Financial Conflict of Interest Guidelines Office of Research & Commercialization August 24, 2012

Transcription

1 OFFICE OF RESEARCH & COMMERCIALIZATION Financial Conflict of Interest Guidelines Office of Research & Commercialization August 24, 2012 Purpose The university promotes objectivity in research by establishing standards to ensure research is free from bias resulting from investigator financial conflicts of interest. The following guidelines in concert with the university s conflict of interest policies set forth the university s procedures for defining, disclosing, managing and reporting investigator financial conflicts of interests who are engaged in research Applicability The guidelines apply to investigators who are involved with the design, conduct or reporting of sponsored and non-sponsored research. Initiating Authority Office of the Provost and Vice President for Research & Commercialization (ORC) Introduction ORC is responsible to maintain up-to-date written financial conflicts of interest policies and procedures that comply with federal regulations, state statutes, and university regulations. ORC will post a financial conflict of interest web page outlining the university s conflict of interest program to inform investigators of their responsibilities, meet federal regulatory requirements, and serve as a resource to promote objectivity in research. The university has identified the Faculty Relations Office and ORC as designated institutional officials to solicit and review disclosures of financial conflicts of interest, conflicts of commitment, and outside activity. Investigators Federal regulations and university policy require investigators engaged in the design, conduct, or reporting of research to disclose financial conflicts of interest on an annual basis or more frequently as 1

2 needed. Investigators are required to report significant financial interests that are related to their university responsibilities. 1) Investigators who are planning to participate in sponsored research must disclose their significant financial interest (and those of the investigator s spouse and dependent children) no later than the time of application to the sponsor. Investigators will certify whether they have a significant financial interest on the ORC Proposal Transmittal Form at the time of proposal submission. 2) Investigators must disclose significant financial interests prior to the expenditure of any sponsored funds. ORC will verify Investigator s disclosure prior to establishing a sponsored project account. 3) Investigators who are participating in research must submit an up-dated disclosure if they have entered into a significant financial interest since their last disclosure. 4) Investigators are required to complete university financial conflict of interest training prior to engaging in research no less than once every four years. University financial conflict of interest training consists of the CITI on-line module. ORC is responsible for delivering the financial conflicts of interest training and tracking investigator s training completion. 5) Investigators participating in research who are transferring from another institution must complete a conflict of interest disclosure and report all significant financial interests at the time of sponsor application but no later than thirty (30) calendar days from the date of employment. An investigator s disclosure must include updated information regarding any previously disclosed significant financial interest (e.g., updated value of equity interests, royalty distributions, and remuneration from outside entities). 6) Investigators engaged in research must submit an updated financial conflict of interest disclosure within thirty (30) calendar days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest. 7) Faculty, Executive Service staff and Post doctorial employees will report financial conflicts of interest on the on-line Potential Outside Activity, Employment, and Conflict of Interest and Commitment Faculty Report form (AA-21). Administrative and Professional, University Support Personnel Staff, Other Personnel Services staff, Adjunct Faculty (OPS) and students when applicable, will report conflicts of interest on the Potential Outside Activity, Employment, and Conflict of Interest and Commitment Report form (ORC- COI) via a hard copy disclosure submission process. 8) Investigators will cooperate with university designated officials to complete accurate financial conflicts of interest disclosure forms within the designated time periods, and provide related disclosure documents and information when required to enable the university to complete federal agency and state financial conflict of interest management reports. 2

3 Determining Relatedness and Whether a Significant Financial Interest is Affected by the Research 1) The university designated official(s) will review financial conflicts of interest disclosures to determine whether they are considered a significant financial interest, and refer the investigator s financial conflict of interest disclosure to the university s Conflict of Interest Committee. 2) The university s Conflict of Interest Committee will review the investigator s significant financial interest disclosure to determine if it could directly and significantly affect the design, conduct, or reporting of the research. 3) The university s Conflict of Interest Committee must determine whether the significant financial interest is related to the investigator s research. A significant financial interest is related to the research when the interest could be affected by the research; or is in an entity whose financial interest could be affected by the research results and outcomes. 4) The university s Conflict of Interest Committee will determine appropriate mitigation measures to manage or eliminate the significant financial interest by requiring exemption requests, monitoring plans or other appropriate management plans to ensure the research is free from bias or financial conflicts resulting from investigator significant financial interests. Remedies ORC in conjunction with the Office of Finance and Accounting, the Office of Faculty Relations, and the Office of General Counsel may take the following actions to ensure investigator compliance with university conflict of interest policies and procedures: 1) PeopleSoft Project account set-up will be suspended until investigator(s) completes the financial conflict of interest disclosure form. 2) ORC in conjunction with the Office of Finance and Accounting will inactivate PeopleSoft Projects whose investigator(s) have not completed the financial conflict of interest disclosure form or who have not completed financial conflict of interest training as outlined in these guidelines. 3) ORC will suspend or terminate subrecipient/affiliate agreements if their investigators have not completed required financial conflicts of interest training as outlined under the agreement. 4) Initiate appropriate personnel disciplinary action(s) to ensure compliance with the university s conflict of interest policies and procedures and these guidelines. 3

4 Subrecipient and Affiliates Financial Conflict of Interest Responsibilities 1) Subrecipients/Affiliates are responsible for disclosing significant financial interests that are directly related to the subrecipient/affiliates work being performed for the university. 2) ORC, as a part of the written subrecipient/affiliates agreement, will include terms establishing whether the financial conflict of interest policy of the university or that of the subrecipient/affiliate will apply. 3) The subrecipient/affiliate will certify to the university that its conflict of interest policies comply with Title 42 CFR Parts 50 and 94. If the subrecipient/affiliate is unable to certify that it has a compliant financial conflict of interest policy as delineated in CFR 42 Parts 50 and 94, the university agreement must require the subrecipient/affiliate, and their investigators, to be subject to the university s financial conflicts of interest policy, procedures and guidelines. 3) The university subrecipient/affiliate agreement will specify time period(s) to report significant financial interests related to the work performed for the university taking into consideration the university s reporting requirements to its funding sponsors. Subrecipients/affiliates must report significant financial interests related to the work performed by subrecipient/affiliate prior to the expenditure of funds under the agreement; and within sixty (60) calendar days of any significant financial interest identified subsequent to agreement execution. 4) If the subreciepient/affiliate is subject to the university s financial conflict of interest policies their investigators must complete financial conflict of interest training within thirty (30) calendar days of agreement execution. 5) Subrecipients/Affiliates subject to university financial conflict of interest policies and procedures must complete the financial conflicts of interest disclosure form enclosed in this guideline as Appendix A. Managing Conflicts of Interest 1) The university will designate an institutional official(s) to solicit and review disclosures of significant financial interests and will establish a conflict of interest committee to review disclosures and make recommendations to university officials. 2) The designated official(s) will review all investigator disclosures of significant financial interest prior to the expenditure of research funds, and refer cases to the Conflict of Interest Committee for evaluation and final determination. 3) When the designated official(s) or the Conflict of Interest Committee (Committee) determines an investigator has a significant financial interest that is related to their research and could affect the research and/or is in an entity whose financial interest could be affected by the research results and outcomes, the Committee will develop an exemption request, monitoring plan or management plan that shall specify the actions taken to mitigate and Manage the significant financial interest. Examples of 4

5 conditions and restrictions ORC or the Conflict of Interest Committee might impose to manage a financial conflict of interest include, but are not limited to: a) public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research); b) disclosure of financial conflicts of interest to subjects when the research involves human subjects research; c) appointment of an independent monitor authorized to take measures to protect the design, conduct and reporting of the research against bias resulting from the significant financial interest; d) modification of the research plan; e) change of personnel or personnel responsibilities, or the removal of personnel from participation in all or portions of the research; f) reduction or elimination of the financial interest (e.g., sale of an equity interest); or g) severance of relationships that create financial conflicts. 4) Designated official(s) must review new investigator significant financial interest disclosures or existing investigators disclosing new significant financial interests within sixty (60) days of the disclosure date to determine: a) whether a significant financial interest exists; b) whether the significant financial interest is related to the research; c) and if so, implement on an interim basis, a management plan that specifies actions that have been, and will be taken to Manage the significant financial interest. ORC will refer the financial conflict of interest disclosure to the Conflict of Interest Committee for further review and final determination. d) Investigators will agree, in writing, to appropriate terms and conditions of a monitoring plan, management plan and/or exemption request as a condition for performing their research to mitigate the conflict(s). 5) When ORC identifies or is informed that a significant financial interest was not disclosed timely by an investigator, and/or a subrecipient under a sponsored project, or, for whatever reason, the significant financial interest was not previously reviewed by the university during an ongoing research project, ORC will take the following actions within sixty (60) days: a) review the significant financial interest; 5

6 b) determine whether the significant financial interest is related to the investigators research, and/or is related to the subrecipient/affiliate statement of work being performed for the university; c) determine whether a financial conflict of interest exists; and, if so: (i) implement, on an interim basis, a management plan that will specify the actions that have been, and will be, taken to Manage the financial conflicts of interest; (ii) complete a Retrospective Review within one hundred and twenty calendar days (120) to determine whether the research or portions thereof, conducted during the time period of the noncompliance was biased in the design, conduct or reporting of the research. ORC will maintain the following documents on file for any Retrospective Reviews: a) project number; b) project title; c) names of all program directors(pd)/principal investigators(pi); d) name of the investigator with the financial conflict of interest; e) name of the entity with which the investigator has a financial conflict of interest; f) reasons for the retrospective review; g) detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed); h) conclusions of the review. (iii) Based on the Retrospective Review ORC will take the following action: a) update the university s financial conflict of interest sponsored report by specifying the action(s) ORC will take to Manage the significant financial interest; b) notify the research sponsor if bias is found, and submit a mitigation report with a description of the impact of the bias on the research activity. The report will include the university s actions to eliminate or mitigate the effect of the bias to include: (1) impact on the research project; (2) extent of harm done including any qualitative and quantitative data to support any actual or future harm; and (3) analysis of whether the research project is salvageable. 6) ORC is responsible for monitoring and adherence to investigator Exemption Requests, Monitoring Plans, and management plans issued by designated official(s) and/or the Conflict of Interest Committee. 7) ORC is responsible for ensuring the public has access to information concerning an investigator s significant financial interest prior to the investigator(s) expenditure of research funds when: (i) the significant financial interest is still held by the senior/key personnel (investigator), and (ii) the designated official(s) or the Conflict of Interest Committee determines the significant financial interest is related to 6

7 the investigator(s) research. When the requirements for public access are applicable ORC will make the following information available through its conflict of interest web site: a) investigator name, title and role under the research project; b) name of the entity in which the significant financial interest is held; c) nature of the significant financial interest; and d) the approximate dollar value of the significant financial interest in the following ranges: (i) $5,000 - $9,999; (ii) $10,000 - $19,999; (iii) $20,000 - $100,000 by increments of $20,000; (iv) amounts above $100,000 by increments of $50,000; or when applicable (v) a statement that the interest cannot be readily determined through reference to public prices or fair market value. ORC will update the web site annually or within sixty (60) days of receipt or identification of new information concerning the senior/key employee s significant financial interest. Public access information will remain available on the ORC Conflict of Interest web site for three (3) years from the date the information was most recently updated. Significant financial interests meeting public access requirements that have been eliminated prior to the expenditure of research funds will not be posted on the ORC Conflict of Interest web site. Sponsored Conflict of Interest Reports Prior to the expenditure of funds and when required by a research sponsor, ORC will provide financial conflict of interest reports for those investigators disclosing significant financial interests when: 1) the financial conflict of interest is related to the investigator s research; and 2) the financial conflict of interest could affect the research and/or is in an entity whose financial interest could be affected by the research results and outcomes. The funding sponsor s report will include monitoring and/or management plans to eliminate or mitigate the conflict. Significant financial interests that have been eliminated prior to the expenditure of funds will not be reported to the funding sponsor. Significant financial interests disclosed after the university submits a sponsor report will be reported to the sponsor within sixty (60) calendar days from the date of disclosure. Significant financial interests disclosed by new faculty will be disclosed within sixty (60) calendar days from the disclosure date. University significant financial interest reports will include monitoring and management plans and mitigation reports when warranted. When required, Retroactive Reports will be included with the university s significant financial interest reports to the sponsor, and include the reportable elements outlined in the Managing Conflicts of Interests section (paragraph 4c.(ii) and (iii))of these guidelines. 7

8 Definitions Conflict of Interest means a divergence between an individual s private interests and his or her employment obligations to the university such that an independent observer may reasonably question whether the individual s actions or decisions are influenced or determined by considerations other than the best interest of the university. Conflict of Commitment means an employee s devotion of time to activities that adversely affect his or her capability to meet their primary university responsibilities. Examples may include but are not limited to outside employment, pro bono or volunteer work, and government service in the public interest. Outside Activity or Employment means any compensated or uncompensated secondary employment or activity, private practice, private consulting, teaching, research, or other activity that is not part of the employee s assigned duties at the university. Financial Conflict of Interest means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of sponsored and non-sponsored research. Immediate Family means the employee s spouse, dependent children and/or individuals living in the same household. Investigator means the project director (PD) or principal investigator (PI) and any other person, regardless of title or position who is responsible for the design, conduct or reporting of sponsored and non-sponsored research. The term includes key personnel, collaborators or consultants who are responsible for the design, conduct or reporting of sponsored and non-sponsored research. Senior/Key Personnel means the project director (PD) or principal investigator (PI), and any other person identified as senior/key personnel in the sponsored research application, progress report, or any other technical or sponsored report. Institutional Responsibilities means an investigator s professional responsibilities on behalf of the university. Institutional responsibilities include research, teaching, professional practice, university committee memberships, and service on panels such as university review boards or data and safety monitoring boards. Manage means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias or personal financial gain. Proposal Transmittal Form is the Office of Research & Commercialization s on-line administrative and compliance form submitted by the investigator with a sponsored proposal and routed to academic/research units and ORC for review and approval. 8

9 Research means a systematic experiment, study, demonstration, or survey designed to develop or contribute general knowledge (basic research) or specific knowledge (applied research) in all fields by establishing, discovering, developing, elucidating, or confirming engineering, science, medicine, education, mathematics, humanities, and research involving human subjects or animals. The term includes product development to include a diagnostic test or drug. 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 immediate family that reasonably appears to be related to the investigator s university 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 (12) months preceding the disclosure and the value of any equity interest or fixed asset value of the entity as of the date of disclosure, when aggregated, equals or exceeds $5,000; (ii) with regard to any non-publically traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve (12) months preceding the disclosure, when aggregated, equals or exceeds $5,000 or when the investigator or the investigator s immediate family holds any equity interest (e.g., stock, stock options, or other ownership interest); or (iii) intellectual property rights and interests (e.g., patents, copyrights & trademarks), upon receipt of income related to such rights and interests (2) the occurrence of any reimbursed travel (i.e., that which is paid on behalf of the investigator and not reimbursed to the investigator related to the investigator s institutional responsibilities. This disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency, or is funded through a sponsored contract or grant through the Office of Research & Commercialization. (3) The term significant financial interest does not include: (i) salary, royalties, or other remuneration paid by the university (ii) income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with the university. (iii) income from service on advisory committees, review panels for a Federal, state, or local government agency, institution of higher education, an academic teaching hospital, medical center, or research institute affiliated with the university. Subrecipient/Affiliate means a compensated or un-compensated subcontractor, subrecipient, consultant, collaborator or other third party entity performing research services for the university under a written or verbal agreement. 9