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The web site itself may have changed. You can check the current page or check for previous versions at the Internet Archive. Yahoo! is not affiliated with the authors of this page or responsible for its content. Albany College of Pharmacy i Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct (Approved bythe Faculty, October 16, 1997) (Items in bold italics are suggested revisions following faculty approval and prior to Trusttee approval) Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct ii Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct Table of Contents I. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
A. General Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 B. Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 II. Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 III. Rights and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
A. Research Integrity Officer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 B. Whistleblower . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 C. Respondent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 D. Deciding Official . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 IV. General Policies and Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
A. Responsibility to Report Misconduct . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 B. Protecting the Whistleblower . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6 C. Protecting the Respondent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 D. Cooperation with Inquiries and Investigations . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 E. Preliminary Assessment of Allegations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7 V. Conducting the Inquiry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
A. Initiation and Purpose of the Inquiry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 B. Sequestration of the Research Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 C. Appointment of the Inquiry Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 D. Charge to the Committee and the First Meeting . . . . . . . . . . . . . . . . . . . . . . . . . . 8 E. Inquiry Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 VI. The Inquiry Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
A. Elements of the Inquiry Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 B. Comments on the Draft Report by the Respondent and the Whistleblower . . . 8-9 C. Inquiry Decision and Notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 D. Time Limit for Completing the Inquiry Report . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct iii VII. Conducting the Investigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
A. Purpose of the Investigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 B. Sequestration of the Research Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 C. Appointment of the Investigation Committee . . . . . . . . . . . . . . . . . . . . . . . . 10-11 D. Charge to the Committee and the First Meeting . . . . . . . . . . . . . . . . . . . . . . . . . 11 E. Investigation Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 VIII. The Investigation Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 A. Elements of the Investigation Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 B. Comments on the Draft Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-13 C. Institutional Review and Decision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 D. Transmittal of the Final Investigation Report to ORI . . . . . . . . . . . . . . . . . . . . . 13 E. Time Limit for Completing the Investigation Report . . . . . . . . . . . . . . . . . . . . . 13 IX. Requirements for Reporting to ORI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-15 X. Institutional Administrative Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 XI. Other Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
A. Termination of Institutional Employment or Resignation Prior to Completing
Inquiry or Investigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 B. Restoration of the Respondent's Reputation . . . . . . . . . . . . . . . . . . . . . . . . . 15-16 C. Protection of the Whistleblower and Others . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 D. Allegations Not Made in Good Faith . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 E. Interim Administrative Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 XII. Record Retention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 1 I. Introduction
A. General Policy The Albany College of Pharmacy was founded in 1881, and is one of the oldest and
most well-respected colleges of pharmacy in the country. Although excellence in
student education is the College's primary function, research in the areas of faculty
development and student training is becoming increasingly important. It is of
paramount importance that research at ACP is conducted in a highly ethical and
responsible mannor. In this regard, ACP has adopted the current policy for fairly
dealing with scientific misconduct. B. Scope This policy and the associated procedures apply to all individuals at Albany College
of Pharmacy engaged in research that is supported by or for which supportis
requested from Public Health Service (PHS). The PHS regulation at 42 C.F.R. Part
50, Subpart A (Federal Register reference) applies to any research, research-training
or research-related grant or cooperative agreement with PHS. This policy applies to
any person engaged in research that is paid by, under the control of, or affiliated
with the institution, such as scientists, trainees, technicians and other staff members,
students, fellows, guest researchers, or collaborators at Albany College of Pharmacy. The policy and associated procedures will normally be followed when an allegation
of possible misconduct in science is received by an institutional official. Particular
circumstances in an individual case may dictate variation from the normal procedure
deemed in the best interests of Albany College of Pharmacy and PHS. Any change
from normal procedures also must ensure fair treatment to the subject of the inquiry
or investigation. Any significant variation should be approved in advance by the
Director of Research Administration of Albany College of Pharmacy. II. Definitions A. Allegation means any written or oral statement or other indication of possible
scientific misconduct made to an institutional official. B. Conflict of interest means the real or apparent interference of one person's interests
with the interests of another person, where potential bias may occur due to prior or
existing personal or professional relationships. C. Deciding Official means the institutional official who makes final determinations on Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 2 allegations of scientific misconduct and any responsive institutional actions. The
Deciding Official will not be the same individual as the Research Integrity Officer
and should have no direct prior involvement in the institution's inquiry, investigation,
or allegation assessment. For ACP, the Deciding Official will be the President and
Dean. D. Good faith allegation means an allegation made with the honest belief that scientific
misconduct may have occurred. An allegation is not in good faith if it is made with
reckless disregard for or willful ignorance of facts that would disprove the allegation. E. Inquiry means gathering information and initial fact-finding to determine whether
an allegation or apparent instance of scientific misconduct warrants an investigation. 1 F. Investigation means the formal examination and evaluation of all relevant facts to
determine if misconduct has occurred, and, if so, to determine the responsible person
and the seriousness of the misconduct. 2 G. ORI means the Office of Research Integrity, the office within the U.S. Department
of Health and Human Services (DHHS) that is responsible for the scientific
misconduct and research integrity activities of the U.S. Public Health Service. H. PHS means the U.S. Public Health Service, an operating component of the DHHS. I. PHS regulation means the Public Health Service regulation establishing standards
for institutional inquiries and investigations into allegations of scientific misconduct,
which is set forth at 42 C.F.R. Part 50, Subpart A, entitled "Responsibility of PHS
Awardee and Applicant Institutions for Dealing With and Reporting Possible
Misconduct in Science." J. PHS support means PHS grants, contracts, or cooperative agreements or applications
to PHS. K. Research Integrity Officer means the institutional official responsible for assessing
allegations of scientific misconduct and determining when such allegations warrant
inquiries and for overseeing inquiries and investigations. L. Research record means any data, document, computer file, computer diskette, or any Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 3 other written or non-written account or object that reasonably may be expected to
provide evidence or information regarding the proposed, conducted, or reported
research that constitutes the subject of an allegation of scientific misconduct. A
research record includes, but is not limited to, grant or contract applications, whether
funded or unfunded; grant or contract progress and other reports; laboratory
notebooks; notes; correspondence; videos; photographs; X-ray film; slides;
biological materials; computer files and printouts; manuscripts and publications;
equipment use logs; laboratory procurement records; animal facility records; human
and animal subject protocols; consent forms; medical charts; and patient research
files. M. Respondent means the person against whom an allegation of scientific misconduct
is directed or the person whose actions are the subject of the inquiry or investigation.
There can be more than one respondent in any inquiry or investigation. N. Retaliation means any action that adversely affects the employment or other
institutional status of an individual that is taken by an institution or an employee
because the individual has in good faith, made an allegation of scientific misconduct
or of inadequate institutional response thereto or has cooperated in good faith with
an investigation of such allegation. O. Scientific misconduct or misconduct in science means 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. 3 P. Whistleblower means a person who makes an allegation of scientific misconduct. Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 4 III. Rights and Responsibilities A. Research Integrity Officer
The President and Dean of ACP will appoint the Research Integrity Officer who will
have primary responsibility for implementation of the procedures set forth in this
document. The Research Integrity Officer will be an institutional official who is well
qualified to handle the procedural requirements involved and is sensitive to the
varied demands made on those who conduct research, those who are accused of
misconduct, and those who report apparent misconduct in good faith. The Research Integrity Officer will appoint the inquiry and investigation committees
and ensure that necessary and appropriate expertise is secured to carry out a thorough
and authoritative evaluation of the relevant evidence in an inquiry or investigation.
The Research Integrity Officer will attempt to ensure that confidentiality is
maintained. The Research Integrity Officer will assist inquiry and investigation committees and
all institutional personnel in complying with these procedures and with applicable
standards imposed by government or external funding sources. The Research
Integrity Officer is also responsible for maintaining files of all documents and
evidence and for the confidentiality and the security of the files. The Research Integrity Officer will report to the Office of Research Integrity (ORI)
as required by regulation and keep ORI apprised of any developments during the
course of the inquiry or investigation that may affect current or potential DHHS
funding for the individual(s) under investigation or that PHS needs to know to ensure
appropriate use of Federal funds and otherwise protect the public interest. 4 B. Whistleblower
The whistleblower will have an opportunity to testify before the inquiry and
investigation committees, to review portions of the inquiry and investigation reports
pertinent to his/her allegations or testimony, to be informed of the results of the
inquiry and investigation, and to be protected from retaliation. Also, if the Research
Integrity Officer has determined that the whistleblower may be able to provide
pertinent information on any portions of the draft report, these portions will be given
to the whistleblower for comment. The whistleblower is responsible for making allegations in good faith, maintaining confidentiality, and cooperating with an inquiry or investigation. Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 5 C. Respondent
The respondent will be informed of the allegations when an inquiry is opened and
notified in writing of the final determinations and resulting actions. The respondent
will also have the opportunity to be interviewed by and present evidence to the
inquiry and investigation committees, to review the draft inquiry and investigation
reports, and to have the advice of counsel. The respondent is responsible for maintaining confidentiality and cooperating with
the conduct of an inquiry or investigation. If the respondent is not found guilty of
scientific misconduct, he or she has the right to receive institutional assistance in
restoring his or her reputation. 5 D. Deciding Official
The Deciding Official (President and Dean) will receive the inquiry and/or
investigation report and any written comments made by the respondent or the
whistleblower on the draft report. The Deciding Official will consult with the
Research Integrity Officer or other appropriate officials and will determine whether
to conduct an investigation, whether misconduct occurred, whether to impose
sanctions, or whether to take other appropriate administrative actions [see section X]. IV. General Policies and Principles A. Responsibility to Report Misconduct
All employees or individuals associated with Albany College of Pharmacy should
report observed, suspected, or apparent misconduct in science to the Research
Integrity Officer. If an individual is unsure whether a suspected incident falls within
the definition of scientific misconduct, he or she may call the Research Integrity
Officer or the Office of the President to discuss the suspected misconduct informally.
If the circumstances described by the individual do not meet the definition of
scientific misconduct, the Research Integrity Officer will refer the individual or
allegation to other offices or officials with responsibility for resolving the problem. At any time, an employee may have confidential discussions and consultations about
concerns of possible misconduct with the Research Integrity Officer and will be
counseled about appropriate procedures for reporting allegations. B. Protecting the Whistleblower
The Research Integrity Officer will monitor the treatment of individuals who bring
allegations of misconduct or of inadequate institutional response thereto, and those Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 6 who cooperate in inquiries or investigations. The Research Integrity Officer will
ensure that these persons will not be retaliated against in the terms and conditions of
their employment or other status at the institution and will review instances of
alleged retaliation for appropriate action. Employees should immediately report any alleged or apparent retaliation to the
Research Integrity Officer. Also the institution will protect the privacy of those who report misconduct in good
faith 6 to the maximum extent possible. For example, if the whistleblower requests anonymity, the institution will make an effort to honor the request during the
allegation assessment or inquiry within applicable policies and regulations and state
and local laws, if any. The whistleblower will be advised that if the matter is
referred to an investigation committee and the whistleblower's testimony is required,
anonymity may no longer be guaranteed. Institutions are required to undertake
diligent efforts to protect the positions and reputations of those persons who, in good
faith, make allegations. 7 C. Protecting the Respondent
Inquiries and investigations will be conducted in a manner that will ensure fair
treatment to the respondent(s) in the inquiry or investigation and confidentiality to
the extent possible without compromising public health and safety or thoroughly
carrying out the inquiry or investigation. 8 The respondant will have the right to see all documentation accumulated during
the investigation. In addition, the respondant will have the opportunity to request
specific information (in writing) from the whistlebower(s). Institutional employees accused of scientific misconduct may consult with legal
counsel or a non-lawyer personal adviser (who is not a principal or witness in the
case) to seek advice. D. Cooperation with Inquiries and Investigations
Institutional employees will cooperate with the Research Integrity Officer and other
institutional officials in the review of allegations and the conduct of inquiries and
investigations. Employees have an obligation to provide relevant evidence to the
Research Integrity Officer or other institutional officials on misconduct allegations. E. Preliminary Assessment of Allegations
Upon receiving an allegation of scientific misconduct, the Research Integrity Officer
will immediately assess the allegation to determine whether there is sufficient Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 7 evidence to warrant an inquiry, whether PHS support or PHS applications for
funding are involved, and whether the allegation falls under the PHS definition of
scientific misconduct. V. Conducting the Inquiry A. Initiation and Purpose of the Inquiry
Following the preliminary assessment, if the Research Integrity Officer determines
that the allegation provides sufficient information to allow specific follow-up,
involves PHS support, and falls under the PHS definition of scientific misconduct,
he or she will immediately initiate the inquiry process. In initiating the inquiry, the
Research Integrity Officer should identify clearly the original allegation and any
related issues that should be evaluated. The purpose of the inquiry is to make a
preliminary evaluation of the available evidence and testimony of the respondent,
whistleblower, and key witnesses to determine whether there is sufficient evidence
of possible scientific misconduct to warrant an investigation. The purpose of the
inquiry is not to reach a final conclusion about whether misconduct definitely
occurred or who was responsible. The findings of the inquiry must be set forth in an
inquiry report. B. Sequestration of the Research Records
After determining that an allegation falls within the definition of misconduct in
science and involves PHS funding, the Research Integrity Officer must ensure that
all original research records and materials relevant to the allegation are immediately
secured. The Research Integrity Officer may consult with ORI for advice and
assistance in this regard. C. Appointment of the Inquiry Committee
The Research Integrity Officer, in consultation with other institutional officials as
appropriate, will appoint an inquiry committee and committee chair within 10 days
of the initiation of the inquiry. The inquiry committee should consist of individuals
who do not have real or apparent conflicts of interest in the case, are unbiased, and
have the necessary expertise to evaluate the evidence and issues related to the
allegation, interview the principals and key witnesses, and conduct the inquiry.
These individuals may be scientists, subject matter experts, administrators, lawyers,
or other qualified persons, and they may be from inside or outside the institution. The Research Integrity Officer will notify the respondent of the proposed committee
membership in 10 days. If the respondent submits a written objection to any
appointed member of the inquiry committee or expert based on bias or conflict of
interest within 5 days, the Research Integrity Officer will determine whether to
replace the challenged member or expert with a qualified substitute. Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 8 D. Charge to the Committee and the First Meeting
The Research Integrity Officer will prepare a charge for the inquiry committee that
describes the allegations and any related issues identified during the allegation
assessment and states that the purpose of the inquiry is to make a preliminary
evaluation of the evidence and testimony of the respondent, whistleblower, and key
witnesses to determine whether there is sufficient evidence of possible scientific
misconduct to warrant an investigation as required by the PHS regulation. The
purpose is not to determine whether scientific misconduct definitely occurred or who
was responsible. At the committee's first meeting, the Research Integrity Officer will review the
charge with the committee, discuss the allegations, any related issues, and the
appropriate procedures for conducting the inquiry, assist the committee with
organizing plans for the inquiry, and answer any questions raised by the committee.
The Research Integrity Officer and institutional counsel will be present or available
throughout the inquiry to advise the committee as needed. E. Inquiry Process The inquiry committee will normally interview the whistleblower, the respondent,
and key witnesses as well as examining relevant research records and materials.
Then the inquiry committee will evaluate the evidence and testimony obtained during
the inquiry. After consultation with the Research Integrity Officer and institutional
counsel, the committee members will decide whether there is sufficient evidence of
possible scientific misconduct to recommend further investigation. The scope of the
inquiry does not include deciding whether misconduct occurred or conducting
exhaustive interviews and analyses. VI. The Inquiry Report A. Elements of the Inquiry Report
A written inquiry report must be prepared that states the name and title of the
committee members and experts, if any; the allegations; the PHS support; a summary
of the inquiry process used; a list of the research records reviewed; summaries of any
interviews; a description of the evidence in sufficient detail to demonstrate whether
and investigation is warranted or not; and the committee's determination as to
whether an investigation is recommended and whether any other actions should be
taken if an investigation is not recommended. Institutional counsel will review the
report for legal sufficiency. B. Comments on the Draft Report by the Respondent and the Whistleblower
The Research Integrity Officer will provide the respondent with a copy of the draft
inquiry report for comment and rebuttal and will provide the whistleblower, if he or
she is identifiable, with portions of the draft inquiry report that address the Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 9 whistleblower's role and opinions in the investigation. 1. Confidentiality
The Research Integrity Officer may establish reasonable conditions for
review to protect the confidentiality of the draft report. 2. Receipt of Comments
Within 14 calendar days of their receipt of the draft report, the whistleblower
and respondent will provide their comments, if any, to the inquiry committee.
Any comments that the whistleblower or respondent submits on the draft
report will become part of the final inquiry report and record. 9 Based on the comments, the inquiry committee may revise the report as appropriate. C. Inquiry Decision and Notification 1. Decision by Deciding Official
The Research Integrity Officer will transmit the final report and any
comments to the Deciding Official, who will make the determination of
whether findings from the inquiry provide sufficient evidence of possible
scientific misconduct to justify conducting an investigation. The inquiry is
completed when the Deciding Official makes this determination, which will
be made within 90 days of the first meeting of the inquiry committee. Any
extension of this period will be based on good cause and recorded in the
inquiry file. 2. Notification
The Research Integrity Officer will notify both the respondent and the
whistleblower in writing of the Deciding Official's decision of whether to
proceed to an investigation and will remind them of their obligation to
cooperate in the event an investigation is opened. The Research Integrity
Officer will also notify all appropriate institutional officials of the Deciding
Official's decision. D. Time Limit for Completing the Inquiry Report
The inquiry committee will normally complete the inquiry and submit its report in
writing to the Research Integrity Officer no more than 60 calendar days following
its first meeting, 10 unless the Research Integrity Officer approves an extension for good cause. If the Research Integrity Officer approves an extension, the reason for
the extension will be entered into the records of the case and the report. 11 The respondent also will be notified of the extension. VII. Conducting the Investigation Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 10 A. Purpose of the Investigation
The purpose of the investigation is to explore in detail the allegations, to examine the
evidence in depth, and to determine specifically whether misconduct has been
committed, by whom, and to what extent. The investigation will also determine
whether there are additional instances of possible misconduct that would justify
broadening the scope beyond the initial allegations. This is particularly important
where the alleged misconduct involves clinical trials or potential harm to human
subjects or the general public or if it affects research that forms the basis for public
policy, clinical practice, or public health practice. The findings of the investigation
will be set forth in an investigation report. Legal counsel will be consulted prior to the start of the investigation to ensure that
the investigation is performed in a manner consistent with the legal rights of all
individuals involved. B. Sequestration of the Research Records
The Research Integrity Officer will immediately sequester any additional pertinent
research records that were not previously sequestered during the inquiry. This
sequestration should occur before or at the time the respondent is notified that an
investigation has begun. The need for additional sequestration of records may occur
for any number of reasons, including the institution's decision to investigate
additional allegations not considered during the inquiry stage or the identification of
records during the inquiry process that had not been previously secured. The
procedures to be followed for sequestration during the investigation are the same
procedures that apply during the inquiry. C. Appointment of the Investigation Committee
The Research Integrity Officer, in consultation with other institutional officials as
appropriate, will appoint an investigation committee and the committee chair within
10 days of the notification to the respondent that an investigation is planned or as
soon thereafter as practicable (within 30 days of the completion of the inquiry). The
investigation committee should consist of at least three individuals who do not have
real or apparent conflicts of interest in the case, are unbiased, and have the necessary
expertise to evaluate the evidence and issues related to the allegations, interview the
principals and key witnesses, and conduct the investigation. 12 These individuals may be scientists, administrators, subject matter experts, lawyers, or other qualified
persons, and they may be from inside or outside the institution. Individuals
appointed to the investigation committee may also have served on the inquiry
committee. The Research Integrity Officer will notify the respondent of the proposed committee
membership within 5 days. If the respondent submits a written objection to any
appointed member of the investigation committee or expert, the Research Integrity Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 11 Officer will determine whether to replace the challenged member or expert with a
qualified substitute. D. Charge to the Committee and the First Meeting 1. Charge to the Committee
The Research Integrity Officer will define the subject matter of the
investigation in a written charge to the committee that describes the
allegations and related issues identified during the inquiry, defines scientific
misconduct, and identifies the name of the respondent. The charge will state
that the committee is to evaluate the evidence and testimony of the
respondent, whistleblower, and key witnesses to determine whether, based
on a preponderance of the evidence, scientific misconduct occurred and, if
so, to what extent, who was responsible, and its seriousness. During the investigation, if additional information becomes available that
substantially changes the subject matter of the investigation or would suggest
additional respondents, the committee will notify the Research Integrity
Officer, who will determine whether it is necessary to notify the respondent
of the new subject matter or to provide notice to additional respondents. 2. The First Meeting
The Research Integrity Officer, with the assistance of institutional counsel,
will convene the first meeting of the investigation committee to review the
charge, the inquiry report, and the prescribed procedures and standards for
the conduct of the investigation, including the necessity for confidentiality
and for developing a specific investigation plan. The investigation
committee will be provided with a copy of these instructions and, where PHS
funding is involved, the PHS regulation. E. Investigation Process
The investigation committee will be appointed and the process initiated within 30
days of the completion of the inquiry, if findings from that inquiry provide a
sufficient basis for conducting an investigation. 13 The investigation will normally involve examination of all documentation including,
but not necessarily limited to, relevant research records, computer files, proposals,
manuscripts, publications, correspondence, memoranda, and notes of telephone
calls. 14 Whenever possible, the committee should interview the whistleblower(s), the respondents(s), and other individuals who might have information regarding aspects
of the allegations. 15 Interviews of the respondent should be tape recorded or transcribed. All other interviews should be transcribed, tape recorded, or
summarized. Summaries or transcripts of the interviews should be prepared, Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 12 provided to the interviewed party for comment or revision, and included as part of
the investigatory file. 16 VIII. The Investigation Report A. Elements of the Investigation Report
The final report submitted to ORI must describe the policies and procedures under
which the investigation was conducted, describe how and from whom information
relevant to the investigation was obtained, state the findings, and explain the basis
for the findings. The report will include the actual text or an accurate summary of
the views of any individual(s) found to have engaged in misconduct as well as a
description of any sanctions imposed and administrative actions taken by the
institution. 17 B. Comments on the Draft Report 1. Respondent
The Research Integrity Officer will provide the respondent with a copy of the
draft investigation report for comment and rebuttal. The respondent will be
allowed 14 days to review and comment on the draft report. The
respondent's comments will be attached to the final report. The findings of
the final report should take into account the respondent's comments in
addition to all the other evidence. The respondent has the right to review the draft investigation report with
his / her legal counsel or personal advisor as described previously. 2. Whistleblower
The Research Integrity Officer will provide the whistleblower, if he or she
is identifiable, with those portions of the draft investigation report that
address the whistleblower's role and opinions in the investigation. The report
should be modified, as appropriate, based on the whistleblower's comments. 3. Institutional Counsel
The draft investigation report will be transmitted to the institutional counsel
for a review of its legal sufficiency. Comments should be incorporated into
the report as appropriate. 4. Confidentiality
In distributing the draft report, or portions thereof, to the respondent and
whistleblower, the Research Integrity Officer will inform the recipient of the Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 13 confidentiality under which the draft report is made available and may
establish reasonable conditions to ensure such confidentiality. For example,
the Research Integrity Officer may request the recipient to sign a
confidentiality statement or to come to his or her office to review the report. C. Institutional Review and Decision
Based on a preponderance of the evidence, the Deciding Official will make the final
determination whether to accept the investigation report, its findings, and the
recommended institutional actions. If this determination varies from that of the
investigation committee, the Deciding Official will explain in detail the basis for
rendering a decision different from that of the investigation committee in the
institution's letter transmitting the report to ORI. The Deciding Official's explanation
should be consistent with the PHS definition of scientific misconduct, the
institution's policies and procedures, and the evidence reviewed and analyzed by the
investigation committee. The Deciding Official may also return the report to the
investigation committee with a request for further fact-finding or analysis. The
Deciding Official's determination, together with the investigation committee's report,
constitutes the final investigation report for purposes of ORI review. When a final decision on the case has been reached, the Research Integrity Officer
will notify both the respondent and the whistleblower in writing. In addition, the
Deciding Official will determine whether law enforcement agencies, professional
societies, professional licensing boards, editors of journals in which falsified reports
may have been published, collaborators of the respondent in the work, or other
relevant parties should be notified of the outcome of the case. The Research
Integrity Officer is responsible for ensuring compliance with all notification
requirements of funding or sponsoring agencies. D. Transmittal of the Final Investigation Report to ORI
After comments have been received and the necessary changes have been made to
the draft report, the investigation committee should transmit the final report with
attachments, including the respondent's and whistleblower's comments, to the
Deciding Official, through the Research Integrity Officer. E. Time Limit for Completing the Investigation Report
An investigation should ordinarily be completed within 120 days of its initiation, 18 with the initiation being defined as the first meeting of the investigation committee.
This includes conducting the investigation, preparing the report of findings, making
the draft report available to the subject of the investigation for comment, submitting
the report to the Deciding Official for approval, and submitting the report to the
ORI. 19 IX. Requirements for Reporting to ORI Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 14 A. An institution's decision to initiate an investigation must be reported in writing to the
Director, ORI, on or before the date the investigation begins. 20 At a minimum, the notification should include the name of the person(s) against whom the allegations
have been made, the general nature of the allegation as it relates to the PHS
definition of scientific misconduct, and the PHS applications or grant number(s)
involved. 21 ORI must also be notified of the final outcome of the investigation and must be provided with a copy of the investigation report. 22 Any significant variations from the provisions of the institutional policies and procedures should be explained
in any reports submitted to ORI. B. If an institution plans to terminate an inquiry or investigation for any reason without
completing all relevant requirements of the PHS regulation, the Research
Integrity Officer will submit a report of the planned termination to ORI, including
a description of the reasons for the proposed termination. 23 C. If the institution determines that it will not be able to complete the investigation in
120 days, the Research Integrity Officer will submit to ORI a written request for an
extension that explains the delay, reports on the progress to date, estimates the date
of completion of the report, and describes other necessary steps to be taken. If the
request is granted, the Research Integrity Officer will file periodic progress reports
as requested by the ORI. 24 D. When PHS funding or applications for funding are involved and an admission of
scientific misconduct is made, the Research Integrity Officer will contact ORI for
consultation and advice. Normally, the individual making the admission will be
asked to sign a statement attesting to the occurrence and extent of misconduct. When
the case involves PHS funds, the institution cannot accept an admission of scientific
misconduct as a basis for closing a case or not undertaking an investigation without
prior approval from ORI. 25 E. The Research Integrity Officer will notify ORI at any stage of the inquiry or
investigation if: 1. there is an immediate health hazard involved; 26 2. there is an immediate need to protect Federal funds or equipment; 27 3. there is an immediate need to protect the interests of the person(s) making the
allegations or of the individual(s) who is the subject of the allegations as well
as his/her co-investigators and associates, if any; 28 4. it is probable that the alleged incident is going to be reported publicly; 29 or 5. the allegation involves a public health sensitive issue, e.g., a clinical trial; or 6. there is a reasonable indication of possible criminal violation. In this Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 15 instance, the institution must inform ORI within 24 hours of obtaining that
information. 30 X. Institutional Administrative Actions Albany College of Pharmacy will take appropriate administrative actions against individuals
when an allegation of misconduct has been substantiated (at the conclusion of the
investigation). 31 If the Deciding Official determines that the alleged misconduct is substantiated by the
findings, he or she will decide on the appropriate actions to be taken, after consultation with
the Research Integrity Officer. The actions may include: ! withdrawal or correction of all pending or published abstracts and papers emanating
from the research where scientific misconduct was found. ! removal of the responsible person from the particular project, letter of reprimand,
special monitoring of future work, probation, suspension, salary reduction, or
initiation of steps leading to possible rank reduction or termination of employment; ! restitution of funds as appropriate. XI. Other Considerations A. Termination of Institutional Employment or Resignation Prior to Completing Inquiry
or Investigation The termination of the respondent's institutional employment, by resignation or
otherwise, before or after an allegation of possible scientific misconduct has been
reported, will not preclude or terminate the misconduct procedures. If the respondent, without admitting to the misconduct, elects to resign his or her
position prior to the initiation of an inquiry, but after an allegation has been reported,
or during an inquiry or investigation, the inquiry or investigation will proceed. If the
respondent refuses to participate in the process after resignation, the committee will
use its best efforts to reach a conclusion concerning the allegations, noting in its
report the respondent's failure to cooperate and its effect on the committee's review
of all the evidence. B. Restoration of the Respondent's Reputation
If the institution finds no misconduct and ORI concurs, after consulting with the
respondent, the Research Integrity Officer will undertake reasonable efforts to
restore the respondent's reputation. Depending on the particular circumstances, the
Research Integrity Officer should consider notifying those individuals aware of or
involved in the investigation of the final outcome, publicizing the final outcome in
forums in which the allegation of scientific misconduct was previously publicized,
or expunging all reference to the scientific misconduct allegation from the Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 16 respondent's personnel file. Any institutional actions to restore the respondent's
reputation must first be approved by the Deciding Official. C. Protection of the Whistleblower and Others 32 Regardless of whether the institution or ORI determines that scientific misconduct
occurred, the Research Integrity Officer will undertake reasonable efforts to protect
whistleblowers who made allegations of scientific misconduct in good faith and
others who cooperate in good faith with inquiries and investigations of such
allegations. Upon completion of an investigation, the Deciding Official will
determine, after consulting with the whistleblower, what steps, if any, are needed to
restore the position or reputation of the whistleblower. The Research Integrity
Officer is responsible for implementing any steps the Deciding Official approves.
The Research Integrity Officer will also take appropriate steps during the inquiry and
investigation to prevent any retaliation against the whistleblower. D. Allegations Not Made in Good Faith
If relevant, the Deciding Official will determine whether the whistleblower's
allegations of scientific misconduct were made in good faith. If an allegation was
not made in good faith, the Deciding Official will determine whether any
administrative action should be taken against the whistleblower. E. Interim Administrative Actions
Institutional officials will take interim administrative actions, as appropriate, to
protect Federal funds and ensure that the purposes of the Federal financial assistance
are carried out. 33 XII. Record Retention After completion of a case and all ensuing related actions, the Research Integrity Officer will
prepare a complete file, including the records of any inquiry or investigation and copies of
all documents and other materials furnished to the Research Integrity Officer or committees.
The Research Integrity Officer will keep the file for three years after completion of the case
to permit later assessment of the case. ORI or other authorized DHHS personnel will be
given access to the records upon request. 34 Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 17 1. 42 C.F.R.
The web site itself may have changed. You can check the current page or check for previous versions at the Internet Archive. Yahoo! is not affiliated with the authors of this page or responsible for its content. Albany College of Pharmacy i Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct (Approved bythe Faculty, October 16, 1997) (Items in bold italics are suggested revisions following faculty approval and prior to Trusttee approval) Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct ii Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct Table of Contents I. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
A. General Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 B. Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 II. Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 III. Rights and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
A. Research Integrity Officer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 B. Whistleblower . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 C. Respondent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 D. Deciding Official . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 IV. General Policies and Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
A. Responsibility to Report Misconduct . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 B. Protecting the Whistleblower . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6 C. Protecting the Respondent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 D. Cooperation with Inquiries and Investigations . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 E. Preliminary Assessment of Allegations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7 V. Conducting the Inquiry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
A. Initiation and Purpose of the Inquiry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 B. Sequestration of the Research Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 C. Appointment of the Inquiry Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 D. Charge to the Committee and the First Meeting . . . . . . . . . . . . . . . . . . . . . . . . . . 8 E. Inquiry Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 VI. The Inquiry Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
A. Elements of the Inquiry Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 B. Comments on the Draft Report by the Respondent and the Whistleblower . . . 8-9 C. Inquiry Decision and Notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 D. Time Limit for Completing the Inquiry Report . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct iii VII. Conducting the Investigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
A. Purpose of the Investigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 B. Sequestration of the Research Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 C. Appointment of the Investigation Committee . . . . . . . . . . . . . . . . . . . . . . . . 10-11 D. Charge to the Committee and the First Meeting . . . . . . . . . . . . . . . . . . . . . . . . . 11 E. Investigation Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 VIII. The Investigation Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 A. Elements of the Investigation Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 B. Comments on the Draft Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-13 C. Institutional Review and Decision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 D. Transmittal of the Final Investigation Report to ORI . . . . . . . . . . . . . . . . . . . . . 13 E. Time Limit for Completing the Investigation Report . . . . . . . . . . . . . . . . . . . . . 13 IX. Requirements for Reporting to ORI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-15 X. Institutional Administrative Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 XI. Other Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
A. Termination of Institutional Employment or Resignation Prior to Completing
Inquiry or Investigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 B. Restoration of the Respondent's Reputation . . . . . . . . . . . . . . . . . . . . . . . . . 15-16 C. Protection of the Whistleblower and Others . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 D. Allegations Not Made in Good Faith . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 E. Interim Administrative Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 XII. Record Retention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 1 I. Introduction
A. General Policy The Albany College of Pharmacy was founded in 1881, and is one of the oldest and
most well-respected colleges of pharmacy in the country. Although excellence in
student education is the College's primary function, research in the areas of faculty
development and student training is becoming increasingly important. It is of
paramount importance that research at ACP is conducted in a highly ethical and
responsible mannor. In this regard, ACP has adopted the current policy for fairly
dealing with scientific misconduct. B. Scope This policy and the associated procedures apply to all individuals at Albany College
of Pharmacy engaged in research that is supported by or for which supportis
requested from Public Health Service (PHS). The PHS regulation at 42 C.F.R. Part
50, Subpart A (Federal Register reference) applies to any research, research-training
or research-related grant or cooperative agreement with PHS. This policy applies to
any person engaged in research that is paid by, under the control of, or affiliated
with the institution, such as scientists, trainees, technicians and other staff members,
students, fellows, guest researchers, or collaborators at Albany College of Pharmacy. The policy and associated procedures will normally be followed when an allegation
of possible misconduct in science is received by an institutional official. Particular
circumstances in an individual case may dictate variation from the normal procedure
deemed in the best interests of Albany College of Pharmacy and PHS. Any change
from normal procedures also must ensure fair treatment to the subject of the inquiry
or investigation. Any significant variation should be approved in advance by the
Director of Research Administration of Albany College of Pharmacy. II. Definitions A. Allegation means any written or oral statement or other indication of possible
scientific misconduct made to an institutional official. B. Conflict of interest means the real or apparent interference of one person's interests
with the interests of another person, where potential bias may occur due to prior or
existing personal or professional relationships. C. Deciding Official means the institutional official who makes final determinations on Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 2 allegations of scientific misconduct and any responsive institutional actions. The
Deciding Official will not be the same individual as the Research Integrity Officer
and should have no direct prior involvement in the institution's inquiry, investigation,
or allegation assessment. For ACP, the Deciding Official will be the President and
Dean. D. Good faith allegation means an allegation made with the honest belief that scientific
misconduct may have occurred. An allegation is not in good faith if it is made with
reckless disregard for or willful ignorance of facts that would disprove the allegation. E. Inquiry means gathering information and initial fact-finding to determine whether
an allegation or apparent instance of scientific misconduct warrants an investigation. 1 F. Investigation means the formal examination and evaluation of all relevant facts to
determine if misconduct has occurred, and, if so, to determine the responsible person
and the seriousness of the misconduct. 2 G. ORI means the Office of Research Integrity, the office within the U.S. Department
of Health and Human Services (DHHS) that is responsible for the scientific
misconduct and research integrity activities of the U.S. Public Health Service. H. PHS means the U.S. Public Health Service, an operating component of the DHHS. I. PHS regulation means the Public Health Service regulation establishing standards
for institutional inquiries and investigations into allegations of scientific misconduct,
which is set forth at 42 C.F.R. Part 50, Subpart A, entitled "Responsibility of PHS
Awardee and Applicant Institutions for Dealing With and Reporting Possible
Misconduct in Science." J. PHS support means PHS grants, contracts, or cooperative agreements or applications
to PHS. K. Research Integrity Officer means the institutional official responsible for assessing
allegations of scientific misconduct and determining when such allegations warrant
inquiries and for overseeing inquiries and investigations. L. Research record means any data, document, computer file, computer diskette, or any Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 3 other written or non-written account or object that reasonably may be expected to
provide evidence or information regarding the proposed, conducted, or reported
research that constitutes the subject of an allegation of scientific misconduct. A
research record includes, but is not limited to, grant or contract applications, whether
funded or unfunded; grant or contract progress and other reports; laboratory
notebooks; notes; correspondence; videos; photographs; X-ray film; slides;
biological materials; computer files and printouts; manuscripts and publications;
equipment use logs; laboratory procurement records; animal facility records; human
and animal subject protocols; consent forms; medical charts; and patient research
files. M. Respondent means the person against whom an allegation of scientific misconduct
is directed or the person whose actions are the subject of the inquiry or investigation.
There can be more than one respondent in any inquiry or investigation. N. Retaliation means any action that adversely affects the employment or other
institutional status of an individual that is taken by an institution or an employee
because the individual has in good faith, made an allegation of scientific misconduct
or of inadequate institutional response thereto or has cooperated in good faith with
an investigation of such allegation. O. Scientific misconduct or misconduct in science means 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. 3 P. Whistleblower means a person who makes an allegation of scientific misconduct. Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 4 III. Rights and Responsibilities A. Research Integrity Officer
The President and Dean of ACP will appoint the Research Integrity Officer who will
have primary responsibility for implementation of the procedures set forth in this
document. The Research Integrity Officer will be an institutional official who is well
qualified to handle the procedural requirements involved and is sensitive to the
varied demands made on those who conduct research, those who are accused of
misconduct, and those who report apparent misconduct in good faith. The Research Integrity Officer will appoint the inquiry and investigation committees
and ensure that necessary and appropriate expertise is secured to carry out a thorough
and authoritative evaluation of the relevant evidence in an inquiry or investigation.
The Research Integrity Officer will attempt to ensure that confidentiality is
maintained. The Research Integrity Officer will assist inquiry and investigation committees and
all institutional personnel in complying with these procedures and with applicable
standards imposed by government or external funding sources. The Research
Integrity Officer is also responsible for maintaining files of all documents and
evidence and for the confidentiality and the security of the files. The Research Integrity Officer will report to the Office of Research Integrity (ORI)
as required by regulation and keep ORI apprised of any developments during the
course of the inquiry or investigation that may affect current or potential DHHS
funding for the individual(s) under investigation or that PHS needs to know to ensure
appropriate use of Federal funds and otherwise protect the public interest. 4 B. Whistleblower
The whistleblower will have an opportunity to testify before the inquiry and
investigation committees, to review portions of the inquiry and investigation reports
pertinent to his/her allegations or testimony, to be informed of the results of the
inquiry and investigation, and to be protected from retaliation. Also, if the Research
Integrity Officer has determined that the whistleblower may be able to provide
pertinent information on any portions of the draft report, these portions will be given
to the whistleblower for comment. The whistleblower is responsible for making allegations in good faith, maintaining confidentiality, and cooperating with an inquiry or investigation. Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 5 C. Respondent
The respondent will be informed of the allegations when an inquiry is opened and
notified in writing of the final determinations and resulting actions. The respondent
will also have the opportunity to be interviewed by and present evidence to the
inquiry and investigation committees, to review the draft inquiry and investigation
reports, and to have the advice of counsel. The respondent is responsible for maintaining confidentiality and cooperating with
the conduct of an inquiry or investigation. If the respondent is not found guilty of
scientific misconduct, he or she has the right to receive institutional assistance in
restoring his or her reputation. 5 D. Deciding Official
The Deciding Official (President and Dean) will receive the inquiry and/or
investigation report and any written comments made by the respondent or the
whistleblower on the draft report. The Deciding Official will consult with the
Research Integrity Officer or other appropriate officials and will determine whether
to conduct an investigation, whether misconduct occurred, whether to impose
sanctions, or whether to take other appropriate administrative actions [see section X]. IV. General Policies and Principles A. Responsibility to Report Misconduct
All employees or individuals associated with Albany College of Pharmacy should
report observed, suspected, or apparent misconduct in science to the Research
Integrity Officer. If an individual is unsure whether a suspected incident falls within
the definition of scientific misconduct, he or she may call the Research Integrity
Officer or the Office of the President to discuss the suspected misconduct informally.
If the circumstances described by the individual do not meet the definition of
scientific misconduct, the Research Integrity Officer will refer the individual or
allegation to other offices or officials with responsibility for resolving the problem. At any time, an employee may have confidential discussions and consultations about
concerns of possible misconduct with the Research Integrity Officer and will be
counseled about appropriate procedures for reporting allegations. B. Protecting the Whistleblower
The Research Integrity Officer will monitor the treatment of individuals who bring
allegations of misconduct or of inadequate institutional response thereto, and those Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 6 who cooperate in inquiries or investigations. The Research Integrity Officer will
ensure that these persons will not be retaliated against in the terms and conditions of
their employment or other status at the institution and will review instances of
alleged retaliation for appropriate action. Employees should immediately report any alleged or apparent retaliation to the
Research Integrity Officer. Also the institution will protect the privacy of those who report misconduct in good
faith 6 to the maximum extent possible. For example, if the whistleblower requests anonymity, the institution will make an effort to honor the request during the
allegation assessment or inquiry within applicable policies and regulations and state
and local laws, if any. The whistleblower will be advised that if the matter is
referred to an investigation committee and the whistleblower's testimony is required,
anonymity may no longer be guaranteed. Institutions are required to undertake
diligent efforts to protect the positions and reputations of those persons who, in good
faith, make allegations. 7 C. Protecting the Respondent
Inquiries and investigations will be conducted in a manner that will ensure fair
treatment to the respondent(s) in the inquiry or investigation and confidentiality to
the extent possible without compromising public health and safety or thoroughly
carrying out the inquiry or investigation. 8 The respondant will have the right to see all documentation accumulated during
the investigation. In addition, the respondant will have the opportunity to request
specific information (in writing) from the whistlebower(s). Institutional employees accused of scientific misconduct may consult with legal
counsel or a non-lawyer personal adviser (who is not a principal or witness in the
case) to seek advice. D. Cooperation with Inquiries and Investigations
Institutional employees will cooperate with the Research Integrity Officer and other
institutional officials in the review of allegations and the conduct of inquiries and
investigations. Employees have an obligation to provide relevant evidence to the
Research Integrity Officer or other institutional officials on misconduct allegations. E. Preliminary Assessment of Allegations
Upon receiving an allegation of scientific misconduct, the Research Integrity Officer
will immediately assess the allegation to determine whether there is sufficient Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 7 evidence to warrant an inquiry, whether PHS support or PHS applications for
funding are involved, and whether the allegation falls under the PHS definition of
scientific misconduct. V. Conducting the Inquiry A. Initiation and Purpose of the Inquiry
Following the preliminary assessment, if the Research Integrity Officer determines
that the allegation provides sufficient information to allow specific follow-up,
involves PHS support, and falls under the PHS definition of scientific misconduct,
he or she will immediately initiate the inquiry process. In initiating the inquiry, the
Research Integrity Officer should identify clearly the original allegation and any
related issues that should be evaluated. The purpose of the inquiry is to make a
preliminary evaluation of the available evidence and testimony of the respondent,
whistleblower, and key witnesses to determine whether there is sufficient evidence
of possible scientific misconduct to warrant an investigation. The purpose of the
inquiry is not to reach a final conclusion about whether misconduct definitely
occurred or who was responsible. The findings of the inquiry must be set forth in an
inquiry report. B. Sequestration of the Research Records
After determining that an allegation falls within the definition of misconduct in
science and involves PHS funding, the Research Integrity Officer must ensure that
all original research records and materials relevant to the allegation are immediately
secured. The Research Integrity Officer may consult with ORI for advice and
assistance in this regard. C. Appointment of the Inquiry Committee
The Research Integrity Officer, in consultation with other institutional officials as
appropriate, will appoint an inquiry committee and committee chair within 10 days
of the initiation of the inquiry. The inquiry committee should consist of individuals
who do not have real or apparent conflicts of interest in the case, are unbiased, and
have the necessary expertise to evaluate the evidence and issues related to the
allegation, interview the principals and key witnesses, and conduct the inquiry.
These individuals may be scientists, subject matter experts, administrators, lawyers,
or other qualified persons, and they may be from inside or outside the institution. The Research Integrity Officer will notify the respondent of the proposed committee
membership in 10 days. If the respondent submits a written objection to any
appointed member of the inquiry committee or expert based on bias or conflict of
interest within 5 days, the Research Integrity Officer will determine whether to
replace the challenged member or expert with a qualified substitute. Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 8 D. Charge to the Committee and the First Meeting
The Research Integrity Officer will prepare a charge for the inquiry committee that
describes the allegations and any related issues identified during the allegation
assessment and states that the purpose of the inquiry is to make a preliminary
evaluation of the evidence and testimony of the respondent, whistleblower, and key
witnesses to determine whether there is sufficient evidence of possible scientific
misconduct to warrant an investigation as required by the PHS regulation. The
purpose is not to determine whether scientific misconduct definitely occurred or who
was responsible. At the committee's first meeting, the Research Integrity Officer will review the
charge with the committee, discuss the allegations, any related issues, and the
appropriate procedures for conducting the inquiry, assist the committee with
organizing plans for the inquiry, and answer any questions raised by the committee.
The Research Integrity Officer and institutional counsel will be present or available
throughout the inquiry to advise the committee as needed. E. Inquiry Process The inquiry committee will normally interview the whistleblower, the respondent,
and key witnesses as well as examining relevant research records and materials.
Then the inquiry committee will evaluate the evidence and testimony obtained during
the inquiry. After consultation with the Research Integrity Officer and institutional
counsel, the committee members will decide whether there is sufficient evidence of
possible scientific misconduct to recommend further investigation. The scope of the
inquiry does not include deciding whether misconduct occurred or conducting
exhaustive interviews and analyses. VI. The Inquiry Report A. Elements of the Inquiry Report
A written inquiry report must be prepared that states the name and title of the
committee members and experts, if any; the allegations; the PHS support; a summary
of the inquiry process used; a list of the research records reviewed; summaries of any
interviews; a description of the evidence in sufficient detail to demonstrate whether
and investigation is warranted or not; and the committee's determination as to
whether an investigation is recommended and whether any other actions should be
taken if an investigation is not recommended. Institutional counsel will review the
report for legal sufficiency. B. Comments on the Draft Report by the Respondent and the Whistleblower
The Research Integrity Officer will provide the respondent with a copy of the draft
inquiry report for comment and rebuttal and will provide the whistleblower, if he or
she is identifiable, with portions of the draft inquiry report that address the Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 9 whistleblower's role and opinions in the investigation. 1. Confidentiality
The Research Integrity Officer may establish reasonable conditions for
review to protect the confidentiality of the draft report. 2. Receipt of Comments
Within 14 calendar days of their receipt of the draft report, the whistleblower
and respondent will provide their comments, if any, to the inquiry committee.
Any comments that the whistleblower or respondent submits on the draft
report will become part of the final inquiry report and record. 9 Based on the comments, the inquiry committee may revise the report as appropriate. C. Inquiry Decision and Notification 1. Decision by Deciding Official
The Research Integrity Officer will transmit the final report and any
comments to the Deciding Official, who will make the determination of
whether findings from the inquiry provide sufficient evidence of possible
scientific misconduct to justify conducting an investigation. The inquiry is
completed when the Deciding Official makes this determination, which will
be made within 90 days of the first meeting of the inquiry committee. Any
extension of this period will be based on good cause and recorded in the
inquiry file. 2. Notification
The Research Integrity Officer will notify both the respondent and the
whistleblower in writing of the Deciding Official's decision of whether to
proceed to an investigation and will remind them of their obligation to
cooperate in the event an investigation is opened. The Research Integrity
Officer will also notify all appropriate institutional officials of the Deciding
Official's decision. D. Time Limit for Completing the Inquiry Report
The inquiry committee will normally complete the inquiry and submit its report in
writing to the Research Integrity Officer no more than 60 calendar days following
its first meeting, 10 unless the Research Integrity Officer approves an extension for good cause. If the Research Integrity Officer approves an extension, the reason for
the extension will be entered into the records of the case and the report. 11 The respondent also will be notified of the extension. VII. Conducting the Investigation Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 10 A. Purpose of the Investigation
The purpose of the investigation is to explore in detail the allegations, to examine the
evidence in depth, and to determine specifically whether misconduct has been
committed, by whom, and to what extent. The investigation will also determine
whether there are additional instances of possible misconduct that would justify
broadening the scope beyond the initial allegations. This is particularly important
where the alleged misconduct involves clinical trials or potential harm to human
subjects or the general public or if it affects research that forms the basis for public
policy, clinical practice, or public health practice. The findings of the investigation
will be set forth in an investigation report. Legal counsel will be consulted prior to the start of the investigation to ensure that
the investigation is performed in a manner consistent with the legal rights of all
individuals involved. B. Sequestration of the Research Records
The Research Integrity Officer will immediately sequester any additional pertinent
research records that were not previously sequestered during the inquiry. This
sequestration should occur before or at the time the respondent is notified that an
investigation has begun. The need for additional sequestration of records may occur
for any number of reasons, including the institution's decision to investigate
additional allegations not considered during the inquiry stage or the identification of
records during the inquiry process that had not been previously secured. The
procedures to be followed for sequestration during the investigation are the same
procedures that apply during the inquiry. C. Appointment of the Investigation Committee
The Research Integrity Officer, in consultation with other institutional officials as
appropriate, will appoint an investigation committee and the committee chair within
10 days of the notification to the respondent that an investigation is planned or as
soon thereafter as practicable (within 30 days of the completion of the inquiry). The
investigation committee should consist of at least three individuals who do not have
real or apparent conflicts of interest in the case, are unbiased, and have the necessary
expertise to evaluate the evidence and issues related to the allegations, interview the
principals and key witnesses, and conduct the investigation. 12 These individuals may be scientists, administrators, subject matter experts, lawyers, or other qualified
persons, and they may be from inside or outside the institution. Individuals
appointed to the investigation committee may also have served on the inquiry
committee. The Research Integrity Officer will notify the respondent of the proposed committee
membership within 5 days. If the respondent submits a written objection to any
appointed member of the investigation committee or expert, the Research Integrity Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 11 Officer will determine whether to replace the challenged member or expert with a
qualified substitute. D. Charge to the Committee and the First Meeting 1. Charge to the Committee
The Research Integrity Officer will define the subject matter of the
investigation in a written charge to the committee that describes the
allegations and related issues identified during the inquiry, defines scientific
misconduct, and identifies the name of the respondent. The charge will state
that the committee is to evaluate the evidence and testimony of the
respondent, whistleblower, and key witnesses to determine whether, based
on a preponderance of the evidence, scientific misconduct occurred and, if
so, to what extent, who was responsible, and its seriousness. During the investigation, if additional information becomes available that
substantially changes the subject matter of the investigation or would suggest
additional respondents, the committee will notify the Research Integrity
Officer, who will determine whether it is necessary to notify the respondent
of the new subject matter or to provide notice to additional respondents. 2. The First Meeting
The Research Integrity Officer, with the assistance of institutional counsel,
will convene the first meeting of the investigation committee to review the
charge, the inquiry report, and the prescribed procedures and standards for
the conduct of the investigation, including the necessity for confidentiality
and for developing a specific investigation plan. The investigation
committee will be provided with a copy of these instructions and, where PHS
funding is involved, the PHS regulation. E. Investigation Process
The investigation committee will be appointed and the process initiated within 30
days of the completion of the inquiry, if findings from that inquiry provide a
sufficient basis for conducting an investigation. 13 The investigation will normally involve examination of all documentation including,
but not necessarily limited to, relevant research records, computer files, proposals,
manuscripts, publications, correspondence, memoranda, and notes of telephone
calls. 14 Whenever possible, the committee should interview the whistleblower(s), the respondents(s), and other individuals who might have information regarding aspects
of the allegations. 15 Interviews of the respondent should be tape recorded or transcribed. All other interviews should be transcribed, tape recorded, or
summarized. Summaries or transcripts of the interviews should be prepared, Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 12 provided to the interviewed party for comment or revision, and included as part of
the investigatory file. 16 VIII. The Investigation Report A. Elements of the Investigation Report
The final report submitted to ORI must describe the policies and procedures under
which the investigation was conducted, describe how and from whom information
relevant to the investigation was obtained, state the findings, and explain the basis
for the findings. The report will include the actual text or an accurate summary of
the views of any individual(s) found to have engaged in misconduct as well as a
description of any sanctions imposed and administrative actions taken by the
institution. 17 B. Comments on the Draft Report 1. Respondent
The Research Integrity Officer will provide the respondent with a copy of the
draft investigation report for comment and rebuttal. The respondent will be
allowed 14 days to review and comment on the draft report. The
respondent's comments will be attached to the final report. The findings of
the final report should take into account the respondent's comments in
addition to all the other evidence. The respondent has the right to review the draft investigation report with
his / her legal counsel or personal advisor as described previously. 2. Whistleblower
The Research Integrity Officer will provide the whistleblower, if he or she
is identifiable, with those portions of the draft investigation report that
address the whistleblower's role and opinions in the investigation. The report
should be modified, as appropriate, based on the whistleblower's comments. 3. Institutional Counsel
The draft investigation report will be transmitted to the institutional counsel
for a review of its legal sufficiency. Comments should be incorporated into
the report as appropriate. 4. Confidentiality
In distributing the draft report, or portions thereof, to the respondent and
whistleblower, the Research Integrity Officer will inform the recipient of the Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 13 confidentiality under which the draft report is made available and may
establish reasonable conditions to ensure such confidentiality. For example,
the Research Integrity Officer may request the recipient to sign a
confidentiality statement or to come to his or her office to review the report. C. Institutional Review and Decision
Based on a preponderance of the evidence, the Deciding Official will make the final
determination whether to accept the investigation report, its findings, and the
recommended institutional actions. If this determination varies from that of the
investigation committee, the Deciding Official will explain in detail the basis for
rendering a decision different from that of the investigation committee in the
institution's letter transmitting the report to ORI. The Deciding Official's explanation
should be consistent with the PHS definition of scientific misconduct, the
institution's policies and procedures, and the evidence reviewed and analyzed by the
investigation committee. The Deciding Official may also return the report to the
investigation committee with a request for further fact-finding or analysis. The
Deciding Official's determination, together with the investigation committee's report,
constitutes the final investigation report for purposes of ORI review. When a final decision on the case has been reached, the Research Integrity Officer
will notify both the respondent and the whistleblower in writing. In addition, the
Deciding Official will determine whether law enforcement agencies, professional
societies, professional licensing boards, editors of journals in which falsified reports
may have been published, collaborators of the respondent in the work, or other
relevant parties should be notified of the outcome of the case. The Research
Integrity Officer is responsible for ensuring compliance with all notification
requirements of funding or sponsoring agencies. D. Transmittal of the Final Investigation Report to ORI
After comments have been received and the necessary changes have been made to
the draft report, the investigation committee should transmit the final report with
attachments, including the respondent's and whistleblower's comments, to the
Deciding Official, through the Research Integrity Officer. E. Time Limit for Completing the Investigation Report
An investigation should ordinarily be completed within 120 days of its initiation, 18 with the initiation being defined as the first meeting of the investigation committee.
This includes conducting the investigation, preparing the report of findings, making
the draft report available to the subject of the investigation for comment, submitting
the report to the Deciding Official for approval, and submitting the report to the
ORI. 19 IX. Requirements for Reporting to ORI Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 14 A. An institution's decision to initiate an investigation must be reported in writing to the
Director, ORI, on or before the date the investigation begins. 20 At a minimum, the notification should include the name of the person(s) against whom the allegations
have been made, the general nature of the allegation as it relates to the PHS
definition of scientific misconduct, and the PHS applications or grant number(s)
involved. 21 ORI must also be notified of the final outcome of the investigation and must be provided with a copy of the investigation report. 22 Any significant variations from the provisions of the institutional policies and procedures should be explained
in any reports submitted to ORI. B. If an institution plans to terminate an inquiry or investigation for any reason without
completing all relevant requirements of the PHS regulation, the Research
Integrity Officer will submit a report of the planned termination to ORI, including
a description of the reasons for the proposed termination. 23 C. If the institution determines that it will not be able to complete the investigation in
120 days, the Research Integrity Officer will submit to ORI a written request for an
extension that explains the delay, reports on the progress to date, estimates the date
of completion of the report, and describes other necessary steps to be taken. If the
request is granted, the Research Integrity Officer will file periodic progress reports
as requested by the ORI. 24 D. When PHS funding or applications for funding are involved and an admission of
scientific misconduct is made, the Research Integrity Officer will contact ORI for
consultation and advice. Normally, the individual making the admission will be
asked to sign a statement attesting to the occurrence and extent of misconduct. When
the case involves PHS funds, the institution cannot accept an admission of scientific
misconduct as a basis for closing a case or not undertaking an investigation without
prior approval from ORI. 25 E. The Research Integrity Officer will notify ORI at any stage of the inquiry or
investigation if: 1. there is an immediate health hazard involved; 26 2. there is an immediate need to protect Federal funds or equipment; 27 3. there is an immediate need to protect the interests of the person(s) making the
allegations or of the individual(s) who is the subject of the allegations as well
as his/her co-investigators and associates, if any; 28 4. it is probable that the alleged incident is going to be reported publicly; 29 or 5. the allegation involves a public health sensitive issue, e.g., a clinical trial; or 6. there is a reasonable indication of possible criminal violation. In this Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 15 instance, the institution must inform ORI within 24 hours of obtaining that
information. 30 X. Institutional Administrative Actions Albany College of Pharmacy will take appropriate administrative actions against individuals
when an allegation of misconduct has been substantiated (at the conclusion of the
investigation). 31 If the Deciding Official determines that the alleged misconduct is substantiated by the
findings, he or she will decide on the appropriate actions to be taken, after consultation with
the Research Integrity Officer. The actions may include: ! withdrawal or correction of all pending or published abstracts and papers emanating
from the research where scientific misconduct was found. ! removal of the responsible person from the particular project, letter of reprimand,
special monitoring of future work, probation, suspension, salary reduction, or
initiation of steps leading to possible rank reduction or termination of employment; ! restitution of funds as appropriate. XI. Other Considerations A. Termination of Institutional Employment or Resignation Prior to Completing Inquiry
or Investigation The termination of the respondent's institutional employment, by resignation or
otherwise, before or after an allegation of possible scientific misconduct has been
reported, will not preclude or terminate the misconduct procedures. If the respondent, without admitting to the misconduct, elects to resign his or her
position prior to the initiation of an inquiry, but after an allegation has been reported,
or during an inquiry or investigation, the inquiry or investigation will proceed. If the
respondent refuses to participate in the process after resignation, the committee will
use its best efforts to reach a conclusion concerning the allegations, noting in its
report the respondent's failure to cooperate and its effect on the committee's review
of all the evidence. B. Restoration of the Respondent's Reputation
If the institution finds no misconduct and ORI concurs, after consulting with the
respondent, the Research Integrity Officer will undertake reasonable efforts to
restore the respondent's reputation. Depending on the particular circumstances, the
Research Integrity Officer should consider notifying those individuals aware of or
involved in the investigation of the final outcome, publicizing the final outcome in
forums in which the allegation of scientific misconduct was previously publicized,
or expunging all reference to the scientific misconduct allegation from the Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 16 respondent's personnel file. Any institutional actions to restore the respondent's
reputation must first be approved by the Deciding Official. C. Protection of the Whistleblower and Others 32 Regardless of whether the institution or ORI determines that scientific misconduct
occurred, the Research Integrity Officer will undertake reasonable efforts to protect
whistleblowers who made allegations of scientific misconduct in good faith and
others who cooperate in good faith with inquiries and investigations of such
allegations. Upon completion of an investigation, the Deciding Official will
determine, after consulting with the whistleblower, what steps, if any, are needed to
restore the position or reputation of the whistleblower. The Research Integrity
Officer is responsible for implementing any steps the Deciding Official approves.
The Research Integrity Officer will also take appropriate steps during the inquiry and
investigation to prevent any retaliation against the whistleblower. D. Allegations Not Made in Good Faith
If relevant, the Deciding Official will determine whether the whistleblower's
allegations of scientific misconduct were made in good faith. If an allegation was
not made in good faith, the Deciding Official will determine whether any
administrative action should be taken against the whistleblower. E. Interim Administrative Actions
Institutional officials will take interim administrative actions, as appropriate, to
protect Federal funds and ensure that the purposes of the Federal financial assistance
are carried out. 33 XII. Record Retention After completion of a case and all ensuing related actions, the Research Integrity Officer will
prepare a complete file, including the records of any inquiry or investigation and copies of
all documents and other materials furnished to the Research Integrity Officer or committees.
The Research Integrity Officer will keep the file for three years after completion of the case
to permit later assessment of the case. ORI or other authorized DHHS personnel will be
given access to the records upon request. 34 Albany College of Pharmacy Policy for Responding to Allegations of Scientific Misconduct 17 1. 42 C.F.R.
