Research Compliance Services

ClinicalTrials.gov

Title: ClinicalTrials.gov
Policy Owner: Research Compliance Services, Office of the Vice President for Research
Applies to: Employees, Faculty, Students, Other
Campus Applicability:  All Campuses
Effective Date: May 25, 2018
For More Information, Contact Office of the Vice President for Research
Contact Information: (860) 486-3001
Official Website: http://research.uchc.edu/

 

REASON FOR POLICY

The purpose of this policy is to ensure investigators at the University comply with the requirements for registering and reporting results of clinical trials at ClinicalTrials.gov.

The University is committed to the mission of public availability of clinical trial information and to complying with the related requirements of the Food and Drug Administration (FDA), National Institutes of Health (NIH), the Centers for Medicare and Medicaid Services (CMS) and other federal agencies and departments for using ClinicalTrials.gov.  Investigators for certain clinical trials are required to register and report results at ClinicalTrials.gov for certain clinical trials, including those involving the FDA, NIH, and CMS.  The International Committee of Medical Journal Editors (ICMJE) also imposes a similar requirement as a condition for seeking publication in participating journals.

APPLIES TO

All University faculty, employees, students, postdoctoral fellows, residents and other trainees, and agents who supervise or conduct clinical trials needing to be registered at ClinicalTrials.gov.

POLICY STATEMENT

It is the responsibility of the Principal Investigator (or other equivalent individual) supervising or conducting a clinical trial that must be registered at ClinicalTrials.gov to ensure that the registration, results reporting, related consent form and other applicable requirements are met with the required timeframes.  Any failure to fulfill these requirements may result in limitations on publications or grant submissions or other sanctions.

The University’s Protocol Registration and Results System (PRS) Administrator within Research Compliance Services is available to provide assistance in navigating the PRS system, administering requests by ClinicalTrials.gov, and with compliance questions related to these requirements.

ENFORCEMENT

Violations of this policy may result in appropriate disciplinary measures in accordance with University By-Laws, General Rules of Conduct for All University Employees, applicable collective bargaining agreements, the University of Connecticut Student Code, and other applicable University Policies.

Authority

42 CFR part 11 (FDA)

NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (NIH)

Medicare Clinical Trial Policies (CMS)

Clinical Trials (ICMJE)

Policy History:

Adopted: 5/25/2018 (Approved by President’s Cabinet)

Export Control and Economic Sanctions Policy

Title: Export Control and Economic Sanctions Policy
Policy Owner: Office of the Vice President for Research
Applies to: Faculty, Staff, Students, Others
Campus Applicability:  All
Effective Date: 12/14/2015
For More Information, Contact Research Compliance Services
Contact Information: exportcontrol@uconn.edu, or (860) 486-8704
Official Website: https://ovpr.uconn.edu/services/rics/export-control/

 

REASON FOR POLICY

Export control and economic sanctions regulations aim to protect the national security, foreign policy, and economic interests of the United States.  Export control regulations govern how certain information, technologies, and commodities can be transmitted overseas or to a foreign national on U.S. soil, whereas economic sanctions regulations restrict transactions with certain countries, institutions, and individuals. The scope of the these regulations is broad: they cover exports in virtually all fields of science, engineering, and technology, apply to research activities regardless of the source of funding, and impose restrictions on activities by U.S. persons that occur outside the United States. Failure to comply with these laws can have serious consequences, both for the institution and for the individual researcher. The potential penalties include fines and imprisonment. These laws are collectively referred to as “Export Control Laws.”

The University of Connecticut (UConn) encourages and supports open research and the free exchange of ideas. Although most university activities and research are exempt from export control laws, UConn engages in activities, research, and the development of new technologies that are subject to Export Control Laws. UConn has established the procedures necessary to ensure the university and its employees remain in full compliance.

APPLIES TO 

This policy applies to all faculty, staff, students, researchers, and all other individuals working at the University of Connecticut Storrs, Regional Campuses, and UConn Health.

POLICY STATEMENT

UConn is committed to compliance with Export Control Laws, including those implemented by the U.S. Department of Commerce through its Export Administration Regulations (EAR), the U.S. Department of State through its International Traffic in Arms Regulations (ITAR), as well as embargo regulations imposed by the U.S. Treasury Department through its Office of Foreign Assets Control (OFAC).

The Office of the Vice President for Research (OVPR) is the designated authority charged with compliance oversight of the U.S. export control and economic sanctions requirements for UConn and has final authority on such matters. Research Compliance Services, an office within OVPR, is the functional administrative unit charged with the responsibility for oversight of export control and economic sanctions compliance and recordkeeping.

Individuals acting on behalf of the University, including faculty, staff and students, are responsible for complying with applicable Export Control Laws, including requirements related to international travel, the proper handling, transfer, access, storage, control, and dissemination of export controlled hardware, software, information, technology, and technical data to destinations and persons outside of the U.S., as well as in some cases, to foreign nationals at the university engaging in instruction, conducting research, or providing service activities.

The University typically conducts fundamental research in basic and applied science or engineering, which is widely and openly published and made available to the scientific and academic community. This allows for the Fundamental Research Exclusion, which means the research results are exempt from Export Control Laws. But Export Control Laws could apply if the research is not considered fundamental research, or if the research has restrictions on publication, foreign national participation, or restricted access to/disclosure of research results.  Please contact Research Compliance Services if you have any questions on whether or not Export Control Laws apply to your particular activity.

In order to comply with Export Control Laws applicable to international travel, the University will not permit or support travel to any country subject to a comprehensive U.S. Government embargo (as set forth in the UConn International Travel procedure, unless the travel falls within the scope of a license or exception granted by law and is reviewed in advance and approved in writing by the OVPR Senior Export Control Officer under this policy and the export control compliance protocols and procedures available online at: https://ovpr.uconn.edu/services/rics/export-control/.

ENFORCEMENT

Violations of this policy may result in appropriate disciplinary measures in accordance with University Laws and By-Laws, General Rules of Conduct for All University Employees, applicable collective bargaining agreements, and the University of Connecticut Student Code.

The civil and criminal penalties associated with violating Export Control Laws can be severe, ranging from administrative sanctions including loss of research funding, to monetary penalties, and imprisonment. Anyone found to have engaged in conduct contrary to this policy is subject to disciplinary action by the university up to and including dismissal or expulsion and civil or criminal prosecution.

PROCEDURES

Export control compliance protocols and procedures are available online at: https://ovpr.uconn.edu/services/rics/export-control/.

POLICY HISTORY

Policy created: 12/14/2015 (Approved by the Vice President for Research)

Revision History:

1/12/2016 (Approved and Adopted by the UConn Health Policy Committee)
7/3/2018 (Non-Substantive edits per the Office of General Counsel)
9/18/2018 (Non-Substantive edits per the Office of General Counsel)

Policy on Alleged Misconduct in Research

Title: Policy on Alleged Misconduct in Research
Policy Owner: Office of Vice President for Research
Applies to: Faculty, Staff, Students, Others
Campus Applicability:  All Campuses
Effective Date: 9/15/2017
For More Information, Contact Michelle K. Williams
Contact Information: (860) 486-3001
Official Website: http://research.uconn.edu

 

It is the expectation and policy of the University of Connecticut, including its Regional Campuses and the University of Connecticut Health Center (the “University”), that the design, conduct, oversight and reporting of research be carried out with the highest standards of integrity and ethical behavior. While the primary responsibility for integrity and ethical behavior in research rests with those who conduct it, the University strives to establish an environment that promotes the responsible conduct of research, encourages reporting of any research related concerns, and addresses promptly and effectively any allegations of research misconduct.

This policy sets forth a process for determining whether research misconduct has occurred and taking appropriate action.  The following are the key components: (1) responsibilities and time lines (2) the handling of an allegation, including the initial inquiry and if necessary, the full investigation, (3) the final report and the imposition of University Actions if research misconduct is found, and (5) the respondent’s right to appeal.

Definitions

Allegation – means a disclosure of possible research misconduct through any means of communication, including written or oral statements.

Complainant(s) – The Complainant(s) is a person who in good faith makes an allegation of research misconduct.

Conflict of Interest – A conflict of interest as applied to this policy exists when a member of the Inquiry Committee or the Special Review Board has a collaborative professional, personal or financial relationship with a Respondent(s), Complainant(s), potential witnesses or others involved in the matter which might influence the member or might reasonably be perceived to influence the member. Membership in the same academic department as a Respondent(s) or Complainant(s) may, but does not necessarily constitute a conflict of interest.

Evidence – means any document, tangible item, or testimony offered or obtained during a research misconduct proceeding that tends to prove or disprove the existence of an alleged fact.

Good Faith –as applied to a Complainant(s) or witness, means having a belief in the truth of one’s allegation or testimony that a reasonable person in the Complainant(s)’s or witness’ position could have, based on the information known to the Complainant(s) or witness at the time. Making a research misconduct allegation or cooperating with a research misconduct proceeding is not in good faith if one knowingly or recklessly disregards information that would negate the research misconduct or testimony.

As applied to a committee member, good faith means cooperating with the research misconduct proceeding by carrying out the duties assigned impartially for the purpose of helping the University meet its responsibilities. A committee member does not act in good faith if his/her acts or omissions on the committee are dishonest or influenced by personal, professional, or financial conflicts of interest with those involved in the research misconduct proceeding.

Inquiry – means a preliminary information gathering and preliminary fact-finding activity conducted by the Inquiry Committee as described in this policy.

Inquiry Committee—means the committee that conducts the Inquiry.

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

Person – means any individual, corporation, partnership, institution, association, unit of government, or legal entity, however organized.

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.

Report – means the report summarizing the findings and conclusions prepared by the Inquiry Committee or Special Review Board.

Research – means a systematic experiment, study, evaluation, demonstration or survey designed to develop or contribute to general knowledge (basic research) or specific knowledge (applied research) relating broadly to public health by establishing, discovering, developing, elucidating or confirming information about, or the underlying mechanism relating to, biological causes, functions or effects, diseases, treatments, or related matters to be studied.

Research record – means 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 any documents and materials provided to federal oversight agencies or an institutional official by a Respondent(s) in the course of the research misconduct proceeding. The research record could include instrumentation that stores research records.

Research Misconduct – means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.

  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 the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. Authorship disputes are not defined as plagiarism in this policy.

Research misconduct does not include honest errors or differences of opinion.

Research Misconduct Proceeding – means any actions related to alleged research misconduct taken by the University, including but not limited to, research misconduct assessments, inquiries, investigations, federal agency oversight reviews, hearings, and administrative appeals.

Respondent(s) – means the person against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding.

Retaliation – for the purpose of this policy means an adverse action taken against a Complainant(s), witness, or committee member by the University, or anyone associated with the research misconduct proceedings, in response to:

  1. A good faith allegation of research misconduct; or,
  2. Good faith cooperation with a research misconduct proceeding.

Special Review Board or SRB – means the board that conducts the Investigation.

VPR – means the University’s Vice President for Research or the successor in function.

Time Limitations

Unless otherwise required by law, this Policy applies only to research misconduct occurring within six years prior to the date that the University receives an allegation of research misconduct.

The six year limitation does not apply if: (1) the Respondent continues or renews any incident of alleged research misconduct that occurred before the six-year limitation by citing, republishing or otherwise using the Research Record that is alleged to have been fabricated, falsified, or plagiarized, or (2) if a federal agency with appropriate jurisdiction or the University, determines that the alleged misconduct, if it occurred, would possibly have a substantial adverse effect on the health or safety of the public.

Jurisdictional Authority

This policy applies to any research, research training, or activities related to research, such as the operation of tissue and data banks and the dissemination of research information proposed, performed, reviewed, or reported, or any research record generated from that research, regardless of source of financial support, which is conducted using the facilities, resources, or funds of the University.  The policy also applies to the actions of faculty, staff, contractors, students or trainees who are employed, contracted, enrolled, working or performing research activities at the University at the time the alleged research misconduct occurred.

This policy does not apply to alleged research misconduct performed by persons who are not faculty, employees or contractors of the University, or are not students or trainees working at the University, when the alleged research misconduct occurred.  This policy is limited to addressing research misconduct as defined in the policy and no other types of misconduct or non-compliance.  When the allegation of research misconduct relates to activities funded by the U.S. Public Health Service (PHS), the University applies the requirements of the PHS regulations at 42 C.F.R. Part 93 and this policy is intended to meet those requirements.  When the allegation of research misconduct relates to activities funded by the National Science Foundation (NSF) the University applies the requirements of the NSF at 45 C.F.R. 689 and this policy is intended to meet those requirements.  When the allegation of research misconducts relates to activities funded by other agencies or sponsors, the University applies the requirements of those agencies or sponsors and the policy is intended to meet those requirements.  When the allegation of research misconduct relates to activities that are not otherwise funded or supported, or where there are no agency or sponsor specific requirements the University will apply the requirements of this policy. Where required, this policy may be modified to the extent necessary to conform to the requirements of PHS, NSF and other funding agencies or sponsors. Where there is a discrepancy between this Policy and either applicable laws or regulations or the requirements of the funding agency or sponsor, the law/regulation or agency/sponsor requirement will take precedence unless it is less restrictive.

Responsibilities

Faculty, Staff, Students and Trainees – University faculty, staff, students and trainees must conduct research in accordance with the highest standards of integrity and ethical behavior of their profession. University faculty, staff, students and trainees must report instances of suspected research misconduct, as defined in this Policy.  All faculty, staff, students and trainees must cooperate fully with the administration and implementation of this Policy.

Research Integrity Officer (RIO) – The RIO has primary responsibility and authority for implementation of the procedures set forth in this policy. The RIO will be an institutional official who is well qualified to handle the procedural requirements involved and is sensitive to the varied demands made on those who conduct research, those who are accused of misconduct, and those who report apparent misconduct in good faith.  The RIO serves as the principal contact point for interactions with Complainant(s), Respondent(s), witnesses, University officials, and federal agencies or sponsors.  It is the RIO’s responsibility to keep University officials informed, as required by policy or on a need-to-know basis, of the status of research misconduct proceedings.  The RIO serves as executive secretary (non-voting) of the Inquiry Committee and SRB.  The RIO is designated by the VPR and may be a single University wide RIO or a separate RIO for each campus.

The RIO will assist the Inquiry Committee, SRB and all institutional personnel in complying with these procedures and with applicable standards imposed by government or external funding sources. The RIO is also responsible for maintaining all research records and evidence in accordance with applicable policies and regulations.

The RIO will report to federal agencies, funding agencies and or other external entities as required by regulation to keep them apprised of any developments during the inquiry or investigation that may affect current or potential funding for the individual(s) under investigation or that the government agency needs to know to ensure appropriate use of public funds or otherwise protect the public interest.

Inquiry Committee It is the Inquiry Committee’s responsibility to conduct the inquiry into allegations of research misconduct in accordance with this policy, and to recommend to the VPR whether an investigation of research misconduct is warranted.

The Inquiry Committee will consist of the RIO and a minimum of three faculty members appointed by the VPR.  The chair of the Inquiry Committee will be one of the three faculty members. The VPR may appoint other individuals to serve as either voting or non-voting members of the Inquiry Committee. A majority of the committee participants will be faculty.  The Inquiry Committee may be appointed as a standing committee or on an as needed basis at the discretion of the VPR.  For a standing committee terms the VPR will appoint members for a set term of no more than five years, which may be staggered and with reappointment possible after a one year rotation off the committee.  The VPR will make legal counsel available to the Inquiry Committee as necessary, which may include appointing counsel (internal or outside counsel) to assist in the conduct of the Inquiry.

Special Review Board (SRB) – The SRB conducts an investigation in accordance with this policy in response to a recommendation by the Inquiry Committee. The purpose of the investigation is to recommend to the VPR whether the Respondent has committed research misconduct.

The SRB will be appointed by the VPR upon receipt of a recommendation for investigation from the Inquiry Committee. The SRB will consist of the RIO and a minimum of senior faculty members.  The chair of the SRB will be one of the three faculty members.  Some or all of the members of the Inquiry Committee may be included on the SRB. Every attempt will be made to appoint the SRB in a manner that will guarantee that the SRB has the requisite scientific expertise needed to conduct an investigation. In the event that it is necessary, individuals with appropriate scientific expertise from institutions other than the University may be added as voting members to the membership of the SRB. The VPR may appoint other individuals, as s/he feels necessary to serve as voting or non-voting members of the Inquiry Committee.  A majority of the committee participants will be faculty of the University. The VPR will make legal counsel available to the SRB as necessary, which may include appointing counsel (internal or outside counsel) to assist in the conduct of the Investigation.

Vice President for Research (VPR) – The VPR is the responsible institutional official of the University under whose jurisdiction this policy is implemented and enforced, and is the final arbiter for issues related to research misconduct adjudicated under this Policy.  In the event the VPR is not able to fulfill the requirements of this Policy, the President of the University will appoint a replacement.

Protection of the Complainant(s) and the Respondent(s)

Complainant(s) – The University will protect from retaliation all employees and students who have made an allegation of research misconduct (see the University’s Non-Retaliation Policy at http://policy.uconn.edu/2011/05/24/non-retaliation-policy ).

Respondent(s) – It is the policy of the University that until research misconduct inquiries or investigations are completed, Respondent(s) are considered innocent of the research misconduct allegations made against them, and protected against arbitrary and capricious actions that might be taken against them by deans, department heads or supervisors. This protection, however, will not prevent the University from exercising its duty under this Policy to sequester evidence or to conduct research misconduct inquiries or investigations, nor the ability to take interim administrative measures as described in this Policy.

Confidentiality

Disclosure of the identity of respondents and complainants in research misconduct proceedings is limited to those who need to know, consistent with a thorough, competent, objective and fair research misconduct proceeding as allowed by law. The University may have to disclose the identity of respondents and complainants to federal officials under certain circumstances.

Except as otherwise provided by law, confidentiality must be maintained for any records or evidence from which research subjects might be identified. Disclosure in this circumstance is limited to those who have a need to know to carry out a research misconduct proceeding.

Handling an Allegation of research misconduct

All reports and concerns related to actual or potential research misconduct, regardless of who receives the report, should be promptly referred to the RIO.  After receiving an allegation of research misconduct the RIO will assess the allegation(s) to determine if it meets the definition of research misconduct and is sufficiently credible and specific so that the allegations can be effectively investigated.

Review with Complainant:  Unless the allegation is anonymous, the RIO will:

  1. Review the substance and nature of the research misconduct with the Complainant(s)
  2. Inform the Complainant(s) that once specific details such as names are discussed with the RIO, the research misconduct review process must be invoked and cannot be suspended or stopped until the process has been concluded.
  3. Inform the Complainant(s) that the report may be submitted anonymously. The Complainant(s) will also be advised that confidentiality cannot be guaranteed, and that the their identity may be revealed on a need-to-know basis, may be inferred during the inquiry or investigation or may be required to be disclosed to a federal oversight agency or under applicable laws;
  4. Notify the Complainant(s) that, if the report has not been made in written form, it will be put in writing by the RIO. The Complainant(s) will be asked to provide as much detail as possible regarding the research misconduct and offered an opportunity to review the written allegation of research misconduct.
  5. Notify the Complainant(s) that he/she will not participate in the fact-finding phase, or in any other aspect of the determination of misconduct, other than as a witness.
  6. Notify the Complainant(s) of the expectation that the Complainant will keep confidential the allegation of misconduct.

Review with Respondent:  The RIO may discuss the allegation of research misconduct with the Respondent(s) and other individuals as needed to determine if the issues that form the basis of the research misconduct are appropriate for consideration through the research misconduct process.

Referral to Other University Entities:  The RIO will refer the issue to other appropriate entities within the University such as the Office of Audit, Compliance and Ethics, law enforcement, institutional review board, and institutional animal care and use committee, as the RIO believes appropriate, or as required by policy or regulation.

Review with VPR:  The RIO will confer with the VPR or their designee to review the substance of the allegation of research misconduct and determine if an inquiry is warranted.

Findings that Allegations Were Not Made in Good Faith:  If at any point it is determined that an allegation of research misconduct was not made in Good Faith this finding will be conveyed in writing to the Provost and the VPR, and made part of the Inquiry or Investigative report as applicable.  The Provost, in consultation with the VPR, the Dean of the appropriate School, and Office of Faculty and Staff Labor Relations and taken in a manner consistent with the relevant collective bargaining agreement, will determine what will  be taken by the University in response to a finding that allegations were not made in good faith.

Conduct of an Inquiry

The purpose of an inquiry is to conduct an initial review of evidence to determine whether an allegation of research misconduct warrants investigation. An inquiry does not require a full review of all the evidence related to the allegation of research misconduct.  An inquiry is warranted if the RIO determines that:

  1. A reasonable basis for concluding that the allegation falls within the definition of research misconduct and
  2. The allegation is sufficiently credible and specific so that potential evidence of research misconduct can be effectively evaluated.

Appointment of Inquiry Committee:  The VPR will appoint an Inquiry Committee.  Any member of the committee who believes he/she may have a conflict of interest or the appearance of one must declare such. Any member of the committee may identify other committee member(s) as having a conflict of interest.  The VPR will review any declared or identified potential conflicts of interest and make the determination regarding the member’s participation on the committee.

The Complainant(s) and Respondent(s) will be provided with a roster of the Inquiry Committee’s membership, and given the opportunity to identify committee member(s) as having a conflict of interest.  The VPR will review any identified potential conflicts of interest and make the determination regarding the member’s participation on the committee.

In the event a member becomes unable or unwilling at any point to serve, the VPR may appoint a replacement member.

Notification of Respondent:  The RIO will make a reasonable effort to notify all identified Respondent(s) that a research misconduct inquiry has been initiated and describe the nature of the allegation of research misconduct. The correspondence will include a copy of the allegation and a copy of this policy. Notification that an inquiry has been initiated will be sent to the VPR, the Respondent(s) Dean and Department Head, and the Office of Audit Compliance & Ethics.

Securing Evidence:  At the research misconduct inquiry stage or on or before the date on which the Respondent(s) is notified the inquiry begins the RIO, along with other staff as needed (e.g., Information Technology Department, Facilities, law enforcement, etc.) must take all reasonable and practical steps to obtain custody of all records and evidence needed to conduct the research misconduct proceeding, inventory the records and evidence, and sequester them in a secure manner.  Where the research records or evidence encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments.

The RIO has the authority to sequester evidence and records in accordance with university policy.  The RIO will seek the cooperation of the Respondent(s) in identifying and sequestering records and evidence.

Where appropriate and if requested, the Respondent(s) will be provided copies of, or reasonable supervised access to the sequestered research records.

The authority to sequester evidence by the RIO shall extend through the entirety of the research misconduct proceedings.  Additional items will be sequestered whenever they become known or relevant to the inquiry or investigation. The sequestered research record and evidence shall be maintained as required by applicable policies and regulation.

In the event that a Respondent(s) has not been identified, but a decision to initiate an inquiry has been made as described above, the RIO has the authority to sequester research records as described, but only after conferring with the director of that unit, and providing the director with a copy of the research misconduct allegations.

Conduct of Inquiry:  The Inquiry Committee will conduct the inquiry by an objective analysis of all the evidence including interviews with individuals with information relevant to the inquiry. The Complainant(s), if known, will be offered the opportunity to be interviewed by the Inquiry Committee.

Respondent Interview:  The Respondent(s) will be interviewed by the Inquiry Committee and the Respondent will be provided an opportunity to provide written questions regarding the research misconduct, if desired. The Respondent(s) has the right to be represented at his/her own expense by legal counsel and/or to be accompanied by a union representative if the respondent is covered by a collective bargaining agreement.  Counsel and/or the union representative will serve in a role consistent with an investigatory interview, but may not materially disrupt the process.

Respondent’s Failure to Cooperate:  In the event the Respondent(s) refuses to cooperate with the inquiry, the Inquiry Committee will, after reasonable attempts to engage the Respondent(s)’s cooperation, continue the inquiry without testimony or other evidence from the Respondent(s).

Additional Respondents:  Should additional Respondent(s) be identified at any time during the research misconduct Proceeding, they will be notified as described in this Policy and may be included as part of an ongoing inquiry or investigation, or as Respondent(s) in a new process as determined by the RIO in consultation with the VPR.

Timeline for the Inquiry:  The inquiry’s start date is the date that the Inquiry Committee meets to review the allegation of research misconduct and plan the inquiry. The inquiry should be completed within 60 calendar days after the start date unless circumstances warrant a longer period.  If the inquiry takes longer than 60 days to complete, the RIO will inform the VPR and the Respondent of the basis for the extension and the inquiry report will document the reasons for exceeding 60 days.

Determination Concerning Inquiry:  At the completion of the inquiry the Inquiry Committee shall determine whether the allegation of research misconduct warrants or does not warrant an investigation.

An investigation is warranted if the Inquiry Committees determines by a majority vote of the appointed voting members that there is a reasonable basis for concluding the allegation falls within the definition of research misconduct, involves biomedical or behavioral research, research training or activities related to that research or research training, and the preliminary information gathering and preliminary fact finding from the inquiry indicates the allegation may have substance.

The Committee will prepare a draft report that includes:

  1. The name and position of the Respondent(s);
  2. Copies of the notification of inquiry to the Respondent(s);
  3. A description of the allegation(s) of research misconduct;
  4. Sources of research support including, for example, grant numbers, grant applications, contracts, and publications listing the agency’s support;
  5. A summary of the evidence reviewed and interviews conducted;
  6. The conclusion of the inquiry and the basis for recommending that the allegation of research misconduct warrants or does not warrant an investigation.

A copy of the draft report will be provided to the Complainant(s) and Respondent(s).  The Complainant(s) and Respondent(s) will have 14 calendar days to provide written comment on the findings of the inquiry. The time to provide comments may be extended at the discretion of the RIO  Any written comments shall be reviewed by the Inquiry Committee in order to evaluate whether any substantively new information has been provided that should be considered before the Inquiry Committee makes a final decision on a recommendation. The comments will be included as part of the final report.

A copy of the final report will be provided to the VPR, the Respondent(s), and the Complainant(s).

If the Inquiry Committee does not find an investigation is warranted, the University shall make reasonable and practical efforts effort to protect or restore the position and reputation of the Respondent(s), Complainant(s), witnesses and committee members and to counter potential or actual retaliation against them. If the Respondent so requests, the conclusions of the inquiry will be made public.  Once this is completed, the research misconduct proceeding will be closed.

Agency Notification:  If the Inquiry Committee finds an investigation is warranted, the RIO will provide agencies having a statutory right of notification, a final copy of the inquiry report.  The agencies will be provided the inquiry report within 30 days of the Inquiry Committee submitting the final report to the VPR, but before initiating the investigation.  Upon request, the RIO will provide to agencies having statutory right of notification, copies of the research records and evidence reviewed.

Early Termination of research misconduct Proceedings – Admission of research misconduct

If at any point, other than a finding that an Inquiry or Investigation is not warranted, University plans to terminate a Research Misconduct Proceeding before its completion on the basis that the Respondent(s) has admitted to committing research misconduct, a settlement with the Respondent(s) has been reached, or for any other reason, the RIO will promptly notify the VPR and the applicable federal agency of the University’s plan, and seek approval of the plan from the agency.

If the Respondent(s) admits to committing research misconduct, appropriate University Actions as described in this Policy will be applied.

Conduct of an Investigation

The purpose of an investigation is (i) to determine whether research misconduct did or did not occur for each separate identified allegation, (ii) if misconduct was found, to identify the misconduct as falsification, fabrication or plagiarism (iii) to determine whether it was intentional, knowing or in reckless disregard, (iv) to identify the person(s) responsible for the misconduct and (v) to summarize the facts and the analysis supporting the conclusions. An investigation will be initiated within 30 days of the Inquiry Committee’s determination that an investigation is warranted.

Appointment of SRB:  The VPR will appoint a Special Review Board or SRB.

Any member of the SRB who believes he/she may have a conflict of interest or the appearance of one must declare such. Any member of the committee may identify other SRB member(s) as having a conflict of interest.  The VPR will review any declared or identified potential conflicts of interest and make the determination regarding the member’s participation on the SRB.

The Complainant(s) and Respondent(s) will be provided with a roster of the SRB membership, and given the opportunity to identify committee member(s) as having a conflict of interest.  The VPR will review any identified potential conflicts of interest and make the determination regarding the member’s participation on the SRB.

In the event a member becomes unable or unwilling at any point to serve, the VPR may appoint a replacement member.

Notification of Investigation:  The RIO will notify the Complainant(s) and Respondent(s) in writing that an investigation will be initiated, and of the composition of the SRB.  The notification to the Respondent(s) will also include any new allegations of research misconduct that may have been raised during the course of the inquiry or any allegations that may have been dropped from the inquiry.

Timeline for the Investigation:  The date of initiation of the investigation will be the first date the SRB meets to review the allegations of research misconduct and plan its investigation.  The investigation, including any appeals, should be completed within 120 calendar days of its initiation. If circumstances prevent the SRB from completing the investigation within 120 days, the RIO will submit a written request for an extension of time to complete the investigation to the VPR and any applicable oversight agency.

Conduct of the Investigation:  The SRB will use diligent efforts to ensure that the investigation is thorough, sufficiently documented, and includes examination of all research records and evidence relevant to reaching a decision on the merits of the allegations.  The SRB will evaluate the report of the Inquiry Committee and examine the evidence and research records relevant to the allegation of research misconduct.  The SRB and/or counsel for the SRB will interview each Respondent(s), Complainant(s), and any other available witness (es) reasonably identified as having information regarding relevant aspects of the investigation, including witnesses identified by the Respondent(s).  Interviews will be recorded or transcribed and provided to the interviewee for correction. The SRB will diligently pursue all substantive issues and discovered leads that are determined relevant to the investigation, including any evidence of additional instances of possible research misconduct, and continue the investigation to completion.

Respondent’s Rights:  During the investigation the Respondent(s) has the right to:

  1. Be interviewed by the SRB;
  2. Be represented at his/her own expense by legal counsel and/or be accompanied by a union representative. Counsel and the union representative will serve in a role consistent with an investigatory interview, but will not materially disrupt the process.
  3. Expect the SRB to exercise reasonable perseverance in obtaining answers to written questions raised by the Respondent(s) and directed to the Complainant(s) or to those witnesses who provide testimony to the SRB;
  4. To identify witnesses;
  5. Review a copy of the transcript of the Respondent(s)’s testimony for accuracy;
  6. Review and comment upon a draft of the SRB’s report before the report is finalized and before the SRB makes a final decision on its findings

Evidentiary Standards:  A finding of research misconduct requires that a majority of the appointed voting members of the SRB determine, by a preponderance of the evidence that (1) the Respondent significantly departed from accepted practices of the relevant research community, and (2) the misconduct was committed intentionally, knowingly, or recklessly.

The University or applicable federal agency has the burden of proof for making a finding of research misconduct. The destruction, absence of, or Respondent(s)’s failure to provide research records adequately documenting the questioned research is evidence of research misconduct where the University establishes by a preponderance of the evidence that the Respondent(s) intentionally, knowingly, or recklessly had research records and destroyed them, had the opportunity to maintain the records but did not do so, or maintained the records and failed to produce them in a timely manner and that the Respondent(s)’s conduct with regard to such records constitutes a significant departure from accepted practices of the relevant research community.

The Respondent(s) has the burden of going forward with and the burden of proving, by a preponderance of the evidence, any and all affirmative defenses raised. In determining whether the University has carried the burden of proof imposed by this part, the Committee shall give due consideration to admissible, credible evidence of honest error or difference of opinion presented by the Respondent.

The Respondent(s) has the burden of going forward with and proving by a preponderance of the evidence any mitigating factors that are relevant to a decision to impose administrative actions following a research misconduct proceeding.

Preparation of a Draft Report and Preliminary Findings:  Upon the completion of the Investigation, the SRB will prepare a written draft report of the investigation containing its preliminary findings. The draft Report will include:

  1. A description of the nature of the allegation(s) of research misconduct;
  2. The research project’s funding support, including, for example, any grant numbers, grant applications, contracts, and publications listing support;
  3. A description of the specific allegations of research misconduct considered in the Investigation.
  4. Copies of the University policies and procedures under which the Investigation was conducted;
  5. An identification and summary of the research records and evidence reviewed, and identification of any evidence taken into custody but not reviewed;
  6. For each separate allegation of research misconduct identified during the Investigation, a preliminary finding as to whether research misconduct did or did not occur, and if so:
    1. Identify whether the research misconduct was falsification, fabrication, or plagiarism, and if it was intentional, knowing, or in reckless disregard;
    2. Summarize the facts and the analysis which support the preliminary conclusion and consider the merits of any reasonable explanation by the respondent;;
    3. Identify the specific funding support;
    4. Identify whether any publications need correction or retraction;
    5. Identify the person(s) responsible for the research misconduct;
    6. List any current support or known applications or proposals for support that the Respondent(s) has pending with all extramural agencies.

The draft report will be provided to the Complainant(s) and Respondent(s) for comment.  The comments of the Respondent(s) and Complainant(s) on the draft report, if any, must be submitted within 30 days of their receipt of the draft report.  If requested, the Respondent(s) will be provided another opportunity to be heard by the SRB in person and to provide any additional information, or call additional witnesses to provide new information that may have a bearing on the SRB’s preliminary findings. The SRB will take into consideration any additional written information or information provided by witnesses.

Final Report and Final Findings:  If written comments on the draft report are received, the SRB will consider the comments. The SRB will then make its final decision and prepare a final report of the investigation. In addition to the elements of the draft report, the final report will include any written comments provided by Respondent or Complainant, a transcript or recording of the final hearing with the SRB (if any), and any new information provided by the Respondent(s) or Complainant.

Within twenty (20) business days of receipt of the SRB’s final report, the VPR shall inform the SRB of a decision to accept the report, or return it to the SRB for additional consideration. In the latter case, a decision not to accept the report will be accompanied by an explanation as to why the report was not accepted. The SRB will consider the VPR’s explanation, and resubmit the final report. The VPR will then make a final decision on whether the Respondent committed research misconduct.

If the VPR determines that the Respondent(s) did not commit research misconduct, the University shall make reasonable and practical efforts effort to protect or restore the position and reputation of the Respondent(s), Complainant(s), witnesses and committee members and to counter potential or actual retaliation against them.

If the VPR determines that the Respondent(s) committed research misconduct, the VPR will proceed in accordance with “University Actions in Response to a Final Finding of Research Misconduct” below.   If the research in question involved human subjects, the VPR will notify the Institutional Review Board. If the research in question involved animal subjects, the VPR will notify the Institutional Animal Care Committee.

Notifications:  After the VPR makes a final decision, the RIO shall send the final Report to the Respondent(s), the VPR, the Respondent(s)’s Dean and Department Head, the AVPRC, the President of the University of Connecticut, the Office of Audit, Compliance & Ethics, and applicable federal and/or state agencies.

Interim Protective Actions

At any time during the research misconduct proceedings the VPR may take appropriate interim actions to protect public health, federal funds and equipment, and the integrity of the research process.  Necessary actions will vary according to the circumstances of each case and may include but are not limited to delaying the publication of research results or submission of funding proposals, requiring supervision of one or more researchers, requiring approvals for actions relating to the research that did not previously require approval, auditing pertinent records, or contacting other institutions that may be affected by the allegation of research misconduct.

The relevant University Officials and federal agencies will be immediately notified if there is reason to believe any of the following conditions exist at any time during the research misconduct proceedings:

  1. Health or safety of the public is at risk, including an immediate need to protect human or animal subjects;
  2. Federal resources or interests are threatened;
  3. Research activities should be suspended;
  4. There is reasonable indication of possible violations of civil or criminal law;
  5. Federal action is required to protect the interests of those  involved  in  the  research misconduct Proceeding;
  6. The University believes the research misconduct proceeding may be made public prematurely so that the federal government may take appropriate steps to safeguard evidence and protect the rights of those involved;
  7. The research community or public should be informed.

University Actions in Response to a Final Finding of Research Misconduct

If the VPR determines that the Respondent committed research misconduct, the matter will be referred to the relevant supervisor who will review the report with the Office of Faculty and Staff Labor Relations.  Any action that is imposed by the University will comply with the procedures set forth in the University By-Laws or other applicable polices and any applicable collective bargaining agreement, including any right to appeal such actions.   Actions that may be imposed include but are not limited to:

  • Notification to professional and/or scientific societies
  • Clarification, correction, or retraction of the research record
  • Education or training
  • Reassignment of duties
  • Restrictions of specific activities or expenditures
  • Oversight or supervision of research activities
  • Special review of research activities
  • Termination or restriction of research support
  • Termination of fellowship support
  • Adjustment of research space allocation or resources
  • Adjustment of salary
  • Letter of warning or reprimand
  • Suspension
  • Dismissal

The University will cooperate with and assist in carrying out any administrative actions imposed by a relevant federal agency as a result of a final finding of research misconduct by that agency.

Retention and Custody of Records of the Research Misconduct Process

All records of the research misconduct process and any institutional appeals will be kept secure by the RIO according to the State of Connecticut Records Retention Schedule or seven (7) years, whichever is longer. If required by federal regulation, documentation of the SRB’s investigation will be made available to the appropriate federal oversight office.

Cooperation with Federal Agencies

The University will cooperate with any federal agency with appropriate jurisdiction during its oversight reviews of the University and its research misconduct proceedings, and during the process under which the Respondent may contest the federal agency’s finding of research misconduct and proposed administrative actions.  This includes providing, as necessary to develop a complete record of relevant evidence, research records, and other evidence under the University’s control or custody, or in the possession of, or accessible to persons subject to University authority.

The University will report to any federal agency with appropriate jurisdiction any proposed settlements, admissions of research misconduct, or institutional findings of misconduct that arise at any stage of a misconduct proceeding.

Promulgation of the Policy for Review of Alleged Misconduct of Research

This Policy will be made available via the University website.

(Signed)
_________________
Radenka Maric, Ph.D.
Vice President for Research

Policy History

Revised 9/15/2017 [Approved by President’s Cabinet]