Financial Conflict of Interest (FCOI) Policy

Updated May 2017 – (Applies to investigators submitting NIH/NSF research applications on or after August 24, 2012 as well as to PIs on active NIH and NSF awards)

Introduction. In accordance with Public Health Service (PHS) regulation 42 CFR Part 50 Subpart F (grants and cooperative agreements) and 45 CFR Part 94 (contracts), and consistent the with the provisions of the National Science Foundation (NSF) Proposal & Award Policies & Procedures Guide, Part II, Award & Administration Guide (AAG) Chapter IV.A, Kalamazoo College has developed the following policy on financial conflict of interest (FCOI) for investigators applying for or holding grants from the National Institutes of Health (NIH) or the National Science Foundation (NSF). The PHS and NSF requirements were “designed to promote objectivity in PHS- [and NSF-] funded research by establishing standards to ensure that the design, conduct, and reporting of research […] is not biased by any conflicting financial interests of an Investigator […]. The regulation places the responsibility for the identification and management of investigators’ FCOI with the institution, which oversees the Investigator’s activities.”

Scope. The following statement of policy applies to Kalamazoo College investigators applying to or holding grants from the NIH or the NSF.

The term investigator means the principal investigator, co-principal investigators/co-project directors, and any other person at the institution who is responsible for the design, conduct, or reporting of research activities funded or proposed for funding by the NIH or the NSF.

Fiduciary responsibility. Members of the Kalamazoo College community serve the public trust and thus have a clear obligation to conduct the business of the College in a manner consistent with those responsibilities. All decisions of the board, officers of the College, faculty, and staff are to be made solely on the basis of a desire to promote the best interests of the College and the public good.

In the spirit of the public trust, faculty or staff proposing to receive funds from the NIH or the NSF for research activities must disclose – before submitting a proposal – any substantive financial conflict of interest that may reasonably affect how the project is carried out. A possible conflict of interest does not preclude acceptance of NIH or NSF funding, but appropriate safeguards may need to be implemented in certain situations.

Institutional official. Kalamazoo College designates the Director of Faculty Grants as the institutional official who reviews financial disclosure statements from each investigator who is proposing or carrying out NIH- or NSF-funded research.

Process to inform investigators. The Director of Faculty Grants will direct the investigator to the FCOI policy, including the training requirement.

Training. Investigators must receive FCOI training before submitting an NIH/NSF application and repeat the training at least once every four years. Training must take place right away if a) an investigator
is new to Kalamazoo College; b) Kalamazoo College revises its FCOI policy in a way that affects requirements of investigators; or c) the investigator is not in compliance with the policy. Investigators can find the NIH FCOI training module at the following link: https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html

Upon successful completion of the training module, the investigator must print a copy of the certificate of
completion, keep one copy, and send another copy to the Director of Faculty Grants (the Institutional
Official).

Disclosure of Significant Financial Interest (SFI). Before submitting a grant proposal to the NIH or the NSF, the investigator must complete the College’s Financial Disclosure Form and turn it in to the Director of Faculty Grants. On the form, the investigator must report all significant financial interests (including those of his or her spouse or domestic partner and dependent children)

1. that would reasonably appear to be affected by the research activities; or
2. in entities whose financial interests would reasonably appear to be affected by such activities.

The proposal may not be submitted until the Financial Disclosure Form has been completed and turned in.

Significant Financial Interest Definition: SFI is defined by the regulation as:

1. A financial interest consisting of one or more of the following interests of the investigator (and those of the investigator’s spouse or domestic partner and dependent children) that reasonably appears to be related to the investigator’s institutional responsibilities:
   1. With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. Remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
   2. With regard to any non-publicly traded entity, a significant financial interest exists if the
      value of any remuneration received from the entity in the twelve months preceding the
      disclosure, when aggregated, exceeds $5,000, or when the investigator any equity interest
      (e.g., stock, stock option, or other ownership interest); or
   3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
2. Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available) related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. Disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.

Exclusions – The term significant financial interest does not include:

1. Salary or other remuneration from Kalamazoo College
2. Income from investment vehicles such as mutual funds or retirement accounts, as long as the investigator does not directly control the investment decisions made in these vehicles
3. Income from seminars, lectures, or teaching engagements sponsored by government agencies, institutions of higher education, academic teaching hospitals, medical centers, or research institutions affiliated with institutions of higher education
4. Income from service on advisory committees or review panels for government agencies, institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with institutions of higher education
5. Unlicensed intellectual property that does not generate income.

In addition to disclosing any financial conflict of interest at the time of proposal submission, investigators are required to update their financial disclosures during the period of the award, either on an annual basis or as new significant financial interest are obtained.

If the investigator has no significant financial interests to disclose, he or she is required to certify the lack of such interests.

A possible FCOI may not preclude acceptance of the grant or contract in question; but appropriate disclosures or other safeguards may need to be implemented and accepted by both the investigator and the institution. Information received on possible financial interests in a proposed project will be kept strictly confidential, except where public disclosure is a safeguard the investigator and College have agreed upon or such disclosure is required by law or court order.

Guidelines for identifying conflicts of interest. The Director of Faculty Grants will review all financial disclosures, determine whether a conflict of interest exists, and decide what conditions or restrictions (if any) should be imposed to manage, reduce, or eliminate any conflict of interest. A conflict of interest exists when the reviewer reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of the proposed or funded research activities.

Examples of conditions or restrictions that might be imposed to manage, reduce or eliminate conflicts of interest include, but are not limited to:

1. public disclosure of significant financial interests;
2. monitoring of research by independent reviewers;
3. modification of the research plan;
4. disqualification from participation in the portion of the NSF-funded research that would be
5. affected by significant financial interests;
6. divestiture of significant financial interests; or
7. severance of relationships that create conflicts.

If the Director of Faculty Grants determines that imposing conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the Director of Faculty Grants may allow the research to go forward without imposing such conditions or restrictions.

Compliance. Investigators are expected to comply fully and promptly with the policy.

Reporting. If the Director of Faculty Grants determines that a conflict of interest exists or if the conflict of interest policy is violated, the College will follow federal regulations regarding notification of the sponsoring agency.

Record-keeping. The Director of Faculty Grants will maintain records of all financial disclosures and of all actions taken to resolve conflicts of interest for at least three years beyond the termination or completion of the grant to which they relate, or until the resolution of any PHS or NSF action involving those records, whichever is longer.

Sub-recipients. Kalamazoo College is responsible for ensuring that all sub-recipients comply with federal regulations regarding FCOI. The investigator will notify the Director of Faculty Grants if a subrecipient is affiliated with the project. It is the responsibility of the investigator working with the Director of Faculty Grants to ensure that the sub-recipient provides any necessary FCOI documentation prior to proposal submission. The College shall enter into a written agreement with each sub-recipient that shall specify whether this policy or the applicable policy of the sub-recipient institution will apply to subrecipient investigators. The agreement will specify timing for reporting FCOIs by sub-recipients to Kalamazoo College to enable timely review and reporting of such FCOIs in compliance with funding agency requirements. Kalamazoo College will report any identified FCOI on the part of a sub-recipient to the relevant federal agency within 60 days of disclosure.

NOTE: This policy was originally drafted in 2009 based on PHS regulation 42 CFR Part 50, Subpart F and the NSF Proposal & Award Policies & Procedures Guide, Part II, Award & Administration Guide (AAG) Chapter IV.A and updated according to the NIH 2011 Final Rule in 2012. Parts of this policy were also adapted from the Conflict of Interest Policies at Allegheny College, Hope College, and Smith College, and from Kalamazoo College’s Conflict of Interest Policy for the Board of Trustees and Officers of the College.

Financial Disclosure Form for faculty and staff applying for Kalamazoo College-administered research grants from the National Institutes of Health or the National Science Foundation.

Complete and submit the Conflict of Interest Disclosure Form prior to proposal submission.

This form must be turned in prior to proposal submission.

Please visit the Office of the Provost webpage for the most up-to-date version of the Faculty Handbook.

Policy on the Ownership of Intellectual Property created at Kalamazoo College

Revision of: July 10, 2003

Introduction
A. Kalamazoo College (hereinafter "the College") seeks to clarify with this policy the rights of the College and its faculty, staff, and students with respect to intellectual property.

Copyright

B. Traditional works of scholarship are works such as books, articles, manuscripts, data collections, drawings, sketches, designs, plays, writings, musical scores, films, photographs, transcriptions, mechanical productions and other works of art. (a) The copyright to traditional works of scholarship created by faculty or students shall be owned by the creator. (b) The copyright to traditional works of scholarship created by staff within the scope of their work shall be owned by the College.

C. (a) The copyright to curricular material or software created by faculty or students using normal College resources shall be owned by the creator. (b) The copyright to curricular material or software created by faculty or students using special College funding shall be jointly owned by the College and the creator. (c) The copyright to curricular material or software created by staff within the scope of their work shall be owned by the College.

D. For the purpose of determining copyright ownership, works, such as notes, notebooks, models, data collections, and manuals, created in the process of creating traditional works of scholarship, curricular material, or software shall be considered in the same way as their final product.

E. Works created for the purpose of College governance and operations, such as policies, memoranda, and reports, created by faculty, staff or students within the scope of their work shall be owned by the College.

F. The copyright to other works created by faculty, staff or students within the scope of their work shall be owned by the College.

G. The College disclaims ownership of copyright to any work created by faculty, staff or students outside the scope of their work.

Patents, Trade Secrets and Know-How

H. (a) Patents, trade secrets and know-how created by faculty and students using normal College resources shall be owned by the creator. (b) Patents, trade secrets and know-how created by faculty and students using special College funding shall be jointly owned by the College and the creator. (c) Patents, trade secrets and know-how created by staff within the scope of their work shall be owned by the College.

I. Any patentable invention resulting from work under the auspices of special College funding must be promptly disclosed in writing to the Provost.

J. The College disclaims ownership of patents, trade secrets and know-how created by faculty, staff or students outside the scope of their work.

Other agreements

K. Specific agreements made between the College and creators, or among the College, creators, and outside parties, take precedence over this policy. Creators are strongly encouraged to make specific agreements regarding intellectual property ownership when appropriate.

Procedures for handling disputes

L. Should disputes arise with respect to this policy, either the Provost, on behalf of the institution, or the creator may request the appointment of an ad-hoc committee to review the dispute and make a recommendation to the President for final decision. The membership of the committee will consist of one person selected by the Provost, one person selected by the creator, and one person mutually agreed upon by both parties. The committee will have access to the College's legal counsel if necessary.

Administration

M. This policy shall be administered by the Provost, who shall be the final
arbiter in any dispute regarding intellectual property, subject to
Paragraph L, above.

Terms

N. "Normal use" of college resources is taken to mean those resources provided to faculty, staff, and students to carry out their normally assigned duties, such as salary, start-up funds, office space, faculty development grants, and basic computer, clerical, and office services.

O. "Special College funding" means monetary or non-monetary resources extended to an individual or individuals for development of a project or program outside the usual scope of their work. Given the relative rarity of such funding, resources shall be considered special College funding only if explicitly declared as such by the College administration. Special College funding will entail supplemental resources provided in addition to those normal professional and technical support resources supplied by the College.

P. A "creator" is the person or group who authors, creates, or invents works of authorship, copyrights, patents, know-how or other intellectual property rights.

Q. "Staff," for the purposes of this policy, includes all non-faculty employees of the College, including full-time and part-time employees (including student employees), consultants, and independent contractors.

Please visit the Business Office Purchasing Policies page for the most up-to-date information.

Please see the Institutional Review Board Policy Manual website for more information.

Kalamazoo College Institutional Policies and Procedures Relating to Ethical Standards in the Conduct of Research

Approved by the Faculty Executive Committee November 2009

We are grateful to Bryn Mawr College for allowing us to use their policy as a starting point for our own.

An underlying principle of all research is the quest for truth. The credibility of research must be above reproach if the public trust is to be maintained. Any compromise of the ethical standards required for conducting research cannot be condoned. While breaches in such standards are rare, they must be dealt with promptly and fairly by all parties in order to preserve the integrity of the research community and of the College.

“Misconduct,” as used herein, is defined as:

Fraudulent or improper practice in conducting research or reporting the results of research, including intentional falsification or fabrication of data, plagiarism, or intentional misrepresentation of data collection and analysis, or other practices that seriously deviate from those that are commonly accepted within the scientific or scholarly community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgment of data.

Serious misappropriation of research funds, including but not limited to diversion of such funds to personal or non-college use. The term “serious misappropriation,” as used herein, is not contemplated to include minor deviations within budget categories, nor funds expended under reasonable circumstances within the scope and goals of the originally proposed research.

If research misconduct is suspected, the following procedures apply:

1. Allegations of misconduct should be reported immediately in writing to the Provost. All such allegations shall be signed. The confidentiality of those who, in good faith, report apparent misconduct will be protected to the extent possible.
2. Upon review, the Provost (or in lieu of the Provost a designated member of the faculty or the Associate Provost) shall conduct a preliminary inquiry (which shall include informal consultation with the accused) into the circumstances of the allegations and determine whether there are sufficient grounds to indicate that these have validity. The Provost (or his or her designee) shall attempt to complete this initial inquiry within 60 days, after which a written report shall be prepared which states what evidence was reviewed, summarizes relevant interviews, and includes the conclusions of the inquiry. The
   individual against whom the allegation was made shall be given a copy of the full report of inquiry.
3. If the Provost finds sufficient evidence to suggest that the allegations may be true, and after consulting with the Director of Faculty Grants, the Provost shall appoint, within 30 days, an investigative body of impartial experts to conduct the formal examination and evaluation of all facts to determine whether misconduct has taken place. The Public Health Service’s Office of Scientific Inquiry or other appropriate agency shall be notified that a formal investigation is being initiated.
4. At the time the investigative body is appointed, the Provost shall inform in writing the individual about whom allegations have been made that an investigation is to be conducted and shall present to him/her a statement of the allegations. This statement shall include information on the nature of the allegations and the focus of the investigation and shall inform the person being investigated of the opportunity to defend his/her conduct and provide comments and other relevant information to the investigative body. In addition, the Provost will provide the individual with a full report of findings from the
   informal investigation as well as a statement indicating that the investigation and adjudication of the alleged misconduct will be limited to the formal charges laid out in the statement of the allegations. The same individual shall be informed of his/her right to be represented in preparing and/or giving his/her response in this and all subsequent
   phases of the investigation.
5. The investigative body shall conduct a formal examination and evaluation of all relevant facts to determine whether the allegations of misconduct are valid. The investigative body may call witnesses, examine research data (both published and unpublished), and
   seek expert opinion both inside and outside the College to aid in the scientific or scholarly audit.
   1. The investigative body shall attempt to complete its investigation within 120 days. If an extension of the investigation period is needed, such an extension must be approved by the Public Health Service’s Office of Scientific Integrity or other appropriate agency, if required by that agency. All parties involved in the investigation shall strive to maintain confidentiality of information.
   2. Interim administrative actions, as appropriate to the allegations, may be taken prior to the completion of the investigation if such actions are necessary to protect the welfare of human or animal subjects of research or to prevent the inappropriate use of funds.
6. Having completed its investigation, the investigative body shall submit its findings of fact and recommendations in writing to the Provost.
   1. If the investigative body’s findings fail to confirm an instance of misconduct, all participants in the investigation, including the Director of Faculty Grants shall be so informed in writing by the Provost. Diligent efforts will be undertaken, as appropriate, to restore the reputation of the individual alleged to have engaged in misconduct.
   2. If the investigative body has reason to believe that unfounded charges have been brought with malicious or dishonest intent, the investigative body shall recommend consideration of the appropriate action by relevant faculty committees and by the administration.
   3. If the investigative body finds that the allegations are substantiated and that misconduct has occurred, the accused shall have the right of appeal. If the appeal does not alter the decision of the investigative body, the following actions shall be taken by the Provost:
      1. The agency sponsoring the research shall be informed of the findings of the investigation.
      2. Publishers and editors of journals shall be informed if manuscripts emanating from fraudulent research have been submitted or published.
7. The institution will maintain, for a minimum of three years, after Public Health Service or other appropriate agency acceptance of the final report, all documentation accruing from the investigative actions of the institution.

Kalamazoo College’s Responsible Conduct of Research Policy for Students

Effective June 1, 2010

With the Senior Individualized Project (SIP) as a requirement for graduation and many courses requiring research projects, undergraduate research is an integral part of a Kalamazoo College education. In addition to training students in research methods, Kalamazoo College is committed to educating students in the ethical conduct of research. To that end, all departments agree to educate their majors about how to conduct research ethically and responsibly as appropriate to their discipline. Some departments include ethics training in courses required for the major and/or require students to take an online tutorial in the responsible conduct of research before beginning their SIP or other research experience. Departments with a formal training protocol in place should send a description of the training to the Director of Faculty
Grants. Also, students applying for IRB approval for a research project must include in their application an assurance that they have been trained in the responsible conduct of research through an approved course or online training module.

Kalamazoo College also requires that any student engaging in research supported by funds from the National Science Foundation complete an approved training module or course in the responsible conduct of research before beginning the research project as mandated in section 7009 of the America Competes Act of 2007 (Federal Register: August 20, 2009, Volume 74, Number 160, pp. 42126-42128). Faculty mentors will ensure that NSF-supported students complete this training and send a certification of the completed training to the Director of Faculty Grants.

The National Science Foundation’s requirement states that “each institution that applies for financial assistance from the Foundation for science and engineering research or education describe in its grant proposal a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, and postdoctoral researchers participating in the proposed research project,” and lays out the following institutional responsibilities:

1. An institution must have a plan in place to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduates, graduate students, and postdoctoral researchers who will be supported by NSF to conduct research. As noted in GPG Chapter II.C.1.e, institutional certification to this effect is required for each proposal.
2. While training plans are not required to be included in proposals submitted to NSF, institutions are advised that they are subject to review, upon request.
3. An institution must designate one or more persons to oversee compliance with the RCR training requirement.
4. Institutions are responsible for verifying that undergraduate students, graduate students, and postdoctoral researchers supported by NSF to conduct research have received training in the responsible and ethical conduct of research.

Please see the Travel Policies section on the Business Office website for more information.