026.000 - Research Integrity

I. Policy

It is the policy of the University of California, Santa Cruz, to treat research fraud and other unethical research practices by its employees as instances of employee misconduct.

Research is the key to the methodical discovery or creation of new knowledge. If research of any kind is to be properly conducted, the integrity and intellectual honesty of those involved must be of the highest standard. Faculty and others responsible for supervising research by students or peers have a special obligation to promote and maintain an environment that encourages absolute intellectual honesty and integrity. This environment should promote open communication among researchers; an emphasis on quality rather than quantity of research; appropriate supervision of personnel; maintenance of accurate records related to research data, procedures and results; and equitable assignment of credit and responsibility for research and publications.

Behaviors classifiable as misconduct in research include fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. Misconduct does not include honest error or differences in interpretations or judgments of data.

The policies adopted to govern the maintenance and scrutiny of research integrity at the University of California, Santa Cruz follow:

1. University Policy on Faculty Conduct and the Administration of Discipline, including the Faculty Code of Conduct, Academic Personnel Policy 015. This policy applies to all persons holding an appointment in a faculty title whether or not the title confers membership in the Academic Senate.
2. University Policy on Disclosure of Financial Interest in Private Sponsors of Research, Academic Personnel Manual 028.
3. Policy on Outside Professional Activities of Faculty Members, Academic Personnel Manual 025.
4. Regents’ Policy 7303, Service Obligations and Leaves of Absences.
5. The University of California Policy on Protection of Animal Subjects, Presidential Policy Memorandum 100-6, Contracts and Grants Manual Section 18-400. This policy applies to all persons engaged in research activities using animals.
6. The University of California Policy on the Protection of Human Subjects, Presidential Policy Memorandum 100-5, Contracts and Grants Manual Section 18-200. This policy applies to all persons engaged in research activities involving use of people as research subjects.
7. Guidelines on University-Industry Relations (May 17, 1989), Contracts and Grants Manual Section 1-340). This policy applies to all persons engaged in research activities.
8. University Regulation No. 4, Special Services to Individuals and Organization, Academic Personnel Policy 020 and Contracts and Grants Manual Section 1-320.
9. University Policies Applying to Campus Activities, Organizations, and Students—Part A, Student Conduct and Discipline (October 31, 1983).
10. Business and Finance Bulletin G-39, Conflict of Interest Policy and Compendium of Specialized University Policies, Guidelines, and Regulations Related to Conflict of Interest (Revised April 15, 1986 and June 15, 1989).
11. Guidelines for Disclosure and Review of Principal Investigators’ Financial Interest in Private Sponsors of Research (April 27, 1984), Contracts and Grants Manual Sections 2-582 and 2-650.
12. University of California Patent Policy (April 1, 1990), Contracts and Grants Manual Section 11-220.
13. University Copyright Policy (August 1, 1992).
14. The definition of fraud in academic research and the means for the prevention of dishonesty in research recommended by the Committee on the Integrity of Research of the Association of American Universities.
15. Any policies or regulations concerning research fraud and unethical conduct issued by federal, state and private agencies from which the University has accepted research funding.
16. The University of California Policy On Integrity in Research. This policy applies to all persons engaged in research activities.

When considering allegations of scientific fraud and research misconduct, the University will consider the statement of ethics of the professional society of which the person accused is a member.

Each individual engaged in research at the University is required to become informed and to follow the relevant policies and procedures related to research integrity of the University and the agencies funding their research.

II. Procedures for Handling Allegations of Research Misconduct

A. Reporting Misconduct

1. Suspicion of fraudulent or unethical research practices should be reported immediately to the appropriate administrator who is closest to the research (principal investigator, department chair, ORU director). The report may be either verbal or in writing. The administrator receiving the report shall notify the relevant divisional dean. Alternatively, the report may be made directly to the relevant divisional dean. Complaints from outside the University should be directed to the relevant divisional dean. All reports of misconduct must be kept strictly confidential to the extent allowed by law to protect the identity of all parties concerned.
2. Complainants may elect to keep their identities confidential; however, it may be necessary for the complainant to testify if the investigation is to proceed when other documentary support is not available. This is especially true if the complainant has directly observed unethical research practices.

B. Preliminary Assessment

1. The administrator receiving the report shall first determine whether the research in question is supported by or support is requested from the Public Health Service (PHS). If the research is sponsored by or support is requested from PHS, the administrator shall refer to the supplemental requirements of section III of this policy.
2. The administrator receiving the report shall conduct an informal inquiry to gather factual information about the complaint. The inquiry is designed to separate allegations deserving of further investigation from frivolous, unjustified, or clearly mistaken allegations.
3. If the administrator receiving the complaint determines that the complaint is groundless, or if the person reporting the misconduct is unprepared to testify to the misconduct and such testimony would constitute the only adequate evidence of the misconduct, an inquiry should not be undertaken. The complainant should be informed of the decision not to proceed and a memorandum to the Vice Chancellor for Research should be prepared by the relevant administrator explaining why the complaint was dismissed.
4. If the administrator receiving the complaint determines from the report and/or from other information that misconduct in research may have occurred, an inquiry should be initiated (see below). If the initial report of misconduct is oral, either the administrator receiving the complaint or the person making the report must must put it in written form, with supporting documentation (if available), before the inquiry can proceed. If not already informed, the Vice Chancellor for Research and any other relevant administrators (ORU director, department chair, and principal investigator) should be notified of the complaint at this time. The identity of the complainant shall be kept confidential to the extent allowed by law.

C. Conducting the Inquiry (60 calendar days)

1. The Vice Chancellor for Research shall either serve as investigator or shall appoint an investigator (a member of the Senate faculty) to conduct an inquiry to determine whether there is reasonable cause to believe that the policies and regulations of the University, federal or state laws, or private agency regulations have been violated. The investigator will ensure that necessary and appropriate expertise is secured to carry out a thorough and authoritative evaluation of the relevant evidence in the inquiry. The inquiry should be initiated immediately.
2. Within ten (10) calendar days of receiving the written report of fraudulent or unethical research practices, the Vice Chancellor for Research or the appointed investigator shall, after seeking advice of General Counsel, inform the respondent in writing of the report, the name of the person who will investigate the report, and the process to be followed.
3. If the research is sponsored by or support is requested from PHS, the RIAC and Executive Vice Chancellor shall refer to the supplemental requirements of section III of this policy.
4. The Vice Chancellor for Research or the investigator shall contact only those necessary for the investigation and apprise them of the need for confidentiality. No inquiries should be made outside the University at this juncture, unless absolutely necessary. The identity of the complainant shall be kept confidential to the extent allowed by law
5. The Vice Chancellor for Research or the investigator shall prepare a draft report of the inquiry. The report must state the name and title of investigator and experts, if any; the allegations; the PHS support, if any; a summary of the inquiry process used; a list of the research records reviewed; summaries of any interviews; a description of the evidence in sufficient detail to demonstrate whether an investigation is recommended and whether any other actions should be taken if an investigation is not recommended. General counsel will review the report for legal sufficiency.
6. One copy of the draft inquiry report shall be retained by the Vice Chancellor for Research and copies shall be sent to the complainant and respondent.
7. The VCR or investigator will take reasonable steps to prevent real or apparent conflicts of interest in inquiries.
8. The VCR or investigator may establish reasonable conditions for review to protect the confidentiality of the draft report.
9. Within 14 calendar days of their receipt of the draft report, the complainant and respondent will provide their comments, if any, to the investigator. Any comments that the complainant or respondent submits on the draft report will become part of the final inquiry report and record. Based on the comments, the investigator may revise the report as appropriate.
10. If the individual who reported the alleged misconduct is dissatisfied with the outcome, the individual may take the report to the Vice Chancellor for Research, if the initial report was made by an appointed investigator; otherwise, the individual may take the report to the Executive Vice Chancellor, who will review the matter and decide whether additional action should be taken, in accordance with these procedures.
11. If the Vice Chancellor for Research, after reviewing the investigator’s report or their own findings, determines that there are reasonable grounds to support a finding of misconduct in violation of University policies or regulations, and/or Federal or State laws, and/or private agency regulations, the Vice Chancellor for Research shall report the findings to the Executive Vice Chancellor in writing, including the evidence to support the conclusion. The appropriate administrators (relevant divisional dean, department chair, and principal investigator) shall be informed of the findings in writing.
12. The respondent shall be informed, in writing, of the outcome of the inquiry.
13. If the inquiry has produced adequate evidence to support a finding of misconduct, the Vice Chancellor for Research and the respondent may attempt to reach an informal resolution. The resolution shall be committed to writing, signed by both parties, and maintained by the Vice Chancellor for Research. Those with a need to know should be informed of the outcome.
14. This stage of an investigation shall normally be completed within sixty (60) calendar days of the date of the formal notification to the respondent referred to in II.B.1. above. Extension of time for cause may be granted by the Vice Chancellor for Research. The respondent shall be notified and the record of the extension shall include documentation of the reasons for exceeding the 60-day inquiry period.
15. The respondent may be represented by a person of the respondent's choosing, who could be an attorney, during the inquiry.

D. Formal Investigation (120 calendar days)

1. If an informal resolution is not achieved, the Executive Vice Chancellor shall transmit the written report of the Vice Chancellor for Research to the Research Integrity Advisory Committee (RIAC) , which will review the report and, if necessary, conduct a further investigation. The investigation process shall be initiated within 30 calendar days of the completion of the inquiry, if findings from that inquiry provide a sufficient basis for conducting an investigation. The respondent shall receive a copy of the transmittal letter and the written report.
2. The RIAC shall carry out its investigation within ninety (90) calendar days, while ensuring fairness and securing the necessary expertise to carry out a thorough and authoritative evaluation of the relevant evidence. If requested by the Committee, General Counsel will be assigned to assist in the investigation.
3. The RIAC shall provide the respondent the opportunity to respond to the allegations and evidence in the complaint and to be represented during the formal investigation.
4. The RIAC and Executive Vice Chancellor will take reasonable steps to prevent real or apparent conflicts of interest in investigations.
5. If the research is sponsored by or support is requested from PHS, the RIAC and Executive Vice Chancellor shall refer to the supplemental requirements of section III of this policy.
6. Investigations will be conducted in a manner that will ensure fair treatment to the respondent(s) in the inquiry or investigation and confidentiality to the extent possible without compromising public health and safety or thoroughly carrying out the inquiry or investigation.
7. The Executive Vice Chancellor, in consultation with the RIAC, shall inform any relevant funding agencies of the investigation and the results of the investigation in a manner that is consistent with agency guidelines.
8. If the RIAC determines that the allegations are not supported by the evidence, it shall inform the Executive Vice Chancellor and recommend dismissal of the case within ten (10) calendar days from the conclusion of the investigation. If the Executive Vice Chancellor accepts this recommendation, the Executive Vice Chancellor will prepare a brief report within seven (7) calendar days, informing the respondent, the complainant, and relevant administrators of the results and findings of the formal inquiry.
9. Report of the Research Integrity Advisory Committee.
   
   • a. If the RIAC determines that the respondent has engaged in unethical or fraudulent research practices, it shall submit a written report of its findings and recommendations to the Executive Vice Chancellor, informing the respondent, the complainant, and relevant administrators (the Vice Chancellor for Research, divisional dean, department chair, and principal investigator) of the results and findings of the formal inquiry within ten (10) calendar days from the conclusion of the investigation.
   • b. The RIAC’s findings must be supported by documented evidence.
   • c. The reasoning that led to the Committee’s conclusions should be presented in detail.
   • d. The RIAC may recommend disciplinary action to the Executive Vice Chancellor. Any recommendations will be based upon relevant personnel policies (See Section E, below), and requirements of any applicable granting or contracting agency.
10. The Executive Vice Chancellor, based upon the recommendations of the RIAC and the relevant campus administrator, will determine whether there was misconduct. The Executive Vice Chancellor will provide the respondent and relevant administrators (Vice Chancellor for Research, divisional dean, department chair, and principal investigator) a copy of the RIAC report and the determination of misconduct. The respondent may respond in writing to the results of the investigation within ten (10) calendar days.
11. Within ten (10) calendar days of the date of the respondent’s written response, the Executive Vice Chancellor will, if appropriate, initiate disciplinary action.
12. The formal stage of an investigation shall normally be completed within one hundred and twenty (120) calendar days. It is acknowledged that the nature of some cases may require an extension of the time period. Extensions of time for good cause may be granted by the Executive Vice Chancellor. All relevant parties will be notified of any time extensions.

E. Procedures for Handling Findings of Research Misconduct

The Executive Vice Chancellor shall submit the findings of the RIAC to the appropriate administrative officer indicated below with the recommendation that disciplinary proceedings be initiated in accordance with Section E of these procedures.

F. Disciplinary and Grievance Procedures

Disciplinary recommendations and Grievance procedures will be based upon policies or Memoranda of Understanding relevant to the positions held by the complainant and/or the respondent at the University. The policies for each category of university employee are outlined in the following sources:

1. Academic Senate Members

• a. ‘University Policy on Faculty Conduct and the Administration of Discipline.’ Academic Personnel Manual Section 015; also published as Appendix IV of The Manual of the Santa Cruz Division of the Academic Senate.
• b. Bylaw 335, ‘Privilege and Tenure Divisional Committees,’ The Manual of the Santa Cruz Division of the Academic Senate.
• c. ‘Procedures for Implementation of University Policy on Faculty Conduct and Administration of Discipline,’ Academic Personnel: Campus Policies and Procedures, Section 002.015.

2. Non-Senate Academic Appointees, including Librarians.

• a. Academic Personnel Policy 140 - Appeals
• b. Discipline and dismissal action involving exclusively represented non-Senate academic appointees must conform to the requirements of the Memoranda of Understanding for those groups of employees.

3. Students

• a. ‘Academic Integrity’ and ‘Student Conduct’ sections, Campus Handbook
• b. ‘Student Conduct and Discipline,’ section 50.00, Rule Book: Policies and Regulations Applying to Campus Activities, Organizations, and Students.

4. Staff. Appointees in this category are either (1) exclusively represented by a union, in which case the relevant Memorandum of Understanding applies to disciplinary actions taken against them, or (b) covered by staff personnel policies, specifically:

• a. ‘Corrective Action,’ ‘Employee Grievances,’ and ‘Administrative Review,’ sections 270-290, Staff Personnel Manual and ‘Dismissal of Regular Status Employees,’ section 740, Staff Personnel Manual.
• b. ‘Grievances,’ ‘Corrective Action,’ and ‘Dismissal of Regular Status Employees,’ sections 170, 185, and 190, Administrative and Professional Staff Program Policy.
• c. ‘Administrative Review’ and ‘Termination of Appointment,’ sections 70 and 85, Management and Professional Staff Program Policy.
• d. ‘Resolution of Concerns’ and ‘Termination of Appointment,’ Policies 22 and 28, Executive Program Personnel Policies.

III. Additional requirements for PHS-related research

A. Requirements for Reporting to ORI

1. An institution’s decision to initiate an investigation must be reported in writing to the Director, ORI, on or before the date the investigation begins. At a minimum, the notification should include the name of the person(s) against whom the allegations have been made, the general nature of the allegation as it relates to the PHS definition of scientific misconduct, and the PHS applications or grant number(s) involved. ORI must also be notified of the final outcome of the investigation and must be provided with a copy of the investigation report within 120 calendar days of the initiation of the investigation. Any significant variations from the provisions of the institutional policies and procedures should be explained in any reports submitted to ORI.
2. If an institution plans to terminate an inquiry or investigation for any reason without completing all relevant requirements of the PHS regulation, the Executive Vice Chancellor will submit a report of the planned termination to ORI, including a description of the reasons for the proposed termination.
3. If the institution determines that it will not be able to complete the investigation in 120 days, the Executive Vice Chancellor will submit to ORI a written request for an extension that explains the delay, reports on the progress to date, estimates the date of completion of the report, and describes other necessary steps to be taken. If the request is granted, the Executive Vice Chancellor will file periodic progress reports as requested by the ORI.
4. When PHS funding or applications for funding are involved and an admission of scientific misconduct is made, the Executive Vice Chancellor will contact ORI for consultation and advice. Normally, the individual making the admission will be asked to sign a statement attesting to the occurrence and extent of misconduct. When the case involves PHS funds, the institution cannot accept an admission of scientific misconduct as a basis for closing a case or not undertaking an investigation without prior approval from ORI.
5. The institution will report to ORI as required by regulation and keep ORI apprised of any developments during the course of the inquiry or investigation that may affect current or potential DHHS funding for the individual(s) under investigation or that PHS needs to know to ensure appropriate use of Federal funds and otherwise protect the public interest.
6. The investigation report submitted to ORI must describe the policies and procedures under which the investigation was conducted, describe how and from whom information relevant to the investigation was obtained, state the findings, and explain the basis for the findings. The report will include the actual text or an accurate summary of the views of any individual(s) found to have engaged in misconduct as well as a description of any sanctions imposed and administrative actions taken by the institution.
7. The Executive Vice Chancellor will notify ORI at any stage of the inquiry or investigation if:
   • a. there is an immediate health hazard involved;
   • b. there is an immediate need to protect Federal funds or equipment;
   • c. there is an immediate need to protect the interests of the person(s) making the allegations or of the individual(s) who is the subject of the allegations as well as their co-investigators and associates, if any;
   • d. it is probable that the alleged incident is going to be reported publicly; or
   • e. the allegation involves a public health sensitive issue, e.g., a clinical trial; or
   • e. there is a reasonable indication of possible criminal violation. In this instance, the institution must inform ORI within 24 hours of obtaining that information.

B. Other Considerations

1. Restoration of the Respondent’s Reputation
If the institution finds no misconduct and ORI concurs, after consulting with the respondent, the Executive Vice Chancellor will undertake reasonable efforts to restore the respondent’s reputation. Depending on the particular circumstances, the Executive Vice Chancellor should consider notifying those individuals aware of or involved in the investigation of the final outcome, publicizing the final outcome in forums in which the allegation of scientific misconduct was previously publicized, or expunging all reference to the scientific misconduct allegation from the respondent’s personnel file. Any institutional actions to restore the respondent’s reputation must first be approved by the Executive Vice Chancellor.

2. Protection of the Complainant and Others
Regardless of whether the institution or ORI determines that scientific misconduct occurred, the Executive Vice Chancellor will undertake reasonable efforts to protect complainants who made allegations of scientific misconduct in good faith and others who cooperate in good faith with inquiries and investigations of such allegations. Upon completion of an investigation, the Executive Vice Chancellor will determine, after consulting with the complainant, what steps, if any, are needed to restore the position or reputation of the complainant. The Executive Vice Chancellor is responsible for implementing any steps the Executive Vice Chancellor approves. The Executive Vice Chancellor will also take appropriate steps during the inquiry and investigation to prevent any retaliation against the complainant.

3. Allegations Not Made in Good Faith
If relevant, the Executive Vice Chancellor will determine whether the complainant’s allegations of scientific misconduct were made in good faith. If an allegation was not made in good faith, the Executive Vice Chancellor will determine whether any administrative action should be taken against the complainant.

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

C. Record Retention

After completion of a case and all ensuing related actions, the VCR will prepare a complete file, including the records of any inquiry or investigation and copies of all documents and other materials furnished to the Executive Vice Chancellor or committees. The Executive Vice Chancellor will keep the file for three years after completion of the case to permit later assessment of the case. ORI or other authorized DHHS personnel will be given access to the records upon request.

8. 42 C.F.R. ' 50.103(d)(3).
17. 42 C.F.R. ' 50.104(a)(4); 42 C.F.R. ' 50.103(d)(15).