83 FR 38316 - Findings of Research Misconduct

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 83, Issue 151 (August 6, 2018)

Page Range		38316-38317
FR Document		2018-16693

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.

Federal Register, Volume 83 Issue 151 (Monday, August 6, 2018)

[Federal Register Volume 83, Number 151 (Monday, August 6, 2018)]
[Notices]
[Pages 38316-38317]
From the Federal Register Online  [www.thefederalregister.org]
[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

38316 Federal Register / Vol. 83, No. 151 / Monday, August 6, 2018 / Notices

months or more exposure over a IV. References Neurological Disorders and Stroke
lifetime. Because of the duration of use, The following reference marked with (NINDS), National Institutes of Health
the nonclinical assessment for an asterisk (*) is on display at the (NIH), grants R01 NS039860 and R01
marketing approval should include Dockets Management Staff (see NS064976–01A2. The administrative
general toxicity studies, developmental ADDRESSES) and is available for viewing actions, including five (5) years of
and reproductive toxicity studies, an by interested persons between 9 a.m. debarment, were implemented
assessment of carcinogenic potential, and 4 p.m., Monday through Friday; it beginning on July 13, 2018, and are
and supporting toxicokinetic and also is available electronically at https:// detailed below.
pharmacokinetic studies. www.regulations.gov. References FOR FURTHER INFORMATION CONTACT:
FDA is aware of the serious risk Wanda K. Jones, Dr.P.H., Interim
without asterisks are not on display
associated with smoking and is Director, Office of Research Integrity,
because they have copyright restriction,
committed to facilitating the 1101 Wootton Parkway, Suite 750,
or they are available as published
development of therapies to support Rockville, MD 20852, (240) 453–8200.
articles and books. Please contact the
smoking cessation efforts. This guidance
person identified in the FOR FURTHER SUPPLEMENTARY INFORMATION:
focuses on novel components of the
INFORMATION CONTACT section to Christian Kreipke, Ph.D., Wayne State
drug product formulation, heat-
schedule a date to inspect references University: ORI issued a charge letter
generated products, and impurities that
without asterisks. enumerating findings of research
are generally not well characterized.
1. Madsen, L.R., N.H. Vinther Krarup, T.K. misconduct and proposing HHS
Orally inhaled nicotine-containing
Bergmann, et al., 2016, ‘‘A Cancer That administrative actions. Dr. Kreipke
tobacco products, including electronic
Went Up in Smoke: Pulmonary Reaction (‘‘Respondent’’) subsequently requested
nicotine delivery systems currently
to E-Cigarettes Imitating Metastatic a hearing before an Administrative Law
marketed in the United States, have Cancer,’’ Chest, 149(3):e65–67. Judge (ALJ) of the Departmental Appeals
already been associated with toxicity 2. Ghosh, A., R.C. Coakley, T. Mascenik, et Board to dispute these findings. A
concerns (Refs 1–4). An adequate al., 2018, ‘‘Chronic E-Cigarette Exposure hearing before the ALJ was held on July
nonclinical assessment, as described in Alters the Human Bronchial Epithelial
this guidance, can address the potential Proteome,’’ American Journal of
10–12, 2017. On May 31, 2018, the ALJ
toxicity of chemicals from orally Respiratory and Critical Care Medicine, issued his recommended decision,
inhaled nicotine-containing drug epub ahead of print February 26, 2018, finding that Respondent recklessly
products. As noted in the guidance, doi: 10.1164/rccm.201710–2033OC. caused or permitted twenty-three (23)
* 3. Olmedo, P., W. Goessler, S. Tanda, et al., instances of research misconduct in his
sponsors can use an alternative 2018, ‘‘Metal Concentrations in E-
approach if that approach provides three (3) grant applications, two (2)
Cigarette Liquid and Aerosol Samples: articles on which he was the first listed
adequate safety information. The Contribution of Metallic Coils,’’
This draft guidance is being issued Environmental Health Perspectives,
author, and two (2) posters on which he
consistent with FDA’s good guidance 126(2): doi: 10.1289/EHP2175. was the first listed author. The ALJ held
practices regulation (21 CFR 10.115). 4. Rubinstein, M.L., K. Delucchi, N.L. that appropriate administrative actions
The draft guidance, when finalized, will Benowitz, and D.E. Ramo, 2018, included a five-year debarment from
represent the current thinking of FDA ‘‘Adolescent Exposure to Toxic Volatile any contracting or subcontracting with
Organic Chemicals From E-Cigarettes,’’ any agency of the United States and
on nonclinical testing of orally inhaled Pediatrics, epub ahead of print March 5,
nicotine-containing drug products. It from eligibility for or involvement in
2018, doi: 10.1542/peds.2017–3557. nonprocurement programs of the United
does not establish any rights for any
Dated: July 31, 2018. States referred to as ‘‘covered
person and is not binding on FDA or the
public. You can use an alternative Leslie Kux, transactions.’’ 2 CFR parts 180 and 376.
approach if it satisfies the requirements Associate Commissioner for Policy. The ALJ held it was an appropriate
of the applicable statutes and [FR Doc. 2018–16726 Filed 8–3–18; 8:45 am] administrative action to also impose a
regulations. This guidance is not subject BILLING CODE 4164–01–P five-year prohibition from serving in
to Executive Order 12866. any capacity to the U.S. Public Health
Service (PHS), including but not limited
II. Paperwork Reduction Act of 1995 DEPARTMENT OF HEALTH AND to, service on any PHS advisory
This guidance refers to previously HUMAN SERVICES committee, board, or peer review
approved collections of information that committee, or as a consultant. The ALJ
are subject to review by the Office of Office of the Secretary noted that ORI also had proposed that
Management and Budget (OMB) under the publisher of certain articles be
Findings of Research Misconduct notified of the need to retract those
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections AGENCY: Office of the Secretary, HHS. articles and that retraction had already
of information in 21 CFR part 312 have ACTION: Notice. occurred by the time of his
been approved under OMB control recommended decision.
number 0910–0014. The collections of SUMMARY: Notice is hereby given that on Under the regulation, the ALJ’s
information resulting from special July 13, 2018, the U.S. Department of recommended decision went to the
protocol assessments have been Health and Human Services (HHS) Assistant Secretary for Health, who did
approved under OMB control number Debarring Official, on behalf of the not modify it and forwarded it to the
0910–0470. Secretary of HHS, issued a final notice HHS Debarring Official, who is the
of debarment based on an deciding official for the debarment. The
sradovich on DSK3GMQ082PROD with NOTICES

III. Electronic Access Administrative Law Judge’s findings of ALJ decision constituted the findings of
Persons with access to the internet research misconduct against Christian fact to the HHS Debarring Official in
may obtain the draft guidance at either Kreipke, Ph.D., former Research accordance with 2 CFR 180.845(c). On
https://www.fda.gov/Drugs/Guidance Associate Professor, Wayne State July 13, 2018, the HHS Debarring
ComplianceRegulatoryInformation/ University. Dr. Kreipke engaged in Official issued a final notice of
Guidances/default.htm or https:// research misconduct in research debarment to begin on July 13, 2018,
www.regulations.gov. supported by National Institute of and end on July 12, 2023.

VerDate Sep<11>2014 17:36 Aug 03, 2018 Jkt 244001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\06AUN1.SGM 06AUN1

Document Created: 2018-11-06 10:37:19
Document Modified: 2018-11-06 10:37:19

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		Wanda K. Jones, Dr.P.H., Interim Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200.
FR Citation		83 FR 38316

83 FR 38316 - Findings of Research Misconduct

DEPARTMENT OF HEALTH AND HUMAN SERVICESOffice of the Secretary

Federal Register Volume 83, Issue 151 (August 6, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary