Financial Conflict of Interest Policy and Procedural Manual

Transcription

1 Financial Conflict of Interest Policy and Procedural Manual Financial Conflict of Interest... 1 Policy and Procedural Manual... 1 Financial Conflict of Interest Policy... 2 Disclosure of Financial Conflicts of Interest... 5 Conflict Review and Determination... 5 Management of Financial Conflicts of Interest... 5 Noncompliance... 6 Sponsor and Public Disclosure... 7 Sub-Recipients and Grant Sub-Awards... 7 Policy Violation and Disciplinary Action... 8 Mandatory Education... 8 Records Retention... 9 Fiancial Interests Disclosure Form Required Information in Financial Conflict of Interest Reports Required Information in Documentation of Retrospective Reviews Required Information in Written Responses to Public Requests... 14

2 Page 2 of 14 Financial Conflict of Interest Policy Policy Owner: Mary Clem Effective Date: 02/10/2013 Department: Office of Research and Sponsored Programs Revised Date: 04/13/ General Policy Regulations 42 CFR 50 Subpart F and 45 CFR 94 of the U.S. Department of Health and Human Services requires all Public Health Service (PHS) sponsored Investigators and their families to disclose financial conflicts of interest that hold potential to directly and significantly affect the design, conduct or reporting of PHS-sponsored research. Similarly, AAG Chapter IV.A contains the National Science Foundation s (NSF) policy on conflicts of interest. This Financial Conflicts of Interest (FCOI) Policy is designed to meet PHS and NSF regulatory requirements. It is predicated on the expectation that Investigators conduct their affairs so as to avoid or minimize conflicts and respond appropriately when conflicts arise. Investigators have an obligation to become familiar with and abide by this policy. Violation of this FCOI policy may constitute cause for disciplinary or other administrative action. 2.0 Policy Definitions Public Health Service (PHS) of the U.S. Department of Health and Human Services includes 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. Investigator means any individual responsible for the design, conduct or reporting of sponsored research or proposals for such funding. This may include principal investigator, co-investigator, postdoctoral associates, senior scientists, graduate students, collaborators or consultants, as appropriate. Family means an Investigator s immediate family, including spouse and dependent children. Significant Financial Interest means (1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities: (i) 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,

3 Page 3 of 14 as determined through reference to public prices or other reasonable measures of fair market value; (ii) 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); or (iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests. (2) The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; 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; 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 teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. (3) 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 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. The Institution's FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution's FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research. Financial Conflict of Interest (FCOI) means a Significant Financial Interest that has potential to directly and significantly affect the design, conduct or reporting of sponsored research. Institutional Responsibilities means the Investigator s responsibilities as part of their University appointment, such as research, teaching, professional practice, program administration and service.

4 Page 4 of 14 Research is a systematic investigation, study, or experiment designed to contribute to generalizable knowledge, which encompasses basic and applied research and product development. Institutional Official (IO) is the individual accountable for oversight of this policy and who has authority to suspend related activities until FCOI are resolved or other appropriate action is implemented. At the University, the IO is the Director of Research & Sponsored Programs. Conflict of Interest Committee (COI Committee) means the IO may assemble an ad hoc committee to advise conflict of interest matters. Members may include faculty, senior staff and/or outside experts. The Committee will review potential financial conflicts and devise a plan to manage actual conflicts ( Management Plan ) consistent with regulatory requirements and objective pursuit of research. Management Plan means the document created by St. Catherine University that specifies the actions to eliminate, reduce and/or manage a FCOI. Management may consist of a disclosure in presentations and manuscripts, removing the conflicted individual from primary oversight of the research, or reducing or eliminating the financial interest via a structured plan. Key elements of a management plan include: Role and principal duties of the conflicted Investigator in the research project; Conditions of the management plan; How the management plan is designed to safeguard objectivity in the research project; Confirmation of the Investigator s agreement to the management plan; How the management plan will be monitored to ensure Investigator compliance, and other information as needed. Mitigation Report is the document created as the result of a FCOI that was not identified or managed properly. The Mitigation Report should include: the elements documented in the retrospective review; 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. For-Profit Entity is an organization, institution, corporation, or other legal entity that is organized or operated for the profit or financial benefit of its shareholders or other owners. A for-profit organization is considered to be a small business if it is independently owned and operated, if it is not dominant in the field in which research is proposed, and if it employs no more than 500 persons. 3.0 Referenced Documents Exhibit A - Financial Interests Disclosure Form Exhibit B - Required Information in Financial Conflict of Interest Reports Exhibit C - Required Information in Documentation of Retrospective Reviews Exhibit D - Information to be included in Written Responses to Public Requests

5 Page 5 of 14 Disclosure of Financial Conflicts of Interest 1.0 Policy All Public Health Service (PHS) agency (such as AHRQ, HRSA, and NIH) and National Science Foundation (NSF)-sponsored Investigators and their families must disclose financial conflicts of interest that hold potential to directly and significantly affect the design, conduct or reporting of sponsored research. 1) All Investigators must submit Disclosure Forms (Exhibit A) to the Office of Research & Sponsored programs to communicate Significant Financial Interests on the timeline described below. a) Initially, at the time a proposal is submitted to an NSF or PHS entity. b) Thereafter, Disclosure Forms must be updated: I. Within 30 days of discovering or acquiring (e.g., through purchase, marriage or inheritance) any new Significant Financial Interest; and II. Annually in the period of an award, beginning with the anniversary date of the original disclosure. 2) The University will not submit grant proposals to NSF and PHS entities on behalf of Investigators who have not submitted Disclosure Forms. Conflict Review and Determination 1.0 Policy Disclosure Forms will be reviewed promptly by Institutional Official or designee to determine whether a Significant Financial Interest meets the definition of a Financial Conflict of Interest. The following questions may help guide determination: a) Would the Investigator risk a financial loss depending on the outcome of the research? b) Are there potential financial gains to the Investigator based on the outcome of the research? c) If the entity in question or the Investigator s relationship with that entity stands to benefit from the research (as a vendor, sub-recipient or otherwise interested party), is there a compelling scientific or technical reason for such a relationship? d) Would there be cause for a reasonable person to question the Investigator s ability to be objective in conducting and reporting the research? Management of Financial Conflicts of Interest 1.0 Scope Where a Financial Conflict Of Interest exists, the Institutional Official, assisted by the Conflict of Interest Committee will determine how to manage, eliminate or reduce the conflict.

6 Page 6 of 14 If a FCOI exists, one or more steps should be taken to reduce or eliminate conflict, such as: a) Monitoring of research by independent reviewers; b) Modifying the research plan; c) Disqualifying Investigator from participation in the portion of the federallyfunded research that would be affected by Significant Financial Interests; d) Divesting of Significant Financial Interests; e) Severing relationships that create conflicts; or f) Publicly disclosing the FCOI. The IO, COI Committee and Investigator will discuss features and implementation of the Management Plan, and the Investigator must agree in writing to the Plan before research can proceed. If the COI Committee and Investigator cannot agree upon a Management Plan, the relevant regulatory bodies and funding agencies will be notified. Noncompliance 1.0 Policy If a FCOI was not identified or managed appropriately due to failure to: a) Disclose a Significant Financial Interest determined to be a FCOI; b) Appropriately review or manage an FCOI; c) Materially comply with a Management Plan for a FCOI. Then the Institutional Official will assemble a COI Committee to carry out these steps: a) Within 120 days of the determination of noncompliance, to complete a Retrospective Review of the Investigator s activities and project to determine whether any research (or portion thereof) conducted during the time period of the noncompliance was biased in the design, conduct or reporting of research; b) Document the Retrospective Review, including at a minimum, but not necessarily limited to, the elements set forth in the attached Exhibit C; c) Update the previously submitted FCOI Report, specifying the actions taken to manage the FCOI going forward; and d) If bias is found, notify NSF or PHS sponsor and submit a Mitigation Report (the document created as a result of a FCOI that was not identified or managed properly) that includes: a. Elements documented in the retrospective review, b. A description of the impact of the bias on the research project and c. The plan of action to eliminate or mitigate the effect of the bias (i.e. impact on the research project, extent of harm done, including any qualitative and quantitative data to support any actual or future harm, analysis of whether research project is salvageable. e) Thereafter, FCOI reports are to be submitted annually.

7 Page 7 of 14 Sponsor and Public Disclosure 1.0 Scope To the extent permitted by law, Disclosure Forms, FCOI Management Plans and related documents will be confidential. However, under certain circumstances, the University may be required to share information with sponsors or the public. The Investigator will be informed of any disclosure. Within 60 days of the identification of a new FCOI, the University must share information with PHS and NSF sponsors on FCOI and related management plans, with information provided per Exhibit B, along with a statement that the information is current as of the date of the correspondence and subject to updates on at least an annual basis. Prior to the expenditure of any funds for a PHS-funded research project, the University must meet minimum PHS disclosure requirements concerning any Significant Financial Interest that meets all three of the following criteria: a) Was disclosed and is still held by the senior and key personnel; b) Was determined to be related to the PHS-funded research; and c) Was determined to be a FCOI. Specifically, the University must post the information at or respond to public requests for information, providing information in Exhibit D in writing within five business days of the request. Information posted on the University s website will be updated at least annually, and within sixty days of the receipt or identification of information concerning additional significant financial interests of senior/key personnel for PHS or NSF funded research that was not previously disclosed. In situations of documented non-compliance involving a PHS-sponsored clinical research project evaluating the safety or effectiveness of a drug, medical device, or treatment, the Investigator must disclose FCOI in each public presentation of the results of the affected research and request an addendum to previously published presentations. Sub-Recipients and Grant Sub-Awards 1.0 Policy The University is responsible for ensuring all sub-recipients the individuals and organizations contracted to perform service under NSF or PHS grants where St. Catherine is the prime grantee--comply with applicable federal regulations regarding FCOI. The University s written agreement with each sub-recipient will specify whether this policy or the applicable policy of the sub-recipient s institution, will apply to sub-

8 Page 8 of 14 recipient Investigators. The sub-recipient agreement initiated by Office of Research & Sponsored Programs will specify the timing for reporting of FCOIs by sub-recipients to the University to enable timely review and reporting with funding agency requirements. Policy Violation and Disciplinary Action 1.0 Policy Violation of this policy is grounds for discipline of an Investigator or other employee. If it is decided to impose sanctions, those conditions will be described by the Institutional Official in a written explanation to the Investigator, COI Committee and IRB, where applicable. The Investigator will also be notified of the right to appeal the decision. The IO will promptly notify NSF or PHS and prime awardee, where appropriate, of action taken or to be taken. The following acts violate the University s FCOI Policy: a) Intentionally reporting incomplete, misleading or erroneous information on a Disclosure Form; b) Failing to make a required disclosure of a known Significant Financial Interest; c) Failure to provide information related to financial disclosures or possible conflicts of interest; d) Failure to abide by the terms of a FCOI Management Plan. A violation of this policy is grounds for discipline of an Investigator or other employee. Sanctions that may be imposed for violation include but are not limited to any of the following: a) Letter of admonition; b) Temporary suspension of access to active research funding, either for a fixed term or pending completion of a remediation plan; c) Temporary suspension of rights to apply for research funding as a PI, either for a fixed term or pending completion of re-training and remediation; d) Investigation and mitigation of possible bias in research resulting from improperly disclosed FCOIs and reporting within 120 days of discovery of the violation of corrective action to the relevant funding agency/ies; e) Inquiry into possible academic and research misconduct per University policy and related disciplinary actions outlined in the Constitution & Bylaws of the Faculty and Employee Handbook. Mandatory Education 1.0 Scope Each Investigator must complete FCOI education per federal regulations and University policy: a) Prior to engaging in research funded by NSF, NIH and other PHS-affiliated agencies and at least every four years thereafter. b) If the University s FCOI Policy is amended to affect requirements of Investigators, c) If the investigator is new to the institution, or d) If an Investigator has not complied with this policy or with a Management Plan.

9 Page 9 of 14 For investigators who have or are seeking research sponsorship from non-phs and NSF agencies, the above training activities are optional but strongly recommended. The Collaborative Institutional Training Initiative (CITI) is the University s provider of mandatory FCOI education. Go to to register as a new user. If you are a returning user, or if you have come from another institution, you should use your previous username and password. You will want to affiliate with St. Catherine University (under affiliate with another university). Any previously completed coursework will now show up. If you have already completed a course for another institution, you will not need to take it again until the certification expires (every four years from completion date). Records Retention 1.0 Policy The Office of Research and Sponsored Programs will retain all FCOI Disclosure Forms, Management Plans, and related documents and records for up to seven years as required by the grant or contractual agreement, as well as federal and state laws, as applicable. Some documents, particularly contracted projects, may stipulate longer retention requirements. See the grant or contract agreement for specific terms. Where any litigation, claim, financial management review or audit is started before the expiration of the retention period, records shall be retained until all activities are resolved and final action taken. All records will be retained electronically for the required Retention Period on the Office of Research and Sponsored Program s institutional network drive. Hard (paper) copies of all records will be retained in the Office of Research and Sponsored Program s files folders created for each applicable grant or contract. At the end of the Retention Period, all applicable documents will be destroyed.

10 Page 10 of 14 Name: Financial Interests Disclosure Form Exhibit A Page 1 I am reporting on activities: for the year as an addendum to my most recent report Yes No 1. Compensation (including travel expenses): have you or a member of your family received compensation from an entity for activities such as consulting, expert witness, advisory board membership, and the like? If yes, furnish information on an additional page. Yes No 2. Equity: do you or a member of your family own stock or hold stock options with a publicly-traded or privately-owned entity? If yes, furnish information on an additional page. Yes No 3. Role: do you or a member of your family serve as a director, trustee, officer or other key employee in a for-profit entity, partnership, business, or other entity outside of the St. Catherine University? If yes, furnish information on an additional page. Yes No 4. Intellectual Property: do you or a member of your family have rights to and/or receive royalties from intellectual property (including, patents copyrights and trademarks but excluding academic or scholarly works) licensed to and/or owned by a for-profit entity? Do NOT include intellectual property owned or managed by St. Catherine University. If yes, furnish information on an additional page. Certification: I have read and understand the St. Catherine University s policy on Financial Conflict of Interest in NSF and PHS-Funded research and have completed this report to the best of my knowledge and belief, If required, I will comply with any conditions or restrictions imposed by St. Catherine University to manage any real or perceived conflicts. Should my financial or managerial interests, or those of my Family, change in a way that results in different answers to any of the questions asked in this report, I agree to submit a revised form within 30 days. (date) (signature) Additional page(s) attached

11 Page 11 of 14 Financial Interests Disclosure Form Exhibit A Page 2 Addition to Financial Disclosure Report of: Reporting for: Self Family member: Name: Relationship: Name of External Entity: Address of External Entity: Type of external relationship: (check all that apply) Consultant Speaker Advisory Board or Committee Equity Holdings Governing Board or Officer Intellectual Property Rights Royalty Income Other (describe below) Amount of compensation or financial interest in reporting period: $ If travel paid by entity: Destination Amount $ Comments or explanatory information:

12 Page 12 of 14 Exhibit B Financial Conflict of Interest Reports Required Information (1) Project number: (2) PD/PI (or Contact PD/PI if multiple PD/PIs): (3) Name of Investigator with the FCOI: (4) Name of the entity with which the Investigator has a FCOI: (5) Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium): (6) Value of the financial interest (dollar ranges are permissible): a. $0-$4,999 b. $5,000-$9,999 c. $10,000-$19,999 d. amounts between $20,000-$100,000 by increments of $20,000 e. amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through references to public prices or other reasonable measures of fair market value. (7) A description of how the financial interest relates to the federally-funded research and the basis for the determination that the financial interest conflicts with such research: (8) A description of the key elements of the Management Plan, including: a. Role and principal duties of the conflicted investigator in the research project: b. Conditions of the management plan: c. How the Management Plan is designed to safeguard objectivity in the research project: d. Confirmation of the investigator s agreement to the Management Plan: e. How the Management Plan will be monitored to ensure investigator compliance: f. Other information as needed.

13 Page 13 of 14 Required Information: (1) Project number: (2) Project title: Exhibit C Documentation of Retrospective Reviews (3) PD/PI or contact PD/PI if a multiple PD/PI model is used: (4) Name of the Investigator with the FCOI: (5) Name of the entity with which the Investigator has an FCOI: (6) Reason(s) for the retrospective review: (7) Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed): (8) Findings of the review: (9) Conclusions of the review:

14 Page 14 of 14 Required Information (1) The Investigator s name: Exhibit D Written Responses to Public Requests (2) The Investigator s title and role with respect to the research project: (3) The name of the entity in which the SFI is held: (4) The nature of the SFI: (5) The approximate dollar value of the SFI (dollar ranges are permissible): a. $0 $4,999; $5,000 $9,999 b. $10,000 $19,999 c. amounts between $20,000 $100,000 by increments of $20,000 d. amounts above $100,000 by increments of $50,000 e. or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.