Winthrop University Hospital Research Financial Interests Disclosure Policy

Transcription

1 This policy sets forth Winthrop-University Hospital s (WUH) requirements and guidelines for disclosing applicable Research Financial Interests. It includes: I. Definitions of Key Terms II. Policy and Procedures for Research Financial Interests Disclosures III. Review of Disclosures IV. Appeal Process V. Compliance with the VI. Program to Educate VII. Review and Evaluation of Policy I. Definitions of Key Terms Compelling Circumstances are those facts that convince the Institution s Conflict of Interest Committee (COIC) that a financially interested individual should be permitted to conduct human subjects research. When considering a request by a financially interested individual to conduct human subjects research, the circumstances that the COIC may evaluate include the nature of the research, the magnitude of the interest and the degree to which it is related to the research, the extent to which the interest could be directly and substantially affected by the research, and the degree of risk to the human subjects involved that is inherent in the research protocol. The COIC may also consider the extent to which the interest is amenable to effective oversight and management. In addition, despite conflicting financial interests, the COIC may find that there is a strong scientific or humanitarian reason to allow the research to proceed under the direction of the conflicted Investigator. This may be allowed to occur, for example, in circumstances in which the Investigator has special expertise regarding the particular drug, device or method under investigation that uniquely qualifies him or her to conduct the investigation; where the Institution has special facilities or equipment that are unavailable at most other institutions in the United States that allow or facilitate the proposed research; and/or where the Investigator or the Institution is particularly well situated to enroll study subjects because of the patient population and/or catchment area of the Institution and its affiliated health care providers. Conflict of Interest: shall be understood to encompass actual or potential conflict of interest, or the appearance of conflict of interest. In the conduct of externally supported activities, conflict may arise when an Investigator at the Institution is, or may be, in a position to influence activities or institutional decisions in a way that could lead to personal gain for the Investigator or the Investigator's family, or give an improper advantage to third parties in their dealings with the Institution. Conflicts may also arise when Investigators have outside obligations of any kind that are in substantial conflict with the Investigator's institutional responsibilities or if an Investigator is an inventor of an item being used for research he or she will be directing. The potential for conflict of interest may arise from specific actions taken by Investigators, or by the nature of positions they hold at the Institution and/or outside the Institution, or by the financial interests they or their immediate family hold. Institutional Conflicts of Interest: A possible conflict of interest based upon the Winthrop- University Hospital s Intellectual Property, substantial donations or gifts the Institution may receive, the financial interests of institutional leaders, or other financial interests that might Revised July, of 11

2 reasonably affect the design, conduct, reporting, review or oversight of human subjects research, or undermine the integrity of the human research protection program. Conflict of Interest Committee (COIC) is the Committee established by the Institution and authorized through the Winthrop-University Hospital Board of Trustees to evaluate potential Conflicts and to determine the extent, if any, to which a Conflict of Interest is amenable to effective oversight and management. At Winthrop, the COIC will review potential conflicts of interest. The COIC will be comprised of the following: COIC Chair COIC Co-Chair Director of the WUH IRB Director of Sponsored Programs Representative of the Hospital s Office of Corporate Compliance Clinical Research Investigator Vice President of Administration The COIC Chair and Co-Chair will be appointed by the Chief Academic Officer. The COIC Co-chair, who will act on the Chairs behalf when the chair is not present. If a potential Conflict that relates to the Institution or Institution-affiliated persons (rather than to Investigators) is reported to or otherwise known by the COIC, then the COIC will consider such Conflict and report their findings to the Compliance Department for review and action. Each new COIC member will receive an education packet of current federal guidelines and regulations and must sign an attestation to maintain the confidentiality of personal disclosure information. Conducting Research means, with respect to a research protocol, designing research, directing research or serving as the Principal Investigator, enrolling research subjects (including obtaining subjects informed consent) or making decisions related to eligibility to participate in research, analyzing or reporting research data, or submitting manuscripts concerning the research for publication. Covered Individual includes any faculty, staff, student, resident, fellow or administrator who, under the aegis of the Institution or pursuant to review and approval of the Institution s IRB, conducts research involving human subjects. Financially Interested Company means a commercial entity with financial interests that would reasonably appear to be affected by the conduct or outcome of the research. This term includes companies that compete with the sponsor of the research or the manufacturer of the investigational product, if the covered individual actually knows that the financial interests of such a company would reasonably appear to be affected by the research. This term also includes any entity acting as the agent of a financially interested company (e.g., a contract research organization). Financially Interested Individual means a Covered Individual who holds a significant financial interest that would reasonably appear to be affected by human subjects research with which the individual is associated. Revised July, of 11

3 Human Subjects Research includes all research meeting the definition of research performed with human subjects as these terms are defined in the federal Common Rule (45 C.F.R. Part 46 and 21 C.F.R. Part 56), regardless of the source of research funding, whether the research would meet certain exemptions outlined in the federal Common Rule, or whether the research is otherwise subject to federal regulation. In the event that the Common Rule definitions of human subjects or research are modified through rulemaking, any such revisions shall apply for the purposes of this policy. Immediate Family means spouse and dependent children. Institution means Winthrop-University Hospital Investigator is the Principal Investigator, Co-Investigator, Sub-Investigator and all other persons who are responsible for the design, conduct, or reporting of institutional programs, projects, activities or services supported through applications for funding made with the assistance of or through Winthrop-University Hospital that qualify as human subjects research performed in part or whole at Winthrop or overseen by the Winthrop-University Hospital IRB. For the purposes of this policy, reporting requirements for "Investigator" shall include the Investigator's spouse, birth/adoptive/stepparent, -child, -siblings, all in-laws, grandparent or grandchild or spouses thereof, and those who reside in the same residence. Public Health Service (PHS) funded research is research sponsored by the United States PHS which includes the National Institutes of Health (NIH). This includes projects funded directly by the PHS to Winthrop, such as NIH grants and any PHS funded projects on which Winthrop is a sub-contractor or collaborator (including all cooperative group studies including but not limited to GOH, COG and SWOG.) Investigators on these projects are subject to additional requirements effective August 24, 2012, as set forth in the PHS Funded Research Addendum to this Policy. Responsible Institutional Official is the individual who is responsible for the oversight of research programs. At Winthrop, this individual is the Chief Academic Officer. Responsible IRB is the Institutional Review Board (or boards) with jurisdiction over the research as specified in the Federal-Wide Assurance (FWA) that the institution has provided to the U.S. Department of Health and Human Services (HHS) Office of Human Research Protection (OHRP). Related to Research means financial interest in the sponsor, product or service being tested, or competitor of the sponsor. 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 clinical research and product development. Significant Financial Interests include the following interests of a covered individual or his or her spouse and dependent children or of any foundation or other entity significantly controlled or directed by a covered individual or his or her spouse or dependent children: Revised July, of 11

4 a. An ownership interest that, when aggregated for the covered individual and his or her spouse and dependent children meets any of the following criteria: 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. For purposes of this definition, 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 (or the Investigator s spouse or dependent children) holds any equity interest (e.g.,stock, stock option, or other ownership interest); 3. Represents 5% or more interest in any one single entity. 4. A proprietary interest of any value that is related to the research including, but not limited to, a patent, trademark, copyright or licensing agreement. 5. A board or executive relationship related to the research, regardless of compensation. 6. 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 [based upon actual travel costs] 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 Significant Financial Interests do not include the following types of financial interests: 1) salary, royalties, or other remuneration paid by Winthrop to the Investigator if the Investigator is currently employed or otherwise appointed by Winthrop, including intellectual property rights assigned to Winthrop and agreements to share in royalties related to such rights; 2) income from investment vehicles, such as mutual funds and 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 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; or income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic Revised July, of 11

5 teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. Technology means the drug or device being tested in the clinical study. II. and Procedures This policy applies to all forms of external support for Winthrop-University Hospital s (herein to be referred to as Institution) research programs, projects, activities and services, solicited and unsolicited, including gifts and donations. The Administrative Office of the Hospital s Institutional Review Board (WUH IRB) will review every proposal submission to ensure that the Principal Investigator has attested that the appropriate disclosure forms, if any, have been submitted for all personnel participating in the proposed research study. Additional disclosure and training requirements are applicable to Investigators who are applying for, have been awarded or are collaborators on PHS funded research. The responsibilities and obligations of covered individuals to the Institution must be clearly separated from personal financial interests or other obligations. Prudent stewardship of funds requires protecting institutional research, education and public service from being compromised by the private interests or obligations of any Investigator. To meet these objectives and to ensure compliance with federal regulations (42 CFR 50) Winthrop University Hospital requires each covered individual to disclose all significant financial interests and obligations: 1. that would reasonably appear to be directly and significantly affected by the research, educational or creative activities for which external funding is sought; or 2. in entities whose financial interests or obligations would reasonably appear to be directly and significantly affected by such activities. This requirement is designed to avoid actual or potential conflicts of interest, or even the appearance of a conflict of interest. The Institutional Review Board (IRB) Office will distribute this policy annually to all covered individuals. Anyone conducting research involving human subjects will be required to sign an attestation on the appropriate new project IRB submission form which confirms willingness to comply with this policy. The IRB cannot approve research in which there is a declared financial interest until the organization s conflict of interests evaluation has been completed and reviewed by the convened IRB. The Financial Interests Disclosure Attestation (located on the WUH IRB Submission/Application Form) will be required with each submission to the responsible IRB. The Principal Investigator must query all individuals listed on the study and/or FDA form If any such individual believes he/she may have a conflict of interest as described in this policy, that individual must complete the Winthrop Research Financial and Other Interests Disclosure Form to be submitted with the IRB Submission/Application Form. In addition, copies of all FDA forms 3454 and 3455 submitted to sponsors at any point during the study must also be forwarded immediately upon completion to the WUH IRB Administrative Office regardless of which Winthrop IRB Committee oversees the protocol. Revised July, of 11

6 At any time throughout the year, covered individuals are required to disclose to the IRB Office any new (has not been reported on previous disclosure form) interests or obligations (a) which could reasonably appear to be directly and significantly affected by any research, educational or creative activities for which external funding is being provided or (b) in entities whose financial interests or obligations could reasonably appear to be directly and significantly affected by such activities. Note: Disclosure of equity interests and positions of related individuals that may also create a conflict or the perception of a conflict of interest must also be reported. Department Chairs and other supervisory administrators shall not encourage or condone impermissible conflicts of interest in their faculty or researchers. Non-compliance with the requirements or provisions of this policy, including misrepresentation of the information required by the Financial Interests Disclosure Attestation, will be sanctioned (see below Compliance with this Policy). A Conflict of Interest can occur when: 1. A Significant Financial Interest of an Investigator at the Institution would reasonably be expected to be directly and significantly affected by the design, conduct or reporting by the Investigator of an Institutional research, educational or public service activity; 2. An Investigator at the Institution has a significant non-institutional obligation to an individual or a private organization that provides support for Institutional research, educational or public service activity; or 3. An investigator has a proprietary interest in the device or drug (Technology) in question, for example, the investigator may be an inventor or co-inventor of the Technology being used in a clinical study to be directed by that investigator or an item being considered for purchase by Winthrop-University Hospital. 4. An Investigator at the Institution has a relationship with or obligation to an entity, an organization or a company that provides the Institution with support through an agreement to perform a research program, project, activity or service supervised by the Investigator including: a. Consulting arrangements between an Investigator at the Institution and a business enterprise that supports or is supported by Institutional programs involving the Investigator; b. Consulting arrangements between an Investigator at the Institution and a business enterprise that is licensed to commercialize Institutional technologies invented by the Investigator; c. Significant Financial Interests of an Investigator at the Institution in a business enterprise that supports or is supported by the Investigator's institutional research; d. Significant Financial Interests of an Investigator at the Institution in a business enterprise that owns or has applied for the patent, manufacturing or marketing rights to a drug, device or procedure that is a subject of, or will predictably result from, the Investigator's Institutional research; e. Significant Financial Interests of an Investigator at the Institution in a business enterprise that is known by the Investigator to own or have applied for patent, Revised July, of 11

7 manufacturing or marketing rights that can reasonably be expected to compete with a device, product or procedure that will predictably result from or has resulted from the Investigator's Institutional research. 5. Institutional staff members, administrators, affiliated persons, or the Institution itself have Significant Financial Interests that may be affected by the research, and those Interests are known by, or during the research predictably could become known by, the Investigators who are conducting the study. 6. Institutional conflicts of interest are of significant concern when financial interests create the potential for inappropriate influence over the institution's activities, personnel, or resources. The risks of such conflicts include the possibility that the integrity and objectivity of the institution's research may be threatened or may be perceived to be threatened; such risks are particularly acute in human subjects research, when the protection of human subjects may be adversely affected. The underlying principle is that Winthrop-University Hospital is obligated to protect against exposure to these risks as they may affect the integrity of human subjects research or the safety of participants when performed at or under the auspices of the Institution. 7. Conflicts of Interest based upon Intellectual Property: Winthrop-University Hospital may own certain Intellectual Property in the form of Patents or Pending Patents. In addition, in most cases, the individual that invented the specific technology will still be employed by Winthrop-University Hospital. Winthrop-University Hospital may license such Patents or Pending Patents to a third party company or set up a new company to pursue further research and to market the Patents. If Winthrop-University Hospital, any of its employees or the inventor are approached to conduct Human Subjects research that makes use of the specific product or item protected by such a Patent or Pending Patent, no such research may take place until the matter is referred to the Conflict of Interest Committee. The Conflict of Interest Committee will consider the matter and direct the IRB on how to proceed. There is no threshold for disclosure for possible Conflicts based upon Intellectual Property, all possible conflicts must be reported. 8. Conflicts of Interest based upon substantial donations or gifts: Winthrop-University Hospital may, from time to time, receive large donations from individuals or corporate entities to conduct focused research in specific areas of medicine, or it may receive large donations for other uses, including but not limited to naming rights. Winthrop-University Hospital is committed to unbiased research and will not allow donations or gifts to influence the conduct of its research. The decisions of the IRB and other institutional committees are independent from influence from outside entities. Winthrop-University Hospital will not allow a donor to impose a research plan that is not acceptable to the leaders of the institution. An ad-hoc committee, or a sub-committee of the Conflict of Interest Committee will be set up to determine a management plan related to any research conducted based upon such a donation. The Conflict of Interest Committee will enforce this plan and provide the IRB with specific guidelines to use when considering such research. The threshold for disclosure of gifts or donations that will trigger disclosure is $300,000. The threshold for disclosure of financial interests of senior leadership is the same as that for researchers, it is set forth in the section entitled Significant Financial Interests below. Revised July, of 11

8 III. Review of Disclosures 1. The Winthrop-University Hospital Research Financial and Other Interests Disclosure Form will serve as the mechanism for identifying and reporting significant financial interests and obligations by all Covered Individuals at the Institution. Institutional conflicts may also be identified by other sources, such as individuals who review grants and manage donations and gifts, Hospital Administrators or Department Chairs or Division Chiefs. When individuals identify an organizational conflict of interest, they shall be reported to the Office of Corporate Compliance which will then report it to the IRB Administrative Office. 2. New and Continuing Review submissions for either the Winthrop IRB or Western IRB will not be accepted if the Financial Disclosure/Conflict of Interest Attestation section on the IRB Submission/Application and Continuing Review Form has not been completed. Additionally, the Disclosure Form must be updated during the performance period of a study whenever significant financial interests or obligations change or arise. 3. All Applications will be forwarded to the COIC Chair by the IRB Director. (Disclosure Forms completed for review by the Western IRB will be forwarded to the IRB Director at Winthrop by the Director of Sponsored Programs, the Hospital liaison to the Western IRB). The COIC Chair will determine whether a potential conflict of interest may exist. If so determined, the Chairperson shall decide whether or not to convene the full COIC. The Chair will forward all necessary information to the COIC members before the meeting is convened. The Chief Academic Officer, the IRB Director, the Department Chairperson and the Financially Interested Individual will be notified that the COIC is meeting to consider the potential conflict of interest. The Financially Interested Individual will be given the opportunity to submit a statement for review by the COIC. The COIC is charged with determining what conditions or restrictions, if any should be imposed by the Institution to manage, reduce or eliminate a conflict of interest. In doing so, the COIC s recommendations will be calibrated to correspond to the seriousness of the conflict of interest, and the likelihood that the conflict of interest could in fact influence persons to make inappropriate, unfair or unwise decisions in their conduct or oversight of human subjects research. The evaluation criteria used by the COIC do not vary by funding or regulatory oversight. The primary methods the COIC will consider in controlling, managing or eliminating conflicts of interest shall include: (i) Eliminating the conflict by referring the study to another site at which investigators are not conflicted, by referring the study to non-conflicted investigators at the Hospital, or by divesting or sequestering the conflicting financial interest or eliminating the investigator s leadership role; (ii) Requiring that investments posing a conflict of interest in a research study be frozen for a designated period of time lasting beyond the termination of the study, with the investigator allowed neither to sell nor transfer those interests until the end of that time period, thus providing for a forced attenuation of the research study and its results from the investigator s conflicting financial interest; Revised July, of 11

9 (iii) Disclosing the conflicting financial interest or leadership role to sponsors, research subjects, i.e., during the informed consent process, and/or journals and other publications. The following is sample informed consent language that the COIC may recommend be added to the Introduction section of the Consent Form document: The Investigator, Dr. ----, has a personal financial interest [or advisory/board or directors role] in [name of the sponsoring company or other interested entity] that may be affected by the outcome of this research study. This interest has been reported to the Winthrop-University Hospital s Conflict of Interest Committee. Please discuss with the Investigator any questions or concerns you may have about this issue. The Investigator is required to answer your questions about any conflicting interests that any member of the study team may have in regard to this research. Additional questions or concerns about these issues should be directed to: [IRB Chair and contact information]. The COIC may recommend more detailed written disclosure, depending on the circumstances and severity of the conflict of interest; (iv) Providing independent monitoring of the subject recruitment and/or informed consent processes; (v) Requiring independent monitoring and oversight of subject-researcher interactions, data gathering, data analysis, and/or data reporting; (vi) Arranging for review of all adverse events, including review of subject records on a comprehensive, periodic or sampled basis to assure that reports of adverse events have been timely and properly made; and/or (vii) Adopting procedures for the updating of information relating to the conflict, if it appears that the conflict might change in any appreciable way over the course of a research study. The Chief Academic Officer will report the COIC s decision to the appropriate department head, Chairperson, Director or Vice President. The IRB Director will act as the liaison to the WUH IRB and will inform the WUH IRB of the COIC s findings. These recommendations will be forwarded to the IRB Committee. Upon review of a particular protocol where a conflict has been identified the IRB Committee may accept the COIC s recommendations, however, the IRB Committee may impose a more stringent conflict management strategy that exceeds the COIC recommendations. 6. The Chief Academic Officer shall inform all sponsoring agencies or institutions of cases in which the Institution has placed a restriction on the Investigator to manage the conflict of interest or finds it is unable to satisfactorily manage an actual or potential conflict of interest. 7. The review of Research Financial and Other Interest Disclosure Forms requires the exercise of the utmost discretion by all participants. To the maximum extent permitted by federal and state law and by institutional policy, all elements of this process are to be treated as strictly confidential. The purpose of confidentiality is to assure that the integrity of the research and the Investigator, as well as the interests of the Institution, is protected at all times. 8. The Office of the IRB will provide administrative support to the COIC. It will maintain all original disclosures and records of all actions taken by the COIC to resolve actual or potential Revised July, of 11

10 conflicts of interest until at least five (5) years after the termination or completion of the research study to which they relate. 9. An annual summary of COIC s actions will be reported to the Hospital Board of Trustees through the Board s Compliance Committee. IV. Appeal Process The COIC determination may be appealed in writing to the Chair of the COIC by the Financially Interested Individual. The Financially Interested Individual can submit any documentation to support his/her request for appeal. The Chairperson will convene the COIC to consider the requested appeal within 15 business days of receipt. A final determination will be issued directly to the Financially Interested Individual. Any additional appeals will be heard and decided by the Chief Academic Officer, who will convene a committee to include the Chief Academic Officer and at a minimum a faculty person and an administrator. These individuals will not be affiliated with the Financially Interested Individual s department. Legal Counsel may also be required to advise the Committee. The Committee s decision is final. V. Compliance with this Policy Covered Individual responsibility: In cases in which a Covered Individual fails to comply with the Research Financial Interest Disclosure Policy, including misrepresenting information required on either the Research Financial and Other Interest Disclosure Form or the IRB Submission/ Application (Financial Disclosure/Conflict Of Interest Attestation section), the COIC Chairperson shall report non-compliance promptly in writing to the Chief Academic Officer and the IRB Chairperson. The Chief Academic Officer in conjunction with the IRB Chairperson and the IRB Director will review all applicable research studies and take appropriate action. Penalties for Non-Compliance: Failure to comply with the requirements of this Policy may lead to sanctions, including reprimand, censure, termination of funding, ineligibility for proposal submission and review, and suspension from all research activities. Failure to comply with this Policy or any misrepresentation of a Conflict of Interest may also be reported to and acted upon through the Medical Staff disciplinary process, in accordance with the Medical Staff By-Laws. Sanctions under that process can result, in egregious cases, in suspension or dismissal from the Medical Staff. The Chief Academic Officer shall report to the appropriate external funding source any instance in which an Investigator participating in externally funded research has not complied with this policy, and the specific corrective measures taken by the Institution. VI. Program to Educate the Institutional Community One of the best means to avoid disclosure issues is to educate all members of the institutional community in recognizing actual and potential Conflicts of Interest, or the appearance of such. It is essential that all persons subject to this policy be informed of its contents as well as understand the meaning of conflict of interest. Therefore, each Covered Individual and all department heads will receive this Policy annually. The Office of the IRB will be available to conduct educational workshops. Revised July, of 11

11 VII. Review and Evaluation of the Policy This policy has been reviewed and approved by the Chief Academic Officer and the Compliance Committee of the Hospital s Board of Trustees. The Chief Academic Officer shall periodically review this policy to determine if it is working as intended and whether any modifications are needed. The result of this review and evaluation as well as any changes in the Policy will be made available to the institutional community. Revised July, of 11