Policy on Research Misconduct

I. Purpose

To provide an appropriate policy and related procedures regarding the investigating and reporting of possible Research Misconduct, as defined herein, generally and to ensure compliance, when applicable, with institutional responsibilities under the Public Health Service (“PHS”) Policies on Research Misconduct regulations at 42 CFR Part 93, which apply to Research Misconduct (as such term is defined therein) and related allegations involving PHS supported research, research training programs, and research training-related activities, as well as applications or proposals for PHS support for same (collectively, “PHS Supported Research”).

II. Policy

It is the goal of the Touro University System (“Touro” or the “University”) to recognize when Research Misconduct undermines the integrity of the scientific process and the research enterprise. This policy was developed to prevent, detect, and address Research Misconduct in Touro research programs.

In all scientific and research activities, Touro expects the individuals performing research to observe the highest standards of honesty and professional conduct. It is integral for the enterprise of scientific and medical research to maintain the trust and confidence of both the scientific community and the public at large in the integrity of the scientific process. Unethical behavior represents a breach of confidence among scientists and researchers. It also undermines the confidence of the public and research subjects in the reliability of science and medicine. For these reasons, Touro considers Research Misconduct to be a betrayal of fundamental academic, medical, and scientific principles and shall promptly deal with all instances of possible Research Misconduct according to the procedures set forth in this policy.

III. Scope

A.             This policy applies to all research, research training, or activities related to research or research training conducted in all units of the Touro University System, regardless of the source of funding for the research, and to any person paid by, under the control of, or affiliated with Touro, including individuals who held such positions at the time of the alleged Research Misconduct.

B.             This policy and associated procedures will be followed by Touro upon receipt of an allegation of possible Research Misconduct. Allegations of Research Misconduct may arise in connection with the proposal, conduct, review, or reporting of research, including any Research Record (as defined below) generated from that research. Allegations may be disclosed through any means of communication, including written or oral statement or other communication. When applying this policy to allegations of Research Misconduct involving non-PHS Supported Research, Touro may, to the extent not prohibited by law, and where circumstances clearly warrant, and with the prior approval of the Office of General Counsel and notice to the Respondent, waive or deviate from specific policy requirements.

C.              Allegations brought more than six (6) years after the alleged Research Misconduct occurred will not normally be investigated, unless there is a compelling reason to do so, such as when circumstances indicate that the alleged Research Misconduct was not reasonably discoverable at an earlier time. This six (6) year limit does not apply for PHS Supported Research where (i) the Respondent continues or renews any incident of alleged Research Misconduct that occurred before the six (6) year limitation through republication,  citation in processed data, journal articles, funding proposals or data repositories, submitted or published manuscripts, PHS grant applications, progress reports, posters, presentations, and other research records, or other use for the potential benefit of the Respondent of the Research Record that is alleged to have been Fabricated, Falsified, or Plagiarized (as defined below) (the “Subsequent Use Exception”); or (ii) ORI (as defined below) or Touro, following consultation with ORI, determines that the alleged Research Misconduct, if it occurred, would possibly have a substantial adverse effect on the health or safety of the public. The Subsequent Use Exception applies only to the portion of the research record that is alleged to have been Fabricated, Falsified, or Plagiarized. For alleged Research Misconduct that appears subject to this Subsequent Use Exception, but Touro determines is not subject to the exception, Touro will document its determination that the Subsequent Use Exception does not apply and will retain this documentation for at least seven (7) years after completion of the institutional proceeding or the completion of any HHS proceeding.  

IV. Definitions

A.             Allegation means disclosure of possible Research Misconduct through any means of communication and brought directly to the attention of Touro or HHS official.

B.             Assessment means a consideration of whether an allegation of Research Misconduct appears to fall within the definition of Research Misconduct; appears to involve PHS-supported biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training; and is sufficiently credible and specific so that potential evidence of Research Misconduct may be identified. The assessment only involves the review of readily accessible information relevant to the allegation. 

C.              Complainant means a person or entity who in Good Faith makes an allegation of Research Misconduct. A number of different sources may serve as a Complainant, including a party outside of Touro, a journal, or ORI. 

D.             Conflict of Interest means unresolved personal, professional, or financial conflicts of interest with the Complainant, Respondent, or witnesses.

E.              Deciding Official means the individual who makes final findings on Research Misconduct proceedings and any responsive Touro actions. At Touro, the Deciding Official is usually the Dean of the relevant school (the “Dean”). If the Dean is unable to serve as Deciding Official for any reason, the President or the President’s designee will act as Deciding Official.

F.              Good Faith as applied to a Complainant or witness means having a belief in the truth of one’s allegations or testimony that a reasonable person in the same position could have based on the information known to the person at the time. Good Faith as applied to a member of the inquiry committee (“Inquiry Committee”) or investigation committee (“Investigation Committee”) means cooperating with the Research Misconduct Proceeding by carrying out the duties assigned impartially for the purpose of helping Touro meet its responsibilities under this policy.

G.             HHS means the U.S. Department of Health and Human Services.

H.             Inquiry means gathering information and initial fact-finding to determine whether an allegation or apparent instance of Research Misconduct warrants an Investigation.

I.               Institutional Record comprises (a) The records that the University compiled or generated during the Research Misconduct proceeding, except records the University did not consider or rely on. These records include, but are not limited to: (1) Documentation of the assessment as required by § 93.306(c). (2) If an inquiry is conducted, the inquiry report and all records (other than drafts of the report) considered or relied on during the inquiry, including, but not limited to, research records and the transcripts of any transcribed interviews conducted during the inquiry, information the respondent provided to the institution, and the documentation of any decision not to investigate as required by § 93.309(c). (3) If an investigation is conducted, the Investigation report and all records (other than drafts of the report) considered or relied on during the investigation, including, but not limited to, research records, the transcripts of each interview conducted pursuant to § 93.310(g), and information the respondent provided to the institution. (4) Decision(s) by the Deciding Official such as the written decision from the Deciding Official under § 93.314. (5) The complete record of any University appeal consistent with § 93.315. (b) A single index listing all the research records and evidence that the University compiled during the Research Misconduct proceeding, except records the institution did not consider or rely on. (c) A general description of the records that were sequestered but not considered or relied on.

J.              Intentionally means to act with the aim of carrying out the act.

K.             Investigation means the formal development of a factual record and the examination of that record leading to a decision not to make a finding of Research Misconduct or to a recommendation for a finding of Research Misconduct which may include a recommendation for other appropriate actions, including administrative actions.

L.              Knowingly means to act with awareness of the act.

M.            Notice generally means a written communication served in person, sent by mail or its equivalent to the last known street address of the addressee, or sent electronically to the last known email address of the addressee.

N.             ORI means the Office of Research Integrity, the office within HHS that is responsible for addressing research integrity and misconduct issues related to PHS Supported Research.

O.             Preponderance of the Evidence means proof by information that, compared with that opposing it, leads to the conclusion that the fact at issue is more probably true than not true.

P.              To act recklessly means to propose, perform, or review research, or report research results, with indifference to a known risk of Fabrication, Falsification, or Plagiarism. 

Q.             Research Integrity Officer (“RIO”) means a senior official appointed by Touro to implement this policy, assess allegations, and manage the Inquiry and Investigation process. At Touro, the initial RIO is the Senior Vice President for Research. If the Senior Vice President for Research is unable to serve as RIO for any reason, the President will designate an acting RIO.

R.             Research Misconduct means Fabrication, Falsification, or Plagiarism in proposing, performing, reviewing, or reporting research results. The following definitions apply:

1.     Fabrication is making up data or results and recording or reporting them.
2.     Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
3.     Plagiarism is appropriating another person’s ideas, processes, results, or words, without giving appropriate credit. Plagiarism includes the unattributed verbatim or nearly verbatim copying of sentences and paragraphs from another’s work that materially misleads the reader regarding the contributions of the author. It does not include the limited use of identical or nearly identical phrases that describe a commonly used methodology. Plagiarism does not include self-plagiarism or authorship or credit disputes, including disputes among former collaborators who participated jointly in the development or conduct of a research project.

A finding of Research Misconduct requires that the Institution determine that:

(a) There is a significant departure from accepted practices of the relevant research community;
(b)  The misconduct is committed intentionally, knowingly, or recklessly; and
(c)  The allegation is proven by a Preponderance of the Evidence

Honest error or differences of opinion do not constitute Research Misconduct.

S.              Research Misconduct Proceedings means any actions related to alleged Research Misconduct taken under this policy, including but not limited to allegation assessments, Inquiries, and Investigations.

T.             Research Record means (i) the record of data or results that embody the facts resulting from scientific inquiry, including but not limited to, research proposals, laboratory records (both physical and electronic), progress reports, abstracts, theses, oral presentations, internal reports, journal articles, and (ii) any documents and materials provided to funding agencies or the University by a Respondent in the course of the Research Misconduct Proceedings.

U.             Respondent means the person against whom an allegation of Research 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.

V.              Retaliation means an adverse action taken against a Complainant, witness or Committee member by the University or an employee in response to a Good Faith allegation or Good Faith cooperation with a Research Misconduct Proceeding.

V. General Policies and Principles

A. Responsibility to Report Misconduct and Cooperate During Proceedings

1. Employees or individuals associated with Touro who believe in Good Faith that an act of Research of Misconduct has occurred or is occurring have an obligation to report such suspected Research Misconduct to the RIO, or to any individual listed below, who is then required to immediately direct the allegation to the RIO:

a. A Department Chairperson;
b. The Dean; or
c. Legal/Compliance.

2. All members of the Touro community have an obligation to provide relevant evidence regarding allegations.
3. Touro employees are required, as a condition of their employment or affiliation, to cooperate with the University in the review of allegations and participate in these procedures, including providing all relevant documents and data, attending meetings, and answering questions put to them, upon reasonable notice.
4. If others subject to this policy, for example guest researchers, refuse to cooperate with these procedures, Touro report same to government authorities as required and applicable and may, at its discretion, disassociate itself from their research and or revoke all University support and/or approval.

B. Problematic Conduct that Does not Qualify as Research Misconduct

1. 1. 1. The RIO will evaluate each allegation to assess whether the alleged conduct is within the scope of this policy.
      2. If the RIO determines the alleged conduct does not constitute Research Misconduct but involves other problematic conduct, the allegation may be referred to the appropriate University Office or committee for further investigation (e.g., an IRB, Privacy Officer, or Director of Human Resources).
      3. Outside consultants may also be engaged to assist with such matters, at Touro’s discretion. On a case-by-case basis, Touro also reserves the right to employ the procedures in this policy to address problematic conduct that does not qualify as Research Misconduct.
      4. Examples of problematic conduct that may not rise to the level of Research Misconduct, but may warrant referral by the RIO, include but are not limited to: 

a. Intentional or reckless disregard of, or significant and substantial departure from accepted research practices, applicable federal regulations, University policies, IRB directives on the appropriate and ethical conduct of human research, or recognized research ethics;
b. The submission of research forms or documents required by study sponsors, which do not constitute Research Records, that contain intentional or reckless material misstatement or omissions;
c. Misuse of research funding or violation of the terms of the funding agreement; or
d. Falsification of academic or professional credentials.

C.  Role of IRB and/or IACUC in Problematic Conduct Involving Research with Human and/or Animal Subjects

1. 1. 1. If an allegation of Research Misconduct implicates human and/or animal subjects research, the RIO should consult with Touro’s Office of General Counsel and Chair of the IRB and/or IACUC to determine whether certain aspects of the allegation should be handled by the IRB and/or IACUC and its representatives in parallel with the Research Misconduct Proceedings set forth in this policy.
      2. If at any point in a Research Misconduct Proceeding, the RIO determines that the conduct in an allegation does not constitute Research Misconduct but raises concerns about the protection of human and/or animal subjects in research, then the allegation will be referred to the IRB and/or IACUC for investigation and resolution of such matters.
      3. If, in the course of IRB and/or IACUC duties, any IRB and/or IACUC members becomes aware of conduct that might constitute Research Misconduct, the Chair of the IRB and/or IACUC will similarly consult with the RIO and with the Office of General Counsel.
      4. These consultations should be made in compliance with the confidentiality obligations outlined in Section V.D below.

D. Confidentiality in Research Misconduct Proceedings

1. 1. 1. Maximum effort will be taken to preserve the confidentiality of the Research Misconduct Proceedings and information pertaining to the matter. Touro cannot, however, guarantee the confidentiality of the identity of Complainant, Respondent, or any other person involved in any Research Misconduct Proceeding or of the information developed in the course of a Research Misconduct Proceeding.
      2. To the extent possible, the identity of Respondents and Complainants shall be maintained securely and confidentially and no identifying information shall be disclosed, except to: (i) those who need to know in order to carry out a thorough, competent, objective, and fair Research Misconduct Proceeding; (ii) a funding sponsor, government agency, or enforcement body as may be required by law; (iii) as otherwise provided for in this policy; and (iv) as allowed by law.
      3. Any information obtained during the Research Misconduct Proceedings that might identify the subjects of research shall be maintained securely and confidentially and shall not be disclosed, except to those who need to know in order to carry out the Research Misconduct Proceedings or as otherwise allowed or required by law. The determination of those who need to know shall be made by Touro, provided that Touro makes such determination in Good Faith.
      4. Without limiting the foregoing confidentiality protections, Touro has complete authority to interact and communicate with, and disclose information to, federal agencies, institutional review boards (IRBs), academic journals, editors, publishers, co-authors, collaborating institutions or other third parties to the extent that Touro determines in Good Faith that those third parties need to know the information. For example, the identity of the Respondent(s), Complainant(s), and witness(es) will be reported to ORI as required by law. Disclosure of any records or evidence from which research subjects might be identified is limited to those who have a need to know to carry out a Research Misconduct proceeding.
      5. The confidentiality limitation no longer applies once Touro makes a final determination regarding Research Misconduct findings. For example, Touro may manage published data and correct the scientific record once a final determination of Research Misconduct has been made.

E. Protection of Complainants, Respondents, and Others; Consultation with Counsel

1. 1. 1. The RIO and other University representatives involved in the Research Misconduct Proceeding will make all reasonable and practical efforts to protect the rights and reputation of all parties involved in the allegation of Research Misconduct, including the Complainant and the Respondent, throughout the Research Misconduct Proceedings.
      2. It is Touro’s policy that anyone making a Good Faith allegation of Research Misconduct or providing testimony regarding the facts and circumstances surrounding the alleged Research Misconduct during an Inquiry or Investigation shall not suffer Retaliation.
      3. Regardless of whether Touro or ORI determines that Research Misconduct occurred, the RIO will undertake reasonable efforts to protect a Complainant who made an allegation of Research Misconduct in Good Faith and others who cooperate in Good Faith with Inquiries and Investigations of such allegations.
      4. Upon completion of an Investigation, the Deciding Official will determine, after consulting with the Complainant, what steps, if any, are needed to restore the position or reputation of the Complainant.
      5. The RIO is responsible for implementing any steps the Deciding Official approves. (For discussion of the restoration of Respondent’s reputation, see Section VII.B. below.)
      6. Individuals accused of Research 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 and may bring the counsel or personal adviser to interviews or meetings on the case. However, absent special exception, such legal counsel or personal advisers are not permitted to make presentations and are permitted to attend solely to confer with the Respondent at the Respondent’s request and respond to directed questions from Touro and/or Inquiry or Investigation Committees.

F. Ensuring a Fair Research Misconduct Proceeding

1. 1. 1. Reasonable steps shall be taken to ensure thorough, competent, objective, and fair Research Misconduct Proceedings to the extent practicable.
      2. Those conducting the Inquiry or Investigation will be selected on the basis of scientific expertise or other experience that is pertinent to the matter and, prior to selection, shall be evaluated for any unresolved personal, professional, or financial conflicts of interest with the Respondent, Complainant, potential witnesses, or others involved in the matter.
      3. An individual shall also have the right to recuse him/herself.

VI. Procedures For Handling Allegations of Research Misconduct

A. Summary of Research Misconduct Process

1. 1. 1. Once an allegation of Research Misconduct has been made, the RIO, working with the Office of General Counsel, shall promptly decide whether the allegation includes Research Misconduct. Upon such determination, the following procedures will be undertaken pursuant to this policy:

a. Assessment of the allegation;
b. If the appropriate criteria are met, commencement of an initial Inquiry;
c. If the Deciding Official finds it is warranted based on the recommended findings of the RIO, Inquiry Committee, or other designated institutional official, an Investigation to collect data and thoroughly examine the evidence; and
d. Issuance of the Deciding Official’s final finding on the case and appropriate disposition.

1. 1. 2. If at any time during the initial Inquiry or the Investigation information is obtained that reasonably indicates the occurrence of possible criminal violations, the RIO shall promptly notify the Office of General Counsel. The Office of General Counsel shall assist the RIO in determining whether reports should be made to the appropriate office of the sponsoring or funding agency, ORI, appropriate law enforcement officials, or any other relevant organizations or agencies. If jurisdiction exists for PHS Supported Research, ORI must also be notified immediately if Touro has reason to believe that any of the following conditions exist:

a. The health or safety of the public is at risk;
b. There is an immediate need to protect human or animal subjects;
c. HHS resources or interests are threatened;
d. There is reasonable indication of possible violations of civil or criminal law; 
e. Federal action is required to protect the interests of those involved in the Research Misconduct Proceeding;
f. It is probable that the alleged incident will be reported publicly prematurely; or
g. The research community or public should be informed.

1. 1. 3. Additional reports shall be made as required by applicable federal, state, and local law. During the RIO’s initial assessment of allegations, the RIO, in consultation with the Office of General Counsel, shall determine which government agencies, if any, have jurisdiction over the Research Misconduct Proceedings, based upon the funding source of the research to which the allegations apply.
      4. Both Touro and the Respondent bear distinct but defined burdens of proof:

a. Touro has the burden of proof for making a finding of Research Misconduct by a Preponderance of the Evidence. Touro may consider the destruction, absence of, or Respondent’s failure to provide research records as evidence of Research Misconduct where the Respondent claims to possess the records but refused to provide them upon request (42 CFR § 93.105).
b. The Respondent has the burden to demonstrate honest error or difference of opinion as an affirmative defense by a Preponderance of the Evidence (42 CFR § 93.106(b)). Touro will also consider evidence of honest error or difference of opinion to the extent relevant in evaluating whether misconduct was committed intentionally, knowingly, or recklessly. Any determination of honest error must be adequately documented.

B. Submission of Allegation

1.     A Complainant may submit an allegation to the RIO or any of the individuals listed in V.A.1 (a,b,c), who shall report it to the RIO. The RIO may also identify an allegation based upon information received: (a) through informal communications with an individual or (b) from a third party, whether internal or external to Touro, including ORI or another governmental agency. If the RIO determines that the information provided by the potential Complainant constitutes an allegation subject to this policy, the RIO must pursue the allegation even if the potential Complainant chooses not to do so. If an allegation is submitted by the potential Complainant, it will be accepted and reviewed by the RIO to determine whether a Research Misconduct Inquiry is warranted, regardless of the RIO’s opinion of the merits of the allegation.

2.     If, upon receipt of an allegation, it appears that the RIO has any unresolved personal, professional, or financial conflicts of interest with those involved in the allegation, the person conveying the information to the RIO or the RIO will notify the President who shall appoint another qualified individual to serve as interim RIO with respect to the Research Misconduct Proceeding.

3.     If, upon receipt of an allegation, it appears assessment will require or otherwise result in notification to the Respondent, prior to such notification the RIO will take reasonable and practical steps to obtain evidence that may be necessary to conduct the Research Misconduct Proceeding. These steps to obtain evidence include securing custody, inventorying, and sequestering (collectively, to “Secure”) originals or copies of Research Records and other evidence, so long as those copies are substantially equivalent in evidentiary value as the originals. If the Research Misconduct Proceeding progresses beyond the allegation, additional Research Records may need to be Secured.

C. Assessment

1.     Upon receiving or identifying an allegation, the RIO must assess the allegation to determine if an Inquiry is warranted. 

2.     An Inquiry is warranted if the allegation:

a.     falls within the definition of Research Misconduct; 
b.     involves research that is subject to this policy; and 
c.      is sufficiently credible and specific so that potential evidence of Research Misconduct may be identified. 

3.     If the allegation meets these criteria, the RIO shall immediately document the assessment; refer the matter to an Inquiry, which may be conducted by the RIO, another designated institutional official, or an ad hoc committee (the “Inquiry Committee”) and sequester all Research Records and other evidence. 

4.     If the RIO determines that an Inquiry is not warranted, the RIO shall write sufficiently detailed documentation to permit a later review by ORI of why Touro did not proceed to an inquiry and secure the documentation for seven (7) years. 

5.     The matter can then be closed or if other policies of Touro may be implicated, the matter shall be referred to the appropriate department.

D. Inquiry

1.     If using an Inquiry Committee, the RIO may engage individuals from outside of Touro to serve on the Inquiry Committee, in accordance with the confidentiality provisions set forth in Section V.D of this policy. The RIO shall take steps to ensure that the individual(s) selected to serve on the Inquiry Committee do not have real or apparent unresolved personal, professional, or financial conflicts of interest with the Respondent, Complainant, or essential witnesses. Prospective Inquiry Committee members should immediately disclose to the RIO any known conflicts of interest related to the Respondent, Complainant, or essential witnesses.

2.     Prior to initiating the Inquiry, the RIO shall notify the Respondent of the person(s) selected to conduct the Inquiry (the RIO, the members of the Inquiry Committee, or other designated institutional official), and shall give the Respondent the opportunity to submit a written objection to any member within fourteen (14) days of Respondent’s receipt of such notice, based on unresolved personal, professional, or financial conflicts of interest. The RIO shall make a final determination on whether a conflict exists and, if it does, will select another individual to serve on the Inquiry Committee or as designated institutional official. This notification to the Respondent may be combined with or separate from the notification specified in Section VI.D.3 below.

3.     At the time of or before beginning an Inquiry (and after Securing the Research Records and evidence as described in Section VI.D.4 below), the RIO must make a Good Faith effort to notify the Respondent of the Inquiry in writing, if the Respondent’s identity is known. If the identity of the Respondent (or additional Respondents) is not known at the beginning of the Inquiry and becomes known during the Inquiry, notification of the Respondent shall occur as soon as practicable. Such notification will include a statement of the allegation(s) made against the Respondent and a description of the Inquiry process.

4.     To the extent it has not already done so at the allegation stage, Touro must, on or before the date on which the Respondent is notified of the Inquiry (as described in Section VI.D.3 above) or the Inquiry begins, whichever is earlier, promptly Secure all the Research Records and evidence needed to conduct the Research Misconduct Proceeding. When appropriate, at Touro’s discretion, the Respondent(s) may be given copies of, or reasonable, supervised access to, the Research Records and evidence.

5.     If using an Inquiry Committee, the RIO will prepare a charge for the Inquiry Committee that sets forth the purpose of the Inquiry, the Inquiry Committee’s responsibilities, the allegation(s), the standard for determining whether an Investigation is warranted, and the required timeframe for completion of the Inquiry. The purpose of the Inquiry is not to determine whether Research Misconduct definitely occurred or who was responsible, rather it is to determine whether an Investigation is warranted. If applicable, the members of the Inquiry Committee may be told of the possibility that some or all of the Inquiry Committee members may later be asked to assume the responsibilities of an Investigation Committee. Inquiry by the Committee shall begin as soon as possible after the charge is received.

6.     If using an Inquiry Committee or other designated institutional official, the RIO will support the Inquiry Committee or other designated official and be available to answer questions but shall not participate directly in the determination of whether an Investigation is warranted. The RIO will instruct all involved:

a.     to take maximum efforts to conduct the Inquiry in a manner that is respectful and causes the least amount of disruption to all parties; 
b.     to keep all information regarding the Research Misconduct Proceedings and the identity of the Complainant, Respondent, and any witnesses confidential in accordance with this policy; and 
c.      to take steps to prevent Retaliation against the Complainant and any witnesses.

7.     The RIO, Inquiry Committee, or other designated institutional official shall conduct the Inquiry, which generally shall include interviewing the Complainant, the Respondent, and key witnesses, and examining relevant Research Records and materials. The RIO, Inquiry Committee, or other designated institutional official will record or transcribe each interview and provide the recording or transcript to the interviewee for correction. However, not all available evidence must be pursued or reviewed at this stage. The RIO, Inquiry Committee, or other designated institutional official may employ such outside resources (e.g., legal or consulting services) as it deems appropriate to assist in the Inquiry; the engagement of such resources should be coordinated through the Office of General Counsel and the RIO. The Inquiry should be completed within ninety (90) days of its initiation, unless the circumstances warrant a longer period. If the Inquiry takes longer than ninety (90) days to complete, the Inquiry record must document the reasons for the delay.

8.     Upon conclusion of the Inquiry, the RIO, Inquiry Committee, or other designated institutional official shall determine whether an Investigation is warranted. An Investigation is warranted when:

a.     there is a reasonable basis for concluding that the allegation falls within the definition of Research Misconduct; 
b.     the allegation involves research that is subject to this policy; and 
c.      preliminary information-gathering and fact-finding from the Inquiry indicates that the allegation may have substance. The RIO, Inquiry Committee, or other designated institutional official’s role is not to determine whether Research Misconduct actually occurred; rather, it is to determine whether the evidence reviewed creates a reasonable concern that Research Misconduct may have occurred, warranting further fact-finding.

9.     The RIO, Inquiry Committee, or other designated institutional official shall document its determination in a final written report, as specified by the applicable regulations. The final report should generally identify the following:

a.     The names, professional aliases, and positions of the Respondent and Complainant(s);
b.     A description of the allegation(s) of Research Misconduct;
c.      Details about the PHS funding, including any grant numbers, grant applications, contracts, and publications listing PHS Supported Research;
d.     The composition of the Inquiry Committee, if used, including name(s), position(s), and subject matter expertise;
e.     An inventory of sequestered research records and other evidence and description of how sequestration was conducted;
f.      Transcripts of interviews;
g.     Inquiry timeline and procedural history;
h.     Any scientific or forensic analyses conducted;
i.       The basis for recommending that the allegation(s) warrant an investigation;
j.       The basis on which any allegation(s) do not merit further investigation;
k.     Any comments on the Inquiry Report by the Respondent or the Complainant(s);
l.       Any institutional actions implemented, including internal communications or external communications with journals or funding agencies; and
m.    Documentation of potential evidence of honest error or difference of opinion.

10.  The Respondent shall be provided with a copy of the preliminary Inquiry report, and the Respondent shall provide written comments within fourteen (14) days of receipt, unless the RIO, Inquiry Committee, or other designated institutional official, in consultation with the RIO, grants an extension under extenuating circumstances. The Complainant may, at the RIO, Inquiry Committee, or other designated institutional official’s discretion, be provided with a summary or portions of the preliminary Inquiry report, if applicable, for comment within fourteen (14) days of receipt, unless the RIO, Inquiry Committee, or other designated institutional official, in consultation with the RIO, grants an extension under extenuating circumstances. Any comments made by the Complainant or Respondent will be appended to the final Inquiry report of the. Based on the comments, the RIO, Inquiry Committee, or other designated institutional official may revise the report as it deems appropriate.

11.  The final Inquiry report shall be promptly provided to the RIO for transmission to the Deciding Official. The Deciding Official will make a written determination as to whether an Investigation is warranted. If the Deciding Official concludes that an Investigation is warranted, he or she will direct the RIO to appoint an Investigation Committee. If the Deciding Official concludes that an Investigation is not warranted, Touro shall maintain the final Inquiry report and sufficiently detailed documentation of the Inquiry to permit a later assessment of the reasons why an Investigation was not warranted. 

12.  The RIO shall notify the Respondent of the results of the Inquiry, including a copy of the final Inquiry report, applicable regulations, and this policy. Additionally, the RIO may, at the RIO’s discretion, notify the Complainant of the results of the Inquiry and may share relevant portions of the report as necessary to communicate the results. If appropriate, the RIO may also notify publications to which results of implicated research have been submitted that an Investigation has been initiated.

13.  To the extent required by applicable regulations, the RIO will notify the applicable regulatory agency or enforcement body of the decision to begin an Investigation on or before the date the Investigation begins and shall provide a copy of the Inquiry report. For PHS Supported Research, on or before the date on which the Investigation begins, ORI must be notified and provided with the written finding by the Deciding Official and a copy of the RIO, Inquiry Committee, or other designated institutional official’s report, which must include: 

a.     the name and position of the Respondent(s); 
b.     a description of the allegations of Research Misconduct and, if applicable, the PHS Supported Research (including grant numbers, grant applications, contracts, and publications listing PHS Supported Research); 
c.      the basis for recommending that the alleged actions warrant an Investigation; and 
d.     any comments on the report by the Respondent or the Complainant. If requested, Touro must also provide to ORI: 

                                         i.   the institutional policies and procedures under which the Inquiry was conducted; 
                                         ii.  the research records and evidence reviewed, including transcripts or recordings of any interviews, and copies of all relevant documents; and
                                        iii.   the charges for the Investigation Committee to consider.

14.  In some instances, the RIO may determine that it is unnecessary and would be inefficient for all involved to go through the procedures of an Investigation before concluding the matter. This may occur, for example, if the Respondent makes a full confession under circumstances that leave no reasonable questions as to the validity of the confession and the fact that Research Misconduct occurred; where the evidence presented during the Inquiry is otherwise particularly unambiguous and/or compelling; or where the RIO, Inquiry Committee, or other designated institutional official did an exhaustive review of the available evidence in order to meet its charge and determines that there would be no additional evidence to review during a subsequent investigation that could materially impact a conclusion regarding whether Research Misconduct occurred. In such situations it may be appropriate for the Deciding Official to make a finding of Research Misconduct without proceeding through an Investigation. In such cases where no PHS Supported Research is involved, the RIO may recommend that the Deciding Official make a finding in the case based on the Inquiry report. The RIO shall state in writing the reasons why he or she believes that an Investigation is not necessary. If the Deciding Official concurs, he or she may make a finding in the case based on the Inquiry report. In such circumstances, the final Inquiry report shall be deemed the equivalent of the final Investigation Committee report for the remainder of this policy. In cases where PHS Supported Research is involved, it may be appropriate to come to a conclusion of Research Misconduct without proceeding through an Investigation solely in the circumstances of an unambiguous confession by the Respondent, provided that:

a.     The RIO notifies ORI in advance of its intention to close the case at the Inquiry stage;
b.     The Inquiry report is provided to the Respondent with a clear statement that normally in cases involving PHS Supported Research the University does not make a finding of Research Misconduct without conducting an Investigation, but that in the present case it intends to make such a finding based on the Respondent’s unambiguous confession;
c.      The Respondent makes no objection to this process within 14 days of receipt of the draft Inquiry report; and
d.     The confession is fully documented in the record with the Respondent acknowledging that the alleged actions constitute Research Misconduct.

15.  If the Respondent objects in writing to this process on the basis of reasonable grounds, or if ORI determines that further action is necessary to examine the evidence or resolve the outstanding issues, the matter shall proceed to the Investigation stage notwithstanding the RIO’s determination to the contrary. For PHS Supported Research, under no circumstances shall Touro and the Respondent enter into any type of settlement with terms that require confidentiality or otherwise prohibit Touro from communicating with ORI regarding the outcome of the proceedings.

E.    Investigation

1.     If the RIO, Inquiry Committee, or other designated institutional official recommends, and the Deciding Official determines, that further examination and evaluation of the facts underlying the allegation is necessary, an Investigation shall be initiated within 30 days of the determination that an Investigation is warranted.

2.     The RIO shall convene the Investigation Committee to conduct an Investigation. The RIO may engage individuals from outside of Touro to serve on the Investigation Committee, in accordance with the confidentiality provisions set forth in Section V.D of this policy. If appropriate, the Inquiry Committee may be reconstituted by the RIO as the Investigation Committee; alternatively, some or none of the members of the Inquiry Committee may also serve on the Investigation Committee. The RIO shall take steps to ensure that the Investigation Committee includes one or more individuals with appropriate scientific expertise, and that individuals selected to serve on the Investigation Committee do not have unresolved personal, professional, or financial conflicts of interest with the Respondent, Complainant, or essential witnesses. Prospective Investigation Committee members should immediately disclose to the RIO any known conflicts of interest related to the Respondent, Complainant, or essential witnesses.

3.     Prior to initiating the Investigation, the RIO shall notify the Respondent of the allegations (including any new allegations) and the membership of the Investigation Committee and shall give the Respondent the opportunity to submit a written objection to any member of the Investigation Committee within fourteen (14) days of Respondent’s receipt of such notice, based on unresolved personal, professional, or financial conflicts of interest. The RIO shall make a final determination on whether a conflict exists and, if it does, will select another individual to serve on the Investigation Committee. The RIO shall also notify the Respondent that the Respondent may designate an individual as an advocate to counsel and confer with the Respondent, consistent with Section V.E of this policy.

4.     The RIO will prepare a charge for the Investigation Committee that sets forth the purpose of the Investigation, the Investigation Committee’s responsibilities, the allegation(s), the standard for determining whether Research Misconduct occurred, the relevant burden of proof, and the required timeframe for completion of the Investigation. The charge shall require that the Investigation Committee use diligent efforts to ensure that the Investigation is thorough and sufficiently documented and includes examination of all Research Records and evidence relevant to reaching a decision on the merits of the allegation(s).

5.     The RIO will serve as support staff to the Investigation Committee and be available to answer procedural questions but shall not participate directly in the determination of whether Research Misconduct occurred. 

6.     The RIO will instruct all involved:

a.     to take maximum efforts to conduct the Investigation in a manner that is respectful and causes the least amount of disruption for all parties; 
b.     to keep all information regarding the Research Misconduct Proceedings and the identity of the Complainant, Respondent, and any witnesses confidential; and 
c.      to take steps to prevent Retaliation against the Complainant and any witnesses. The Office of General Counsel will be available, as needed, to advise on Committee proceedings.

7.     The Investigation Committee shall conduct the Investigation, which shall include:

a.     diligently pursuing all significant issues and leads discovered that are determined relevant to the Investigation, including any evidence of additional instances of possible Research Misconduct, and continuing the Investigation to completion, and 
b.     interviewing Respondent(s), Complainant(s), and any other available person who has been reasonably identified as having information regarding any relevant aspects of the Investigation, including witnesses identified by the Respondent. 

8.     During interviews, the Investigation Committee shall number all relevant exhibits and refer to any exhibits shown to the interviewee during the interview by that number. All interviews shall be recorded and transcribed, and the recording and transcript shall be provided to each interviewee for correction; the recording or transcript, with any corrections appended, shall be included in the record of the Investigation. If additional allegations are raised during the investigation, Respondents will be notified in writing of the additional allegations raised against them. The Respondent will not be present during the witnesses’ interviews, but Touro will provide the Respondent with a transcript of each interview, with redactions as appropriate to maintain confidentiality. The Investigation Committee may employ such outside resources (e.g., legal or consulting services) as it deems appropriate to assist in the Investigation; the engagement of such resources should be coordinated through the Office of General Counsel and the RIO.

9.     The Investigation should be completed within 180 days of initiation (or as dictated by the applicable funding agency), including conducting the Investigation, preparing the report of findings, providing the draft report for comment, and if required by applicable regulations, sending the final report to the applicable regulatory agency or enforcement body. For PHS Supported Research, if Touro is unable to complete the Investigation in 180 days, Touro will ask ORI for an extension in writing, documenting the reasons for additional time and will notify the Respondent of the revised timeframe. If ORI grants an extension, it may direct Touro to file periodic progress reports.

10.  When the Investigation Committee makes a recommended finding regarding the allegation of Research Misconduct, it shall submit a preliminary report reviewing all information and its recommended finding to the Respondent for written comment. The preliminary report shall adequately detail the evidence that supports or refutes each allegation included in the Investigation. The preliminary report shall include:

a.     Description of the nature of the allegation(s) of Research Misconduct, including any additional allegation(s) addressed during the Research Misconduct Proceeding;
b.     Description and documentation of the PHS Supported Research, including any grant numbers, grant applications, contracts, and publications listing PHS Supported Research. This documentation includes known applications or proposals for support that the Respondent has pending with PHS and non-PHS Federal agencies;
c.      Description of the specific allegation(s) of Research Misconduct for consideration in the Investigation of the Respondent;
d.     Composition of Investigation Committee, including name(s), position(s), and subject matter expertise;
e.     Inventory of sequestered Research Records and other evidence, except records the institution did not consider or rely on. This inventory will include manuscripts and funding proposals that were considered or relied on during the Investigation. The inventory will also include a description of how any sequestration was conducted during the Investigation;
f.      Transcripts of all interviews conducted;
g.     Identification of the specific published papers, manuscripts submitted but not accepted for publication (including online publication), PHS funding applications, progress reports, presentations, posters, or other Research Records that contain the allegedly Falsified, Fabricated, or Plagiarized material;
h.     Any scientific or forensic analyses conducted;
i.       A copy of these policies and procedures;
j.       Any comments made by the Respondent and Complainant(s) on the draft Investigation report and the Committee’s consideration of those comments; and
k.     A statement for each separate allegation of whether the Committee recommends a finding of Research Misconduct.

11.  Touro may, to the extent possible, redact the identities of material witnesses in any evidence made available to the Respondent to protect the confidentiality of the witnesses’ involvement in the Research Misconduct Proceedings. The Respondent will have thirty (30) days to comment on the preliminary report. A draft of the preliminary report (or a summary or portions thereof) also may, at the Investigation Committee’s discretion, be made available to Complainant, with any comments to be submitted by the Complainant within fourteen (14) days. Any comments by the Respondent and/or Complainant shall be considered by the Investigation Committee before the Investigation report is finalized and shall be included in the final report.

12.  Within ten (10) days of receiving comments from the Respondent and Complainant, if any, the Investigation Committee shall prepare and submit a final report, including any factual findings and recommendations as to whether Research Misconduct should be found to have occurred, along with the Respondent’s comments, if any, to the RIO. The RIO will submit the final Investigation report to the Deciding Official, along with a recommendation regarding any notifications that should be made (for example, government agencies or enforcement bodies, relevant journals, co-authors).

13.  Upon review of the final Investigation report, the Deciding Official will make a written determination (i) as to whether Touro accepts the findings and recommendations of the Investigation report; and (2) the appropriate institutional actions in response to the accepted findings of Research Misconduct, in accordance with Section VII.A of this policy.

14.  The RIO will provide the final Investigation report with all attachments to the federal agency or other sponsor funding the research under question, if any, as well as to the Respondent. Additionally, the RIO may, in the RIO’s discretion, notify the Complainant of the results of the Investigation and may share relevant portions of the report as necessary to communicate the results.

15.  The RIO or their authorized delegate shall provide a summary report of the Investigation Committee’s findings to the Department Chairperson, the Dean and the President of the University (the full report will be available upon request).

16.  If and after the Deciding Official finds that Research Misconduct has occurred pursuant to the procedures set forth in this policy, Touro will add the Deciding Official’s written decision to the Investigation report and organize the Institutional Record in a logical manner and transmit the Institutional Record to the ORI.

17.  If the Respondent files any appeals to the Research Misconduct findings or to any related Touro action, the complete record of appeal(s) becomes part of the Institutional Record. After the appeals process has concluded, Touro will promptly notify ORI of the appeal(s) to Research Misconduct findings and/or to Touro related actions, unless the records pertaining to the appeal(s) were sent to the ORI prior to the conclusion of the appeal(s).

F. Appeals

1.     Within seven (7) calendar days of the date of the final Investigation report indicating Research Misconduct occurred, a Respondent may submit a written appeal to the RIO. An appeal must be based solely on new information not previously considered or on a substantial procedural irregularity during the investigation, and must include supporting evidence.

2.     The RIO or designated institutional official will review the appeal and the final Investigation report and may consult with the Office of the General Counsel, the Investigation Committee, and relevant consultants or witnesses. The RIO or designated institutional official will issue a written decision to the Respondent and notify the Department Chairperson, the Dean and the President of the University.

3.     If the appeal is denied, the findings of research misconduct are final. The RIO or designated institutional official will add the Deciding Official’s written decision to the Investigation report and organize the Institutional Record in a logical manner and transmit the Institutional Record to the ORI. The Complainant(s), if known, will be notified of the final outcome.

4.     If the RIO or designated institutional official concurs with the appeal in whole or in part, the RIO will issue a written decision and forward the decision, Investigation report, and evidence to the ORI and will take reasonable steps, as appropriate, to protect or restore the Respondent’s reputation. Required notifications to the funding agencies will be made, as appropriate.

VII. Consequences of Investigation

A. Administrative and/or Disciplinary Actions

1. 1. 1. If the Deciding Official finds that Research Misconduct has occurred pursuant to the procedures set forth in this policy, the Deciding Official will decide on the appropriate administrative or disciplinary actions to be taken, if any, after consultation with the RIO and Office of General Counsel and taking into consideration the recommendations of the Investigation Committee. The actions may include, but are not limited to:

a. Withdrawal or correction of all pending or published abstracts and papers emanating from the research where Research Misconduct was found;
b. Removal of the responsible person from the particular project (assuming it is ongoing);
c. Letters of reprimand, special monitoring of future work, probation, or suspension;
d. Salary reduction;
e. Initiation of steps leading to possible rank reduction or termination of employment;
f. Notification to hospitals and sponsoring agencies with which the individual has been or is affiliated and/or initiation of a review of prior research conducted at Touro by the individual, if there is reason to believe that previous research may be characterized by Research Misconduct; and
g. Restitution of funds, as appropriate, to granting agencies, Touro and/or research subjects.

1. 1. 2. The RIO shall notify the Respondent in writing of any administrative or disciplinary actions to be taken and shall also meet with the Respondent to discuss the Investigation Committee’s recommended findings and the implementation of any such administrative or disciplinary actions. Touro will assist ORI / HHS in administering and enforcing any HHS-authorized administrative actions.

B. Restoration of Respondent's Reputation

1. 1. 1. If the Deciding Official’s finding is that no Research Misconduct occurred, and if the Inquiry or Investigation has resulted in any damage to the Respondent’s reputation, the Respondent shall meet with the RIO to discuss how the Respondent’s record shall be cleared and what reasonable efforts will be taken to restore the Respondent’s reputation.
      2. Any University actions to restore the Respondent’s reputation must first be approved by the Deciding Official.
      3. The implementation of such approved actions will be the responsibility of the RIO. Depending on the particular circumstances, the RIO should consider notifying those individuals aware of or involved in the Inquiry or the Investigation of the final outcome, publicizing the final outcome in forums in which the allegation of Research Misconduct was previously publicized, or expunging all reference to the Research Misconduct allegation from the Respondent’s personnel and/or departmental file.

VIII. Other Considerations

A. Multiple Institutions and Multiple Respondents

1. 1. 1. If the alleged Research Misconduct involves multiple institutions, Touro may work closely with the other affected institutions to determine whether a joint Research Misconduct Proceeding will be conducted.
      2. If so, the cooperating institutions will choose an institution to serve as the lead institution.
      3. In a joint Research Misconduct Proceeding, the lead institution will obtain Research Records and other evidence pertinent to the proceeding, including witness testimony, from the other relevant institutions.
      4. By mutual agreement, the joint Research Misconduct Proceeding may include Committee members from the institutions involved. The determination of whether further Inquiry and/or Investigation is warranted, whether Research Misconduct occurred, and the institutional actions to be taken may be made by the institutions jointly or tasked to the lead institution.
      5. If the alleged Research Misconduct involves multiple Respondents, Touro may either conduct a separate Inquiry for each new Respondent or add them to the ongoing proceedings.
      6. The institution must give additional Respondent(s) notice of and an opportunity to respond to the allegations.

B. Termination of Employment or Resignation Prior to Completing Inquiry or Investigation

1. 1. 1. The termination of the Respondent’s Touro employment or affiliation, by resignation or otherwise, before or after an allegation of possible Research Misconduct is made, will not preclude or terminate the Research Misconduct Procedures, due to the compelling interests of Touro, research colleagues, the IRB or other research review committee, and research subjects in resolving such allegations.
      2. If the Respondent refuses to participate in the process after resignation or otherwise, the Inquiry and Investigation Committees will use their best efforts to reach a conclusion concerning the allegations, noting in their reports the Respondent’s failure to cooperate and its effect on the Committee’s review of all the evidence.

C.  Allegations Not Made in Good Faith

1. 1. 1. If relevant, the Deciding Official will determine whether the Complainant’s allegations were made in Good Faith.
      2. If an allegation was not made in Good Faith, the Deciding Official will determine whether any administrative and/or employment action should be recommended against the Complainant. Submission of a Research Misconduct allegation with malicious intent or for personal enrichment or aggrandizement shall be grounds for an Investigation or sanctions in accordance with applicable University policies.

IX. Record Retention

A. After completion of a case and all ensuing related actions, the RIO will prepare a complete file, including all relevant evidence secured, considered and relied on in the course of the Investigation; a single index of such evidence; documentation, including a general description of sequestered evidence/records that were not considered or relied on and are no longer in the record due to its irrelevance or duplication; the Inquiry final report, including any finding not to investigate; the Investigation final report and all supporting records, including transcripts or recordings of all interviews; and the complete record of any appeal.

B. The RIO will keep the file in a secure manner for seven (7) years after completion of the case, or longer if required by applicable law, to permit later assessment of the case. ORI or other authorized government personnel will be given access to the records as required by law.

X. Effective Date

This policy is effective immediately.

XI. Policy Management

Executive Stakeholder: Senior Vice President of Research
Oversight Office: Office of Research Administration