POLICY AND PROCEDURES Financial Conflict of Interest in Sponsored Projects and Research Last updated 11.30.2016 I. Introduction The New School is committed to maintaining the highest standards of honesty and integrity in research. This policy and the procedures described below will promote integrity in research by the review, identification and management of disclosed financial conflicts of interest.

II. Individuals Covered by this Policy and Procedures This policy and its accompanying procedures apply to Investigators working on externally sponsored projects and research. An investigator is defined as any person who is responsible in part or wholly for the oversight, design, conduct, outcomes, or reporting of an externally funded sponsored project or research activity being administered by The New School (hereinafter “University”). Investigators can include faculty, staff employees, or students, sub-recipients, collaborators or consultants. III. Definitions Significant Financial Interest (SFI): Anything of monetary value rising to the level of significance as defined in Appendix A. A SFI can include salary, other payment for services rendered (e.g. consulting fees or honoraria); equity interests (e.g. stocks, stock options, or other securities); or intellectual property rights. Institutional Responsibilities: means an Investigator’s professional responsibilities on behalf of the University as follows: research, research consultation, teaching, professional practice, institutional committee memberships and service on panels such as the Institutional Review Board. Financial Conflict of Interest in sponsored research (FCOI): Exists when the General Counsel reasonably determines that a SFI could directly and significantly affect the design, conduct or reporting of sponsored research as defined in Appendix B. Designated Official: the Designated Official as defined by 42 CFR Part 50 is the University's General Counsel. Conflicts Review Committee: the University committee appointed at the discretion of the Designated Official charged with reviewing SFI disclosures to reasonably determine of the SFI is a FCOI. Manage: taking action to address a FCOI, which can include reducing or eliminating the FCOI to ensure to the greatest extent possible, that the design, conduct and reporting of research will be free from bias.

Management Plan: the plan that is implemented to manage an identified FCOI. Public Health Service (PHS): comprises all agency divisions of the U.S. Department of Health and Human Services (HHS) and the Commissioned Corps. PHS falls under the leadership of the Assistant Secretary of Health and the Surgeon General within HHS. Further information can be found on the HHS Agencies & Offices website. FCOI Report: the report made to the PHS funded unit in accordance with the requirements set forth in 42 CFR Part 50 informing of the implementation of a management plan relating to a PHS funded research project Research: within this policy research means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test). IV. Investigator Disclosure Procedures Disclosure of SFIs, for PHS funded research 1. All PHS funded investigators are required to disclose any SFIs that are related to their institutional responsibilities (Appendix A.I.) 2. Disclosure is made to the Office of Research Support 3. For PHS funded researchers, disclosure of a SFI must occur (i) at the time of proposal or (ii) within 30 days of discovering or acquiring the SFI Disclosure of SFIs, for non-PHS funded research 1. All non-PHS funded investigators are required to disclose any SFIs that are related to their funded research (Appendix A.II.) 2. Disclosure is made to the Office of Research Support 3. For Non-PHS funded researchers, disclosure must be made in accordance with any specific sponsor requirements, such as the time of award or within a reasonable time of discovering or acquiring the SFI

V. University Review and Reporting Procedures Review of SFIs, for PHS funded research 1. For PHS funded researchers, upon disclosure of a SFI, a member of the Office of Research Support will review the disclosure for completeness and to see if the SFI is related to the Investigator’s externally funded research 2. If it is related, the Office of Research Support will forward the disclosure to the Designated Official for further review 3. Upon review of the SFI disclosure, the Designated Official will decide if the Conflicts Review Committee needs to be convened 4. The Designated Official will determine if the SFI is a FCOI (Appendix B.I.) 5. If the SFI is a FCOI, the Designated Official will develop and implement a management plan and ensure the plan is reported to the PHS Funding Component within 60 days of the disclosure of the SFI

Financial Conflict of Interest in Sponsored Projects and Research: version 11.04.2016

Review of SFIs, for non-PHS funded research 1. For non-PHS funded researchers, upon disclosure of a SFI, a member of the Office of Research Support will review the disclosure for completeness and to see if the SFI is related to the Investigator’s externally funded research 2. If it is related, the Office of Research Support will forward the disclosure to the Designated Official for further review 3. Upon review of the SFI disclosure, the Designated Official will decide if the Conflicts Review Committee needs to be convened 4. The Designated Official will determine if the SFI is a FCOI (Appendix B.II.) 5. If the SFI is a FCOI, the Designated Official will develop and implement a management plan and report the same in accordance with any funding agency requirements. Reporting of FCOIs 1. For PHS funded research, a FCOI report will be sent to the PHS Funding Component within 60 days of the disclosure of the SFI if it is determined that the SFI is a FCOI 2. For PHS funded research, per 42 CFR Part 50, information regarding FCOIs shall be made available within five (5) business days to any request made by the public 3. For non-PHS funded researchers, the FCOI will be reported in accordance with the sponsor’s requirements. VI. Ongoing Review of Identified FCOIs All FCOIs will be reviewed annually by the Designated Official to ensure that the management plan to the greatest extent possible, ensures that the design, conduct and reporting of research will be free from bias.

VII. Non Compliance, Corrective Actions, and Reporting 1. For PHS funded researchers, whenever the University identifies a SFI that was not reported within the prescribed time frames set out in 42 CFR Part 50, the following steps will be taken: a. Within 60 days of the date of disclosure, the Designated Official shall review the disclosure to determine if it is a FCOI; b. If the SFI is a FCOI, a management plan will be implemented and reported to the PHS funding unit; c. In addition to the management plan, per 42 CFR Part 50, a retrospective review will be conducted to determine if there was any bias in the design, conduct or reporting of such research; d. If bias is found, the University will notify the PHS Awarding Component and submit a mitigation report 2. For non-PHS funded researchers, whenever the University identifies a SFI that was not disclosed timely by an Investigator or, for any other reason, was not previously reviewed by the University during an ongoing funded research project, the Designated Official will take corrective and reporting actions as prescribed by the funding agency.

Financial Conflict of Interest in Sponsored Projects and Research: version 11.04.2016

VIII. Training Each investigator shall complete financial conflicts of interest training prior to engaging in research funded by an external grant. The training shall consist of an overview of University policy on financial conflicts of interest, the Investigator’s responsibilities regarding disclosure of significant financial interests and any other regulations or policies relating to financial conflict of interest. Non-PHS funded research The Office of Research Support will facilitate any other training requirement in accordance with funder regulations. PHS-funded research Training must be completed at least once every four years, or immediately if the investigator is (i) new to the university, (ii) found not in compliance with the University’s financial conflict of interest policy or FCOI management plan, or (iii) the University changes this policy in a manner that affects Investigator’s responsibilities.

References 42 CFR Part 50 Subpart F—Promoting Objectivity in Research NIH Financial Conflict of Interest NSF Conflict of Interest Policies, PAPPG January 2017 (nsf17001) NEH General Terms and Conditions for Awards General Guidelines for Awards Funded by the Department of Defense (DoD) DoD Rule on Organizational Conflict of Interest Government acquisition regulations – FAR subpart 9.5

Financial Conflict of Interest in Sponsored Projects and Research: version 11.04.2016

APPENDIX A STANDARDS FOR DISCLOSURE OF SIGNIFICANT FINANCIAL INTEREST I. For PHS funded investigators Per 42 CFR Part 50, the following standards will be used to define significant financial interest: 1. Any current or pending ownership interests (including shares, partnership stake, derivative interest such as stock options) in a privately-held entity held by the investigator or his/her spouse or dependent children related to the investigator’s institutional responsibilities; and/or 2. Any current or pending ownership interest of $5,000 or more (including shares, derivative interests such as stock options) in a publicly traded entity held by the investigator or his/her spouse or dependent children related to the investigator’s institutional responsibilities; and/or 3. Any income amount to $5,000 or more per year per company/entity including payment for services, consulting fees honoraria, licensing or royalty income or any other financial interest in a single entity that amount to $5,000 aggregately received by the investigator, or his/her spouse or dependent children related to the investigator’s institutional responsibilities; and/or 4. Any reimbursed or sponsored travel that amount to $5,000 in aggregate from a single entity over the period of the previous year related to the investigator’s institutional responsibilities.

II. For non-PHS funded investigators Standards to be used to define significant financial interest as defined by grant and institutional policy are as follows; 1. Income (salary, royalties, or other payments) from a single entity which when aggregated for the investigator or his/her spouse or dependent children exceeds $10,000 over twelve months; and/or 2. An equity interest in a single entity held by the investigator, their spouse or dependent child when aggregated is in excess of $10,000 in values as determined through reference to public prices or other reasonable measure of fair market value; and/or 3. A 5% or more ownership in a single entity

Financial Conflict of Interest in Sponsored Projects and Research: version 11.04.2016

APPENDIX B STANDARDS FOR DETERMINATION OF FINANCIAL CONFLICT OF INTEREST I. For PHS funded investigators Per 42 CFR Part 50, the standards for determining when a significant financial interest is a financial conflict of interest are as follows: 1.

2.

The SFI is related to the investigator’s PHS funded research. A SFI is related to an investigator’s PHS funded research when it can be reasonably determined that the SFI: could reasonably affect the PHS funded research, or is in an entity whose financial interest could be affected by the research; and A reasonable determination is made that the SFI could directly and significantly affect the design, conduct or reporting of the PHS-funded research.

II. For non-PHS funded investigators The standards for determining when a significant financial interest is a financial conflict of interest are as follows: 1.

A reasonable determination is made that the SFI could directly and significantly affect the design, conduct or reporting of the funded research.

Financial Conflict of Interest in Sponsored Projects and Research: version 11.04.2016