Conflicts of Interest in Research

Transcription

1 System Fairview Health Services Policy Conflicts of Interest in Research CONTENTS Purpose Policy Definitions General Provisions Reporting, Review and Governance PURPOSE Consistent with its values of integrity, dignity, service and compassion and with Fairview s Conflict of Interest Guiding Principles, and as a non-profit healthcare provider engaging in research, Fairview desires to appropriately address Conflicts of interest, by articulating standards for identifying, addressing, managing and, if necessary, eliminating them across the organization. Central to Fairview s mission and vision is patient care and the health of the community we serve. Fairview recognizes that a productive relationship with its partners, such as the medical community, Business, Industry, and other external entities, is an important factor in realizing the full potential of its mission. To maintain the public trust, to protect the integrity of professional judgment and to ensure appropriate stewardship of resources and compliance with applicable state and federal laws, it is important that external relationships not be or appear to be influenced by factors other than the pursuit of knowledge, the best interests of the patient and appropriate stewardship of resources. This policy intends to balance the important medical and public benefit that external relationships can produce with the possibility that these relationships may cause a Conflict of interest or the perception of a Conflict of interest. Accordingly, while Fairview acknowledges that conflicts will exist, it expects for them to be proactively identified, robustly managed and monitored unless they are inconsistent with Fairview s Conflict of Interest Guiding Principles. POLICY This policy establishes standards for activities that may present a Conflict of interest and for identifying, reporting and oversight of Conflicts of interest as they apply in the area of research. The policy applies to Fairview Researchers, as well as any Fairview employees or others affiliated with Fairview who are responsible for, or in a position to influence, the design, conduct or reporting of research or other scholarly activity. A Conflict of interest can occur when a person has a secondary interest that an independent observer might reasonably determine unduly influences (consciously or unconsciously) their primary interest of acting on behalf of and for the benefit of Fairview and the care to its patients. In the case of research, a conflict of interest arises when a Fairview Researcher compromises professional judgment in carrying out teaching, research, outreach, or public service activities because of an external relationship that directly or indirectly affects the financial or business interest of the Fairview Researcher, an Immediate family member, or an Associated entity. This policy requires that Fairview Researchers and others involved in this activity report potential Conflicts of interest arising from Financial or Business interests and/or Non-financial relationships or those of their Immediate family members or an Associated entity, as well as other situations that are material to the existence of a Conflict of interest. If an actual Conflict of interest is determined to exist or a relationship may be perceived as such, the conflict will be 1

2 addressed through compliance with an identified conflict management plan unless the issue or circumstances cannot be adequately managed or if it is inconsistent with Fairview s Conflict of Interest Guiding Principles. Recognizing that the Academic Health Center of the University of Minnesota has a conflict of interest policy that addresses research and clinical practice, this policy will be consistent with, and not duplicative of reporting processes maintained by the University of Minnesota COI policy. DEFINITIONS Associated entity" means any Business over which an Interested person alone or together with an immediate family member, possesses a business or financial interest that would be required to be disclosed under this policy. Business means any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company joint stock company, receivership, business or real estate trust or any other nongovernmental legal entity organized for profit, nonprofit, or charitable purposes, and which engages or attempts to engage with Fairview. Business interest means holding any position, such as employee, officer or director on a board, including an advisory board, regardless of compensation. Disclose or Disclosure means the act or process of making information available to a third party such as a patient or other relevant audience regarding the existence of a Conflict of interest. Fairview researcher means any Fairview employee and any non-employed medical staff member or other person conducting or participating in research in whole or in part at a Fairview facility or using Fairview non-public information, patients or resources for purposes of research. This definition does not include personnel of the Academic Health Center, University of Minnesota faculty or parties subject to the University Conflict Policy. Financial Interest means an Ownership or investment interest in a Business and/or a Compensation relationship with Business. Ownership or investment interest includes, but is not limited to, stock, stock options, debt interests or other ownership or investment rights and excludes diversified mutual funds, pension funds or other institutional investment funds where the individual does not exercise control over the investments; Compensation relationship includes, but is not limited to, the receipt or expectation to receive any remuneration such as consulting fees, honoraria, salary, rent and royalties and excludes income derived from institutions or practice plans affiliated with the University of Minnesota and/or Fairview, and honoraria received from another academic institution for academic activity. Immediate family" means the Interested person's spouse or domestic partner, dependents, and any other related person that may benefit from the Interested person s actions on behalf of Fairview. Non-financial relationship means relationships with Industry of a non-financial or non-business nature such as family or friendships with individuals employed by Business or Industry or non-compensated roles with Industry. "Participate" means to be a part of the described activity in any capacity including, but not limited to, serving as the principal investigator, co-investigator, research collaborator, or provider of direct services or patient care or having authority over any of the above. The term does not apply to the study participants, unless they are in a position to influence the study s results or have privileged information as to the outcome. Reporting means the act or process of making information available to Fairview regarding a potential conflict of interest. 2

3 GENERAL PROVISIONS Fairview Researchers responsible for, or in a position to influence, the design, conduct, or reporting of research or other scholarly activity must comply with all applicable state and federal laws and regulations, including those related to conflict of interest and objectivity in research. These laws include, but are not limited to, Federal Public Health Service regulations 42 CFR, part 50, subpart F, and 45 CFR, part 94, and National Science Foundation Grant Policy Manual 510 as amended by 60 FR (1995). Potential conflicts of interest arise when a Fairview Researcher participates in teaching, research, outreach or public service activities and the Fairview Researcher, Immediate family members or Associated entity have any reportable Financial or Business interest in the technology, process, product or other subject matter of the activity or in any Business supporting the activity. In general, a potential conflict exists if the Fairview Researcher, immediate family member or associated entity has a business or financial interest that could be enhanced based on the outcome of the activity. Some activities that raise potential conflicts of interest are ordinarily allowable following reporting and, where necessary, the implementation of a management plan. Other activities and external relationships require case-bycase review and only some of the specific relationships may be approved. In such cases, management plans are likely to be required. REPORTING, REVIEW AND GOVERNANCE Reporting Potential Conflicts of Interest to Fairview Any time a Fairview Researcher plans to initiate an activity that may be classified under the preceding paragraph, the Fairview Researcher must complete conflict of interest training and report relevant Financial or Business interests before commencing the activity. Relevant Financial or Business interests that require reporting include the following: 1. Fairview Researcher, Immediate family members, or Associated entity have, as of the reporting date, an equity interest in a Business that is privately held or an aggregated equity interest in a publicly held company representing ownership of 5 percent or more, or a value of $5,000 or more, as determined through reference to public prices or other reasonable measures of fair market value. 2. Fairview Researcher, Immediate family members, or Associated entity have received over the last 12 months, an aggregated annual income of all types from a Business equal to or exceeding $5, Fairview Researcher, Immediate family members, or Associated entity have received royalty income over the last 12 months from a Business that is equal to or exceeds $5, Fairview Researcher or Immediate Family members have a Business interest.. 5. The Fairview Researcher had an occurrence of travel paid for or reimbursed by a business entity, unless the trip was paid for or reimbursed by a governmental agency, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. All Fairview Researchers are required to report potential conflicts of interest related to research activities in accordance with this policy. A Fairview Researcher must report relevant Financial or Business Interests no later than the time of application for research funds from the U.S. Public Health Service (PHS); or prior to submitting an application to the Institutional Review Board (for non-phs-funded research). Annual disclosures are required while the Fairview Researcher remains participating in research. Reporting shall be made to Fairview Research Administration and to Fairview s Chief Compliance Officer using the applicable form. 3

4 Whenever substantial changes occur that may alter the Financial or Business Interests previously reported, an updated form must be submitted within 30 days from the occurrence or circumstances creating a potential conflict. All reports shall be prompt, full and frank, will identify the potential Conflicts of interest and will provide sufficient and relevant detail to adequately review the circumstances or issue. Funding for the project will not be accessible to the Fairview Researcher until the reporting of the Financial or Business interest is reviewed and approval is given, and other appropriate measures have been implemented in accord with this policy. Other Reporting and Disclosure of Conflicts of Interests In addition to the reporting requirements set forth in this policy, various government agencies and sponsors may have additional reporting requirements. All Fairview Researchers are required to comply with such additional requirements. Fairview Researchers must disclose relevant Financial or Business interests to sponsors of research and in reporting by either written or oral communication research results. When submitting a paper for publication, they must disclose to the editor any Financial or Business interest that may be related to the publication. This provision also applies to release of information to news media. Disclosure of a relevant Financial or Business interest must also be made by any Fairview Researcher who makes an appearance, either in person, or by way of a written communication, before any public body, commission, group, or individual, to present facts or to give an opinion respecting any issues or matters up for consideration discussion, or action. When Fairview Researchers participate in sponsored research involving sub-grantees, contractors, or collaborators outside of Fairview, Fairview, to the extent required by the sponsor, will take reasonable steps to ensure that investigators working for these outside entities comply with appropriate conflict of interest reporting and review requirements. These steps may include requiring the investigators to comply with Fairview s policy or obtaining written assurances from the outside entity that it complies with applicable federal regulations or sponsor policies on conflict of interest. Review and Oversight of Potential Conflicts of Interest Subsequent to reporting, and depending on the nature of the matter, the Chief Compliance Officer, or designee, will review the reported information and may either arrive at a determination regarding the matter, or refer it to the Conflict of Interest Review Committee (composed of the Chief Compliance Officer, the Chief Legal Counsel and selected executive and clinical personnel) for further deliberation. This Committee will include the Director of Research Administration in cases that pertain to research. Where subject matter expertise is necessary, that Committee may seek the assistance of a subcommittee that may be formed for special purposes. If the Chief Compliance Officer, or the Conflict of Interest Review Committee determine that a Conflict of interest exists, appropriate mitigating or remedial measures may be taken through a management plan in consultation with the Fairview Researcher. Management plans are intended to maintain transparency and decrease perceptions of influence and may include, but are not limited to, monitoring or follow up of a particular relationship, disclosure to appropriate audiences, or divestiture or modification of relationship with Business or Industry, if necessary. If the issue or circumstances cannot be adequately addressed through a management plan or if the proposed or actual arrangement is inconsistent with Fairview s Conflict of Interest Guiding Principles, the conflict will be eliminated. 4

5 Disclosure of the management plan may be made to appropriate audiences or committees, which may include patients, students, a department, group, or other audiences as necessary. Monitoring and oversight of Conflicts of Interest and management plans will be conducted by the Conflict of Interest Review Committee and the Audit and Compliance Committee. The Chief Compliance Officer will maintain records of all reporting forms filed and all actions taken by the institution, for at least three years beyond the final expenditure report of the award or until resolution of any action by Fairview or governmental agencies involving the records. All records will be maintained in a manner to protect confidentiality but will be accessible to sponsoring agencies as required by federal regulations or sponsor policies. Prior to the expenditure of any funds under a PHS-funded research project, Fairview shall make information concerning identified financial and business conflicts of interest publicly accessible within 5 days of receiving a written request for such information. Enforcement Breaches of this policy include, but are not limited to, failure to file, intentionally filing an incomplete, erroneous, or misleading reporting form or failing to provide additional information as required by the approving authority. A violation of this policy may be the basis for discipline of an employee or other person acting as a Fairview Researcher. If sanctions are necessary, they will be imposed in accordance with other applicable Fairview policies and procedures. The potential sanctions may include a letter of admonition, ineligibility of the Fairview Researcher to use Fairview facilities for research, the imposition of conditions on or supervision of such research, ineligibility for grant applications, or other appropriate sanctions. Additional sanctions may include referral for further action, suspension and up to termination of employment or termination of the agreement with Fairview. In any case in which the U.S. Department of Health and Human Services determines that a PHS-funded project of research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by a Fairview Researcher with a financial conflict of interest that was not managed or reported by Fairview as required by federal regulations, Fairview shall require the Fairview Researcher involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations. If a Fairview Researcher who is involved with sponsored research fails to comply with this policy, then Fairview s Director of Research must promptly inform the Chief Compliance Officer of the violation. To the extent required by the sponsoring agency, the Chief Compliance Officer will then notify the agency of the violation and any corrective action taken or to be taken. Policy Owners: Research Administration Compliance Department Conflict of Interest Review Committee Audit and Compliance Committee Approved by: Board of Directors Research Institutional Official Dates: Date Effective: August 24, 2012 Date Revised: 4/2007; 5/2011; 2/2013; 7/2013; 01/2015 5