Non-Find 2: Addendum to BU Non-PHS Financial Interest Disclosure Form

Transcription

1 CONFLICTS OF INTEREST Non-Find 2: Addendum to BU Non-PHS Financial Interest Disclosure Form Disclosure # (for office use) Please complete this form digitally, if possible. When you are finished, please print and sign. Investigator Name School Department Section / Center (if applicable) Project Title (please state the full title of the BU or BMC project) Principal Investigator on Project Sponsorship (include both Prime and Sub-sponsors, if applicable) Prime Sponsor Sub-Sponsor of this project N/A N/A SBIR? STTR? Phase What entity administers the funds or resources supporting your research? BU CRC (Sponsored Programs) BU MED (ORA) BMC (BMC OGA) (Must use other form) Other: Have you, at any time, previously filed a PSD on this same project? PART I: INTRODUCTION Is there a company or entity which may have interests related to this project, and in which you are disclosing a financial interest (e.g. equity, payments, royalties)? Note: If your disclosed financial interest consists solely of potential future royalties from a company or entity to which a license has been granted, you should answer. The Committee will let you know whether or not you have over-disclosed. IF, please identify the basis of your disclosure of a financial interest that is not through a company or entity, and then skip to Part VII. Example: I personally own unlicensed intellectual property rights (not owned by BU or BMC) related to the research. N-FIND 2: ADDENDUM TO BU N-PHS 1

2 PART I CONTINUED IF : Full company / entity name Company Address Company URL (if any) Does the financial interest that you disclosed in a company or entity belong to you and/or an immediate family member? Me Family member, Relation to you: PART II: COMPANY / ENTITY DETAIL Is the entity: a non-profit organization? a publicly-traded for profit company? a privately-held for profit company? If this is a privately held for-profit company, what is the developmental stage of this company? The company was founded in (date) The company was founded in (date) but has no assets. and has intellectual property assets, as owner or licensee. Other (describe): Are you or your family member a founder of this entity? Is BU or BMC a founder of this entity? Does BU or BMC have equity in this entity? PART III: FINANCIAL INTEREST DETAIL IF : Do you (or your above referenced family member) have equity in the company/organization? EQUITY TYPE Stock VALUE # of shares % owernship (if applicable) Approximate value Stock options Warrant Other Do you (or your above-referenced family member) receive payments* from the company/organization? Do you (or your above-referenced family member) expect to receive future royalties under a license held by or under negotiation with the company/entity? N-FIND 2: ADDENDUM TO BU N-PHS 2

3 IF TO EITHER OR BOTH OF THE ABOVE: Reason for payment from company/entity Total payments received in the last 12 months Total payments expected in the next 12 months Consulting fees Director s / officer s fees Advisory Board fees Salaried employment Direct royalties (not through BU or BMC) Other *Do T include: (a) salary, or other remuneration (not including royalties) from Boston University; (b) income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities; (c) income from service on advisory committees or review panels sponsored by public or non-profit entities PART IV: INTELLECTUAL PROPERTY RELATED TO THE RESEARCH Is there intellectual property that is related to, or will be developed, used, or studied, in the research project and that is also related to the company/entity disclosed in Part I? If, skip to Part V. If, answer the following regarding this Intellectual Property: Identify the related IP by name or title Does the company or entity described in Part II own, have a license, have an option to receive a license, or, was it formed for purposes of developing, the Intellectual Property described above? Who created/invented this IP? What is the subject matter of this intellectual property? What is the nature of this IP (e.g. patent, patent application, copyright) Was it invented or authored as part of your BU or BMC work? If, has the IP been disclosed to BU Office of Technology Transfer? Has a patent application been filed? Has a trademark protection application been filed? The application was filed by: BU Office of Technology Transfer Other, Describe: Is the application pending? Issued? Withdrawn? Abandoned? Transferred to you? N-FIND 2: ADDENDUM TO BU N-PHS 3

4 PART V: IS THE COMPANY/ENTITY POTENTIALLY FINANCIALLY INTERESTED IN THE RESEARCH? a. Will the company/entity receive pre-publication access to results of the research? b. Is the company/entity sponsoring or providing resources to the research? If Yes above, describe how the company/entity is providing resources or input to the research, if at all. c. Does the company/entity develop or distribute products or services (or competitive products or services) that will be improved or assessed in the research? If Yes above, describe any product or service (either in the business plan, in development or on the market) of the company/entity that is related to this project of research. In your description indicate how the product or service might affect the general public. Is the purpose, use or application of the product or service for governmental uses, consumer or personal health uses, research tools, etc. If for treatment or diagnosis, is it FDA regulated? Also describe whether such products or services are currently on the market. d. Does company or entity disclosed have rights in any invention, technology, device, drug, program, method or IP used, developed, potentially improved or studied in the research? If Yes above, describe how the technology (IP, product or service) is involved in the research (including research aim). IF you answered to any of the above questions (Part V: a-d), answer the following. Otherwise, skip to Part VI. Describe any rights of the company/entity, if any, in the results of the research (including research aim). Describe the importance of the related technology to the overall business mission of the company/entity. Describe the importance of the research to the overall business of the company/entity. Describe whether and how the research could affect the company/entity s commercial interests; prospects for securing investors; product development programs or potential market for its products or services. Otherwise, could the company or entity benefit or incur loss as a result of the research? N-FIND 2: ADDENDUM TO BU N-PHS 4

5 PART VI: RELEVANT INFORMATION ABOUT THE PROJECT a. Describe the specific aims of the project and specific nature of the research as related to your disclosure: b. Describe whether and how human subjects will be involved in the research, whether an IRB exemption has been received, the nature of any risk to human subjects and the IRB protocol #: c. Describe whether students or postdoctoral fellows will work on the research and the nature of their roles: d. If an FDA-regulated clinical trial is proposed: Has an IND or IDE been applied for or obtained to clinically test the relevant technology? Who will be the Sponsor under the IND/IDE? Is this an investigator-initiated IND or IDE? e. Describe your proposed protocols, if any, for reducing bias in research (e.g., blinded research design, data safety monitoring board, independent scientists in key roles): f. Describe your own proposed roles in the research: Please generally describe your role and responsibility in respect to the research project, including whether you will be a Principal Investigator on the project or on any Protocol under the project (e.g., IRB, IACUC, IBC protocol); whether you are the chair of a department or the director of a laboratory or clinic in which research will be performed; whether you plan to apply as sponsor for an IND or IDE, etc. Specifically please answer: Will you draft the research proposal? Will you design a protocol? Will you engage in data collection? Will you make contributions to authorship on presentations or publications? Will you supervise research trainees? Will you supervise graduate students? Will you be the PI on an IRB protocol? If not, who will be the IRB PI, and what will be your role in human subjects work (recruitment, enrollment, obtaining informed consent, clinical evaluation of subjects, adverse event reporting) Will you perform or supervise laboratory work? If no, who will do so? Will you perform or supervise primary data analysis? If not, who will perform primary data analysis? (Include Name, Title, Supervisor, and any Qualifications) N-FIND 2: ADDENDUM TO BU N-PHS 5

6 PART VII: FINAL COMMENTS 1. Overall: Could it appear to an objective member of the public that your financial interest could potentially affect your activities in connection with this research? If so, why? 2. If you have any additional comments, add them here: PART VIII: SIGNATURE I understand and agree that I must promptly file an update to this Disclosure Addendum annually and if any of the information reported here should change materially. I certify that I have read and understand the Boston University Policy on Investigator s Conflicts of Interest, that I have made all required disclosures, and that I will comply with the applicable Policy and any conditions imposed by the University to manage, reduce or eliminate a conflict of interest. Name Signature Date BU Mailing Address Department Telephone # Fax # Please return this form by to coi@bu.edu. Hard copy materials can be faxed to or sent to the following address: Compliance Coordinator Conflicts of Interest Office of Research Compliance 85 East Newton St., M-810F Boston, MA N-FIND 2: ADDENDUM TO BU N-PHS 6