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    HARVARD MEDICAL SCHOOL

    '. :

    .

    '

    John E. Dahlberg, Ph.D., Director

    Division of Investigative Oversight

    Office for Research Integrity

    1101 Wootton Parkway

    Suite 750

    Rockville, MD 20852

    Re: DIO:

    Matter

    of

    Dear Dr. Dahlberg:

    CONFIDENTIAL

    GRETCHEN BRODNICKI, J .D.

    DEAN

    FOR FACULTY AND

    RESEARCH INTEGRITY

    25 SHATTUCK STREET

    BOSTON, MAsSACHUSETTS 02115

    TEL:

    (617) 432-2496

    FAX:

    (617) 432-7462

    GRETCHEN_BRODNICICI@HMS:HARVARD.EDU

    June

    S

    2012

    Enclosed please find the fmal determination, final reports and documentary record in the

    above-referenced investigation. As you will see, there was a fmding of research misconduct.

    Please do not hesitate to contact me at 617-432-2496

    or

    Gretchen [email protected] if you have any questions or need any additional

    information.

    Enclosures

    cc: Kristin Bittinger (w/o enclosures)

    Ellen Berkman, J.D. (w/o enclosures)

    Sincerely,

    : J ~ 6 ~

    Gretchen Brodnicki

    Dean for Faculty and

    Research Integrity

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (7)(A)

    (b) (6), (b)(7)(C)

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    MASSACHUSEITS GENERAL H O S P I T L ~ HARVARD MEDICAL

    SCHOOL

    Jeffrey Flier, M.D.

    Dean

    of

    the Faculty of Medicine

    Harvard Medical School

    25 Shattuck Street

    Boston,

    MA

    02115

    Dear Dr. Flier:

    PAUL

    S

    RUSSELL, MD

    John Homans Professor

    of

    Surgery

    Harvard

    Visiting Surgeon and Chief, Transplantation Unil

    Massachusetts General Hospital, Boslon, MA 02114

    (617)

    726-2801

    May 22, 2012

    \@V

    On behalfof the Harvard Medical School Standing Committee on Facility Conduct, I am

    writing to convey to you the recommendation

    of the Standing Committee relating to an investigation

    into allegations that

    in the laboratory

    of

    , might

    have conimitted research misconduct

    This matter commenced in October 2007, when Margaret Dale, J.D., former Research

    Integrity Officer and Dean for Faculty and Research Integrity at HMS, was notified by Gerianne

    Sands, J.D., Associate General Counsel at Fred Hutchinson Cancer Research Center (FHCRC)

    that might . The research

    reported in was conducted at HMS while in

    laboratory. , where

    in the Division of Basic Sciences.

    The allegations against were first brought forward

    by

    another former fellow in

    laboratory at FHCRC, prepared a detailed

    report setting forth allegations against related to . In

    addition, provided a series

    of

    PowerPoint presentations supporting allegations.

    After an initial assessment, and in accordance with institutional policies and federal

    regulations, a joint inquiry panel was appointed to look into the matter and to report its findings and

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C) (b) (6), (b)(7)(C) (b) (6), (b)(7)(C)

    (b)

    (6)

    ,

    (b)

    (7)

    (C

    )

    (b)

    (6),

    (b)

    (7)

    (C)

    (b) (7)(A)

    (b) (7)(A)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (7)(A) (b) (6), (b)(7)(C) (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    PAUL S. RUSSELL, M.D.

    conclusions to the Chair of the Standing Committee on Faculty Conduct. The inquiry panel,

    comprised

    of

    Professor ,

    Professor and Professor

    , reviewed the matter and recommended that it proceed to investigation in accordance

    with institutional policies, Public Health Service regulations and the Department of Defense

    directive. The Chair

    of

    the Standing Committee on Faculty Conduct, Paul S. Russell, M.D.,

    John Romans Distinguished Professor of Surgery, accepted the recommendations

    of

    the inquiry

    panel and his recommendations were accepted

    by

    you. The final determinations

    of

    the inquiry

    panel were then forwarded to the respondent, the federal Office of Research Integrity and the

    Department

    of

    Defense.

    The members

    of

    the inquiry panel agreed to serve as members

    of

    an investigative panel.

    The investigative panel was charged with applying the standard for review set forth in 42 CFR

    Sec. 50.102 to determine whether committed research misconduct.

    1

    As detailed in the

    attached investigation report, the panel met three times at the end

    of

    2010 and early 2011 to review

    the written submissions

    of

    the respondent and complainant, to interview and

    and to consider the evidence against While the panel reached

    preliminary conclusions in March 2011, it held issuance of its draft

    report pending its formal inquiry into allegations against a second respondent.

    The conclusions of that review did not ultimately alter the findings of the investigative panel.

    Consequently, on , a draft report was shared with declined

    to comment in .

    The panel issued its final report on They concluded that

    Specifically, the panel concluded that

    .

    The Standing Committee met on March 22,2012 to consider the matter. At the meeting, we

    reviewed the investigative panel's report and the accompanying documentation, met with the

    investigation staff, and interviewed , a representative on behalf of the investigative paneL

    1

    42 CFR Sec. 50.102 was the regulation in effect when the alleged misconduct occurred. "Misconduct" or

    "Misconduct in Science" is defined as fabrication, falsification, plagiarism or other practices that seriously deviate

    from those that are commonly accepted within the scientific community for proposing, conducting or reporting

    research. It does not include honest error or honest differences in interpretations or judgments of data. The

    investigation was conducted in compliance with that standard, but the procedural requirements

    of

    42 CFR Part

    93,

    the revised regulation covering misconduct, were followed with respect to the panel's investigative process.

    2

    (b) (6), (b)

    (7)(C)

    (b) (6),

    (b)(7)

    (C)

    (b) (6), (b)(7)(C) (b) (6), (b)(7)(C)

    (b) (7)(A)(b) (7)(A)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C) (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C) (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C) (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    PAUL S. RUSSELL,

    M.D.

    Conclusions

    Having reviewed and considered carefully the final report

    of

    the investigative panel,

    including the accompanying documentation, we conclude that the work of the investigative panel

    was thorough

    and fair.

    We agree with the conclusion

    of

    the investigative panel tha

    Although we find

    In particular, it

    does

    not

    appear from the record that exercised primary data

    results were

    preliminary.

    See

    investigation report, exhibit 8,

    p.

    11). A careful review

    of

    all primary data

    supporting the paper before submission might have

    showing the reported This might have

    inspired a more careful review of the

    Recommendations

    We agree with the recommendation of the investigative panel that the Office for Research

    Integrity, Department

    of

    Defense and appropriate institutional officials at HMS be notified

    of

    the

    outcome of this investigation.

    We also agree with the panel that FHCRC, and be notified in writing

    of the conclusion of this matter.

    These are the conclusions and recommendations of the Standing Committee on Faculty

    Conduct. Please feel free to call on us if we can be of further assistance.

    Enclosures

    SjJerel

    y

    , )

    r

    Jul

    g

    ~ ~ u / r U J

    Paul

    S.

    Russell, M.D.

    Chairperson

    3

    (b) (6), (b)(7)(C)

    (b) (6), (b)

    (7)(C)

    (b) (6), (b)

    (7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C) (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

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    HARVARD MEDICAL SCHOOL

    May 29, 2012

    Via Email

    Dear

    CONFIDENTIAL

    JEFFREY

    S.

    FUER, MD

    DEAN OF

    THE FACULTY OF

    MEDICINE

    HARVARD MEDICAL

    SCHOOL

    25 SHATTUCK ST.

    BOSTON, MA 02II5

    I am writing to inform you of the determinations Harvard Medical School has reached after reviewing and

    considering the final conclusions and recommendations of the HMS Standing Committee on Faculty Conduct, as

    set forth in their letter to me of as well as the Investigation Panel's report, and the rest of

    documentary record

    in

    this case.

    After careful consideration, I have accepted the findings, conclusions, and recommendations of the Standing

    Committee and the Investigation Panel.

    I also agree with the panel that FHCRC, and be notified in writing

    of

    the conclusion of this

    matter.

    If you have any further questions conceming this matter, including any questions about the implementation of the

    Standing Committee's recommendations, please contact Gretchen Brodnicki, the HMS Dean for Faculty and

    Research Integrity, at Gretchen [email protected], or at 617-432-2496.

    Sincerely,

    ean

    of

    the Faculty

    of

    Medicine

    cc: Gretchen Brodnicki

    Kristin Bittinger

    Ellen Berkman, J.D. (Office

    of

    the General Counsel)

    Enclosures

    (

    b

    )

    (

    6

    )

    (b) (6)

    (b) (6), (b)(7)(C) (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    CONFIDENTIAL

    .

    . Because the research in

    question was conducted while , the HMS Office for Professional

    Standards and Integrity (OPSI) took the administrative lead in staffing the matter? The

    complainant in this matter is in

    . prepared a very detailed report dated November

    and provided these materials to the FHCRC panel

    in the course of its related review. In addition,

    FHCRC secured and sequestered all available

    primary data relevant to the inquiry and, in view

    of

    the jurisdict ion

    ofHMS

    over the allegations

    discussed in this report, provided these data and submissions to HMS.

    In compliance with institutional policy and federal regulation,3 was notified

    of

    commencement

    of

    the inquiry and provided with our names as proposed members

    of

    the review

    panel. raised no objection to our service on the inquiry panel or to our continued service on

    this investigation panel. We are Professor ,

    Professor , and

    Professor Gretchen Brodnicki, J.D., Research Integrity Officer and

    Dean for Faculty and Research Integrity,4 Mortimer Litt, M.D., HMS Senior Scientific

    Investigator, Kristin Bittinger, HMS Director of Scientific Integrity,s and

    of

    the

    OPSI also served as staffto the panel.

    In

    addition, a representative

    ofthe

    Harvard University

    Office

    of

    General Counsel (Ellen Berkman, J.D.) was available to advise us throughout the

    proceedings and attended both inquiry and investigative panel meetings.

    3 The inquiry and subsequent investigation were conducted in accordance with the HMS Principles nd Procedures

    for

    Dealing with llegations ofFaculty Misconduct

    and the Public Health Services Rule, 42 CFR Part 93, and the

    Department of Defense INSTRUCTION 3210.7 (May 14,2004), which implements Dodd DIRECTIVE 3216.2.

    4 Dean Brodnicki arrived at HMS in July 2008.

    5 Ms. Bittinger arrived at HMS

    in

    April 2009.

    2

    (b) (6), (b)(7)(C)

    (b) (6), (b)

    (7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C) (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b)(6),(b)(7)(C)

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    CONFIDENTIAL

    Although we initially

    met

    in April 2008 for orientation and document review, the bulk of

    the inquiry was conducted through the end

    of2009

    and early 2010.

    6

    This panel convened two

    meetings

    on

    March 20,2009 and March

    30,2009

    to further discuss the allegations, the

    documentation, and the available primary image data. Following these

    meetings, we requested that

    On July 29, 2009, we met in the laboratory of to

    review relevant original slides.

    7

    Following our review

    of

    the available slides, we posed follow-

    up questions with an additional opportunity to respond

    that he had not previously addressed. Through counsel,

    The allegations under review relate to paper, which reported

    on

    the

    ; (ii)

    ; (iii)

    3

    (b) (6),

    (b)(7)

    (C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6),

    (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    CONFIDENTIAL

    In a previous paper, using the expressed by

    .8 They observed

    that the

    .

    Based on experience derived from this paper,

    .

    .

    The authors reported, as expected, that

    Furthermore,

    .

    . Upon joining group,

    4

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)

    (C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C) (b)

    (6),

    (b)

    (7)

    (C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6),

    (b)(7)

    (C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    CONFIDENTIAL

    .

    9

    See Inquiry Report, Exhibit

    8,

    p.

    8).

    efforts to gather insight from regarding potential causes for difficulty with

    the protocol,

    r. Following regarding the discrepancies and the

    challenges he encountered in his attempt to follow the protocol, including a trip by

    , brought concerns to the attention of

    immediately notified institutional officials at FRCRC .

    alleges that that had been

    . According to

    , the real data did not demonstrate

    .

    set forth

    one allegation with numerous subparts identifying specific

    manipulations alleged

    on

    the figures in At the

    conclusion

    of

    the inquiry, we found

    .

    The final inquiry report was provided to Paul Russell, M.D., Chair

    of

    the Standing

    Committee on Faculty Conduct, for review and approval. Dr. Russell concurred with the

    conclusions ofthis panel's inquiry and recommended to Jeffrey Flier, M.D., Dean ofthe Faculty

    of

    Medicine, Dr. Flier

    concurred with Dr. Russell's recommendation (Exhibit 4).

    5

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C) (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C) (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C) (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C) (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C) (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    CONFIDENTIAL

    LLEG TIONS ND FINDINGS

    The facts and findings set forth in the inquiry report regarding each allegation are

    incorporated by reference into this report. We focus here on the additional information provided

    by as each relates to the pending allegations.

    however, , to fully understand their

    experimental basis one must consider to

    explore the

    Briefly, the method is supposed to consist

    of

    the following steps:

    13

    7

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    CONFIDENTIAL

    A review

    of

    the literature among members

    of this investigation panelled to the following conclusions as

    14

    15

    .

    8

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    CONFIDENTIAL

    In summary, to answer the

    questions asked This contributed (i)

    , (ii)

    and (iii)

    It must be emphasized that the above reconstruction describes potential sources of human

    error, and does not, alone, describe events that fall within the definition

    of

    research misconduct.

    It is very common for scientific assays to detect a combination

    of

    genuine signal and background

    noise; this paper's use of a method that included background labeling does not constitute

    scientific misconduct. Scientific research is always limited to the use

    of

    techniques that are

    available at the time: a technique may initially seem promising yet difficult, and remedies may be

    attempted that generate artifacts.

    16

    9

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    CONFIDENTIAL

    10

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    CONFIDENTIAL

    11

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    CONFIDENTIAL

    12

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    CONFIDENTIAL

    13

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    CONFIDENTIAL

    (A)

    14

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    CONFIDENTIAL

    (

    IS

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    CONFIDENTIAL

    In view

    of

    our review

    ofthe

    original sections,

    Our review of the original slide that produced figure

    21,

    however, revealed

    A review

    of

    By simply comparing the

    16

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    CONFIDENTIAL

    .

    (

    CONCLUSIONS

    We have reviewed the documentary record relating to against

    the numerous submissions from ,

    throughout this process, the slides that we were able to locate and review, and the

    of

    , and In reviewing these materials, we

    have been mindful

    of

    our charge as an Investigation Panel. Mindful

    of

    that charge, we have

    determined that

    18

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C) (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C) (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    CONFIDENTIAL

    RECOMMEND TIONS

    In accordance with the applicable institutional policies and federal regulations and for the

    reasons stated above, we recommend this matter be referred to HMS officials with such finding

    and a recommendation that OR and DoD be notified.

    19

    (b) (7)(A)

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    List of Zou Exhibits

    Exhibit 1:

    Exhibit 2: .

    Exhibit

    3:

    Letter

    of

    Dr. Paul Russell, Chair

    of

    he Standing Committee on Faculty Conduct,

    affinning the decision

    of

    he Inquiry panel.

    Exhibit 4: Deciding Official Letter, signedby Jeffrey Flier, M.D., Dean ofthe Faculty

    of

    Medicine, following inquiry.

    Exhibit

    5:

    Notification to the Office of Research Integrity (ORI) of decision of Inquiry

    Panel to proceed to investigation.

    Exhibit 6: Notification to the Department

    of

    Defense (DoD)

    of

    decision

    of

    Inquiry Panel

    to proceed to investigation.

    Exhibit 7: Transcript

    of

    testimony of

    Exhibit

    8:

    Transcript of testimony of

    Exhibit 9: Transcript of testimony of

    Exhibit 10:

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    rticles

    (b) (6), (b)(7)(C)

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    rticles

    (b) (6), (b)(7)(C)

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    rticles

    (b) (6), (b)(7)(C)

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    rticles

    (b) (6), (b)(7)(C)

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    articles

    (b) (6), (b)(7)(C)

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    rticles

    (b) (6), (b)(7)(C)

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    RETRACTION

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    MASSACHUSETTS GENERAL HOSPITAL HARVARD

    MEDICAL

    SCHOOL

    PAULS.RUSSELL,M.D. ,

    I :

    John Homans Distinguished Professor of Surgery .

    Wi

    ~ Harvard m

    Senior Surgeon

    Massachusetts General Hospital, Boston, MA 02114

    (617) 726-2801

    May 12,2010

    Jeffrey S. Flier, M.D.

    Dean

    of he

    Faculty

    of

    Medicine

    Harvard Medical School

    25 Shattuck Street

    Boston,

    MA

    02115

    .Dear Dr. Flier:

    On

    behalfof the

    Harvard

    Medical

    School

    StandilJ.g Committee on

    Faculty Conduct,

    I

    am

    writing to convey

    to

    you my recommendation, as chair of he Standing

    Committee,

    relating to

    . allegations former Harvard Medical School (HMS)

    As

    the attached inquiry report details,

    the allegations

    in this matter

    were

    first to HMS's

    attention by at Fred Hutchinson Cancer

    Research Center (FHCRC) conveyed to

    . fonner Research Integrity Officer

    and

    Dean

    for

    Facility and Research Integrity

    at

    HMS

    that

    in

    the _

    laboratory of

    laboratory moved to FHCRC in 2002. After an initial assessment and

    in accordance

    with

    institutional policies, a joint

    inqUlly

    panel

    was

    appointed to look into the matter.

    The

    inquiry panel

    was comprised of Professor

    Professor

    and

    Professor of

    The inquiry panel was charged with determining whether or not the

    matter warranted a further investigative process. It was detennined that

    National Institute of Health and the Department of Defense

    and, therefore the matter was subject to the Public Health Services Rule, 42 CFR Part 93 and the

    Department ofDefense INSTRUCTION 3210.7 (May 14,2004).

    The inquiry panel met in person

    on

    four

    occasions

    to review

    submitted in support several written responses submitted by

    the

    respondent and all available onginal

    source documentation,

    including original croscope slides

    sequestered

    and

    provided through FHCRC. As

    indicated

    in their report,

    the

    inquiry

    panel

    members

    concluded

    that there was sufficient

    evidence to wiimuit

    proceeding

    to i n v s t i g ~ o n

    3

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C) (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C) (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C) (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    PAUL S. RUSSELL, MD.

    The report

    of he

    inquiry panel

    was

    submitted to

    me, as chair

    of

    he

    Standing

    Committee, on

    May

    5, 2010 to

    consider the matter.

    I

    reviewed

    inquiry

    panel's

    report and

    the

    accompanying

    documentation.

    Conclusion

    2

    (b) (6), (b)(7)(C)

    (b) (7)(A)

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    PAUL S. RUSSELL, M.D.

    3

    (b) (7)(A)

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    PAUL S. RUSSELL, M.D.

    Recommendations

    I agree with:the inquiry l that

    Because NIH and

    DOD fimding

    was involved, the Office of

    Research Integrity (OR ) of he Public Health Service

    and

    the Department ofDefense should

    be .

    notified of he decision.

    These are the conclusions

    and

    recommendations

    of

    he chair, on behalfof he

    Standing

    Committee

    on

    Faculty Conduct

    Enclosures

    4

    Sincerely,

    P

    lliL S w ~

    Paul Russell, M.D.

    Chair

    (b) (7)(A)

    (b) (7)(A)

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    HARVARD MEDICAL

    SCHOOL

    May

    25,

    2010

    VIA ELECTRONIC DELIVERY

    CONFIDENTIAL

    JEFFREY S.

    FLIER,

    MD

    DI AN 0[' THE FACULTY OF MEDICINE

    HARvARD

    MEDICAL ScHOOL

    25

    SHAITUCK ST.

    BOSTON, W,A

    02II5

    I am.

    writing to provide you with the

    final

    conclusions

    of

    he

    HMS

    Standing

    Committee on

    . Faculty Conduct

    and

    to inform you of he determinations reached by the Harvard Medical

    School

    after-

    reviewing the reports and the documentaIy record in this case, including your

    submissions.

    After careful

    o n s i d e ~ t i o ~

    HMS has accepted the findings, conclusions,

    and

    recommendations

    of

    he

    Chair of he

    Standing Committee and the Inquiry

    Panel. We

    agree

    that

    further investigation is warranted in this matter

    and, as

    required by

    institutioDal policy, we will be

    commencing the investigative process.

    Gretchen

    Brodnicki, J.D., Dean for Faculty

    arid

    Research Integrity at the Medical

    School,

    will

    be

    in contact with you concerning the investigative process. Please let her know

    if you have

    any

    questions.

    Sincerely,

    J J J ? ~

    Dean of

    he

    Faculty of Medicine

    Enclosure

    cc: Gretchen Brodnicki, J.D.

    Ellen e r l o n ~ J.D.

    ~ ~ ~

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    Harvard MedicalSchool .

    John

    E. Dahlberg, Ph.D., Director

    Division of Investigative Oversight

    Office for Research Integrity

    .1101 Wootton Parkway

    .

    Suite 750

    Rockville, MD

    20852

    Re:

    DIO:

    '

    Dear Dr. Dahlberg:

    CONFIDENTIAL

    25

    Shattuck

    Street

    Boston. Massachusetts 021 i 5

    (617) 432-3191

    FAX:

    (617) 432-0566

    Office for

    Research

    Issues

    May 25, 2010

    I enclose full inquiry panel report , Standing Committee report,

    and

    determination letter

    in the inquiry

    of he

    allegation

    As

    you will see, we wil l be proceeding to

    .

    further

    investigation.

    Please

    do

    not hesitate to contact

    me

    at

    617-432-2496 or .

    Gretchen

    Brodnicki(a),hms.harvard.edu i f

    you

    have any questions or need any-additional .

    information.

    Enclosures

    cc:

    Kristin Bittinger, J.D. (w/o enclosures)

    Ellen Berkman, J.D. ( flo enclosures)

    Sincerely?

    r\..

    ()

    &

    ~ ~

    L . L _ ~ ~ - ~

    Gretchen A. Brodnicki

    h

    Dean for Faculty and

    Research Integrity

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    . _ ...- ............. .

    25 Shattuck street

    Harvard Medical. School

    . .Boston. Massachusetts 02115

    (617) 432-3191

    CONFIDENTIAL

    Mr. Jay Winchester -

    Office

    of

    the

    Staff

    Judge Advocate .

    Medical Research and Development Command

    United States Army

    Department ofDefense ..

    504 Scott Street

    Fort Detrick

    Frederick, Maryland 21702-5012

    FAX: 301-619-5034

    FAX: (617) 432-0566

    Office

    for

    Research Issues

    May 25, 2010

    Re: Research Misconduct Inquiry ofAllegations

    Dear Mr. Winchester:

    ,

    ,I

    I enclo'se the

    fujI

    inquiry panel report, Standing Committee report, and detennination letter

    in the research misconduct inquiry of the allegation As you will see, we

    will be proceeding to further investigation.

    The data subject to the pending allegations were fimded,

    in

    part, through a Department of

    Army Grant ) and

    two

    NllI grants The Office for Research

    Integrity (ORl) is simultaneously being notified of he results of his inquiry.

    Please do not hesitate to contact me at 617-432-2496 or

    . Gretchen [email protected] if you have any questions or need any additional

    information. . .

    Sincerely,

    - - 0

    I ~ ~ ~ g ~

    Gretchen A. Brodnicki

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    Enclosures

    cc:

    Kristin Bittinger, lD w/o enclosures

    Ellen

    Berkman,

    J.D.

    w/o

    enclosures

    2

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    7

    HARVARD

    M E D l ~ L

    'SOHOOL

    OFFICE FOR RESEARCH fSSUES

    O

    N

    FiDENTJAL

    (b) (6), (b)(7)(C)

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    HARVARD MEDICAL SCHOOL

    Transcription of

    the

    Meeting with

    Conducted on October 5,2010

    InquiIy Panel Members Present:

    Sta ff Members Present: Gretchen Brodnicki (GB), Kristin Bittinger (KB),

    Pat Gilligan (PG), and Ellen Berkman (EB).

    Witness, by telephone:

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(a), (b)(7)(c)

    (b) (6), (b)(7)(C)

    HHS-PSC000053

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    2

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(a), (b)(7)(c)

    HHS-PSC000054

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    3

    (b) (6), (b)(7)(a), (b)(7)(c)

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    4

    (b) (6), (b)(7)(a), (b)(7)(c)

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    5

    (b) (6), (b)(7)(a), (b)(7)(c)

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    6

    (b) (6), (b)(7)(a), (b)(7)(c)

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    7

    (b) (6), (b)(7)(a), (b)(7)(c)

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    8

    (b) (6), (b)(7)(a), (b)(7)(c)

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    9

    (b) (6), (b)(7)(a), (b)(7)(c)

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    10

    (b) (6), (b)(7)(a), (b)(7)(c)

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    11

    (b) (6), (b)(7)(a), (b)(7)(c)

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    12

    (b) (6), (b)(7)(a), (b)(7)(c)

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    13

    (b) (6), (b)(7)(a), (b)(7)(c)

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    (b) (6), (b)(7)(a), (b)(7)(c)

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    15

    (b) (6), (b)(7)(a), (b)(7)(c)

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    16

    (b) (6), (b)(7)(a), (b)(7)(c)

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    (b) (6), (b)(7)(a), (b)(7)(c)

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    HARVARD MEDICAL

    SCHOOL

    Transcription of the Meeting

    with

    Conducted on December 17, 2010

    InquirY Panel Members Present:

    StaffMembers Present: Gretchen Brodnicki (GB), Kristin Bittinger

    (KB),

    Pat Gilligan (PG), and Ellen Berkman (EB).

    Witness, by telephone:

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(a), (b)(7)(c)

    (b) (6), (b)(7)(C)

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    (b) (6), (b)(7)(a), (b)(7)(c)

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    3

    (b) (6), (b)(7)(a), (b)(7)(c)

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    4

    (b) (6), (b)(7)(a), (b)(7)(c)

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    5

    (b) (6), (b)(7)(a), (b)(7)(c)

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    6

    (b) (6), (b)(7)(a), (b)(7)(c)

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    7

    (b) (6), (b)(7)(a), (b)(7)(c)

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    8

    (b) (6), (b)(7)(a), (b)(7)(c)

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    9

    (b) (6), (b)(7)(a), (b)(7)(c)

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    10

    (b) (6), (b)(7)(a), (b)(7)(c)

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    (b) (6), (b)(7)(a), (b)(7)(c)

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    HARVARD

    MEDICAL SCHOOL

    Transcription of the

    Meeting with

    Conducted on

    March

    29, 2011

    Inquiry Panel Members Present:

    Staff Members Present: Kristin Bittinger, , Ellen Berkman, and Patrick Gilligan.

    Witness.

    by

    web conference:

    1

    i

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(a), (b)(7)(c)

    (b) (6), (b)(7)(C)

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    (b) (6), (b)(7)(a), (b)(7)(c)

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    3

    (b) (6), (b)(7)(a), (b)(7)(c)

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    4

    (b) (6), (b)(7)(a), (b)(7)(c)

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    6

    (b) (6), (b)(7)(a), (b)(7)(c)

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    7

    (b) (6), (b)(7)(a), (b)(7)(c)

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    8

    (b) (6), (b)(7)(a), (b)(7)(c)

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    9

    (b) (6), (b)(7)(a), (b)(7)(c)

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    10

    (b) (6), (b)(7)(a), (b)(7)(c)

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    11

    (b) (6), (b)(7)(a), (b)(7)(c)

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    (b) (6), (b)(7)(a), (b)(7)(c)

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    13

    (b) (6), (b)(7)(a), (b)(7)(c)

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    15

    (b) (6), (b)(7)(a), (b)(7)(c)

    HHS-PSC000098

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    16

    (b) (6), (b)(7)(a), (b)(7)(c)

    HHS-PSC000099

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    17

    (b) (6), (b)(7)(a), (b)(7)(c)

    HHS-PSC000100

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    19

    (b) (6), (b)(7)(a), (b)(7)(c)

    HHS-PSC000102

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    20

    (b) (6), (b)(7)(a), (b)(7)(c)

    HHS-PSC000103

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    21

    (b) (6), (b)(7)(a), (b)(7)(c)

    HHS-PSC000104

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    22

    (b) (6), (b)(7)(a), (b)(7)(c)

    HHS-PSC000105

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    23

    (b) (6), (b)(7)(a), (b)(7)(c)

    HHS-PSC000106

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    24

    (b) (6), (b)(7)(a), (b)(7)(c)

    HHS-PSC000107

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    25

    (b) (6), (b)(7)(a), (b)(7)(c)

    HHS-PSC000108

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    27

    (b) (6), (b)(7)(a), (b)(7)(c)

    HHS-PSC000110

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    Page 1 of 1

    From:

    Sent: Tuesday, January 24, 2012 2:44 PM

    To: Bittinger, Kristin

    L.

    Subject: RE: Confidential: Draft report from HMS panel

    Dear Kristin,

    Thank you for giving me the opportunity to see the draft report. I do not have any comment

    as

    I have stated

    my

    viewes in all previous responses. I deeply apologize for the precious time spent on this by the committee

    members.

    Sincerely,

    >

    From: [email protected]

    >

    To:

    >

    CC:

    [email protected]; [email protected];

    [email protected]

    > Date: Thu, 22 Dec 2011 17:22:21 -0500

    >

    Subject: Confidential: Draft report from

    HMS

    panel

    >

    >

    ,

    >

    > Attached please find a copy of a draft report of the Harvard Medical School Investigation Panel regarding the

    allegations I believe

    that

    you

    are

    familiar with many of

    the

    documents referenced within this report,

    however, we. are happy to provide you with copies of all of the documents. Harvard Medical School is on break

    unti l January 3rd, however, and the hard copy materials will not be sent until

    that

    time. In view of this, we will

    extend your time for review

    of

    this

    draft

    report.

    >

    > We invite you

    to

    comment and/or respond to the enclosed draft prior to February 3, 2012. Your response

    and/or comments will be shared with the Investigation Panel, who may revise the report based on such additional

    information. Regardless, all comments will be attached to the report when it is finalized and submitted to the

    Standing Committee on Faculty Conduct

    for

    final recommendation regarding this matter. The Standing

    Committee's final recommendations will go to

    Dean

    Flier, as the deciding official in this matter. You will have an

    opportunity to speak directly with

    the

    Standing Committee if you desire.

    >

    > Please let me know

    if

    you have

    any

    questions. I am happy

    to

    discuss the process directly with you.

    >

    > Thank you again for your continued cooperation.

    >

    >

    Regards,

    > Kristin

    >

    > Kristin L Bittinger, M.S., J.D.

    >

    Director

    of

    Scientific

    Integrity

    >

    Office for Professional Standards and Integrity

    > Harvard Medical School

    > 25 Shattuck Street

    > Gordon Hall, Suite 210C

    >

    Boston, Massachusetts 02115

    > (617) 432-7769

    3/13/2012

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b)(6),(b)(7)(C)

    HHS-PSC000112

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    ase

    Tracking System

    Page 1 of 1

    FOIA 12-0452; Appeal 13-0118

    Index

    of

    ORI Case

    l

    j

    and 2011-29 -

    CONFIDENTIAL

    FOR FOIA

    USE

    ONLY

    72

    Case

    Indexes

    found.

    DATE

    FILE

    TO

    FROM

    TYPE OF

    ATTACHMENTS

    SUMMARY OF DOCUMENTATION

    DESIGNATION DOCUMENTATION

    10102/2007

    DALHBERG DALE

    CONVERSATION

    NONE

    DOCUMENT

    02/1612008

    KRUEGER

    PRICE

    EMAIL

    NONE

    PUBLICATION

    03/06/2008

    KRUEGER

    PRICE

    EMAIL

    RETRACTION AND

    PUBLICATION

    ARTICLE

    12/10/2008

    BRODNICKI

    LlPSHULTZ

    EMAIL

    NONE

    12/10/2008

    LlPSHULTZ

    BRODNICKI

    EMAIL NONE

    04/28/2009

    BRODNICKI

    LlPSHULTZ

    EMAIL NONE

    04/28/2009

    LlPSHULTZ BRODNICKI

    EMAIL

    NONE

    08/20/2009

    BRODNICKI

    LlPSHULTZ

    EMAIL NONE

    https:llori.hhs.gov/intranet/CaseTracking/caseindex _rpt. php

    3/2312013

    HHS-PSC000113

    (b) (7)(A)(b) (7)(A)

    (b) (7)(A)

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    Case Tracking System Page 2

    o 1

    DATE

    FILE

    TO

    FROM

    TYPE OF

    ATTACHMENTS SUMMARY OF DOCUMENTATION

    DESIGNATION

    DOCUMENTATION

    08/27/2009 LlPSHULTZ

    BRODNICKI

    EMAIL

    NONE

    11/18/2009 BRODNICKI

    HOHMANN EMAIL

    NONE

    01/12/2010

    BRODNICKI

    LlPSHULTZ EMAIL

    NONE

    01/14/2010 LlPSHULTZ CC:BITTINGER

    BRODNICKI

    EMAIL

    NONE

    01/19/2010 BRODNICKI

    LlPSHULTZ

    EMAIL

    NONE

    03/30/2010 BRODNICKI

    LlPSHULTZ EMAIL

    NONE

    04/13/2010 BRODNICKI

    LlPSHULTZ EMAIL

    NONE

    04/14/2010

    LlPSHULTZ

    BRODNICKI

    EMAIL

    NONE

    "

    05/25/2010

    DAHLBERG CC:BITTINGER,

    BRODNICKI

    LETTER

    INQUIRY REPORT

    BERKMAN

    WI ATTCHMNTS

    &

    DETERMINATION

    https:llori.hhs.gov/intranet/CaseTracking/caseindexJPt.php

    3/2312013

    HHS-PSC000114

    (b) (7)(A) (b) (7)(A)

    (b) (7)(A)

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    Case Tracking System

    Page 3

    o 1

    DATE

    FILE

    TO

    FROM

    TYPE OF

    ATTACHMENTS

    SUMMARY OF DOCUMENTATION

    DESIGNATION

    DOCUMENTATION

    LETTER

    10107/2010

    BRODNICKI LlPSHULTZ EMAIL

    NONE

    10/21/2010

    BRODNICKI LlPSHULTZ EMAIL

    NONE

    10/21/2010

    LlPSHULTZ

    BRODNICKI

    EMAIL

    NONE

    10/22/2010

    BRODNICKI DAHLBERG EMAIL

    NONE

    11/19/2010

    DAHLBERG EMAIL

    NONE

    11/24/2010

    LlPSHULTZ

    BRODNICKI EMAIL

    NONE

    01/27/2011

    ASKORI

    EMAIL

    NONE

    01/27/2011

    ASKORI/MAHLER/ROCHEZITAYMAN EMAIL

    NONE

    01/2712011

    ASKORIIDAH LBERG

    EMAIL

    NONE

    https:llori.hhs.gov/intranet/CaseTracking/caseindex_rpt.php 3/2312013

    HHS-PSC000115

    (b) (7)(A)

    (b) (7)(A)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (7)(A)

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    Case Tracking System

    Page 4 o 1

    DATE

    FILE

    TO FROM

    TYPE OF

    ATTACHMENTS

    SUMMARY OF DOCUMENTATION

    DESIGNATION

    DOCUMENTATION

    01/30/2011

    DAHLBERG

    EMAIL NONE

    01/30/2011

    DAHLBERG

    EMAIL

    NONE

    02/24/2011

    DAHLBERG CC:SPRUNG/PRICE

    EMAIL

    NONE

    03/21/2011

    DAHLBERG

    EMAIL

    NONE

    SWEM(US

    04/11/2011

    DAHLBERG CC: EAST

    DOJ

    EMAIL NONE

    ATTRNY)

    04/11/2011

    SWEM CC:DAHLBERG, ROCHEZ

    DAHLBERG

    EMAIL NONE

    06/08/2011

    BRODNICKI

    LlPSHULTZ

    EMAIL

    NONE

    07/06/2011

    LlPSHULTZ

    BRODNICKI

    EMAIL

    NONE

    07/06/2011

    BRODNICKI

    LlPSHULTZ

    EMAIL

    NONE

    https://ori.hhs.gov/intranet/Case Tracking/caseindex_rpt. php

    312312013

    HHS-PSC000116

    (b) (7)(A)(b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (7)(A)

    (b) (7)(A)

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    Case Tracking System

    Page 5 o 1

    DATE

    FILE

    TO

    FROM

    TYPE OF

    ATTACHMENTS

    SUMMARY OF DOCUMENTATION

    DESIGNATION

    DOCUMENTATION

    10/19/2011 LlPSHULTZ BRODNICKI EMAIL

    NONE

    10/19/2011 KABAK

    BRODNICKI EMAIL

    NONE

    10/19/2011 BRODNICKI

    LlPSHULTZ

    EMAIL NONE

    10/19/2011 BRODNICKI

    KABAK

    EMAIL

    NONE

    10/19/2011 KABAK

    BRODNICKI EMAIL

    NONE

    10/24/2011

    TABAK, ROCKEY, BAR DAHLBERG EMAIL NONE

    10/25/2011

    TABAK/ROCKEY/BAR

    DIO/ORI MEMO NONE

    01/24/2012

    BRODNICKI

    KABAK

    EMAIL NONE

    02/01/2012

    Brodnicki

    Kabak

    Email none

    02/01/2012

    Kabak

    Brodnicki Email none

    https:llori.hhs.gov/intranet/CaseTracking/caseindexJPt.php

    3/23/2013

    HHS-PSC000117

    (b) (7)(A) (b) (7)(A)

    (b) (7)(A)

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    Case Tracking System

    Page 6

    o

    1

    DATE

    FILE

    TO FROM

    TYPE OF

    ATTACHMENTS

    SUMMARY OF DOCUMENTATION

    DESIGNATION

    DOCUMENTATION

    02/01/2012

    Brodnicki Kabak

    Email none

    02/01/2012

    Kabak Brodnicki

    Email none

    02/01/2012

    SynanlFisher Kabak

    Email none

    02/27/2012

    Rochez, East Cc: Dahlberg Dahlberg

    Email None

    02127/2012

    Brodnicki; Bittinger Cc; Dahlberg Dahlberg

    Email

    NONE

    02/27/2012

    Dahlberg; Bittinger Brodnicki

    Email NONE

    02/27/2012

    Brodnicki Cc: Dahlberg

    Dahlberg

    Email

    NONE

    05/17/2012

    Dahlberg Cc:Swem/Puyce East

    Email

    none

    05/17/2012

    East Cc:Fleming/Morgan Dahlberg

    Email

    none

    https:llori.hhs.gov/intranet/CaseTracking/caseindex_rpt. php

    3/23/2013

    HHS-PSC000118

    (b) (7)(A)

    (b) (7)(A)

    (b) (7)(A)

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    Case Tracking System

    Page 7

    o

    1

    DATE

    FILE

    TO

    FROM

    TYPE OF

    ATTACHMENTS

    SUMMARY OF DOCUMENTATION

    DESIGNATION DOCUMENTATION

    Dahlberg

    05/17/2012

    Cc: Flem ng/Morgan/Swem/Buyce

    East

    Email

    none

    06105/2012

    Dahlberg

    Brodnicki Letter

    Investigation Report

    Cc: Bittinger/Berkman/Godin/Kell

    and Exhibits

    Investigation Report

    06/07/2012 East Cc: Dahlberg

    Dahlberg

    Email

    ( NOT Attached to

    FILE COPY)

    06/07/2012

    Dahlberg Cc: Swem

    East

    Email

    NONE

    06/07/2012 East Cc: Dahlberg

    Dahlberg Email

    NONE

    https:llori.hhs.gov intranetlCaseTracking/caseindex_rpt. php 3123/2013

    HHS-PSC000119

    (b) (7)(A) (b) (7)(A)

    (b) (7)(A)

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    Case Tracking System

    Page 8

    o

    1

    DATE

    FILE

    TO

    FROM

    TYPE OF

    ATTACHMENTS

    SUMMARY OF DOCUMENTATION

    DESIGNATION DOCUMENTATION

    06/08/2012 Brodnicki Kabak

    Email NONE

    06/08/2012 Kabak Brodnicki Email NONE

    06/08/2012

    Brodnicki Kabak

    Letter

    NONE

    Jan.27 and Jan.

    30,2011 email

    07/17/2012

    Dahlberg

    Email exchange between

    DIO Director and

    Complaint

    08/24/2012

    Dahlberg Email

    https://ori.hhs.gov/intranet/CaseTracking/caseindexJPt.php

    3123/2013

    HHS-PSC000120

    (b) (7)(A)

    (b) (6), (b)(7)(C)

    (b) (7)(A)

    (b) (7)(A)

    (b) (7)(A)

  • 8/10/2019 HHS Combined FOIA Production

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    Case Tracking System

    Page 9 o 1

    DATE

    FILE

    TO

    FROM

    TYPE OF

    ATTACHMENTS

    SUMMARY OF DOCUMENTATION

    DESIGNATION DOCUMENTATION

    082012.pdf

    08/27/2012

    Dahlberg Email

    none

    INQUIRY REPORT

    05/25/2010

    DAHLBERG CC:BITTINGER,

    BRODNICKI

    WI ATTACHMENTS

    LETTER

    BERKMAN

    & DETERMINATION

    LTR

    06/05/2012

    Dahlberg

    Brodnicki Letter

    Investigation Report

    Cc:Bittinger/Berkman/Godin/Kell and Exhibits

    04/02/2012

    Taymen Cc: Rochez Schwendinger

    Email

    NONE

    04/10/2012

    Dahlberg Cc: Mahler;Rochez; Szakaly

    Taymen

    Email

    NONE

    https:llori.hhs.gov/intranet/CaseTracking/caseindexJpt.php

    3/23/2013

    HHS-PSC000121

    (b) (7)(A)

    (b) (6), (b)(7)(C)

    (b) (7)(A)

    (b) (7)(A)

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    Case Tracking System

    Page 1 o 1

    DATE

    FILE

    TO

    FROM

    TYPE OF

    ATTACHMENTS

    DESIGNATION

    DOCUMENTATION

    SUMMARY OF DOCUMENTATION

    04/10/2012

    Taymen; Cc:Mahler, Rochez, Szakaly,

    JD

    Dahlberg

    Email NONE

    08/20/2012

    Bradley\Kabak\Wright\Dahlberg

    Garfinkel

    Email

    None

    08/20/2012

    Bradley, et

    al

    Garfinkel

    Email None

    https:llori.hhs.govlintranetICaseTracking/caseindex_rpt.php

    312312013

    HHS-PSC000122

    (b) (7)(A) (b) (7)(A)

    (b) (7)(A)

  • 8/10/2019 HHS Combined FOIA Production

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    Dahlberg, John E (HHS/OASH)

    From:

    Sent:

    To:

    Cc:

    Subject:

    Dahlberg, John E (HHS/OASH)

    Monday, August

    27,2012

    11:42

    AM

    Dahlberg, John E (HHS/OASH)

    RE

    HMS review panel decision

    With the receipt of the Harvard report, DIO has initiated its separate oversight review of the investigation. During this

    review, the records are not available to others. DIO staff may wish to discuss this matter

    with

    you as either a witness or

    as the complain 'lnt,

    but

    we are not at a point where this has yet been discussed. Thank you for your offer

    to

    assist.

    Sincerely,

    John Dahlberg,

    Ph.D.

    Director, Division

    of

    Investigative Oversight

    Office of Research Integrity

    240-453-8800

    From

    Sent Friday, August 24, 2012 2:30 PM

    To:

    Dahlberg, John E (HHSjOASH)

    Subject HMS

    review panel decision

    Dear Dr. Dahlberg,

    I received a note from the HMS review panel

    I would like

    to request to see the final report from the HMS review panel regarding the investigation in order to comment on

    it and help OR conduct a thorough review process.

    Regards,

    Begin forwarded message:

    From:

    "Brodnicki, Gretchen A.

    II

    Subject: Confidential

    Date:

    August 20, 2012 1 13:05 PM GMT-05:00

    To:

    1

    HHS-PSC000123

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (7)(A)(b) (7)(A)

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    I attach confidential correspondence

    to

    you for your review.

    Thank you,

    Gretchen Brodnicki, J.D.

    Dean for Faculty and Research Integrity

    Harvard Medical School

    25 Shattuck Street, Suite 108

    Boston, MA 02115

    (t) (617) 432-2496

    (f) (617) 432-0566

    Gretchen [email protected]

    HHS-PSC000124

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    Dahlberg. John E (HHS/OASH)

    From:

    Sent:

    To:

    Subject:

    Attachments:

    Dear Dr. Dahlberg,

    Friday, August 24,20122:30

    PM

    Dahlberg, John E (HHS/OASH)

    HMS review panel decision

    I received a note from the HMS review panel

    I would like

    to request to see the fmal report from the HMS review panel regarding the investigation in order to comment on

    it and help OR conduct a thorough review process.

    Regards,

    Begin forwarded message:

    From:

    "Brodnicki, Gretchen A."

    Subject: Confidential

    Date: August 20, 2012 1 13:05

    PM

    GMT-05:00

    To:

    ,

    I attach confidential correspondence to you for your review.

    Thank you,

    Gretchen Brodnicki, J.D.

    Dean for Faculty and Research Integrity

    Harvard Medical School

    25 Shattuck Street, Suite 108

    Boston, MA 02115

    (t) (617) 432-2496

    f)

    (617) 432-0566

    Gretchen [email protected]

    1

    HHS-PSC000125

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(a), (b)(7)(c)

    (b) (7)(A)

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    HARVARD MEDICAL SCHOOL

    G R E T H ~ N BRODNICKI. J.D.

    DEAN

    FOR FAcul:n'

    AND

    RESEARCH INTEGnm

    2 SHATTUCK STREET

    BOSTON.

    l\1ASSACHI1SF,nS 02115

    Tn: (617) 432-2496

    FAX: (617) 432-7462

    [email protected]>.EI>ll

    August 20,

    20 12

    I am writing

    to

    let you know the resolution of the concerns you raised

    to

    Harvard Medical

    School (HMS) regarding possible research misconduct

    A thorough investigation ofyolll' allegations was conducted by an HMS

    The same

    HMS

    faculty panel also conducted a formal inquiry into

    yoUI

    allegations against

    Confidentiality requirements preclude

    me

    ti OI11 giving you more information about ollr

    findings, but I want to assure you that this was a thorough,

    fail

    and objective process.

    review.

    Thank

    you

    for bringing this matter to our attention

    and

    for

    your cooperation with the detailed

    Sincerely,

    X"

    ) . v _ ~ t ~ 6 r u 7 J . - G - ~ k

    Gl'etcnen Brodnicki

    Dean

    for

    Faculty

    and

    Research Integrity

    HHS-PSC000126

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (7)(A)

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    Garfinkel, usan

    J

    (HHS OASH)

    From:

    Sent:

    To:

    Cc:

    Subject:

    FYI on

    case

    Garfinkel, Susan J (HHS/OASH)

    Monday, August 20, 2012 2:24

    PM

    Bradley, Ann (HHS/OASH)

    Kabak, Shara (HHS/OPHS/ORI); Wright, David E (OS/OASH); Dahlberg,

    John E (HHS/OASH)

    Confidential:

    I got a call from Gretchen Brodnicki at Harvard regarding this case. HMS has finished the investigation

    The usual HMS process at

    the

    closure of a case is to inform

    the

    complainant of

    the

    outcome, very simply

    that findings were made or not. Gretchen called because they are ready to send the complainant this

    letter and wanted ORI to know that there may be a public backlash from complainant.

    Susan

    Susan Garfinkel,

    Ph.D.

    Office of Research Integrity

    Division of Investigative Oversight

    Phone: 240-453-8421

    1

    HHS-PSC000127

    (b) (6), (b)(7)(a), (b)(7)(c)

    (b) (7)(A)

    (b) (7)(A)

    (b) (7)(A)

  • 8/10/2019 HHS Combined FOIA Production

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    Dahlberg. John E HHS/OASH)

    From:

    Sent:

    To:

    Subject:

    Dear Dr. Dahlberg,

    Tuesday, July 17, 20121 :31 PM

    Dahlberg, John E (HHS/OASH)

    misconduct case

    I am in contact with the d am aware that the Harvard investigation has a final report

    I would also like to see the report from Harvard as soon as possible and offer comments

    that may be useful for OR

    in

    the oversight review and final report. I hope that all the issues ofthis case in

    particular are discussed with all relevant parties,

    including the

    Regards,

    On

    Jan 30,2011, at

    11

    :59 AM, Dahlberg, John E (HHS/OASH) wrote:

    I will attempt to answer your questions for all of the recipients of this email, as quite likely I would have been

    asked to do so in any event. I am sympathetic to your concerns as the complaint in these two cases that the

    process has been protracted, and has not reached closure. However, 42 C.F.F

    Part

    93

    is pretty clear that once

    allegations are made and considered to meet the definition

    of

    research misconduct, the inquiry and investigation

    process should be overseen by neutral unbiased institutional officials and scientists comprising the committees.

    The complainant

    mayor

    may not be a useful fact witness, depending on circumstances, but has no special

    status beyond being a possible fact witness.

    f

    you fell you have identified additional evidence of possible value

    to an ongoing process, the institution is expected to consider it, and if not, OR would do so during its oversight

    review that begins after receipt

    of

    the final investigation report.

    You correctly note that the regulation does not require that the complainant be provided all of portions of either

    the inquiry or investiqation report for review. It is not a complainant's responsibility to judge the merits

    of

    the

    evidence for or against findings

    of

    misconduct. Such decisions are quite complex and based on far more that

    simply demonstrating that a figure or statement is wrong or falsified.

    Sincerely,

    1

    HHS-PSC000128

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(a), (b)(7)(c)

    (b) (7)(A)(b) (7)(A)

    (b) (7)(A)

    (b) (6), (b)(7)(C)

    b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (7)(A)

    (b) (6), (b)(7)(a), (b)(7)(c)

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    John Dahlberg, Ph.D

    Director, Divison oflnvestigative Oversight

    Office

    of

    Research Integrity

    Sent: Thursday, January 27, 2011 4:32 PM

    To:

    S

    OPHS askORI (HHS/OPHS)

    Subject: to Dr. John Dahlberg

    This email is directed to the following individual:

    John Dahlberg, Ph.D., Director

    of

    Division oflnvestigative Oversight,

    I m writing to ask your opinion regarding PHS Policies on Research Misconduct, 42 CFR Part 93. It states that

    a requirement

    of

    an institution that accepts PHS funds for research includes: A thorough, competent, objective,

    and fair response to allegations of research misconduct consistent with, and within the time limits

    of

    the final

    rule, including precautions to ensure that individuals responsible for carrying out any part of the research

    misconduct proceeding do not have unresolved personal, professional, or financial conflicts

    of

    interest with the

    complainant, respondent, or witnesses.

    I have two questions regarding this policy and would like to hear your opinion.

    The underlying presumption is that an institution is inherently biased against making determinations of research

    misconduct against its members (or former members) and thus may not want to review all the evidence that

    implicates that member. The institution therefore may do what it can to avoid consideration

    of

    additional

    evidence that it becomes aware of, and also attempt to prevent the complainant from seeing the draft report.

    Regards,

    2

    HHS-PSC000129

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

  • 8/10/2019 HHS Combined FOIA Production

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    CASE SUMMARY no names):

    3

    HHS-PSC000130

    (b) (7)(A)

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    HHS-PSC000131

    (b) (7)(A)

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    . 4 DEPARTMENT OF Illi LTII -

    HUM N

    SERVICES

    + ~ , . : : : : l .

    Office

    of

    the Assistant Secretary for H

    Office

    of

    Research Integrity

    CONFIDENTIAL

    June 8, 2012

    Gretchen Brodnicki, i l l

    Dean for Faculty Research and Research Integrity

    Harvard Medical School

    25 Shattuck Street

    Boston, MA 02115

    RE:

    Dear

    Ms_

    Brodnicki:

    1101

    Wootton Parkway, Suite

    750

    Rockville, MD 20852

    Phone: 240-453-8800

    FAX: 301-594-0043

    Email: [email protected]

    The Division

    of

    Investigative Oversight DIO), Office of Research Integrity ORl), has

    received the report

    of

    the investigation with attachments, by Harvard Medical School

    HHS-PSC000132

    (b) (7)(A)

    (b) (6), (b)(7)(a), (b)(7)(c)

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    Kabak, Shara HHS/OPHS/ORI)

    From:

    Sent:

    Brodnicki, Gretchen A. [[email protected]]

    Friday, June 08, 2012 1 07

    PM

    To:

    Kabak, Shara (HHS/OPHS/ORI)

    Subjec,:

    RE: CONFIDENTIAL

    Shara,

    y apologies - my lette r indicated our internal account numbers, not the official NIH-assigned grant numbers. The two

    NIH

    grants are as follows:

    Please do

    not

    hesitate to contact me with any further questions.

    Thanks,

    Gretchen

    From:

    Kabak, Shara (HHS/OPHS/ORI) [mailto:[email protected]]

    Sent Friday, June 08, 2012 11:22 AM

    To:

    Brodnicki, Gretchen A.

    Subject CONFIDENTIAL

    Gretchen,

    Thank you.

    Regards,

    Shara

    Shara Kabak, PhD

    Office of Research Integrity

    Division of Investigative Oversight

    Phone: 240-453-8800

    1

    HHS-PSC000133

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (7)(A)

    (b) (7)(A)

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    Dahlberg, John E HHS/OASH)

    From:

    Sent:

    To:

    Dahlberg,

    John

    E

    HHS/OASH)

    Thursday, June 07, 2012 12:24 PM

    East,

    David USAWAW)

    Cc:

    Dahlberg,

    John E HHS/OASH)

    Subject:

    RE: Scanned document from Fisher, Raymond HHS/OPHS)

    raymond.fisher.os)

    David,

    with regard

    to

    ORI s system of records notice, the report can only be release following the

    completion of ORI s oversight review and

    case

    closure.

    At

    that point, i the FOIA

    office or

    ORI) receives a

    request,

    a suitably redacted copy can be sent. For example, i

    we

    concur

    that only

    one

    finding was

    made,

    all references to the

    other

    allegations, analyses, and

    findings would

    be redacted.

    This

    is

    not

    to

    day

    that

    other

    legal issues

    might trump our

    privacy issues, but aside from your interest,

    that is how

    we would handle a

    direct

    request.

    And

    Harvard could choose

    to share part or all

    of

    the

    report with the complainant but

    is

    unlikely to

    do

    so).

    John

    -----Original Message-----

    From:

    East,

    David

    USAWAW)

    [mailto:[email protected]]

    sent:

    Thursday, June 87,

    2812

    12:89

    PM

    To: Dahlberg, John E HHS/OASH)

    Cc:

    Swem, Judy USAWAW)

    Subject: Re: Scanned document from

    Fisher,

    Raymond HHS/OPHS) raymond.fisher.os)

    Original Message

    -----

    From: Dahlberg, John E HHS/OASH) [mailto:[email protected]]

    Sent: Thursday, June 87, 2812 11:59 AM

    To: East, David USAWAW)

    Cc: Dahlberg, John E HHS/OASH)

    Subject:

    FW: Scanned document from

    Fisher,

    Raymond HHS/OPHS) raymond.fisher.os)

    Hello David,

    Regards, John

    John Dahlberg, Ph.D.

    Director, Division of Investigative Oversight Office of

    Research

    Integrity 248-453-8888

    248-453-8427 direct)

    1

    HHS-PSC000134

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    Dahlberg.

    John

    E (HHS/OASH)

    From:

    Sent:

    East, David (USAWAW) [[email protected]]

    Thursday, May 17, 2012 5:43 PM

    To:

    Dahlberg, John E (HHS/OASH)

    Cc: Fleming, Sheila P (HHS/OASH); Morgan, Tracy S (HHS/OASH); Swem, Judy (USAWAW);

    Buyce, Pat (USAWAW)

    Subject:

    RE: Harvard Investigation

    Many

    thanks

    for

    the quick response.

    From:

    Dahlberg, John E (HHSjOASH) [mailto:[email protected]]

    Sent:

    Thursday, May 17,

    20122:34

    PM

    To:

    East, David (USAWAW)

    Cc:

    Fleming, Sheila P (HHSjOASH); Morgan, Tracy S (HHSjOASH)

    Subject RE: Harvard Investigation

    Hello David,

    I pinged Harvard

    after

    receiving

    your

    email,

    as

    the report

    was due May

    1.

    I just heard

    that

    it

    should

    be

    sent early next

    week. I

    will

    be on leave next week,

    but

    I will ask

    DIO staff to

    immediately forward a copy of the report and its

    attachments as

    soon as

    it

    arrives.

    This may be a

    time to

    be optimistic.

    Regards, John

    John Dahlberg, Ph.D.

    Director, Division of Investigative Oversight

    Office of Research Integrity

    240-453-8800

    From:

    East, David (USAWAW) [mailto:[email protected]]

    Sent:

    Thursday, May 17,

    2 ~ 2

    2:33 PM

    To: Dahlberg, John E (HHSjOASH)

    Cc:

    Swem, Judy (USAWAW); Buyce, Pat (USAWAW)

    Subject Harvard Investigation

    Hi Dr. Dahlberg,

    Sorry

    to

    bother

    you again,

    but

    I

    wanted

    to

    see

    if

    you

    have any updates on

    the

    status

    of

    the

    Harvard investigation report.

    Thanks.

    David

    David R. East

    Assistant United States Attorney

    United States At torney's Office

    Western District of Washington

    700 Stewart Street I Suite 5220 I Seattle Washington 98101-1271

    a

    206-553-1018 1,I;l, 206-553-4073 I [8J [email protected]

    1

    HHS-PSC000135

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    Confidentiality Notice: E-mails from the United States Attorney's Office normally contain confidential and privileged material,

    and

    are for the

    sole

    use of the intended recipient. Use or distribution

    by

    an unintended recipient is prohibited, and may be a violation of law. If you believe tha t you

    received this e-mail in error, please do not read this e-mail or any attached items. Please delete the e-mail and all attachments, including any

    copies thereof, and inform the sender that you

    have

    deleted the e-mail, all attachments

    and

    any copies thereof . Thank you.

    HHS-PSC000136

  • 8/10/2019 HHS Combined FOIA Production

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    Fisher, Raymond HHS/OPHS)

    From:

    Sent:

    To:

    Subject:

    Kabak, Shara (HHS/OPHS/ORI)

    Wednesday, February

    01,20123:19 PM

    Synan, Kyle C (HHS/OASH); Fisher, Raymond (HHS/OPHS)

    FW:

    From: Brodnicki, Gretchen

    A.

    [mailto:Gretchen [email protected]

    Sent Wednesday, February 01, 2012 10:29 AM

    To:

    Kabak,

    Shara (HHS/OPHS/ORI)

    Subject RE:

    Thanks so much.

    From: Kabak, Shara (HHS/OPHS/ORI) [mailto:[email protected]

    Sent

    Wednesday, February 01, 2012 10:28

    AM

    To: Brodnicki, Gretchen A.

    Subject

    RE:

    Gretchen,

    Your request

    for

    an extension is reasonable and we will expect the report on May 1, 2012.

    Shara

    From: Brodnicki, Gretchen

    A.

    [mailto:Gretchen [email protected]

    Sent Wednesday, February 01, 2012 10: 18 AM

    To:

    Kabak,

    Shara (HHS/OPHS/ORI)

    Subject RE:

    Shara,

    My apologies - I mis-calendared the due date for

    our

    update, and thought

    it

    wasn't due until February 20

    Please

    do not hesitate

    to

    contact me with any questions.

    Thanks,

    Gretchen

    From: Kabak, Shara (HHS/OPHS/ORI) [mailto:[email protected]

    Sent Wednesday, February 01, 20129:11 AM

    To: Brodnicki, Gretchen A.

    Subject

    1

    HHS-PSC000137

    (b) (7)(A)

    (b) (7)(A)

    (b) (7)(A)

    (b) (7)(A)

    (b) (7)(A)

    (b) (7)(A)

    (b) (7)(A)

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    Hi

    Gretchen,

    Regards,

    Shara

    Shara Kabak, PhD

    Office of Research Integrity

    Division of Investigative Oversight

    Phone: 240-453-8428

    HHS-PSC000138

    (b) (7)(A)

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  • 8/10/2019 HHS Combined FOIA Production

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    Kabak, Shara HHS/OPHS/ORI)

    From:

    Sent:

    Brodnicki, Gretchen A [[email protected]]

    Wednesday, October 19, 2011 2:55 PM

    To:

    Kabak, Shara (HHS/OPHS/ORI)

    Subject:

    RE:

    Shara,

    Thank you for the extension, and for

    your

    advice

    with

    respect

    to

    the need for two reports. We will handle accordingly.

    Thanks,

    Gretchen

    From: Kabak, Shara (HHS/OPHS/ORI) [mailto:[email protected]]

    Sent:

    Wednesday, October 19 2011 2:32 PM

    To: Brodnicki, Gretchen A.

    Subject: RE:

    Gretchen,

    Thank you for the update. I appreciate the extra work you had to do after interviewing the complainant, and grant you a

    9 day extension. We will expect

    the

    investigation report around January 16 2012.

    Please feel free to contact me with any questions.

    Regards,

    Shara

    From: Brodnicki, Gretchen

    A.

    [mailto:Gretchen [email protected]]

    Sent: Wednesday, October 19 2011 1:01 PM

    To: Kabak, Shara (HHS/OPHS/ORI)

    Subject: RE:

    Dear Shara,

    t

    1

    HHS-PSC000140

    (b) (7)(A)

    (b) (7)(A)

    (b) (7)(A)

    (b) (7)(A)

    (b) (7)(A)

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    Thanks,

    Gretchen

    From: Kabak,

    Shara

    (HHS/OPHS/ORI) [mailto:[email protected]]

    Sent:

    Wednesday, October

    19 2011 12:38 PM

    To: Brodnicki, Gretchen A.

    Subject:

    Hi

    Gretchen,

    Thank you,

    Shara

    Shara Kabak,

    PhD

    Office

    of

    Research

    Integrity

    Division

    of

    Investigative Oversight

    Phone:

    240-453-8428

    2

    HHS-PSC000141

    (b) (7)(A)

    (b) (7)(A)

  • 8/10/2019 HHS Combined FOIA Production

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    Lipshultz, Gary HHS/OASH)

    From:

    Sent:

    To:

    Subject:

    Gretchen,

    Lipshultz, Gary (HHS/OASH)

    Wednesday, October 19,

    2011

    1 39

    PM

    '8rodnicki, Gretchen A.'

    RE: Request for status of 010 Cases

    Thank you for your

    prompt

    reply. The extensions you requested have been granted.

    is

    listed

    as an

    unknown

    respondent which stemmed from a telephone call with Dr. Dahlberg and Ms. Bit tinge were allegations

    of

    plagiarism; falsification and fabrication in a presentation. The phone call took place on August

    2,

    2011.

    Gary

    From:

    Brodnicki, Gretchen

    A.

    [mailto:Gretchen [email protected]

    Sent

    Wednesday, October

    19

    2 111:15 PM

    To:

    Lipshultz, Gary (HHS/OASH)

    Cc: Dahlberg, John E (HHS/OASH)

    Subject:

    RE:

    Request for status

    of 1

    Cases

    Gary and John,

    I sincerely apologize. In reviewing the case files, I thought I had responded

    to

    John about case number Instead,

    however, I mistakenly updated Dr. Ambalavanar on case with data about the status

    of

    I apologize and will

    be

    correcting that immediately.

    In

    the meantime, here

    is

    information our status on these matters, and our requests

    for

    extensions where necessary:

    1

    HHS-PSC000142

    (b) (7)(A)

    (b) (7)(A)

    (b) (7)(A)

    Non-responsive

    NR

    NR(b) (7)(A)

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    Dahlberg. John E HHS/OASH)

    From:

    Sent:

    To:

    Subject:

    Dear Mr. Dahlberg

    Monday, March 21,20113:16 PM

    Dahlberg, John E (HHS/OASH)

    request

    Thanks

    1

    HHS-PSC000144

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)(b) (6), (b)(7)(C)

    (b) (7)(A)

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    Dahlberg. John E HHS/OASH)

    From:

    Sent:

    To:

    Cc:

    Subject:

    Dear Dr. Dahlberg,

    Thursday, February 24, 2011 3:52 PM

    Dahlberg, John E (HHS/OASH)

    Jeff Sprung; Alan - Price

    I would like to know whether Fred Hutchinson Cancer Research Center submitted to ORI (or another

    government agency) the results

    of

    their preliminary assessment of

    Regards,

    On 30 Jan 2011, at 08:59, Dahlberg, John E (HHS/OASH) wrote:

    I will attempt to answer your questions for all of the recipients of this email, as quite likely I would have been

    asked to do so in any event. I am sympathetic to your concerns as the complaint in these two cases that the

    process has been protracted, and has not reached closure. However,42 C.F.F Part 93 is pretty clear that once

    allegations are made and considered to meet the definition of research misconduct, the inquiry and investigation

    process should be overseen by neutral unbiased institutional officials and scientists comprising the committees.

    The complainant mayor may not be a useful fact witness, depending on circumstances, but has no special status

    beyond being a possible fact witness. f you fell you have identified additional evidence ofpossible value to an

    ongoing process, the institution is expected to consider it, and

    if

    not, ORI would do so during its oversight

    review that begins after receipt of the final investigation report.

    You correctly note that the regulation does not require that the complainant be provided all

    of

    portions

    of

    either

    the inquiry or investiqation report for review. It is not a complainant s responsibility to judge the merits

    of

    the

    evidence for or against findings

    of

    misconduct. Such decisions are quite complex and based on far more that

    1 HHS-PSC000145

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (7)(A)

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    simply demonstrating that a figure or statement is wrong or falsified. I

    Sincerely,

    John Dahlberg, Ph.D

    Director, Divison

    of

    Investigative Oversight

    Office

    of

    Research Integrity

    Sent: Thursday, January 27,2011 4:32 P

    To: S OPHS askORI (HHS/OPHS)

    Subject: to Dr. John Dahlberg

    This email is directed to the following individual:

    John Dahlberg, Ph.D., Director of Division oflnvestigative Oversight,

    I am writing to ask your opinion regarding PHS Policies

    on

    Research Misconduct, 42 CFR Part 93.

    It

    states that

    a requirement

    of

    an institution that accepts PHS funds for research includes: A thorough, competent, objective,

    and fair response to allegations

    of

    research misconduct consistent with, and within the time limits

    of

    the final

    rule, including precautions to ensure that individuals responsible for carrying out any part

    of

    the research

    misconduct proceeding do not have unresolved personal, professional, or financial conflicts

    of

    interest with the

    complainant, respondent, or witnesses.

    Regards,

    2

    HHS-PSC000146

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    CASE SUMMARY no names):

    3

    HHS-PSC000147

    (b) (6), (b)(7)(C)

    (b) (7)(A)

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    HHS-PSC000148

    (b) (7)(A)(b) (6), (b)(7)(C)

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    I will attempt to answer your questions for all of the recipients

    of

    this email, quite likely I would have been

    asked to do so in any event. I am sympathetic to your concerns as the complaint in these two cases that the

    process has been protracted, and has not reached closure. However, 42 C.F.F Part 93 is pretty clear that once

    allegations are made and considered to meet the definition of research misconduct, the inquiry and investigation

    process should be overseen by neutral unbiased institutional officials and scientists comprising the committees.

    The complainant mayor may not be a useful fact witness, depending on circumstances, but has no special status

    beyond being a possible fact witness. If you fell you have identified additional evidence of possible value to an

    ongoing process, the institution is expected to consider it, and

    if

    not, ORI would do so during its oversight

    review that begins after receipt

    ofthe

    final investigation report.

    You correctly note that the regulation does not require that the complainant be provided all of portions of either

    the inquiry or investiqation report for review.

    It

    is not a complainant's responsibility to judge the merits of the

    evidence for or against findings of misconduct. Such decisions are quite complex and based on far more that

    simply demonstrating that a figure or statement is wrong or falsified.

    Sincerely,

    John Dahlberg, Ph.D

    Director, Divison of Investigative Oversight

    Office

    of

    Research Integrity

    From

    Sent: Thursday, January 27, 2 114:32 PM

    To: OS OPHS askORI (HHS/OPHS)

    Subject: to Dr. John Dahlberg

    This email is directed to the following individual:

    John Dahlberg, Ph.D., Director

    of

    Division

    of

    Investigative Oversight,

    I am writing to ask your opinion regarding PHS Policies on Research Misconduct, 42 CFR Part 93.

    It

    states that

    a requirement

    of

    an institution that accepts PHS funds for research includes: A thorough, competent, objective,

    and fair response to allegations of research misconduct consistent with, and within the time limits

    of

    the final

    rule, including precautions to ensure that individuals responsible for carrying out any part of the research

    misconduct proceeding do not have unresolved personal, professional, or financial conflicts of interest with the

    complainant, respondent, or witnesses.

    I have two questions regarding this policy and would like to hear your opinion.

    2

    HHS-PSC000150

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

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    Regards,

    CASE SUMMARY no names):

    3

    HHS-PSC000151

    (b) (6), (b)(7)(C)

    (b) (6), (b)(7)(C)

    (b) (7)(A)

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    HHS-PSC000152

    (b) (7)(A)

    (b) (6), (b)(7)(C)

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    Dahlberg, John E HHS/OASH)

    From:

    Sent:

    To:

    Cc:

    Dahlberg,

    John E

    (HHS/OASH)

    Sunday, January 30, 2011 12:00 PM

    Subject:

    Dahlberg,

    John E (HHS/OASH)

    RE:

    to Dr

    John

    Dahlberg

    I

    will

    attempt

    to