Departmental Research Administrators Workgroup (DRAW)

1. Departmental Research Administrators Workgroup (DRAW) August 21, 2012 deMarneffe 218

2. Agenda • Announcements/Updates • New PHS Regulations • NIH Biosketches vs. Other Support • A-133 Audit Update • NIH Update • Post-Award Update • Q & A - All

3. Announcements Job Vacancies Research Administration: • Research Finance Coordinator • Administrative Assistant Department: • Grant Administrator

4. 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.

5. 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

6. Changes in PHS Research Management Billing

7. 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

8. 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

9. 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

10. 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

11. 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

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

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

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 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

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. 15

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 16

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 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 17

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 18

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 !! 19

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

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 …

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 22

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 23

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!) 24

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

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

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 27

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

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 29

30. 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

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 31

32. 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

33. Biosketch vs. Other Support Material posted on the Research Intranet under Pre-Award / Tips & Helpful Info • http://research.mclean.harvard.edu/PreAward/docs/BioSketches_vs_Other_Support.docx

34. A-133 Audit Update

35. 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

36. Results – FY11 Two Findings • Unallowable Costs Of 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. • Procurement PHS 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.

37. 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.

38. 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

39. Front entry page Expense Module

40. 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

41. 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.

42. Accounting Detail • Override funding information for unallowable lines, charge them to unrestricted source

43. Attestation

44. 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.

45. PHS Procurement Procedures for Research Purchases >$100,000 Apply to Capital and Non-Capital Goods and Services • 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.

46. Step 1- Click on Comment Bubble Click on comment bubble

47. Step 2 - Click Add Attachment Click Add Attachment

48. NIH Update

49. 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.

50. 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!