Rev.ised 6/26/12

1Office for Interactions with Industry | 617-643-7752 | [email protected] | http://pulse.partners.org/OII/index.html 1

New Public Health Service Regulations:Summary of Major Changes For Researchers and Partners

McLean HospitalResearch Town MeetingJune 22, 2012

Rev.ised 6/26/12

mailto:[email protected]


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

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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 not extended 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



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.

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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

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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

1. Income that exceeds *$5000* (changed from $10,000!), measured on rolling 12-month basis – some exceptions

2. Equity in a public company that exceeds $5000

3. Aggregated income + equity/ownership interest from a public company that exceeds $5000, measured on a rolling 12-month basis

4. ANY equity/ownership interest in a private company

5. IP rights, upon receipt of income

6. ALL reimbursed and “sponsored” travel expenses – different bucket – some exceptions

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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

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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 !!

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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



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 …



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

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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

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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!)

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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

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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

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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

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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

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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

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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



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

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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


Rev.ised 6/26/12

Documents

Transcript of Rev.ised 6/26/12