Conflict of Interest

It is of the utmost importance to Cancer Alliance of Nebraska that our research is conducted while meeting the highest ethical standards and in compliance with all applicable federal and state laws. In order to identify, evaluate, and address existing and potential conflicts of interest, CAN selects an external committee of experienced volunteers that oversees conflicts of interest that may exist among physician researchers, CAN staff, or relatives of researchers or staff. All researchers and staff members are required to abide by CAN’s Conflict of Interest Policy and must complete an annual Conflict of Interest Report.

If you are a researcher who needs to complete the annual Conflict of Interest Report, please click below.

Conflict of Interest Policy

Purpose:          The Missouri Valley Cancer Consortium (MVCC) is committed to carrying out the design, conduct and reporting of clinical research with the highest standards of integrity and ethics and in compliance with applicable federal and state laws related to conflict of interest. The scientific credibility and the general acceptance of the results of a clinical investigation clearly depend on the integrity and objectivity of the people conducting research trials. Even the suggestion that an investigator, or their immediate family member, has a bias may cast doubt on the validity of study results. The purpose of this policy is to set forth the principles for identifying the potential for conflicts and the procedures for evaluating and addressing both potential and existing conflicts to assure that they do not improperly affect research or other activities. The Public Health Service, in 42 CFR Part 50, Subpart F, requires that grantee institutions have written conflict of interest policies. The intent of this regulatory requirement is to promote “objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be biased by any conflicting financial interest of an investigator.” In addition, the Food and Drug Administration (FDA) requires clinical investigators participating in studies submitted with FDA marketing applications to file disclosures of significant financial interests of themselves and their immediate family members (21 CFR Part 54) . This Policy describes types of conflicts of interest, identifies when disclosure should be provided, and explains the mechanism for administration and enforcement. This policy is applicable to all employees and investigators, as defined below, as well as contracted staff. Participation includes having an active role in the development of protocols, the conduct of clinical trials, as well as the reporting of study results.

Policy: DEFINITIONS

“Conflict of Interest” means a situation in which an employee, investigator, or immediate family member has

significant financial interest or other personal involvement that may compromise, or have the appearance of compromising, his or her professional judgment or integrity in designing, conducting, or reporting research.

“Employee” means any member of a MVCC committee, any individual holding a full-time or part-time position within MVCC, and any consultant or subcontractor who provides services to MVCC related to the design, conduct or reporting of MVCC research.

“FDA” means the Food and Drug Administration of the U.S. Department of Health and Human Services.

“Immediate Family Member” includes an employee’s or investigator’s spouse and dependent children.

“Investigator” means the Principal Investigator, a study chair, any collaborating investigator, and any other person who is responsible for the design, conduct, or reporting of research funded by the Public Health Service, or proposed for such funding.

“PHS” means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS.

“PHS Awarding Component” means the organizational unit of the PHS that funds the research undertaken by MVCC.

“Research” means a systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research and product development.

“Significant financial interest” means:  a financial interest consisting of one or more of the following interests that appears to be related to the investigator’s institutional responsibilities:

With regard to any publicly traded entity – if the value of any remuneration received from entity in past twelve months of disclosure, when aggregated, exceeds $5,000.  This includes salary, and payment for services (consulting fees, honoraria, paid authorship); equity interest (stock, stock options, or other owned interest).

With regard to non-publicly traded entities – if value of any remuneration received from entity in past twelve months of disclosure, when aggregated, exceeds $5,000 or when investigator (or spouse, dependent) holds any equity interest (stock, stock option, or other ownership interest.

Intellectual property rights and interest (patents, copyrights) upon receipt of income related to such rights/interests.

Investigator must also disclose occurrence of any reimbursed or sponsored travel related to their institutional responsibilities.  This does not include travel paid or reimbursed by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or research institute that is affiliated with an institution of high education.  This disclosure must include nature of trip, sponsor/organizer, the destination, duration, and value of the trip.

The term does not include:

  • remuneration, such as salary or consulting fees, from MVCC;

Income from investment vehicles such as mutual funds and retirement accounts provided investigator does not control these accounts

  • income from seminars, lectures, or teaching engagements sponsored by federal, state, or local government agencies, an institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education;
  • income from service on advisory committees or review panels for federal, state, or local government agencies, an institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education;
  • equity interest in business enterprises or entities where the value of such interests, when aggregated for the investigator or employee and immediate family members meets both of the following tests: does not exceed $5,000 in value as determined on the basis of public prices or other reasonable measures of fair market value, and does not represent more than a five percent (5) ownership interest in any single entity; or
  • salary, royalties or other payments that when aggregated for the employee or investigator and immediate family members over the next twelve months, are not expected to exceed $5,000.
  1. Policy

A conflict of interest is considered to occur whenever a MVCC employee, investigator, or an immediate family member has an existing or potential significant financial interest that impairs, or appears to impair, that individual’s independence and objectivity in the discharge of his/her responsibilities. A conflict of interest also exists when, in the reasonable determination of the MVCC COIC, a significant financial interest could directly and significantly affect the design, conduct, or reporting of MVCC research. Employees and investigators should avoid conflicts of interest and/or the potential for conflicts through financial arrangements with third parties that could have a special interest in a protocol or its findings. Entities that could have such a special interest include all organizations that are involved in the development, production and/or distribution of products used in medical research protocols conducted by the MVCC.

Conflict of interest could include any of the items as defined under “significant financial interest”.

Following completion of a trial, individuals providing leadership in the design or conduct of the study should refrain from activities primarily targeted at marketing of the product.

  1. Disclosure

All employees and investigators, as defined above, must file annual statements with MVCC, the NCI during investigator registration and updates, and with each study group in accordance with each study groups’ specific conflict of interest policy.  The statement includes identifying potential conflicts of interest and disclosing their known significant financial interests and those of their immediate family members. They must also disclose any official positions in an organization, other than MVCC, involved in developing, producing, and/or distributing products that may be used in the course of conducting research protocols performed by the MVCC. This is done by submitting a Conflict of Interest Disclosure Form to the MVCC Operations Office for each study group when indicated by their specific policy.

Conflicts that develop subsequently during the design or conduct of a clinical trial or during the dissemination of results must be disclosed within thirty (30) days of acquiring or discovering a significant financial interest. At the beginning of any presentation of the results of a clinical trial, through either oral presentation or publication, an investigator should disclose, if applicable, private sources of funding provided specifically for the study.

Examples of interests that must be disclosed include, but are not limited to:

  • An employee or investigator participating in a research project expects to receive royalty payments for intellectual property derived from that study.
  • An employee or investigator has the authority to assign other professionals to complete tasks and activities in connection with a research project in which he or she and/or immediate family members have a significant financial interest, as that term is defined in this policy.
  • An employee or investigator receives sponsored research support or contributions (whether in cash or in kind) from a business in which he or she and/or immediate family members have a significant financial interest.
  • An employee or investigator takes administrative action on behalf of MVCC that benefits a business in which he or she and/or immediate family members have a significant financial interest.
  • An employee or investigator who has influence over procurement decisions purchases goods and/or services on behalf of MVCC from a business in which he or she and/or immediate family members have a significant financial interest.
  1. INSTITUTIONAL RESPONSIBILITIES
  1. Enforcement; Sanctions

Initial Review by the MVCC COIC: The co-chairs of the MVCC COIC will review each disclosure form to ensure that it has been properly filled out and signed by the Investigator/Support Personnel to determine the existence of any Significant Financial Interest.

  1. If NO Significant Financial Interest is disclosed, the disclosure form is filed and no further action is required.
  2. If a Significant Financial Interest is disclosed, the co-chairs of the MVCC COIC shall determine whether it is related to any grants or contracts, or to any open clinical research. The nature of the study is reviewed relative to the Significant Financial Interest, and is then referred to the MVCC COIC. The MVCC COIC shall determine whether any Financial Conflict of Interest exists and, if so, how to manage, reduce, or eliminate the Financial Conflict of Interest.
  1. Conflict of Interest Committee Review Process. The MVCC COIC shall review (and, where necessary, investigate) all information contained in the disclosure to determine whether an Investigator/Support Personnel’s Significant Financial Interest is related to the research and, if so, whether it constitutes a Financial Conflict of Interest.

The following are possible determinations the MVCC COIC may make regarding Financial Conflicts of Interest:

  1. If it is determined that there is no Significant Financial Interest, the MVCC COIC shall notify the Investigator/Support Personnel in writing, and this correspondence shall be included in the project file.
  2. If it is determined that there is a Significant Financial Interest, the MVCC COIC shall determine whether any Financial Conflict of Interest exists and, if so, how to manage, reduce, or eliminate the Financial Conflict of Interest before expenditure of project funds, including developing and implementing a management plan and, if necessary a retrospective review and mitigation report.

Examples of conditions or restrictions that might be imposed in a management plan include, but are not limited to:

  1. Public disclosure of Financial Conflicts of Interest (e.g., when presenting or publishing the research).
  2. Disclosure of Financial Conflicts of Interest directly to participants.
  3. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the Financial Conflict of Interest.
  4. Modification of the research plan.
  5. Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research.

The co-chairs of the MVCC COIC shall convene the COIC within 60 days of realizing a significant conflict of interest to review the matter.  Steps taken will include but not be limited to:

  1. Review the Significant Financial Interest,
  2. Determine whether it is related to the research,

iii. Determine whether a Financial Conflict of Interest exists, and, if so,

  1. Implement, on at least an interim basis, a management plan specifying the actions that have been and will be taken to manage such Financial Conflict of Interest going forward.

Management Plan Standards:

Conflict of $5,000-$49,999

Paragraph will be inserted into the consent stating the manufacturer and name of the drug, the investigator who has the conflict, and the fact that the conflict has been reviewed both by the MVCC COI Committee as well as the presiding IRB.

Conflict over $50,000

Paragraph will be inserted into the consent stating the manufacturer and name of the drug, the investigator who has the conflict, and the fact that the conflict has been reviewed both by the MVCC COI Committee as well as the presiding IRB.

Investigator participation and enrollment will be monitored quarterly to ensure conflict is not being manipulated to the benefit of the investigator who holds the significant conflict of interest.  This will be documented in both the study and COIC records.

Appeal Rights: If the Investigator/Support Personnel disagrees with a management plan developed by the MVCC COIC, he/she may appeal the determination by submitting a written request and any supporting materials to the MVCC COIC for reconsideration within 14 days after receiving notification of the management plan. The MVCC COIC shall review the request and supporting materials and issue its final determination, which shall not be subject to further appeal. The Investigator/Support Personnel shall sign any management plan required by the MVCC COIC before any funds may be expended.

Ongoing Monitoring: Whenever MVCC implements a management plan, MVCC, through the MVCC COIC, shall monitor Investigator/Support Personnel compliance with the management plan on an ongoing basis until the research is completed.

  1. Reporting; Record Keeping

Prior to expending grant funds, MVCC shall report to the PHS Awarding Component the existence of a conflicting interest and assure that the interest has been managed, reduced or eliminated. MVCC will also report any subsequently identified conflict and manage, reduce, or eliminate that conflict within 60 days of identification. MVCC will make conflict information available to the Department of Health and Human Services (HHS) upon request. MVCC shall maintain records of all financial disclosures and all actions taken with respect to each conflict of interest for at least three (3) years from the date of submission of the final expenditures report.

  1. Disqualification from Leadership Role in Clinical Trials

If an employee or investigator discloses a significant financial interest that is above $5,000, then he or she cannot be involved in the development and management of a MVCC clinical trial:

  1. NONCOMPLIANCE

If it is determined that an employee or investigator has a conflict of interest, the person with said conflict must comply with the MVCC COIC management plan.  If compliance does not occur, MVCC must, within 120 days, complete a retrospective review of the investigator’s NIH funded research activities to determine bias in the conduct or reporting of research; document retrospective review consistent with regulation; document determination as to whether there was any bias in design, conduct or reporting of NIH funded research.

Failure of an employee or investigator to comply with the MVCC COIC management plan could result in the individual not being able to utilize a protocol involving the research product for which there is a conflict. Failure to disclose a conflict of interest as required by this policy or participation in MVCC activities after such participation has been prohibited could result in the loss of privileges to participate in any research activities of the MVCC.

MVCC shall notify the PHS Awarding Component if the failure of an investigator to comply with the conflict of interest policy has biased the design, conduct, or reporting of the PHS-funded research. In any case in which HHS determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an investigator with a conflicting interest that was not disclosed or managed as required by this policy, MVCC will require that investigator to disclose the conflicting interest in each public presentation of the results of the research.

  1. PUBLIC ACCESSIBILITY

MVCC will ensure public accessibility, via the MVCC website (aboutmvcc.org), of the MVCC Conflict of Interest Policy and any significant conflict of interest of its investigator and employees.  This information will include the name and title of the person with the conflict, the entity in which the significant conflict of interest exists, the nature of the significant financial conflict of interest, and the approximate dollar value of the significant conflict of interest in the following ranges: $5,000-$9,999; $10,000-$19,999; and anything over $20,000 will be reported within $20,000 increment ranges.

VII. TRAINING REQUIREMENTS

Each Investigator and MVCC employee must complete the following training presentation prior to conducting NIH research and every 4 years after or whenever significant updates to policy warrants re-training:

http://grants.nih.gov/grants/policy/coi/

Training must be done immediately if any of the following occur:

MVCC COI policies change in a way that changes investigator requirements

A new investigator joins the MVCC program

Investigator is not compliant with MVCC’s conflict of interest policy or management plan