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Financial Conflict of Interest for Externally Funded Research

1.  INTRODUCTION

This policy governing financial conflicts of interest (FCOI) applies to all Investigators of Lewis & Clark College who apply to or receive external research support from the following federal agencies:  the National Science Foundation and Public Health Service (PHS) Agencies, including but not limited to the National Institutes of Health.The Institutional Official is responsible for ensuring implementation of this policy and may suspend all relevant activities until the financial conflict of interest is resolved or other action deemed appropriate by the Institutional Official is implemented.

2.  POLICY STATEMENT

Federal regulations governing grants from certain federal agencies (e.g. NSF and PHS agencies including NIH) require that the College adopt, monitor, and enforce a Financial Conflict of Interest Policy covering financial conflicts that may arise as a result of research funded by such agencies. (See regulations at 42 CFR 50.601 and following.) The College recognizes that these conflicts may arise due to interests and investments that faculty and their families may have. The existence of a significant financial interest and any resulting financial conflict(s) is not prohibited in and of itself, but such conflicts must be disclosed to the College and managed appropriately. For these reasons Lewis & Clark College adopts the following Financial Conflict of Interest Policy.

3.  PROCEDURES

All Investigators who apply for or receive grants from the Federal agencies identified above are required to follow the procedures set forth below.

a.   Disclosures of Significant Financial Interests

Using the College’s FCOI Disclosure Form, each investigator shall disclose to the Institutional Official all Significant Financial Interests (i) that would reasonably appear to be affected by the research or educational activities funded or proposed for funding by the grant source; or (ii) in entities whose financial interests would reasonably appear to be affected by such activities. The disclosure form can be downloaded here: Financial Conflict of Interest Form

 

Investigators must ensure that required disclosures have been submitted by all other co”‘investigators and Senior/Key Personnel on their project.

b.   Disclosures of Travel

Investigators must also disclose reimbursed or sponsored travel related to their institutional responsibilities, as defined below in the definition of Financial Interest.  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 need not be disclosed. Such disclosures must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and, if known, the monetary value.  The Institutional Official will determine if additional information is needed (e.g., the monetary value if not already disclosed) to determine whether the travel constitutes a Financial Conflict of Interest with the Investigator’s research.

c.   Timing of Disclosures

Investigators and designated personnel are required to submit FCOI disclosures as follows:

  • Prior to submission of a proposal to the designated external funding agency.
  • Annual updates:  In September of each year, Investigators and Senior/Key Personnel shall complete a FCOI Annual Disclosure Form and submit it to the Institutional Official.
  • Within 30 days of acquiring or discovering any new reportable significant financial interests.
  • Investigators joining the College who are conducting research sponsored by the agencies to which this policy applies will provide all necessary disclosures within 30 days.
  • All Investigators with active external funding from the federal agencies referenced in the above Policy Statement at the time of this Policy’s adoption will complete the required disclosure form before October 15, 2012.

d.   Review of Disclosures

The Institutional Official shall review financial disclosures prior to the expenditure of any funds and determine whether a Financial Conflict of Interest exists. A Financial Conflict of Interest will exist if the Institutional Official or designee determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of federally-supported research.

e.   Management Plans

Written plans will manage, reduce, or eliminate any Financial Conflict(s) of Interest. Such plans will be designed to meet applicable legal requirements, facilitate the local resolution or management of any conflict, and protect the sensitivity of disclosed information. If the Institutional Official determines that there is a Financial Conflict of Interest, he or she must approve a written management plan before any related research goes forward.  The affected investigator is responsible for developing and submitting a proposed management plan to, and in consultation with, the Institutional Official.  Management Plans may include one or more elements, such as the following:

  • Monitoring of the sponsored program by independent researchers or reviewers, the Institutional Official, an FCOI Committee, or a designee.
  • Modifications to the research or program plan.
  • Appointment of an oversight panel or person to review research/scholarship.
  • Limitations on the employee’s involvement in personnel or other decisions on behalf of the College.
  • Divestiture of Significant Financial Interests and/or
  • Other arrangements that manage, reduce, or eliminate a potential Financial Conflict of Interest.

4.  REPORTING TO A FEDERAL AGENCY

If any identified conflict or non-compliance requires reporting to the sponsoring federal agency, the Institutional Official will produce such a report in accordance with applicable regulations.

5.  INVESTIGATOR NON-COMPLIANCE

a.   Disciplinary Action

If an Investigator fails to comply with this Policy, the Institutional Official may suspend all relevant activities or take other disciplinary action until the matter is resolved or other action deemed appropriate by the Institutional Official is implemented.  The decision to impose sanctions on an Investigator because of failure to comply with this Policy or with the decision of the Institutional Official will 1) be described in writing to the Investigator and 2) notify the individual of his/her right to appeal the decision.

b.     Retrospective Review

In some cases the Institutional Official may determine that a Financial Conflict of Interest was not identified or managed in a timely manner, including but not limited to an Investigator’s failure to disclose a Significant Financial Interest that is determined to be a Financial Conflict of Interest, or an Investigator’s failure to materially comply with a management plan for a Financial Conflict of Interest.  In such cases a committee appointed by the Institutional Official will complete a retrospective review of the Investigator’s activities and the research project to determine whether the research conducted during the period of non-compliance was biased in the design, conduct or reporting of the research. 

Documentation of the retrospective review shall include the project number, project title, PI, name of Investigator with the Financial Conflict of Interest, name of the entity with which the Investigator has the Financial Conflict of Interest, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review. 

The Institutional Official will update any previously submitted report to the funding agency, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward.  If bias by the investigator is found, the report will include a mitigation report in accordance with the applicable regulations, including a description of the impact of the bias on the research project and the plan of action to eliminate or mitigate the effect of the bias.

6.  TRAINING

Each Investigator must complete training on this Policy prior to engaging in research funded by the above-referenced federal agencies, and at least every four years thereafter. Investigators must also complete training within a reasonable period of time as determined by the Institutional Official in the event that this Policy is substantively amended in a manner that affects the requirements of Investigators, or if it is determined that the Investigator has not complied with this policy or with a management plan related to their activities. 

All Investigators with active external funding from the federal agencies referenced in the above Policy Statement at the time of this Policy’s adoption will complete Training before October 15, 2012.

7.  RECORD RETENTION

The Institutional Official will retain all disclosure forms, conflict management plans, and related documents for a period of three years from the date the final expenditure report is submitted to the funding agency.

8.  CONFIDENTIALITY

To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be kept confidential.  However, the College may make such information available to the agency funding the research or to a requestor of information concerning financial conflict of interest related to relevant federal funding, if requested or required. If the College is requested to provide disclosure forms, conflict management plans, and related information to an outside entity, the Investigator will be informed of this disclosure.

9.  PUBLIC ACCESSIBILITY

The information to be made available shall be consistent with the requirements of the applicable federal regulation or official funding agency policy. The College will respond to any requestor within five business days of the request, with information concerning any Significant Financial Interest that meets the following criteria:

  1. The Significant Financial Interest was disclosed and is still held by the Senior/key personnel;
  2. A determination has been made that the Significant Financial Interest is related to the federally funded research; and
  3. A determination has been made that the Significant Financial Interest is a Financial Conflict of Interest.

10.  REGULATORY AUTHORITY

This policy implements the requirements of 42 CFR 50 and 45 CFR 94; where there are substantive differences between this policy and the requirements, the requirements shall take precedence.

11.  SUBRECIPIENTS AND SUBAWARDEES

When the College works with subrecipients or subawardees of grant funds from the federal agencies to which this Policy applies, it will enter into written agreements specifying whether the subrecipient institution will follow College’s FCOI Policy or its own. Subrecipients and subawardees will be required to comply with any applicable federal regulations.

 

DEFINITIONS

Term

Definition

Family

Any member of the Investigator’s immediate family, specifically, any dependent children, spouse or domestic partner.

Financial Conflict of Interest

A Significant Financial Interest that Lewis & Clark College (hereinafter “College”) reasonably determines could directly and significantly affect the design, conduct or reporting of the externally sponsored research.

Financial Interest

  • 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, or paid authorships for other than scholarly works); any equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights and interests (e.g., patents, trademarks, service marks, and copyrights), upon receipt of royalties or other income related to such intellectual property rights and interests.
  • 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 rather than 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.
  • DOES NOT INCLUDE:

a)     salary, royalties, or other remuneration from the College;

b)    income from the authorship of academic or scholarly works;

c)     income from seminars, lectures, or teaching engagements sponsored by or from advisory committees or review panels for U.S. Federal, state or local governmental agencies; U.S. institutions of higher education; U.S. research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers; or

d)    equity interests 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.

Institutional official

The individual within the College who is responsible for the solicitation and review of disclosures of significant financial interests including those of the Investigator’s family related to the Investigator’s institutional responsibilities.  For the purposes of this policy, the Institutional Official is designated as an Associate Dean of the College of Arts & Sciences or other official appointed by the Executive Council.

Institutional responsibilities

The Investigator’s responsibilities associated with his or her College appointment or position, including but not limited to research, teaching, clinical activities, administration, and institutional, internal and external professional committee service.

Investigator

Any individual who is responsible for the design, conduct, or reporting of research sponsored by the federal agencies specified above, or proposals for such funding, and where agency funds flow through the College for management and distribution.

NSF

The National Science Foundation.

Public Health Service or PHS

The Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority of the PHS may be delegated. The components of the PHS include, but are not limited to, the Administration for Children and Families, Administration on Aging, Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Federal Occupational Health, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, and Substance Abuse and Mental Health Services Administration.

Research

A systematic investigation, study, or experiment designed to contribute to generalizable knowledge, including behavioral and social-sciences research.  The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug).

Senior/key personnel

The project director or the Investigator and any other person identified  by the Investigator,  in the grant application, progress report, or any other report submitted to the funding agency by the College as independently responsible for the design, conduct, or reporting of the research. All of the following may be considered Senior/Key Personnel, to the extent they are independently responsible for the design, conduct or reporting of the research:  professorial faculty, research associates, emeritus faculty, subrecipient personnel, postdoctoral research associates, research collaborators, visiting scientists, individuals with courtesy appointments, as well undergraduate, graduate and post-doctoral students.  The term does not commonly apply to departmental research administrators or research administrative professionals.

Significant Financial Interest

A Financial Interest that reasonably appears to be related to the Investigator’s Institutional Responsibilities, and:

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

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

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

d)    is income related to intellectual property rights and interests not reimbursed through the College.

 

Revised and Approved by the Executive Council August 2, 2012

 

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