Global Mental Health (U19).
research, Respondent shall ensure that a SUPPLEMENTARY INFORMATION: Date: November 16, 2015.
plan for supervision of Respondent’s Time: 8:00 a.m. to 5:00 p.m.
duties is submitted to ORI for approval; I. Background Agenda: To review and evaluate grant
the supervision plan must be designed In FR Doc. 2015–27587 of October 29, applications.
to ensure the scientific integrity of 2015 (80 FR 66546), there was a Place: Hotel Monaco, 700 F Street NW.,
Respondent’s research contribution; sentence inadvertently omitted from the Washington, DC 20001.
Respondent agreed that he shall not text of the notice. The error is identified Contact Person: Karen Gavin-Evans, Ph.D.,
participate in any PHS-supported and corrected in the Correction of Errors Scientific Review Officer, Division of
research until such a supervision plan is section below. Extramural Activities, National Institute of
submitted to and approved by ORI; Mental Health, NIH, Neuroscience Center,
Respondent agreed to maintain II. Correction of Errors 6001 Executive Boulevard, Room 6153, MSC
responsibility for compliance with the In FR Doc. 2015–27587 of October 29, 9606, Bethesda, MD 20892, 301–451–2356,
agreed upon supervision plan; 2015 (80 FR 66546), make the following gavinevanskm@mail.nih.gov.
(3) that any institution employing him correction: This notice is being published less than 15
shall submit, in conjunction with each 1. On page 66546, second column, in days prior to the meeting due to the timing
application for PHS funds, or report, FR Doc. 2015–27587, last paragraph, limitations imposed by the review and
manuscript, or abstract involving PHS- line 13, after ‘‘otherwise working with funding cycle.
supported research in which PHS,’’ add ‘‘Respondent neither admits Name of Committee: National Institute of
Respondent is involved, a certification nor denies ORI’s findings of research Mental Health Special Emphasis Panel;
to ORI that the data provided by misconduct; the settlement is not an Research Education Programs (R25) for HIV/
Respondent are based on actual admission of liability on the part of the AIDS Research.
experiments or are otherwise Respondent’’ so that the corrected Date: November 20, 2015.
legitimately derived and that the data, section of the last paragraph in the Time: 11:00 a.m. to 2:00 p.m.
procedures, and methodology are second column reads: Agenda: To review and evaluate grant
accurately reported in the application, ‘‘Respondent stated that she is not applications.
report, manuscript, or abstract; and currently involved in U.S. Public Health Place: National Institutes of Health,
(4) to exclude himself voluntarily Service (PHS)-supported research and Neuroscience Center, 6001 Executive
from serving in any advisory capacity to has no intention of applying for or Boulevard, Rockville, MD 20852, (Telephone
PHS including, but not limited to, engaging in PHS-supported research or Conference Call).
service on any PHS advisory committee, otherwise working with PHS. Contact Person: Aileen Schulte, Ph.D.,
board, and/or peer review committee, or Respondent neither admits nor denies Scientific Review Officer, Division of
as a consultant for period of five years ORI’s findings of research misconduct; Extramural Activities, National Institute of
beginning on September 23, 2015. Mental Health, NIH, Neuroscience Center,
the settlement is not an admission of
6001 Executive Blvd., Room 6140, MSC 9608,
FOR FURTHER INFORMATION CONTACT: liability on the part of the Respondent.’’
Bethesda, MD 20892–9608, 301–443–1225,
Acting Director, Division of Dated: October 30, 2015. aschulte@mail.nih.gov.
Investigative Oversight, Office of Donald Wright, Name of Committee: National Institute of
Research Integrity, 1101 Wootton
Acting Director, Office of Research Integrity. Mental Health Special Emphasis Panel;
Parkway, Suite 750, Rockville, MD Mental Health Services Conflicts.
[FR Doc. 2015–28440 Filed 11–6–15; 8:45 am]
20852, (240) 453–8200. Date: November 23, 2015.
BILLING CODE 4150–31–P
Donald Wright, Time: 1:00 p.m. to 2:30 p.m.
Acting Director, Office of Research Integrity. Agenda: To review and evaluate grant
DEPARTMENT OF HEALTH AND applications.
[FR Doc. 2015–28437 Filed 11–6–15; 8:45 am]
HUMAN SERVICES Place: National Institutes of Health,
BILLING CODE 4150–31–P
Neuroscience Center, 6001 Executive
National Institutes of Health Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
DEPARTMENT OF HEALTH AND Contact Person: Karen Gavin-Evans, Ph.D.,
National Institute of Mental Health;
HUMAN SERVICES Scientific Review Officer, Division of
Notice of Closed Meetings
Extramural Activities, National Institute of
Office of the Secretary Pursuant to section 10(d) of the Mental Health, NIH, Neuroscience Center,
Federal Advisory Committee Act, as 6001 Executive Boulevard, Room 6153, MSC
Findings of Research Misconduct;
amended (5 U.S.C. App.), notice is 9606, Bethesda, MD 20892, 301–451–2356,
Correction
hereby given of the following meetings. gavinevanskm@mail.nih.gov.
AGENCY: Office of the Secretary, HHS. The meetings will be closed to the (Catalogue of Federal Domestic Assistance
ACTION: Correction of notice. public in accordance with the Program No. 93.242, Mental Health Research
provisions set forth in sections
srobinson on DSK5SPTVN1PROD with NOTICES
Grants, National Institutes of Health, HHS)
SUMMARY: This document corrects an 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
error that appeared in the notice Dated: November 3, 2015.
as amended. The grant applications and
published in the October 29, 2015, the discussions could disclose Carolyn A. Baum,
Federal Register entitled ‘‘Findings of confidential trade secrets or commercial Program Analyst, Office of Federal Advisory
Research Misconduct.’’ property such as patentable material, Committee Policy.
DATES: Effective Date: November 9, and personal information concerning [FR Doc. 2015–28385 Filed 11–6–15; 8:45 am]
2015. individuals associated with the grant BILLING CODE 4140–01–P
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Document Created: 2015-12-14 15:04:54
Document Modified: 2015-12-14 15:04:54
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Acting Director, Division of Investigative Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200. | |
| FR Citation | 80 FR 69230 |
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