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###### Department of Health and Human Services

###### Office of the Secretary

# AGENCY:

Office of the Secretary, HHS.

# ACTION:

Notice.

# 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.                          ( print 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