ࡱ> ?B<=>K ~^bjbjTSTS ;d694i694i$H-  (((<<<8t<<y&T%.%.%V%'Hf*D+wwwwwww${~Tx5(N,&&"N,N,x.%(V%Sy2333N,^V%8V%w3N,w33Dl4rV%,xn>wy<yn.~R-*~|rr~(rN,N,3N,N,N,N,N,xx|1nN,N,N,yN,N,N,N,~N,N,N,N,N,N,N,N,N, X j:  PHS agencies include: AHRQ, ATSDR, CDC, FDA, HRSA, IHS, NIH, OASH, OASPE, OASPR, ACL, ACF, ONC, and SAMHSA. Several other health-related research sponsors comply with PHS guidelines. A list can be found HYPERLINK "http://thefdp.org/default/fcoi-clearinghouse/fcoi-agencies/"here. This form can be completed electronically in Microsoft Word, saved and e-mailed to  HYPERLINK "mailto:COI-compliance@andrew.cmu.edu" COI-compliance@andrew.cmu.edu. If you have questions, please email or call 412-268-5858. Instructions You have been identified as an Investigator who will be participating in a ý research project as a subcontractor or consultant, or as a future ý Investigator who is not currently able to use the SPARCS system to submit a disclosure. In order to comply with the Public Health Services regulations on Conflict of Interest, you must submit a financial interest disclosure to ý Mellon. If you believe this does not apply to you, or if you have Significant Financial Interests of a type that this form is not designed to handle, please contact us at  HYPERLINK "mailto:COI-compliance@andrew.cmu.edu" COI-compliance@andrew.cmu.edu. Investigator Responsibilities As defined by federal regulation, Investigator means the Project Director, Principal Investigator or any other person, regardless of title or position, who is responsible for design, conduct or reporting of research funded or proposed for funding. This includes all key personnel identified in the grant application, progress report or other report submitted to the funding agency by the Institution. U.S. Federal regulations require that recipients of research funding disclose certain financial interests to the university. As a PHS funded Investigator, you are required to disclose certain financial relationships with external organizations. This includes remuneration received or ownership interests held by you, your spouse, or your dependent children that are related to your Institutional Responsibilities in regard to your research collaboration with ý. Investigators are responsible for filing an accurate disclosure annually and within thirty (30) days of discovering or acquiring (through marriage, purchase, gift, inheritance, etc.) a new Significant Financial Interest. Your disclosure will be reviewed by ýs Office of Research Integrity and Compliance (ORIC). If it appears that you may have a Financial Conflict of Interest, you will be contacted by someone from ORIC. At that point, you may be asked to provide additional details about your disclosed information. All Investigators must become familiar with PHS and ý policies regarding Financial Conflicts of Interest in Research. Information is embedded in this disclosure form and available on the ý ORIC website. Consistent with PHS regulations all PHS funded Investigators must complete training on FCOI. In addition to review of the information contained in this disclosure document, Investigators need to complete an  HYPERLINK "http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm" online tutorial before spending on a new award. Please refer to the following: ý policies on HYPERLINK "http://www.cmu.edu/policies/administrative-and-governance/conflict-of-interest-commitment.html"Conflict of Interest and Commitment, HYPERLINK "http://www.cmu.edu/policies/research/compliance-financial-coi-research.html"Financial Conflicts of Interest in Research, and  HYPERLINK "/research-compliance/organizational-conflict-of-interest/documents/cmu-policy-oci-2016.pdf" Organizational Conflict of Interest HYPERLINK "/research-compliance/conflict-of-interest/documents/guidelines-coi.pdf"ý Guidelines on Compliance with Financial Conflict of Interest Regulations HYPERLINK "http://www.cmu.edu/research-compliance/conflict-of-interest/index.html"ý COI webpage Definitions This form is designed to help you disclose Significant Financial Interests (SFI) related to your Institutional Responsibilities. These terms are defined as follows: Significant Financial Interests (SFI) include certain payments, ownership interests, and intellectual property rights and interests. Remember, you need only disclose these financial relationships if they relate to your Institutional Responsibilities in your collaboration with ý, as described below. You should disclose relationships with both U.S. and foreign entities. What should be disclosed depends on a number of factors. SFI includes and you should disclose: Your salary from your home institution, if the work you do there is related to the work you will do in collaboration with ý. Financial ties with publicly traded companies if the value of any compensation or payment in the preceding 12 months, plus the value of any equity interest as of the date of this disclosure, exceeds $5,000. This includes salary, payment for services, stock, stock options or other ownership interest. For example, if Acme paid you $3,000 for consulting and you own $1,000 of Acme stock, you need not disclose this. However, if you were paid $3,000 for consulting and own $2,500 of stock, you should disclose as the aggregated amount exceeds $5,000. Financial ties with private entities not publicly traded, if you have any equity such as stock, stock options, or other ownership regardless of dollar value. Additionally, you should disclose any compensation or payment in the preceding 12 months which exceeds $5,000. Income from intellectual property rights and interests such as patents and copyright, upon receipt of income, where the payments are not from ý Mellon and exceed $5,000. SFI does not include (so you need not disclose): Salary, royalties, or other payments from ý Mellon; Investments such as mutual funds where you do not directly control investment decisions; Income from seminars, lectures, or teaching engagements sponsored by a U.S. government agency, institution of higher education, academic teaching hospital, medical center or research institute affiliated with a U.S. institution of higher education. You must disclose these forms of income if they come from a non-U.S. institution. Income from service on an advisory committee or review panel for a U.S. government agency, institution of higher education, academic teaching hospital, medical center, or research institute affiliated with a U.S. institution of higher education. You must disclose these forms of income if they come from a non-U.S. institution. Institutional Responsibilities involve a variety of scholarly and professional obligations carried out on behalf of an institution such as teaching, research, scholarship, professional practice and service (on university, association, advisory or technical committees, editorial boards). Activities related to an individuals field of professional expertise are usually either Institutional Responsibilities or related to their Institutional Responsibilities. Because you are an External Collaborator, you only need to report SFIs related to your Institutional Responsibilities to ý Mellon, through any subcontracts or consulting agreements you have with ý. Examples of Institutional Responsibilities to ý: Research - conducting research related to ones professional expertise under a subcontract or consulting agreement to ý; Practice engaging in professional practice of ones craft or art at ý Examples of activities related to Institutional Responsibilities to ý: Consulting - providing your professional expertise to a start-up company, non-governmental organization or other university if it is in an area related to your collaboration with ý; Expert testimony using your professional expertise to provide testimony on behalf of a client or as part of a government proceeding in an area related to your collaboration with ý; Service serving on an advisory board or committee in a topical area where you have professional expertise related to your collaboration with ý; Other paid work writing a textbook in an area of expertise related to your collaboration with ý. Examples of activities NOT related to Institutional Responsibilities to ý: Teaching giving ski lessons; teaching courses on a topic unrelated to your collaboration with ý; Service - participating on a committee as a parent for your childs school; Consulting in an area unrelated to this research collaboration Other paid work writing a novel, jury duty. For purposes of this disclosure, you means you and your immediate family (spouse, domestic partner, or dependent child). Contact Information Full Name of Individual Making this Disclosure:  FORMTEXT      Home Institution:  FORMTEXT      E-mail:  FORMTEXT      Telephone:  FORMTEXT      Name of Carnegie Mellon research partner(s):  FORMTEXT      Title of the research proposal on which you are partnering with CMU:  FORMTEXT       Please list below any additional individuals at your institution who are participating in this research collaboration with CMU who are Key Personnel or otherwise responsible for the design, conduct or reporting of this research proposal. We will contact these individuals and ask them to complete a disclosure as well. Name:  FORMTEXT      Research role:  FORMTEXT      E-mail address:  FORMTEXT      Name:  FORMTEXT      Research role:  FORMTEXT      E-mail address:  FORMTEXT      Name:  FORMTEXT      Research role:  FORMTEXT      E-mail address:  FORMTEXT      Name:  FORMTEXT      Research role:  FORMTEXT      E-mail address:  FORMTEXT      D.1. Relationships with Publicly Traded Entities  FORMCHECKBOX  Yes  FORMCHECKBOX No I (or my spouse, domestic partner, or dependent children) have an ownership interest in a publicly traded entity related to my Institutional Responsibilities to ý.  FORMCHECKBOX  Yes  FORMCHECKBOX No I (or my spouse, domestic partner, or dependent children) have received payments or compensation exceeding $5,000 from a publicly traded entity in the last twelve (12) months, related to my Institutional Responsibilities to ý. If you answered yes to either of the preceding questions, please continue below. Otherwise, proceed to section D.2. Provide details below regarding the type of relationship you have with each privately held entity which meets either of the above criteria. Attach additional pages if necessary.Name of publicly traded external entity:  FORMTEXT       Does total for this entity over the past 12 months exceed $5,000?  FORMCHECKBOX  Yes  FORMCHECKBOX No Type of Financial Interest (check all that apply) Comments Stock  FORMCHECKBOX  Yes  FORMTEXT       Stock options  FORMCHECKBOX  Yes Other form of ownership  FORMCHECKBOX  Yes Payment for consulting or advising  FORMCHECKBOX  Yes Payment for serving on the Board  FORMCHECKBOX  Yes Payment for speaking engagement(s)  FORMCHECKBOX  Yes Payment for editorial services  FORMCHECKBOX  Yes Payment for other roles/services  FORMCHECKBOX  Yes Royalties related to Intellectual Property  FORMCHECKBOX  Yes Name of publicly traded external entity:  FORMTEXT       Does total for this entity over the past 12 months exceed $5,000?  FORMCHECKBOX  Yes  FORMCHECKBOX No Type of Financial Interest (check all that apply) Comments Stock  FORMCHECKBOX  Yes  FORMTEXT       Stock options  FORMCHECKBOX  Yes Other form of ownership  FORMCHECKBOX  Yes Payment for consulting or advising  FORMCHECKBOX  Yes Payment for serving on the Board  FORMCHECKBOX  Yes Payment for speaking engagement(s)  FORMCHECKBOX  Yes Payment for editorial services  FORMCHECKBOX  Yes Payment for other roles/services  FORMCHECKBOX  Yes Royalties related to Intellectual Property  FORMCHECKBOX  Yes D.2. Relationships with Privately Held Entities  FORMCHECKBOX  Yes  FORMCHECKBOX No I (or my spouse, domestic partner, or dependent children) have an ownership interest in a privately held entity related to my Institutional Responsibilities.  FORMCHECKBOX  Yes  FORMCHECKBOX No I (or my spouse, domestic partner, or dependent children) have received payments or compensation exceeding $5,000 from a privately held entity in the last twelve (12) months, related to my Institutional Responsibilities. If you answered yes to either of the above questions, please continue below. Otherwise, proceed to section E. Provide details below regarding the type of relationship you have with each privately held entity meeting the criteria above. Attach additional pages if necessary.Name of privately held external entity:  FORMTEXT       Type of Ownership Interest Yes Comments Stock  FORMCHECKBOX  Yes  FORMTEXT       Stock options  FORMCHECKBOX  Yes Other form of ownership  FORMCHECKBOX  Yes Does total for this entity over the past 12 months exceed $5,000?  FORMCHECKBOX  Yes  FORMCHECKBOX No Type of Payment (Check all that apply) Comments Payment for consulting or advising  FORMCHECKBOX  Yes  FORMTEXT       Payment for serving on the Board  FORMCHECKBOX  Yes Payment for speaking engagement(s)  FORMCHECKBOX  Yes Payment for editorial services  FORMCHECKBOX  Yes Payment for other roles/services  FORMCHECKBOX  Yes Royalties related to Intellectual Property  FORMCHECKBOX  Yes Name of privately held external entity:  FORMTEXT       Type of Ownership Interest Yes Comments Stock  FORMCHECKBOX  Yes  FORMTEXT       Stock options  FORMCHECKBOX  Yes Other form of ownership  FORMCHECKBOX  Yes Does total for this entity over the past 12 months exceed $5,000?  FORMCHECKBOX  Yes  FORMCHECKBOX No Type of Payment (Check all that apply) Comments Payment for consulting or advising  FORMCHECKBOX  Yes  FORMTEXT       Payment for serving on the Board  FORMCHECKBOX  Yes Payment for speaking engagement(s)  FORMCHECKBOX  Yes Payment for editorial services  FORMCHECKBOX  Yes Payment for other roles/services  FORMCHECKBOX  Yes Royalties related to Intellectual Property  FORMCHECKBOX  Yes OtherDo you have any financial interests or family relationships that you believe create an actual or perceived conflict of interest with your work on this research project?  FORMCHECKBOX  Yes  FORMCHECKBOX  No If yes, please describe.  FORMTEXT       Sponsored or Reimbursed Travel - Complete only if you currently have an subaward or consulting agreement from a PHS agency through CMU If you are completing this form at the time of a proposal submission and do not yet have a subcontract or consulting agreement from a PHS agency through ý, skip this section and move on to section G. Your obligation to report travel will begin when an award is made. The Public Health Service requires that all recipients of PHS funding disclose all travel that is paid for on their behalf or for which they are reimbursed. There are several exceptions to travel reporting, as follows: This requirement does not apply to travel sponsored by a U.S. federal, state or local government, a U.S. institution of higher education, a U.S. academic teaching hospital or a U.S. research institute affiliated with an institution of higher education. This disclosure is only required when the dollar value of sponsored travel from a single sponsor exceeds $5,000 in 12 months. If you are not certain whether the value exceeds this threshold, you may ask your travel sponsor, or err on the side of disclosing. For example, if Acme Inc. has reimbursed you, in the past twelve (12) months, for a single short trip to a nearby city, you likely have not exceeded the threshold. If Acme Inc. sends you on several trips, or for a single trip that lasts an extended period of time, you may have exceeded the threshold and should disclose. Please list all such travel within the previous twelve (12) months below. In the future, you are to disclose such travel to the ý COI office within thirty (30) days of its completion. 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If you have upcoming travel already planned in the next 12 months, you may also disclose it here. You will not need to disclose this travel again within 30 days of completion, unless the information changes.SponsorPurposeDestinationDates of Travel FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT      Signature & Certification Please acknowledge your understanding by checking the three boxes below  FORMCHECKBOX  I understand that at the time the award is made, I must complete an online conflict of interest training before I can receive any funds.  FORMCHECKBOX  I understand that I am to comply with ýs policies related to Financial Conflict of Interest and research. As a researcher receiving federal funds, I understand that I have an obligation to adhere to applicable federal regulations regarding Financial Conflict of Interest.  FORMCHECKBOX  To the best of my knowledge, I have disclosed all of my financial relationships as required by ý policy and federal regulations. I understand that I have a continuing responsibility to comply with these and update my disclosure as necessary. Signature:  FORMTEXT      ____________________________________________________ Date:  FORMTEXT      ________________________________________________________ This form can be completed electronically in Microsoft Word, saved and e-mailed to  HYPERLINK "mailto:COI-compliance@andrew.cmu.edu" COI-compliance@andrew.cmu.edu. If you have questions please call 412-268-5858. Endnotes     ý Significant Financial Interest Disclosure (SFI) For External Collaborators of Researchers Supported by the Public Health Service (PHS) Agencies  PAGE \* MERGEFORMAT 3 June 2023 ý Significant Financial Interest Disclosure (SFI) for External Collaborators Research Complying With Public Health Service (PHS) Conflict of Interest Regulations June 2023   HYPERLINK "http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf" HHS FCOI regulation, HYPERLINK "https://nsf.gov/publications/pub_summ.jsp?ods_key=pappg"NSF FCOI requirements  Institutional responsibilities involve a variety of scholarly and professional obligations carried out on behalf of the university such as teaching, research, scholarship, professional practice and service (on university, association, advisory or technical committees, editorial boards). Activities related to an individuals field of professional expertise are usually either Institutional Responsibilities or related to their Institutional Responsibilities. 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Significant Financial Interests (SFI) include certain payments, ownership interests and intellectual property rights and interests as defined by 42 CFR Part 50 and 45 CFR Part 94. Details are provided in this document in section C.  Financial Conflict of Interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct or reporting of PHS-funded research. 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