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New PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Investigator Responsibilities Campus-Wide Overview 2012 1PHS Financial Conflict of.

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Presentation on theme: "New PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Investigator Responsibilities Campus-Wide Overview 2012 1PHS Financial Conflict of."— Presentation transcript:

1 New PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Investigator Responsibilities Campus-Wide Overview 2012 1PHS Financial Conflict of Interest (FCOI) Regulatory Requirements

2 INTRODUCTION Section 1 PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training August 24, 2012 2

3 Note!!! This presentation applies only to Public Health Service (PHS) regulations. All definitions & requirements are for OUHSC faculty/staff who have or are applying for a Public Health Service (PHS) award. Other Conflict of Interest policies also apply to all faculty, staff, and students. Those policies may be found at this site.  http://research.ouhsc.edu/forms-policies/financial-conflicts-of-interest-fcoi/regents- policy-conflict-of-interest/ http://research.ouhsc.edu/forms-policies/financial-conflicts-of-interest-fcoi/regents- policy-conflict-of-interest/  It is the responsibility of al faculty, staff, and students to be familiar with and in compliance with all applicable state law and University policies PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training August 24, 2012 3

4 Purpose of the Updated Regulation The regulation is aimed at ensuring that the design, conduct, or reporting of research funded under PHS grants and cooperative agreements will not be biased by any conflicting financial interest of the investigators responsible for the research. PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training August 24, 2012 4

5 Summary of Regulatory Changes: Key Changes Blue indicates change from 1995 regulations Requirement that institution determines if a disclosed financial interest is related to the employee’s institutional responsibilities (change from study responsibilities only)  OUHSC PHS Investigator discloses all Significant Financial Interests (SFIs) PHS definition: de minimis threshold for disclosure is lowered (to $5K), includes any equity, and scope of outside compensation subject to disclosure is broadened (now includes non-profit organizations) Disclosure for financial interests in the previous 12 months (new timetable) PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training August 24, 2012 5

6 Summary of Regulatory Changes: Key Changes, cont. Blue indicates change from 1995 regulations Travel, reimbursed or covered, must be disclosed to institution regardless of dollar amount (new) Paid authorship, royalties, copyrights, textbooks, must be disclosed to institution (new) Mandatory training requirement every 4 years for investigators (new) Timely disclosure of any changes in significant financial interest must occur within 30 days (new) PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training August 24, 2012 6

7 KEY DEFINITIONS Section 2 PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training August 24, 2012 7

8 Key Definitions: Public Health Service (PHS) Includes  National Institutes of Health (NIH)  Centers for Disease Control & Prevention (CDC)  Food & Drug Administration (FDA)  Agency for Healthcare Research & Quality (AHRQ)  Health Resources & Services Administration (HRSA)  Indian Health Service (IHS)  Substance Abuse & Mental Health Services Administration (SAMHSA)  Agency for Toxic Substances & Disease Registry (ATSDR)  Administration for Children and Families (ACF)  Centers for Medicare & Medicaid Services (CMS)  Federal Occupational Health (FOH) PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training August 24, 2012 8

9 Key Definitions: Investigator “Project Director/Principal Investigator (PD/PI) as well as any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research or proposed for such funding  Applies to sub-investigators, sub-recipients, sub-grantees, collaborators, subcontractors, or consortium members  Includes state flow-through if originating source is a PHS agency PD/PI is responsible for identifying all individuals who might be considered an Investigator on a PHS award PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training August 24, 2012 9

10 Key Definitions: Investigator, cont. You are considered an Investigator if you are: A Principal Investigator (PI)/Project Director (PD) Senior/Key Personnel All significant contributors or collaborators if responsible for design, conduct or reporting of research Designated by the PI/PD as responsible for design, conduct or reporting of research  This could include administrative staff if the PD/PI determines that they could influence the design, conduct, or reporting of research It is the PI’s responsibility to identify all Investigators as defined by the PHS regulations PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training August 24, 2012 10

11 Key Definitions: Institutional Responsibilities An Investigator’s “professional responsibilities on behalf of the institution” Examples include but are not limited to  Research  Research consultation  Teaching  Professional practice  Speaking Engagements  Institutional committee memberships  Service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training Only disclose Significant Financial Interests related to an Investigator’s institutional responsibilities August 24, 2012 11

12 Definition: Significant Financial Interest (SFI) Blue indicates change from 1995 regulations Payments from a publicly traded entity over the 12 months preceding the disclosure that, when aggregated, exceeds $5,000 as of the date of the disclosure  Includes salary and any payment for services not otherwise identified as salary such as 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; Intellectual Property rights and interests and any payment for services, salary, consulting fees, honoraria, paid authorship PHS Financial Conflict of Interest (FCOI) Regulatory Requirements12 Includes spouse and dependent children!!!

13 Definition: Significant Financial Interest (SFI) cont. Blue indicates change from 1995 regulations Payments from a non-publicly traded entity in the twelve months preceding the disclosure that, when aggregated, exceeds $5,000  Investigator holds any equity interest (e.g., stock, stock option, or other ownership interest)  Includes non-profits (such as foundations) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests Investigators also must disclose the occurrence of any reimbursed or sponsored travel regardless of amount August 24, 2012 PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training13

14 Key Definitions: SFI – Excluded Sources – No disclosure Required You do NOT have to disclose if the SFI comes from the following sources: Salary, royalties, or other remuneration from current institution Agreements to share in royalties related to Intellectual Property Rights assigned to OUHSC Mutual funds and retirement accounts with no investigator control of investment Income from teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center or an academic research institute Income from service on committees or review panels for a federal, state, or local government agency, institution of higher education, an academic teaching hospital, a medical center, or an academic research institute. PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training If your SFI comes from any other source, you must disclose August 24, 2012 14

15 Key Definitions: Financial Conflict of Interest (FCOI) An interest that could directly and significantly affect the design, conduct or reporting of the research Conflict of interest is a situation in which financial or other personal considerations:  may compromise,  may involve the potential for compromising  may have the appearance of compromising an employee’s objectivity in meeting University duties or responsibilities, including research activities Determined by OUHSC  The Investigator does NOT determine FCOI, only discloses SFI PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training August 24, 2012 15

16 Key Definitions: SFI vs. FCOI A significant financial interest (SFI) is defined by the PHS criteria on slides 12 & 13  All PHS Investigators must disclose all SFIs A Significant Financial Interest (SFI) is not always an FCOI The designated Institutional official* determines if an FCOI exists when a SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research * Designated Institutional Official is the OUHSC Vice President for Research PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training August 24, 2012 16

17 DISCLOSURE PROCESS Section 3 PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training August 24, 2012 17

18 SFI Disclosure Process An Investigator must disclose to the institution all significant financial interests (SFIs) (and those of his/her spouse and dependent children) RELATED TO HIS/HER INSTITUTIONAL RESPONSIBILITIES at the time the research proposal is submitted to the grant awarding agency PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training August 24, 2012 18

19 SFI Disclosure Process PHS Financial Conflict of Interest (FCOI) Regulatory Requirements 19

20 Significant Financial Interest (SFI) Disclosure Process 1.Project Director/Principal Investigator (PD/PI) is responsible for his/her own SFI disclosure and determines who meets the definition of “Investigator” on their project  The PD/PI identifies all other individuals, regardless of title or position, who he/she identifies as responsible for the design, conduct, or reporting of research or proposed for such funding  It is the PD/PI’s responsibility, in conjunction with department assistance, to notify and secure disclosures from the identified Investigators 2.The designated Investigators complete the Significant Financial Interests Form (SFIF)  Project-based form – one form for each project for each designated Investigator (completed form may be duplicated for multiple projects)  If the Investigator has no SFIs, no further action is required  If the Investigator has one or more SFIs, he/she completes the SFI Attachment (1 per SFI entity) PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training August 24, 2012 20

21 SFI Disclosure Process, cont. 3. The identified Investigators send the completed SFIF and, if applicable, the SFI attachments to ORA (hscora@ouhsc.edu)hscora@ouhsc.edu  All disclosures must be received by ORA before an application can be approved for submission 4.A copy of the SFIF is forwarded to the Vice President for Research (OUHSC Institutional Official) for review  Institutional Official evaluates every PHS-research-related SFI in the context of each PHS project to determine if the interest creates a Financial Conflict of Interest (FCOI)  May involve the Investigator in that review process 5. If the Institutional Official determines there is no FCOI, the process is complete August 24, 2012 PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training21

22 SFI Disclosure Process, cont. 6.If the Institutional Official determines there is an FCOI, then he will work with the investigator to create a FCOI management plan.  Within 60 days of receipt of disclosure  Application may be submitted without management plan as long as all SFIs for all designated Investigators have been disclosed  The original disclosure along with the decision is kept in the proposal file and will be used to verify at the Just-in-Time (JIT) and award stages 7.The Institutional Official reports details of FCOI and management plan to funding agency PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training August 24, 2012 22

23 SFI Disclosure Process: When to Disclose SFI? No later than at the time of application for PHS-funded research Within thirty days of discovering or acquiring a new Significant Financial Interest At least annually, in accordance with the specific time period during the period of award. PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training Disclosure includes spouse and dependent children August 24, 2012 23

24 TRAINING, TRAVEL, PAID AUTHORSHIP & PUBLIC DISCLOSURE Section 4 PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training August 24, 2012 24

25 Training Funding cannot be released until all designated Investigators have successfully completed the OUHSC FCOI training  The PD/PI must designate all Investigators on ORA Routing Form, or notify ORA of personnel changes  ORA verifies completion of training prior to award set-up All Investigator(s)designated by the PD/PI should take the mandatory training as soon as possible  Must repeat training every 4 years  Or immediately if designated an Investigator by a PD/PI. PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training August 24, 2012 25

26 Travel Disclosure All Investigators must complete Travel Supplemental Disclosure Form (TSDF) for  any reimbursed travel or  any sponsored travel i.e. paid on behalf of the Investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available One form per travel event Disclosure must occur within 30 days of reimbursement or travel event if sponsored travel PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training Exclusions! It’s not as bad as you think. Remember the SFI Excluded Sources August 24, 2012 26

27 Paid Authorship All Investigators must disclose paid authorship not covered in the SFI exclusion list as part of the Significant Financial Interest Disclosure.  Within 30 days of occurrence (if greater than >$5,000) OR  When the aggregate from a single entity exceeds >5,000 PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training Exclusions! It’s not as bad as you think. Remember the SFI Excluded Sources August 24, 2012 27

28 Public Accessibility of FCOI Information OUHSC must make publicly available certain information about FCOIs that were identified involving investigators by responding to requests within 5 business days. Remember! An FCOI is not an SFI. OUHSC is not obligated to disclose SFIs PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training August 24, 2012 28

29 DETAILED REGULATION CHANGES For Reference Only 29PHS Financial Conflict of Interest (FCOI) Regulatory Requirements

30 Definition of Investigator 1995 Anyone involved in the design, conduct, and reporting of the research 2012 Project Director/Principal Investigator as well as 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 includes subawardees and may include collaborators or consultants 30PHS Financial Conflict of Interest (FCOI) Regulatory Requirements

31 Significant Financial Interests (SFI) Threshold 1995 De minimis threshold of $10,000 for disclosure generally applies to payments aggregated for the Investigator and the Investigator’s spouse and dependent children Equity: An equity interest that exceeds $10,000 in value or more than a 5% ownership interest in any single entity 2012 De minimis threshold of $5,000 for disclosure applies to any remuneration received from the entity aggregated together with the value of any equity interest. Includes any equity interest in non-publically traded entities OUHSC may apply higher standards for what constitutes an SFI 31PHS Financial Conflict of Interest (FCOI) Regulatory Requirements

32 SFI Reporting Period 1995 In the next 12 months 2012 In the previous 12 months 32PHS Financial Conflict of Interest (FCOI) Regulatory Requirements

33 Which SFIs Need to be Disclosed Once Threshold is Met? 1995 Only those SFI the Investigator deems related to the PHS-funded research OSR-100 2012 All SFI related to the Investigator’s institutional responsibilities Annual disclosure Updates required within 30 days of change or occurrence (travel/paid authorship) 33PHS Financial Conflict of Interest (FCOI) Regulatory Requirements

34 Excluded from Disclosure Requirement 1995 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 for the Investigator and the Investigator’s spouse and dependent children meets both of the following tests: does not exceed $10,000 in value and does not represent more than a 5% ownership interest in any single entity. 2012 Income from seminars, lectures, or teaching engagements, or service on advisory committees or review panels sponsored by a Federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. Income or service for any other type of organization must be reported. 34PHS Financial Conflict of Interest (FCOI) Regulatory Requirements

35 Types of SFI Excluded 1995 Excludes 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 2012 Same 35PHS Financial Conflict of Interest (FCOI) Regulatory Requirements

36 SBIR/STTR Phase I 1995 Excluded 2012 Excluded Phase II is included 36PHS Financial Conflict of Interest (FCOI) Regulatory Requirements

37 Intellectual Property (IP) 1995 Royalties are included among the “payments” subject to the $10,000 threshold. 2012 The threshold of $5,000 applies to licensed IP rights (e.g., patents, copyrights), royalties from such rights, and agreements to share in royalties related to licensed intellectual property rights. Excluded  Unlicensed IP that doesn’t generate income  IP rights assigned to the Institution and agreements to share in royalties related to such rights 37PHS Financial Conflict of Interest (FCOI) Regulatory Requirements

38 Paid Authorship* 1995 Not included 2012 Included Doesn’t include academic textbooks, etc. 38PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Remember – SFI disclosure doesn’t necessarily mean FCOI

39 Travel Reimbursements and Sponsored Travel 1995 Not included 2012 Disclose the occurrence of ANY reimbursed travel or sponsored travel related to institutional responsibilities NOT required to disclose travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. 39PHS Financial Conflict of Interest (FCOI) Regulatory Requirements

40 Sub-recipients and Reporting of Identified FCOIs 1995 Institutions must take reasonable steps to ensure that Investigators working for sub-recipients comply with the regulations by requiring those Investigators to comply with the institution’s policy, or by requiring the entities to provide assurances to the institution that will enable the institution to comply 2012 Incorporate as part of a written agreement terms that establish whether the FCOI policy of the awardee Institution or that of the sub- recipient will apply to sub-recipient Investigators, and include time periods to meet disclosure and/or FCOI reporting requirements Sub-recipient Institutions who rely on their FCOI policy must report identified FCOIs to the awardee Institution in sufficient time to allow the awardee Institution to report the FCOI to NIH to meet reporting obligations. 40PHS Financial Conflict of Interest (FCOI) Regulatory Requirements

41 FCOI Training 1995 No requirement 2012 Each Investigator must complete training prior to engaging in research related to any PHS- funded grant or contract and at least every four years, and immediately under the following circumstances:  If institutional FCOI policies change in a manner that affects Investigator requirements  An Investigator is new to an Institution  An Institution finds an Investigator noncompliant with Institution’s FCOI policy or management plan. 41PHS Financial Conflict of Interest (FCOI) Regulatory Requirements

42 Information on an identified Financial Conflict of Interest (FCOI) reported by the Institution to NIH 1995 Grant/Contract number, PI, name of Investigator with FCOI, whether FCOI was managed, reduced, or eliminated 2012 Requirements in 1995 regulations, plus: Name of the entity with which the Investigator has a FCOI; Nature of FCOI, e.g., equity, consulting fees, travel reimbursement, honoraria; Value of the financial interest $0- 4,999; $5K-9,999; $10K-19,999; amts between $20K-$100K by increments of $20K; amts above $100K by increments of $50K or statement that a value cannot be readily determined 42PHS Financial Conflict of Interest (FCOI) Regulatory Requirements

43 Information on an identified Financial Conflict of Interest (FCOI) reported by the Institution to NIH, con’t 2012  A description how the financial interest relates to PHS-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research Role and principal duties of the conflicted Investigator in the research project Conditions of the management plan How the management plan is designed to safeguard objectivity in the research project Confirmation of the Investigator’s agreement to the management plan How the management plan will be monitored to ensure Investigator compliance Other information as needed.  Annual Report with status of the FCOI and changes to the management plan PHS Financial Conflict of Interest (FCOI) Regulatory Requirements43

44 Public Accessibility 1995 No requirement 2011 Make information available concerning identified FCOIs held by senior/key personnel via a publicly accessible Web site or by a written response to any requestor within 5 business days of a request, and update such information as specified in the rule. This information will include at a minimum the Investigators name, title, and role; the name of the entity in which the SFI is held; the nature of the SFI; and the approximate dollar value of the SFI, or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value. 44PHS Financial Conflict of Interest (FCOI) Regulatory Requirements

45 FAQs and Resources NIH 42 CFR 50 Subpart F  http://grants.nih.gov/grants/compliance/42_cfr_50_subpart_f.htm http://grants.nih.gov/grants/compliance/42_cfr_50_subpart_f.htm NIH FCOI Page  http://grants.nih.gov/grants/policy/coi/index.htm http://grants.nih.gov/grants/policy/coi/index.htm NIH FAQs – New and Updated (3/21/2012)  http://grants.nih.gov/grants/policy/coi/coi_faqs.htm http://grants.nih.gov/grants/policy/coi/coi_faqs.htm OUHSC Office of Research FCOI Page  http://research.ouhsc.edu/forms-policies/financial-conflicts-of-interest- fcoi/ http://research.ouhsc.edu/forms-policies/financial-conflicts-of-interest- fcoi/ Board of Regents Policy  http://research.ouhsc.edu/forms-policies/financial-conflicts-of-interest- fcoi/regents-policy-conflict-of-interest/ http://research.ouhsc.edu/forms-policies/financial-conflicts-of-interest- fcoi/regents-policy-conflict-of-interest/ PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training August 24, 2012 45

46 Contact Information Office of Research Administration Phone: (405)271-2090 Email: hscora@ouhsc.edu website: http://research.ouhsc.eduhttp://research.ouhsc.edu 46PHS Financial Conflict of Interest (FCOI) Regulatory Requirements


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