1. May 21, 2013Research Administrators Workgroup

2. 2 Agenda Introductions Announcements / Updates NIH Public Access Policy (Pam Hastings) FY12 PHS Consolidated A-133 Report (Raquel Espinosa) Billing Agreements / Partners Internal Direct Charging Unilateral Agreements Q & A – All

3. Pre-award Announcements

4. 4 Due to the very high volume of grant proposals anticipated over the next couple of months, please be reminded of the internal deadlines: 10 and 5 business days before the Sponsor deadline date of draft and final proposals

5. 5 Temporary” contact for SF424 Application and Progress Reports SF424 #5 Person to be contacted on matters involving this application #19 Authorized Representative Mrs. Raquel Espinosa Tel 617-855-2922 Fax 617-855-3745 email : Research_Admin@mclean.harvard.edu Research_Admin@mclean.harvard.edu Title: Director, Research Administration NIH progress reports, the “Research Performance Progress Reports” (RPPR) should reference Raquel as the Institutional Official

6. 6 Statement of Intent SOI Cooperating Institutional Business Contact Information John Cavanaugh Tel 855-2285 Fax 617-855-3745 email: McLSubContracts@partners.org McLSubContracts@partners.org

7. McLean PeopleSoft Payroll Fix

8. 8 It was noted that there are problems processing research funding changes in PeopleSoft before the monthly payroll run. Workaround: Effective immediately McLean stops approving all research funding changes four days prior to the McLean monthly payroll run. Example: if monthly payroll falls on a Thursday of the month, all changes submitted from Monday – Thursday will not be processed.

9. 9 Salary Issues Salary issues should be directed to: PHSSalaryIssueAdj@partners.org

10. PeopleSoft- Research Post Only Transactions

11. Reminder: Research Post-Only (RPO) Transaction  Effective 6/1/13, Departments will be required to utilize the RPO transaction when submitting post-only transactions  Initial roll-out took place 4/1/13 and Research Management will continue to accept the previous method through 5/31/13 o RPO transaction replaces the previous method of entering a Post Only EDC, which required the DA to add ‘Post-Only’ comments o Many new features were added to the RPO, including:  Ability for a single entry for multiple consecutive changes  Ability for side-by-side comparison of “effective” and “new” distribution o Webinar training available at the following site:  https://phsragconnect.partners.org/rpowebinar https://phsragconnect.partners.org/rpowebinar o Look for revised Employee Data Change SOP in June 11

12. New PCRO Helpline and Hotline information

13. The Partners Clinical Research Office (PCRO) has established a dedicated PCRO Help Line 617-954-9392 and Mailbox PCRO@partners.org for the PHS research community for information, assistance and answers to questions related to industry-sponsored clinical research contract and budget negotiation and approval, fund activation, Medicare Coverage Analysis and Medicare device petition issues. PCRO@partners.org The PCRO Help Line 617-954-9392 and PCRO Mailbox PCRO@partners.org are listed on the PCRO website at:PCRO@partners.org http://www.partners.org/Medical-Research/Resources/Research-Support/PCRO/Default.aspx Experienced PCRO staff with knowledge of industry-sponsored clinical research contract and budget negotiations and approval, fund activation, Medicare Coverage Analysis, Medicare device petition and, institutional policies and procedures will respond to calls and emails within one business day. 13

14. FY12 Pd 2 Effort Certification – ECFs Past Due

15. Effort Reports were due on May 8, 2013. Currently there are still 14 incomplete forms left at McLean. Thank you to all administrators and investigators that have already completed their Effort Certification Forms! Please contact the Effort Reporting Team with any questions or concerns at phseffort@partners.orgphseffort@partners.org ECFs by Status Pre-Review3 Certification9 Post-Review2 Completed100 Total114 McL Effort Forms by Status As of 5/20/13 FY12 Pd 2 Effort Certification – ECFs Past Due DEADLINE May 8 – Deadline for effort reports return (marked as completed in Insight) ESCALATION May 23 – Chief, Dept Admin, Institutional Research Administrator, and Entity Compliance Officer June 7 – Entity VP Research, PHS Vice President of RM and RF, PHS Compliance Officer + everyone above June 21 – PHS VP Finance + everyone above

16. DEADLINE May 8 – Deadline for effort reports return (marked as completed in Insight) ESCALATION May 23 – Chief, Dept Admin, Institutional Research Administrator, and Entity Compliance Officer June 7 – Entity VP Research, PHS Vice President of RM and RF, PHS Compliance Officer + everyone above June 21 – PHS VP Finance + everyone above FY12 Pd 2 Effort Certification Deadlines & Escalation Please contact the Effort Team via their mailbox at phseffort@partners.org if you need help or have any of the following issues:phseffort@partners.org Investigator left the institution during the reporting period and cannot sign Investigator is on a leave of absence and cannot sign Investigator assigned to me belongs in another department We are ready to assist you now. Don’t wait until escalation to get help! Please contact the Effort Team via their mailbox at phseffort@partners.org if you need help or have any of the following issues:phseffort@partners.org Investigator left the institution during the reporting period and cannot sign Investigator is on a leave of absence and cannot sign Investigator assigned to me belongs in another department We are ready to assist you now. Don’t wait until escalation to get help!

17. Harvard Stem Cell Institute

18. 18 Harvard Stem Cell Institute (HSCI) recently instituted more strict rebudgeting requirements for their awards to Partners hospitals. These requirements will make the proposal submission and award management significantly more onerous.  HSCI will reject any invoice that has an expense in a budget category for which there was no budget included in the proposal  Due to the way the PeopleSoft general ledger reports expense activity, freight expenses associated with a supply purchase report in the “Other Expenses” category instead of “Supplies.” HSCI will reject any invoice that reports an amount in Other Expenses if there wasn’t a budget for Other Expenses in the proposal  Rebudgeting for more than 20% of any budget line requires HSCI’s prior approval. After-the-fact-approval, meaning requesting a rebudget after we have overspent a budget category, is not allowable  Carry forward of unspent funds is not automatic and must be justified Budgeting for Harvard Stem Cell Institute (HSCI) Awards

19. Budgeting for Harvard Stem Cell Institute (HSCI) Awards (cont.) As a result of these more strict requirements, Pre-Award will now ask you to include the following budget categories in your new applications for HSCI awards:  Other Direct Costs - $50-$100 to cover freight and other ancillary charges if the budget also includes supplies or equipment  Travel - $50 to cover local and other travel not anticipated at the time of proposal submission 19

20. NIH Access Policy

21.  Is peer-reviewed  And, is accepted for publication in a journal on or after April 7, 2008;  And, arises from:  Any direct funding from an NIH grant or cooperative agreement active in Fiscal Year 2008 or beyond, or;  Any direct funding from an NIH contract signed on or after April 7, 2008, or;  Any direct funding from the NIH Intramural Program, or;  An NIH employee. 21

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32. Differences Products Participants Accomplishments Impact Special Reporting Resources/Tools

33. RPPR: Section C – Products (Publications/Public Access) C.1 Publications C.2 Website(s) or other internet site(s) C.3 Technologies or techniques C.4 Inventions, patent applications and/or licensesC.5 Other products and resources Products

34. Products

35. 35 MyNCBI Dashboard for the Principal Investigator

36. MyNCBI – My Bibliography with “AWARD VIEW”

37. 37 “AWARD VIEW” – NIH Public Access Compliance color codes

38. Is there an NIHMSID# ? Yes – Then the submission process has already begun. Check that submission was approved. No - Contact Pam Hastings, for assistance. x2460 chastings@partners.org

39. Questions? Contact Pam Hastings, Manager Library Resources 617-855-2460 chastings@partners.org

40. FY12 Audit Update PHS Consolidated A-133

41. FY12 Audit Testing Award testing included 34 research grants, 27 PI interviews based on Compliance Controls Questionnaires and 260 direct cost selections. Service Center testing included 7 Cores and 40 direct cost selections. Compliance Controls testing included Activities Allowed & Unallowed Asset Inventory Cash Management Cost Sharing Davis-BaconFFATA & FSR Reporting Effort Reporting Eligibility Period of AvailabilityProcurement Program IncomeSpecial Tests & Provisions Sub-recipient MonitoringUnallowable Costs

42. Audit Results - Four Findings 2012-1 Equipment 2012-2 Davis-Bacon 2013-3 Period of Availability 2012-4 Federal Funding Accountability and Transparency Act (FFATA)

43. 2012-1 Equipment OMB Circular A-110 Section 34(f)(3) requires organizations which receive federal funding and which purchase equipment to perform a physical inventory of the federally funded equipment at least once every two years and reconcile the results to equipment records. Of the 34 inventory items selected, PwC noted one item at McLean Hospital whose serial and tag number was not appropriately reflected within Partners HealthCare’s equipment records. Cause This item had malfunctioned and was returned to the supplier for a replacement. However, equipment records were not updated to reflect the replacement item’s equipment tag and serial number within the inventory management system.

44. 2012-2 Davis-Bacon Non-federal entities shall include in their construction contracts subject to the Davis-Bacon Act a requirement that the contractor or subcontractor comply with the requirements of the Davis-Bacon Act and the Department of Labor regulations (29 CFR part 5, Labor Standards Provisions Applicable to Contacts Governing Federally Financed and Assisted Construction). This includes a requirement for the contractor or subcontractor to submit to the non-Federal entity weekly, for each week in which any contract work is performed, a copy of the payroll and a statement of compliance (certified payrolls) (29CFR sections 5.5 and 5.6). PwC tested purchase orders greater than $100K, a $4.6M selection was made related to a construction contract which was subject to Davis-Bacon requirements as outlined within the Notice of Award. The Davis-Bacon requirements were not communicated to the contractor as part of the construction contract and there was no evidence of certified weekly payroll submissions to demonstrate compliance with Davis-Bacon..

45. 2012-3 Period of Availability OMB Circular A-110 (2 CFR section 215.28) “a recipient may charge to the grant only allowable costs resulting from obligations incurred during the funding period.” PwC noted one instance of a grant which had $33,986 in salary expenses incurred subsequent to the grant end date. Charges were not redirected prior to the end date of the award or removed after the grant ended.

46. 2012-4 Federal Funding Accountability and Transparency Act (FFATA) Beginning October 1, 2010, the FFATA reporting requirement was effective for Partners HealthCare. This law requires that Grant, Cooperative Agreement, and Contract recipients report information related to subawards issued which have an obligation of $25,000 or greater by the end of the month following the month in which the subaward agreement or modification was fully executed. These reports are required to be submitted once each time a subagreement or modification is fully executed for all applicable awards. Six of the 14 reports selected for testing were late.

47. Corrective Action Plan 2012-1 Equipment Partners HealthCare agrees with the finding and the auditors recommendations. The McLean biennial inventory was completed in October 2012 with the Near Infrared Video Fear Conditioning System properly tagged and recorded in the Hospital’s asset inventory. Management has emphasized the importance of accurate inventory records and provided training to the McLean Research Community in January 2013. Additionally, Partners HealthCare will upgrade existing research asset inventory systems in FY13. 2013-3 Period of Availability 2012-4 FFATA

48. Corrective Action 2012-2 Davis-Bacon Partners HealthCare agrees with the finding and the auditors recommendations. Management has reviewed the current award portfolio for all Partners HealthCare hospitals and confirmed that this is the only grant subject to the Davis-Bacon Act. The existing contract with the construction vendor has been amended to incorporate Davis-Bacon terms and conditions. Payroll records, retroactive to the start of construction in January 2012, have also been reviewed for proper certification as required under the Act. Hospital Real Estate Offices and Partners Research Management will follow standard operating procedures to ensure that federally funded construction contracts incorporate all terms and conditions included in the prime award. Partners HealthCare has documented internal procedures to ensure that all applicable terms and conditions are incorporated into construction contracts.

49. Corrective Action 2012-3 Period of Availability Partners HealthCare agrees with the finding and the auditors recommendations. Costs charged after the award end date have been removed from the grant as of November 2012. Management views this as an isolated circumstance. During FY13, Management will increase the focus on salaries charged to grants that are ending through monthly notification of upcoming end dates and routine fund monitoring procedures. Management will direct future payroll allocations to discretionary sources if a new salary distribution is not identified prior to the end date of the award.

50. Corrective Action 2012-4 FFATA Partners HealthCare agrees with the finding and the auditors recommendations. Management has emphasized the importance of FFATA compliance and identified key control points to strengthen existing standard operating procedures for FFATA reporting requirements. Internal procedures were updated in February 2013 with system enhancements to be completed by May 2013.

51. Status of Prior Year Findings 11-1 Unallowable Costs - Of the 261 direct costs tested, PwC noted one expenditure for which the Principal Investigator (PI) on the grant charged alcohol as well as a lunch for an individual unrelated to the grant totaling $43.96 through his travel card. 11-2 Procurement - Of 15 purchases over $100,000 selected for testing PwC identified 12 purchases for which Partners HealthCare did not have evidence supporting the (a) basis for contractor selection,(b) justification for lack of competition when competitive bids or offers are not obtained, and (c) basis for award cost or price. Management's corrective actions in response to Prior Year Findings from fiscal year 2011 were fully implemented during fiscal year 2012. There were no exceptions noted in the current year testing of travel expenses and purchases greater than $100,000.

52. Resources Link to the FY12 A-133 Report on the Partners Home Page http://www.partners.org/Medical-Research/Institutional- Information/apex A-133 Outlook Mailbox –PHSA133@partners.org

53. Questions?

54. Billing Agreements / Partners Internal Direct Charging

55. Overall Summary Principal Investigators (PI)/Researchers are sometimes employees of one institution while physically perform all work at another local institution.  Billing agreements facilitate invoicing between two local institutions  Direct charging of salary/stipend and fringe via a PeopleSoft Employee Data Change (EDC) is done in lieu of billing agreements between Partners hospitals or entity departments.  Both cover salary and fringe only, with the exception of training grant and similar mechanisms.  Overhead is not allowed, with the exception MIT Student Billing Agreements. *A subcontract should be used if the work will take place at both institutions to address the possibility of intellectual property being developed at either institution and other legal terms and conditions.

56. Harvard Workgroup Established approximately 14 months ago to bring together Harvard Affiliates with the goal of improving or streamlining research operations. 1.Beth Israel Medical Center, 2.Children's Hospital Boston, 3.Dana-Farber Cancer Institute, 4.Harvard Medical School, 5.Harvard School of Public Health, 6.Harvard University, 7.Joslin Diabetes Center 8.Partners Healthcare *Guidance document specifically for billing agreements across the Affiliates, including templates, has been developed and agreed to by the Workgroup.

57. Types of Billing Agreements 1.Investigator Salary and Fringe Agreements 2.Institutional Training Grant (i.e. T32) 3.Mentored Awards with trainee slots (i.e. K12) 4.MIT Student Agreements (outgoing agreements only)

58. Partners Internal Direct Charging Across Partners hospitals: A researcher is an employee of one Partners hospital, but is performing all work associated with a particular Research project in another Partners hospital.  Requirements: Researcher should be a T32 trainee or hold a joint appointment and have required lab accesses. Researcher should be delineated in the proposal budget and justification indicating that all work is happening at the Prime hospital, although s/he is paid by another Partners hospital.  Allocation Process: The Prime Awardee Department Administrator (DA) is responsible for notifying the DA at the Payroll Entity responsible for processing the PeopleSoft employee data change (EDC) to add the new fund to the individual’s distribution, and providing justification for the EDC. The Payroll Entity DA is responsible for adding the cross-institutional fund to the researcher’s distribution through PeopleSoft. Indirect costs are assessed at the Prime Awardee as all work takes place there. Fringe will be charged to the Payroll Entity via a monthly allocation program. .

59. Internal Direct Charging – Across Department Across Department (within the same hospital): A researcher is performing work on a particular research project outside his/her normal chief code. Work does not have to be performed specifically in department space where funding is derived, but rather can be done in the individual’s normal workspace since the work is taking place within the same entity  Allocation Process: The DA managing the Prime Award is responsible for notifying the DA of the external chief code to add the new fund to the individual’s distribution, and providing justification for the EDC. The comments field of the EDC must indicate which chief code the work is taking place in, along with a confirmation that communication across the respective Departments validating the allocation amount has occurred.

60. Fund Management  Monitoring of expenses, including the salary expenses allocated by the Payroll or Trainee Entity/Department, is the responsibility of the Prime Awardee’s DA. A PeopleSoft fund number for the Payroll Entity will not be established  Pro-active notifications of budget overages, or surplus, by the Prime Awardee DA to the Payroll or Trainee Entity’s DA is required throughout the project.  The Payroll or Trainee Entity DA will be able to view the salary allocation of their employee the day following approval of the EDC via Insight.  Any changes to the payroll allocation must be discussed with the Prime Awardee DA before additional EDCs are submitted.  The Payroll Entity DA is responsible for submitting the EDC to remove the individual from the project by project end date.  Post-Award GA will also communicate across central portfolio managers to ensure allocation is appropriate as part of the EDC review.

61. Unilateral Agreements

62. 62 Unilateral Agreements As of 12/01/11, Partners RM started issuing unilateral modifications and foregoing a secondary PI approval by the Contracts Team as part of a new effort to streamline outgoing subcontract and PSA modifications. Unilateral process should be followed in any instance where Partners does not require the Subcontractor to remit a fully-executed, bilateral modification.

63. 63 Unilateral Agreements Unilateral modifications should only be for: No cost extension (NCE) Approval of carryforward funds Updating contact information or other administrative changes All renewal modifications between Partners institutions that do not change substantive terms or reduce anticipated budget by more than the prime award reductions and not more than 10% All other modifications should continue to be bilateral and executed by both parties.

64. 64 QUESTIONS? Contact: Raquel Espinosa respinosa@partners.org 617-855-2868