80 FR 52324 - Findings of Research Misconduct

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 80, Issue 167 (August 28, 2015)

Page Range		52324-52324
FR Document		2015-21354

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Brandi Blaylock, Wake Forest School of Medicine: Based on an investigation conducted by Wake Forest School of Medicine (WFSOM) and additional analysis conducted by ORI, ORI found that Ms. Brandi Blaylock, former Graduate Student, WFSOM, engaged in research misconduct in research supported by National Institute of Drug Abuse (NIDA), National Institutes of Health (NIH), grant R01 DA012460 and Ruth L. Kirschstein National Research Service Award (NRSA) K31 DA033106. ORI found that Respondent engaged in research misconduct by falsifying and/or fabricating data reported in two poster presentations, several laboratory meetings, and progress reports associated with NIDA, NIH, grant R01 DA012460. Specifically, ORI found that the Respondent knowingly presented falsified and/or fabricated data indicating that twelve non-human primates (either rhesus or cynomolgus monkeys) responded to anti-abuse nicotinic acetylcholine and/or dopamine receptor selective compounds in self-selectivity assays for cocaine, methamphetamines, or nicotine when the compounds were never given to the monkeys per protocol. Respondent has not applied for or engaged in U.S. Public Health Service (PHS)-supported research within the last three (3) years and has stated that she has no intention of engaging in PHS-supported research in the future. Ms. Blaylock has entered into a Voluntary Settlement Agreement and has voluntarily agreed: (1) That if within three (3) years from the effective date of the Agreement, Respondent receives or applies for PHS support, Respondent agreed to have her research supervised for a period of three (3) years beginning on the date of her employment in a position in which she receives or applies for PHS support and to notify her employer(s)/ institution(s) of the terms of this supervision; Respondent agreed that prior to the submission of an application for PHS support for a research project on which her participation is proposed and prior to her participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of her duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of her research contribution; Respondent agreed that she 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; (2) that if within three (3) years from the effective date of the Agreement, Respondent receives or applies for PHS support, Respondent agreed that for a period of three (3) years beginning on the data of her employment in a position in which she receives or applies for PHS support, any institution employing her 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 (3) to exclude herself 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 a period of three (3) years, beginning on August 4, 2015.

Federal Register, Volume 80 Issue 167 (Friday, August 28, 2015)

[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)]
[Notices]
[Page 52324]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-21354]


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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:
    Brandi Blaylock, Wake Forest School of Medicine: Based on an 
investigation conducted by Wake Forest School of Medicine (WFSOM) and 
additional analysis conducted by ORI, ORI found that Ms. Brandi 
Blaylock, former Graduate Student, WFSOM, engaged in research 
misconduct in research supported by National Institute of Drug Abuse 
(NIDA), National Institutes of Health (NIH), grant R01 DA012460 and 
Ruth L. Kirschstein National Research Service Award (NRSA) K31 
DA033106.
    ORI found that Respondent engaged in research misconduct by 
falsifying and/or fabricating data reported in two poster 
presentations, several laboratory meetings, and progress reports 
associated with NIDA, NIH, grant R01 DA012460.
    Specifically, ORI found that the Respondent knowingly presented 
falsified and/or fabricated data indicating that twelve non-human 
primates (either rhesus or cynomolgus monkeys) responded to anti-abuse 
nicotinic acetylcholine and/or dopamine receptor selective compounds in 
self-selectivity assays for cocaine, methamphetamines, or nicotine when 
the compounds were never given to the monkeys per protocol.
    Respondent has not applied for or engaged in U.S. Public Health 
Service (PHS)-supported research within the last three (3) years and 
has stated that she has no intention of engaging in PHS-supported 
research in the future.
    Ms. Blaylock has entered into a Voluntary Settlement Agreement and 
has voluntarily agreed:
    (1) That if within three (3) years from the effective date of the 
Agreement, Respondent receives or applies for PHS support, Respondent 
agreed to have her research supervised for a period of three (3) years 
beginning on the date of her employment in a position in which she 
receives or applies for PHS support and to notify her employer(s)/
institution(s) of the terms of this supervision; Respondent agreed that 
prior to the submission of an application for PHS support for a 
research project on which her participation is proposed and prior to 
her participation in any capacity on PHS-supported research, Respondent 
shall ensure that a plan for supervision of her duties is submitted to 
ORI for approval; the supervision plan must be designed to ensure the 
scientific integrity of her research contribution; Respondent agreed 
that she 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;
    (2) that if within three (3) years from the effective date of the 
Agreement, Respondent receives or applies for PHS support, Respondent 
agreed that for a period of three (3) years beginning on the data of 
her employment in a position in which she receives or applies for PHS 
support, any institution employing her 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
    (3) to exclude herself 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 a period of three (3) years, beginning on August 4, 
2015.

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. 2015-21354 Filed 8-27-15; 8:45 am]
 BILLING CODE 4150-31-P

52324 Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices

Dated: August 14, 2015. support, Respondent agreed to have her DEPARTMENT OF HEALTH AND
James Macrae, research supervised for a period of three HUMAN SERVICES
Acting Administrator, Health Resources and (3) years beginning on the date of her
Services Administration. employment in a position in which she National Committee on Vital and Health
Approved: August 17, 2015. receives or applies for PHS support and Statistics: Meeting
Sylvia M. Burwell, to notify her employer(s)/institution(s) Pursuant to the Federal Advisory
Secretary. of the terms of this supervision; Committee Act, the Department of
[FR Doc. 2015–21246 Filed 8–27–15; 8:45 am] Respondent agreed that prior to the Health and Human Services (HHS)
BILLING CODE 4165–15–P submission of an application for PHS announces the following advisory
support for a research project on which committee meeting.
her participation is proposed and prior Name: National Committee on Vital
DEPARTMENT OF HEALTH AND to her participation in any capacity on and Health Statistics (NCVHS); Full
HUMAN SERVICES PHS-supported research, Respondent Committee Meeting.
shall ensure that a plan for supervision Time and Date:
Office of the Secretary of her duties is submitted to ORI for September 16, 2015; 9:00 a.m.–5:30 p.m.
Findings of Research Misconduct approval; the supervision plan must be EST.
designed to ensure the scientific September 17, 2015; 8:30 a.m.–12:00
AGENCY: Office of the Secretary, HHS. integrity of her research contribution; p.m. EST.
ACTION: Notice. Respondent agreed that she shall not Place: U.S. Department of Health and
participate in any PHS-supported Human Services, Centers for Disease
SUMMARY: Notice is hereby given that research until such a supervision plan is
the Office of Research Integrity (ORI) Control and Prevention, National Center
submitted to and approved by ORI; for Health Statistics, 3311 Toledo Road,
has taken final action in the following
Respondent agreed to maintain Auditorium A and B, Hyattsville,
case:
Brandi Blaylock, Wake Forest School responsibility for compliance with the Maryland 20782, (301) 458–4524.
of Medicine: Based on an investigation agreed upon supervision plan; Status: Open.
conducted by Wake Forest School of (2) that if within three (3) years from Purpose: The purpose of this meeting
Medicine (WFSOM) and additional the effective date of the Agreement, is to review NCVHS Status of Activities,
analysis conducted by ORI, ORI found Respondent receives or applies for PHS outline remaining objectives and
that Ms. Brandi Blaylock, former support, Respondent agreed that for a deliverables for 2015 and engage in
Graduate Student, WFSOM, engaged in period of three (3) years beginning on strategic planning for the next phase of
research misconduct in research the data of her employment in a Committee work. The Committee will
supported by National Institute of Drug position in which she receives or review and coordinate ongoing efforts
Abuse (NIDA), National Institutes of applies for PHS support, any institution being carried out by Subcommittees and
Health (NIH), grant R01 DA012460 and implementing its ACA-designated
employing her shall submit in
Ruth L. Kirschstein National Research Review Committee. Additional topics
conjunction with each application for
Service Award (NRSA) K31 DA033106. will include one action item for
PHS funds, or report, manuscript, or approval: a letter on § 1179 of the
ORI found that Respondent engaged abstract involving PHS-supported
in research misconduct by falsifying HIPAA statute; and a presentation on
research in which Respondent is the IOM Report ‘‘Vital Signs: Core
and/or fabricating data reported in two
involved, a certification to ORI that the Metrics for Health and Health Care
poster presentations, several laboratory
data provided by Respondent are based Progress.’’ The Working Group on HHS
meetings, and progress reports
associated with NIDA, NIH, grant R01 on actual experiments or are otherwise Data Access and Use will continue
DA012460. legitimately derived, and that the data, strategic discussions on Building a
Specifically, ORI found that the procedures, and methodology are Framework for Guiding Principles for
Respondent knowingly presented accurately reported in the application, Data Access and Use.
falsified and/or fabricated data report, manuscript, or abstract; and The times shown above are for the full
indicating that twelve non-human (3) to exclude herself voluntarily from Committee meeting. Subcommittee
primates (either rhesus or cynomolgus serving in any advisory capacity to PHS issues will be included as part of the
monkeys) responded to anti-abuse including, but not limited to, service on Full Committee schedule.
nicotinic acetylcholine and/or any PHS advisory committee, board, Contact Person for More Information:
dopamine receptor selective compounds and/or peer review committee, or as a Substantive program information may
in self-selectivity assays for cocaine, consultant for a period of three (3) years, be obtained from Rebecca Hines, Acting
methamphetamines, or nicotine when beginning on August 4, 2015. Executive Secretary, NCVHS, National
the compounds were never given to the Center for Health Statistics, Centers for
monkeys per protocol. FOR FURTHER INFORMATION CONTACT: Disease Control and Prevention, 3311
Respondent has not applied for or Acting Director, Office of Research Toledo Road, Room 6316, Hyattsville,
engaged in U.S. Public Health Service Integrity, 1101 Wootton Parkway, Suite Maryland 20782, telephone (301) 458–
(PHS)-supported research within the 750, Rockville, MD 20852, (240) 453– 4715. Summaries of meetings and a
last three (3) years and has stated that 8200. roster of committee members are
she has no intention of engaging in PHS- available on the NCVHS home page of
Lhorne on DSK5TPTVN1PROD with NOTICES

supported research in the future. Donald Wright, the HHS Web site: http://
Ms. Blaylock has entered into a Acting Director, Office of Research Integrity. www.ncvhs.hhs.gov/, where further
Voluntary Settlement Agreement and [FR Doc. 2015–21354 Filed 8–27–15; 8:45 am] information including an agenda will be
has voluntarily agreed: BILLING CODE 4150–31–P posted when available.
(1) That if within three (3) years from Should you require reasonable
the effective date of the Agreement, accommodation, please contact the CDC
Respondent receives or applies for PHS Office of Equal Employment

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Document Created: 2015-12-15 11:04:58
Document Modified: 2015-12-15 11:04:58

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, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200.
FR Citation		80 FR 52324

80 FR 52324 - Findings of Research Misconduct

DEPARTMENT OF HEALTH AND HUMAN SERVICESOffice of the Secretary

Federal Register Volume 80, Issue 167 (August 28, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary