[Federal Register Volume 83, Number 151 (Monday, August 6, 2018)]
[Notices]
[Pages 38316-38317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16693]


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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 on July 13, 2018, the U.S. 
Department of Health and Human Services (HHS) Debarring Official, on 
behalf of the Secretary of HHS, issued a final notice of debarment 
based on an Administrative Law Judge's findings of research misconduct 
against Christian Kreipke, Ph.D., former Research Associate Professor, 
Wayne State University. Dr. Kreipke engaged in research misconduct in 
research supported by National Institute of Neurological Disorders and 
Stroke (NINDS), National Institutes of Health (NIH), grants R01 
NS039860 and R01 NS064976-01A2. The administrative actions, including 
five (5) years of debarment, were implemented beginning on July 13, 
2018, and are detailed below.

FOR FURTHER INFORMATION CONTACT: 
    Wanda K. Jones, Dr.P.H., Interim Director, Office of Research 
Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 
453-8200.

SUPPLEMENTARY INFORMATION: 
    Christian Kreipke, Ph.D., Wayne State University: ORI issued a 
charge letter enumerating findings of research misconduct and proposing 
HHS administrative actions. Dr. Kreipke (``Respondent'') subsequently 
requested a hearing before an Administrative Law Judge (ALJ) of the 
Departmental Appeals Board to dispute these findings. A hearing before 
the ALJ was held on July 10-12, 2017. On May 31, 2018, the ALJ issued 
his recommended decision, finding that Respondent recklessly caused or 
permitted twenty-three (23) instances of research misconduct in his 
three (3) grant applications, two (2) articles on which he was the 
first listed author, and two (2) posters on which he was the first 
listed author. The ALJ held that appropriate administrative actions 
included a five-year debarment from any contracting or subcontracting 
with any agency of the United States and from eligibility for or 
involvement in nonprocurement programs of the United States referred to 
as ``covered transactions.'' 2 CFR parts 180 and 376. The ALJ held it 
was an appropriate administrative action to also impose a five-year 
prohibition from serving in any capacity to the U.S. Public Health 
Service (PHS), including but not limited to, service on any PHS 
advisory committee, board, or peer review committee, or as a 
consultant. The ALJ noted that ORI also had proposed that the publisher 
of certain articles be notified of the need to retract those articles 
and that retraction had already occurred by the time of his recommended 
decision.
    Under the regulation, the ALJ's recommended decision went to the 
Assistant Secretary for Health, who did not modify it and forwarded it 
to the HHS Debarring Official, who is the deciding official for the 
debarment. The ALJ decision constituted the findings of fact to the HHS 
Debarring Official in accordance with 2 CFR 180.845(c). On July 13, 
2018, the HHS Debarring Official issued a final notice of debarment to 
begin on July 13, 2018, and end on July 12, 2023.

[[Page 38317]]

    Respondent's grant applications, articles, and posters in question 
examined the differential effects of endothelin receptor antagonists on 
traumatic brain injury-induced hypoperfusion of cerebral blood flow, 
neuronal cell injury, and cognition in rat animal models.
    Respondent recklessly included falsely described images in the 
following grant applications:

 R01 NS064976-01A1 submitted to NINDS, NIH (unfunded)
 R01 NS064976-01A2 submitted to NINDS, NIH (funded)
 R01 NS065824-01 submitted to NINDS, NIH (unfunded)

    Respondent recklessly included falsely described images in the 
following publications and posters:
     ``Differential effects of endothelin receptor A and B 
antagonism on cerebral hypoperfusion following traumatic brain 
injury.'' Neurological Research 32(2):209-14, 2010 Mar (``NR2010''). 
Retracted in Neurological Research 39(5):472, 2017 May.
     ``Clazosentan, a novel endothelin A antagonist, improves 
cerebral blood flow and behavior after traumatic brain injury.'' 
Neurological Research 33(2):208-13, 2011 Mar (``NR2011-1''). Retracted 
in Neurological Research 39(5):472, 2017 May.
     2009 poster for a Department of Veterans Affairs (VA) 
presentation: ``Using endothelin-A antagonists to ameliorate 
hypoperfusion and cognitive deficits following brain trauma: towards a 
clinical trial'' (``VA2009'').
     2010 poster for a VA presentation: ``Endothelin-1 receptor 
A antagonists improve neurologic and cognitive outcome following TBI'' 
(``VA2010'').
    The following findings of research misconduct were proven by a 
preponderance of the evidence. Respondent recklessly included:

 falsely described Fluoro-Jade stained images of rat brain 
cells in:
    --Figure 8 (left panel) in R01 NS064976-01A1
    --Figure 8B (left panel) in R01 NS064976-01A2
    --Figures 4A-F in R01 NS065824-01
    --Figure 3 (right and left panels) in NR2011-1
    --Figure 5C in NR2010
    --Figure 3 (panel 3) and Figure 6 (right and left panels) in VA2009
    --Figure 3 (panel 3) and Figure 6 (right and left panels) in VA2010
 falsely described systolic blood pressure curves in Figures 4A 
and 4B in NR2010
 falsely described cerebral blood flow graphs in:
    --Figure 5 (left panel) in R01 NS064976-01A1
    --Figure 5 (left panel) in R01 NS064976-01A2
    --Figure 3A in NR2010
    --Figure 5 in VA2009
    --Figure 5 in VA2010
 falsely described Western blot images in one of the following 
three grant applications (because at least one of the three must be 
false): Figure 1 (me+TBI panel for VEGF) in R01 NS065824-01, Figure 2B 
in R01 NS064976-01A1, and Figure 2B in R01 NS064976-01A2
 falsely described Western blot images in:
    --Figure 2A in R01 NS064976-01A1
    --Figure 2A in R01 NS064976-01A2
 a falsely described image of lectin labeled rat brain section 
in Figure 2C in R01 NS065824-01

    Thus, the research misconduct findings set forth above became 
effective, and the following administrative actions have been 
implemented for a period of five (5) years, beginning on July 13, 2018:
    (1) Dr. Kreipke is debarred from any contracting or subcontracting 
with any agency of the United States Government and from eligibility or 
involvement in nonprocurement programs of the United States Government 
referred to as ``covered transactions'' pursuant to HHS' Implementation 
(2 CFR part 376) of Office of Management and Budget (OMB) Guidelines to 
Agencies on Governmentwide Debarment and Suspension (2 CFR part 180); 
and
    (2) Dr. Kreipke 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.

Wanda K. Jones,
Interim Director, Office of Research Integrity.
[FR Doc. 2018-16693 Filed 8-3-18; 8:45 am]
 BILLING CODE 4150-31-P