Conflict of Interest Updates: Policy, Travel (PHS) and Rolling disclosures. OSP Forum August 20,

Transcription

1 Conflict of Interest Updates: Policy, Travel (PHS) and Rolling disclosures OSP Forum August 20,

2 Agenda Background Updates to MIT COI Policy Updates to Travel Policy for PHS investigators New Rolling disclosure process Notification strategy Impact on award set-up 2

3 Impact of new regulations on COI Review Increased volume and complexity of the information being disclosed (due to change in the type of information required to be disclosed) Review process is more involved (role of Designated Official, more frequent back-andforth with faculty) More time needed to review and process COI disclosures, not meeting compliance 3

4 Summary of Updates to the MIT Policies and Procedures on Conflicts of Interest in Research Changes are effective on August 22, Existing Summary of Change Rationale Policy Statement A statement of what is a financial conflict of interest, and the need for Investigators to disclosure their financial relationships Definitions No specific definition of aggregate which lead to multiple interpretations and inconsistencies in reporting No definition of Sponsored Travel thus all travel by PHS investigators required to be reported Introduction paragraph talks more about what a COI is and the importance of disclosing to MIT Aggregate means the consolidated total of monies received from a single entity (i.e. through Remuneration, Sponsored Travel, Equity Interests, etc.) Sponsored Travel sets deminimus threshold of $5K in Aggregate, have to look back 12 months at time of proposal submission Faculty Feedback suggested clarity and more information so people understand what a COI is and why it s important to disclose Faculty feedback suggested a more comprehensive definition that would capture all of the different types of income or payments received from an entity. Faculty were overwhelmed by having to report ALL travel. The new definition cuts back on what is reportable Definition of Family did not include domestic partner Definition of Family now includes domestic partner Consistent with HR definition 4

5 Travel reporting -- one substantive change that only affects PHS investigators Sponsored Travel means (a) travel expenses paid to an Investigator or travel paid on an Investigator s behalf, by a single entity in any 12-month period and (b) travel reimbursed to or paid on behalf of an Investigator s Family by a single entity in any 12-month period ONLY if such travel reasonably appears to be related to the Investigator s Institutional Responsibilities. See the PHS Addendum for more information. 5

6 Based on the travel changes, an Investigator discloses at time of proposal submission, looking back 12 months: Just travel (hotel, meals, transportation, etc ) If aggregate per entity adds to $5k over last 12 months Travel and consulting If aggregate per entity adds to $5k over last 12 months Travel by Investigator and his/her Family Investigator completes a separate disclosure for each traveler type NIH states that looking back over the previous twelve-month period provides baseline information that allows MIT to take into account whether Investigators have an ongoing financial relationship with an entity providing a payment or reimbursement or whether the payment or reimbursement was limited in duration 6

7 An Investigator need not disclose Sponsored Travel paid for or reimbursed by: MIT (e.g. paid from MIT funds or from sponsored awards funds managed at MIT) U.S. Federal, state or local governmental agencies U.S. Institutes of higher education U.S. Research institutions affiliated with institutions of higher education U.S. Academic teaching hospitals and medical centers 7

8 For Example Professor Wang has been invited to give a talk to Stanford University colleagues. The trip and the stipend provided amount to $6,000 because Stanford also paid for the travel expenses of her husband. Does this need to be disclosed? Professor Diaz is invited to give a seminar at BigCo s brand new San Diego office. His travel is paid for, along with modest stipend ($500). They did not tell him directly, but she estimates the cost to exceed $5,000. Does this need to be disclosed? Professor Nair did a consulting project for Acme Printing at a rate of $3,000 over the 12 months. Does this need to be disclosed? In addition, Acme Printing reimbursed Professor Nair for a trip to tour their headquarters and new manufacturing facilities, at a value of $2,500. Does this need to be disclosed? Where should it be disclosed? Professor Klein has been invited to Germany to give a talk to his colleagues at Max Plank Institute in Hamburg. The trip and the stipend are estimated at $9,000. Does this need to be disclosed? 8

9 New MyCOI landing page: Disclosing travel with ease 9

10 Create a new Travel Disclosure 10

11 Travel related to an SFI 11

12 *Required info to be entered in the Travel screen fields 12

13 Disclosed travel displayed in context of an SFI entity 13

14 14

15 Under your SFI s it is clearly visible Travel ONLY versus Travel which is related to an SFI No risk to using the travel disclosure to log in all your travel and keep it in one place. You calculate when it s an SFI, the system does not. 15

16 Questions????? 16

17 Rolling COI the New Annual Process Going forward, we will be eliminating the summer annual disclosure process and moving to a cycle In the rolling cycle, the 12 month clock re-starts whenever an Investigator revises his/her master disclosure GOAL: Reduce administrative burden, increase compliance 17

18 Preliminary Feedback from Faculty Advisory Group, Deans, VPR was Favorable Rolling is good disclosures do not become some special event Not seen as an additional administrative burden Provides more opportunity to update regularly, increasing compliance with reporting System generated notifications will help Investigators with compliance 18

19 19

20 Distribution of New NIH/NSF Awards FY NIH NSF July Aug Sep Oct Nov Dec Jan Feb Mar Apr May June 20

21 Events Triggering Revision When they add/modify an SFI When a new award in the PHS/NSF hierarchy is received (only if they didn't file a full disclosure at proposal stage) When it has been 12 months since the last revision was completed Many revisions will be triggered by new awards or by new SFIs throughout the year 21

22 MyCOI landing page: Revise with ease 22

23 CREATE 23

24 REVISE 24

25 VIEW 25

26 System-Generated Notifications to help with compliance WHEN 2 months prior to month of expiration (Batched sent 1 st of month) 1 month prior to month of expiration (Batched sent 1 st of month) 5 days prior to actual expiration date (Sent by COI Officer) WHO PI: Reminder to revise COI disclosure PI: Reminder AO, CA: Summary listing all PIs in their unit PI: Notification of deadline DLC Head, AO, CA: Summary listing all PIs in their unit If PI does not complete his/her revision by the expiration date, accounts will be put in restricted status this rarely happens 26

27 Expiration Reports Available on the COI Website: a great tool for monitoring & compliance Expiring Disclosures PI: Master list. Useful when someone asks, When does Dr. Wu s disclosure expire? Expiring Disclosures School For Asst Deans. Shows all PIs where the PI has an active award somewhere in their area. Disclosures due soonest are at the top. Expiring Disclosures CA, DLC For OSP. Sorted by CA, then by DLC. Within a DLC, PIs with disclosures due soonest are at the top. Expiring Disclosures DLC For AOs and Dept Heads. Shows any PI that has an active award in their area. Disclosures due soonest are at the top. 27

28 Note: Access to expiration reports requires MIT certificates 28

29 Notifications Likely To Raise Awareness Of Investigators Who Have Left MIT! What DLCs should do Work with OSP CA to transfer, terminate, change PI on active awards as per the PI Transfer Checklist Work with COI Officer to make sure any COI requirements for old and new PIs are being fulfilled Failure to report changes of Investigator/Key Person to Sponsor is a critical compliance issue. 29

30 PI Transfer Checklist This Checklist is a tool for Principlal Investogators (PIs) and Departments, Labs and Centers (DLC) administrators to assist in ensuring that all pertinent activities are properly closed out and/or transferred for PIs transferring to a different institution. This Checklist may not include everything, however it is an attempt to highlight the more common issues /concerns that complicate and potentially slow down the transition of a PI, or cause problems after a PI transfers to a new institution. Area Checklist Item Responsibility Point Of Contact Award Management Transfer Terminate Change PI If requesting award transfer to gaining institution, contact Sponsor and coordinate request and timing of award transfer. If award will remain at MIT until end date, arrange for a change in PI at MIT and initiate notification of change to Sponsor; or initiate award termination. Determine whether a sub-award to gaining institution is appropriate if award remains at MIT. Notify OSP of departing PI and communicate award transfer decisions. Advise PI and DLC regarding Sponsor requirements for award transfer; coordinate with Sponsor's business office as needed. Ensure salary certification requirements have been met prior to faculty departure from MIT Coordinate with Sponsored Accounting to ensure proper and accurate; reconciliation of accounts, completion of financial reports, and close-out of awards. PI DLC DLC DLC OSP DLC DLC OSP NE DLC Administrative Officer Return unexpended start-up, retention, or other funds to funding source Coordinate with Sponsored Accounting to determine correct balance to be transferred to gaining institution. DLC DLC Ensure technical and patent reports are complete and have been submitted prior to faculty departure from MIT DLC Initiate formal notification to Sponsor, co-signed by OSP DLC Terminate non-disclosure agreements or transfer to gaining institution as applicable OSP

31 Impacts Overall, the impacts of the upcoming changes on award setup are minor and are likely to result in improvements for Investigators & DLCs 31

32 Impacts On Award Setup Going forward, OSP will stop requiring No Key Persons confirmation for both new award and increments from PHS hierarchy sponsors if there are no Key Persons listed on the proposal Fewer accounts on Hold for No Key Person confirmation 32

33 Key Person History DLCs will now be able to use Coeus to track key persons and their history on a project New feature to make reporting easier 33

34 Impacts On Award Setup If COI master disclosure has been revised by Investigator between proposal and award, no need for revision at award stage. Fewer accounts on Hold at award stage. Proposal 1 submitted (N, N, N) SFI event Proposal 1 awarded Proposal 1 will be included in disclosure COI disclosure created COI Timeline No Hold prompt if disclosure approved 34

35 Impacts More frequent deactivation of proposals after 1 year instead of longer; monthly going forward Fewer proposals for PIs to address on COI disclosure If revisions are spread throughout the year, PIs could be out of compliance year-round instead of mainly Aug/Sep Potentially more questions from PIs/DLCs year-round If revisions are spread throughout the year, COI officer can review and approve more readily. Holds at award stage likely to be shorter 35

36 QUESTIONS? 36

37 37