80_FR_31156 80 FR 31052 - Findings of Research Misconduct

80 FR 31052 - Findings of Research Misconduct

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 80, Issue 104 (June 1, 2015)

Page Range31052-31052
FR Document2015-13054

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Ryan Asherin, Oregon Health Authority: Based on the report of an investigation conducted by the Oregon Health Authority (OHA) and analysis conducted by ORI in its oversight review, ORI found that Ryan Asherin, former Surveillance Officer and Principal Investigator, OHA, Public Health Division engaged in research misconduct in research supported by the Centers for Disease Control and Prevention (CDC) Emerging Infections Program Grant 5U01CI00306-05. ORI found that the Respondent engaged in research misconduct by falsifying and/or fabricating data that were included in the CDC research record, a manuscript submitted to JAMA Intern Med in January 2013, a published CDC report (CDC Morbidity and Mortality Weekly Report 61(09):157-162, March 2012), and presentations in 2012 to CDC and at the 11th Biennial Congress of the Anaerobe Society. ORI found that the Respondent falsified and/or fabricated fifty-six (56) case report forms (CRFs) while acquiring data on the incidence of Clostridium difficile infections in Klamath County, Oregon. Specifically, the Respondent (1) fabricated responses to multiple questions on the CRFs for patient demographic data, patient health information, and Clostridium difficile infection data, including the diagnoses of toxic megacolon and ileus and the performance of a colectomy, with no evidence in patient medical records to support the responses; and (2) falsified the CRFs by omitting data on the CRFs that clearly were included in patient medical records. Mr. Asherin has entered into a Voluntary Settlement Agreement (Agreement) and has voluntarily agreed for a period of two (2) years, beginning on May 12, 2015:

Federal Register, Volume 80 Issue 104 (Monday, June 1, 2015)
[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Notices]
[Page 31052]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13054]


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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.

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SUMMARY: Notice is hereby given that the Office of Research Integrity 
(ORI) has taken final action in the following case:
    Ryan Asherin, Oregon Health Authority: Based on the report of an 
investigation conducted by the Oregon Health Authority (OHA) and 
analysis conducted by ORI in its oversight review, ORI found that Ryan 
Asherin, former Surveillance Officer and Principal Investigator, OHA, 
Public Health Division engaged in research misconduct in research 
supported by the Centers for Disease Control and Prevention (CDC) 
Emerging Infections Program Grant 5U01CI00306-05.
    ORI found that the Respondent engaged in research misconduct by 
falsifying and/or fabricating data that were included in the CDC 
research record, a manuscript submitted to JAMA Intern Med in January 
2013, a published CDC report (CDC Morbidity and Mortality Weekly Report 
61(09):157-162, March 2012), and presentations in 2012 to CDC and at 
the 11th Biennial Congress of the Anaerobe Society.
    ORI found that the Respondent falsified and/or fabricated fifty-six 
(56) case report forms (CRFs) while acquiring data on the incidence of 
Clostridium difficile infections in Klamath County, Oregon. 
Specifically, the Respondent (1) fabricated responses to multiple 
questions on the CRFs for patient demographic data, patient health 
information, and Clostridium difficile infection data, including the 
diagnoses of toxic megacolon and ileus and the performance of a 
colectomy, with no evidence in patient medical records to support the 
responses; and (2) falsified the CRFs by omitting data on the CRFs that 
clearly were included in patient medical records.
    Mr. Asherin has entered into a Voluntary Settlement Agreement 
(Agreement) and has voluntarily agreed for a period of two (2) years, 
beginning on May 12, 2015:

    (1) To have his research supervised; Respondent agrees that 
prior to submission of an application for U.S. Public Health Service 
(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 agrees that he will not participate in any PHS-supported 
research until such a supervision plan is submitted to and approved 
by ORI; Respondent agrees to maintain responsibility for compliance 
with the agreed upon supervision plan;
    (2) that any institution employing him must 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
    (3) 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 FURTHER INFORMATION CONTACT: Acting Director, 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. 2015-13054 Filed 5-29-15; 8:45 am]
 BILLING CODE 4150-31-P



                                             31052                                      Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices

                                             the collection of information; and to                                      hours estimated for this Information                      Total Estimated Annualized burden
                                             transmit or otherwise disclose the                                         Collection Request are summarized in                    hours:
                                             information. The total annual burden                                       the table below.

                                                                                                                                                                                                   Average
                                                                                                                                                              Number of
                                                                                                                                           Number of                               Total          urden per       Total burden
                                                                                 Form name                                                                  responses per
                                                                                                                                          respondents                           responses         response           hours
                                                                                                                                                              respondent                          in hours)

                                             Rural Outreach Benefits Counseling Grant Program Meas-
                                               ures ...................................................................................                10                 1               10               1.5                15

                                                   Total ..............................................................................                10                 1               10               1.5                15



                                               HRSA specifically requests comments                                      2012 to CDC and at the 11th Biennial                    including, but not limited to, service on any
                                             on: (1) The necessity and utility of the                                   Congress of the Anaerobe Society.                       PHS advisory committee, board, and/or peer
                                             proposed information collection for the                                       ORI found that the Respondent                        review committee, or as a consultant.
                                             proper performance of the agency’s                                         falsified and/or fabricated fifty-six (56)              FOR FURTHER INFORMATION CONTACT:
                                             functions; (2) the accuracy of the                                         case report forms (CRFs) while                          Acting Director, Office of Research
                                             estimated burden; (3) ways to enhance                                      acquiring data on the incidence of                      Integrity, 1101 Wootton Parkway, Suite
                                             the quality, utility, and clarity of the                                   Clostridium difficile infections in                     750, Rockville, MD 20852, (240) 453–
                                             information to be collected; and (4) the                                   Klamath County, Oregon. Specifically,                   8200.
                                             use of automated collection techniques                                     the Respondent (1) fabricated responses
                                                                                                                        to multiple questions on the CRFs for                   Donald Wright,
                                             or other forms of information
                                             technology to minimize the information                                     patient demographic data, patient health                Acting Director, Office of Research Integrity.
                                             collection burden.                                                         information, and Clostridium difficile                  [FR Doc. 2015–13054 Filed 5–29–15; 8:45 am]
                                                                                                                        infection data, including the diagnoses                 BILLING CODE 4150–31–P
                                             Jackie Painter,                                                            of toxic megacolon and ileus and the
                                             Director, Division of the Executive Secretariat.                           performance of a colectomy, with no
                                             [FR Doc. 2015–13088 Filed 5–29–15; 8:45 am]                                evidence in patient medical records to                  DEPARTMENT OF HEALTH AND
                                             BILLING CODE 4165–15–P                                                     support the responses; and (2) falsified                HUMAN SERVICES
                                                                                                                        the CRFs by omitting data on the CRFs
                                                                                                                        that clearly were included in patient                   Meeting of the 2015 Hurricane Sandy
                                             DEPARTMENT OF HEALTH AND                                                   medical records.                                        Conference: Translating Research Into
                                             HUMAN SERVICES                                                                Mr. Asherin has entered into a                       Practice
                                                                                                                        Voluntary Settlement Agreement                          AGENCY: Department of Health and
                                             Office of the Secretary                                                    (Agreement) and has voluntarily agreed                  Human Services, Office of the Secretary.
                                             Findings of Research Misconduct                                            for a period of two (2) years, beginning
                                                                                                                                                                                ACTION: Notice.
                                                                                                                        on May 12, 2015:
                                             AGENCY: Office of the Secretary, HHS.                                        (1) To have his research supervised;                  SUMMARY:   The Department of Health and
                                             ACTION: Notice.                                                            Respondent agrees that prior to submission of           Human Services (HHS) Office of the
                                                                                                                        an application for U.S. Public Health Service           Assistant Secretary for Preparedness
                                             SUMMARY:   Notice is hereby given that                                     (PHS) support for a research project on which
                                                                                                                        the Respondent’s participation is proposed              and Response (ASPR) is hereby giving
                                             the Office of Research Integrity (ORI)                                     and prior to Respondent’s participation in              notice that ASPR will convene a
                                             has taken final action in the following                                    any capacity on PHS-supported research,                 Hurricane Sandy Conference:
                                             case:                                                                      Respondent shall ensure that a plan for                 Translating Research into Practice
                                                Ryan Asherin, Oregon Health                                             supervision of Respondent’s duties is                   public meeting on August 10–11, 2015.
                                             Authority: Based on the report of an                                       submitted to ORI for approval; the                      The purpose of the meeting is to broadly
                                             investigation conducted by the Oregon                                      supervision plan must be designed to ensure             share, with interested stakeholders,
                                             Health Authority (OHA) and analysis                                        the scientific integrity of Respondent’s
                                                                                                                        research contribution; Respondent agrees that
                                                                                                                                                                                outcomes of Hurricane Sandy recovery
                                             conducted by ORI in its oversight                                          he will not participate in any PHS-supported            science research and training projects
                                             review, ORI found that Ryan Asherin,                                       research until such a supervision plan is               awarded under ASPR FOAs EP–HIT–
                                             former Surveillance Officer and                                            submitted to and approved by ORI;                       13–001 and EP–HIT–14–001, Centers for
                                             Principal Investigator, OHA, Public                                        Respondent agrees to maintain responsibility            Disease Control and Prevention (CDC)
                                             Health Division engaged in research                                        for compliance with the agreed upon                     FOAs TP13–001 and OH13–002, and
                                             misconduct in research supported by                                        supervision plan;                                       National Institute of Environmental
                                             the Centers for Disease Control and                                          (2) that any institution employing him
                                                                                                                        must submit, in conjunction with each
                                                                                                                                                                                Health Sciences (NIEHS) FOAs RFA–
                                             Prevention (CDC) Emerging Infections                                       application for PHS funds, or report,                   ES–13–008 and NOT–ES–13–003.
                                             Program Grant 5U01CI00306–05.                                              manuscript, or abstract involving PHS-                  Meeting participants will discuss
                                                ORI found that the Respondent                                           supported research in which Respondent is               opportunities to build a community of
                                             engaged in research misconduct by                                          involved, a certification to ORI that the data          practice around Hurricane Sandy
Lhorne on DSK2VPTVN1PROD with NOTICES




                                             falsifying and/or fabricating data that                                    provided by Respondent are based on actual              recovery research and the path forward
                                             were included in the CDC research                                          experiments or are otherwise legitimately               for translating Hurricane Sandy
                                             record, a manuscript submitted to JAMA                                     derived and that the data, procedures, and              recovery science research results into
                                                                                                                        methodology are accurately reported in the
                                             Intern Med in January 2013, a published                                    application, report, manuscript, or abstract;           practice; highlight Hurricane Sandy
                                             CDC report (CDC Morbidity and                                              and                                                     recovery science grants as a model for
                                             Mortality Weekly Report 61(09):157–                                          (3) to exclude himself voluntarily from               disaster research science preparedness;
                                             162, March 2012), and presentations in                                     serving in any advisory capacity to PHS                 and demonstrate the benefit of


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Document Created: 2015-12-15 15:18:35
Document Modified: 2015-12-15 15:18:35
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactActing Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200.
FR Citation80 FR 31052 

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