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Policy

Research Misconduct Policy

Procedural Flowchart

1.00 Purpose

CSUMB is committed to ethical principles and procedures regarding integrity in all forms of research activity for which CSUMB is responsible. To further such commitment and to comply with California State University Executive Order No. 89042 Code of Federal Regulations 93 or other university entity, for which CSUMB is responsible, regardless of the source of funding or whether the research is funded. In the case of conflict between regulations of the funding or regulatory agency and the Department of Health and Human Services (DHHS), the more restrictive regulations shall prevail.

This policy is intended to reflect the University's commitment to the principles, goals, and ideals described in the CSUMB Vision Statement and its core values.

2.00 Scope

This policy is intended to carry out CSUMB's responsibilities under federal law. This policy and the associated procedures apply to any 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 CSUMB, such as scientists, trainees, technicians and other staff members, students, fellows, faculty, guest researchers, or collaborators global to CSUMB.

This policy and the associated procedures shall not apply to authorship or collaboration disputes and applies only to allegations of research misconduct that occurred within six years of the date CSUMB received the allegation.

The policy and associated procedures shall normally be followed when an allegation of possible misconduct in research is received by a CSUMB official. Particular circumstances in an individual case may dictate variation from the normal procedure deemed in the best interests of CSUMB and/or PHS. Any change from normal procedures also shall ensure fair treatment to the subject of the inquiry or investigation. Any significant variation should be approved in advance by the Research Integrity Officer at CSUMB.

3.00 Definitions

Allegation means any written or oral statement or other indication of possible research misconduct made to a CSUMB official.

California Faculty Association (CFA) is a statewide union that represents faculty members, librarians, coaches, and counselors of the California State University (CSU).

Collective Bargaining Agreement (CBA) sets out the terms and conditions of employment for faculty members, librarians, coaches, and counselors of the California State University (CSU).

Complainant means a person who in good faith makes an allegation of research misconduct.

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.

CSUMB means California State University, Monterey Bay.

Deciding Official (DO) shall be the Provost and Vice President for Academic Affairs or designee. The Deciding Official shall not be the same individual as the Research Integrity Officer and should have no direct prior involvement in CSUMB's inquiry, investigation, or allegation assessment. A Deciding Official's appointment of an individual to assess allegations of research misconduct, or to serve on an inquiry or investigation committee, shall not be considered direct prior involvement.

DHHS means the Department of Health and Human Services.

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 or witness, means having a belief in the truth of one's allegation or testimony that a reasonable person in the complainant's or witness's position could have, based on the information known to the complainant or witness at the time. An allegation or cooperation with a research misconduct proceeding is not in good faith if it is made with knowing or reckless disregard for information that would negate the allegation or testimony. Good faith as applied to a committee member means cooperating with the purpose of helping CSUMB meet its responsibilities under any applicable federal regulations. 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 proceedings

Inquiry means preliminary information-gathering and preliminary fact-finding that meets the criteria and follows the procedures of any applicable federal regulations.

Institutional Member means a person who is employed by, is an agent of or is affiliated by contract or agreement with an institution. Institutional members may include, but are not limited to, officials, tenured and tenure track faculty, teaching and support staff, temporary faculty, lecturers, researchers, research coordinators, clinical technicians, postdoctoral and other fellows, students, volunteers, agents, and contractors, subcontractors, and sub-awardees, and their employees.

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

Misconduct in Research (Research Misconduct) means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. 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. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Misconduct in research does not include honest error or differences of opinion.

Office of Research Integrity or ORI means the federal office to which the DHHS Secretary has delegated responsibility for addressing research integrity and misconduct issues related to PHS supported activities.

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.

Public Health Service or PHS means 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 Services, National Institutes of Health and Substance Abuse and Mental Health Services Administration, and the Offices of the Regional Health Administrators.

PHS Support means PHS funding, or applications or proposals therefore, for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or training that may be provided through: PHS grants, cooperative agreements, or contracts or sub-grants or subcontracts under those PHS funding instruments; or salary or other payments under PHS grants, cooperative agreements or contracts.

Records of research misconduct proceedings means: (1) the research records and evidence secured for the research misconduct proceeding pursuant to this policy and any applicable federal regulations, except to the extent the Research Integrity Officer determines and documents that those records are not relevant to the proceeding or that the records duplicate other records that have been retained; (2) the documentation of the determination of irrelevant or duplicate records; (3) the inquiry report and final documents (not drafts) produced in the course of preparing that report, including the documentation of any decision not to investigate; (4) the investigation report and all records (other than drafts of the report) in support of the report, including the recordings or transcripts of each interview conducted; and (5) the complete record of any appeal within the institution from the finding of research misconduct.

Research Integrity Officer (RIO) shall be designated by the Provost and Vice President for Academic Affairs. The RIO is responsible for: (1) assessing allegations of research misconduct to determine if they fall within the definition of research misconduct, are covered by federal regulations, and warrant an inquiry on the basis that the allegation is sufficiently credible and specific so that potential evidence of research misconduct may be identified; and (2) overseeing inquiries and investigations and (3) the other responsibilities described in this policy. If the RIO is a faculty member, work performed in this capacity may be used as evidence for retention, tenure, promotion, or post-tenure evaluations.

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 a federal agency or CSUMB official by a respondent in the course of the research misconduct proceeding.

Respondent means the person against whom an allegation of research misconduct is directed or the person whose actions are the subject of the inquiry or investigation. There can be more than one respondent in any inquiry or investigation.

Retaliation means any action that adversely affects the employment or other institutional status of an individual that is taken by an institution or an employee in response to (1) a good faith allegation of research misconduct; or (2) good faith cooperation with a research misconduct proceeding.

4.00 Rights & Responsibilities

4.10 Research Integrity Officer (RIO)

The Provost and Vice President for Academic Affairs designee shall serve as the Research Integrity Officer (RIO) and shall have primary responsibility for implementation of this research misconduct policy.

Responsibilities of the RIO include the following duties related to research misconduct proceedings:

  • Consult confidentially with persons uncertain about whether to submit an allegation of research misconduct;
  • Receive allegations of research misconduct;
  • Assess each allegation of research misconduct in accordance with §6.10 of this policy to determine whether it falls within the definition of research misconduct and warrants an inquiry;
  • As necessary, take interim action and notify ORI of special circumstances, in accordance with §5.60 of this policy;
  • Sequester research data and evidence pertinent and limited to the allegation of research misconduct in accordance with §6.30 of this policy and maintain it securely in accordance with this policy and applicable law and regulation;
  • Provide confidentiality to those involved in the research misconduct proceeding as required by federal regulations, other applicable law, and institutional policy;
  • Notify the respondent and provide opportunities for him/her to respond to allegations, evidence, and committee reports in accordance with §6.30 of this policy;
  • Inform respondents, complainants, and witnesses of the procedural steps in the research misconduct proceeding;
  • Appoint the chair and members of the inquiry and investigation committees, ensure that those committees are properly staffed and that there is appropriate expertise to carry out a thorough and authoritative evaluation of the evidence;
  • Determine whether each person involved in handling an allegation of research misconduct has an unresolved personal, professional, or financial conflict of interest and take appropriate action, including refusal, to ensure that no person with such conflict is involved in the research misconduct proceeding;
  • In cooperation with other CSUMB officials, take all reasonable and practical steps to protect or restore the positions and reputations of good faith complainants, witnesses, and committee members and counter potential or actual retaliation against them by respondents or other institutional members;
  • Keep the Deciding Official and others who need to know apprised of the progress of the review of the allegation of research misconduct;
  • If applicable, notify and make reports to the appropriate regulatory agency as required by federal regulations. Ensure that administrative actions taken by CSUMB and the appropriate regulatory agency are enforced and take appropriate action to notify other involved parties, such as sponsors, law enforcement agencies, professional societies, and licensing boards of those actions; and
  • Maintain records of the research misconduct proceeding and make them available to the appropriate funding or regulatory agency in accordance with §9.60 of this policy.

4.20 Complainant

The complainant shall be responsible for making allegations in good faith, maintaining confidentiality, and cooperating with the inquiry and investigation. As a matter of good practice, the complainant should be interviewed at the inquiry stage and given the transcript or recording of the interview for correction. The complainant shall be interviewed during an investigation, and be given the summary of the interview for correction.

4.30 Respondent

The respondent shall be responsible for maintaining confidentiality and cooperating with the conduct of an inquiry and investigation. The respondent shall be entitled to:

  • A good faith effort from the RIO to notify the respondent in writing at the time of or before beginning an inquiry
  • An opportunity to comment on the inquiry report and have his/her comments attached to the report
  • Be notified of the outcome of the inquiry, and receive a copy of the inquiry report that includes a copy of, or refers to any applicable federal and institutional policies and procedures on research misconduct
  • Be notified in writing of the allegations to be investigated within a reasonable time after the determination that an investigation is warranted, but before the investigation begins (within 30 days after CSUMB decides to begin an investigation), and be notified in writing of any new allegations, not addressed in the inquiry or in the initial notice of investigation, within a reasonable time after the determination to pursue those allegations;
  • Be interviewed during the investigation, have the right to be accompanied by a representative of his or her choosing, including an agent of California Faculty Association, during any interviews, have the opportunity to correct the recording or transcript, and have the corrected recording or transcript included in the record of the investigation;
  • Have interviewed during the investigation any witness who has been reasonably identified by the respondent as having information on relevant aspects of the investigation, have the recording or transcript provided to the witness for correction, and have the corrected recording or transcript included in the record of investigation; and
  • Receive a copy of the draft investigation report and, concurrently, a copy of, or supervised access to the evidence on which the report is based, and be notified that any comments shall be submitted within 30 days of the date on which the copy was received and that the comments will be considered by CSUMB and addressed in the final report.

The respondent should be given the opportunity to admit that research misconduct occurred and that he/she committed the research misconduct. With the advice of the RIO and CSUMB legal counsel, the DO may terminate the institution's review of an allegation that has been admitted if CSUMB's acceptance of the admission and any proposed settlement is approved by ORI or appropriate regulatory agency.

4.40 Deciding Official (DO)

The Provost and Vice President for Academic Affairs, or designee, shall receive the inquiry report and after consulting with the RIO, decide whether any investigation is warranted under the criteria in any applicable federal regulations such as 42 CFR § 93.307(d). Any finding that an investigation is warranted shall be made in writing by the DO and shall be provided to ORI or the appropriate regulatory agency, together with a copy of the inquiry report meeting the requirements of the appropriate federal regulations, within 30 days of the finding. If it is found that an investigation is not warranted, the DO and the RIO shall ensure that detailed documentation of the inquiry is retained for at least 7 years after termination of the inquiry, so that ORI may assess the reasons why CSUMB decided not to conduct an investigation.

The DO shall receive the investigation report and, after consulting with the RIO and other appropriate officials, decide the extent to which CSUMB accepts the findings of the investigation and, if research misconduct is found, decide what, if any, institutional administrative actions are appropriate. The DO shall ensure that the final investigation report, the findings of the DO and a description of the any pending or completed administrative action are provided to ORI or the appropriate regulatory agency, as required by federal regulations.

5.00 General Policies & Principles

5.10 Reports of Misconduct

Reports of observed, suspected, or apparent misconduct in research are directed to the RIO. Such reports may originate from employees or any individual associated with CSUMB. Any official who receives an allegation of research misconduct shall report it immediately to the RIO. If an individual is unsure whether a suspected incident falls within the definition of research misconduct, he or she may consult with the RIO to discuss the suspected research misconduct informally, which may include discussing it anonymously and/or hypothetically. If the circumstances described by the individual do not meet the definition of research misconduct, the RIO will refer the individual or allegation to other offices or officials with responsibility for resolving the problem. At any time, a CSUMB member may have confidential discussions and consultations about concerns of possible misconduct with the RIO and shall be counseled about appropriate procedures for reporting allegations.

At any time, an institutional member may have confidential discussions within legal boundaries and consultations about concerns of possible misconduct with the Research Integrity Officer and shall be counseled about appropriate procedures for reporting allegations.

5.20 Cooperation with Research Misconduct Proceedings

If it is determined that an investigation will occur, the appropriate administrator shall be informed. Institutional members, including respondents, have an obligation to provide evidence relevant to research misconduct allegations to the RIO or other institutional officials.

5.30 Confidentiality

The RIO shall (1) limit disclosure of the identity of respondents, complainants and witnesses to those who need to know in order to carry out a thorough, competent, objective and fair research misconduct proceeding consistent with the Collective Bargaining Agreement (CBA) and applicable laws; and (2) except as otherwise prescribed by law, limit the disclosure of any records or evidence from which research subjects might be identified to those who need to know in order to carry out a research misconduct proceeding. The RIO should use appropriate mechanisms to ensure that there is no disclosure of identifying information.

5.40 Protecting Complainants, Witnesses, and Committee Members

Institutional members may not retaliate in any way against complainants, witnesses, or committee members. Institutional members should immediately report any alleged retaliation against complainants, witnesses or committee members to the RIO, who shall review the matter and, as necessary, make all reasonable and practical efforts to counter any potential or actual retaliation and protect and restore the position and reputation of the person against whom the retaliation is directed.

5.50 Protecting the Respondent

As requested and as appropriate, the RIO and other institutional officials shall make all reasonable and practical efforts to protect or restore the reputation of persons alleged to have engaged in research misconduct, but against whom no finding of research misconduct is made. During the research misconduct proceeding, the RIO is responsible for ensuring that respondents receive all the notices and opportunities provided for in federal regulations and the policies and procedures of the institution. A respondent may consult with the California Faculty Association and/or another personal advisor (who is not a principal or witness in the case) to seek advice and may bring the counsel, representative of the California Faculty Association or personal adviser to interviews or meetings on the case.

5.60 Appeals

Respondents have a right to appeal the decision. The appeal shall be submitted to the RIO within 60 days from the date of the respondent's receipt of the decision. The appeal shall be in writing and should include a detailed statement of any disputed facts and any new defenses to the allegations. Any additional relevant information may also be included in the appeal. (see section 9.40)

The RIO shall respond to the appeal within 30 days.

5.70 Interim Administrative Actions and Notifying ORI of Special Circumstances

Throughout the research misconduct proceeding, the RIO will review the situation to determine if there is any threat of harm to public health, federal funds and equipment, or the integrity of the research process. In the event of such a threat, the RIO will, in consultation with other institutional officials and the appropriate regulatory agency, take appropriate interim action to protect against any such threat. Interim action might include additional monitoring of the research process and the handling of federal funds and equipment, reassignment of personnel or of the responsibility for the handling of federal funds and equipment, additional review of research data and results or delaying publication. The RIO shall, at any time during a research misconduct proceeding, notify the appropriate regulatory agency immediately if he/she has reason to believe that any of the following conditions exist:

  • Health or safety of the public is at risk, including an immediate need to protect human or animal subjects;
  • HHS resources or interests are threatened;
  • Research activities should be suspended;
  • There is a 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 research misconduct proceeding may be made public prematurely and HHS action may be necessary to safeguard evidence and protect the rights of those involved; or
  • The research community or public should be informed.

6.00 Conducting the Assessment & Inquiry

6.10 Assessment of Allegations

Upon receiving an allegation of research misconduct, the RIO shall immediately assess the allegation to determine whether it is sufficiently credible and specific so that potential evidence of research misconduct may be identified, whether it is within the jurisdictional criteria of federal agencies, and whether the allegation falls within the definition of research misconduct in this policy and any applicable federal regulations. An inquiry shall be conducted if these criteria are met. The assessment period should be brief. In conducting the assessment, the RIO need not interview the complainant, respondent, or other witnesses, or gather data beyond any that may have been submitted with the allegation, except as necessary to determine whether the allegation is sufficiently credible and specific so that potential evidence of research misconduct may be identified. The RIO shall, on or before the date which the respondent is notified of the allegation, obtain custody of, inventory, and sequester all research records and evidence needed to conduct the research misconduct proceeding, as provided in §6.30 of this policy.

6.20 Initiation & Purpose of the Inquiry

If the RIO determines that the criteria for an inquiry are met, he or she will immediately initiate the inquiry process. The purpose of the inquiry is to conduct an initial review of the available evidence to determine whether to conduct an investigation. An inquiry does not require a full review of all the evidence related to the allegation.

6.30 Notice to Respondent; Sequestration of Research Records

At the time of or before beginning an inquiry, the RIO must notify the respondent in writing. If the inquiry subsequently identifies additional respondents, they must be notified in writing. On or before the date on which the respondent is notified, or the inquiry begins, whichever is earlier, the RIO shall take all reasonable and practical steps to obtain custody of all the research records and evidence needed to conduct the research misconduct proceeding, inventory the records and evidence and sequester them in a secure manner, except that 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 may consult with the appropriate regulatory agency for advice and assistance in this regard.

6.40 Appointment of the Inquiry Committee

The RIO, in consultation with other CSUMB officials as appropriate, shall appoint an inquiry committee and committee chair within 10 daysof the initiation of the inquiry or as soon thereafter as practical. The appropriate dean or administrator shall be notified upon appointment of the inquiry committee. The inquiry committee shall consist of individuals who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the inquiry nor is a complainant and should include individuals with the appropriate scientific or professional expertise to evaluate the evidence and issues related to the allegation, interview the principals and key witnesses, and conduct the inquiry. Faculty who serve on the inquiry committee may use such service as evidence in retention, tenure, promotion, or post-tenure evaluations.

6.50 Charge To the Committee & First Meeting

The RIO shall prepare a charge for the inquiry committee that:

  • Sets forth the time for completion of the inquiry;
  • Describes the allegations and any related issues identified during the allegation assessment;
  • States that the purpose of the inquiry is to conduct an initial review of the evidence, including the testimony of the respondent, complainant and key witnesses, to determine whether an investigation is warranted, not to determine whether research misconduct definitely occurred or who was responsible;
  • States that an investigation is warranted if the committee determines: (1) there is a reasonable basis for concluding that the allegation falls within the definition of research misconduct and is within the jurisdictional criteria of the appropriate federal code; and, (2) the allegation may have substance, based on the committee's review during the inquiry.
  • Informs the inquiry committee that they are responsible for preparing or directing the preparation of a written report of the inquiry that meets the requirements of this policy. At the committee's first meeting, the RIO shall review the charge with the committee, discuss the allegations, any related issues, and the appropriate procedures for conducting the inquiry, assist the committee with organizing plans for the inquiry, and answer any questions raised by the committee. The RIO shall be present or available throughout the inquiry to advise the committee as needed.

6.60 Inquiry Process

The inquiry committee shall normally interview the complainant, the respondent, and key witnesses as well as examining relevant research records and materials. The inquiry committee shall evaluate the evidence, including the testimony obtained during the inquiry. After consultation with the RIO, the committee members will decide whether an investigation is warranted based on the criteria in this policy and in any applicable federal regulations. The scope of the inquiry is not required to and does not normally include deciding whether misconduct definitely occurred, determining definitely who committed the research misconduct or conducting exhaustive interviews and analyses. However, if a legally sufficient admission of research misconduct is made by the respondent, misconduct may be determined at the inquiry stage if all relevant issues are resolved. In that case, the institution shall promptly consult with the appropriate federal regulatory agency to determine the next steps that should be taken. (See §4.30).

6.70 Time for Completion

The inquiry, including preparation of the final inquiry report and the decision of the DO on whether an investigation is warranted, shall be completed within 60 calendar days of initiation of the inquiry, unless the RIO determines that circumstances clearly warrant a longer period. If the RIO approves an extension, the inquiry record must include documentation of the reasons for exceeding the 60-day period.

7.00 The Inquiry Report

7.10 Elements of the Inquiry Report

A written inquiry report shall be prepared that includes the following information: (1) the name and position of the respondent; (2) a description of the allegations of research misconduct; (3) the funding support, if any, for example, grant numbers, grant applications, contracts and publications listing specific financial support; (4) the names and titles of the committee members and experts who conducted the inquiry; (5) a summary of the inquiry process used; (6) a list of research records reviewed; (7) summaries of any interviews; (8) the basis for recommending or not recommending that the allegations warrant an investigation; (9) any comments on the draft report by the respondent or complainant and (10) whether any actions should be taken if an investigation is not recommended. Institutional counsel should review the report for legal sufficiency. Modifications should be made as appropriate in consultation with the RIO and the inquiry committee.

7.20 Notification to the Respondent and Opportunity to Comment

The RIO shall notify the respondent whether the inquiry found an investigation to be warranted, include a copy of the draft inquiry report for comment within 10 days, and include a copy of or refer to the applicable federal regulations and CSUMB's policy on research misconduct.

Any comments that are submitted shall be attached to the final inquiry report.

Based on the comments, the inquiry committee may revise the draft report as appropriate and prepare it in final form. The committee will deliver the final report to the RIO.

7.30 Institutional Decision and Notification

7.3.1 Decision by Deciding Official

The RIO shall transmit the final inquiry report and any comments to the DO, who shall determine in writing whether an investigation is warranted. The inquiry is completed when the DO makes this determination.

7.3.2 Notification to ORI

Within 30 calendar days of the DO's decision that an investigation is warranted, the RIO shall provide the appropriate regulatory agency with the DO's written decision and a copy of the inquiry report. The RIO shall also notify those institutional officials who need to know of the DO's decision.

7.3.3 Documentation of Decision Not to Investigate

If the DO decides that an investigation is not warranted, the RIO shall secure and maintain the inquiry report and the DO's written decision for 7 years after the termination of the inquiry.

8.00 Conducting the Investigation

8.10 Initiation & Purpose

The investigation shall begin within 30 calendar days after the determination by the DO that an investigation is warranted. The purpose of the investigation is to develop a factual record by exploring the allegations in detail and examining the evidence in depth, leading to recommended findings on whether research misconduct has been committed, by whom, and to what extent. In conducting the investigation, the RIO will pursue diligently all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of additional instances of possible research misconduct, and continue the investigation to completion. If in the course of the investigation the RIO determines there are additional instances of research misconduct, he or she will notify the Respondent as provided in Section 4.20 of this policy.

8.20 Notifying the ORI & Respondent; Sequestration of Research Records

On or before the date on which the investigation begins, the RIO shall: (1) notify the ORI Director of the decision to begin the investigation and provide the appropriate regulatory agency a copy of the inquiry report; and (2) notify the respondent in writing of the allegations to be investigated. The RIO shall also give the respondent written notice of any new allegations of research misconduct within a reasonable amount of time of deciding to pursue allegations not addressed during the inquiry or in the initial notice of the investigation. The RIO will, prior to notifying respondent of the allegations, take all reasonable and practical steps to obtain custody of and sequester in a secure manner all research records and evidence needed to conduct the research misconduct proceedings that were not previously sequestered during the inquiry. 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 need for additional sequestration of records for the investigation 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.

8.30 Appointment of the Investigation Committee

The RIO, in consultation with other institutional officials as appropriate, shall appoint an investigation committee and the committee chair within 10 daysof the beginning of the investigation or as soon thereafter as practical. The investigation committee shall consist of individuals who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the investigation nor is a complainant and should include individuals with the appropriate scientific or professional expertise to evaluate the evidence and issues related to the allegation, interview the respondent and complainant and conduct the investigation. Individuals appointed to the investigation committee may also have served on the inquiry committee. Faculty who serve on the investigation committee may use such service as evidence in retention, tenure, promotion, or post-tenure evaluations.

8.40 Charge to the Committee and the First Meeting

8.4.1 Charge to the Committee

The RIO 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;
  • Identifies the respondent;
  • Informs the committee that it must conduct the investigation as prescribed in §8.50
  • 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 any applicable federal regulations.

8.4.2 First Meeting

The RIO shall 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 shall be provided with a copy of this policy and any applicable federal regulations. The RIO shall be present or available throughout the investigation to advise the committee as needed.

8.50 Investigation Process

The investigation committee and the RIO shall:

  • Use diligent efforts to ensure that the investigation is thorough and sufficiently documented and includes examination of all research records and evidence relevant to reaching a decision on the merits of each allegation;
  • Take reasonable steps to ensure an impartial and unbiased investigation to the maximum extent practical;
  • Interview each respondent, complainant, and any other available person who has been reasonably identified as having information regarding any relevant aspects of the investigation, including witnesses identified by the respondent, and record or transcribe each interview, provide the recording or transcript to the interviewee for correction, and include the recording or transcript in the record of the investigation; and
  • Pursue diligently all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of any additional instances of possible research misconduct, and continue the investigation to completion.

8.60 Time for Completion

The investigation is to be completed within 120 days from the first meeting of the committee, including conducting the investigation, preparing the report of findings, providing the draft report for comment and sending the final report to the appropriate regulatory agency.

9.00 The Investigation Report

9.10 Elements of the Investigation Report

The investigation committee and the RIO 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
  • The respondent's c.v. or resume
  • Describes and documents the PHS support (if any), 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 shall: (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 the 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 financial 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 any federal agencies.

9.20 Comments on the Draft Report & Access to Evidence

9.2.1 Respondent

The RIO shall give the respondent a copy of the draft investigation report for comment and, concurrently, a copy of, or supervised access to the evidence on which the report is based. The respondent shall be allowed 30 days from the date he/she received the draft report to submit comments to the RIO. The respondent's comments shall be included and considered in the final report.

9.2.3 Confidentiality

In distributing the draft report, or portions thereof, to the respondent, the RIO shall inform the recipient of the confidentiality under which the draft report is made available and may establish reasonable conditions to ensure such confidentiality.

9.30 Decision by Deciding Official

The RIO shall assist the investigation committee in finalizing the draft investigation report, including ensuring that the respondent's comments are included and considered, and transmit the final investigation report to the DO, who shall determine in writing: (1) whether the institution accepts the investigation report, its findings, and the recommended institutional actions; and (2) the appropriate institutional actions in response to the accepted findings of research misconduct. If this determination varies from the findings of the investigation committee, the DO shall, as part of his/her written determination, explain in detail the basis for rendering a decision different from the findings of the investigation committee. Alternatively, the DO may return the report to the investigation committee with a request for further fact-finding or analysis. When a final decision on the case has been reached, the RIO shall normally notify both the respondent and the complainant in writing. After informing the appropriate federal regulatory agency, the DO shall 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 shall be responsible for ensuring compliance with all notification requirements of funding or sponsoring agencies.

9.40 Appeals

Appeals (see §4.3.1) shall be completed within 120 days of its filing, unless ORI finds good cause for an extension based on CSUMB's written request for an extension that explains the need for such an extension.

9.50 Notice to the Appropriate Federal Agency of Institutional Findings and Actions

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

9.60 Maintaining Records for Review by ORI

The RIO shall maintain "records of research misconduct proceedings." Unless custody has been transferred to a federal agency or that the appropriate regulatory agency has advised in writing that the records no longer need to be retained, records of research misconduct proceedings shall be maintained in a secure manner for seven years after completion of the proceeding.

10.00 Completion of Cases; Reporting Premature Closures to Appropriate Regulatory Agency

Generally, all inquiries and investigations shall be carried through to completion and all significant issues will be pursued diligently. The RIO shall notify the appropriate regulatory agency in advance if there are plans to close a case at the inquiry, investigation, or appeal stage on the basis that respondent has admitted guilt, a settlement with the respondent has been reached, or for any other reason, except: (1) closing of a case at the inquiry stage on the basis that an investigation is not warranted; or (2) a finding of no misconduct at the investigation stage.

11.00 Institutional Administrative Actions

If the DO determines that research misconduct is substantiated by the findings, he or she shall decide on the appropriate actions to be taken, after consultation with the RIO. The administrative actions may include:

  • Withdrawal or correction of all pending or published abstracts and papers emanating from the research where research misconduct was found;
  • Removal of the responsible person from the particular project, letter of reprimand, special monitoring of future work, sanctions imposed in a disciplinary action as described in the CBA and any applicable state laws, or termination of employment;
  • Restitution of funds to the grantor agency as appropriate; and
  • Other action appropriate to the misconduct.

12.00 Other Considerations

12.10 Termination or Resignation Prior to Completing Inquiry or Investigation

The termination of the respondent's institutional employment, by resignation or otherwise, before or after an allegation of possible research misconduct has been reported, will not preclude or terminate the research misconduct proceeding or otherwise limit any of the institution's responsibilities under federal law. If the respondent, without admitting to the misconduct, elects to resign his or her position after the institution receives an allegation of research misconduct, the assessment of the allegation shall proceed, as well as the inquiry and investigation, as appropriate based on the outcome of the preceding steps. If the respondent refuses to participate in the process after resignation, the RIO and any inquiry or investigation committee shall use their best efforts to reach a conclusion concerning the allegations, noting in the report the respondent's failure to cooperate and its effect on the evidence.

12.20 Restoration of the Respondent's Reputation

Following a final finding of no research misconduct, the RIO shall undertake all reasonable and practical efforts to restore the respondent's reputation. Depending on the particular circumstances and the views of the respondent, the RIO shall publicize the final outcome in any forum in which the allegation of research misconduct was previously publicized. Any institutional actions to restore the respondent's reputation should first be approved by the DO.

12.30 Protections of the Complainant, Witnesses and Committee Members

During the research misconduct proceeding and upon its completion, regardless of whether it was determined that research misconduct occurred, the RIO shall undertake all reasonable and practical efforts to protect the position and reputation of, or to counter potential or actual retaliation against, any complainant who made allegations of research misconduct in good faith and of any witnesses and committee members who cooperate in good faith with the research misconduct proceeding. The DO shall determine, after consulting with the RIO, and with the complainant, witnesses, or committee members, respectively, what steps, if any, are needed to restore their respective positions or reputations or to counter potential or actual retaliation against them. The RIO shall be responsible for implementing any steps the DO approves.

12.40 Allegations Not Made in Good Faith

If relevant, the DO shall determine whether the complainant's allegations of research misconduct were made in good faith, or whether a witness or committee member acted in good faith. If the DO determines that there was an absence of good faith he/she will determine whether any administrative action should be taken against the person who failed to act in good faith.

13.00 Continuous Renewal

This policy shall be assessed in ten years from its effective date to determine its effectiveness and appropriateness. The policy may be revised as needed.

s/ Dianne F. Harrison

President

Effective Date: August 7, 2008

Certification of Process

Reviewed by: Research Misconduct Group, Policy Facilitation Team, Division of University Advancement, Foundation, Division of Student Affairs, Academic Affairs Council, Academic Senate Executive Committee, the Committee for Post Graduate Studies and Research, Academic Senate, President's Cabinet, Division of Administration and Finances, Provost, and President.

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