Rev.ised 6/26/12

1. New Public Health Service Regulations:Summary of Major Changes For Researchers and PartnersMcLean HospitalResearch Town MeetingJune 22, 2012 Rev.ised 6/26/12

2. Introduction/Orientation New federal regulations governing Investigators’ personal financial interests in Public Health Service-funded research go into effect on August 24, 2012 The new regulations are revisions to existing Public Health Service regulations that have been in effect since 1995 The new regulations impose new burdens on Investigators and on Partners These requirements are mandated under federal law; we have no choice but to follow them Key Issues for Investigators under the new regulations: On-going obligation to report new “significant financial interests” related to their institutional responsibilities, including company-paid travel expenses, as they arise, within 30 days Mandatory training Public accessibility

3. What Research is Subject to the New Requirements? All research that is funded by the Public Health Service All research that is funded by foundations and other non-profits that have also chosen to follow the Federal Regs Partners has notextended the new requirements of the Federal Regs to any research funded by any other sources – so research funded by other government agencies (e.g., DOE, DOD), other non-profits or by industry is not subject to the new requirements But some COI processing still done

4. What Individuals are Affected by the New Regulations? The regulations apply to “Investigators” Investigators are PIs, PDs, key personnel, and anyone else, regardless of title, who is responsible for the design, conduct, or reporting of research Can include grad students, post-docs, collaborators, and others, especially if they will be authors on papers If you are responsible for the design, conduct or reporting of any research project funded by the Public Health Service or any foundation or non-profit that has chosen to adopt the Federal regulations, then these new requirements apply to you. 4

5. Investigator Obligations: Disclosure of Significant Financial Interests The Federal regs require Investigators to disclose to Partners their new Significant Financial Interests (including those of their spouse and dependent children) that are *related to their Partners responsibilities* Different standard from current NIH regs – “related to a particular research grant” What are my “Partners responsibilities?” All of your hospital or other Partners activities, including research, clinical care, education and other Partners activities, such as involvement in purchasing or serving on a Partners or hospital committee or board 5

6. Investigator Obligations: Disclosure of Significant Financial Interests The Federal regs require Investigators to disclose to Partners new Significant Financial Interests related to their Partners responsibilities What is a “Significant Financial Interest (SFI)?” Receipt by you or your spouse/dependent children of any of the following from a non-Partners entity Income that exceeds *$5000* (changed from $10,000!), measured on rolling 12-month basis – some exceptions Equity in a public company that exceeds $5000 Aggregated income + equity/ownership interest from a public company that exceeds $5000, measured on a rolling 12-month basis ANY equity/ownership interest in a private company IP rights, upon receipt of income ALL reimbursed and “sponsored” travel expenses – different bucket – some exceptions 6

7. Paid Travel Expenses Must Always be Reported! The regulations define a “Significant Financial Interest” – which must then be reported – as including any payment of your travel expenses by an outside entity regardless of dollar amount and regardless of anything else previously received from the company The only items that have to be reported are destination, duration, purpose, sponsor (not dollar amounts) Included: An entity reimburses you for an expense you paid: cab fare, expenses for a job interview, etc. Also included: A company pays for your expenses directly – “sponsored travel” – e.g., company pays for hotel/plane tickets directly Some exceptions 7

8. Investigator Obligations: Disclosure of Significant Financial Interests Exceptions – things that don’t have to be disclosed Salary, royalties, through the institution Equity, and related income, in mutual funds, etc. Travel expenses paid directly by a company to Partners under a Partners agreement and not directly reimbursed by the company to the investigator Payments received from: US government agencies US institutions of higher education and research institutes affiliated with them Academic teaching hospitals, or Medical centers Provided the payments are for: Income from seminars, lectures, teaching engagements; or service on advisory committees or review panels; or travel reimbursement or sponsored travel. NOTE: Professional Associations are NOT excluded !! 8

9. Investigator Obligations: Disclosure of Significant Financial Interests – WHEN??? • New Updating Disclosure Responsibilities! • In addition to the existing annual disclosure responsibility, investigators must now UPDATE their disclosure within 30 days of the acquisition or discovery of a new SFI • What is a “new” SFI? • NIH FAQ issued 5/18/12 – clarifies that a “new SFI” exists only when you receive/acquire, from the same outside entity, an SFI that is “a different type and nature” from what you have previously reported; or same type and nature from a different outside entity • Have confirmed this with NIH

10. Investigator Obligations: Disclosure of New Significant Financial Interests within 30 days 30 day clock starts upon receipt of payment Travel: Same general rule – if you are reimbursed, must report within 30 days of receiving reimbursement If outside entity pays for your expenses directly – “sponsored travel” – report within 30 days of the travel date You can report your travel prospectively if you already know the info If SFI’s are not reported on time – may require burdensome process for investigator …

11. Consequences of late reporting by investigator If an Investigator fails to report new SFI’s within 30 days, and the institution determines it is an FCOI: Retrospective review must be conducted 120 days to determine whether there was bias Documentation of the review Update to PHS if any changes to a previously-submitted report If bias is found Notification to PHS Mitigation Report Same process must be followed if Investigator fails to comply with a management plan, or the institution fails to timely review a disclosed interest that is an FCOI 11

12. How Does This All Translate at Partners? The annual form has always required disclosure of financial interests with a $0 threshold that are related to your Partners responsibilities: This threshold already includes what is in the new definition of SFI, except for travel All Investigators will continue to be required to complete an annual disclosure form. This single form will replace The form Investigators previously had to complete for each grant at the time of Progress Reports; and Any other requirement to complete an annual Partners disclosure form Good news! Fewer forms to complete !! The annual form will draw upon your previous disclosures and will ensure that your SFI disclosures are up-to-date for the previous calendar year 12

13. How Does This All Translate at Partners? At the time of application for a grant – you will need to make sure that all SFI disclosures are up-to-date as of that date (will draw on previous disclosures) At Progress Report time for each of your grants, you will need to make sure that you have completed your Annual Form and any required SFI Updates. In between these transaction points, you will need to disclose new SFI’s within 30 days This is where the $5000 threshold becomes relevant (except for travel expenses!) 13

14. How Do You Do The Updates? The revised annual disclosure form includes questions to capture new elements in the definition of SFI (this form is currently open for completion) A new Update form is being developed for reporting updates of new SFIs A special form for capturing reimbursed or sponsored travel is being developed Both new forms will go live in August

15. Investigator Obligations: Must Complete Training The institution has to provide training on the institution’s policy, the investigator’s disclosure obligations, and the PHS regulations as follows: Before an investigator engages in any PHS-funded research – researcher cannot begin until he/she is trained Every 4 years thereafter Immediately if The institution’s policy changes An investigator is new to the institution An investigator is out of compliance with Partners conflicts of interest policy or a management plan

16. Training – Proposed Implementation Formal Training Program Content: under development Platform: CITI has been selected (same as IRB and RCR) Population: All Investigators Notice system: working with Research Management and CCOI co-chairs to design tracking and notification system with escalation mechanisms Launch: email notice to all Investigators of training requirement, with link to training program – this summer Informal Training Program Multiple announcements and presentations over the summer 16

17. Public Accessibility: FCOIs of Senior/Key Personnel The institution must make publicly available certain information about FCOIs of Senior/Key personnel by Posting on public website; or Responding to requests within 5 business days Senior/Key personnel are PD/PI and any other person identified by the institution as senior/key in the application, progress report, or any other report to the Public Health Service Annual updating or sooner if new information is obtained Information made public: Name of senior/key personnel with FCOI Title and role on project Name of entity in which FCOI is held Nature of the FCOI Dollar amount/dollar range

18. Institutional Obligations: Analysis of Disclosures The institution (Partners) must analyze each disclosed SFI within the context of your research projects to: Determine whether it’s related to any of the research projects (could the SFI be affected by the research) Used to be an investigator determination – now it’s the institutions If so, determine whether the related SFI constitutes a Financial Conflict of Interest (FCOI) – (whether the SFI could directly and significantly affect the research) If so, develop the management plan, and Report to the Public Health Service For a new SFI, we must do this within 60 days 18

19. Other New Requirements Monitoring: Institution must monitor investigator compliance with a management plan On an on-going basis Until conclusion of the Public Health Service-funded project Subawards: Agreements with subrecipients are required regarding Whose policy controls if both tiers have compliant policies Certification of policy compliance by the subrecipient if its policy controls Time periods for reporting by subrecipient to awardee institution of identified FCOIs; time periods for awardee reports to PHS of subrecipient FCOIs Reporting: Institution must report to PHS identified FCOIs prior to expenditure of funds under that award More detailed reporting is required

20. Executive Summary of Key Issues for Investigators Requirements of the regs apply to all investigators responsible for the design, conduct or reporting of Public Health Service-funded research, and some foundations Broader reporting obligation: Lower dollar threshold – $5000 (instead of $10,000 under old regulations), measured on rolling 12 month basis All SFI’s related to your institutional responsibilities Timing of disclosure – on-going obligation to report as new SFI’s are acquired 30 day window for reporting Includes all travel expenses reimbursed by or paid by an outside entity, regardless of dollar value If Investigators fail to report in a timely manner, institution must conduct retrospective review Investigators must get trained Information about FCOI’s of senior/key personnel must be made public These are federal mandates 20

21. Compliance with New PHS Regs Full compliance no later than August 24, 2012, AND Immediately upon making the institution’s revised conflicts of interest policy publicly accessible QUESTIONS AND DISCUSSION