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Conflict of Interest Updates: Policy, Travel (PHS) and ‘Rolling’ disclosures

OSP Forum August 20, 2013

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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

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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-and-forth’ with faculty)

• More time needed to review and process COI disclosures, not meeting compliance

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A statement of what is a financial conflict of interest, and the need for Investigators to disclosure their financial relationships

Introduction paragraph talks more about what a COI is and the importance of disclosing to MIT

Faculty Feedback suggested clarity and more information so people understand what a COI is and why it’s important to disclose

Summary of Updates to the MIT Policies and Procedures on Conflicts of Interest in Research Changes are effective on August 22, 2013.

Existing Summary of Change Rationale

Policy Statement

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 Definition of Family did not include “domestic partner”

Aggregate means the consolidated total of monies received from a single entity (i.e. through Remuneration, Sponsored Travel, Equity Interests, etc.) Sponsored Travel sets de-minimus threshold of $5K in Aggregate, have to look back 12 months at time of proposal submission Definition of Family now includes ‘domestic partner’

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 Consistent with HR definition

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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.

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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

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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

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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?

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New MyCOI landing page: Disclosing travel with ease

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“Create” a new Travel Disclosure

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Travel related to an SFI

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*Required info to be entered in the Travel screen fields

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Disclosed travel displayed in context of an SFI entity

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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.

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Questions?????

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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

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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 e-mail notifications will help

Investigators with compliance

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Distribution of New NIH/NSF Awards – FY13

0

5

10

15

20

25

30

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July Aug Sep Oct Nov Dec Jan Feb Mar Apr May June

NIH

NSF

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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

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MyCOI landing page: Revise with ease

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“CREATE”

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“REVISE”

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“VIEW”

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System-Generated Notifications to help with compliance

WHEN 2 months prior to month of expiration (Batched – sent 1st of month)

1 month prior to month of expiration (Batched – sent 1st 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 email listing all PIs in their unit

PI: Notification of deadline DLC Head, AO, CA: Summary email 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

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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.

Note: Access to expiration reports requires MIT certificates 28

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

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Failure to report changes of Investigator/Key Person to Sponsor is a critical compliance issue.

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.

PI OSP NE18-901 DLC Administrative Officer

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.

DLC

Determine whether a sub-award to gaining institution is appropriate if award remains at MIT.

DLC

Notify OSP of departing PI and communicate award transfer decisions.

DLC

Advise PI and DLC regarding Sponsor requirements for award transfer; coordinate with Sponsor's business office as needed.

OSP

Ensure salary certification requirements have been met prior to faculty departure from MIT

DLC

Coordinate with Sponsored Accounting to ensure proper and accurate; reconciliation of accounts, completion of financial reports, and close-out of awards.

DLC

Return unexpended start-up, retention, or other funds to funding source

DLC

Coordinate with Sponsored Accounting to determine correct balance to be transferred to gaining institution.

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

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Impacts

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

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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

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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

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Impacts On Award Setup

Proposal 1 submitted (N, N, N)

SFI event

COI disclosure

created

Proposal 1

awarded

COI Timeline No Hold prompt if disclosure approved

Proposal 1 will be included in disclosure

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.

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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

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QUESTIONS?

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