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Policy 7.8
Policy on Research Misconduct

Responsible Official: VP for Research Administration
Administering Division/Department: Research Compliance
Effective Date: May 15, 2008
Last Revision: August 16, 2016

Policy Sections:

Overview

This policy sets forth the policies and procedures that should be followed in reporting, inquiring into and investigating allegations of research misconduct.

Applicability

 

This Policy and Procedure (the Policy) applies to all Institutional Members as that term is defined herein.

 

This document sets forth procedures for handling Allegations of Research Misconduct (e.g., fabrication, falsification and plagiarism). Federal regulations require that certain procedures be followed in handling Allegations of Research Misconduct involving Research that receives federal funding, and these procedures incorporate those requirements as appropriate. This Policy will apply if the allegations received concern Allegations of Research Misconduct.

 

To the extent that the subject matter of allegations falls within the scope of another University policy or falls under the jurisdiction of another University unit, such matters shall be handled in accordance with the relevant University policy and referred to the relevant University unit as appropriate.  Non-limiting examples include referrals to the following units:

 

¿  Institutional Review Board (IRB) for matters falling within the scope of the Emory University Institutional Review Board Policies and Procedures;

¿  Institutional Animal Care and Use Committee (IACUC) for matters falling within the scope of IACUC policies, procedures,  and  guidelines;

¿  Conflict of Interest (COI) for matters falling within the scope of Policy 7.7: Policy for Investigators Holding a Financial Interest in Research;

¿  The relevant school(s)/unit(s) at issue for matters falling within the scope of Policy 7.30: Policy on Authorship Guidelines and Dispute Resolution.

¿  Matters falling within the scope of Policy 7.9:   Guidelines for Responsible Conduct of Scholarship and Research shall be handled within the local department or unit in accordance with that policy.

 

If the allegations received include allegations that would fall under another policy and allegations that would fall under this Policy, then the Administrative Official, will: Establish an Inquiry Committee (and, if necessary, an Investigation Committee) under this Policy to review Allegations of Research Misconduct, and refer the other allegations to the appropriate school, unit or office at the university for review.  Notwithstanding the foregoing, the Administrative Official, RIO and other unit(s) involved may agree upon a joint fact-finding process.   See Section 7.8.01.C.8 below.

Policy Details

 

This document is divided into sections.

 

Section 7.8.01 sets forth the procedure for reporting Allegations of Research Misconduct, as well as Emory’s policy prohibiting retaliation against anyone who reports any such allegations in Good Faith.

 

Section 7.8.02 describes the roles and responsibilities of key persons and committees in implementing the procedures under this Policy.

 

Section 7.8.03 sets forth the procedure for handling Allegations of Research Misconduct.   Section 7.8.03 is designed to comply with federal regulatory requirements for the conduct of Inquiries and Investigations into Allegations of Research Misconduct Involving Federally-Sponsored Research and it is based in part on the Office of Research Integrity’s “Sample Policy and Procedures for Responding to Allegations of Research Misconduct. found at http://ori.dhhs.gov/policies/ori_policies.shtml.

 

The Policy Definitions Section sets forth the definitions of terms under this Policy.

 

Section 7.8.01

 

Statement of Policy and General Principles

 

A.  Use of Capitalized/Italicized Words: This Policy on Research Misconduct is referred to throughout this document as the Policy. The meanings of all other capitalized, italicized terms used in this Policy are set forth below in the Policy Definitions Section.

 

B.  Statement of Policy: The validity of Research and other scholastic endeavors is based on the implicit assumption of honesty and objectivity by the investigator and on the explicit premise that Research data can be verified. An academic institution and its faculty, students and staff must uphold this principle and endeavor to maintain public trust in the Research process.

 

An academic institution’s primary responsibility is to create and maintain an academic environment that fosters ethical behavior in scholarship and serves to prevent misconduct in Research and to promote Research that is carried out in accordance with all applicable regulations and policies. In order to carry out this responsibility, faculty, staff and students must immediately report any evidence of Research Misconduct to the appropriate administrative officials of Emory University (hereafter also referred to as “Emory,” “University,” or the Institution). These officials, in turn, must promptly report such allegations to the RIO for handling in accordance with this Policy if the allegations concern Research Misconduct. This Policy sets forth the procedures that must be followed in reporting, inquiring into, and investigating such allegations.

 

C.  General Principles: The following general principles apply to all proceedings under this Policy:

 

1.   Responsibility to Report Research Misconduct: All Institutional Members to whom this Policy applies must immediately report any observed or suspected Research Misconduct to their supervisor, the chair or chief administrator of their department, the dean/director of their unit, or directly to the RIO. If an allegation is initially reported to anyone other than the RIO, then that person, in turn, must report the allegation to the RIO.   Similarly, if the RIO initially receives a report, then s/he should notify the appropriate Administrative Official and any other appropriate administrators and/or University committees or units that may have jurisdiction over the issue.  Units should not undertake to conduct reviews of allegations of Research Misconduct on their own.

 

If an individual is not sure whether or not a particular incident or practice constitutes Research Misconduct that is covered by this Policy, then s/he may call the RIO to discuss the matter confidentially and obtain guidance. Such calls may be made anonymously.

 

Contact information for the Research Integrity Officer is as follows:

 

Director

 

Office of Compliance Emory University

1599 Clifton Road, Room 4.105

 

Atlanta, GA 30322

 

Phone: 404-727-2398

 

Fax:         404-727-2328


Email:  kwest02@emory.edu

 

 

In addition, individuals may make anonymous reports through the Emory University Trust Line by calling

1-888-550-8850. The Trust Line is operated by an independent third party who will maintain the caller’s anonymity, while ensuring that the caller’s report is routed to the proper individuals within the University. Individuals may also make anonymous reports through the Emory Trust Line Online. Online reports are triaged by the same third-party vendor that manages the Emory University Trust Line.

 

2.  Responsibility to Cooperate with Inquiries and Investigations: All Emory University employees, faculty, students, agents, and other Institutional Members are obliged to cooperate fully with theRIO, Administrative Official and other institutional officials in the review of allegations and the conduct of any proceedings under this Policy. Such persons also are obligated to provide any relevant Evidence to the RIO, any Inquiry Committee, any Investigation Committee, as well as any appropriate governmental regulatory or funding agency.

 

3.  Inform Researchers and Administrators of this Policy: Emory University shall work to ensure that its faculty, staff, students and administrators who are involved in Research are aware of and familiar with this Policy and any changes thereto. Emory also shall stress to all such persons and administrators the importance of complying with this Policy.

 

4.  Administrative Actions/Sanctions: At any time during or after an Inquiry, Investigation, or Research Misconduct Proceeding , Emory University, on its own initiative or in consultation with appropriate governmental agencies, reserves the right to take any Administrative Actions/Sanctions  necessary to protect the health and safety of Research subjects; to protect the funds or resources of sponsors; to protect the University’s reputation and academic integrity; to protect the integrity of the Research process; to comply with any applicable governmental laws, regulations or policies; and/or to comply with any contractual obligations. These actions may include, but are not limited to, additional monitoring of the Research process and the handling of funds and equipment; reassignment of personnel or of the responsibility for the handling of funding/resources; additional review of Research data and results; withdrawal of pending abstracts; manuscripts, publications, and grant applications; and suspension of a Respondent (provided, however, that suspension prior to the completion of an Investigation shall be without interruption of salary or benefits).

 

5.  Notification of Government Agencies and Sponsors: If the allegations received are Allegations of Research Misconduct relating to Research that receives support from a sponsor other than Emory University, then the RIO will make the following notifications to Research sponsors (specifically including but not limited to ORI and the NSF OIG):

 

Notification of the allegations on or before the initiation of an Investigation regarding Allegations of Research Misconduct;

 

Notification of the allegations when there is existence of the special circumstances set forth in Section 7.8.01-C.6

below.

 

Notification of the findings of Research Misconduct at the conclusion of an Investigation.

 

6.  Notification of Allegations When There Are Special Circumstances: At any time during any phase of a Research Misconduct Proceeding, the RIO will notify the Administrative Official, any government agency that is supporting the Research, or any other Research sponsor, if any, of the allegations when  the circumstances set forth below exist. In the case of Research receiving PHS Support the RIO shall provide notice to ORI, and in the case of Research receiving NSF Support, the RIO will notify the NSF OIG. Circumstances requiring notification are as follows:

 

a.            Health or safety of the public is at risk, including an immediate need to protect human or animal subjects.

 

b.            The  resources  or  interests  of  any  governmental  agency  providing  support  to  the  Research including,  but not limited to HHS, PHS or NSF, are threatened.

 

c.            Research activities should be suspended.

 

d.            There is a reasonable indication of possible violations of civil or criminal law.

 

e.            In the case of Federally-Sponsored Research, the federal government’s action is required to protect the interests of those involved in Research Misconduct Proceedings.

 

f.             In the case of Federally-Sponsored Research, the Institution believes that a Research Misconduct Proceeding may be made public prematurely so that the federal government may be required to take appropriate steps to safeguard Evidence and protect the rights of those involved.

 

g.             The research/scientific community or public should be informed, as determined by the Institution or appropriate government agency.


7.  Relationship Between this Policy and Federal Regulations: Federally-Sponsored Research projects are subject to specific laws, regulations and policies (collectively, Governmental Requirements). In the case of

Federally-Sponsored Research supported by funding from the PHS, the applicable Governmental Requirements are set forth at 42 CFR Part 93, which can be found athttp://www.access.gpo.gov/nara/cfr/waisidx_06/42cfr93_06.html.

 

In the case of Research supported by funding from the NSF, the applicable Governmental Requirements are set forth in 45 CFR Part 689, which can be found athttp://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr689_06.html.

 

In some cases, Governmental Requirements specify that certain provisions be set forth within this Policy, and Emory has incorporated those requirements herein. From time to time, the University shall review this Policy in order to cause the Policy to remain in conformance with such requirements. If, however, there is, at any time, a conflict between such Governmental Requirements and this Policy, the Governmental Requirements shall supersede this Policy and must be followed with regard to any matters on which this Policy and such Governmental Requirements differ.

 

8.  Non-Exclusivity of this Policy: Particular allegations and events may fall within the scope of more than one University policy and/or more than one set of Governmental Requirements. In addition, more than one University unit or government regulatory entity may have jurisdiction over certain allegations or events. Accordingly, the fact that proceedings are brought under this Policy does not preclude additional proceedings before other University units or committees and/or under other policies or regulations. For example, certain allegations regarding Research involving human subjects may fall within the scope of this Policy and within the scope of policies and procedures set forth by the Emory Institutional Review Board (IRB). In any case in which another University unit or committee may have jurisdiction pursuant to another applicable regulation or policy, the Administrative Official may, with the concurrence of that University unit or committee, combine the fact-finding proceedings under the other policy with those under this Policy, for example, by permitting a representative from that unit or committee to serve as a member of any Inquiry Committee, or Investigation Committee, established under this Policy, and to report the facts found in such Inquiry or Investigation back to the University unit or committee for possible adoption, subject to the sequestration obligations of this Policy. [See, Research Misconduct Involving Noncompliance in Human Subjects Research Supported by the Public Health Service: Reconciling Separate Regulatory Systems, The Hastings Center Report [0093-0334], vol:44, iss:s3; pg. S2-S26 (2014)]. Members of such University unit(s) or committee(s) with concurrent jurisdiction must comply with the confidentiality requirements under this Policy; provided, however, that such units/committees may make any disclosures permitted pursuant to Section 7.8.01.C.9.   In this respect, said units/committees agree to coordinate with the RIO regarding  any  such  disclosures.

 

9.  Confidentiality: The RIO, Administrative Official, Committee Members and other institutional officials involved in the conduct of proceedings under this Policy and members of University committee/units with concurrent jurisdiction, as referenced in Section 7.8.01.C.8 above, shall limit the disclosure of the following information to those who need to know in order to fulfill requirements of the Policy, fulfill any applicable Governmental Requirements (including required reporting or disclosures by other University units or committees under ancillary proceedings), respond to any subpoena or other legal request for information/materials, and to carry out any proceeding conducted under this Policy (or ancillary proceeding) in a thorough, competent, fair and objective manner:

 

a.            The identity of the Complainant (if known) and the Respondent; and

 

b.            Any records or Evidence from which Research subjects might be identified.

 

Notwithstanding the foregoing, the Administrative Official and RIO, may, as necessary, inform and consult with such institutional administrators/personnel and experts as necessary for the appropriate conduct of any review and/or proceedings, institutional response, and administration of research integrity at the institution, including the identity of the Complainant and/or Respondent and records or Evidence (e.g., consultation with IT personnel to sequester records; consultation with departmental/divisional chairs to ensure cooperation with investigation; consultation with human resources personnel to prevent adverse action while proceedings are pending; consultation with expert consultant to ensure proper sequestration or initial review, etc.).  In this regard, the RIO may use written confidentiality agreements or other mechanisms to ensure that a recipient does not make any further disclosure of identifying information.

 

10.  Protecting Complainants, Witnesses and Committee Members: Institutional Members may not retaliate in any way against Complainants, witnesses or Committee Members. Institutional Members should immediately report any alleged or apparent retaliation against Complainants, witnesses or Committee Members to the RIO, who shall review the matter and, as necessary, make all reasonable and practical efforts to counter any potential or actual Retaliation and protect and restore the position and reputation of the person against whom the Retaliation is

directed. The Administrative Official and other appropriate University officials shall cooperate with the RIO in ensuring that retaliation does not occur.

 

11.  Protecting the Respondent -- Restoration of Reputation: The Administrative Official involved in the conduct of proceedings under this Policy will make all reasonable and practical efforts to protect and restore the reputation of persons alleged to have engaged in Research Misconduct, but against whom no finding of Research Misconduct or any other violation is made.  The method for restoring the Respondent’s reputation shall be determined by the Administrative Official in his/her reasonable discretion on a case-by-case basis.  In this regard, the obligation to restore Respondent’s reputation may be satisfied, in whole, or in part, as follows:


(a)  Resolution at Initial Assessment:  By the RIO or Administrative Official providing the Respondent with a general letter setting forth that the allegation was not sufficiently credible and specific so that potential Evidence of Research Misconduct could be identified to warrant initiation of proceedings under this Policy, if the matter is terminated after the initial review of allegations.

 

(b)  Resolution at Inquiry or Investigation: By the Administrative Official providing the Respondent with a general letter setting forth that there were no findings of Research Misconduct or other violations on the part of the Respondent, along  with  any  other  pertinent  findings  of  the  proceedings.

 

In either case, the Respondent may share the letter with others in his/her discretion. Alternatively, or in addition to providing the general letter, the Administrative Official, may provide a letter similar to that described in (a) or (b) above to specific sponsors or journals who were affected by the Research that was reviewed. The Administrative Official may, in his/her reasonable discretion, take such other action as he/she deems appropriate to restore Respondent’s reputation.

 

12.  Costs: Costs incurred by the RIO and the Office of Compliance in conjunction with their roles and responsibilities as outlined in this policy will be borne by the school(s) whose Administrative Official(s)participates in the review and/or resolution of any respective allegations of Research Misconduct under this policy.  Costs may include, but are not limited to:  (a) costs for hard drives and IT services to copy data; (b) costs for translators; (c) cost for court reporters; (d) costs for laboratory analysis; (e) costs for document/data storage; (f) costs for copying services;   (g) travel costs for witnesses; and (h) costs for procuring audio/video of witness testimony.

 

SECTION 7.8.02

 

Roles and Responsibilities:

 

Set forth below are the various persons and committees who are involved in proceedings under this Policy, along with a description of their responsibilities.

 

1.  Research Integrity Office or RIO: The Director of the Office of Compliance will serve as the RIO. The RIO shall be familiar with this Policy and with other applicable Governmental Requirements and Emory policies. The RIO shall be responsible for the general oversight and administration of proceedings under this Policy.  The RIO may appoint a designee(es) from staff members of the Office of Compliance to assist the RIO in carrying out his/her duties and throughout this Policy references to the RIO shall include the RIO’s designee(s). The RIO’s responsibilities shall include the following activities:

 

a.  Consult confidentially with persons uncertain about whether to submit an allegation of Research Misconduct.

 

b.  Receive Allegations of Research Misconduct.

 

c.  Assess any allegations received to determine whether they fall within the scope of this Policy.

 

d.  Consult with the proper Administrative Official regarding the initiation and administration of any necessary Inquiry or

Investigation.

 

e.  Make any notifications and reports to government regulatory agencies with jurisdiction over the review of Allegations of Research Misconduct and/or University officials, committees or units required or permitted by this Policy, applicable Government Requirements or other University policies.

 

f. Inform Respondents, Complainants, and witnesses of procedural steps in the Research Misconduct proceedings under this Policy.

 

g.  Sequester Research data and Evidence pertinent to the allegations received and maintain it securely in accordance with this Policy and applicable Governmental Requirements.

 

h.  Maintain records of Research Misconduct Proceedings carried out under this Policy in accordance with any applicable record retention requirements set forth in Emory policies or applicable Governmental Requirements and make such records available to appropriate governmental agencies as required by applicable Governmental Requirements.

 

i. Assist any Inquiry Committee or Investigation Committee in complying with this Policy and with all other applicable

Governmental Requirements and Emory policies.

 

j.  Work to ensure the confidentiality of the proceedings and to maintain the security and confidentiality of records of proceedings carried out under this Policy.

 

k.   Apprise President, Provost, Trustees of proceedings under this Policy as specifically set forth herein or as may be necessary to ensure appropriate conduct of proceedings, institutional response and administration of research integrity at the institution.

 

l. Take any other actions necessary to carry out the duties of the RIO under this Policy.

 

2.  Administrative Official: The Administrative Official for a particular proceeding under this Policy is the Dean


or Director (or his/her designee) of the Emory school or unit in which the Respondent works (or, in the case of a student Respondent, is enrolled).  Throughout this Policy references to the Administrative Official shall include the Administrative Official’s designee.  If Allegations of Research Misconduct involve more than one school or unit at Emory, the Deans or Directors (or their designees) for each school/unit may serve as co-Administrative Officials and the duties assigned to

an Administrative Official under this policy shall be shared by the co-Administrative Officials.  In the event that Dean or Director of a school or unit is the subject of the allegations that are being made, then the appropriate Vice President (or his/her designee) shall serve as the Administrative Official. The Administrative Official, in consultation with other appropriate Emory administrators, shall be responsible for reviewing/implementing recommendations of any Inquiry Committee or Investigation Committee and prescribing appropriate Administrative Actions/Sanctions, if any, in response to a committee’s findings. The Administrative Official’s responsibilities shall include the following activities:

 

a.  Provide confidentiality to those involved in any proceedings under this Policy in accordance with all applicable

Governmental Requirements and/or Policy requirements.

 

b.  In consultation with the RIO, appoint the chair and members of any Inquiry Committee or Investigation Committee, and ensure that these committees are properly staffed with persons with appropriate expertise to carry out a thorough and authoritative evaluation of the Evidence.

 

c.  Determine whether each person involved in handling any allegations under this Policy has any unresolved personal, professional or financial conflict of interest and take appropriate action, including recusal to ensure that no person with such a conflict is involved in the proceedings.

 

d.  In cooperation with other institutional officials and in accordance with Sections 7.8.01.C.10 and 11, take all reasonable and practical steps to protect and restore the position and reputation of any Good Faith Complainant, witness, Committee Member, and Respondent against whom no finding has been made, and counter potential or actual Retaliation against them by Respondent or other Institution Members;

 

e.  Ensure that Administrative Actions taken by the Institution and appropriate governmental agencies are enforced.

 

f. Cooperate with the RIO in determining appropriate notification of other involved parties such as sponsors, appropriate governmental agencies, law enforcement agencies, journals and other publishers, and professional and licensing boards of Administrative Actions/Sanctions taken, as required by Governmental Requirements and University policies.

 

g.   Alone, or as appropriate, in combination with Chair of Inquiry or Investigation Committee signs and sends notices to sponsors, law enforcement agencies, journals and other publishers, professional and licensing boards, and governmental agencies not otherwise notified by RIO as set forth elsewhere in this policy, as required by this Policy, Governmental Requirements and/or Administrative Actions/Sanctions.

 

h.  Notify the Respondent of the proceedings and provide opportunities for him/her to review/comment/respond to allegations, evidence and committee reports.

 

i.  Receive and evaluate any report provided by any Inquiry Committee or Investigation Committee and take any action regarding such reports as is required pursuant to this Policy or any applicable Governmental Requirements.  Specifically, the Administrative Official shall take the following actions with regard to each of the reports named below:

 

(1)  Inquiry Committee Report: Review the report and, in consultation with the RIO and other appropriate institutional officials, make an Administrative Determination regarding (a) whether to accept the Inquiry Committee's findings as to whether an Investigation is warranted under the criteria set forth in applicable laws and University policies; (b) whether to accept any other of the Inquiry Committee’s recommendations; and (c) whether to impose any new or additional requirements. The Administrative Official shall inform the chair of the department(s) where the matter originates of the Administrative Determination by the Administrative Official. If an Investigation is to be initiated, the Administrative Official also shall ensure that the RIO sends any required notice of the initiation of an Investigation to ORI (and/or any other appropriate governmental agency) along with a copy of Inquiry Committee’s report.

 

(2)  Investigation Committee Report: Review the report and, in consultation with the RIO and other appropriate institutional officials, make an Administrative Determination regarding (a) whether to accept the Investigation Committee’s findings; (b) whether to accept the Investigation Committee’s recommendations, including recommendations regarding Administrative Actions/Sanctions; and (c) whether to impose any new or additional requirements.  The Administrative Official shall inform the chair of the department(s) where the matter originates of the Administrative Determination. As appropriate, the Administrative Official also shall ensure that the RIO notifies ORI (and/or any other appropriate governmental agency) in writing of the Administrative Official’s Administrative Determination with regard to findings and Administrative Actions/ Sanctions and provides a copy of the Investigation Committee Report.

 

j.   Take any other actions necessary to carry out the duties of the Administrative Official under this Policy.

 

3.  Complainant:  The Complainant is the person who brings forward any allegations under this Policy. The Complainant is responsible for making all allegations in Good Faith; for maintaining confidentiality; and for cooperating with any Inquiry Committee or Investigation Committee.  If the Complainant’s identity is known, the Complainant should be interviewed as a part of any Inquiry or Investigation conducted under this Policy. A Complainant may make


allegations anonymously and request that anonymity be preserved throughout the proceeding. The RIO shall take reasonable steps to keep the Complainant’s identity confidential, but the RIO also shall advise the Complainant that an absolute guarantee of confidentiality and/or anonymity cannot be provided.  Furthermore, the RIO and any committee appointed under this Policy may take the fact that allegations are made anonymously into consideration in determining whether the allegations are substantive and/or brought in Good Faith. If it is determined that the allegations are not substantive or brought in Good Faith, and the allegations can be attributed to a specific person(s), the matter may be referred to the Administrative Official for School/unit involved. The Administrative Official will determine whether any administrative action should be taken against the person who failed to act in Good Faith.

 

4.  Respondent: The Respondent is the person against whom allegations are brought. The Respondent is responsible for maintaining confidentiality and cooperating with the RIO and with any Inquiry or Investigation. The Respondent should be interviewed as a part of any Inquiry or Investigation conducted under this Policy.

 

5.  Inquiry Committee: The Inquiry Committee shall conduct any Inquiry required under this Policy. The Administrative Official shall select the members and chair of any Inquiry Committee. In making this selection, the Administrative Official shall consult with the RIO and shall take care to ensure that all persons taking part in the Inquiry do not have real or apparent Conflicts of Interest and do have the necessary and appropriate expertise to properly conduct the Inquiry. Alternatively, a school or unit may have a standing committee with Inquiry or Investigation committee members appointed by the Administrative Official, and in such cases, the Chair of the standing committee shall select members of the standing committee to form an Inquiry or Investigation subcommittee to review a particular matter and also shall appoint the chair of the subcommittee. If the Administrative Official deems it necessary or desirable, then some or all members of the Inquiry Committee may be selected from outside the University. Additionally, the Inquiry Committee, may in its discretion, retain the advice of subject matter experts in the evaluation of the matter, provided, however, that any such experts shall be subject to the confidentiality requirements of this Policy. The Inquiry Committee is responsible for the following activities:

 

a.  Following this Policy and all other applicable policies, procedures, and Governmental Requirements in carrying out its

Inquiry duties.

 

b.  Providing a report at the conclusion of the Inquiry that meets all requirements of this Policy and any applicable Governmental Requirements. The report shall include findings, conclusions, and recommendations and shall be provided to the Administrative Official and to the RIO.

 

c.  Taking all reasonable steps to conduct its Inquiry in a fair and impartial manner and to protect the confidentiality of all aspects of the proceedings.

 

d.  The Chair of the Inquiry Committee shall assist the Administrative Official in signing and/or transmitting any notices required pursuant to this Policy, Governmental Requirements and/or Administrative Actions/Sanctions.

 

e.   Take any other actions as may be necessary to carry out the duties of the Inquiry Committee under this Policy and/or

Governmental Requirements.

 

6.  Investigation Committee: The Investigation Committee shall conduct any Investigation required under this Policy. The Administrative Official in consultation with the RIO shall select the members of the Investigation Committee.  In making this selection, the Administrative Official shall consult with the RIO and shall take care to ensure that all persons taking part in the Investigation do not have real or apparent Conflicts of Interest and do have the necessary and appropriate expertise to properly conduct the Investigation.   Additionally, a school may have a standing

committee with Inquiry or Investigation committee members appointed by the Administrative Official, and in such cases, the Chair of the standing committee shall select members of the standing committee to form a Inquiry or Investigation subcommittee to review a particular matter and also shall appoint the chair of the subcommittee. If necessary, some

or all members of the Investigation may be selected from outside the University. Additionally, the Investigation Committee, may in its discretion, retain the advice of subject matter experts in the evaluation of the matter, provided, however, that any such experts shall be subject to the confidentiality requirements of this Policy. The Investigation Committee is responsible for the following activities:

 

a.  Following this Policy and all other applicable policies, procedures, and Governmental Requirements in carrying out its

Investigation duties.

 

b.  Providing a report at the conclusion of the Investigation that meets all requirements of this Policy and any applicable Governmental Requirements. The report shall include findings, conclusions, and recommendations and shall be provided to the Administrative Official and to the RIO.

 

c.  Taking all reasonable steps to conduct its Investigation in a fair and impartial manner and to protect the confidentiality of all aspects of the proceedings.

 

d.  The Chair of the Investigation Committee shall assist the Administrative Official in signing and/or transmitting any notices required pursuant to this Policy, Governmental Requirements and/or Administrative Actions/Sanctions.

 

e.   Take any other actions as may be necessary to carry out the duties of the Investigation Committee under this Policy

and/or Governmental Requirements.


SECTION 7.8.03

 

Procedures to be Followed for Matters Involving Allegations of Research Misconduct                

 

A.  Scope and Applicability of Section 7.8.03 of this Policy:   Section 7.8.03 of this Policy is intended, in part, to carry out Emory University’s responsibilities under applicable federal regulations regarding handling of Allegations of Research Misconduct involving Federally-Sponsored Research, including 42 CFR Part 93 and 45 CFR §§ 689.1 to .10. Section 7.8.03 applies to matters in which all of the following elements are present:

 

1.  Allegations of Research Misconduct. Allegations of Research Misconduct include allegations of Fabrication, Falsification or Plagiarism in proposing, performing or reviewing Research, Research proposals, or in reporting Research results;

 

AND

 

2.  The Allegations of Research Misconduct concern a person who, at the time of the alleged Research Misconduct, was an Institutional Member.

 

B.  Classification of Allegations: Upon receipt of any allegations, the RIO will perform an assessment to determine if the allegations are (1) Allegations of Research Misconduct involving an Institutional Member; or (2) allegations that fall outside of the scope of this Policy. Allegations of Research Misconduct involving an Institutional Member will be handled in accordance with the procedure set forth in this Section 7.8.03.  Allegations that fall outside of the scope of the Policy shall be referred by the RIO to the appropriate University unit, committee or official for handling.   In addition, the RIO shall refer to such other units, committees or officials those allegations which may fall both under this Policy and under the jurisdiction of any other University policy/committee.

 

C.   Assessment of Allegations of Research Misconduct:   Upon classifying an allegation as an Allegation of Research Misconduct that involves an Institutional Member, the RIO will promptly assess the allegation to determine whether it is sufficiently credible and specific so that potential Evidence of Research Misconduct may be identified. The assessment should be completed as promptly as is reasonably possible.    In conducting the assessment, the RIO may, but is not required, to interview the Complainant, Respondent, or other witnesses. The RIO may, but is not required to gather data beyond any that may have been submitted with the allegation, except as necessary to determine whether the allegation is sufficiently credible and specific so that the potential evidence of Research Misconduct may be identified. If additional subject matter expertise is required, the RIO may utilize a consultant within or outside of Emory to assist with the assessment, if needed, and/or consult with the Administrative Official and/or the chair of any standing committee on scientific integrity.  If the Respondent makes a legally sufficient admission of Research Misconduct at the initial assessment stage, Research Misconduct may be determined at this stage if all relevant issues are resolved.  If this is the case, the RIO will secure a written confession detailing the specifics of the Research Misconduct and the matter will be sent to a committee appointed by the Administrative Official to determine corrective action plan and sanctions. For Research receiving PHS Support, however, the RIO and Administrative Official shall consult with ORI regarding the next steps to be taken in such a case.

 

If the assessment does not find credible and specific allegations of Research Misconduct, the matter will be considered closed by the RIO and the Administrative Official and the parties will be notified, where possible. If the research subject to the allegations is Federally-Sponsored Research, the RIO shall secure and maintain for seven (7) years after completion of the assessment the Research Records and Evidence obtained during the assessment, unless ORI has advised the RIO in writing that the University no longer needs to retain the records.   All records shall be made available upon request to governmental agencies as may be required by, and in accordance with, all applicable laws.  Notwithstanding the foregoing, in the case in which the RIO does not find credible and specific allegations of Research Misconduct concerning non-Federally-Sponsored Research, the RIO, in his/her discretion, may release the Records and Evidence after 6 months.

 

D.  Inquiry Procedure:

 

1.  Initiation and Purpose of Inquiry:  If the RIO determines that the criteria for an Inquiry are met then the RIO will notify and consult with the appropriate Administrative Official. If the Administrative Official concurs in the assessment, then the Administrative Official shall initiate the Inquiry. The purpose of the Inquiry is to conduct an initial review of the available Evidence to determine whether to conduct an Investigation. An Inquiry does not require a full review of all the Evidence related to the Allegations of Research Misconduct.

 

2.  Notice to Respondent, Complainant and Others: At the time of or before beginning an Inquiry, the Administrative Official shall make a reasonable, good faith effort to notify any known Respondent in writing. If the Inquiry identifies additional Respondents, they must be notified in writing. The Administrative Official also shall make a reasonable, good faith effort to notify the Complainant of the initiation of the Inquiry if the Complainant is known. If the Inquiry involves a published article or other document, then a good faith attempt to notify any co-authors of the article/document who are not otherwise parties in the Inquiry shall be made in order to determine if any such co-authors may have Evidence pertinent to the proceedings. .

 

3.  Interim Administrative Actions/Sanctions and Notifications of Institution Officials, Government Agencies and Sponsors:

 

a.            The Administrative Official will notify the Chair/Dean/Director of his/her unit of the initiation of the Inquiry.


b.            The Administrative Official in consultation with the RIO shall take any appropriate Administrative Actions/Sanctions in accordance with Section 7.8.01-C.4.

 

c.            The RIO shall make any notifications to government agencies with jurisdiction over the review of

Allegations of Research Misconduct.

 

d.             The Administrative Official, alone, or in conjunction with the Chair of an Inquiry or Investigation Committee shall notify government agencies and sponsors in accordance with Section 7.8.01-C.5.

 

4.  Sequestration of the Research Records: On or before the date on which the Respondent is notified of the allegations or the Inquiry begins, the RIO shall take all reasonable and practical steps to obtain custody of the Research Records and Evidence needed to conduct the Research Misconduct Proceeding; inventory the Research Records and Evidence; and sequester them in a secure manner, except that if the Research Records or Evidence encompass scientific instruments shared by a number of users, then custody may be limited to copies of the data or Evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments. The RIO may employ such institutional personnel and experts as may be necessary to ensure appropriate sequestration.

 

5.  Appointment of the Inquiry Committee: Promptly after the initiation of the Inquiry, the Administrative Official in consultation with the RIO shall appoint at least three members to form an Inquiry Committee and shall choose a committee chair.  If the school involved has a standing committee to review Allegations of Research Misconduct, then the chair of that standing committee shall follow the committee procedures for appointing members of an Inquiry Committee. The Inquiry Committee must consist of individuals who do not have unresolved personal, professional, or financial Conflicts of Interest with those involved with the Inquiry, and should include individuals with the appropriate expertise to evaluate the Evidence and issues related to the allegations, interview the Respondent, Complainant and key witnesses, and conduct the Inquiry. Some or all members of the Inquiry Committee may be selected from outside the University. Alternatively, the Administrative Official may appoint a standing committee that is authorized to conduct Inquiries and to add or use members when necessary to provide the necessary expertise and/or to eliminate Committee Members with Conflicts of Interest.

 

6.  Notification of Complainant and Respondent: The Administrative Official must make a reasonable, good faith attempt to notify the Complainant and the Respondent in writing of the names of persons who have been selected to serve as members of the Inquiry Committee. The Complainant and the Respondent shall have ten days from the receipt of this notice in which to provide the RIO with any written objection to the membership of the Inquiry Committee

. If a notice is sent via email, the date of receipt is considered to be the date the email is sent.  If no objection is received within this period, then any objection on the part of the Complainant or Respondent to the Inquiry Committee shall be considered waived. If an objection is made, then in order for it to be considered, it must be made in Good Faith and must set forth in sufficient detail a reasonable basis for the objection (e.g., Conflict of Interest). The Administrative Official in consultation with the RIO shall consider any objection, and if they determine that the objection is reasonable, the Administrative Official shall appoint a new member of the Inquiry Committee. If they determine that the objection is not made in Good Faith and/or is unreasonable, the membership of the Inquiry Committee shall stand.

 

7.  Charge to the Inquiry Committee and First Meeting: The RIO shall prepare a charge for the Inquiry Committee that:

 

a.            Establishes a time for the completion of the Inquiry;

 

b.            Describes the allegation(s) against the Respondent and any related issues identified during the assessment process;

 

c.            Advises the Inquiry Committee that the purpose of the Inquiry is to make a preliminary evaluation of the Evidence and testimony of the Respondent, Complainant, and key witnesses to determine whether there is sufficient substantive evidence of possible Research Misconduct to warrant an Investigation;

 

d.                Advises the Inquiry Committee that if during the Inquiry, additional information becomes available that substantially changes the subject matter of the Inquiry or suggests additional Respondents, then the Inquiry Committee should notify the RIO, who in conjunction with the Administrative Official, will determine whether it is necessary to notify the Respondent of the new subject matter, or provide notice to additional Respondents.

 

e.            Advises the Inquiry Committee that an Investigation is warranted if the Inquiry Committee determines that: (1) there is a reasonable basis for concluding that the allegation falls within the definition of Research Misconduct; and (2) the allegation may have substance, based on the Inquiry Committee’s review during the Inquiry;

 

f.            Advises the Inquiry Committee that it should make a finding as to whether the allegations were made in

Good Faith;

 

g.           Advises the Inquiry Committee that it is responsible for preparing or directing the preparation of a written report of the Inquiry that meets the requirements of this Policy and, in the case of Research receiving PHS Support, meets the requirements of 42 CFR §93.309(a);


h.            Makes clear that the Inquiry Committee is not tasked with determining whether Research Misconduct

occurred or if so, who was responsible; and

 

i.            Makes clear that the Inquiry Committee must take all reasonable steps to ensure the confidentiality of the Research Misconduct Proceedings.

 

At the Inquiry Committee’s first meeting, the RIO shall review the charge, discuss the allegations and any related issues, review the appropriate procedures for conducting the Inquiry, and answer any questions raised by the Inquiry Committee. The RIO will assist the Inquiry Committee with organizing plans for the Inquiry. The RIO (or their designee) must be present or available throughout the Inquiry to advise the Inquiry Committee as needed.  In addition, the RIO may be available at the Inquiry Committee meeting if the RIO and the Chair of the Inquiry Committee mutually agree

that the RIO’s presence would benefit the proceeding

 

8.  Conduct of the Inquiry: The Inquiry Committee should interview the Complainant, Respondent, and relevant witnesses as well as reviewing pertinent regulations, Research Records and materials. The Inquiry Committee should evaluate the Evidence and testimony and, after consultation with the RIO, determine whether there is sufficient substantive Evidence of possible Research Misconduct to recommend further Investigation based on the criteria found  in this Policy and the criteria found in any applicable Government Requirements (e.g., for Research receiving PHS Support, the criteria found in 42 CFR §93.307(d)). The scope of the Inquiry will not normally include deciding whether Research Misconduct actually occurred. However, if the Respondent makes a legally sufficient admission of Research Misconduct at the Inquiry stage, Research Misconduct may be determined at the Inquiry stage if all relevant issues are resolved and the RIO obtains a signed, written admission from the Respondent that details the specifics of the Research Misconduct. For Research receiving PHS Support, however, the RIO and Administrative Official shall consult with ORI regarding the next steps to be taken in such a case.

 

9.  Inquiry Committee Procedures: The Inquiry Committee shall take care to keep sufficiently detailed documentation of the conduct of the Inquiry in order to permit a later assessment of the reasons for its determination as to whether an Investigation was necessary. Rules of evidence applicable in courts of law shall not apply in the conduct of the Inquiry, and although parties are free to consult with legal counsel at their own expense, legal counsel shall not be permitted to attend any interviews or other proceedings conducted by the Inquiry Committee. Legal counsel for the Respondent may only conduct interviews of persons employed by the University through arrangement with the University’s Office of the General Counsel and with the consent of the person to be interviewed.

 

10.   Inquiry Committee’s Report: Once the Inquiry Committee has reviewed all Evidence and come to a conclusion as to whether or not an Investigation should be conducted, it must draft an Inquiry Committee Report that includes the following information:

 

a.             The name and position of the Respondent;

 

b.            A description of any federal support, including, in the case of Research receiving PHS Support, grant numbers, grant applications, contracts, and publications listing the PHS Support;

 

c.            A description of the Allegations of Research Misconduct;

 

d.            A description of the Evidence reviewed, a summary of all relevant interviews, and the basis for the Inquiry Committee’s conclusions and findings, including findings as to whether the allegations were brought in Good Faith; and recommendations as to whether an Investigation should proceed; and

 

e.            A recommendation as to other steps to be taken, if any. For example, if the Inquiry Committee determines that an Investigation is not warranted, it may recommend other actions to be taken.    These recommendations may include, but are not limited to, recommendations with regard to the Complainant if the Inquiry Committee finds sufficient evidence to support a finding that the allegations against the Respondent were not made in Good Faith or recommendations regarding Administrative Actions/Sanctions.

 

The Inquiry Committee Report may be reviewed by University legal counsel for legal sufficiency and by the RIO for policy compliance. Modifications, if any, should be made by the Inquiry Committee after consultation with the RIO and/or University  legal  counsel.

 

11.  Notification to the Respondent and Complainant and Opportunity to Comment: The RIO shall notify the Respondent of the recommendation of the Inquiry Committee as to whether an Investigation is warranted. The RIO will provide a draft of the Inquiry Committee Report to the Respondent for comment, and for Research receiving PHS Support the RIO shall include a copy of or a reference to 42 CFR Part 93. All respondents will be provided with a copy of or web link to Emory’s policies and procedures on Research Misconduct. The RIO will provide to the Complainant for comment a summary of the Inquiry Committee Report and/or relevant portions of the report regarding the Complainant’s testimony. The parties shall have ten days in which to provide their comments to the Inquiry Committee.

If the draft of the Inquiry Committee Report is sent via email, the date of receipt is considered to be the date the email is sent.  The Inquiry Committee may, but is not required to, revise the Inquiry Committee Report based on the comments submitted. Any comments submitted will be attached to the Inquiry Committee Report and become a part of the Inquiry Record.  In the case of both the Complainant and the Respondent, comments must be limited to perceived factual errors in the report or comments regarding the Committee’s failure to consider specific Evidence or Records that


were provided to the Committee during the proceeding.

 

12.  Transmittal of the Final Report: The Inquiry Committee will transmit the final Inquiry Committee Report

to the Administrative Official and to the RIO.

 

13.  Institutional Decision and Notification: After receipt and review of the Inquiry Committee Report and any comments from Respondent and Complainant, the Administrative Official, in consultation with the RIO and other appropriate institutional officials, shall make a written Administrative Determination as to (a) whether to accept the Inquiry Committee’s findings, including those regarding whether an Investigation is warranted; (b) whether to accept any other recommendations put forward by the Inquiry Committee; and (c) whether to impose any new or additional requirements. In making this Administrative Determination, the Administrative Official shall give considerable weight to the findings and recommendations of the Inquiry Committee. In the event that the Administrative Official rejects the Inquiry Committee’s findings and/or recommendations, he/she shall set forth in the written Administrative Determination the reasons therefor. The Inquiry is completed when the Administrative Official completes this Administrative Determination.  The Administrative Official shall notify the Respondent and the Complainant in writing of the Administrative Determination and provide the RIO and Respondent with copies of the Administrative Determination and the final Inquiry Report. The Administrative Official must notify the Respondent whether the Inquiry found that an Investigation is warranted. The notice must include a copy of the Inquiry Report and include a copy of or refer to this part and the institution's policies and procedures adopted under its assurance. The Administrative Official may notify the Complainant who made the allegation whether the Inquiry found that an Investigation is warranted. The Administrative Official may provide relevant portions of the report to the Complainant for comment. The chair of the department(s) where the matter emanates from shall be informed of the Administrative Determination by the Administrative Official.

 

14.  Notification to Governmental Agencies: If the Administrative Official makes the Administration Determination to initiate an Investigation, then within thirty days of that finding, the RIO must notify any federal governmental agency that has jurisdiction over the review of Allegations of Research Misconduct, and the Administrative Official, alone, or in conjunction with the Chair of the Inquiry Committee, shall notify sponsors of the Research involved in accordance with Section 7.8.01-C.5.

 

15.  Decision not to Initiate an Investigation: If the decision is made not to initiate an Investigation, the University shall secure and maintain sufficiently detailed documentation of the Inquiry to permit a later assessment of the reasons why an Investigation was not conducted, subject to the record-keeping requirements specified in 7.8.03.D.17. For Research receiving PHS Support, these documents must be provided to ORI or other authorized HHS personnel upon request. The University also must notify PHS, other relevant PHS agencies or any other appropriate governmental agencies of any special circumstances that may exist pursuant to Section 7.8.01.C.6.  

 

16.  Time Limit for Inquiry Phase: By not later than sixty days after the date of the Inquiry Committee’s initial meeting, the Inquiry Committee should complete its conduct of the Inquiry and transmit the final Inquiry Committee Report to the Administrative Official and the Administrative Official should issue his/her Administrative Determination. If circumstances exist that require an extension of this sixty day period, then the Inquiry Committee shall make these circumstances known to the Administrative Official and the RIO, after consulting the Administrative Official, shall decide whether the circumstances warrant the grant of an extension, and if so, the length of that extension. If an extension of time is approved, the RIO shall document in writing the reason for the extension for inclusion in the Records of Research Misconduct  Proceedings.

 

17.  Record-Keeping Requirements: The RIO shall keep all records from the Inquiry Committee or otherwise related to the Inquiry in a secure manner for the time period specified below after the later of the date on which the Inquiry or any subsequent Investigation concludes, except those records retained as documentation of the decision not to initiate an Investigation, which are described in Section 7.8.03-D.15. All records shall be made available upon request to governmental agencies as may be required by, and in accordance with, all applicable Governmental Requirements.

 

a.       For Federally-Sponsored Research, the RIO shall keep all records from the Inquiry Committee or otherwise related to the Inquiry in a secure manner for seven (7) years after the later of the date on which the Inquiry or any subsequent Investigation concludes, unless ORI has advised the RIO in writing that the University no longer needs to retain the records. 

 

b.       For Research that is not Federally-Sponsored Research, the RIO shall keep all records from the Inquiry Committee or otherwise related to the Inquiry in a secure manner for three (3) years after the later of the date on which the Inquiry or any subsequent Investigation concludes.

 

 

18.  Early Termination of an Inquiry: If the Inquiry Committee determines that circumstances (e.g., full retraction of allegations, admission of Respondent) make it appropriate to terminate the Inquiry early, then the Inquiry Committee may document its reasons for an early termination in a report and submit the report to the RIO and the Administrative Official for consideration and a decision as to whether the Inquiry may be terminated. In the case of Federally-Sponsored Research, a copy of the report also must be provided to the sponsor and early termination must be approved by the sponsor, the RIO and the Administrative Official. (Specifically, in the case of Research receiving PHS Support, a copy of this report should be provided to ORI for determination as to whether early termination is appropriate or further Inquiry or an Investigation is necessary.) The resignation or termination of a Respondent prior to the

conclusion of an Inquiry shall not in and of itself be sufficient justification to support the early termination of an Inquiry.

 

19.    Restoration of Reputations: In the event that the Inquiry Committee determines that an Investigation is not warranted and no other violations are found, the University will diligently make appropriate efforts to restore the reputation of the Respondent and to protect the position and reputation of any Complainant who brought allegations in Good Faith in accordance with Sections 7.8.01.C.10 and 11  above.

 

20.   Joint Inquiry/Investigation:  In the event that allegations of Research Misconduct involves more than one university, the RIO, in conjunction with the Administrative Official, will consult with the other university(ies) involved to determine whether to and how to conduct a joint Inquiry/Investigation.

 

E.  Investigation Procedure:

 

1.  Initiation of the Investigation: The Administrative Official and the RIO must initiate an Investigation by no later than thirty days after the determination by the Administrative Official that an Investigation should be initiated.

 

2. Purpose of the Investigation: The purpose of the Investigation is to develop a factual record by exploring the allegations in detail and examining the Research Records and all other evidence in depth, leading to recommended findings on whether Research Misconduct has been committed, by whom, and to what extent. The Investigation also will determine whether there are additional instances of possible Research Misconduct that would justify broadening the scope of the Investigation beyond the original allegations.

 

3.  Finding of Research Misconduct: In order to find that a Respondent has committed Research Misconduct, the Investigation Committee must find that (a) there was a significant departure from accepted practices of the relevant research community; and (b) the Research Misconduct was committed intentionally, knowingly or recklessly; and (c) the allegations are proved by a