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Research Administration For Scientists COMP 290-083 Tim Quigg Class 15: April 21 University/Industry Research Collaboration Issues.

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Presentation on theme: "Research Administration For Scientists COMP 290-083 Tim Quigg Class 15: April 21 University/Industry Research Collaboration Issues."— Presentation transcript:

1 Research Administration For Scientists COMP 290-083 Tim Quigg Class 15: April 21 University/Industry Research Collaboration Issues

2 2.Licensing Agreements 3. Industry-Sponsored Research 4. Conflict of Interest 1. NDA/CDA/PIA

3 Non-Disclosure Agreements One or Two Way PROPRIETARY INFORMATION EXCHANGE AGREEMENT This Agreement is entered into by and between Corporation, a corporation organized and existing under the laws of Delaware, by and through its Electronic Systems, having offices at Baltimore, Maryland (hereinafter referred to as “Corporation”) and the University of North Carolina, Chapel Hill, a corporation organized and existing under the laws of by and through its Division, having offices at 245 Sitterson Hall, UNC Chapel Hill, NC 27599 (hereinafter referred to as “UNC ”). Subject of Corporation information: Strategy and proposal information for DARPA Class Program. Subject of UNC information: Strategy and proposal information for DARPA Class Program. Purpose of exchange: To enable teaming discussions for the DARPA Class Program. The parties hereto desire to exchange the information described above, and considered by them to be proprietary, for the above-stated purpose. The party furnishing the proprietary information will be referred to as the “Disclosing Party” and the party receiving the proprietary information will be referred to as the “Receiving Party”. In order to provide for the protection of such proprietary information from unauthorized use and disclosure, the parties hereby agree that the disclosure of such information between them shall be subject to the following terms and conditions:

4 Non-Disclosure Agreements 1.Only that information disclosed in written form and identified by a marking thereon as proprietary, or oral information which is identified as proprietary at the time of disclosure and confirmed in writing within thirty (30) days of its disclosure, shall be considered proprietary and subject to this Agreement. 2.The exclusive points of contact with respect to the delivery and control of proprietary information disclosed hereunder are designated by the parties as follows: UNC:Faculty Member name, address and phone Corporation:Contact name, address and phone Either party may change its point of contact by written notice to the other. Definition of Confidential Information

5 Non-Disclosure Agreements Duration 3.Information identified and disclosed as provided in this Agreement shall be held by the Receiving Party in confidence for a period of 5 year(s) from the date of receipt. During such period, such information shall be used only for the purpose stated above and shall not be disclosed to any third party. Neither party shall be liable for disclosure pursuant to judicial action or government regulation or requirement, provided that the originating party is given prompt notice of such government or judicial action and is afforded an opportunity to respond prior to disclosure by the Receiving Party.

6 Non-Disclosure Agreements Degree of Care 4.The parties shall have no obligation under this Agreement to hold information in confidence which, although identified and disclosed as stated herein, has been or is: a)developed by the Receiving Party independently and without the benefit of information disclosed hereunder by the Disclosing Party; b)lawfully obtained by the Receiving Party from a third party without restriction; c)publicly available without breach of this Agreement; d)disclosed without restriction by the Disclosing Party to a third party, including the United States Government; or e)known to the Receiving Party prior to its receipt from the Disclosing Party. 5.Each party shall use not less than the degree of care used to prevent disclosure of its own proprietary information to prevent disclosure of information received in accordance with this Agreement. In no event, however, shall less than a reasonable standard of care be used.

7 Non-Disclosure Agreements Export Control 6.All information received and identified in accordance with this Agreement shall remain the property of the Disclosing Party and shall be returned upon request. Nothing contained herein shall be construed as a right or license, express or implied, under any patent copyright, or application therefore, of either party by or to the other party. 7.Any U. S. Government classified information disclosed by one party to the other shall be handled in accordance with the Department of Defense Industrial Security Manual for Safeguarding Classified Information (DoD 5220.22-M) or the National Industrial Security Program Operating Manual (NISPOM), their supplements, and other applicable U. S. Government security regulations. 8.The Receiving Party represents and warrants that no technical data delivered to it by the Disclosing Party shall be exported from the United States without first complying with all requirements of the International Traffic in Arms Regulations and the Export Administration Act, including the requirement for obtaining any export license, if applicable. The Receiving Party shall first obtain the written consent of the Disclosing Party prior to submitting any request for authority to export any such technical data.

8 Non-Disclosure Agreements Governing Law – Authorized Signature 9.The terms and conditions herein constitute the entire agreement and understanding of the parties and shall supersede all communications, negotiations, arrangements and agreements, either oral or written, with respect to the subject matter hereof. No amendments to or modifications of this Agreement shall be effective unless reduced to writing and executed by the Parties hereto. The failure of either party to enforce any term hereof shall not be deemed a waiver of any rights contained herein. 10.The effective date of this Agreement shall be the date of the last signature below. This Agreement shall expire one (1) year from the effective date hereof unless extended in writing by the parties hereto. The obligations of the parties contained in paragraph 3 above shall continue in effect notwithstanding the expiration of this Agreement. 11.This Agreement shall be governed and interpreted in accordance with the laws of the State of Maryland except its rules in regard to choice of laws. CORPORATIONUNIVERSITY OF NORTH CAROLINA, CHAPEL HILLBY: TYPED NAME: TITLE: DATE: AGREEMENT NO.:

9 University/Industry Research Collaboration Issues 1. NDA/CDA/PIA 2. Licensing Agreements

10 Licensing Agreement THIS LICENSE AGREEMENT is made and entered into this ___ day of _______, 199__ between THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL having an address at CB #4105, 308 Bynum Hall, Chapel Hill, N.C. (hereinafter referred to as University) and _________________, a corporation organized and existing under the laws of _________ and having an address at ____________________________________, (hereinafter referred to as Licensee). W I T N E S S E T H WHEREAS, University owns and controls an invention known as " ________"; file #OTD ______ (hereafter, "Invention"); and WHEREAS, the Invention was developed by __________ (hereafter, "Inventor"), of the University; and WHEREAS, Licensee is desirous of producing, using and selling products which include the use of Invention and is willing to expend its best efforts and resources to do so if it can obtain a license to use the Invention under the terms and conditions set forth herein; and WHEREAS, University desires to facilitate a timely transfer of its information and technology concerning the Invention for the ultimate benefit of the public and this transfer is best accomplished by the grant of this license; and WHEREAS, in the opinion of the University, this transfer can best be accomplished consistent with its mission by affiliation with Licensee; NOW, THEREFORE, for and in consideration of the covenants, conditions, and undertakings hereinafter set forth, it is agreed by and between the parties as follows:

11 Licensing Agreement 1. Definitions 1.1 "University Technology" means any unpublished research and development information, know-how, and technical data in the possession of the Inventor prior to the effective date of this Agreement which relates to and is necessary for the practice of the Invention and which University has the right to provide to Licensee. l.2 "Licensed Products" means any method, procedure, product, or component part thereof whose manufacture or sale includes any use of University Technology or Patent Rights. 1.3 "Patent Rights" means any U.S. patents and/or patent applications covering the Invention owned or controlled by University prior to or during the term of this Agreement and which University has the right to provide to Licensee, as well as any continuations, continuations in part, divisionals, provisionals, continued prosecution applications, or reissues thereof, and any foreign counterpart of any of the foregoing. 1.4 "Net Sales Price" means the invoiced sales price, less any charges for (a) sales taxes or other taxes separately stated on the invoice and (b) shipping and insurance charges. 1.5 "Net Sales" means the total Net Sales Price of Licensed Products, after deducting actual allowances for returned or defective goods, less trade discounts, but before cash discounts. Licensed Products will be considered sold when billed out, or when delivered or paid for before delivery, whichever first occurs. 1.6 "Licensed Territory" means ___________________. 1.7 "Licensed Field" means, and is limited to, the practice of the Invention for _________________.

12 Licensing Agreement 2.Grant of License and Term 2.1 University grants to Licensee to the extent of the Licensed Territory a non-exclusive right and license to use University Technology in the Licensed Field, subject to all the terms and conditions of this Agreement. 2.2 University grants to Licensee to the extent of the Licensed Territory, an exclusive license under the Patent Rights and the right to make, use and sell Licensed Products in the Licensed Field, upon the terms and conditions set forth herein. 2.3 Any license granted herein is exclusive for a term beginning on the date of execution of this Agreement and, unless terminated sooner as herein provided, ending at the expiration of the last to expire patent included in the Patent Rights, or if no patents mature from said Patent Rights, such license shall terminate 15 years from the date of its commencement. 2.4 Licensee shall not disclose any unpublished University Technology furnished by University pursuant to Paragraph 2.1 above to third parties during the term of this Agreement or any time thereafter, provided, however, that disclosure may be made of any such University Technology at any time: (1) with the prior written consent of University, or (2) after the same shall have become public through no fault of Licensee. 2.5 Notwithstanding the foregoing, any and all licenses granted hereunder are subject to the rights of the United States Government which arise out of its sponsorship of the research which led to the Invention.

13 Licensing Agreement 3. License Fee and Royalties 3.1 Licensee shall pay to University a license issue fee in the amount of _______________. Licensee will pay a further license fee in the form of reimbursement of the costs (including attorney's fees) arising out of the patenting of the Invention pursuant to Article 9 of this Agreement. Both the license issue fee and the reimbursement of patenting costs shall be non-refundable and shall not be a credit against any other amounts due hereunder except as may be provided for elsewhere in this Agreement. Reimbursement of patenting costs shall be due upon monthly billings from University. 3.2 Beginning on the effective date of this Agreement and continuing for the life of this Agreement, Licensee will pay University a running royalty of ___________ of all Net Sales of the Licensed Product(s). 3.3 Licensee agrees to make quarterly written reports to University within 30 days after the first days of each January, April, July, and October during the life of this Agreement and as of such dates, stating in each such report the number, description, and aggregate Net Selling Prices of Licensed Products sold or otherwise disposed of during the preceding three calendar months and upon which royalty is payable as provided in Article 3.2 hereof. The first such report shall include all such Licensed Products so sold or otherwise disposed of prior to the date of such report. Until Licensee has achieved a first commercial sale of a Licensed Product a report shall be submitted by Licensee at the end of each January, April, July and October after the effective date of this Agreement and will include a full written report describing Licensee’s technical and other efforts made towards such first commercial sale for all Licensed Products under development.

14 Licensing Agreement 3. License Fee and Royalties 3.4 Concurrently with the making of each such report, Licensee shall pay to the University royalties at the rate specified in Article 3.2 of this Agreement on the Licensed Products included therein. 3.5 If in any calendar year during the term of this Agreement, total amounts payable under Paragraph 3.2 hereof are less than the minimum amount indicated in the Schedule below corresponding to such calendar year, Licensee shall pay the University within thirty (30) days after the end of such calendar year, the difference between the amounts payable for such calendar year and said minimum amount. SCHEDULE Calendar YearMinimum Amounts 199__ 199__ 199__ 199__ and all subsequent years 3.6 Should this Agreement become effective or terminate or expire during a calendar year, the minimum royalty under paragraph 3.5 for such portion of a year shall be determined by multiplying the minimum royalty set forth in said paragraph for the year in which this Agreement becomes effective, terminates or expires, by a fraction, the numerator of which shall be the number of days during such calendar year for which this agreement shall be in effect and the denominator of which shall be 365.

15 Licensing Agreement 3. License Fee and Royalties 3.7 In the event of default in payment of any payment owing to University under the terms of this Agreement, and if it becomes necessary for University to undertake legal action to collect said payment, Licensee shall pay all legal fees and costs incurred by University in connection therewith. 3.8 University may, by written notice to Licensee, terminate this Agreement during any April subsequent to the year ______________, if Licensee has not practiced the Invention during each calendar year which precedes each such April to the extent of generating earned royalties under paragraph 3.2 of this Agreement in the amount of ___________________. 4.Best Efforts 4.1 Licensee shall use its best efforts to proceed diligently with the manufacture and sale of Licensed Products and shall earnestly and diligently offer and continue to offer for sale such Licensed Products, both under reasonable conditions, during the period of this Agreement. 4.2 In particular, Licensee will use its best efforts to meet the performance milestones set forth in Appendix A, which is attached hereto.

16 Licensing Agreement 5.Cancellation by University 5.1 It is expressly agreed that, notwithstanding the provisions of any other paragraph of this contract, if Licensee should fail to deliver to University any royalty at the time or times that the same should be due to University or if Licensee should in any material respect violate or fail to keep or perform any covenant, condition, or undertaking of this Agreement on its part to be kept or performed hereunder, then and in such event University shall have the right to cancel and terminate this Agreement, and the license herein provided for, by written notice to Licensee if Licensee has failed to cure any such breach within 30 days of receipt of written notice from University describing such breach. Licensee's right to cure a breach will apply only to the first two breaches properly noticed under terms of this Agreement, regardless of the nature of those breaches. Any subsequent breach by Licensee will entitle University to terminate this Agreement upon proper notice. 5.2 Alternatively, should Licensee be in breach or default as set forth above, and should University be in a position where it could rightfully terminate this Agreement, then in its sole discretion, University may convert this exclusive license to a non-exclusive license upon giving notice of such decision to Licensee. 5.3 If Licensee should be adjudged bankrupt or enter into a composition with or assignment for the benefit of its creditors, then in such event University shall have the right to cancel and terminate this Agreement, and the license herein provided for, by written notice to Licensee. 5.4 Any termination or cancellation under any provision of this Agreement shall not relieve Licensee of its obligation to pay any royalty or other fees (including attorney's fees pursuant to Article 3.1 hereof) due or owing at the time of such cancellation or termination.

17 Licensing Agreement 6. Disposition of Licensed Products On Hand Upon Cancellation or Termination 6.1 Upon cancellation of this Agreement or upon termination in whole or in part, Licensee shall provide University with a written inventory of all University Technology and Licensed Products in process of manufacture, in use or in stock. Except with respect to termination pursuant to Paragraph 5.1, Licensee shall have the privilege of disposing of the inventory of such Licensed Products within a period of one hundred and eighty (180) days of such termination upon conditions most favorable to University that Licensee can reasonably obtain. Licensee will also have the right to complete performance of all contracts requiring use of the University Technology, Patent Rights (except in the case of termination pursuant to Paragraph 5.1) or Licensed Products within and beyond said 180-day period provided that the remaining term of any such contract does not exceed one year. All Licensed Products which are not disposed of as provided above shall be delivered to University or otherwise disposed of, in University's sole discretion, and at Licensee's sole expense. 7. Use of University's Name 7.1 The use of the name of University, or any contraction thereof, in any manner in connection with the exercise of this license is expressly prohibited except with prior written consent of University. 8. University Use 8.1 It is expressly agreed that, notwithstanding any provisions herein, University is free to use University Technology, Patent Rights and Licensed Products for its own research, public service, clinical, teaching and educational purposes without payment of royalties. Furthermore, University shall be free to publish University Technology, as it sees fit.

18 Licensing Agreement 9. Patents and Infringements 9.1 Licensee shall bear the cost of filing and prosecuting U.S. Patent applications included within the Patent Rights. Such filings and prosecution shall be by counsel of University's choosing and shall be in the name of University. University shall keep Licensee advised as to the prosecution of such applications by forwarding to Licensee copies of all official correspondence, (including, but not limited to, Applications, Office Actions, responses, etc.) relating thereto. Licensee shall have the right to advise University as to such prosecution, and further, shall have the right to make reasonable requests as to the conduct of such prosecution. 9.2 As regards filing of foreign patent applications corresponding to the U.S. applications described in paragraph 9.1 above, Licensee shall designate that country or those countries, if any, in which Licensee desires such corresponding patent application(s) to be filed. Licensee shall pay all costs and legal fees associated with the preparation and filing of such designated foreign patent applications and such applications shall be in the University's name. University may elect to file corresponding patent applications in countries other than those designated by Licensee, but in that event University shall be responsible for all costs associated with such non- designated filings. In such event, Licensee shall forfeit its rights under this license in the country(ies) where University exercises its option to file such corresponding patent applications.

19 Licensing Agreement 9. Patents and Infringements 9.3 If the production, sale or use of Licensed Products under this Agreement by Licensee results in any claim for patent infringement against Licensee, Licensee shall promptly notify the University thereof in writing, setting forth the facts of such claim in reasonable detail. As between the parties to this Agreement, Licensee shall have the first and primary right and responsibility at its own expense to defend and control the defense of any such claim against Licensee, by counsel of its own choice. It is understood that any settlement of such actions must be approved by University. Such approval shall not be unreasonably withheld. University agrees to cooperate with Licensee in any reasonable manner deemed by Licensee to be necessary in defending any such action. Licensee shall reimburse University for any out of pocket expenses incurred in providing such assistance. 9.4 In the event that any Patent Rights licensed to Licensee are infringed by a third party, Licensee shall have the primary right, but not the obligation, to institute, prosecute and control any action or proceeding with respect to such infringement, by counsel of its choice, including any declaratory judgment action arising from such infringement. 9.5 Notwithstanding for foregoing, and in University's sole discretion, University shall be entitled to participate through counsel of its own choosing in any legal action involving the Invention. Nothing in the foregoing sections shall be construed in any way which would limit the authority of the Attorney General of North Carolina.

20 Licensing Agreement 10. Waiver 10.1 It is agreed that no waiver by either party hereto of any breach or default of any of the covenants or agreements herein set forth shall be deemed a waiver as to any subsequent and/or similar breach or default. 11. License Restrictions 11.1 It is agreed that the rights and privileges granted to Licensee are each and all expressly conditioned upon the faithful performance on the part of the Licensee of every requirement herein contained, and that each of such conditions and requirements may be and the same are specific license restrictions. 12. Assignments 12.1 This Agreement is binding upon and shall inure to the benefit of the University, its successors and assigns. However, this Agreement shall be personal to Licensee and it is not assignable by Licensee to any other entity without the written consent of University, which consent shall not be withheld unreasonably.

21 Licensing Agreement 13. Indemnity 13.1 Licensee agrees to indemnify, hold harmless and defend University, its officers, employees, and agents, against any and all claims, suits, losses, damage, costs, fees, and expenses asserted by third parties, both government and private, resulting from or arising out of the exercise of this license. 14. Insurance 14.1 Licensee is required to maintain in force at its sole cost and expense, with reputable insurance companies, general liability insurance and products liability insurance coverage in an amount reasonably sufficient to protect against liability under paragraph 13, above. The University shall have the right to ascertain from time to time that such coverage exists, such right to be exercised in a reasonable manner. 15. Independent Contractor Status. 15.1 Neither party hereto is an agent of the other for any purpose. 16. Late Payments 16.1 In the event royalty payments or fees are not received by University when due, Licensee shall pay to University interest and charges at the maximum rate of interest allowed by law on the total royalties or fees due.

22 Licensing Agreement 17. Warranties 17.1 University makes no warranties that any patent will issue on University Technology or Invention. University further makes no warranties, express or implied as to any matter whatsoever, including, without limitation, the condition of any invention(s) or product(s), that are the subject of this Agreement; or the merchantability or fitness for a particular purpose of any such invention or product. University shall not be liable for any direct, consequential, or other damages suffered by Licensee or any others resulting from the use of the Invention or Licensed Products. 18. Accounting and Records 18.1 Licensee will keep complete, true and accurate books of account and records for the purpose of showing the derivation of all amounts payable to University under this Agreement. Such books and records will be kept at Licensee's principal place of business for at least three (3) years following the end of the calendar quarter to which they pertain, and will be open at all reasonable times for inspection by a representative of University for the purpose of verifying Licensee's royalty statements, or Licensee's compliance in other respects with this Agreement. The representative will be obliged to treat as confidential all relevant matters. 18.2 Such inspections shall be at the expense of University, unless a variation or error exceeding U.S. $1,000, or the equivalent, is discovered in the course of any such inspection, whereupon all costs relating thereto paid by Licensee. 18.3 Licensee will promptly pay to University the full amount of any underpayment, together with interest thereon at the maximum rate of interest allowed by law.

23 Licensing Agreement 19. Compliance with Laws 19.1 In exercising its rights under this license, Licensee shall fully comply with the requirements of any and all applicable laws, regulations, rules and orders of any governmental body having jurisdiction over the exercise of rights under this license. Licensee further agrees to indemnify and hold University harmless from and against any costs, expenses, attorney's fees, citation, fine, penalty and liability of every kind and nature which might be imposed by reason of any asserted or established violation of any such laws, order, rules and/or regulations. 20. U.S. Manufacture 20.1 It is agreed that any Licensed Products sold in the United States shall be substantially manufactured in the United States. 21. Notices 21.1 Any notice required or permitted to be given to the parties hereto shall be deemed to have been properly given if delivered in person or mailed by first-class certified mail to the other party at the appropriate address as set forth below or to such other addresses as may be designated in writing by the parties from time to time during the term of this Agreement. UNIVERSITY LICENSEE Associate Vice Provost Office of Technology Development CB #4105, 308 Bynum Hall UNC-CH Chapel Hill, NC 27599-4105

24 Licensing Agreement 22. Governing Laws 22.1 This Agreement shall be interpreted and construed in accordance with the laws of the State of North Carolina. 23. Complete Agreement 23.1 It is understood and agreed between University and Licensee that this license constitutes the entire Agreement, both written and oral, between the parties, and that all prior agreements respecting the subject matter hereof, either written or oral, expressed or implied, shall be abrogated, canceled, and are null and void and of no effect. 24.Severability 24.1 In the event that a court of competent jurisdiction holds any provision of this Agreement to be invalid, such holding shall have no effect on the remaining provisions of this Agreement, and they shall continue in full force and effect. 25. Survival of Terms 25.1 The provisions of Articles 6, 7, 8, 9, 13, 14, 17, 18, 19, 21, 22, and 23 shall survive the expiration or termination of this Agreement.

25 Licensing Agreement IN WITNESS WHEREOF, both University and Licensee have executed this Agreement, in duplicate originals, by their respective officers hereunto duly authorized, the day and year first above written. Inventors have likewise indicated their acceptance of the terms hereof by signing below. THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL By:____________________________By:_____________________ Name:___________________ Associate Vice Provost, Technology Development Title:__________________ INVENTORS: __________________________

26 University/Industry Research Collaboration Issues 1. NDA/CDA/PIA 2. Licensing Agreements 3. Industry-Sponsored Research Unrestricted Gift – Good Sponsored Research Agreement – Be Careful IP Clauses Right of First Negotiation/Refusal Publication Clauses Prime/Sub on Federally Sponsored Research Agreement IP Clauses Appropriate FAR Clauses Cultural Issues

27 University/Industry Research Collaboration Issues 1. NDA/CDA/PIA 2. Licensing Agreements 3. Industry-Sponsored Research 4. Conflict of Interest

28 It’s About Public Trust Longstanding interest in objectivity in research and financial conflict of interest. Key Question: “Is the situation likely to interfere or appear to interfere with the independent judgment one is supposed to show as a professional performing official duties?” Conflict of Interest

29 The university held equity in the company developing the drug, and the lead doctor held one-third of its shares of stock. Researchers testing new way to replace defective genes to treat enzyme disorders. 18 year old Jesse Gelsinger died from the gene therapy study. University of Pennsylvania (1999) Conflict of Interest

30 Trust Test –Would relevant others [employers, clients, professional colleagues, or the general public] trust my judgment if they knew I was in this situation? It’s About Public Trust Conflict of Interest

31 It must also require that those financial disclosures are updated during the period of the award, either on an annual basis, or as new reportable significant financial interests are obtained. Institutional policy must ensure that investigators have provided all required financial disclosures at the time the proposal is submitted to NSF or NIH. Conflict of Interest

32 Management plan required. NSF notified only if the institution finds that it is unable to satisfactorily manage an actual or potential conflict of interest. NSF requirement – Significant Financial Interest Disclosure in connection with research application. Includes faculty member, spouse or dependent children. Conflict of Interest

33 NIH requirement – Significant Financial Interest Disclosure in connection with research application. Includes faculty member, spouse or dependent children. Management plan required. Institute Grants Management Officer notified. Conflict of Interest

34 PHS Definition (42 CFR 50.603) –Significant Financial Interest means anything of monetary value, including but not limited to, salary or other payments for services; equity interests; and intellectual property rights. Significant Financial Interest Conflict of Interest

35 PHS Definition (42 CFR 50.603) –The term does not include: Salary, royalties, or other remuneration from the applicant institution; Any ownership interests in the institution, if the institution is an applicant under the SBIR Program; Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities; Income from service on advisory committees or review panels for public or nonprofit entities; An equity interest that when aggregated does not exceed $10,000 of FMV and does not represent more than a 5% ownership interest in any single entity; or Salary, royalties or other payments that when aggregated are not expected to exceed $10,000. Significant Financial Interest Conflict of Interest

36 Interest must be either… –Managed; –Reduced; or –Eliminated Management Plan –Include brief, general explanation of actions taken but Exclude personal financial data Updates –Conflict of Interest declarations are made annually or as new SFI’s are obtained Significant Financial Interest Conflict of Interest

37 THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL POLICY ON CONFLICTS OF INTEREST AND COMMITMENT This Policy on Conflicts of Interest and Commitment (hereinafter, the "Policy") provides guidelines for relationships between the University and its faculty, staff, and students with private industry, federal and state government, and the nonprofit sector that will help to assure the primacy of academic integrity. The University encourages employees to engage in appropriate outside relationships, but members of the University community are expected to avoid conflicts of interest that have the potential to directly and significantly affect the University’s interests, compromise objectivity in carrying out University responsibilities, or otherwise compromise performance of University responsibilities, unless such conflicts are disclosed, reviewed, and managed in accordance with this Policy.

38 The fact that an individual has a conflict of interest does not imply that the conflict is unethical or impermissible; it means simply that the relation of the conflict to the individual’s University responsibilities must be carefully examined because conflicts of interest - real or perceived - may impair performance of our missions of teaching, research, and public service, as well as jeopardize public trust and support. THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL POLICY ON CONFLICTS OF INTEREST AND COMMITMENT

39 Examples of Potential Conflicts CATEGORY I: Activities or relationships that are routinely allowable and are not required to be disclosed pursuant to the Policy because they do not represent significant potential for compromising the objectivity of research results, the welfare and rights of human research subjects, the integrity of faculty-student interactions, or other interests of the University, the sponsor, or the public* 1.Receiving royalties for published scholarly works and other materials or for inventions pursuant to the University's Patent and Copyright Policies. 2.Membership in and service on professional associations, learned societies, professional review or advisory panels and accreditation bodies; presentation of lectures, papers, concerts, or exhibits; participation in seminars and conferences; and reviewing or editing scholarly publications and books are permitted. 3.Ownership of or equity in a corporation used solely for one’s consulting activities. 4.Requiring or recommending one’s own or one’s family member’s textbook or other teaching aids, materials, software, equipment, or the like to be used in connection with University instructional programs.

40 Examples of Potential Conflicts CATEGORY II: Activities or relationships that may be allowable following disclosure and, where necessary, the implementation of monitoring procedures or other forms of management to ensure the integrity of research and other institutional activities. CATEGORY III: Activities or relationships presenting such serious risks that they will be presumed to be inappropriate unless it is determined that they can be managed in accordance with this Policy. In such cases, a heavy burden will rest with the covered individual to demonstrate to the University’s satisfaction the compatibility of such relationships with University policy prior to going forward with the proposed activity.

41 Required and Suggested Monitoring Activities 1.At the outset, monitors should meet with the affected covered individual and his or her chair to review the circumstances of the activities and relationships to be monitored, explain the monitors’ function and authority, and address questions or concerns. Monitors must be mindful that conflicts cannot be managed successfully without cooperation and assistance from the covered individual being monitored. Monitors should approach their task in a spirit of collegiality, not adversity, and such a spirit should inform interactions with the covered individual to be monitored wherever possible.

42 Required and Suggested Monitoring Activities 2.All monitors must meet annually with the covered individual and regularly (at least once in approximately the middle of each semester and as appropriate during the summer sessions) with students and trainees (e.g., post-doctoral fellows, residents, or in some cases junior faculty) of the covered individual who has an activity that is being monitored. Because students or trainees not directly involved in an approved COI may still be affected by a covered individual’s commitments, monitors should meet with every member of the covered individual’s research group.

43 Required and Suggested Monitoring Activities 3.All students and trainees involved in research studies with a covered individual who has an approved COI must be informed of the COI in writing either at the beginning of the student’s or trainee’s involvement with the study or upon approval of a COI and a management plan for the COI, whichever comes later. The management plan will assign responsibility for sending written notice to the students and trainees. Such written notice shall inform the students and trainees: a) that the approved COI exists, and b) that their concerns, if any, can be discussed with the Chair of the University Committee on Conflicts of Interest, University’s Research Compliance Coordinator, Department Chair, Dean, or, if applicable, the monitor or monitoring panel, as appropriate. Monitors must work with the affected covered individual to introduce procedures in the covered individual’s research group sufficient to assure that such information is communicated on a timely basis to current students and trainees, and to students and trainees who join the project later.

44 Required and Suggested Monitoring Activities 4.Monitors should meet individually with student and trainee members of the covered individual’s research group at least once each year. The primary purpose of both group and individual meetings is to ascertain whether students or trainees perceive any untoward influence on their own or others’ research or education as a result of the conflict being monitored. Students and trainees should be informed that under University policy they may not be retaliated against for good faith disclosures of such concerns.

45 Required and Suggested Monitoring Activities 5.Monitors should review any publications made by the covered individual or members of his or her research group to ensure that significant financial interests have been reported in conjunction with the publication and that the publication is free of any inappropriate influence resulting from such significant financial interests. Monitors should also look for the absence of publications by the covered individual or members of his or her research group, which may indicate inappropriate withholding of research results.

46 Required and Suggested Monitoring Activities 6.Monitors must keep minutes of their meetings and/or activities. Where a Dean has delegated monitoring responsibilities, monitors should report on their activities to the Dean or his designee and to the University Committee and Dean’s committee, where applicable, not less than annually. In order to assist the Dean in ongoing evaluation of approved COIs, such reports should be filed not later than 60 days before the next due date for submission of Conflicts Evaluation Forms.

47 Conflict of Interest (NIH, OER) – overview/ep-coi.html PHS Policy (42CFR50) – 42cfr50_01.html Resources Conflict of Interest

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