Responsible Conduct in Research Policy

Including Responding to Allegations of Misconduct in Research and Related Matters

Office of Sponsored Programs and Research, December 14, 2023

I. Introduction*

1. General Policy

It is the policy of New York Institute of Technology (New York Tech) that research and related scholarly activities at New York Tech be conducted according to the highest ethical standards. This policy encompasses all scholarly and research related activity at New York Tech together with all related forms of publication and dissemination of outcomes and findings.

2. Scope

This policy and the associated procedures apply to all individuals at New York Tech engaged in research, including research that is supported by or for which support is requested from Public Health Service (PHS) and the National Science Foundation (NSF).

This statement of policy and procedures is also intended to carry out this institution's responsibilities under the Public Health Service (PHS) Policies on Research Misconduct, 42 CFR Part 93, and further guidance issued by the Office of Research Integrity (ORI) within the U.S. Department of Health and Human Services (DHHS). This policy applies to any person paid by, under the control of, or affiliated with the institution, such as scientists, trainees, technicians and other staff members, students, fellows, guest researchers, or collaborators at New York Tech.

This policy applies to allegations of research misconduct (fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results) involving:

A person who, at the time of the alleged research misconduct, was employed by, was an agent of, or was affiliated by contract or agreement with this institution; and (1) PHS supported biomedical or behavioral research, research training or activities related to that research or research training, such as the operation of tissue and data banks and the dissemination of research information, (2) applications or proposals for PHS support for biomedical or behavioral research, research training or activities related to that research or research training, or (3) plagiarism of research records produced in the course of PHS supported research, research training or activities related to that research or research training. This includes any research proposed, performed, reviewed, or reported, or any research record generated from that research, regardless of whether an application or proposal for PHS funds resulted in a grant, contract, cooperative agreement, or other form of PHS support.

This statement of policy and procedures does not apply to authorship or collaboration disputes and applies only to allegations of research misconduct that occurred within six years of the date the institution or DHHS received the allegation, subject to the subsequent use, health or safety of the public, and grandfather exceptions found in 42 CFR §93.105(b). This six-year limitation does not apply if the respondent continues or renews any incident of alleged research misconduct that occurred before the end of the six-year period through the citation, republication, or other use for the potential benefit of the respondent of the research record that is alleged to have been fabricated, falsified, or plagiarized. The six-year limitation also does not apply if ORI, or the institution following consultation with ORI, determines that the alleged misconduct, if it occurred, would possibly have a substantial adverse effect on the health or safety of the public.

This policy and associated procedures will normally be followed when an allegation of possible misconduct in research or related activity is received by an institutional official. Particular circumstances in an individual case may dictate variation from the normal procedure as deemed in the best interests of New York Tech. Such circumstances may include but are not limited to obligations assumed by New York Tech on acceptance of an award from a sponsor including the PHS or other sponsor. In such cases, New York Tech shall fulfill any conditions assumed on acceptance of such an award. Any change from normal procedures must ensure fair treatment to the subject of the inquiry or investigation. Any significant variation must be approved in advance by the Vice Provost for Research.

* SECTIONS THAT ARE BASED ON REQUIREMENTS OF THE PHS REGULATIONS CODIFIED AT 42 C.F.R. PART 93, HAVE NOTES THAT INDICATE THE APPLICABLE SECTION NUMBER, E.G. (42 C.F.R. 93.103).

II. Responsible Conduct of Research

New York Tech is committed to supporting responsible and ethical conduct of research and scholarship among its faculty, staff and students. Responsible conduct of research should foster a climate of intellectual honesty and a commitment to ethical responsibilities by academia. All members of the New York Tech community share responsibility for developing and maintaining standards to assure ethical conduct of research and detection of abuse of these standards.

New York Tech continually strives to maintain a research environment that promotes attention to the highest ethical standards for all sponsored and non- sponsored research. It is expected, therefore, that all researchers participate in ongoing education in all core areas that comprise a comprehensive responsible conduct of research curriculum. These core areas include:

Introduction to RCR
Authorship
Collaborative Research
Conflicts of Interest
Data Management
Mentoring
Peer Review
Plagiarism
Research Involving Human Subjects
Research Misconduct
Using Animal Subjects in Research

Recipients of awards from the National Science Foundation (NSF), the USDA National Institute of Food and Agriculture (NIFA), and the National Institutes of Health (NIH) are required to comply with specific requirements to ensure appropriate training in the responsible conduct of research. Researchers applying for, and receiving, support from NSF, NIFA and the NIH will need to be familiar with these respective regulations, as well as provide documentation of appropriate training as required under the terms of the award. Regardless of funding, however, these core ethical values are expected to be upheld in all research conducted at New York Tech and research team education in all applicable areas is highly encouraged.

A) NATIONAL SCIENCE FOUNDATION (NSF) REQUIREMENTS FOR RESPONSIBLE CONDUCT OF RESEARCH (RCR)

The National Science Foundation (NSF) has established a training requirement in the Responsible Conduct of Research (RCR) for students and postdoctoral fellows (postdocs) supported by NSF projects. The requirement also applies to all undergraduates, graduate students, and postdoc researchers who are supported by NSF projects submitted (and subsequently awarded) after January 4, 2010; including competitive renewals (see the NSF Guide for more on the requirement). The new regulations implement provisions of the America COMPETES Act, which requires grantees to provide training and oversight in the responsible and ethical conduct of research for undergraduate and graduate students and postdocs. At New York Tech it is also required that principal investigators review and become familiar with the content of the issues concerning ethical research. At the time an NSF proposal is submitted, the Office of Sponsored Programs and Research must certify that New York Tech has a plan to provide appropriate training and oversight for students (undergraduate and graduate) and postdoctoral fellows, who will be supported by NSF, to conduct research. Plans are not to be submitted with proposals but they are subject to review on request by NSF.

NSF has not specified the content and mode of delivery of the training in the responsible conduct of research, but they have suggested that seminars, web- based programs, workshops and mentoring are some of the acceptable methods of delivery. New York Tech participates in the Collaborative Institutional Training Initiative (CITI), a subscription service providing research ethics training to members of the research community. Therefore, all principal investigators, students, postdocs and research personnel listed on and/or supported by NSF are required to complete, at a minimum, the CITI online training in the Responsible Conduct for Research. To take this module please go to citiprogram.org.

NSF expects that the RCR training be delivered during the first year of an award; however, we recommend that it be taken within 180 days of an individual starting work on the project, to ensure integrity is maintained throughout.

Principal Investigators are responsible for ensuring completion of the RCR education requirements by all postdocs, graduate students, and undergraduates who are supported by NSF projects, including subawards, submitted and subsequently awarded. The Officer of Sponsored Programs and Research will, on a periodic basis, monitor completion of CITI training. The PI will be notified of any individuals who have not satisfied this training requirement.

Noncompliance:

Failure to comply with this training requirement within specified time frames shall constitute grounds for disciplinary action. Disciplinary action is based upon a reasonable investigation of the noncompliance and is consistent with the severity of the violation. A range of examples includes, but is not limited to, additional training/monitoring for minor violations up to limits being placed on the use of NSF-awarded funds for the project supporting these personnel, and/or loss of privilege to apply for new grant funding until the required training has been brought into compliance.

B) U.S. DEPARTMENT OF AGRICULTURE (USDA) NATIONAL INSTITUTE OF FOOD AND AGRICULTURE (NIFA) REQUIREMENTS FOR RESPONSIBLE CONDUCT OF RESEARCH (RCR)

USDA NIFA considers education in RCR critical for excellence, as well as public trust, in science and engineering. The agency requires that program directors, faculty, undergraduate students, postdoctoral researchers, and any staff participating in the awarded research project receive appropriate training and oversight in the responsible and ethical conduct of research; documentation of such training must be maintained and provided to NIFA upon request.

NIFA specifies general requirements for RCR training and indicates that grantees consider CITI training specifically. Therefore, all principal investigators, students, postdocs and research personnel listed on and/or supported by NIFA funding are required to complete, at a minimum, the CITI online training in the Responsible Conduct for Research. To take this module please go to citiprogram.org.

It is the responsibility of the PI to ensure that appropriate training has been completed by all individuals associated with the funded work. The Officer of Sponsored Programs and Research will, on a periodic basis, monitor completion of CITI training. The PI will be notified of any individuals who have not satisfied this training requirement.

Noncompliance:

Failure to comply with this training requirement within specified time frames shall constitute grounds for disciplinary action. Disciplinary action is based upon a reasonable investigation of the noncompliance and is consistent with the severity of the violation. A range of examples includes, but is not limited to, additional training/monitoring for minor violations up to limits being placed on the use of awarded funds for the project supporting these personnel, and/or loss of privilege to apply for new grant funding until the required training has been brought into compliance

C) NATIONAL INSTITUTES OF HEALTH (NIH) REQUIREMENTS FOR RESPONSIBLE CONDUCT OF RESEARCH (RCR)

NIH requires that all Institutional Research Training Grants, Individual Fellowship Awards, Career Development Awards (institutional and individual), Research Education Grants, Dissertation Research Grants or other grant programs with a training component include a plan for how the PI will carry out instruction in responsible conduct of research. Specifically, this applies to the following types of grants: D43, D71, F05, F30, F31, F32, F33, F34, F37, F38, K01, K02, K05, K07, K08, K12, K18, K22, K23, K24, K25, K26, K30, K99/R00, KL1, KL2, R25, R36, T15, T32, T34, T35, T36, T37, T90/R90, TL1, TU2, U2R. Although this plan does not affect overall impact scores, applications will be considered incomplete and will not be reviewed until an acceptable plan of instruction is submitted.

All principal investigators, students, postdocs and research personnel listed on and/or supported by NIH are required to complete, at a minimum, the CITI online training in the Responsible Conduct for Research. To take this module please go to citiprogram.org. NIH has not mandated specific subject requirements, but most acceptable plans have included conflict of interest; human subjects, animal, and safe laboratory practices; mentor/mentee responsibilities and relationships; collaborate research; peer review; data acquisition and lab tools; data management, sharing and ownership; research misconduct; responsible authorship and publication; and scientist as a responsible member of society. (See NIH's Update on the Requirement for Instruction in the Responsible Conduct of Research to learn more about NIH's requirements.)

It is the responsibility of the PI to ensure that appropriate training has been completed by all individuals associated with the funded work. The Office of Sponsored Programs and Research will, on a periodic basis, monitor compliance with the RCR plan outlined in the funded grant. In cases where New York Tech is a subrecipient, general NIH RCR requirements must be met.

Noncompliance:

Failure to comply with this training requirement within specified time frames shall constitute grounds for disciplinary action. Disciplinary action is based upon a reasonable investigation of the noncompliance and is consistent with the severity of the violation. A range of examples includes, but is not limited to, additional training/monitoring for minor violations up to limits being placed on the use of NIH-awarded funds for the project supporting these personnel, and/or loss of privilege to apply for new grant funding until the required training has been brought into compliance.

D) ALL OTHER SOURCES OF FUNDING

New York Tech has chosen to adopt the use of the Responsible Conduct in Research Citi Program Module for all grant recipients no matter the source of award, so that the institution is in compliance with providing training in the Responsible Conduct in Research for all grant dollars awarded to New York Tech.

III. Definitions

Allegation: means a disclosure of possible research misconduct made through any means of communication to an institutional or DHHS official (See 42 C.F.R. §93.201).
Conflict of Interest: means the real or apparent interference of one person's interests with the interests of another person, where potential bias may occur due to prior or existing personal or professional relationships.
Deciding Official: means the institutional official who makes final determinations on allegations of research misconduct and any responsive institutional actions. The Deciding Official will not be the same individual as the Research Integrity Officer and should have no direct prior involvement in the institution's inquiry, investigation, or allegation assessment. Until this Policy is amended, the Deciding Official shall be the Provost.
Good faith allegation: means an allegation made with the honest belief that research misconduct may have occurred. An allegation is not in good faith if it is made with reckless disregard for or willful ignorance of facts that would disprove the allegation.
Inquiry: means preliminary information-gathering and initial fact-finding to determine whether an allegation or apparent instance of research misconduct warrants an investigation (See 42 C.F.R.§93.212).
Investigation: means the formal development of a factual record and the examination and evaluation 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 (See 42 C.F.R.§93.215).
ORI: means the Office of Research Integrity, the office to which the U.S. Department of Health and Human Services (DHHS) Secretary has delegated responsibility for addressing research integrity and misconduct issues related to PHS supported activities (See 42 C.F.R. §93.217).
PHS: means the U.S. Public Health Service, the unit within DHHS that includes the Office of Public Health and Science and the following Operating Divisions: Agency for Healthcare Research and Quality; Agency for Toxic Substances and Disease Registry; Centers for Disease Control and Prevention; Food and Drug Administration; Health Resources and Services administration; Indian Health Service; National Institutes of Health; Substance Abuse and Mental Health Services Administration; and the offices of the Regional Health Administrators (See 42 C.F.R. §93.220).
PHS regulation: means the Public Health Service regulation establishing standards for institutional inquiries and investigations into allegations of research misconduct, which is set forth at 42 C.F.R. Part 93, entitled Public Health Service Policies on Research Misconduct.
Sponsorship: means applications or awards for grants, contracts, or cooperative agreements from any funding body including PHS.
Research Integrity Officer (RIO): means the institutional official responsible for assessing allegations of research misconduct and determining when such allegations warrant inquiries and for overseeing inquiries and investigations. (Until this policy is amended, the Research Integrity Officer shall be the Vice Provost for Research unless otherwise designated by the Provost or President.)
Research record: means any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research or related activity that constitutes the subject of an allegation of research misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.
Respondent: means the person against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding. There can be more than one respondent in any inquiry or investigation (See 42 C.F.R. §93.225).
Retaliation: means an adverse action taken against a complainant, witness, or committee member by an institution or one of its members in response to (a) a good faith allegation of research misconduct or of inadequate institutional response thereto; or (b) good faith cooperation with a research misconduct proceeding (See 42 C.F.R. §93.226). See Code of Conduct and Whistleblower Policy.
Misconduct in research or research misconduct: means fabrication (making up data or results and recording or reporting them), falsification (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), plagiarism (the appropriation of another person's ideas, processes, results, or words without giving appropriate credit), or other practices that seriously deviate from those that are commonly accepted within the academic community for proposing, conducting, or reporting research. It does not include honest error or differences in interpretations or judgments of data (See 42 C.F.R. §93.103).
Whistleblower: means a person who makes an allegation of misconduct in research. See Code of Conduct and Whistleblower Policy.

IV. Rights and Responsibilities

A) RESEARCH INTEGRITY OFFICER

The Research Integrity Officer or designated delegate will, in consultation with the Vice Provost for Research and Provost, appoint inquiry and investigation committees, as required and ensure that necessary and appropriate expertise is secured to carry out a thorough and authoritative evaluation of the relevant evidence in an inquiry or investigation. The RIO or designated delegate will attempt to ensure that confidentiality is maintained.

The RIO or designated delegate will assist inquiry and investigation committees and all institutional personnel in complying with these procedures and with applicable standards imposed by government or external funding sources. The RIO or designated delegate is also responsible for maintaining files of all documents and evidence and for the confidentiality and the security of the files.

The RIO or designated delegate will report to any sponsor requiring a report, as detailed in the relevant award notice, as required by regulation and keep ORI apprised of any developments during the course of the inquiry or investigation that may affect current or potential DHHS funding for the individual(s) under investigation or that PHS needs to know to ensure appropriate use of Federal funds and otherwise protect the public interest (42 C.F.R. §93.318).

B) WHISTLEBLOWER

The whistleblower will have an opportunity to testify before the inquiry and investigation committees, to review portions of the inquiry and investigation reports pertinent to his/her allegations or testimony, to be informed of the results of the inquiry and investigation, and to be protected from retaliation. Also, if the RIO or designated delegate has determined that the whistleblower may be able to provide pertinent information on any portions of the draft report, these portions will be given to the whistleblower for comment.

The whistleblower is responsible for making allegations in good faith, maintaining confidentiality, and cooperating with an inquiry or investigation.

C) RESPONDENT

The respondent will be informed of the allegations when an inquiry is opened and notified in writing of the final determinations and resulting actions. The respondent will also have the opportunity to be interviewed by and present evidence to the inquiry and investigation committees, to review the draft inquiry and investigation reports and submit comments on these drafts, and to have the advice of counsel.

The respondent is responsible for maintaining confidentiality and cooperating with the conduct of an inquiry or investigation. If the respondent is not found guilty of scientific misconduct, he or she has the right to receive institutional assistance in restoring his or her reputation (42 C.F.R. §93.304(k)).

D) DECIDING OFFICIAL

The Deciding Official will receive the inquiry and/or investigation report and any written comments made by the respondent or the whistleblower on the draft report. The Deciding Official will consult with the RIO or designated delegate or other appropriate officials and will determine whether to conduct an investigation, whether misconduct occurred, whether to impose sanctions, or whether to take other appropriate administrative actions [see section X].

V. General Policies and Principles

A) RESPONSIBILITY TO REPORT MISCONDUCT

All employees or individuals associated with New York Tech should report observed, suspected, or apparent misconduct in research or related activities to the RIO or designated delegate. If an individual is unsure whether a suspected incident falls within the definition of research misconduct, he or she may call the RIO or designated delegate at 516.686.1247 to discuss the suspected misconduct informally.

If the circumstances described by the individual do not meet the definition of research misconduct, the RIO or designated delegate will refer the individual or allegation to other offices or officials with responsibility for resolving the problem. At any time, an employee may have confidential discussions and consultations about concerns of possible research misconduct with the RIO or designated delegate and will be counseled about appropriate procedures for reporting allegations.

B) PROTECTING THE WHISTLEBLOWER

The RIO or designated delegate will monitor the treatment of individuals who bring allegations of research misconduct or of inadequate institutional response thereto, and those who cooperate in inquiries or investigations. The RIO or designated delegate will ensure that these persons will not be retaliated against in the terms and conditions of their employment or other status at the institution and will review instances of alleged retaliation for appropriate action.

Employees should immediately report any alleged or apparent retaliation to the RIO or designated delegate.

Also, New York Tech shall protect the privacy of those who report research misconduct in good faith (42 C.F.R. §93.108) to the maximum extent possible. For example, if the whistleblower requests anonymity, the institution will make an effort to honor the request during the allegation assessment or inquiry within applicable policies and regulations and state and local laws, if any. The whistleblower will be advised that if the matter is referred to an investigation committee and the whistleblower's testimony is required, anonymity may no longer be guaranteed. Institutions are required to undertake diligent efforts to protect the positions and reputations of those persons who, in good faith, make allegations of research misconduct (42 C.F.R. §93.304(l)).

C) PROTECTING THE RESPONDENT

Inquiries and investigations will be conducted in a manner that will ensure fair treatment to the respondent(s) in the inquiry or investigation and confidentiality to the extent possible without compromising public health and safety or thoroughly carrying out the inquiry or investigation.

Institutional employees 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. In the event that an accused employee opts to have counsel present at meetings with institutional officials, the proceedings shall be conducted for New York Tech by the General Counsel.

D) COOPERATION WITH INQUIRIES AND INVESTIGATIONS

Institutional employees will cooperate with the RIO or designated delegate and other institutional officials in the review of allegations and the conduct of inquiries and investigations. Employees have an obligation to provide relevant evidence to the RIO, designated delegate, or other institutional officials on research misconduct allegations.

E) PRELIMINARY ASSESSMENT OF ALLEGATIONS

Upon receiving an allegation of research misconduct, the RIO or designated delegate will immediately assess the allegation to determine whether there is sufficient evidence to warrant an inquiry, whether PHS support or PHS applications for funding are involved, and whether the allegation falls under the PHS definition of research misconduct.

VI. Conducting the Inquiry

A) INITIATION AND PURPOSE OF THE INQUIRY

Following the preliminary assessment, if the RIO or designated delegate determines that the allegation provides sufficient information to allow specific follow-up, involves sponsorship that requires action, and/or falls under the PHS definition of research misconduct, he or she will immediately initiate the inquiry process. In initiating the inquiry, the RIO or designated delegate should identify clearly the original allegation and any related issues that should be evaluated. The purpose of the inquiry is to make a preliminary evaluation of the available evidence and testimony of the respondent, whistleblower, and key witnesses to determine whether there is sufficient evidence of possible research misconduct to warrant an investigation. The purpose of the inquiry is not to reach a final conclusion about whether research misconduct definitely occurred or who was responsible.

The findings of the inquiry must be set forth in an inquiry report.

B) SEQUESTRATION OF RECORDS OF RESEARCH OR RELATED ACTIVITY

After determining that an allegation falls within the definition of research misconduct and involves applicable sponsorship, the RIO or designated delegate shall ensure that all original pertinent records and materials relevant to the allegation are immediately secured.

C) APPOINTMENT OF THE INQUIRY COMMITTEE

The RIO or designated delegate should inform other institutional officials as appropriate and will, in consultation with the Vice Provost for Research and Provost, appoint an inquiry committee and committee chair within ten business days of the initiation of the inquiry. The inquiry committee shall consist of individuals who do not have real or apparent conflicts of interest in the case, are unbiased, and have the necessary expertise to evaluate the evidence and issues related to the allegation, interview the principals and key witnesses, and conduct the inquiry. These individuals may be scientists, subject matter experts, administrators, lawyers, or other qualified persons, and they may be from inside or outside the institution. The RIO or designated delegate will notify the respondent of the committee membership within ten business days of the formation of the committee. If the respondent submits a written objection to any appointed member of the inquiry committee or expert based on bias or conflict of interest within five business days, the Vice Provost for Research or Provost will determine whether to replace the challenged member or expert with a qualified substitute.

D) CHARGE TO THE COMMITTEE AND THE FIRST MEETING

The RIO or designated delegate shall prepare a charge for the inquiry committee that describes the allegations and any related issues identified during the allegation assessment and states that the purpose of the inquiry is to make a preliminary evaluation of the evidence and testimony of the respondent, whistleblower, and key witnesses to determine whether there is sufficient evidence of possible research misconduct to warrant an investigation.

At the inquiry committee's first meeting, the RIO or designated delegate will review the charge with the committee, discuss the allegations, any related issues, and the appropriate procedures for conducting the inquiry, assist the committee with organizing plans for the inquiry, and answer any questions raised by the committee.

E) INQUIRY PROCESS

The inquiry committee will normally interview the whistleblower, the respondent, and key witnesses as well as examine relevant research records and materials. Then the inquiry committee will evaluate the evidence and testimony obtained during the inquiry. After consultation with the RIO or designated delegate and institutional counsel, the committee members will decide whether there is sufficient evidence of possible research misconduct to recommend further investigation. The scope of the inquiry does not include deciding whether research misconduct occurred or conducting exhaustive interviews and analyses.

F) ELEMENTS OF THE INQUIRY REPORT

A written inquiry report must be prepared that states the name and title of the committee members and experts, if any; the allegations; the affected sponsorship support; a summary of the inquiry process used; a list of the research records reviewed; summaries of any interviews; a description of the evidence in sufficient detail to demonstrate whether an investigation is warranted or not; and the committee's determination as to whether an investigation is recommended and whether any other actions should be taken if an investigation is not recommended.

Institutional counsel will review the inquiry report for legal sufficiency.

G) COMMENTS ON THE DRAFT INQUIRY REPORT BY THE RESPONDENT AND THE WHISTLEBLOWER

The RIO or designated delegate will provide the respondent with a copy of the draft inquiry report for comment and rebuttal and will provide the whistleblower, if he or she is identifiable, with a summary of the inquiry findings for comment.

Confidentiality
The RIO or designated delegate shall establish reasonable conditions for review to protect the confidentiality of the draft inquiry report.
Receipt of Comments
Within ten business days of their receipt of the draft inquiry report, the whistleblower and respondent will provide their comments, if any, to the inquiry committee. Any comments that the whistleblower or respondent submits on the draft inquiry report will become part of the final inquiry report and record (42 C.F.R. §93.304(e)).

Based on the comments, the inquiry committee may revise the report as appropriate.

H) INQUIRY DECISION AND NOTIFICATION

Decision by Deciding Official
The RIO or designated delegate will transmit its final inquiry report and any comments to the Deciding Official, who will make the determination of whether findings from the inquiry provide sufficient evidence of possible research misconduct to justify conducting an investigation. The inquiry is completed when the Deciding Official makes this determination, which will be made within 60 days of the first meeting of the inquiry committee. Any extension of this period will be based on good cause and recorded in the inquiry file.
Notification
The RIO or designated delegate will notify both the respondent and the whistleblower in writing of the Deciding Official's decision of whether to proceed to an investigation and will remind them of their obligation to cooperate in the event an investigation is opened. The RIO or designated delegate will also notify all appropriate institutional officials of the Deciding Official's decision.

I. TIME LIMIT FOR COMPLETING THE INQUIRY REPORT

The inquiry committee must complete the inquiry and submit its report in writing to the RIO or designated delegate within 60 calendar days of the inquiry's initiation following its first meeting (42 C.F.R. §93.307(g)), unless circumstances clearly warrant a longer period and accordingly the RIO or designated delegate approves an extension for good cause. If the RIO or designated delegate approves an extension, the reason for the extension will be entered into the records of the case and the report (42 C.F.R.§93.307(g)). The respondent also will be notified of the extension.

VII. Conducting the Investigation

A) PURPOSE OF THE INVESTIGATION

The purpose of the investigation is to explore in detail the allegations, to examine the evidence in depth, and to determine specifically whether research misconduct has been committed, by whom, and to what extent. The investigation will also determine whether there are additional instances of possible research misconduct that would justify broadening the scope beyond the initial allegations. This is particularly important where the alleged misconduct involves clinical trials or potential harm to human subjects or the general public or if it affects research that forms the basis for public policy, clinical practice, or public health practice. The findings of the investigation will be set forth in an investigation report.

B) SEQUESTRATION OF THE RESEARCH RECORDS

The RIO or designated delegate will immediately sequester any additional pertinent research records that were not previously sequestered during the inquiry.

This sequestration should occur before or at the time the respondent is notified that an investigation has begun. The need for additional sequestration of records may occur for any number of reasons, including the institution's decision to investigate additional allegations not considered during the inquiry stage or the identification of records during the inquiry process that had not been previously secured. The procedures to be followed for sequestration during the investigation are the same procedures that apply during the inquiry.

C) APPOINTMENT OF THE INVESTIGATION COMMITTEE

The RIO or designated delegate will, in consultation with other institutional officials as appropriate, appoint an investigation committee and committee chair within ten business days of the notification to the respondent that an investigation is planned or as soon thereafter as practicable. The investigation committee should consist of at least three individuals who do not have real or apparent conflicts of interest in the case, are unbiased, and have the necessary expertise to evaluate the evidence and issues related to the allegations, interview the principals and key witnesses, and conduct the investigation. These individuals may be scientists, administrators, subject matter experts, lawyers, or other qualified persons, and they may be from inside or outside the institution. Individuals appointed to the investigation committee may also have served on the inquiry committee.

The RIO or designated delegate will notify the respondent of the committee membership within five days of the committee's formation. If the respondent submits a written objection to any appointed member of the investigation committee within five days of receiving notice of the committee membership, the RIO or designated delegate will determine whether to replace the challenged member with a qualified substitute.

D) CHARGE TO THE INVESTIGATION COMMITTEE AND THE FIRST MEETING

1. Charge to the Committee

The RIO or designated delegate will define the subject matter of the investigation in a written charge to the committee that:

Describes the allegations and related issues identified during the inquiry and identifies the respondent;
Informs the committee that it must conduct the investigation;
Defines research misconduct;
Informs the committee that it must evaluate the evidence and testimony to determine whether, based on a preponderance of the evidence, research misconduct occurred and, if so, the type and extent of it and who was responsible;
Informs the committee that in order to determine that the respondent committed research misconduct it must find that a preponderance of the evidence establishes that: (1) research misconduct, as defined in this policy, occurred (respondent has the burden of proving by a preponderance of the evidence any affirmative defenses raised, including honest error or a difference of opinion); (2) the research misconduct is a significant departure from accepted practices of the relevant research community; and (3) the respondent committed the research misconduct intentionally, knowingly, or recklessly; and
Informs the committee that it must prepare or direct the preparation of a written investigation report that meets the requirements of this policy and 42 CFR §93.313. During the investigation, if additional information becomes available that substantially changes the subject matter of the investigation or would suggest additional respondents, the committee will notify the RIO or designated delegate, who will determine whether it is necessary to notify the respondent of the new subject matter or to provide notice to additional respondents.

2. The First Meeting

The RIO or designated delegate will convene the first meeting of the investigation committee to review the charge, the inquiry report, and the prescribed procedures and standards for the conduct of the investigation, including the necessity for confidentiality and for developing a specific investigation plan. The investigation committee will be provided with a copy of this statement of policy and procedures and 42 CFR Part 93. The RIO will be present or available throughout the investigation to advise the committee as needed. The investigation committee will be provided with a copy of these instructions and, where PHS funding is involved, the PHS regulations.

E) INVESTIGATION PROCESS

The investigation committee will be appointed and the process initiated within 30 calendar days of the completion of the inquiry, if findings from that inquiry provide a sufficient basis for conducting an investigation (42 C.F.R. §93.310(a)).

The investigation will normally involve examination of all documentation including, but not necessarily limited to, relevant research records, computer files, proposals, manuscripts, publications, correspondence, memoranda, and notes of telephone calls (42 C.F.R. §310(e)). Whenever possible, the committee should interview the whistleblower(s), the respondents(s), and other individuals who might have information regarding aspects of the allegations (42 C.F.R. §310(g)). Interviews of the respondent must be tape recorded or transcribed. All other interviews must be transcribed, tape recorded, or summarized. Summaries or transcripts of the interviews must be prepared, provided to the interviewed party for comment or revision, and included as part of the investigatory file (42 C.F.R. §310(g)).

IX. The Investigation Report

A) ELEMENTS OF THE INVESTIGATION REPORT

The final report submitted to ORI must describe the policies and procedures under which the investigation was conducted, describe how and from whom information relevant to the investigation was obtained, state the findings, and explain the basis for the findings. The report will include the actual text or an accurate summary of the views of any individual(s) found to have engaged in research misconduct as well as a description of any sanctions imposed and administrative actions taken by the institution (42 C.F.R. §93.313; 42 C.F.R. §93.315).

The investigation committee and the RIO or designated delegate are responsible for preparing a written draft report of the investigation that:

Describes the nature of the allegation of research misconduct, including identification of the respondent;
Describes and documents the PHS support, including, for example, the numbers of any grants that are involved, grant applications, contracts, and publications listing PHS support;
Describes the specific allegations of research misconduct considered in the investigation;
Includes the institutional policies and procedures under which the investigation was conducted, unless those policies and procedures were provided to ORI previously;
Identifies and summarizes the research records and evidence reviewed and identifies any evidence taken into custody but not reviewed; and
Includes a statement of findings for each allegation of research misconduct identified during the investigation. Each statement of findings must: (1) identify whether the research misconduct was falsification, fabrication, or plagiarism, and whether it was committed intentionally, knowingly, or recklessly; (2) summarize the facts and the analysis that support the conclusion and consider the merits of any reasonable explanation by the respondent, including any effort by respondent to establish by a preponderance of the evidence that he or she did not engage in research misconduct because of honest error or a difference of opinion; (3) identify the specific PHS support; (4) identify whether any publications need correction or retraction; (5) identify the person(s) responsible for the misconduct; and (6) list any current support or known applications or proposals for support that the respondent has pending with non-PHS federal agencies.

B) Comments on the Draft Report and Access to Evidence

1. Respondent

The RIO or designated delegate will give the respondent a copy of the draft investigation report for comment and rebuttal. Along with a copy of the draft investigation report, the respondent will also be given a copy of, or allowed supervised access to, the evidence on which the draft investigation report is based. The respondent will be allowed 30 calendar days from the date of receipt of the draft investigation report to submit any comments, and any comments submitted by the respondent will be included and considered in the final report (42 C.F.R. §93.312(a)).

2. Whistleblower

The RIO or designated delegate may provide the whistleblower, if he or she is identifiable, with those portions of the draft investigation report that address the whistleblower's role and opinions in the investigation. The whistleblower may submit comments to the portion of the draft investigation received within 30 calendars days of receiving such portions. The report should be modified, as appropriate, based on the whistleblower's comments (See 42 CFR §93.312(b) and §93.313(g)).

3. Institutional Counsel

The draft investigation report will be transmitted to the institutional counsel for a review of its legal sufficiency. Comments will be incorporated into the report as appropriate.

4. Confidentiality

In distributing the draft investigation report, or portions thereof, to the respondent and whistleblower, the RIO or designated delegate will inform the recipient of the confidentiality under which the draft investigation report is made available and may establish reasonable conditions to ensure such confidentiality. For example, the RIO or designated delegate may request the recipient to sign a confidentiality statement or to come to his or her office to review the report.

C) INSTITUTIONAL REVIEW AND DECISION

Based on a preponderance of the evidence, the Deciding Official will make the final determination whether to accept the investigation report, its findings, and the recommended institutional actions. If this determination varies from that of the investigation committee, and PHS sponsorship is involved, the Deciding Official will explain in detail the basis for rendering a decision different from that of the investigation committee in the institution's letter transmitting the report to ORI. The Deciding Official's explanation should be consistent with the PHS definition of research misconduct, the institution's policies and procedures, and the evidence reviewed and analyzed by the investigation committee. The Deciding Official may also return the report to the investigation committee with a request for further fact-finding or analysis. The Deciding Official's determination, together with the investigation committee's report, constitutes the final investigation report for purposes of ORI review.

When a final decision on the case has been reached, the RIO or designated delegate will notify both the respondent and the whistleblower in writing. In addition, the Deciding Official will determine whether law enforcement agencies, professional societies, professional licensing boards, editors of journals in which falsified reports may have been published, collaborators of the respondent in the work, or other relevant parties should be notified of the outcome of the case. The RIO or designated delegate is responsible for ensuring compliance with all notification requirements of funding or sponsoring agencies.

D) TRANSMITTAL OF THE FINAL INVESTIGATION REPORT TO ORI

After comments have been received and the necessary changes have been made to the draft report, the investigation committee will transmit the final report with attachments, including the respondent's and whistleblower's comments, to the Deciding Official, through the RIO or designated delegate.

Unless an extension has been granted, the RIO or designated delegate must, within the 120-day period for completing the investigation, submit the following to ORI: (1) a copy of the final investigation report with all attachments; (2) a statement of whether the institution accepts the findings of the investigation report; (3) a statement of whether the institution found research misconduct and, if so, who committed the research misconduct; and (4) a description of any pending or completed administrative actions against the respondent.

E) TIME LIMIT FOR COMPLETING THE INVESTIGATION REPORT

An investigation must be completed within 120 days of its initiation (unless New York Tech is granted an extension by ORI as described below), with the initiation being defined as the first meeting of the investigation committee. This includes conducting the investigation, preparing the report of findings, making the draft report available to the subject of the investigation for comment, submitting the report to the Deciding Official for approval, and submitting the report to the ORI (42 C.F.R. §93.311(a)).

The institution's decision to initiate an investigation must be reported in writing to the Director of ORI on or before the date the investigation begins (42 C.F.R. §93.310(b)). At a minimum, the notification must include the name of the person(s) against whom the allegations have been made, the general nature of the allegation as it relates to the PHS definition of research misconduct, the PHS applications or grant number(s) involved, and a copy of the inquiry report (42 C.F.R. §93.309(a)). ORI must also be notified of the final outcome of the investigation and must be provided with a copy of the investigation report (42 C.F.R. §93.315). Any significant variations from the provisions of the institutional policies and procedures should be explained in any reports submitted to ORI.
If the institution plans to terminate an inquiry or investigation for any reason without completing all relevant requirements of the PHS regulation, the RIO or designated delegate will submit a report of the planned termination to ORI, including a description of the reasons for the proposed termination (42 C.F.R. §93.316).
If the institution determines that it will not be able to complete the investigation in 120 days, the RIO or designated delegate will submit to ORI a written request for an extension that explains the delay, reports on the progress to date, estimates the date of completion of the report, and describes other necessary steps to be taken. If the request is granted, the RIO or designated delegate will file periodic progress reports as requested by the ORI (42 C.F.R. §93.311(b)).
When PHS funding or applications for funding are involved and an admission of research misconduct is made, the RIO or designated delegate will contact ORI for consultation and advice. Normally, the individual making the admission will be asked to sign a statement attesting to the occurrence and extent of research misconduct. When the case involves PHS funds, the institution cannot accept an admission of research misconduct as a basis for closing a case or not undertaking an investigation without prior approval from ORI (42 C.F.R. §93.316).
The RIO or designated delegate will notify ORI at any stage of the inquiry or investigation if:
- health or safety of the public is at risk, including an immediate need to protect human or animal subjects (42 C.F.R. §93.318(a));
- there is an immediate need to protect Federal funds, equipment, or interests (42 C.F.R. §93.318(b));
- there is an immediate need to protect the interests of the person(s) making the allegations or of the individual(s) who is the subject of the allegations as well as his/her co-investigators and associates, if any (42 C.F.R. §93.318(e));
- it is probable that the alleged incident or research misconduct proceeding is going to be reported publicly (42 C.F.R. §93.318(f));
- the research community or public should be informed (42 C.F.R. §93.318(g)); or
- there is a reasonable indication of possible criminal or civil law violation(s). (42 C.F.R. §93.318(d)).

X Institutional Administrative Actions

New York Tech will take appropriate administrative actions against individuals when an allegation of research misconduct has been substantiated.

If the Deciding Official determines that the alleged research misconduct is substantiated by the findings, he or she will decide on the appropriate actions to be taken, after consultation with the RIO or designated delegate. The actions may include, as appropriate: withdrawal or correction of all pending or published abstracts and papers emanating from the research where scientific misconduct was found, removal of the responsible person from the particular project, letter of reprimand, special monitoring of future work, probation, suspension, salary reduction, restitution of funds, or initiation of steps leading to possible rank reduction or termination of employment.

XI. Notice and Reporting to ORI and Cooperation with ORI

The RIO or designated delegate has lead responsibility for ensuring that the institution:

Files an annual report with ORI containing the information prescribed by ORI.
Sends to ORI with the annual report such other aggregated information as ORI may prescribe on the institution's research misconduct proceedings and the institution's compliance with 42 CFR Part 93.
Notifies ORI immediately if, at any time during the research misconduct proceeding, it has reason to believe that health or safety of the public is at risk, DHHS resources or interests are threatened, research activities should be suspended, there is reasonable indication of possible violations of civil or criminal law, federal action is required to protect the interests of those involved in the research misconduct proceeding, the institution believes that the research misconduct proceeding may be made public prematurely, or the research community or the public should be informed.
Provides ORI with the written finding by the responsible institutional official that an investigation is warranted and a copy of the inquiry report, within 30 days of the date on which the finding is made.
Within 120 days of beginning an investigation, or such additional days as may be granted by ORI, provides ORI with the investigation report, a statement of whether the institution accepts the investigation's findings, a statement of whether the institution found research misconduct and, if so, who committed it, and a description of any pending or completed administrative actions against the respondent.
Seeks advance ORI approval if the institution plans to close a case at the inquiry, investigation, or appeal stage on the basis that the respondent has admitted guilt, a settlement with the respondent has been reached, or for any other reason, except the closing of a case at the inquiry stage on the basis that an investigation is not warranted or a finding of no misconduct at the investigation stage.
Cooperates fully with ORI during its oversight review and any subsequent administrative hearings or appeals, including providing all research records and evidence under the institution's control, custody, or possession and access to all persons within its authority necessary to develop a complete record of relevant evidence.

XII. Other Considerations

A) TERMINATION OF INSTITUTIONAL EMPLOYMENT OR RESIGNATION

Prior to the completion of an inquiry or investigation, the termination of the respondent's institutional employment, by resignation or otherwise, before or after an allegation of possible research misconduct has been reported, will not preclude or terminate the research misconduct proceedings.

If the respondent, without admitting to the research misconduct, elects to resign his or her position prior to the initiation of an inquiry, but after an allegation has been reported, or during an inquiry or investigation, the inquiry or investigation will proceed. If the respondent refuses to participate in the process after resignation, the committee will use its best efforts to reach a conclusion concerning the allegations, noting in its report the respondent's failure to cooperate and its effect on the committee's review of all the evidence.

B) RESTORATION OF THE RESPONDENT'S REPUTATION (42 C.F.R. §93.304(k))

If the institution finds no research misconduct and ORI concurs, the RIO or designated delegate will, after consulting with the respondent, undertake reasonable efforts to restore the respondent's reputation. Depending on the particular circumstances, the RIO or designated delegate should consider notifying those individuals aware of or involved in the investigation of the final outcome, publicizing the final outcome in forums in which the allegation of research misconduct was previously publicized, or expunging all reference to the research misconduct allegation from the respondent's personnel file. Any institutional actions to restore the respondent's reputation must first be approved by the Deciding Official.

C) PROTECTION OF THE WHISTLEBLOWER AND OTHERS (42 C.F.R. §93.304(l))

Whether or not a finding of research misconduct is made, the RIO or designated delegate will undertake reasonable efforts to protect whistleblowers who made allegations of research misconduct in good faith and others who cooperate in good faith with inquiries and investigations of such allegations. Upon completion of an investigation, the Deciding Official will determine, after consulting with the whistleblower, what steps, if any, are needed to restore the position or reputation of the whistleblower. The RIO or designated delegate is responsible for implementing any steps the Deciding Official approves. The RIO or designated delegate will also take appropriate steps during the inquiry and investigation to prevent any retaliation against the whistleblower.

D) ALLEGATIONS NOT MADE IN GOOD FAITH

If relevant, the Deciding Official will determine whether the whistleblower's allegations of research misconduct were made in good faith. If an allegation was not made in good faith, the Deciding Official will determine whether any administrative action should be taken against the whistleblower.

E) INTERIM ADMINISTRATIVE ACTIONS (42 C.F.R. §93.304(h))

Institutional officials will take interim administrative actions, as appropriate, to protect Federal funds, ensure that the purposes of the Federal financial assistance are carried out, and protect the integrity of the PHS supported research process.

XIII. Record Retention

After completion of a case and all ensuing related actions, the RIO or designated delegate will prepare a complete file, including the records of any inquiry or investigation and copies of all documents and other materials furnished to the RIO or designated delegate or committees. ORI or other authorized DHHS personnel will be given access to the records upon request (42 C.F.R. §93.317(c)).

The RIO or designated delegate must maintain and provide to ORI upon request "records of research misconduct proceedings" as that term is defined by 42 CFR §93.317. Unless custody has been transferred to DHHS or ORI has advised in writing that the records no longer need to be retained, records of research misconduct proceedings must be maintained in a secure manner for seven years after completion of the proceeding or the completion of any PHS proceeding involving the research misconduct allegation. The RIO or designated delegate is also responsible for providing any information, documentation, research records, evidence or clarification requested by ORI to carry out its review of an allegation of research misconduct or of the institution's handling of such an allegation.