Chapter 8 : Research Compliance

Introduction to Research Compliance

Regulatory and compliance considerations for federal grants ensure that research is conducted ethically, legally, and in alignment with sponsor and institutional policies, covering areas such as human subjects (IRB), animal welfare (IACUC), data security, and financial integrity. Investigators must adhere to these regulations throughout the grant lifecycle, with oversight from institutional offices to maintain accountability, transparency, and eligibility for continued funding.

CSUSB’s Research Compliance Webpage

Conflict of Interest (COI)

Conflict of Interest (COI). All federal investigators are required to disclose any significant financial interests (SFIs) or relationships that could directly or indirectly affect—or appear to affect—the objectivity of their funded research. These disclosures must be submitted prior to proposal submission and updated annually or within 30 days of any relevant changes, in compliance with federal regulations (e.g., PHS/NIH or NSF COI policies).

​The CSUSB/UEC Financial Conflict of Interest (FCOI) Policy aims to ensure transparency and integrity in externally sponsored research by requiring investigators to disclose any significant financial interests that could influence their research activities. This policy mandates that disclosures be made prior to proposal submissions and updated during the award period, with specific requirements varying based on the funding agency, such as NIH, NSF, DOE, or non-governmental sponsors. Disclosed conflicts are confidentially reviewed, and if necessary, a resolution plan is developed to manage, reduce, or eliminate the conflict. Compliance with this policy is essential for maintaining ethical standards and public trust in the university's research endeavors. More information is available on the CSUSB/UEC Financial Conflict of Interest Policy Web Page.

CSUSB Federal Disclosure Form (FCOI) - must be completed by investigators prior to submission of a NIH/PHS grant proposal and upon the receipt and during administration of the award. Must also be completed by investigators prior to submission of a NSF/USDA grant proposal, when new personnel is added and when the investigator's financial interest changes.

Institutional Review Board (IRB)

The California State University, San Bernardino Institutional Review Board (IRB) mission is to assure, both in advance and by periodic review, appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group peer review process to review research protocols and related materials (e.g., informed consent documents, surveys, interview questions, and protocol design) to ensure the protection of the rights and welfare of human subjects of research. This is in accordance with federal regulations in the Federal Office of Human Research Protections CFR Title 45 Part 46 and the Federal Food and Drug Administration Title 21 Part 50 and Part 56.

The ethical responsibility of institution’s IRB is to ensure, regardless of whether the research is subject to the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule), it will be guided by a statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution. The requirements of our federal mandate further assure students, faculty, staff, and external researchers operate within the requirements of Federalwide Assurance of Compliance with the U.S. Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP). The CSUSB IRB OHRP Federal Assurance number is FWA00004865.

Researchers (students, staff, faculty, administrators) are invited to attend the meeting when their IRB application is being reviewed by the full board committee. Attending the meeting will facilitate the approval of your IRB application so you can address any concerns and clarifications the board has regarding your protocol. Please direct requests to attend meetings with the Research Compliance Officer at 909-537-7588 or mgillesp@csusb.edu to provide meeting details.

Please plan to submit your protocols accordingly and with due diligence. Your attention to detail is important in filling out the human subjects application to ensure IRBs timely, thorough, and efficient review.. Please note the IRB does not meet during the winter or summer break to review bull board applications, you can find IRB meeting details on the website.

IRB Board Members

Human Subjects / IRB: Steps for Institutional Review Board approvals:

IRB Process Flowchart

Human Subject Ethics Training in the Protection of Human Participants

The Collaborative IRB Training Initiative (CITI) course contains training modules for Biomedical and Social and Behavioral Science research. The CITI training program provides training in the following:

• Financial Conflict of Interest (FCOI/COI)
• IRB (Human Subjects)
• IACUC (Animal Subjects)
• Export Controls
• RCR (Responsible Conduct of Research). Instructions for registering for RCR can be found here.

The IRB application cannot be approved without all investigators completing the CITI Human Subjects Training for the appropriate group and uploading the certificates in the online IRB application.

CITI Training Website IRB

Register and Complete CITI Human Subjects Training for CSUSB members.

Investigators (administration, faculty, staff, and students) must complete either Group 1 or Group 2 CITI. Do NOT complete the Students in Research Module or the Responsible Conduct of Research Module as these are NOT mandatory training modules required by the IRB with the submission of your application.

CSUSB CITI users will be able to access the CITI training website through their MyCoyote user ID and password. Unaffiliated campus members will still be able to access the system through the CITI training website noted below under "Collaborators".

Animal Subjects / IACUC

The Institutional Animal Care and Use Committee (IACUC) is responsible for reviewing protocols for research involving animal subjects. The IACUC must approve all research and educational use of live, vertebrate animals.

CITI Training Website For IACUC

To submit a protocol for use of animals, complete the application available below and email to both Dr. Dionisio Amodeo at dionisio.amodeo@csusb.edu and Michael Gillespie at mgillesp@csusb.edu.

Applications to Use Animals for Research or Teaching

IACUC Application Form

IACUC Protocol Amendment Form

IACUC Protocol Renewal Form

IACUC Guidelines Use of Avian and Reptilian Embryos

IACUC Surgical Procedures Form

For additional information on Links to Policies, Laws, and Regulations refer to CSUSB’s Office of Academic Research: The Institutional Animal Care and Use Committee

Biological Safety Committee

The Biosafety Committee's purpose is:

1. to review and approve research and education using gene engineering procedures.
2. to establish policies for safe use of biohazardous material.
3. to establish policies for other biological and health-related issues (for example, procedure to follow in case of needle sticks).

           IBC Application Form

           IBC Protocol Amendment Form

           IBC Protocol Renewal Form

           Principal Investigator Responsibilities

           Biosafety Levels

           Recommended Biosafety Levels

           NIH Guidelines

           CDC Biosafety in Microbiological & Laboratory Laboratories 5th Edition

To submit a protocol for use of animals, complete the application available below and email to Dr. David Rhoads at drhoads@csusb.edu and Mr. Michael Gillespie at mgillesp@csusb.edu

Radiation Safety

Radiation Safety is reviewed and approved by CSUSB’s Research Compliance Office; they are responsible for reviewing and approving protocols for research and education using radioactive materials.

Radiation Safety Application Form

Radiation Use and Survey Form

Radioactive Waste Accumulation and Disposal Form

Export Controls

U.S, laws regulate the distribution of strategically important technology, services, and information to foreign nationals and foreign countries.  Export regulations help to protect U.S. national security, U.S. Economic Competitiveness, Prevent the proliferation of WMD/Terrorism, and support International Treaties and U.S. Foreign Policy. Non-compliance with federal requirements can result in large fines, penalties, and other sanctions.  To adhere to federal export control regulations CSUSB requires its faculty, staff, and students to comply with the export control regulations of the U.S.

If you will be conducting research abroad, you need to consider export control issues that will likely impact your research and travel. Examples of activities impacted by export control regulations include:

• Direct export of a controlled item
• Access and/or use of a controlled item by a foreign national
• Travel to a restricted country
• International and domestic collaborations
• Conversations involving controlled technology
• Taking or shipping a controlled item out of the U.S., such as a laptop.

The U.S. government maintains several export control regulations that may impact research conducted at CSUSB. The Export Administration Regulations (EAR) under the U.S. Dept. of Commerce regulate exports of commercial items and technology with potential military applications. These are also referred to as dual-use items. The International Traffic in Arms Regulations (ITAR) under the U.S. Dept. of State regulate exports of items and services specifically designed for military applications. The Office of Foreign Assets Control (OFAC) under the U.S. Dept. of Treasury prohibits certain transactions with countries subject to boycotts, trade sanctions, and embargoes.

Please note a ‘deemed export’ includes releasing, furnishing, showing or disclosing export controlled technical information to a Non-U.S. Person, even in the U.S., is considered to be a ‘deemed’ export to the home country(ies) of the Non-U.S. Person.

The CSU Office of General Counsel Export Control Flowchart

This can be used to determine if export control regulations apply to you. Information on sanctions can be found at the U.S Department of Treasury Office of Foreign Assets Controls.

The California State University Export Controls Manual

Licenses from the U.S. Department of State or the U.S. Department of Commerce may be required to export.

If your sponsored research might be subject to export control or you have questions regarding export control compliance, contact Michael Gillespie, Research Compliance Officer, at mgillesp@csusb.edu or (909) 537-7588.

Responsible Conduct of Research (RCR) and the Fundamental Principles of Research

Policy. Integrity – honesty, fairness, responsibility, and accountability are at the very essence of the Academic Research enterprise and crucial to society’s trust in science. A framework of Responsible Conduct of Research developed by the HHS Office of Research. Integrity includes training topics on research misconduct, protection of human and animal subjects in research, conflict of interest, data management, mentor and trainee responsibilities, collaborative research, authorship and publications, peer review, biosafety, and whistleblowing. All CSUSB employees, students and the individuals affiliated with CSUSB by a contract or agreement who engage in research and/or scholarly activities under the CSUSB or UEC auspices are subject to RCR and shall uphold the highest level of research integrity. CSUSB requires training to ensure the highest ethical and professional standards for conducting research. RCR training is intended to promote awareness of principles and practices that facilitate ethical and professional conduct across all research disciplines.

The Office of Academic Research in consultation with faculty and staff developed The CSUSB RCR Training Plan. This plan complies with the RCR training requirements set forth by the National Science Foundation (NSF), the National Institutes of Health (NIH) and the United States Department of Agriculture (USDA). Associate Provost for Research maintains the plan. CSUSB requires all CSUSB principal investigators (PI), co-principal investigators (co-PIs), senior and key personnel, postdoctoral, graduate, undergraduate students, trainees, and fellows who receive funding from NSF, NIH, and USDA complete the RCR training. The CSUSB RCR training plan is located here. The training can be completed using the Collaborative Institutional Training Initiative (CITI) and/or by completing an approved Research Ethics course or through other approved training mechanisms listed in the CSUSB RCR Training Plan. Please note that NIH requires at least 8 hours of face-to-face RCR training. For the complete description, visit the NIH Update on the Requirement for Instruction in the Responsible Conduct of Research.

Committee on the Responsible Conduct of Research

Training Plan

This working document describes the plan developed by CSUSB’s Office of Academic Research, Office of Research & Sponsored Programs, and the Office of Research Compliance to provide training in RCR. PIs, Co-PIs, Senior Personnel, postdoctoral researchers, undergraduate & graduate students, and staff engaged in research are required to complete the appropriate RCR training.

Research Integrity

Integrity in research and scholarly, and creative activities is a University’s paramount value. Responsible Conduct of Research and the fundamental principles of Research Integrity – honesty, fairness, responsibility and accountability are at the very essence of the Academic Research enterprise and crucial to society’s trust in science.

CSUSBs Web Page on Research Integrity

A framework of Responsible Conduct of Research developed by the HHS Office of Research Integrity includes training topics on research misconduct, protection of human and animal subject in research, conflict of interest, data management, mentor and trainee responsibilities, collaborative research, authorship and publications, peer review, biosafety and whistleblowing.

All CSUSB employees, students and the individuals affiliated with CSUSB by a contract or agreement who engage in research and/or scholarly activities under the CSUSB or UEC auspices are subject to Responsible Conduct of Research and shall uphold the highest level of research integrity.

Research Integrity Officer (RIO) is the person who has lead responsibility for ensuring that the institution takes all reasonable and practical steps to foster a research environment that promotes the responsible conduct of research, research training, and activities related to that research or research training, discourages research misconduct, and deals promptly with allegations or evidence of possible research misconduct.

The Associate Provost for Research or a designee serves as the CSUSB RIO. The responsibilities of the RIO are located below. Should you have any questions please send an email to researchcompliance@csusb.edu.

Responsibilities of Research Integrity Officer

Additional information can be found in:

• ORI Handbook for Institutional Research Integrity Officers

CDC Summary of the Research Integrity Officer Responsibilities

Policy on Upholding Research Integrity and Responding to the Allegations of Research Misconduct

Sources:

• 42 CFR Parts 50 and 93 (2005)

• NIH Guide to the Handling of Research Misconduct Allegations

• OMB 78 FR 78589

Integrity in research, scholarly, and creative activities is a University’s paramount value.

Responsible Conduct of Research and the fundamental principles of Research Integrity – honesty, fairness, responsibility and accountability are at the very essence of the Academic Research enterprise and crucial to society’s trust in science.

The National Institutes of Health identifies the following tenants of Research Integrity:

• the use of honest and verifiable methods in proposing, performing, and evaluating research

• reporting research results with particular attention to adherence to rules, regulations, guidelines, and

• following commonly accepted professional codes or norms.

A framework of Responsible Conduct of Research developed by the HHS Office of Research Integrity includes training topics on research misconduct, protection of human and animal subjects in research, conflict of interest, data management, mentor and trainee responsibilities, collaborative research, authorship and publications, peer review, biosafety, and whistleblowing.

California State University San Bernardino (CSUSB) requires training to ensure the highest ethical and professional standards for conducting research. Responsible Conduct of Research training is intended to promote awareness of principles and practices that facilitate ethical and professional conduct across all research disciplines.

All CSUSB employees, students and the individuals affiliated with CSUSB by a contract or agreement who engage in research and/or scholarly activities under the CSUSB’s or an affiliated Auxiliary’s auspices are subject to Responsible Conduct of Research and shall uphold the highest level of research integrity.

Thus, allegations of misconduct in scholarship and research must be treated with the utmost seriousness and examined carefully and responsibly.

It is the shared responsibility of all members of our academic community to ensure that misconduct in scholarship and research is dealt with in a timely and effective manner and all employees or individuals associated with CSUSB are required to report to Associate Provost for Research, observed, suspected, or apparent misconduct including, but not limited to plagiarism, falsification, and fabrication of data, misuse of funds and equipment, and violations of the policies of the Institutional Review Board (IRB) and the Institutional Animal Care and Use Committee.

Section 1. Definitions

Abuse of confidentiality: releasing the ideas or data of others that were shared with the legitimate expectation of confidentiality (e.g., disclosing ideas from others' grant proposals, award applications, or manuscripts for publication when one is a reviewer for granting agencies or journals or is an internal destroying property of others, such as experiments, research papers, supplies, equipment, or products of research or scholarship).

Allegation: a disclosure of possible research misconduct through any means of communication. The disclosure may be by a written or oral statement or other communication.

Complainant: A person who in good faith makes an allegation of research misconduct. They may also make an allegation of inadequate institutional response to such an allegation of research misconduct. The role of the complainant is limited. Once the complainant has made an allegation of research misconduct, that person does not participate in the proceeding other than as a witness. (A complainant is not the equivalent of a “party” in a private dispute.) The University must pursue allegations of research misconduct independent of the complainant’s role.

Conflict of Interest: financial, personal, or professional relationships that may compromise, or appear to compromise a person’s decisions.

Deciding Official (DO): The person who shall make the final determination as to whether research misconduct has taken place, and shall initiate administrative action against those found to have committed research misconduct, ordinarily the President or Provost, or a designee.

The Deciding Official does not serve as the Research Integrity Officer and is not directly involved in the institution’s preliminary assessment, inquiry, or investigation.

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

Fabrication is making up data or results and recording or reporting them.

Failure to report observed research misconduct: covering up or otherwise failing to report observed, suspected, or apparent research misconduct by others.

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.

Inquiry: Preliminary information gathering and initial fact-finding to determine whether an allegation or apparent instance of research misconduct warrants an investigation.

Investigation: The formal examination and evaluation of all relevant facts to determine misconduct has occurred, and if so, the responsible person and the seriousness of the misconduct.

Misuse of funds: stealing or expending research funds on goods or services which violate allowability and/or reasonability and/or allocability of costs as defined in the Cost Principles section of OMB 78 FR 78589.

ORI: Office of Research Integrity, an independent entity within the U.S. Department of Health and Human Services reporting to the Secretary of the Department of Health and Human Services. ORI is responsible for protecting the integrity of PHS extramural and intramural research programs.

Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.

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

Research: a systematic experiment, study, evaluation, demonstration or survey designed to develop or contribute to general knowledge or specific knowledge by establishing, discovering, developing, elucidating or confirming information about, or the underlying mechanism relating to, the matters of study.

Research Integrity Officer (RIO): The person who has lead responsibility for ensuring that the institution takes all reasonable and practical steps to foster a research environment that promotes the responsible conduct of research, research training, and activities related to that research or research training, discourages research misconduct, and deals promptly with allegations or evidence of possible research misconduct, ordinarily Associate Provost for Research or a designee.

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

Research misconduct does not include honest error(s) or differences of opinion.

Research record: the record of data or results that embody the facts resulting from scientific inquiry or other scholarly endeavors, including but not limited to research proposals, laboratory records (physical and electronic), progress reports, progress reports, abstracts, theses, oral presentations, internal reports, journal articles, correspondence, and any documents and materials provided to an institutional official in the course of a research misconduct proceeding.

Respondent: The person against whom an allegation of research misconduct is directed, or the person who is the subject of the inquiry or investigation. There can be more than one respondent in any inquiry or investigation.

Retaliation: An intentional act of reprisal, threat or intimidation by a CSUSB employee that has a material and substantial adverse effect on the terms and conditions of employment or other status of a complainant who, in good faith, has made an allegation of research misconduct or inadequate institutional response thereto, or who has cooperated in good faith with an investigation of such allegations.

Sabotage or other property violations: stealing, tampering with, or destroying  property of others, such as experiments, research papers, supplies, equipment, or products of research or scholarship.

Section 2. Scope

This Policy is intended to comply with institutional responsibilities under the Public Health Service (PHS) Policies on Research Misconduct, 42 CFR Part 93. Other federal agencies have published their research misconduct regulations; to the extent those regulations apply  to an allegation of research misconduct and are inconsistent with this Policy, CSUSB employees and students shall comply with the applicable regulatory requirements.

This Policy applies to allegations of research misconduct (as defined by this Policy) involving any person who, at the time of the alleged research misconduct, was employed by, or was affiliated by contract or agreement with CSUSB or UEC at CSUSB, including without limitation officials, tenured and non-tenured faculty, teaching and support staff, researchers, technicians, post-doctoral and other fellows, students and volunteers.

This Policy also applies to other research-related misconduct including defined in this Policy: abuse of confidentiality, failure to report observed research misconduct, misuse of funds, retaliation and sabotage or other property violations and directing or encouraging others to engage in any of the above offenses.

This Policy also applies to research that is not federally funded.

This Policy does not apply to authorship or collaboration disputes and applies only to allegations of research misconduct that occurred within six years of the date CSUSB or an affiliated Auxiliary or the U.S. Department of Health and Human Services (HHS) received the allegation subject to the subsequent use, health or safety of the public, and grandfather exceptions articulated in 42 C.F.R. § 93.105(b).

Concerning students involved in allegations of research misconduct that involve federal funding, the Office of Student Conduct and Ethical Development and the Office of Undergraduate Studies or the Office Graduate Studies will be notified of the initiation of any inquiries and/or investigations and will be informed of the findings of any such inquiries and/or investigations, including receiving copies of all inquiry and/or investigation reports.

Allegations of research misconduct against students that do not involve federal funding will ordinarily be referred to the Office of Student Conduct and Ethical Development.

Section 3. Upholding Research Integrity; Research Misconduct Prohibited; Standard of Proof.

All CSUSB employees, students and the individuals affiliated with CSUSB by a contract or agreement who engage in research and/or scholarly activities under the CSUSB’s or an affiliated Auxiliary’s auspices are subject to Responsible Conduct of Research and shall uphold the highest level of research integrity.

CSUSB prohibits research misconduct and investigates and responds to allegations of research misconduct in accordance with this Policy.

A finding of research misconduct requires that:

• There be a significant departure from accepted practices of the relevant research community;

• The respondent committed the research misconduct intentionally, knowingly, or recklessly; and

• The allegation be proven by a preponderance of the evidence.

The destruction of research records, absence of research records, or respondent’s failure to provide research records adequately documenting the questioned research is evidence of research misconduct where the institution establishes by a preponderance of the evidence that the respondent intentionally, knowingly, or recklessly had research records and destroyed them.

CSUSB bears the burden of proof for making a finding of research misconduct. A respondent has the burden of proving, by a preponderance of the evidence, any and all affirmative defenses raised (such as an honest error).

Section 4. Responsibility to Report Research Misconduct

All employees or individuals associated with CSUSB are required to report observed, suspected, or apparent misconduct in research to the RIO. If an individual is unsure whether a suspected incident of misconduct falls within the definition, the individual may meet or contact the RIO to discuss the suspected misconduct informally and confidentially. The RIO contact information is available in the Office of Associate Provost for Research.

If the circumstances described by the individual do not meet the definition of research misconduct or research-related misconduct, the RIO will refer the individual or allegation to other appropriate offices or officials with responsibility for resolving the problem.

Section 5. Cooperation with Inquiries and Investigations

All CSUSB employees shall cooperate with the RIO and/or other University designated officials in the review of allegations and the conduct of inquiries and investigations. Employees have an obligation to provide relevant evidence to the RIO on research misconduct allegations.

Section 6. Confidentiality

The RIO shall (1) limit disclosure of the identity of respondents and complainants to those who need to know in order to carry out a thorough, competent, objective and fair research misconduct proceeding; 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.

Section 7. Protecting Complainants, Witnesses, and Committee Members

CSUSB employees shall not retaliate in any way against complainants, witnesses, or others involved in the review process. Employees should immediately report any alleged or apparent retaliation to the RIO, who shall review the matter and, as necessary, make all reasonable and practical efforts to stop and remedy any potential or actual retaliation.

Section 8. Protecting Respondent

If requested to do so and as appropriate, the RIO and other University 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 applicable federal regulations and CSU policies and procedures.

Section 9. Appointment of Personnel

Deciding Official (DO)

The Provost shall serve as Deciding Official (DO) shall make the final determination as to whether research misconduct has taken place, and shall initiate administrative action against those found to have committed research misconduct in accordance with the relevant Collective Bargaining Agreement.

Research Integrity Officer (RIO)

The Associate Provost for Research shall serve as RIO.

If upon receipt of the allegation, it appears that the RIO has any unresolved personal, professional, or financial conflicts of interest with those involved in the allegations, then the DO shall appoint another qualified individual to serve as Interim RIO with respect to reviewing the allegation and conducting any research misconduct proceeding.

The RIO shall appoint the Inquiry Committee and Investigation Committees in consultation with the Provost and the Chair of the Faculty Senate.

Inquiry and Investigation Committees

The Inquiry Committee shall consist of the following individuals:

• One faculty member from the same College but not from the same department as the respondent.

• One faculty member from an outside College with expertise in the research area of the project under inquiry or with expertise in research misconduct matters. If no person is available with these qualifications from within the University, expertise may be sought from outside the University.

• One Associate Dean who is not from the respondent’s College.

• One faculty member appointed by Faculty Senate.

• One member of the Committee on Responsible Conduct of Research appointed by the committee’s chair.

The Investigation Committee will be constituted in the same manner as the Inquiry Committee. Every effort shall be made to appoint Investigation Committee members who have no prior involvement with the case at hand. Inquiry Committee members may serve on the Investigation Committee only under extraordinary circumstances.

If, upon an inquiry or investigation committee member appointment, it appears that the appointee has any unresolved personal, professional, or financial conflicts of interest with those involved in the allegations, then the RIO shall appoint another qualified individual to serve on the corresponding committee.

Section 10. Process and Timeline

Sequestration of Research Records

The RIO shall, on or before the date on 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.

Those engaged in administering this Policy have all rights necessary to access research records created or maintained by individuals subject to this Policy.

As to timing, on or before the date on which the respondent is notified, or the inquiry begins, whichever is earlier, the RIO must take all reasonable and practical steps to obtain custody of all the research records and evidence needed to conduct the research misconduct  proceeding. The RIO also shall sequester any additional research records that become pertinent to an inquiry or investigation after the initial sequestration.

The RIO is responsible for inventorying the records and evidence.

Notice to Respondent

At the time of or before beginning an inquiry, the RIO must make a good faith effort to notify the respondent in writing. If the inquiry subsequently identifies additional respondents, they  must be notified in writing.

There are three phases of the process: assessment of allegations, inquiry, and investigation.

Assessment of Allegations

Upon receiving an allegation of research misconduct, the RIO immediately will assess it to determine whether the allegation:

• Falls within the definition of research misconduct, and

• Is sufficiently credible and specific so that potential evidence of research misconduct may be identified.

An inquiry must be conducted if these criteria are met.

The assessment period should be brief, preferably concluded within a week - seven (7) calendar days. 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 preliminary assessment shall be documented and all records pertaining to the review of allegations will be retained by the RIO for seven (7) years following the completion of the proceeding.

Inquiry

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.

Inquiry Process

The inquiry committee shall examine relevant research records and materials as well as normally interview the complainant, the respondent and key witnesses. Then the inquiry committee shall evaluate the evidence, including the testimony obtained during the inquiry. After consultation with the RIO, the committee members shall decide whether an investigation is warranted. 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 ORI to determine the next steps that should be taken.

Time for Completion

The inquiry, including preparation of the final inquiry report and the decision of the DO on whether an investigation is warranted, must be completed within 90 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 90-day period.

Investigation

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. The investigation shall also determine whether there are additional instances of possible research misconduct that would justify broadening the scope beyond the initial allegations. This is particularly important where the alleged research misconduct involves clinical trials or potential harm to human subjects or the general public or if it affects research that forms the basis for public policy, clinical practice, or public health practice. The findings of the investigation must be reported in an investigation report.

Investigation Process

The investigation committee and the RIO shall:

• Use diligent efforts to ensure that the investigation is thorough and sufficiently documented and includes an 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.

Time for Completion

The investigation shall be completed within 180 days of beginning it, including conducting the investigation, preparing the report of findings, providing the draft report for comment to the respondent, and, as appropriate, sending the final report to ORI or other applicable federal agency or office. However, if the RIO determines that the investigation will not be completed within this 180-day period, they shall submit to University officials and, as appropriate, to ORI or other applicable federal agency or office a written request for an extension, setting forth the reasons for the delay. If the request for an extension is granted and periodic progress reports are requested, the RIO shall ensure that periodic progress reports are filed with University officials and, as appropriate, ORI or other applicable federal agency or office.

Section 11. Appeals

The decision of the DO is final and cannot be appealed.

Section 12: Sanctions and Administrative Actions

If the DO determines that research misconduct is substantiated by findings, they shall decide on the appropriate actions to be taken after consultations with the RIO. These may include removal from project, reimbursement of funds, withdrawal of manuscripts or articles pending or published, and/or disciplinary action.

Section 13. Interim Institutional Actions and Notifying Federal Agencies 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 the DO, Faculty Senate, other institutional officials, and ORI, as necessary, take appropriate interim actions 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 the responsibility for the handling of federal funds and equipment;

• additional review of research data and results; or delaying publication.

RIO shall, at any time during a research misconduct proceeding, notify ORI (or the relevant federal agency) immediately if there is 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;

• Federal 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 federal action may be necessary to safeguard evidence and protect the rights of those involved; or

• The research community or public should be informed.

Section 14. Other Research-related Misconduct Not Included in this Policy

The following types of research-related misconduct are governed by the following policies:

• Financial Conflict of Interest (FCOI) by the FCOI policy.

• Deviations from or violations of the approved IRB protocol by the IRB policy.

• Deviations from or violations of the approved IACUC protocol by the IACUC policy

Safe Working & Inclusive Environments (NSF)

NSF Safe and Inclusive Work Environment Plan for Off Campus or Off-Site Research

The National Science Foundation (NSF) announced in 2023 that, effective January 30, 2023, if a Principal Investigator (PI) submits a new or renewal proposal, the NSF will require the PI to take an additional step when engaging in off-campus and/or off-site research activities. Please see NSF Safe and Inclusive Working Environments.

NSF’s new requirement states that there must be a plan for a safe and inclusive environment created, and distributed in advance to everyone who will participate in an off-campus or off-site research activity prior to those individuals leaving campus to engage in the off-campus/off-site research. NSF defines off-campus or off-site research as data, information, samples being collected off-campus or off-site, such as fieldwork and research activities on vessels and aircraft. Please refer to NSF Proposal and Award Policies & Procedures Guide or PAPPG, Chapter II.D.1.d(viii) and II.3.9 for additional information.

The creation and distribution of the plan is the responsibility of the PI. However, to ease the administrative burden, the Office of Academic Research has prepared a template plan (attached) for PIs to use. Please note:

1.  PI should not submit the plan to NSF for review unless specifically requested in the program solicitation.

2. PI should determine if a proposed research includes any off-campus or off-site research as defined by NSF.

3. PIs are responsible for maintaining and retaining a copy of the plan, as well as documentation of who received the plan (email confirmation, signup sheet, etc.) in the Office of Research and Sponsored Programs (ORSP) file, Sponsored Programs Administration (SPA) file, or in PI or departmental grant files. These records are subject to the same retention schedule as other grant-related administrative records.

4. Plans may be re-used and re-distributed for multiple off-campus research activities but must be updated, as appropriate, to each specific grant proposal.

5. For purposes of compliance with NSF’s new requirement, the following are not considered off-campus or off-site research for purposes of this requirement:

• Meetings and conferences that do not include data/information/samples being collected
• Data/information/samples collected by subrecipients or collaborating organizations at their primary place of performance

6. Determinations about plan requirements must be based on the location and nature of the activities; this assessment is independent of the F&A rate determination  which is based on where the preponderance of the work is performed.

Commitment to Safe and Inclusive Research Environments. California State University, San Bernardino (CSUSB) and University Enterprises Corporation at CSUSB (UEC), or collectively “University” take Discrimination, Harassment, Retaliation (DHR), Title IX, sexual misconduct and Whistleblower very seriously. Harassment includes, but is not limited to, verbal harassment (e.g., epithets, derogatory comments, or slurs), physical harassment (e.g., assault, impeding or blocking movement, or any physical interference with normal work or movement), and visual forms of harassment (e.g., derogatory posters, cartoons, drawings, symbols, or gestures.). Although a single, isolated incident will typically be insufficient to rise to the level of harassment, every individual who believes that they have experienced discrimination, harassment, any form of abuse or violence, stalking or retaliation are encouraged to report the behavior so they can secure the support they need, and the University may respond appropriately. University’s goal is to provide the campus community with education, awareness, reporting options and meaningful assistance. Information on University’s Institutional Equity and Compliance policy and procedures can be found at: https://www.csusb.edu/institutional-equity-compliance, https://www.csusb.edu/human-resources and the UEC employee handbook. These policies apply to any university program or externally-funded sponsored program, including programs that take place off-campus or in the field or on an online platform (e.g., Zoom).

For any questions or if you require additional information concerning this NSF requirement, please contact mgillesp@csusb.edu.

• Safe and Inclusive Work Environments Plan Memo
• Template: Project Specific Plan for Safe and Inclusive Work Environments

NSF FAQs

• NSF FAQs Safe and Inclusive Work Environments