Post on 18-Jan-2018
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Departmental Research Administrators Workgroup (DRAW)
August 21, 2012deMarneffe 218
Agenda
Announcements/Updates
New PHS Regulations
NIH Biosketches vs. Other Support
A-133 Audit Update
NIH Update
Post-Award Update
Q & A - All
Announcements
Job Vacancies
Research Administration:Research Finance CoordinatorAdministrative Assistant
Department:Grant Administrator
Announcements
Reclass of Grant Administrators
Project is underway….Research Administration, HR and Partners Benefits worked together and one on one meetings are currently underway with PI’s and Research Administration.
New Research Management Contacts with Angie Cheng’s Reassignment
Cost Transfers & FSR’s– Brennan Clinton
Billing– Stephen McGurl (Temporary)
Cash and collection– Patricia Gardner
Billing inquiry and customer support– Angie Cheng
Changes in PHS Research Management Billing
Streamlining Intercompany Invoices
Goal: to eliminate outstanding Accounts Receivable within the Partners entities each month
All intercompany monthly invoices (non-final) will be processed for payment via journal entry by the month end close in the calendar month in which they were generated
Includes invoices to/from MGH, BWH, McLean and Spaulding
Monthly (non-Final) Invoices
Monthly invoices will be generated and batched by the Research Finance Billing Team on business day 8 each month
The subcontract payment administrator will send monthly intercompany invoices to the PI/DA no later than business day 10 each month
PI/DA’s will have a reduced review time of 10 days to deny invoices
All invoices will be paid by month end unless specifically denied for scientific reasons
Final Invoices Intercompany final invoice generation will be
prioritized by the Research Finance Billing Team each month
The subcontract payment administrator will also prioritize sending final intercompany invoices to the PI/DA
PI/DA’s will have a reduced review time of 10 days to deny invoices
RF will pay, via journal entry, all approved final invoices as received each month, unless specifically denied for scientific reasons
Other Items to Note
All intercompany invoices will be considered low risk. The dollar threshold for high/low risk is eliminated for intercompany invoices
Invoices that are disputed for scientific or performance reasons will not be paid until resolution occurs
Continuation - Other Items to Note
Invoices with administrative errors will be revised before being paid. Examples of administrative errors are: – Unallowable expenses included on the invoice– Incorrect fund numbers, award amounts or budget
periods– Incorrect cumulative expenditures to date
12Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 12
New Public Health Service Regulations:Summary of Major Changes For Researchers and PartnersMcLean HospitalResearch Town MeetingJune 22, 2012 Rev.ised 6/26/12
13Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 13
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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14Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 14
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
15Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 15
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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16Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 16
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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17Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 17
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 $50003. Aggregated income + equity/ownership interest from a public company that
exceeds $5000, measured on a rolling 12-month basis4. ANY equity/ownership interest in a private company5. IP rights, upon receipt of income6. ALL reimbursed and “sponsored” travel expenses – different bucket – some
exceptions
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18Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 18
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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19Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 19
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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20Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 20
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
21Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 21
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 …
22Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 22
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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23Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 23
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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24Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 24
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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25Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 25
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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26Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 26
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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27Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 27
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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28Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 28
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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29Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 29
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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30Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 3030
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
31Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 31
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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32Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 3232
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
Biosketch vs. Other Support
Material posted on the Research Intranet under Pre-Award / Tips & Helpful Infohttp://research.mclean.harvard.edu/PreAward/docs/BioSketches_vs_Other_Support.docx
A-133 Audit Update
FY12 Audit Testing
Award testing included 34 research grants, 27 PI interviews based on Compliance Controls Questionnaires and 261 direct cost selections.
Compliance testing including: Cost Transfers, Effort Reporting, Unallowable Costs, FSR & FFATA submission rates, Cost Sharing, Subrecipient Monitoring, IRB and IACUC approvals and Procurement procedures.
New this year:– NIH Cap– This year BWH & McL inventory – equipment
Results – FY11 Two Findings
Unallowable CostsOf the 261 direct costs tested, PwC noted one travel
expenditure that included alcohol and lunch for an individual unrelated to the grant totaling $43.96 charged through a Corporate Travel Card.
ProcurementPHS policy requires documentation of competitive
bidding for Capital purchases >$100K. OMB Circular A-110, paragraph 48 requires documentation of competitive bidding for all purchases >$100K and is not limited to capital equipment.
Expense Reports That Include Travel Card Activity
Travel card activity charges based on monthly usage and is independent of the expense report filing.
Expense reports (receipts) are required for all travel card activity.
If the T Card charges to a grant– Identify unallowable expenses when the expense report is
submitted– Override the accounting default to an unrestricted source at
the line level and – Complete a cost transfer journal entry to remove the
unallowable expenses from the grant and charge the same unrestricted source included in the expense report submission.
Unallowable Items
Meals that includes alcohol need to be broken into two lines; one for food and one for alcohol
The expense line for alcohol needs to be coded to the Billing Type “Unallowable – Goverment Program”
Override funding information for unallowable lines, charge them to unrestricted source
Front entry page Expense Module
Split Meals Into Two Lines
One line for alcohol, the other for food Billing Type for alcohol needs to be “Unallowable – Govt Program” Click on Accounting Detail to update to an unrestricted source,
either a sundry fund or Department
Accounting Detail
Employees can click on accounting defaults icon on the individual detail screen for any single line item and change the accounting information to unrestricted (Operating or Sundry Funds) for any individual single line item and only that line item will be charged to the funding information provided.
Accounting Detail
Override funding information for unallowable lines, charge them to unrestricted source
Attestation
PHS Procurement Procedures for Research Purchases >$100,000 Apply to Capital and Non-Capital Goods and Services
Identify 3 or more potential vendors. PI obtains Competitive Bids from 3 qualified vendors and
completes the vendor selection process. Requisition is prepared through e-Buy for routing and
approval with all 3 competitive bids attached. Steps to attach bid support are outlined in the next slides. Requisitions >$100,000 should not be routed for approval without the competitive bids attached.
No changes to existing routing and approval workflow within PeopleSoft.
Materials Management is responsible for maintaining bid documents with the final approved Purchase Order.
Departmental Buyers are responsible for maintaining bid support with the PO for all orders placed outside of Materials Management.
Purchase Orders originally issued for less than $100,000 are subject to competitive bidding if the PO is increased to $100,000 or greater.
PHS Procurement Procedures for Research Purchases >$100,000 Apply to Capital and Non-Capital Goods and Services
Step 1- Click on Comment Bubble
Click on comment bubble
Step 2 - Click Add Attachment
Click Add Attachment
NIH Update
Budget inflation in NIH applications
NIH does not intend to fund inflation escalator in budget in new awards in FY13.
Recommendation: Budget should not include inflation in the out‐years. GA can advise you on alternatives.
Other federal and foundation budgets should include the 2% inflation escalator if allowed by the sponsor.
NIH Progress Reports & fund balances exceeding 25%
NIH reviews actual fund disbursements through the 10th month & will ask for details when the adjusted balance exceeds 25% of the current year –even if balance will be under the limit at end of grant year.
Pending cost transfers, EDCs, subcontractor invoices may contribute to a large balance.
Large, inadequately justified fund balance may result in an unfunded grant year or a reduction in funds.
Review balance & make adjustments in month 9!
Post-Award Announcements/Updates
Recent Sponsor Scrutiny
1. Outstanding Invention & Technical Reports
Future funding impacted in some cases– Department of Defense
2. Invoicing of Federal Contracts Additional justifications needed from
Department, in some cases, to support work conducted & travel
Prompt Payment FAR Clause 52.232-25
Employee Data Changes (EDCs) PeopleSoft 9.1 Challenges
Processing of EDCs has slowed down due to the upgrade
PeopleSoft Team actively working to resolve issues
Employee Data Changes (EDCs) PeopleSoft 9.1 Challenges
Inability to review changes Awaiting Approval– Query under development– May require additional details from DA if FSR due
Inability for Post-GA to sort work list– Fix identified and resolved in June
Last originator not viewable to 2nd level approvers– Fix still pending
Starting in September, meetings will start at 10:30 and end at 12
noon.
Questions?
Contact
Raquel EspinosaPhone: 617-855-2868respinosa@partners.orgrespinosa@mclean.harvard.edu