Policy Statement

Ramapo College of New Jersey (hereinafter referred to as the “College”) is committed to uphold the highest ethical standards in research. This policy is based on the U.S. Department of Health and Human Services Public Health Service Policies on Research Misconduct – Final Rule, Code of Federal Regulations, Vol. 42, Part 93 (Federal Register, Vol. 70, p. 28370 (May 17, 2005, amended Jan. 17, 2025).

Further, for the purposes of research activities that are not sponsored by Health & Human Services, this policy shall be applied and its procedures may only be adjusted as required by the sponsoring agency.

This policy shall be reviewed annually to ensure compliance with governmental regulations.

Purpose of Policy

The purpose of this policy is to communicate the standards expected of faculty, staff, administrators, and academic professionals who participate in sponsored research at or for the College.

The purpose of the procedure is to describe the process followed in those instances in which research misconduct is suspected to have occurred. To the extent permissible, this policy and procedure applies to all sponsored research activity stewarded by the College.

To Whom Does the Policy Apply

This policy applies to all College employees engaged in research activities, whether they are externally funded or not. This includes faculty (full-time, part-time/adjunct, lecturers, professional staff who teach), administrators, staff, as well as individuals contracted by the College to engage in research that is supported by federal, private, or College funds.

Supplemental Resources

• Procedure 301: Research Misconduct
• Appendix 301A: Definitions
• Policy 407: Gifts & Private/Non-governmental Grants
• Policy 220: Grants & Sponsored Programs Compliance
• Policy 649: Financial Conflicts of Interest (Sponsored Research)
• Public Health Service Policies on Research Misconduct – Final Rule, Code of Federal Regulations, Vol. 42, Part 93 (Federal Register, Vol. 70, p. 28370 (May 17, 2005, amended on Jan. 17, 2025)

Contact

Vice Provost for Academic and Faculty Affairs (in capacity as the Research Integrity Officer at the College)

I. Overview & Principles

Allegations of research misconduct are taken very seriously, as are the needs to protect the rights of those who make such complaints in good faith and the rights of those who are accused of research misconduct.

The purpose of this policy and the following procedures are to achieve these goals and to comply with federal regulations including but not limited to:

• the Department of HHS and the National Science Foundation (NSF) regulationswhich define the responsibilities of PHS and NSF research grant awardees fordealing with and reporting possible misconduct in research efforts (42CFR, Part50, Subpart A and 45CFR, Part 689);
• the PHS Act, which requires that each agreement for a grant, contract, or cooperative arrangement for the conduct of biomedical or behavioral research must have, as part of it, assurances that the institution has established an administrative process to review reports of scientific misconduct in connection with biomedical and behavioral research conducted at or sponsored by the institution.

In addition, the NSF has similar regulations governing the conduct of researchers supported by NSF grants. Implicit in these requirements is an understanding that the institution reports any investigation of scientific misconduct that appears to be substantiated. The process described below will be followed when an allegation of research misconduct is received by an institutional official. This process is intended to carry out the College’s responsibilities under the PHS Policies on Research Misconduct, 42 CFR Part 93. It does not apply to authorship or collaboration disputes and applies only to allegations of research misconduct that occurred within six (6) years of the date the institution or HHS received the allegation, subject to the subsequent use, health or safety of the public, and grandfather exceptions in 42 CFR § 93.104(b).

Further, for the purposes of research activities that are not sponsored by HHS, these procedures may be adjusted but only as required by the sponsoring agency.

Principle 1. Responsibility

1. All College employees and students (hereinafter referred to as “institutionalmembers”), are responsible for reporting suspected research misconduct. Institutional members will cooperate with the RIO and other institutional officials in the review of allegations and the conduct of inquiries and investigations.
2. If an individual is unsure whether a suspected incident falls within the definition of research misconduct, the individual may contact the RIO to discuss a hypothetical scenario without naming individuals. Should the hypothetical scenario fall within the definition of research misconduct, the RIO will counsel the individual to follow the process for alleging research misconduct. Should the hypothetical scenario fall outside the purview of research misconduct yet merits further inquiry, the RIO will refer the individual to the appropriate office or entity on campus, which may include but is not limited to: Provost’s Office/Teaching and Learning Core; Equity, Diversity, Inclusion & Compliance (EDIC); People Operations & Employee Resources (POER); the College Ombudsperson; the Institutional Review Board (IRB); and/or the School Dean care of the Institutional Animal Care & Use Committee (IACUC).
3. The individual making the allegation is expected to maintain confidentiality of the report, and to cooperate with the entirety of the assessment, inquiry, and/or investigation processes.
4. If an individual deliberately and knowingly files a false accusation of research misconduct, they will be subject to disciplinary review and possible sanction, in accordance with applicable law/regulation, College policy and/or collective bargaining agreement.

Further, for the purposes of research activities that are not sponsored by HHS, these responsibilities may be adjusted but only as required by the sponsoring agency.

Principle 2. Protections

1. No institutional member may retaliate against individuals bringing forth allegations, witnesses, or others involved in the allegation or investigation.
2. Allegations of research misconduct are handled confidentially in accordance with42 CFR § 93.108 as follows: The College will limit disclosure of the identity ofrespondents and complainants to those who need to know in order to carry out acomprehensive, competent, objective, and fair research misconduct proceeding; and the College, except as otherwise prescribed by law, will 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.
3. In accordance with 42 CFR Part 93, respondents may consult with legal counselor a non-attorney personal adviser (who is not a principal or witness in the case) to seek advice, and may bring the legal counsel or personal adviser to interviews or meetings on the case. The College may permit a legal counsel/personal adviser to be present at interviews and meetings; however, the College restricts the legal counsel/personal adviser’s role to advising (as opposed to representing) the respondent.
4. Throughout the research misconduct proceeding, the RIO will review thematter to determine if there is any threat of harm to public health, federal funds and equipment, or the integrity of the research process. The RIO shall, at any time during a research misconduct proceeding, notify ORI immediately if they have a 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. In the event of such a threat, the RIO will, in consultation with other College officials and ORI, take appropriate interim action to protect against any such threat.

Further, for the purposes of research activities that are not sponsored by HHS, these protections may be adjusted but only as required by the sponsoring agency.

II. Procedures

Generally, all inquiries and investigations will be carried through to completion and all significant issues will be pursued diligently. The RIO must notify ORI in advance if there are plans to close a case at the inquiry, investigation, or appeal stage on the basis that respondent has admitted responsibility, a settlement with the respondent has been reached, or for any other reason, except:

• closing of a case at the inquiry stage on the basis that an investigation is not warranted; or
• a finding of no misconduct at the investigation stage, which must be reported to ORI, as prescribed in this policy and 42 CFR § 93.316.

A. Assessment and Inquiry 
Individuals with concerns regarding potential research misconduct by an institutional member should contact the RIO. Allegations of research misconduct are to be submitted in writing, along with any evidence they have related to the incident, to the RIO.

1. Upon receipt of the allegation, the RIO will initiate an assessment to determinethe validity of the allegation. The initial assessment should be completed within seven (7) days from the receipt of the allegation and associated evidence. 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 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.
2. If the RIO determines that the criteria for an inquiry are met, they 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. Should the inquiry result in no findings or insufficient evidence to substantiate the allegation, the RIO will keep all materials related to the allegation confidentially for six (6) years. Should the inquiry support the allegation, the RIO will proceed to the next step in the process.
3. Prior to commencing an inquiry, the RIO must make a good faith effort to notifythe respondent in writing. If the inquiry subsequently identifies additional respondents, they must also be notified in writing. 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 practicable 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 in instances where the research records or evidence encompass scientific instruments are 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 ORI for advice and assistance in this regard.
4. The RIO, in consultation with the College Provost/VP for Teaching, Learning, andGrowth, will appoint an inquiry committee and chair as soon after the initiation of the inquiry as is practicable. While the membership of the committee may vary depending on the nature of the allegation, the committee, at minimum, will consist of: a.) the RIO, and b.) three (3) individuals from the College, of which two must have the background related to the allegation.
5. No member of the committee should have unresolved personal, professional, or financial conflicts of interest with those involved with the inquiry. The respondent may request that the RIO not appoint specific individuals from the College to serve on the committee on the grounds of a conflict of interest.
6. At the committee’s first meeting, the RIO will review the charge with the committee, discuss the allegations, any related issues, the appropriate procedures for conducting the inquiry, assist the committee with organizing plans for the inquiry, and answer any questions raised by the committee. Specifically, the charge for the inquiry committee:

• • 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:

a. there is a reasonable basis for concluding that the allegation falls within the definition of research misconduct and is within the jurisdictional criteria of 42 CFR § 93.102; and

b.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 and 42 CFR § 93.309(a).

7. The inquiry committee will normally interview the complainant, the respondent, and key witnesses as well as examining relevant research records and materials. Then the inquiry committee will evaluate the evidence, including the testimony obtained during the inquiry, and submit a draft inquiry report. A written inquiry report must be prepared that includes the following information:

• • the name and position of the respondent;
  • a description of the allegations of research misconduct;
  • the funding support for the research in question, including, for example, grant numbers, grant applications, contracts and publications listing said support; and
  • the basis for recommending or not recommending that the allegations warrant an investigation.

The College’s legal counsel should review the report for legal sufficiency. Modifications should be made as appropriate in consultation with the RIO and the inquiry committee. After consultation with the RIO, the committee members will decide whether an investigation is warranted based on the criteria in this policy and 42 CFR § 93.307.

8. 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 calendar days, and include a copy of or refer to 42 CFRPart 93 and the College’s policies and procedures on research misconduct. Any comments that are submitted by the respondent or complainant will 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 finalform. The committee will deliver the final report to the RIO, who will then deliver it to the College Provost. The Provost, in consultation with the RIO, will make a decision whether an investigation is warranted.

9. Within 30 calendar days of the Provost’s decision that an investigation iswarranted, the RIO will provide ORI with the Provost’s written decision and acopy of the final inquiry report. The RIO must provide the following information to ORI upon request:

• • the institutional policies and procedures under which the inquiry was conducted;
  • the research records and evidence reviewed, transcripts or recordings of any interviews (if applicable);
  • copies of all relevant documents; and
  • the charges to be considered in the investigation.

10. The inquiry, including preparation of the final inquiry report and the decision of the Provost on whether an investigation is warranted, must 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.

If the Provost decides that an investigation is not warranted, the RIO shall secure and maintain for 7 years after the termination of the inquiry sufficiently detailed documentation of the inquiry to permit a later assessment by ORI of the reasons why an investigation was not conducted. These documents must be provided to ORI or other authorized HHS personnel upon request.

Further, for the purposes of research activities that are not sponsored by HHS, these procedures may be adjusted but only as required by the sponsoring agency.

B. Investigation

1. The investigation must begin within 30 calendar days after the determination by the Provost that an investigation is warranted. The purpose of the investigation is to explore and examine the allegation and evidence to determine whether research misconduct has occurred, by whom, and to what extent. While the investigation will focus on the initial allegation made, should evidence reveal that additional instances of research misconduct may have occurred, the committee may justify broadening the scope of the investigation. If at any point the evidence points to potential harm to human subjects, College students, or the public, the committee must broaden their scope beyond the initial allegation to further investigate this evidence. Under 42CFR § 93.313 the findings of the investigation must be set forth in an investigation report.
2. On or before the date on which the investigation begins, the RIO must:

• • notify the ORI Director of the decision to begin the investigation and provide ORIa copy of the inquiry report; and
  • notify the respondent in writing of the allegations to be investigated.

The RIO must 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 the respondent of the allegations, take all reasonable and practicable 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.

3. The investigation committee will convene, with members appointed by the RIO in consultation with the Provost. The investigation committee must consist of individuals who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the investigation and should include individuals with the appropriate scientific 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.

4. At the first meeting of the investigation 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;
  • 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:

a. research misconduct, as defined in this policy, occurred (respondent hasthe burden of proving by a preponderance of the evidence any affirmativedefenses raised, including honest error or a difference of opinion);

b. the research misconduct is a departure from accepted practices of the relevant research community; and

c. 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 42CFR §93.313.

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

6. The investigation committee and the RIO must:

• • 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 practicable;
  • Interview each respondent, complainant, and any other available person who has been identified as having information regarding any relevant aspects of the investigation, including witnesses identified by the respondent; 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 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.

7. The investigation is to be completed within 120 days after its commencement, including conducting the investigation, preparing the report of findings, providing the draft report for comment and sending the final report to ORI. However, if the RIO determines that the investigation will not be completed within this 120-day period, they will submit to ORI a written request for an extension, setting forth the reasons for the delay. The RIO will ensure that periodic progress reports are filed with ORI, if ORI grants the request for an extension and directs the filing of such reports.

8. At the conclusion of the investigation, the committee will submit a draft writtenreport to the Provost. This report must include:

a. The individual(s) accused of research misconduct.
b. The nature of the allegation of research misconduct and the specific allegations considered in the investigation. This will include any allegations that were investigated that were beyond the committee’s original scope, as well as the justification for investigating those additional allegations.
c. Identification and summary of research records and evidence reviewed, including any items that were gathered but not reviewed.
d. A statement of the findings for each specific allegation, to include:

• • • the type of research misconduct (falsification, fabrication, plagiarism, etc.);
    • the individual(s) who committed it and the time frame;
    • the committee’s assessment of whether the misconduct was committed intentionally, knowingly, or recklessly;
    • the accused individual(s)’ explanations, which may include an argument that the alleged research misconduct is honest error or difference of opinion;
    • any research related to the misconduct, and whether or not it was published/exhibited and if so, when and where;
    • the identification of any and all financial support of the scholarship related to the misconduct, be it federal, private, or College funds; and
    • the identification of any pending applications or proposals for supportrelated to the misconduct.

e. Recommended sanctions to be imposed by the College.

9. The RIO must 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 will be allowed 30 days from the date they receive the draft report to submit comments to the RIO. The respondent’s comments must be included and considered in the final report. In distributing the draft report, or portions thereof, to the respondent, the RIO will inform the recipient of the confidentiality under which the draft report is made available.

10. The RIO will assist the investigation committee in completing the final investigation report, including ensuring that the respondent’s comments are included and considered, and transmit the final investigation report to the Provost, who will determine whether or not the finding(s) support the allegation(s) of research misconduct.

Should the report conclude there was no support to the allegations, the Provost will notify the respondent in writing of the results of the committee’s investigation, and keep all materials related to the allegation in the respondent’s confidential personnel file for seven (7) years.

Should the report support the allegations, the Provost will notify the respondent in writing of the finding(s) by sharing the committee’s report less the committee’s recommended sanctions.

The Provost will also notify the respondent in writing that, unless an appeal (see section E below) with evidence is made within 10 days:

• • a report of the finding(s) will be submitted to the granting agencies, journal editors, publishers, or other agencies in receipt of any research related to the allegations,
  • the Committee’s report without the committee’s recommended sanctions will be submitted to the College President or their designee.

The Provost will also submit their recommended sanctions, taking into consideration pertinent institutional policy and/or collectively negotiated agreements, and the committee’s recommendations which may be further developed in consultation with the College’s General Counsel.

The RIO is responsible for ensuring compliance with all notification requirements of funding or sponsoring agencies.

Further, for the purposes of research activities that are not sponsored by HHS, these investigation protocols may be adjusted as required by the sponsoring agency.

C. Appeals

The accused individual(s) have the right to appeal the report and may do so in writing to the Provost within the 10-day period. The appeal must include evidence that disproves the findings of the report.

If an appeal with evidence is filed, the Provost must supply it to the investigation committee for review.

If no appeal is filed; an appeal is filed without evidence; or an appeal with evidence is filed and the evidence is found to be unsubstantiated, the Provost will inform all granting agencies, journal editors, publishers, or other agencies in receipt of any scholarship of the findings.

Further, for the purposes of research activities that are not sponsored by HHS, these appeal procedures may be adjusted but only as required by the sponsoring agency.

D. Final Decision

The Provost will notify the College President or their designee in a report that contains the committee’s report, a copy of the notification to granting agencies, etc., and any recommended sanctions to be imposed by the College.
Upon receipt and review of the Provost’s report, if:

• no appeal is filed,
• an appeal is filed without evidence, or
• an appeal with evidence is filed and the evidence is found to be unsubstantiated,

the President or their designee will issue the sanctions in writing to the accusedindividual(s), and notify the appropriate offices or entities on which the sanctions may have an impact (e.g., Academic Dean for course scheduling; People Operations and Employee Resources Department; etc.).

The investigation concludes with the issuance of sanctions by the President or their designee; there are no further appeals.

Further, for the purposes of research activities that are not sponsored by HHS, this final decision making process may be adjusted but only as required by the sponsoring agency.

III. Reporting of Findings and Actions to ORI

Unless an extension has been granted, the RIO must, within the 120-day period for completing the investigation, submit the following to ORI:

• a copy of the final investigation report with all attachments, along with any documentation related to an appeal;
• a statement of whether the College accepts the findings of the investigation report and appeal, if appropriate;
• a statement of whether the College found misconduct and, if so, who committed the misconduct; and
• a description of any pending or completed administrative actions against the respondent.

Further, for the purposes of research activities that are not sponsored by HHS, this reporting may be adjusted but only as required by the sponsoring agency.

IV. Records Retention

The RIO must maintain and provide to ORI, upon request, “records of research misconduct proceedings” as that term is defined by 42 CFR § 93.318. Unless custody has been transferred to HHS or ORI has advised in writing that the records no longer need to be retained, records of research misconduct proceedings must be maintained in a secure manner for seven years after completion of the proceeding involving the research misconduct allegation. The RIO is also responsible for providing any information, documentation, research records, evidence or clarification requested by ORI to carry out its review of an allegation of research misconduct or of the institution’s handling of such an allegation. The entirety of the investigation will be kept within the individual’s confidential personnel file.

Further, for the purposes of research activities that are not sponsored by HHS, these retention practices may be adjusted but only as required by the sponsoring agency.

• Allegation means a statement or indication of possible research misconductmade to a College official.
• Authorship means the definition of authorship that varies across academicdisciplines. In general, authorship means the mechanism for allocation of credit tothe individuals for their contribution to the intellectual value of any research orrelated material that is being presented to an audience. Authorship has important academic, social, intellectual property, and financial implications. Authorship also implies responsibility and accountability for the material that is being presented. Disputes of authorship are not considered research misconduct, however, plagiarism (defined below) is considered research misconduct.
• College means Ramapo College of New Jersey.
• Complainant means the individual(s) who submits an allegation of research misconduct.
• Conflict of Interest means the real or apparent interference of an individual’s interest with the interests of another person, where potential bias may occur due to prior or existing personal or professional relationships.
• Employee means, for the purpose of this policy and procedure only, any individual under the employ of the College, including faculty (full-time, part-time/adjunct, lecturers, professional staff who teach), administrators, and staff, as well as individuals contracted by the College to engage in research that is supported by federal, private, or College funds.
• Fabrication means the invention/making up of data or results and recording or reporting them.
• Falsification means the manipulation of research materials, equipment, or processes; the change or omission of data or results such that the research is not accurately represented in the research record.
• HHS means the U.S. Department of Health and Human Services, the parent agency of the Public Health Service and the National Institutes of Health.
• Inquiry means the gathering of information and initial fact-finding to determine whether an allegation or apparent reported or observed instance of research misconduct warrants an investigation.
• Institutional members means employees (staff, faculty, and administrators) of the College.
• Investigation means the formal examination and evaluation of all relevant facts to determine if research misconduct has occurred and, if so, to determine the responsible individual and the seriousness of the misconduct.
• ORI means the Office of Research Integrity that oversees research misconduct inquiries and investigations on behalf of the Secretary of Health and Human Services. For the purposes of research activities that are not sponsored by HHS, ORI shall refer to the relevant parent agency’s entity with whom responsibility over research misconduct and investigations is vested.
• Plagiarism means the appropriation of another person’s ideas, processes, results, or words without acknowledgement of the original author, or assigning appropriate credit.
• PHS means the U.S. Public Health Service, an operating component of the Department of Health & Human Services.
• PHS regulation means the Public Health Service regulation establishing standards for institutional inquiries – and investigations into allegations of scientific misconduct, which is set forth at 42 C.F.R. Part 50, Subpart A, entitled “Responsibility of PHS Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science.”
• PHS support means PHS grants, contracts, or cooperative agreements or applications therefor.
• Research for the purposes of this policy and procedure only, is defined as, according to federal regulations, a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. The terms scholarship and creative work may also be considered research.
• RIO means the Research Integrity Officer, whose role is designated in this policy, namely, the Vice Provost for Academic and Faculty Affairs, who will act as the College’s RIO.
• Research Misconduct means fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, performing, or reviewing research or in reporting research results. Research Misconduct does not include honest error or differences of opinion (§93.103, 42 CFR Part 93- June 2005). It also does not include authorship disputes. The College reserves the right to require adherence to other definitions of research misconduct as required by contractual obligations with external sponsors of research. To be considered research misconduct, the action must represent a “significant departure from acceptable practices;” have been “committed intentionally or knowingly or recklessly;” and be “proven by preponderance of evidence.” These are the minimum standards for establishing irresponsible behavior.
• Research record means any data, document, computer file, or other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of research misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; surveys and collected survey responses; consent forms; medical charts; and patient research files.
• Respondent means the person against whom an allegation of Research Misconduct is directed or who is the subject of a Research Misconduct proceeding.
• 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 because the individual has, in good faith, made an allegation of research misconduct or of inadequate institutional response thereto or has cooperated in good faith with an investigation of such allegation.
• Sponsored Research is research activity that is supported by internal or external funding.

Policy Statement
Ramapo College is committed to protecting the privacy and confidentiality of personal information, including sensitive Personally Identifiable Information (PII), in compliance with applicable laws and regulations such as the Family Educational Rights and Privacy Act (FERPA), New Jersey statute 56:8-161 and Identity Theft Prevention Act, and the Federal Bureau of Investigation (FBI) classifications of PII.

Reason for Policy
Sets forth policy to ensure proper stewardship and safeguarding of personally identifiable information in accordance with the law.

To Whom does the Policy Apply
All Ramapo employees

Supplemental Resources

• Procedure 410: Data Protection (PII)
• FERPA Policy (Ramapo College)
• Policy 642: Records Retention
• USDOE FERPA Regulations
• New Jersey Identity Theft Prevention Act
• Policy 604: Responsible Use of Electronic Communication
• Statement on Use of Artificial Intelligence in the Workplace
• Cybersecurity Policy and Protocol Manual (PENDING)
• Acceptable Use of College Systems & Data Policy (PENDING)

PROCEDURE 410: DATA PROTECTION (PII)

I. Personal Information Definitions
a. High-Risk Personal Information
The following types of information are considered high-risk and must be protected with the highest level of security measures:

• Social Security number (SSN)
• Driver’s license number or State/Federal identification card number
• Account number, credit or debit card number, in combination with any required security code, access code, or password that would permit access to an individual’s financial account
• User name, email address, or any other account holder identifying information, in combination with any password or security question and answer that would permit access to an online account
• Biometric data (e.g., fingerprints, iris scans)
• Medical and health information, as outlined by HIPAA
• Passport numbers
• Criminal history records

Access to high-risk data is strictly limited to authorized positions on a need-to-know basis.

The college logs and annually reviews systems with access to high-risk data, implements encryption on servers that store sensitive information, and reviews user access controls within those systems and servers to protect this data from unauthorized access, disclosure, or misuse.

b. Moderate-Risk Personal Information
The following types of information are considered moderate-risk and are protected with security controls:

• Date of birth
• Place of birth
• Mother’s maiden name
• Home address
• Email address (when not combined with access information)
• Telephone number
• Employment information
• Educational information
• R Number (employee/student ID)*

Access to moderate-risk data is limited to authorized positions. Additionally, certain combinations of moderate-risk PII may elevate the overall classification to high-risk. Classification determinations regarding these combinations are the responsibility of ITS leadership.

* An R Number is a unique identifier assigned to each student and employee within the institution, and while it is sensitive, it does not directly reveal personal information. On its own, it is considered moderate risk. The risk level of an R number can increase when combined with other sensitive information.

c. Low-Risk Personal Information
The following types of information are considered low-risk data, but should still be handled with care:

• Religious beliefs
• Political affiliations
• Sexual orientation

While these types of information may be less sensitive, measures are taken to protect them from unauthorized access or disclosure.

II. PII Evaluation, Classification, and Authorization
Evaluation. Ramapo College regularly evaluates PII to determine its confidentiality impact level. Factors considered include:

• Identifiability: How easily the PII can be used to identify specific individuals.
• Quantity of PII: Number of individuals affected in case of a breach.
• Data field sensitivity: Sensitivity of individual PII elements.
• Context of use: How PII is collected, stored, used, processed, and disclosed.
• Legal obligations: Compliance requirements for protecting PII.
• Authorized Access: Positions with access to high- and moderate-risk PII
• Location: Sources and locations from which PII is accessed and stored.

Classification. When multiple pieces of moderate-risk PII are combined in a way that could lead to identification or cause significant harm if breached, the overall classification may be elevated to high-risk. Classification determinations regarding these combinations are the responsibility of ITS leadership.

Authorization. Positions authorized to access high- and moderate-risk PII are determined by unit heads in collaboration with system functional administrators. ITS implements security measures to safeguard against unauthorized access or disclosure. By default, student positions are not permitted access to moderate or high-risk PII on any campus system. Any exceptions must be formally requested through ITS and approved by the Vice President with oversight of People Operations and Employee Resources.

III. Data Handling and Breach Notification
All college records are considered property of Ramapo College and must be handled in accordance with state law, institutional requirements, and Ramapo College Records Retention Policy. In the event of a security breach involving personally identifiable information, the College will follow the applicable notification procedures outlined in the New Jersey Identity Theft Prevention Act.

IV. Compliance
Units within the College that handle or process high- and moderate-risk PII are responsible for ensuring the security, privacy, and proper management of that PII. At minimum, employees should always password protect documents containing personally Identifiable Information (PII) before sending them via email.

Ramapo College complies with the Family Educational Rights and Privacy Act (FERPA), which protects the privacy of student education records. The College’s FERPA policy is overseen by the Office of the Registrar in accordance with regulations set forth by the U.S. Department of Education.

The Responsible Unit shall annually review this policy to ensure compliance with FERPA, New Jersey Identity Theft Prevention Act, and other applicable laws and regulations.

Any breach disclosure will be discussed in conjunction with both Legal Counsel and the College’s cyber insurer.

Violations of this policy may result in disciplinary action, up to and including termination of employment or expulsion from the College.

Exceptions to this policy may apply to students and employees in the European Union (EU) and in the European Economic Area (EEA) under the General Data Protection Regulation (GDPR).

POLICY

Ramapo College of New Jersey (hereafter “the College”) is committed to ensuring community engagement by students having the constitutionally protected right to exercise their freedom of speech and assembly. The Student Expressive Activity Policy dictates the time, place, and manner of expressive activity on College property (and property maintained, used, occupied, or controlled by the College), so that expressive activity may occur while maintaining typical College functions and protecting the freedom and safety of all members of the community.

When applying this policy, the College will remain content-neutral, meaning that expressive activity will not be limited based on the content or viewpoint of the expression, or the perceived or real reaction to the expression. All students and student clubs and organizations are subject to the provisions of the Student Code of Conduct found in the Student Handbook. The College, inclusive of those students involved in the expressive activity, will take all appropriate steps to ensure the activity is carried out in a safe and respectful manner. The safety of those involved in the expressive activity and those witnessing, participating, or learning of the activity are of primary importance and the activity may be subjected to limitation or elimination. Some examples of reasons for limitation or elimination may include but are not limited to, threats to harm other persons, causing harm to others, substantially interfering with the rights of others to learn, work, sleep, and study, destruction of property, or violations of the Code of Conduct, local, state, or Federal laws and regulations.

REASON FOR POLICY

The purpose of this policy is to emphasize that Ramapo College supports and affirms a
student’s right to freedom of speech and assembly and to provide proper guidelines and procedures surrounding the expression of these freedoms.

TO WHOM DOES THE POLICY APPLY

All Ramapo College students and student clubs and organizations.

RELATED RESOURCES

• Student Code of Conduct
• Interim Suspension of Clubs and Organizations Policy
• Interim Suspension Policy
• Events & Conferences Policies & Guidelines
• Posting Policy
• Social Media Policy
• Statement of Acceptable Conduct
• Chalking Policy

CONTACTS

• Office of the Dean for Students / Vice President for Student Well-Being
• Office of Events & Conferences
• Department of Public Safety
• Center for Student Involvement
• Office of Student Conduct

I.       Definitions

• Expressive Activity: Expressive Activity refers to forms of student expression that occur on College property and fall within the ambit of the First Amendment to the United States Constitution, which may include, but not be limited to:
  • Protests, demonstrations, rallies, vigils, sit-ins, marches, picketing, and other events by students and student clubs and organizations;
  • Distribution of literature, such as leafleting and pamphleting; and
  • Any other form of expression that is considered a constitutionally protected right.
•  Student Clubs and Organizations: Student clubs and organizations officially recognized by the College.
  • For the purposes of this policy, athletics teams and other College-recognized student groups (such as intramurals and club sports) are included when mentioning “student clubs and organizations”.
• College Property: Any facility or property owned, occupied, operated, leased, controlled, or maintained by the College, including all of the buildings and grounds on the College campus, or any building or property otherwise within the direction, use, and control of the College.
• Time, Place, and Manner: The College has the ability to ensure the effectiveness of expressive activity while maintaining its mission by providing guidelines and directives as to where, when, and how students and student clubs and organizations may conduct expressive activities

II. Process for Conducting an Expressive Activity

While the College recognizes the potential for spontaneous expressive activity and recognizes the rights of students and student clubs and organizations to conduct these activities, the College requests that students and student clubs and organizations register the expressive activity with the Office of Events & Conferences by calling 201-684-7082 or emailing events@ramapo.edu. The Office of Events and Conferences will work with students to ensure that they will have their own reserved space for expressive activities. Also, the Office of Events & Conferences will help to maintain proper guidelines related to the time, place, and manner of the activity. 

Further, the College requests student(s), clubs, or organizations interested in conducting expressive activities consult with the Dean for Students/Vice President for Student Well-Being by calling 201-684-7457. The mission of the Office of the Dean for Students and the Student Well-Being Core centers on the values of well-being; diversity, equity & inclusion; community responsibility; and student engagement. In accordance with this mission, the Dean for Students is committed to supporting students, clubs, and organizations in conducting expressive activities by listening to their concerns so that guidance and directives can be provided before, during, and after the expressive activity takes place.

In cases of both spontaneous and pre-scheduled expressive activities, this policy and procedure will be provided to the organizing parties.

a. Guidelines for Time, Place, and Manner

The Office of Events & Conferences, in consultation with the Office of the Dean of Students or designee, has the authority to guide and direct the students and student clubs and organizations on the appropriate time, place, and manner of the activity so long as the activity considers Guidelines for Conducting Expressive Activity. Any restrictions that may apply would be content-neutral, based on time, place, and manner, and are necessary to preserve the College’s mission.

b. Guidelines for Conducting an Expressive Activity

Students and student clubs and organizations may participate in spontaneous or pre-planned expressive activities on College property as defined by this policy (see Definitions). The following guidelines should be considered:

• • Consider the academic pursuits and official College work of students, faculty, staff, administrators, and visitors;
  • A student club/organization, College group, or external group’s confirmed reservation of College space should not be interrupted;
  • Maintain the physical integrity of the ground around the areas of activity by picking up materials or other litter;
  • Amplification devices in outdoor and indoor locations should not interfere with academic instruction or official college business and operations;
  • Advertising the expressive activity:
    • Use social media to advertise the expressive activity in accordance with the College’s  Social Media Policy.
    • Use physical advertising, including posters and flyers, hung on College property to advertise the expressive activity in accordance with the College’s  Posting Policy.
      • Clubs & organizations should visit  Roadrunner Design’s webpage for information on how to properly print and post physical advertisements.
      • Individual students, not affiliated with a club or organization, may receive permission to advertise for the expressive activity by emailing roadrunnerdesign@ramapo.edu.

Students and student organizations do not represent the viewpoints or expression of the College. Ramapo College of New Jersey does not assume any obligation or responsibility for the content of any distributed materials.

c. Occupying Of Spaces

One form of expressive activity includes occupying spaces in which students choose to remain at a certain location to express themselves. If students and student clubs and organizations choose to occupy a space in this manner, they will be held to the standards of the Student Code of Conduct.

Expressive activity may occur on outdoor College property, as long as the students and student clubs and organizations consider their participants’ and others’ health and safety, adhere to College Policies, inclusive of the Student Expressive Activity Policy, and comply with the Student Code of Conduct.

Due to concerns regarding noise, safety, and preservation of the College mission, any students and student clubs and organizations who wish to occupy indoor College property must first consult with the Dean of Students. Further, such activities must be coordinated and registered with the Office of Events and Conferences.

III.     Enforcement & Violations

The Department of Public Safety, in consultation with the Office of the Dean of Students or designee, has the authority to:

1) determine whether expressive activity violates this policy and

2) inform the organizers of policy violations. 

The Office of the Dean of Students will work with the organizers to provide guidance and direct alternative strategies to the violative activities. If needed, the Department of Public Safety may terminate the activity while maintaining the safety of everyone involved. The following are examples of violations of this policy:

• • Intentionally or recklessly causing physical harm.
  • Intentionally or recklessly causing reasonable apprehension of physical harm.
  • Intentionally or recklessly causing threats to do physical harm.
  • Intentionally or recklessly endangering the welfare of others.
  • Intentionally or recklessly destroying or damaging or threatening to destroy or damage the College property or the property of others.
  • Intentionally, recklessly, or substantially interrupting normal College or College-sponsored activities.
  • Intentionally or recklessly committing acts of discrimination, harassment, bias, or intimidation.
  • Intentionally or recklessly blocking public access to essential services and buildings (i.e. those related to food, healthcare, and emergency services).

a. Student Code of Conduct

Individual students will be held to the standards of the  Student Code of Conduct and the

Interim Suspension Policy, and are subject to the policies and procedures therein. Students are entitled to a fair adjudication process with the Office of Student Conduct.

Student clubs and organizations are subject to the Interim Suspension of Clubs and Organizations Policy.

 b. Compliance With Laws

 Ramapo College of New Jersey is a public, state college. Federal, state, and local laws and regulations are applicable on College property and will be enforced by the Department of Public Safety or external law enforcement agencies.

Policy

Ramapo College of New Jersey is committed to maintaining a respectful and professional academic and working environment. All College employees, students, visitors, and any other third parties are prohibited from engaging in sex-based discrimination and are responsible for fostering an environment free from sexual misconduct. Sexual misconduct refers to the following prohibited offenses:

1. Sexual Harassment
2. Sexual Assault
3. Sexual Exploitation
4. Stalking
5. Dating Violence
6. Domestic Violence

In addition, it is a prohibited offense to retaliate against anyone who files a complaint under this Policy or participates in a related investigation.

Reason for Policy
The College must continue to foster a climate of respect and security on campus as it relates to preventing and responding to acts of sexual misconduct. This policy serves to demonstrate the College’s commitment to:

• Disseminating clear policies and procedures for responding to sexual misconduct reported to the College;
• Engaging in investigative inquiry and resolution of reports that are prompt, fair, equitable, and independent of other investigations that may occur;
• Supporting the parties and holding persons accountable for established violations of this Policy; and
• Providing a written explanation of the rights and options available to persons impacted by sexual misconduct.

To Whom Does the Policy Apply
All employees, students, visitors, vendors, and others

Supplemental Resources

• Procedure 211: Ramapo College Sexual Misconduct Procedure Manual
• Compliance Framework: On May 19, 2020, the U.S. Department of Education (DOE) issued a Final Rule under Title IX of the Education Amendments of 1972. This policy was revised in August 2020 to comply with the Final Rule. Minor revisions to the policy were made in September 2021. Furthermore, the policy complies with the New Jersey Campus Sexual Assault Victim’s Bill of Rights (See Appendix E).

Contact

• Office of Title IX

The procedures governing Policy 211 are described in the Ramapo College Sexual Misconduct Procedure Manual.

The Sexual Misconduct Procedure Manual shall include the following subjects:

• Preface/Emergency Information
• Introduction
• Notice of Coordination with Non-Discrimination Policy & Notice of Non-Discrimination
• Title IX Officers
• Definitions
• Confidentiality
• Reporting
• Supportive Measures
• Interim Measures
• Infromal Resolution
• Title IX Grievance Process
• Sexual Misconduct Grievance Process
• Sanctions
• College Alcohol & Drug Amnesty
• Recordkeeping
• Non-Retaliation
• Revocation by Oder of Law
• Assorted Appendices and Resources

The Sexual Misconduct Procedure Manual shall be reviewed annually by the Responsible Unit.

Policy Statement
Ramapo College of New Jersey is committed to conducting research that is without bias and that conforms to the highest scientific and ethical standards.

Reason for Policy
This policy establishes standards that ensure that design, conduct, and reporting of research performed at the College will be free from bias resulting from financial conflicts of interest.

These guidelines are specific to federal research funded by agencies of the United States federal government. This policy promotes and enforces compliance with requirements of 42 CFR 50, Subpart F, Promoting Objectivity in Research (FCOI Regulation), as implemented in the 2011 Final Rule for grants and cooperative agreements.

To Whom Does the Policy Apply
This policy applies to all faculty, staff, students, and any other members of the College who are responsible for the design, conduct, stewardship, and reporting of research.

Supplemental Resources

• 42 CFR 50, Subpart F, Promoting Objectivity in Research (FCOI Regulation)
• Final Rule 42 CFR Part 50, CFR Part 94
• Supplement A: Significant Financial Interests Disclosure
• Policy 220: Grants & Sponsored Programs Compliance

Contacts
Office of Grants and Sponsored Programs
(201) 684-7374

Procedure 649: Financial Conflict of Interest – Sponsored Research
Date Adopted: June 7, 2022
Date Revised:

A. Definition of Terms
For purposes of this policy, the following terms shall have the following meanings:

• “College” shall mean Ramapo College of New Jersey.
• “Animal Use Committee” shall mean the body that oversees and ensures the appropriate review of the use of vertebrate animals in teaching, testing, and research.
• “College General Counsel” shall mean the College’s General Counsel who serves as the chief legal officer as well as the Ethics Liaison Officer.
• “FCOI” or “Financial conflict of interest” shall mean any instance when an investigator’s significant financial interest could directly and significantly affect the design, conduct, or reporting of the research.
• “FCOI Committee” shall mean a committee convened by the Grants Director to evaluate financial conflict of interest. The members of the committee will include the Grants Director, the Investigator’s Dean, the Provost, a representative from the Institutional Review Board (if applicable), and a representative from the Animal Care and Use Committee (if applicable). The College General Counsel shall serve in an advisory capacity to the FCOI Committee.
• “Institutional Responsibilities” shall mean an Investigator’s professional responsibilities on behalf of the College, which may include for example, activities such as research, research consultation, teaching, professional practice, and institutional committee and panel memberships.
• “Institutional Review Board” (IRB) shall mean the College’s Institutional Review Board that assures the upholding of the highest ethical standards in research involving human subjects.
• “Investigator” shall mean the Project Director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research including collaborators, consultants and sub awardees. For purposes of the regulatory requirements relating to financial interests, the term “Investigator” includes the Investigator’s family including spouse, dependent children and other individuals and relationships that may create, or may be perceived to create a conflict of interest.
• “Management plan (FCOI)” shall mean a written plan instituted by the College to manage, reduce, or eliminate to the fullest extent possible any financial conflict of interest.
• “NIH” shall mean the National Institutes of Health.
• “NSF” shall mean the National Science Foundation.
• “OGSP” shall mean the College’s Office of Grants and Sponsored Programs.
• “PHS” shall mean Public Health Service.
• “HHS” shall mean the United States Department of Health and Human Services, which oversees 11 operating divisions that offer competitive grants, including: the National Institutes of Health; the Health Resources and Services Administration; the Substance Abuse and Mental Health Services Administration, and eight (8) others.
• “SFI” or “significant financial interest” shall mean anything of monetary value that reasonably appears to be related to an Investigator’s institutional responsibilities. Additional guidance can be found in the NIH FCOI regulation and FAQs.

SFI may include:

• • Salary or other payments for services (e.g., consulting fees, honoraria)
  • Equity interests (e.g. stock, stock options, ownership interests)
  • Intellectual property rights (e.g., patents, copyrights and royalties from such rights)
  • Certain travel related to the sponsored research

SFI does not include:

• • Salary, royalties, or other remuneration from the applicant institution
  • Income from investment vehicles in which the Investigator does not directly control the investment decisions made in these vehicles
  • Income from seminars, lectures, or teaching engagements
  • Income from service on advisory committees or review panels
• “Sponsored research” shall mean activities funded by an external agency such as one of the divisions of the HHS, or the National Science Foundation.

B. Training
OGSP has established the following process to train investigators on financial conflict of interest.

The OGSP will hold a financial conflict of interest information session with each Investigator before grant approvals are sought from the Dean and Provost. The OGSP will hold the session within two weeks of a grant proposal being submitted for Dean’s approval. Any Investigator recently hired to work on sponsored research will also be required to attend the FCOI information session. For Investigators whose research is funded, the information session will be held every four years.

Investigators will undergo training again when a change has been made to FCOI policy or procedures, or when the Investigator has been found to be noncompliant with an FCOI management plan or College FCOI policy.

The information session will train Investigators on the federal FCOI regulation, inform the Investigator of Ramapo College’s FCOI policy, the Investigator’s responsibility to disclose significant financial interests, and actions that may be taken when noncompliance is found.

The OGSP will indicate that an Investigator has completed the financial conflict of interest information session by checking the box on the grant approval form, which is completed before a proposal is submitted. The checked box indicates that the Investigator(s) and any applicable subawardees and contractors have completed a significant financial interest disclosure form.

C. Disclosure, Review, and Monitoring
During the grant period, existing Investigators or Investigators who are new participants to the research project must complete the significant financial interest disclosure form annually. The SFI disclosure form must also be completed within 30 days of any change in an SFI (e.g., through purchase, marriage, or inheritance), or within 30 days of discovery of an incidence of SFI.

The form will be reviewed by the Investigator’s Dean, the Institutional Review Board (as appropriate), the Institutional Animal Care and Use Committee (as appropriate), and the Director of the Office of Grants and Sponsored Programs (“OGSP Director”), in consultation with the College General Counsel.

If no significant financial interest is disclosed, no further action is required.

If a significant financial interest that is related to PHS-funded research is found to violate this policy, or that biases the design, conduct, or reporting of the sponsored research, the OGSP Director will take the following actions:

• Immediately inform the Investigator’s Dean, the Provost, and the College General Counsel, and begin gathering further information and supporting documentation from the Investigator and others as applicable. All such documentation and subsequent discussions will be confidential to the extent permitted by applicable law.
• The OGSP Director, Dean, and Provost, in consultation with the College General Counsel, will review the documentation and within 60 days determine if corrective action is necessary.
• The OGSP will notify the funding agency within 60 days if corrective action is necessary.
• Corrective action may include a FCOI management plan that specifies the actions to be taken to manage a financial conflict of interest. Compliance with any corrective actions/management plan will be under the direction of the Investigator’s Dean and the Provost.
• The Director of Grants will promptly notify the funding agency and submit a mitigation report that includes the impact of the bias on the research project and the plan to eliminate or mitigate the bias.

In the event the College identifies an SFI that was not disclosed or managed in a timely manner, the Director of Grants will complete a retrospective review (see section F.iii.).

D. Reporting to NIH
The OGSP Director will submit significant financial interest disclosure forms to the NIH:

• Prior to the expenditure of funds.
• Annually during the grant period.
• Within 60 days of the addition of a new Investigator.
• In the case of the discovery of a new financial conflict of interest, within 60 days of the creation of a FCOI management plan; when corrective action is implemented; and annually until the matter is resolved, or the grant period ends.
• Following a retrospective review to update a previously submitted report.

The College will notify the funding agency and take corrective action if an Investigator fails to comply with this policy or a FCOI management plan appears to have biased the design, conduct, or reporting of the research.

E. Maintenance of Records
All records of FCOI disclosure and the College’s review, response, and action related to the disclosure will be maintained in the OGSP. These records will be maintained for three (3) years from the date of submission of the final expenditures report, or where applicable, from other dates specified in 45 C.F.R. 75.361 (see FAQ A.11) for different situations.

F. Enforcement Mechanisms, Remedies, and Noncompliance

i. Corrective Actions
If a financial conflict of interest is found, actions will be taken to manage, reduce, or eliminate the conflict. These corrective actions will be determined by the FCOI Committee. Corrective actions may include:

• Public disclosure of the significant financial interest (e.g. when presenting or publishing research, to staff working on the project, to the College’s IRB or Animal Use Committee. etc.)
• Removal of an investigator from the portion of the research affected by the SFI
• Disclosure of the significant financial interest to research participants
• Appointment of an independent monitor capable of protecting the research from bias resulting from the FCOI
• Modification of the research plan
• Change of personnel or personnel responsibilities
• Reduction or elimination of the financial interest
• Severance of relationships that create financial conflicts
• Other actions as appropriate

If HHS determines that a clinical research project evaluating the safety or effectiveness of a drug, medical device, or treatment is managed by an Investigator in violation of this policy or related regulations, the Investigator will be required to 1) disclose the financial conflict of interest in each public presentation of the results of the research, and 2) request an addendum to previously published presentations.

The OGSP Director will notify the Investigator of the committee’s decision and of any corrective action, including a FCOI Management Plan.

ii. Appeal Process
If the Investigator does not agree with the committee’s corrective actions, the Investigator can appeal in writing to the OGSP Director within ten (10) days after receipt of notification. The appeal must describe why such conditions and restrictions are inappropriate. The OGSP Director will consult with the President to determine whether a modification is necessary, and their decision will be final.

iii. Retrospective Reviews
If FCOI is not identified or managed in a timely manner, the Director of Grants will convene the FCOI Committee and complete a retrospective review. Retrospective reviews will be completed within 120 days of the determination of non-compliance. The documentation for the retrospective review shall include:

• The funding agency project number and project title,
• Project PD/PI contact information,
• Name of the Investigator with the FCOI,
• Name of the entity with which the Investigator has an FCOI,
• Reason(s) for the retrospective review,
• Methodology used for the retrospective review,
• Findings of the review, and
• Conclusions of the review.

If bias is found, the Director of Grants will notify the funding agency and promptly submit a mitigation report. This report will include information from the retrospective review and FCOI management plan. The report will be submitted annually.

iv. FCOI Management Plan
The FCOI Committee may conduct factual inquiries, consultations, and recommendations as appropriate in order to formulate a financial conflict of interest management plan. The terms of the plan shall be consistent with all applicable legal and regulatory requirements, and the requirements of this policy.

The Management Plan will include at a minimum:

• The role and principal duties of the conflicted Investigator in the research project;
• Conditions of the Management Plan, which may include one or more of the actions described under section F.i. Corrective Actions above;
• How the Management Plan is designed to safeguard objectivity in the research project;
• Confirmation of the Investigator’s agreement to the Management Plan, and
• How the Management Plan will be monitored to insure Investigator compliance.

G. Subrecipients
Before a research proposal is submitted, or a subaward agreement is issued, the College shall secure written assurance that the proposed subrecipient agrees to comply with all applicable PHS, NIH, and/or NSF policies on financial conflict of interest. If the proposed subrecipient has a publicly posted FCOI policy in compliance with PHS, NIH, and/or NSF policy, the subrecipient will provide a certification to the College that such FCOI policy complies with all applicable regulations. To the extent that the subrecipient does not have a compliant FCOI policy, the subrecipient will be required to comply with the College’s FCOI policy.

Subrecipients will be required to report FCOI to the College’s Director of Grants, prior to the expenditure of any funds, and within 45 days of discovering any FCOI. FCOI reported by a subrecipient Investigator will be reported to the PHS and/or NSF by the College on the subrecipient’s behalf.

H. Public Accessibility
Information concerning any FCOI related to an externally-funded research project that has been disclosed to the OGSP will be made publicly accessible. The OGSP web site will list the contact information where the public may request this information, and will respond to any request within five (5) business days. The response will include:

• The Investigator’s name, title, and role in the research project,
• The name of the entity giving rise to the SFI and FCOI,
• The nature of the FCOI, and
• The approximate dollar value of the FCOI.