Policy for Lafayette College Faculty or Staff Members Undertaking Federally Funded Research.

Appendix V

(of the Faculty Handbook)

V.1 Purpose

In response to regulations (including NSF 05-131, Section 510 and 42 CFR Part 50) governing the National Science Foundation (NSF), the United States Department of Health and Human Services (HHS) and its components, including Public Health Services (PHS), the National Institutes of Health (NIH), and other federal organizations, the following statement defines policy and procedures established to manage, reduce, or eliminate conflicts of interest as they relate to federally funded research. [Rev. per 12-17, Board, May 24, 2013]

While the College imposes no restrictions upon faculty and staff members in terms of their research interests, the College is obligated to ensure that federally funded research conducted under its auspices is accomplished with candor, integrity, and free inquiry. The College encourages faculty and staff members to explore new ideas, to establish partnerships with federal agencies, industry, and other organizations, and, subject to Appendix E, to patent and license inventions that may develop from their research.

The College is, however, mindful that such ventures and relationships carry potential risks and conflicts. When conducting research, it is imperative that faculty and staff members maintain objectivity and the highest level of integrity. The opportunity for personal gain – or the appearance of such an opportunity – may jeopardize the research and bring into question the researcher’s objectivity and the validity of the research results. It is the expectation of the College that a faculty or staff member will disclose any financial or related interest that could present a conflict of interest as defined herein or be perceived as presenting such a conflict of interest. Disclosure is a key factor in protecting both the College and the faculty or staff member from potentially embarrassing or harmful allegations of misconduct.

V.2 Definitions

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied research and product development.

Federal agencies require that each investigator (defined as principal investigator, co-principal investigator, senior associate, or other individuals who have significant influence in the design, conduct, and/or reporting of the research) and his/her family (defined as spouse and dependent children) fully disclose financial interests, business affiliations, and/or other relationships that could be perceived as influencing or benefiting from the proposed research. A financial conflict of interest exists when an institutionally designated official (either Lafayette’s Director of Sponsored Programs or, as appropriate under this policy, the Provost, the President, or the Board of Trustees) reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of research or educational activities funded or proposed for funding. [Rev. per 12-17, Board, May 24, 2013]

V.2.1 Definitions Specific to the Department of Health and Human Services [Rev. per 12-17, Board, May 24, 2013]

For the U.S. Department of Health and Human Services which includes the National Institutes of Health (HHS/PHS/NIH), Financial Interest means anything of monetary value received or held by an investigator or an investigator’s family, whether or not the value is readily ascertainable, including, but not limited to, salary or other payments for services (e.g., consulting fees, honoraria, paid authorships for other than scholarly works); equity interest (e.g., stocks, stock options, or other ownership interests); and intellectual property rights (e.g., patents, trademarks, service marks, copyrights, and royalties from such rights). [Rev. per 12-17, Board, May 24, 2013]

For Investigators, Financial Interest also includes any reimbursed or sponsored travel undertaken by the Investigator and related to his/her institutional responsibilities. This includes travel that is paid on behalf of the Investigator as well as travel that is reimbursed, even if the exact monetary value is not readily available. It excludes travel reimbursed or sponsored by U.S. Federal, state or local governmental agencies, U.S. institutions of higher education, research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers. [Rev. per 12-17, Board, May 24, 2013]

Significant Financial Interest means a Financial Interest that reasonably appears to be related to the Investigator’s Institutional Responsibilities, and: [Rev. per 12-17, Board, May 24, 2013]

a) if with a publicly traded entity, the aggregate value of any salary or other payments for services received during the 12 month period preceding the disclosure, and the value of any equity interest during the 12 month period preceding or as of the date of disclosure, exceeds $5,000; or [Rev. per 12-17, Board, May 24, 2013]

b) if with a non-publicly traded entity, the aggregate value of any salary or other payments for services received during the 12 month period preceding the disclosure exceeds $5,000; or [Rev. per 12-17, Board, May 24, 2013]

c) if with a non-publicly-traded company, is an equity interest of any value during the 12 month period preceding or as of the date of disclosure; or [Rev. per 12-17, Board, May 24, 2013]

d) is income exceeding $5,000 related to intellectual property rights and interests not reimbursed through the Institution, or [Rev. per 12-17, Board, May 24, 2013]

e) is reimbursed or sponsored travel related to their institutional responsibilities. [Rev. per 12-17, Board, May 24, 2013]

Financial interest does not include: [Rev. per 12-17, Board, May 24, 2013]

V.2.1.1 Salary, royalties, or other remuneration from the applicant institution; [Rev. per 12-17, Board, May 24, 2013]

V.2.1.2 Income from the authorship of academic or scholarly works; [Rev. per 12-17, Board, May 24, 2013]

V.2.1.3 Income from seminars, lectures, or teaching engagements sponsored by U.S. Federal, state or local government agencies; U.S. institutions of higher education; research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers;[Rev. per 12-17, Board, May 24, 2013]

V.2.1.4 Income from service on advisory committees or review panels for U.S. Federal, state or local governmental agencies; U.S. institutions of higher education; research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers; [Rev. per 12-17, Board, May 24, 2013]

V.2.1.5 An equity interest or income from investment vehicles such as mutual funds and retirement accounts, so long as the investigator does not directly control the investment decisions made in these vehicles. [Rev. per 12-17, Board, May 24, 2013]

Investments in a pooled fund such as a diversified mutual fund are likely to be sufficiently remote that they would not reasonably be expected to create a conflict of interest for a federally funded investigator. Because it is likely that an investigator’s interest in a mutual fund is only a small portion of the fund’s total assets and because only a limited portion of the fund’s assets are placed in the securities of a single insurer, it is unlikely that an investigator’s activities on a federally funded award would affect his or her interest in the mutual fund. Under these circumstances, disclosure is not required. (More detailed regulations regarding the treatment of diversified mutual funds under the government’s conflict of interest rules are available from the federal Office of Government Ethics.) [Rev. per 12-17, Board, May 24, 2013]

V.2.2 Definitions for the National Science Foundation and Other Federal Agencies [Rev. per 12-17, Board, May 24, 2013]

For the National Science Foundation and other federal agencies, significant financial interest means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interest (e.g., stocks, stock options, or other ownership interests); and intellectual property rights (e.g., patents, copyrights, and royalties from such rights). [Rev. per 12-17, Board, May 24, 2013]

Significant financial interest does not include:

V.2.2.1 Salary, royalties, or other remuneration from the applicant institution;

V.2.2.2 Any ownership interests in the institution, if the institution is an applicant under the Small Business Innovation Research Program or Small Business Technology Transfer Program;

V.2.2.3 Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;

V.2.2.4 Income from service on advisory committees or review panels for public or nonprofit entities;

V.2.2.5 An equity interest that, when aggregated for the investigator and the investigator’s spouse and dependent children, meets both of the following tests: does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a 5% ownership interest in any single entity; or

V.2.2.6 Salary, royalties, or other payments that, when aggregated for the investigator and the investigator’s spouse and dependent children, are not expected to exceed $10,000 during a twelve-month period.

Investments in a pooled fund such as a diversified mutual fund are likely to be sufficiently remote that they would not reasonably be expected to create a conflict of interest for a federally funded investigator. Because it is likely that an investigator’s interest in a mutual fund is only a small portion of the fund’s total assets and because only a limited portion of the fund’s assets are placed in the securities of a single insurer, it is unlikely that an investigator’s activities on a federally funded award would affect his or her interest in the mutual fund. Under these circumstances, disclosure is not required. (More detailed regulations regarding the treatment of diversified mutual funds under the government’s conflict of interest rules are available from the federal Office of Government Ethics.)

V.3. Investigator’s Obligation to Disclose Conflicts

V.3.1 Disclosure Procedures: An investigator who proposes to undertake research funded by a federal agency that requires disclosure must submit to the Director of Sponsored Programs a signed Disclosure Form prior to the submission of the proposal. Proposals that require the signature of the Authorized Institutional/Organizational Representative (Director of Sponsored Programs) also require a signed Disclosure Form. Normally, students serving as Excel Scholars will not have to complete Disclosure Forms. If an investigator’s situation changes subsequent to signing the Disclosure Form, he/she is obligated to inform the Director of Sponsored Programs promptly and submit within 30 days a revised Disclosure Form. The Disclosure Forms will become a permanent part of the investigator’s grant file.[Rev. per 12-17, Board, May 24, 2013]

Subcontractors, subawardees, and/or collaborators involved in federally funded grants are subject to the same conflict of interest guidelines as Lafayette investigators. This requirement will be stipulated in subcontracts issued by the College.

HHS/PHS/NIH requires institutions, no fewer than 60 days prior to the expenditure of any funds under an award, to report to PHS the existence of any conflicting interest and assurance that the interest has been managed, reduced, or eliminated in accordance with PHS regulations. NSF requires that only conflicts that have not been managed, reduced, or eliminated prior to expenditure of funds under an award be reported to NSF. Responsibility for reporting conflicts of interest to the federal agencies rests with the Director of Sponsored Programs.

The Director of Sponsored Programs will obtain annually updated Disclosure Forms from investigators who are required to file these forms and monitor those grants that are subject to conditions and/or restrictions, in order to ensure adherence to the imposed conditions or restrictions.

Information disclosed to the Director of Sponsored Programs (and, if necessary, to other College officials) for the resolution of conflict of interest matters shall be held in confidence to the extent legally permissible.

V.3.2 Director of Sponsored Programs’ Decision: If an investigator discloses a potential conflict of interest, the matter must be reviewed by the College’s Director of Sponsored Programs, who will decide within 10 business days whether or not a conflict exists and, if so, under what conditions or restrictions the research can be undertaken so as to reduce or eliminate the conflict. Prior to issuing a decision, the Director of Sponsored Programs will meet with the investigator to discuss the potential conflict and means of managing it (if a conflict exists). Following that meeting, the Director of Sponsored Programs may, in deciding whether or not a conflict exists and how best to manage it, seek advice from HHS/PHS’s Office of Research Integrity, NSF’s Office of General Counsel, or other appropriate authority.

If the Director of Sponsored Programs decides that a conflict of interest exists, the reasons for the decision and the conditions or restrictions under which the research may be conducted will be outlined in writing (“the Decision”) and signed by the investigator and Director of Sponsored Programs. Examples of conditions or restrictions that may be imposed include public disclosure of significant financial interests, divestiture of the financial interests, monitoring of the research by independent reviewers, modification of the research plan, disqualification from participation in the portion of the funded research that would be affected by significant financial interests, and/or severance of the relationships that create the conflict.

V.3.3 Appeal of the Director’s Decision: Within ten business days of receipt of the Decision, an investigator may deliver a written appeal to the Academic Research Committee (ARC), with a copy to the Director of Sponsored Programs. The committee, with the advice of the College’s General Counsel, may recommend to the Provost that the Decision be affirmed, modified, or reversed. The Provost will then render a decision that will be communicated in writing to the investigator and the Director of Sponsored Programs, and the decision of the Provost shall be final.

V.4 Violations of the Conflict of Interest Policy

V.4.1 Director of Sponsored Programs’ Referral to Provost: If the Director of Sponsored Programs believes either (a) that the investigator may have violated imposed conditions or restrictions or (b) that the investigator may have failed to disclose a potential conflict of interest, the Director will notify the investigator of these concerns in writing and will give him/her ten business days to respond in writing. After considering the response, if any, the Director may either (a) deem the concerns to have been satisfactorily allayed or (b) allege to the Provost in writing that the investigator has knowingly violated the Conflict of Interest Policy. If, after prompt review, the Provost concludes that the allegations have merit, the Provost will report in writing to the investigator, who will have ten business days to respond.

V.4.2 Provost’s Referral to ARC: After considering the investigator’s response, if the Provost has determined that there is a reasonable basis to believe that the policy has been violated, the Provost will refer the allegations promptly to ARC in writing. If ARC, in consultation with the Provost, decides that the allegations are sufficiently serious that they may result in either dismissal or suspension of the investigator, the case shall immediately be dealt with according to the procedures outlined in Appendix T.

ARC, in consultation with General Counsel, will promptly review the allegations, hear the testimony of the investigator pursuant to the procedures outlined below, and make its recommendation to the Provost in writing, including the possible imposition of sanctions.

V.4.2.1 At a time deemed appropriate by ARC, ARC shall hold a Hearing in order to receive testimonial evidence and to give the investigator the opportunity to present testimony in his/her own behalf. The Chair shall notify the investigator and the Provost of the time, place, and date so scheduled by certified mail, return receipt requested.

V.4.2.2 The entire proceedings of the Hearing shall be recorded by a professional stenographer, and an accurate transcript shall be promptly produced from that stenographic record and made available to ARC. The Chair of ARC shall preside over the proceedings and act to ensure a fair presentation of all evidence and equitable treatment of all participants, and to maintain decorum. The Provost and the investigator may be accompanied only by counsel chosen by him/her from the Faculty or Administration of the College. Procedures shall not follow formal rules of evidence, but special care shall be taken in evaluating evidence to ensure fairness.

V.4.2.3 At the Hearing, the Provost or his/her designee presents the case for the College, and the investigator presents his/her case. The investigator shall be presumed not to have violated this policy; the burden shall rest upon the College to prove that he/she has done so. During the Hearing, the parties shall have the following rights: to present and examine witnesses; to introduce evidence that has been previously made available to ARC and, through ARC, to the Provost and the investigator; to conduct reasonable cross examination of any witness on any matter relevant to the issue of the Hearing; and to offer relevant evidence in rebuttal. Each party shall give ARC a list of the names of all witnesses and copies of all documentary and other evidence at least 72 hours before the Hearing begins, or, in the event that a party would like to offer rebuttal evidence, at least 24 hours prior to the use of that rebuttal evidence. ARC shall provide copies of any such witness lists or evidence to both parties as promptly as possible, and a list of all witnesses to be summoned by ARC shall be made available to both parties not less than 48 hours before the Hearing begins. Copies of all evidence received or gathered by ARC at any stage shall be made available promptly to both parties, and no new witness(es) may be summoned by either party or by ARC without ARC’s giving both parties 24-hour notice in advance. At its discretion, ARC has the authority to gather such additional evidence as it deems relevant. Under the circumstance that ARC calls the investigator as a witness, the Provost or his/her designee shall be granted the right to question the investigator. However, if the investigator elects not to testify, he/she may not be called as a witness by ARC or by the Provost or his/her designee.

V.4.2.4 Following the presentation of all evidence, the Hearing shall be closed at the time ARC deems appropriate. Thereupon, ARC shall deliberate in executive session, at a time convenient to itself. If a majority of ARC members is persuaded by the evidence that the investigator has violated this policy, then it shall recommend appropriate sanctions. Examples of sanctions include, but are not limited to, the following: letter of reprimand, demotion, salary reduction, restrictions on research activities, and monitoring of future work. If ARC determines that the investigator has not committed any violation of this policy, then it shall recommend that the case be dismissed. Within 10 calendar days of the close of the Hearing, ARC shall record its findings and its recommendations in a written report to the Provost (the “Recommendation”) which shall include the full record of the Hearing. A copy of the Recommendation shall be provided to the investigator and the Director of Sponsored Programs. Normally, ARC shall complete its Recommendation within 30 calendar days after the referral of the matter to ARC from the Provost.

V.4.3 Provost’s Determination: The Provost may accept, reject, or modify the Recommendation of ARC. If, after considering the Recommendation, the Provost determines that the investigator has knowingly violated this Conflict of Interest Policy, the Provost will so notify the investigator, the Director of Sponsored Programs, and ARC in writing (the “Determination”). The Determination shall include a full explanatory justification of the finding and a statement of the sanctions, if any.

V.4.4 Appeal of the Provost’s Determination: Within ten business days of receipt of the Determination, the investigator may appeal it by letter to the Chair of the Appeal and Grievance Committee. The Chair shall designate three members of the Appeal and Grievance Committee to serve as a Review Committee (RC) and shall designate one of them to chair the RC. No RC member shall have a conflict of interest on this matter; it will be presumed that any collaborator, family member, or departmental colleague of the investigator has a conflict of interest.

The charge of the RC is to evaluate the integrity of the entire Determination process and to ensure fairness. The role of the RC is not to question or reevaluate the factual findings of ARC or the Provost. Nor is it the role of the RC to question or reevaluate the Determination, except as provided in “e” below. The RC shall review the Recommendation and the Determination and any written statement(s) about the process based on “a,” “b,” “c,” “d,” or “e” below that might be submitted by the investigator and/or the Provost, and shall ascertain whether the Recommendation and Determination were properly arrived at. The RC shall find that the Recommendation and/or Determination were not properly arrived at if

  1. ARC or the Provost committed a procedural error that had a material (i.e., so substantial and important as to have been decisive) effect on the Recommendation or the Determination; or
  2. ARC or the Provost violated the professional, academic, or EEO rights of the investigator, or did not take into account an earlier violation of those rights, in such a way as to have a material effect on the Recommendation or the Determination; or
  3. the review by ARC or the Provost was conducted in an unfair or inequitable manner, in such a way as to have a material effect on the Recommendation or the Determination; or
  4. ARC or the Provost demonstrably considered non-germane evidence as material; or
  5. the sanction(s) (if any) imposed by the Provost was (were) not consistent with his/her factual findings.

The RC shall reach its decision within 21 calendar days of its receipt of the Determination and the Recommendation. If the RC decides by a majority vote that the Determination was properly arrived at, the RC’s decision to affirm the Determination shall, by the end of that 21-day period, be communicated in a written report to the investigator, the Director of Sponsored Programs, ARC, the Provost, and the President. At this time, the President shall also receive the Provost’s Determination and the ARC Recommendation. If the RC decides by a majority vote that the Determination was not properly arrived at, the RC may, as it sees fit, seek additional evidence or testimony from any party. The RC shall then decide by a majority vote whether it sustains, modifies, or rejects the Provost’s Determination. The RC shall communicate its decision, with a full explanatory justification, in a written report to the investigator, ARC, the Director of Sponsored Programs, the Provost, and the President.

The President shall review the Recommendation of ARC, the Provost’s Determination, and the report of the RC; may interview witnesses at his/her discretion; and shall make a decision in the case within 30 calendar days. The President may affirm, reject, or modify the recommendations of the RC. The President’s final decision, in writing, must be sent to the Investigator, the Director of Sponsored Programs, ARC, the RC, and the Provost.

If the President or, in the absence of an appeal, the Provost determines that the investigator has violated imposed conditions or restrictions without having done so knowingly, the investigator will promptly adhere to such conditions or restrictions and will promptly provide the Director of Sponsored Programs with credible evidence of such adherence.

If the President or, in the absence of an appeal, the Provost determines that the investigator has failed to disclose a conflict of interest without having done so knowingly, the investigator will promptly disclose the conflict as required by this policy and will abide by any conditions or restrictions imposed by the President, or in the absence of an appeal, the Provost.

Subsequent to the process described above, an investigator who does not accept the President’s decision may make a written appeal to the Board of Trustees, through its Secretary, not more than 14 calendar days after receiving the President’s written decision. An appeal is permissible only on the ground that the procedures of the College were not properly followed. Normally, the Board does not undertake a de novo review. The Chair of the Board may appoint a Board Committee to act on its behalf in considering the appeal. The Board may at its discretion interview such persons as it deems appropriate. The Board may either affirm or overturn the President’s decision, or, alternatively, it may request that the case be re-evaluated by either the President, the Provost, or ARC. The Board shall report its decision to the investigator, the President, the Provost, ARC, the RC, and the Director of Sponsored Programs as soon as possible.

V.5 Disclosure to Funding Agencies and Relevant Parties

If the investigator acknowledges or if, at the conclusion of the appeal process, it is determined that the investigator (a) violated imposed conditions or restrictions or (b) failed to disclose a conflict of interest, the Director of Sponsored Programs, if required by federal law or regulations, will notify promptly the funding agency of the conflict and the measures taken to manage the conflict. In addition, if the federally-funded research project involves other investigators, the Director of Sponsored Programs will notify them of the findings.

It should be noted that each funding agency retains the right to take its own action as it deems appropriate, including the suspension or termination of the project. If HHS determines that a PHS/NIH-funded project to evaluate a drug, medical device or treatment was conducted by an investigator with a conflict that was not disclosed or managed, HHS requires the investigator to disclose the conflict in each public presentation (written or oral) of the results of the research. [Rev. per 12-17, Board, May 24, 2013]

Per HHS/PHS/NIH policy, Lafayette’s Director of Sponsored Programs will publish on a publicly-accessible website or respond to any requestor within five business days of the request, information concerning any Significant Financial Interest pertaining to an HHS/PHS/NIH grant that meets the following criteria: [Rev. per 12-17, Board, May 24, 2013]

  1. The Significant Financial Interest was disclosed and is still held by the senior and/or key personnel; [Rev. per 12-17, Board, May 24, 2013]
  2. A determination has been made that the Significant Financial Interest is related to the HHS/PHS/NIH-funded research; and [Rev. per 12-17, Board, May 24, 2013]
  3. A determination has been made that the Significant Financial Interest is a Financial Conflict of Interest. [Rev. per 12-17, Board, May 24, 2013]
V.6 Financial Conflict of Interest Training for HHS/PHS/NIH Investigators

[Rev. per 12-17, Board, May 24, 2013]

Each HHS/PHS/NIH investigator must complete training on the HHS/PHS/NIH financial conflict of interest policy prior to engaging in research funded by HHS/PHS/NIH, and at least once every four years thereafter. HHS/PHS/NIH investigators must also complete training within a reasonable period of time as determined by the Director of Sponsored Programs in the following situations: if this policy is substantially amended in a manner that affects the requirements of the investigators or if it is determined that the investigator has not complied with this policy or with a management plan related to moderating potential financial conflicts of interest. [Rev. per 12-17, Board, May 24, 2013]

V.7 Records Management

As required by the federal government, Lafayette College will retain records of all conflict of interest disclosures and actions for at least three years beyond completion or termination of the grant to which they relate or, where applicable, from other dates specified in 45 C.F.R. 74.53(b) and 92.42(b). These records will be maintained securely and will be held in confidence to the extent legally permissible. [Rev. per 12-17, Board, May 24, 2013]

Faculty or staff members who have questions about this Conflict of Interest Policy should contact the College’s General Counsel and/or the Director of Sponsored Programs.

 

.