1. Welcome to RAIN! Presented by: the folks in RDA with today’s emcee, Kara Drolet Date: February 19, 2015 Research Administration Information Network

2. RAIN Agenda Introduction Updates & timely information: SVPR OIA: Export Controls TTBD OPAM RATE ORIO RFDS USR Research & Academic HR CTO OCTRI Q & A 2 Tracy Zitzelberger RAIN: 2-19-15

3. SVPR - Office of the Senior Vice President for Research 3 RAIN: 2-19-15

4. Research Week 2015: Call for abstracts –May 4-8, 2015 –Registration is now open on ConfToolnow open on ConfTool –Deadline for submission is March 17 4 SVPR: Office of the Senior Vice President for Research Bekki Witt RAIN: 2-19-15

5. Research Week skill development workshops –How to Give a Scientific Talk: Mar. 16 –Data Visualization: Apr. 7 –Preparing a Poster: Apr. 9 More information is available on Research NewsResearch News 5 SVPR: Office of the Senior Vice President for Research Bekki Witt RAIN: 2-19-15

6. 6 Questions? E-mail: researchweek@ohsu.eduresearchweek@ohsu.edu Website: ohsu.edu/researchweekohsu.edu/researchweek SVPR: Office of the Senior Vice President for Research Bekki Witt RAIN: 2-19-15

7. 7 Equipment Monitoring Coming soon to a lab near you! All equipment alarms connected to the Fire and Safety monitoring system will be replaced by Aeroscout Monitors. SVPR: Office of the Senior Vice President for Research Dana Director RAIN: 2-19-15

8. 8 Aeroscout Monitor Highlights Data wirelessly sent to central database every 5 min. Custom temperature, humidity, voltage thresholds Alert notifications in 5 minutes of threshold breach Email, text, and phone call notifications Alert escalation – alert to second tier contacts if alarm state persists Reasonable cost, long-life, AA battery lasts 3 years Daily, Weekly, Monthly data trend reports SVPR: Office of the Senior Vice President for Research Dana Director RAIN: 2-19-15

9. 9 Types of Monitoring Temperature (-200°C to +140°C) Humidity ( 5% to 95%rh ) Voltage (2.5V to 30V) Physical Location (all monitors track physical location) SVPR: Office of the Senior Vice President for Research Dana Director RAIN: 2-19-15

10. 10 Pricing Depending on monitoring needs, all-inclusive prices range from $185 - $310. (This includes any licensing fees picked up by labs.) SVPR: Office of the Senior Vice President for Research Dana Director RAIN: 2-19-15

11. 11 For more information, contact: Craige Mazur mazur@ohsu.edu 503-494-46563 Watch Research News for more on equipment monitoring. SVPR: Office of the Senior Vice President for Research Dana Director RAIN: 2-19-15

12. OIA: Export Controls - Office of International Affairs: Export Controls 12 RAIN: 2-19-15

13. OIA: Export Controls International Travel All international travel needs to be pre-screened. Quick and easy. Located on the Office of Export Controls website under “International Travel”.Office of Export Controls website Jen McCaw 13 RAIN: 2-19-15

14. OIA: Export Controls International Travel System will protect travelers from unknowingly meeting with restricted parties. OHSU will process any needed export permits for travel, if required. Note: First time registration needed. Jen McCaw 14 RAIN: 2-19-15

15. Mobile Devices Know WHAT is on your device BEFORE travel. Information and data may carry restrictions. Encrypted information may still require export license. Be sure to complete the Certification Document and carry a signed copy with you when traveling. 15 OIA: Export Controls RAIN: 2-19-15 Jen McCaw

16. 16 Questions? Jen McCaw mccaw@ohsu.edu (503) 494-2009 Office of Export Controls OIA: Export Controls Jen McCaw RAIN: 2-19-15

17. TTBD - Technology Transfer & Business Development 17 RAIN: 2-19-15

18. TTBD: Technology Transfer & Business Development TTBD Lunch & Learn Presentation “An OHSU Licensing Case Study: Discovering new Human MR Imaging Biomarkers” Thursday, February 26, 2015 12:00-1:00PM Mackenzie Hall 2201 Add to your Outlook Calendar Add to your Outlook Calendar or email borenk@ohsu.edu for an event invite. borenk@ohsu.edu Andrew Watson 18 RAIN: 2-19-15

19. Winter TTBD Newsletter Look for late Feb release in Research News OHSU Conferences Aim to Bring Together Inventors, Investors and Industry What happened at the OHSU Startup Symposium? Commercialization of an MRI Breast Cancer Technology New TTBD Staff Members Subscribe today: techmgmt@ohsu.edutechmgmt@ohsu.edu Andrew Watson 19 TTBD: Technology Transfer & Business Development RAIN: 2-19-15

20. 20 Questions? TTBD Office techmgmt@ohsu.edu 503-494-8200 techmgmt@ohsu.edu Website: www.ohsu.edu/techtransferwww.ohsu.edu/techtransfer Andrew Watson TTBD: Technology Transfer & Business Development RAIN: 2-19-15

21. OPAM - Office of Proposal & Award Management 21 RAIN: 2-19-15

22. OPAM: Office of Proposal & Award Management Effort Reminder Jul-Dec 2014 effort period is closed Forms distributed from OPAM on February 25 Class: Effort Certification/Salary Cap Refresher on March 10 – enroll via CompassCompass Policy & Compliance: Charlie Resare 22 RAIN: 2-19-15

23. OPAM: Office of Proposal & Award Management New Participant Support Cost Policy Clarifies Uniform Guidance Requirements: How to use cost category What types of costs qualify Prior approval requirements Link to Policy Policy & Compliance: Charlie Resare 23 RAIN: 2-19-15

24. OPAM: Office of Proposal & Award Management NIH Interim Grant Conditions Uniform Guidance Pre-Award Changes Waived Prior Approval for Fixed-Price Subawards 8% F&A for Foreign Subawards NIH source here.here Grants Management: Nancy Duncan 24 RAIN: 2-19-15

25. OPAM: Office of Proposal & Award Management NIH Interim Grant Conditions Uniform Guidance Post-Award Changes Administrative and Clerical Staff as Direct Costs: Integral to Project Allocable Not Recovered as Indirect Costs Included in Budget or Prior Written Approval Grants Management: Nancy Duncan RAIN: 2-19-15 25

26. OPAM: Office of Proposal & Award Management NIH Applications Zip + 4 Applications without zip code + 4 for non-OHSU performance sites and non-OHSU key personnel (as required) are encountering submission errors. Be sure to check! Pre-Award: Aric Dutelle RAIN: 2-19-15 26

27. OPAM: Office of Proposal & Award Management NIH Applications NIH Biosketch New format allows applicants to include URL link to a full list of their published work. When including that link, spell the URL out in full, beginning with ‘http://’ (e.g., http://grants.nih.gov/grants/oer.htm). Do not use hyperlinked text (e.g., NIH Grants Web page). eRA system processing will not retain the active link in the assembled application image in eRA Commons. NIH Grants Web page Pre-Award: Aric Dutelle RAIN: 2-19-15 27

28. OPAM: Office of Proposal & Award Management NIH Applications Special Characters NOT-OD-15-058 NOT-OD-15-058 NIH announced that Unicode characters such as Greek letters are functional in Grants.gov as of 2/17/15. However, OHSU investigators should NOT use these codes yet. Grants.gov is accepting them, but most other systems still can not. InfoEd and many other federal grant submission systems and reporting databases (e.g., usaspending.gov) cannot currently support special characters. Pre-Award: Aric Dutelle RAIN: 2-19-15 28

29. OPAM: Office of Proposal & Award Management NIH Applications More on Special Characters NOT-OD-15-058 NOT-OD-15-058 Adobe forms may seem workable for InfoEd but place extra burden on PIs and staff. A generic InfoEd record would still be required and would need to be thoroughly reviewed by department staff and OPAM to ensure accuracy in translation of special characters. More details on this are available in Research News.Research News Pre-Award: Aric Dutelle RAIN: 2-19-15 29

30. OPAM: Office of Proposal & Award Management Grants.gov Submissions Grants.gov Recommends Submission 48-72 Hours PRIOR TO DEADLINE Institutionally, the average is nearly 24-48 hours for submissions to clear Grants.gov to non-NIH sponsors. Please take this into consideration when assembling and routing proposals requiring Grants.gov submission. Pre-Award: Aric Dutelle RAIN: 2-19-15 30

31. OPAM: Office of Proposal & Award Management Uniform Guidance Changes Closeout Deadlines Payment Management System (PMS) 90 days from award end date Final Financial Report (FFR) 120 days from award end date for NIH and NSF awards only. No further draws or FFR revisions are possible past this time frame. Post Award: Pat Cloteaux 31 RAIN: 2-19-15

32. RAIN: 1-15-15 Questions? OPAM Central: orserv@ohsu.edu 4-7784 OPAM Online OPAM: Office of Proposal & Award Management

33. RATE – Research Administration Training & Education 33 RAIN: 2-19-15

34. RATE: Research Administration Training & Education Margaret Gardner 34 Upcoming Classes  Effort Certification/Salary Cap Refresher March 10  Oracle Grants Accounting March 11  Training Grants & Fellowships March 24  RDA 101: Intro to Research Administration April 9 Enroll through Compass. Compass RAIN: 2-19-15

35. RATE: Research Administration Training & Education Margaret Gardner 35 Website refresh Changes to RATE and RAIN pages Big thanks to all who helped with photos! Navigation issues being addressed. Find help at https://o2.ohsu.edu/websupport. https://o2.ohsu.edu/websupport RAIN: 2-19-15

36. ORIO –OHSU Research Integrity Office 36 RAIN: 2-19-15

37. ORIO CoI: Conflict of Interest Update to eCoI Disclosure System  Managers can now use eCoI to generate department compliance records.eCoI  Multiple signature notices Every 14 days for disclosures awaiting signatures. Kara Drolet 37 RAIN 2-19-2015

38. 38 Questions? Kara Drolet, ORIO Associate Director manningk@ohsu.edu 503-494-8849 Conflict of Interest site. RAIN 2-19-2015 ORIO: OHSU Research Integrity Office

39. ORIO IRB: Institutional Review Board Upcoming Changes: IRB Reporting Requirements Unanticipated Problems (UPs) and Protocol Deviations (PDs) Reportable New Information (RNI) Andrea Seykora 39 RAIN: 2-19-2015

40. Upcoming Changes: IRB Reporting Requirements New policy will roll out concurrently with new eIRB system. RNI submission pathway. Studies report per new policy upon transition to new system. ORIO IRB: Institutional Review Board Andrea Seykora RAIN 2-19-2015

41. Differences in reporting requirements ORIO IRB: Institutional Review Board Andrea Seykora Will no longer be reportable New reportable items (sort of) Deviations not due to any action or inaction of the researchers AND did not increase risk to subjects Audit and monitoring reports with any deficiencies RAIN 2-19-2015

42. Rationale for Changes “PD versus UP” is not a regulatory distinction. No need to know about things that were “out of your control” – unless increased risk of harm. Audit and monitoring reports help identify Continuing Noncompliance early. Submitting an audit/monitoring report as a single RNI submission streamlines reporting. ORIO IRB: Institutional Review Board Andrea Seykora RAIN 2-19-2015

43. Reportable New Information (RNI) still NOT required for: “Minor” protocol deviations (though the term is going away). Adverse events that were expected. Adverse events that were unrelated to the study. Monitoring reports and DSMB/C reports with no findings or recommended changes. We’ll ask about these at continuing review. ORIO IRB: Institutional Review Board Andrea Seykora RAIN 2-19-2015

44. ORIO IRB: Institutional Review Board Andrea Seykora Specialized Training There are lots of changes heading your way!! IRB staff is happy to attend your regular department meeting or set up a separate session for specialized training. Please contact Dave Holmgren or the analyst assigned to your department to schedule a visit.Dave Holmgren RAIN 2-19-2015

45. IRB Brown Bag Special Series eIRB Upgrade – Mods & CRQs Thursday February 26 th 11:30 a.m. to 1:00 p.m. in UHS 8B60 This Brown Bag will provide an overview and demonstration of the modification and continuing review submission process in the new eIRB system. You will see the new modification and continuing review questionnaires and learn how the new system improves upon the current process. Andrea Seykora 45 RAIN 2-19-2015 ORIO IRB: Institutional Review Board

46. IRB Brown Bag Special Series eIRB Upgrade – RNIs Tuesday March 10 th 2:00 p.m. to 3:00 p.m. in UHS 8B60 The new eIRB system will handle reporting of Unanticipated Problems and Protocol Deviations through a single pathway called “Reportable New Information (RNI).” In addition, we are revisiting the policy on what items will require investigators to submit a report. This brown bag will introduce you to the new reporting requirements and the process for submitting RNIs via the new eIRB system. Andrea Seykora 46 RAIN 2-19-2015 ORIO IRB: Institutional Review Board

47. IRB Classroom Training 11:30 to 12:30 p.m. in CHH 3178 Introduction to IRB February 19 (Today!) April 16 IRB Q&A March 19 May 21 Register through Compass.Compass 47 Andrea Seykora ORIO IRB: Institutional Review Board RAIN: 2-19-2015

48. 48 Questions? Andrea Seykora, Assistant Research Integrity Officer johnandr@ohsu.edu 503-346-3528 www.ohsu.edu/researchintegrity RAIN 2-19-2015 ORIO: OHSU Research Integrity Office

49. Wrap Up Q & A Next RAIN Meeting: March 19, 2015, 9:30 – 11:00 a.m. Send agenda item requests to: rain@ohsu.edurain@ohsu.edu Or use the RAIN Feedback FormRAIN Feedback Form Everyone 49 RAIN: 2-19-15