1. Welcome to RAIN! Presented by: the folks in RDA with today’s emcee, Rachel Dresbeck Date: February 21, 2013 Research Administration Information Network

2. RAIN Agenda Introduction Updates & timely information: USR Special Guest RFDS RGC SPA RATE ORIO Office of the VPR TTBD CRBO CTO Export Controls Human Resources OHSU Foundation Q & A RAIN: 2-21-2013 2 Rachel Dresbeck

3. ORIO –OHSU Research Integrity Office 3 RAIN: 2-21-2013

4. ORIO IBC: Institutional Biosafety Committee New NIH Regulations for Synthetic Nucleic Acids Starting March 5, 2013, the NIH Guidelines will cover work with Synthetic Nucleic Acids, although many uses of Synthetic Nucleic Acids (e.g. – siRNA) will be exempt from IBC review. In order to comply with revised NIH Guidelines, the IBC is issuing revised forms & policies. Kara Drolet, PhD 4 RAIN: 2-21-2013

5. ORIO IBC: Institutional Biosafety Committee New Synthetic Nucleic Acids NIH Regulations (continued) Revised policies, guidance documents and forms will be posted on the IBC Policies & Forms Page.IBC Policies & Forms Page Use of the updated version of the Initial Classification form and Annual Renewal/Project Modification form will be required for all IBC submissions after March 5, 2013. Kara Drolet, PhD 5 RAIN: 2-21-2013

6. ORIO IBC: Institutional Biosafety Committee DRAFT New PPQ Question “Will this project involve the use of synthetic nucleic acid molecules in cells, organisms or viruses?” (Yes/No) For additional information please review the FAQs on the IBC website. FAQs on the IBC website Kara Drolet, PhD 6 RAIN: 2-21-2013

7. ORIO IBC: Institutional Biosafety Committee DRAFT New PPQ Question (continued) If Yes, the following appears: “Can these synthetic nucleic acid molecules Replicate, or generate nucleic acids that can replicate, or Integrate into DNA, or Produce a toxin lethal in vertebrates with an LD50 of <100ng/kg?” Kara Drolet, PhD 7 RAIN: 2-21-2013

8. ORIO IBC: Institutional Biosafety Committee DRAFT New PPQ Question (continued) If Yes to Any, complete IBC Initial Classification Form and submit with this PPQ. IBC Initial Classification Form OR: Approved IBC registration # is:_____ OR: This project was previously determined to be exempt and no changes are proposed that will affect the exempt status [ ].” If No, the system generates a statement indicating that this work is exempt. Kara Drolet, PhD 8 RAIN: 2-21-2013

9. ORIO IBC: Institutional Biosafety Committee Kara Drolet, PhD 9 RAIN: 2-21-2013 Contact Information: ibc@ohsu.edu 503-494-7887, option 1 Institutional Biosafety Committee Online

10. ORIO CoI: Conflict of Interest CoIR Policy Changes Travel disclosure changes per NIH Clarification: Reimbursed or sponsored travel (only applies to investigators involved in Public Health Service funded research only and their spouse, registered domestic partner or dependent children) that exceeds $5,000 when aggregated per entity over the last twelve (12) months. Kara Drolet, PhD 10 RAIN: 2-21-2013

11. ORIO CoI: Conflict of Interest CoIR Policy Changes Disclosures shall include the purpose of the travel, the identity of the sponsor/organizer, the destination and the duration of the travel, and any other information as requested by the disclosure form or designated official. Instructions in eCoI to be modified accordingly. Kara Drolet, PhD 11 RAIN: 2-21-2013

12. ORIO CoI: Conflict of Interest CoIR Policy Changes Travel sponsored by the following types of entities is exempt: federal, state or local government agency institution of higher education, academic teaching hospital, or research institute affiliated with an institution of higher education Kara Drolet, PhD 12 RAIN: 2-21-2013

13. ORIO CoI: Conflict of Interest Outside Activity/Outside Compensation OHSU Members may not participate in industry sponsored “speakers bureaus” (i.e.- contractual relationships to give one or more talks in which the topic(s) and/or content are provided by the company) or other dedicated marketing, educational or training programs designed solely or predominantly for sales or marketing purposes for a product of an outside commercial entity. Kara Drolet, PhD 13 RAIN: 2-21-2013

14. ORIO CoI: Conflict of Interest Outside Activity/Outside Compensation Once this policy is in effect, any scheduled events may be completed, however, no new engagements should be initiated. Kara Drolet, PhD 14 RAIN: 2-21-2013

15. ORIO CoI: Conflict of Interest Contact Information: coir@ohsu.edu 503-494-7887, option 1 OHSU Conflict of Interest Online Kara Drolet, PhD 15 RAIN: 2-21-2013

16. USR - University Shared Resources RAIN: 2-21-2013 16

17. 17 USR: University Shared Resources Andrew Chitty RAIN: 2-21-2013 OHSU’s Cores Advanced technology centers dedicated to the success of your project. Take advantage of the state-of-the-art resources within the OHSU community. Accessible experts offer: Expert advice - Pre-award consulting - Experimental design - Scientific collaboration

18. 18 USR: University Shared Resources Andrew Chitty RAIN: 2-21-2013 ACC Advanced Computing Center ALMC - Advanced Light Microscopy Bioanalytical/Pharmacokinetics BMISR - Biomedical Informatics DNA Services EIDC - Electronics and Instrument Design  Flow Cytometry GMSR - Gene Microarray Histopathology MPSSR - Massively Parallel Sequencing PSR - Proteomics Shared Resource TGMM - Transgenic Mouse Models

19. 19 USR FCSR: Flow Cytometry Shared Resource Philip Streeter RAIN: 2-21-2013 About OHSU’s Flow Cytometry Shared Resource (FCSR) Flow cytometry refers to technology used to study cells in a fluid stream, allowing detection of physical and/or chemical characteristics of 1000’s of cells per second. flow = use of liquid streams to transport particles or cells cyto = cells metry = measurement

20. 20 Philip Streeter RAIN: 2-21-2013 Enables Simultaneous Study of Many Cells USR FCSR: Flow Cytometry Shared Resource

21. 21 Philip Streeter RAIN: 2-21-2013 Enables Simultaneous Study of Many Cells USR FCSR: Flow Cytometry Shared Resource

22. Fluidics Lasers Optics Electronics 22 Philip Streeter RAIN: 2-21-2013 Flow Cytometers USR FCSR: Flow Cytometry Shared Resource

23. 23 Philip Streeter RAIN: 2-21-2013 Flow Cytometry: Fluidics and Lasers USR FCSR: Flow Cytometry Shared Resource

24. 24 Philip Streeter RAIN: 2-21-2013 Flow Cytometry: Cell Sorting USR FCSR: Flow Cytometry Shared Resource

25. 25 Philip Streeter RAIN: 2-21-2013 Type I Diabetes: Loss of Pancreatic  Cells C Dorrell M Grompe USR FCSR: Flow Cytometry Shared Resource

26. 26 Philip Streeter RAIN: 2-21-2013 FSCR Instrumentation & Services Instrumentation Cell sorting Analytical cytometry Services Analytical flow cytometry Cell sorting, incl. primary human cells Data analysis Consultation, Training/teaching Assist in development of grant applications and manuscripts USR FCSR: Flow Cytometry Shared Resource

27. 27 Philip Streeter RAIN: 2-21-2013 USR FCSR: Flow Cytometry Shared Resource

28. 28 Philip Streeter RAIN: 2-21-2013 USR FCSR: Flow Cytometry Shared Resource

29. 29 USR: University Shared Resources Andrew Chitty RAIN: 2-21-2013 SmartPhone App with Expandable Listings  Description of service Contact info Link to full site

30. 30 USR: University Shared Resources Andrew Chitty RAIN: 2-21-2013 http://www.ohsu.edu/cores-mobile/ chitty@ohsu.edu 503-494-5887 University Shared Resources Online

31. Guest Speaker - Office of Internal Services RAIN: 2-21-2013 31

32. OIS: Office of International Services Sponsorship of Foreign Nationals New OHSU Policy No: 03-10-02003-10-020 All foreign nationals requiring immigration status at OHSU must be approved by OIS before arriving on campus. OIS will work with hosting/hiring department to determine if OHSU-sponsored immigration status is needed and prepare any necessary paperwork. OIS must also approve any extensions of OHSU- sponsored immigration status and OHSU-sponsored permanent residency. Alison Roache Jones, Director 32 RAIN: 2-21-2013

33. Procedures Upon notification from hiring/hosting department, OIS determines if foreign national needs OHSU- sponsored immigration status and prepares necessary paperwork. Prior to expiration of foreign national’s OHSU- sponsored immigration status, OIS contacts the foreign national & hiring/hosting department to determine if immigration status extension is needed and/or feasible based on U.S. regulations. 33 RAIN: 2-21-2013 OIS: Office of International Services Alison Roache Jones, Director

34. Contact Information: OIS@ohsu.edu 503-748-7636 Office of International Services Online 34 RAIN: 2-21-2013 OIS: Office of International Services Alison Roache Jones, Director

35. RFDS –Research Funding & Development Services 35 RAIN: 2-21-2013

36. RFDS: Research Funding & Development Services Research Week Call for Abstracts! Abstract submissions due March 22, 2013 Visit http://www.ohsu.edu/researchweekhttp://www.ohsu.edu/researchweek New: Scholarships available to studentsScholarships Katie Wilkes & Rachel Dresbeck 36 RAIN: 2-21-2013

37. RFDS: Research Funding & Development Services Important Update: NIH Public Access Policy Starting July 1, 2013, the NIH will withhold funds on non-competing renewals if publications arising from it are not in compliance with the NIH Public Access Policy.NIH Public Access Policy Brown bag scheduled for March 1, 2013 at 12 p.m. in Mac Hall 2201 to discuss the policy and tools available to manage compliance. Katie Wilkes & Rachel Dresbeck 37 RAIN: 2-21-2013

38. RFDS: Research Funding & Development Services New: Research Career Development webpageResearch Career Development Katie Wilkes & Rachel Dresbeck 38 RAIN: 2-21-2013 Designed to make writing career development plans for training grants easier. Click class or workshop name for detailed information about target audience (e.g., grad student, postdoc, faculty), frequency & cost to participate (if any).

39. RFDS: Research Funding & Development Services NRSA Workshop: Critical Administrative Tools Planning to apply for an NIH pre- or post-doctoral fellowship this April? We encourage you to attend this informal session with Research Grants & Contracts. Experienced grants analysts walk you through a sample application and answer your questions about the application process. For researchers & administrators. When: February 22, 2013 from 12 to 1 p.m. Where: Vollum Institute, room M1443 Please RSVP to funding@ohsu.edu.funding@ohsu.edu Katie Wilkes & Rachel Dresbeck 39 RAIN: 2-21-2013

40. RFDS: Research Funding & Development Services Questions? funding@ohsu.edu http://www.ohsu.edu/funding http://www.ohsu.edu/researchnews Katie Wilkes & Rachel Dresbeck 40 RAIN: 2-21-2013

41. RGC –Research Grants & Contracts 41 RAIN: 2-21-2013

42. RGC: Research Grants & Contracts Deborah Golden-Eppelein 42 RAIN: 2-21-2013 New: Facilities & Administrative Cost Reduction/Waiver Form Guidance is posted at RDA Forms.RDA Forms

43. RGC: Research Grants & Contracts Deborah Golden-Eppelein 43 RAIN: 2-21-2013 F&A Cost Reduction/Waiver Form Required at the institutional level when: PI is requesting reduced F&A rate from sponsor’s published rate. or PI is requesting reduced F&A rate from our federally negotiated rate.

44. RGC: Research Grants & Contracts Deborah Golden-Eppelein 44 RAIN: 2-21-2013 F&A Cost Reduction/Waiver Form For example, the sponsor has a policy that only allows 10% indirect cost recover, but the PI requests no F&A. Therefore, the F&A Cost Reduction/Waiver form must be completed and approved by department chair and dean/unit head.

45. RGC: Research Grants & Contracts Deborah Golden-Eppelein 45 RAIN: 2-21-2013 F&A Cost Reduction/Waiver Form Not required when: sponsor has published rate that is lower than OHSU’s federally negotiated rate or application is in response to program announcement (PA) with published lower rate For example, training grants & some others are limited to 8% recovery stated in the PA, so the form is NOT required.

46. RGC: Research Grants & Contracts Deborah Golden-Eppelein 46 RAIN: 2-21-2013 F&A Cost Reduction/Waiver Form Some departments may, at their discretion, require completion and approval of the form for any application. With F&A requested at less than OHSU’s negotiated rate, RGC may only uphold the minimum policy as outlined above (slide 37).

47. RGC: Research Grants & Contracts Kellie Guentert 47 RAIN: 2-21-2013 InfoEd Anyone that will be a PI (Fellowship included) must have an HR record - either a paid appointment or non-employee HR Record (a.k.a. External PO). HR ID Number Policy In order to log in and/or approve a proposal, they must also have a User Account. OHSU User Accounts

48. RGC: Research Grants & Contracts Kellie Guentert 48 RAIN: 2-21-2013 InfoEd Security must be set so that PI can view and approve their proposals and for a delegated person to see or route that PI’s proposals. Send requests for security to: rgcfaq@ohsu.edu rgcfaq@ohsu.edu

49. RGC: Research Grants & Contracts Kellie Guentert 49 RAIN: 2-21-2013 InfoEd PI delegation to allow someone to route a proposal no longer requires email from the PI since the PI must be included in the route. RGC helps you set up delegation. This is not automated. To request delegation, contact: rgcfaq@ohsu.edu rgcfaq@ohsu.edu

50. RGC: Research Grants & Contracts Kellie Guentert 50 RAIN: 2-21-2013 ePPQ ePPQ is for items being submitted through RGC. There will be no changes for TTBD, ORIO, and CTO at this time. Preparing and routing the ePPQ and proposal are no longer separate processes. The ePPQ is a COMPONENT of your proposal and should not be marked “Complete” until you have entered all other proposal information.

51. RGC: Research Grants & Contracts Kellie Guentert 51 RAIN: 2-21-2013 Progress Reports (when Signing Official approval/submission required) PPQ/ePPQ not required! New PPQ number is NOT generated PI concurrence w/standard PI Certification language required (GCA will request) Email progress report info to GCA (either the report or which system it’s in – e.g., eRA Commons) If a sub-in & going to Prime, include budget & budget justification for checking compliance.

52. RGC: Research Grants & Contracts Kellie Guentert 52 RAIN: 2-21-2013 Progress Reports that require Grants.gov submission: Prepare in InfoEd Follow steps outlined in Amendment/Supplement User Guide to link to original proposal (PPQ number will have -00# at the end)Amendment/Supplement User Guide Grants.gov submission requirements are needed, including ePPQ and routing.

53. RGC: Research Grants & Contracts Kellie Guentert 53 RAIN: 2-21-2013 ePPQ User Guides Currently in two locations: RATE Bridge RGC Website Eventually, all will be housed on the RATE Bridge Site InfoEd & ePPQ page.InfoEd & ePPQ page

54. RGC: Research Grants & Contracts Kellie Guentert 54 RAIN: 2-21-2013 InfoEd Support RGC Questions: rgcfaq@ohsu.edurgcfaq@ohsu.edu InfoEd & ePPQ training classes are posted on the RATE Course Calendar.RATE Course Calendar

55. SPA –Sponsored Projects Administration 55 RAIN: 2-21-2013

56. Combined OMB Circulars! Link to Proposed Changes Send your comments to James Trotter.James Trotter Deadline for comments to James is April 19 th. SPA: OHSU Sponsored Projects Administration James Trotter 56 RAIN: 2-21-2013

57. Reminder: Changes to Account Set-up Process New process to begin this Friday, February 22 nd Email of process overview sent to all PDFMs OGA will request info on new setups daily Automatic email will be sent to (PDFMs) to collect data SPA: OHSU Sponsored Projects Administration James Trotter 57 RAIN: 2-21-2013

58. Changes to Account Set-up Process Data to be collected: Project Short Name (optional) Building Location Research Type Helpful tip: If either Primary Location or Research Type fields are left blank, the PDFM will continue to see those Projects on the list until they are updated. SPA: OHSU Sponsored Projects Administration James Trotter 58 RAIN: 2-21-2013

59. Addition to End Date Notifications If NIH, ensure all relevant publications are in compliance with NIH Public Access Policy.NIH Public Access Policy NIH will delay processing of non-competing continuation grant awards if publications from those awards do not comply with policy. Award will not be processed by NIH until recipients have demonstrated compliance. NOT-OD-12-160 SPA: OHSU Sponsored Projects Administration James Trotter 59 RAIN: 2-21-2013

60. Effort Certification Time! Jul 1 - Dec 31, 2012: Effort period ended Feb 26, 2013 (estimate): Effort forms distributed Apr 16, 2013: Effort forms due to SPA Questions? Contact Hope Asana 503-494- 6984 spaeffrt@ohsu.edu SPA: OHSU Sponsored Projects Administration James Trotter 60 RAIN: 2-21-2013

61. Staffing Changes Nancy Duncan Policy & Financial Compliance Manager Laura Dolan LD, Effort, & Billing Accounting Technician SPA: OHSU Sponsored Projects Administration James Trotter 61 RAIN: 2-21-2013

62. Need to contact SPA? 503-494-0355 spaacctg@ohsu.edu Sponsored Projects Administration SPA: OHSU Sponsored Projects Administration James Trotter 62 RAIN: 2-21-2013

63. RATE –Research Administration Training & Education 63 RAIN: 2-21-2013

64. March RATE Classes InfoEd & ePPQ Wed. 3/6 Effort Reporting/Salary Cap Tues. 3/12 Post-Award Focus NEW! Tues. 3/26 RDA 101: Intro to Research Administration Thurs. 3/28 RATE: Research Administration Training & Education Margaret Gardner 64 RAIN: 2-21-2013

65. Post-Award Focus (Intermediate) Tuesday, March 26, 1 - 4pm Gain the skills necessary to successfully manage the financial compliance of sponsored projects. For details & registration, visit: RATE Bridge RATE: Research Administration Training & Education Margaret Gardner 65 RAIN: 2-21-2013

66. Essentials of Grant Administration New Dates 3 Wednesdays, starting May 1, 1-4pm Comprehensive overview of grant administration from finding funding to close-out and publishing. For more details & registration links, visit: RATE Bridge RATE Bridge RATE: Research Administration Training & Education Margaret Gardner 66 RAIN: 2-21-2013

67. Questions? Contact Margaret Gardner at: gardnerm@ohsu.edu 503-494-8990 Also, join discussions, get announcements, find course information and more via RATE Bridge. RATE Bridge RATE: Research Administration Training & Education Margaret Gardner 67 RAIN: 2-21-2013

68. ORIO –OHSU Research Integrity Office 68 RAIN: 2-21-2013

69. ORIO IRB: Institutional Review Board IRB Updates The IRB has recruited temporary help to speed up review time for chair approvals: Penny Hogarth MD, Neurology Expanded analyst approval of administrative items. Continue to let us know about urgent items: –Participants awaiting –Funding pending –Critical enrollment windows Kathryn Schuff 69 RAIN: 2-21-2013

70. ORIO IRB: Institutional Review Board New Consent Forms No big changes Reproductive risks language HIV and Drug/alcohol treatment language Commercial development language applies to all studies Instructions for translators For studies in progress, you can continue to use the old forms. Kathryn Schuff 70 RAIN: 2-21-2013

71. ORIO IRB: Institutional Review Board Change to HIPAA Revision to law allows streamlined and consolidated consent forms. Revised HIPAA and Consent Templates will be available in April. Kathryn Schuff 71 RAIN: 2-21-2013

72. ORIO: OHSU Research Integrity Office Analyst Brown Bag Session Repository Refresher Thursday, February 28 th 11:30 a.m. -12:30 p.m. in UHS 8B60UHS 8B60 Kathryn Schuff 72 RAIN: 2-21-2013

73. Wrap Up Q & A Next RAIN Meeting: March 21, 2013, 9:30 – 11:00am Send agenda item requests to: rain@ohsu.edurain@ohsu.edu Or use the RAIN Feedback FormRAIN Feedback Form Everyone RAIN: 2-21-2013 73