2018 SRAI Annual Meeting October 27-31

Transcription

1 2018 SRAI Annual Meeting October Conflicts of Interest Aurali Dade, PhD, Associate Vice President for Research Development, Integrity and Assurance, George Mason University, Fairfax, VA, USA

2 Roadmap What are Conflicts of Interest and Commitment? Types of Conflicts Requirements: Investigator Conflicts of Interest Managing, Reducing, and Eliminating Conflicts Case Studies 2

3 Conflicts of Interest A situation in which a person is in a position to derive personal benefit from actions or decisions made in their official capacity. dictionary.com 3

4 Conflicts of Interest Individual Investigator Conflicts Research Team Conflicts Institutional/Organizational Conflicts Other Conflicts 4

5 Individual Investigator Conflicts Financial Conflicts of Interest: Having Significant Financial Interests in an outside organization that relate to institutional responsibilities and have the potential to bias research (more on this later) Other Conflicts of Interest Nonfinancial reasons that investigator wishes for results to be positive (or negative) leading to the potential to bias the research results 5

6 Individual Investigator Conflicts Individuals may have Conflicts of Interest and/or Conflicts of Commitment These conflicts might be financial or nonfinancial in nature Conflict may be due to family member (or other close individual) and their outside interest, not just those interests held by the individual researcher 6

7 Conflicts of Commitment Typically defined as a researcher dedicating time to personal activities in excess of the time permitted by institutional policy. Also, indicates excessive external activities that might detract from a researcher s ability to perform their primary tasks. Physically present but using Institutional Resources Divulging Institutional IP to an external organization in which researcher has interest 7

8 What are your policies? Equivalent of one day per work week? What does this mean for students? Any restrictions on charging to federal sponsors at external organization? 8

9 Potential Conflicts Due to Sponsor? Private funding sources with particular agenda Funding sources that restrict individuals who can work on the project 9

10 Research Team Conflicts Can be similar to individual conflicts if all members of the team share the interest. Can also have intra team conflicts if some members have outside interest and others do not. Can have inter team conflicts if more than one team is involved. 10

11 Case study #1 Dr. Bo and Dr. Peep have worked together for the past 10 years at Hill University on cloning technologies. Dr. Bo and Dr. Peep were both inventors in a technology that was licensed to an outside company, Clonetons, Inc. That technology shows great promise but requires scientific expertise to finalize a marketable prototype. Clonetons, Inc. hired Dr. Peep as a consultant to help bring this technology to market. Dr. Bo shows up at your door complaining about Dr. Peep spending excess time outside of the university and profiting from the IP that they developed together. Do your policies address this issue? How would you deal with this? 11

12 Institutional Review Board IRB and other committees should be aware of and respond to investigator conflicts Inform subjects about outside interest Methods to reduce/eliminate the potential for bias (double blinding, etc.) Monitor on an ongoing baisis 12

13 Institutional/Organizational Conflicts of Interest Conflicts due to Institutional Interest in IP/outcome of research Conflicts due to donors (gifts) and sponsored funding sources Conflicts due to senior leader s interests in outside organizations Conflicts due to Organizational Influence 13

14 Organizational COI Requirements Example, AF Office of Scientific Research: You and your organization must disclose any potential or actual scientific or non scientific conflict of interest(s) to us. You must also disclose any potential or actual conflict(s) of interest for any subrecipient you include in your proposal. 14

15 Organizational COI Requirements Example, DOJ: Non federal entities are required to use Federal funds in the best interest of the award program. Decisions related to these funds must be free of undisclosed personal or organizational conflicts of interest, both in fact and in appearance. 15

16 What is Conflict in Fact? In the use of award funds (direct or indirect), a recipient or subrecipient should not participate in any decisions, approval, disapproval, recommendations, investigation decisions, or any other proceeding concerning any of the following people or groups: An immediate family member, A partner, An organization in which they are serving as an officer, director, trustee, partner or employee, Any person or organization with whom they are negotiating or who has an arrangement concerning prospective employment, has a financial interest, or for other reasons can have less than an unbiased transaction with the recipient or subrecipient. 16

17 What is Conflict in Appearance? Any action that might result in or create the appearance of: Using an official position for private gain; Giving special treatment to any person; Losing complete independence or objectivity; Making an official decision outside of official channels; or Affecting negatively the confidence of the public in the integrity of the Government or the program. 17

18 Case Study #2 A major donor provides funding for hiring faculty, providing student scholarships, and renovating facilities for the Criminal Justice program at the University of Law. This donor has stringent views on prison reform and regularly visits campus to talk to faculty (both existing and hired with the donor s funding). A major Department of Justice grant is announced to evaluate prison reform options. Does the University of Law have an organizational conflict of interest in this case? What about the faculty hired from the donor s funds? Would you disclose this to the DOJ in your proposal process if you were responsible for COIs at the University of Law? 18

19 Investigator COI Requirements a couple of examples PHS NSF 19

20 PHS FCOI Requirements 42 C.F.R. Part 50, Subpart F Promoting Objectivity in Research Establishes standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under Public Health Service (PHS) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. 20

21 Applicability Each Institution that is applying for, or that receives, PHS research funding by means of a grant or cooperative agreement. Through implementation by the Institution, to each Investigator who is planning to participate in, or is participating in, such research; However, does not apply to SBIR Program Phase I applications. 21

22 Important Definitions Investigator means the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants. 22

23 Important Definitions Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS by the Institution under this subpart. 23

24 Important Definitions Significant financial interest (SFI) means: (1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities: 24

25 Important Definitions SFI cont. (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 months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value; 25

26 Important Definitions SFI cont. (ii) With regard to any non publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or (iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests. 26

27 Important Definitions SFI cont. (2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities*; 27

28 Important Definitions SFI cont. (3) The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or forprofit organization; income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles; 28

29 Important Definitions SFI cont. Exclusions listed under 2 and 3 [Travel or] income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. 29

30 Important Definitions 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. 30

31 Policy Requirements Maintain an up to date, written, enforced compliant policy on FCOIs, and make such policy available via a publicly accessible Web site. Take reasonable steps to ensure subrecipients comply with requirements. 31

32 Educate and Inform Inform each Investigator of the Institution's policy on FCOIs, the Investigator's responsibilities regarding disclosure of SFIs, and of PHS regulations, and Require each Investigator to complete training regarding the same prior to engaging in research related to any PHSfunded grant and at least every four years, and immediately when any of the following circumstances apply: (1) The Institution revises its FCOI policies or procedures in any manner that affects the requirements of Investigators; (2) An Investigator is new to an Institution; or (3) An Institution finds that an Investigator is not in compliance with the Institution's FCOI policy or management plan. 32

33 Modes of Training Online Face to Face Refreshers (updated content and/or reminders of requirements) 33

34 Institutional Responsibilities Designate an institutional official(s) (DO) to solicit and review disclosures of SFIs from each Investigator who is planning to participate in, or is participating in, the PHSfunded research. Committee vs. Individual? 34

35 Disclosure Responsibilities Require that each Investigator who is planning to participate in the PHS funded research disclose to the Institution's DO(s) the Investigator's SFIs (and those of the Investigator's spouse and dependent children) no later than the time of application for PHS funded research. Require each Investigator who is participating in the PHSfunded research to submit an updated disclosure of SFIs at least annually. Require each Investigator who is participating in the PHSfunded research to submit an updated disclosure of SFIs within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest. 35

36 When is an SFI an FCOI? DO(s) determine whether an Investigator's SFI is related to PHS funded research and, if so related, whether the SFI is an FCOI. An Investigator's SFI is related to PHS funded research when the Institution, through its DO(s), reasonably determines that the SFI: could be affected by the PHS funded research; or is in an entity whose financial interest could be affected by the research. May involve investigator in this decision. 36

37 When does an FCOI exist? An FCOI exists when the Institution, through its DO(s), reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS funded research. 37

38 Institutional Responsibilities Take such actions as necessary to manage FCOIs (including subs). Management of an identified FCOI requires development and implementation of a management plan and, if necessary, a retrospective review and a mitigation report. 38

39 Institutional Reporting Responsibilities Provide initial and ongoing (annual and updated) FCOI reports to the PHS: Prior to the Institution's expenditure of any funds under a PHS funded research project, the Institution shall provide to the PHS Awarding Component an FCOI report regarding any Investigator's SFIs found by the Institution to be conflicting and ensure that the Institution has implemented a management plan. 39

40 Institutional Reporting Requirements For any subsequently identified FCOIs, Institution must report to the PHS Awarding Component within sixty days. If Institution identifies an SFI that was not disclosed prior to submission (or within 30 days of new SFI) or was not managed appropriately by institution must conduct retrospective review to determine whether research, conducted prior to the identification and management of the FCOI was biased in the design, conduct, or reporting of such research. Additionally, if bias is found, the Institution is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. 40

41 FCOI Reporting Requirements Elements of the FCOI report shall include, but are not necessarily limited to the following: (i) Project number; (ii) PD/PI or Contact PD/PI if a multiple PD/PI model is used; (iii) Name of the Investigator with the financial conflict of interest; (iv) Name of the entity with which the Investigator has a financial conflict of interest; (v) Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium); (vi) Value of the financial interest (dollar ranges are permissible) or a statement that the interest is one whose value cannot be readily determined; (vii) A description of how the financial interest relates to the PHSfunded research and the basis for the Institution's determination that the financial interest conflicts with such research; and 41

42 FCOI Reporting Requirements (viii) A description of the key elements of the Institution's management plan, including: (A) Role and principal duties of the conflicted Investigator in the research project; (B) Conditions of the management plan; (C) How the management plan is designed to safeguard objectivity in the research project; (D) Confirmation of the Investigator's agreement to the management plan; (E) How the management plan will be monitored to ensure Investigator compliance; and (F) Other information as needed. 42

43 Institutional Requirements Maintain records relating to all Investigator disclosures of financial interests and the Institution's review of, and response to, such and all actions under the Institution's policy or retrospective review, if applicable, for at least three years from the date the final expenditures report is submitted to the PHS or, where applicable, from other dates specified in 45 CFR for different situations. Establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure Investigator compliance as appropriate. 43

44 Provide Certifications (1) Has in effect at that Institution an up to date, written, and enforced administrative process to identify and manage FCOIs; (2) Shall promote and enforce Investigator compliance with this subpart's requirements including those pertaining to disclosure of SFIs; (3) Shall manage FCOIs and provide initial and ongoing FCOI reports to the PHS Awarding Component; (4) Agrees to make information available, promptly upon request, to the HHS relating to any Investigator disclosure of financial interests and the Institution's review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution's determination of a FCOI; and (5) Fully comply with the requirements of this subpart. 44

45 Management of FCOIs (1) Prior expenditure of any funds, the DO(s) shall: review all Investigator disclosures of SFIs; determine whether any SFI relate to PHS funded research; determine whether a FCOI exists; and, if so, develop and implement a management plan that shall specify the actions that have been, and shall be, taken to manage such financial conflict of interest. (2) Review new SFIs within 60 days. (3) Monitor compliance on an ongoing basis. 45

46 Public Disclosure Website or on request of senior/key personnel s FCOIs: Investigator's name; Investigator's title and role; Name of the entity in which the SFI is held; the nature of the SFI; and the approximate dollar value of the SFI There are additional rules for updating/maintaining website. 46

47 Retrospective Review of Noncompliance (i) Implement interim management plan; (ii) Within 120 days complete a retrospective review to determine whether any PHS funded research, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research. The Institution is required to document the retrospective review; such documentation shall include, but not necessarily be limited to, all of the following key elements: (1) Project number; (2) Project title; (3) PD/PI; (4) Name of the Investigator with the FCOI; (5) Name of the entity with which the Investigator has a financial conflict of interest; (6) Reason(s) for the retrospective review; (7) Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed); (8) Findings of the review; and (9) Conclusions of the review. 47

48 Retrospective Review of Noncompliance (iii) Based on the results of the retrospective review, if appropriate, the Institution shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI going forward. If bias is found must notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the Institution's plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). 48

49 NSF Requirements Proposal & Award Policies & Procedures Guide (PAPPG), January 2018, Chapter IX Grantee Standards 49

50 Applicability Each grantee organization employing more than fifty persons to maintain an appropriate written and enforced policy on conflict of interest and that all COIs for each award be managed, reduced or eliminated prior to the expenditure of the award funds. Must also take appropriate measures to ensure subrecipients have an appropriate enforced policy. 50

51 Important Definitions The term "investigator" means the PI/PD, co PI/co PDs, and any other person identified on the proposed project who is responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding by NSF. 51

52 Important Definitions The term "significant financial interest" means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interest (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). 52

53 Important Definitions SFI cont. The term does not include: a. salary, royalties or other remuneration from the proposing organization; b. any ownership interests in the organization, if the organization is an applicant under the SBIR Program or STTR Program; c. income from seminars, lectures, or teaching engagements [or income from service on advisory committees or review panels] sponsored by public or non profit entities; d. an equity interest that, when aggregated for the investigator and the investigator s spouse and dependent children, meets both of the following tests: does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a 5% ownership interest in any single entity; or, are not expected to exceed $10,000 during the prior twelve month period. 53

54 Disclosure Requirements Policy should require that each investigator disclose to a (DO) all SFIs of the investigator (including those of the investigator s spouse and dependent children): (i) that would reasonably appear to be affected by the research or educational activities funded or proposed for funding by NSF; or (ii) in entities whose financial interests would reasonably appear to be affected by such activities. 54

55 Disclosure Requirements An organizational policy must ensure that investigators have provided all required financial disclosures at the time the proposal is submitted to NSF. 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. 55

56 Review Requirements DO must determine whether a COI exists, and determine what conditions or restrictions, if any, should be imposed by the organization to manage, reduce or eliminate such COI. A COI exists when the DO(s) reasonably determines that a SFI could directly and significantly affect the design, conduct, or reporting of NSF funded research or educational activities. 56

57 Management Plan Required? Yes, except: if the DO(s) determines that imposing conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts that may arise from a SFI are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the reviewer(s) may allow the research to go forward without imposing such conditions or restrictions. 57

58 Enforcement The organizational policy must include adequate enforcement mechanisms, and provide for sanctions where appropriate. 58

59 Notification The organizational policy must include arrangements for keeping NSF s Office of the General Counsel (OGC) appropriately informed if the organization finds that it is unable to satisfactorily manage a COI and if the organization finds that research will proceed without the imposition of conditions or restrictions when a conflict of interest exists. When OGC is notified of an unmanageable conflict of interest by a grantee, OGC will examine the organization s policy to make sure it includes procedures for addressing unmanageable COIs, determine what actions the organization plans/has taken, and request confirmation when the actions have been accomplished. 59

60 Recordkeeping Organizations must maintain records of all financial disclosures and of all actions taken to resolve conflicts of interest for at least three years beyond the termination or completion of the grant to which they relate, or until the resolution of any NSF action involving those records, whichever is longer. 60

61 Management Strategies 1) Public disclosure of financial conflicts of interest (e.g., when presenting or publishing); 2) For research projects involving human subjects research, disclosure of FCOIs directly to participants; 3) Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI; 4) Modification of the research plan; 5) Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research; 6) Reduction or elimination of the financial interest; or 7) Severance of relationships that create financial conflicts. From PHS 61

62 Management Strategies 1) public disclosure of significant financial interests; 2) monitoring of research by independent reviewers; 3) modification of the research plan; 4) disqualification from participation in the portion of the NSF funded research that would be affected by significant financial interests; 5) divestiture of significant financial interests; or 6) severance of relationships that create conflicts. From NSF 62

63 Other Requirements State Private Funder Country (other than US) Institutional 63

64 Process flow chart Disclosure SFI/PI? Yes Relationship to Proposed project(s)? Yes Full board review, COI? Yes Manage, Reduce Eliminate No No No further action No Expedited review, Contract with Mason Or question about Conflict? Yes No

65 Case Study #3 Dr. Bland is a PI in the Food and Nutrition program at Big Time University. He owns $40,000 worth of stock in a beverage company that uses natural sweetners to manufacture low calorie drinks. Dr. Bland is submitting a proposal to the NIH to evaluate the role (positive or negative) of reduced and no calorie sweetened beverages on the obesiety epidemic. He discloses his stock in the beverage company as a SFI. Does this SFI pose a FCOI? If so, what management strategies would you suggest? 65

66 Thank you! Questions? Aurali Dade, PhD, Associate Vice President for Research Development, Integrity and Assurance, George Mason University, USA 66