1. Welcome to…RAIN (the meeting formerly known as SPIN) Presented by: the folks in RDA, with today’s emcee, Dana Director Date: July 21, 2011

2. Agenda Intros Updates & timely information from the units: Dana Director TTBD RGC SPA Office of the VPR CRBCO RFDS ORIO Research HR RATE CTO Q & A 2 RAIN: 07.21.2011

3. RGC –Research Grants & Contracts 3 RAIN: 07.21.2011

4. RGC: OHSU Research Grants & Contracts NIH Updates Mandating Use of the Commons to Submit No-Cost Extension Notifications (NOT-OD-11-098) National Institutes of Healthhttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-098.html Change in the NIH Continuous Submission Policy for Reviewers with Recent Substantial Service (NOT-OD-11-093) National Institutes of Healthhttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-093.html NIH, AHRQ, CDC, FDA and NIOSH to Release Updated Electronic Application Forms ADOBE-FORMS-B2 (NOT-OD-11-096) National Institutes of Health Agency for Healthcare Research and Quality Food and Drug Administration National Institute for Occupational Safety and Healthhttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-096.html Deborah Golden-Eppelein 4 RAIN: 07.21.2011

5. NIH Updates (cont’d) Changes to these new form versions appear minor, but InfoEd is doing an analysis and we expect an update in the near future. Just a reminder: eSNAP (electronic submission of Streamlined Non-Competing Award Procedures) is now mandatory. Paper progress reports may only be submitted for awards NOT subject to SNAP. RAIN: 07.21.2011 5 RGC: OHSU Research Grants & Contracts Deborah Golden-Eppelein

6. NIH Reminder: NIH staff and reviewers continue to find applicants trying to circumvent page limits by inserting information into inappropriate places in an application. Check out this cautionary statement from the latest policy reminder (NOT-OD-11-080 ) :http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11- 080.html Yikes! Resist the temptation to overstuff your applications – you may actually be harming your chances for success.NIH may withdraw applications from review and funding consideration for egregious cases in which inappropriate material has been placed in a section or sections of an application without page limits, or in the Appendix. RAIN: 07.21.2011 6 RGC: OHSU Research Grants & Contracts Deborah Golden-Eppelein

7. SPA –Sponsored Projects Administration 7 RAIN: 07.21.2011

8. SPA: OHSU Sponsored Projects Administration Effort Update –Jul10-Dec10 Period 4 Outstanding Effort Statements Reminder: If a statement was returned to you, please make the necessary changes and then send it back to SPA. “Fun” Effort Stats –83% of statements were received by the April 18 th deadline –51% of statements were received during the week before the deadline. –4% of statements required LD adjustments. Amber Roberts 8 RAIN: 07.21.2011

9. SPA: OHSU Sponsored Projects Administration Effort Update –Jan10-Jun10 Effort Period Patches fixing issues from Oracle upgrade will be installed before Effort Statements are ran in the system. Effort Period closes August 15 th LCTA forms are due in August 12 th Statements will be in the mail to campus by August 30 th. *Deadline to return statements is October 19 th * Individuals pulled for FY11 A-133 Audit will need to be returned significantly sooner! Amber Roberts 9 RAIN: 07.21.2011

10. SPA: OHSU Sponsored Projects Administration Laura Smith 10 RAIN: 07.21.2011 FY11 A-133 Audit –Auditors will be selecting test sample beginning of August –SPA will notify the “chosen few” –Please respond timely to requests for information/documents

11. SPA: OHSU Sponsored Projects Administration Charlie Resare 11 RAIN: 07.21.2011 Subrecipient Agreements –2010 Pilot PO Project very successful! Led to easier tracking of Subaward budgets & expenditures –PO’s to be attached on all subawards over the next 12 months. Implementation will be alphabetical by Department Each department will be informed prior to implementation

12. CRBCO –Clinical Research Billing Compliance Office RAIN: 07.21.2011 12

13. CRBCO: OHSU Clinical Research Billing Compliance Epic Research Functionality Upgrade August 4-6th, 2011 new research functionality will be implemented with the Epic 2010 Upgrade Research subject will be “associated” with a study (replacing the FYI) No change from existing policy. Policy still applies only to research subjects receiving clinical services on a research study Conversion of all existing active research FYIs Kristin Hackney 13 RAIN: 07.21.2011

14. CRBCO: OHSU Clinical Research Billing Compliance To view active research trials for a patient -Click on Research Indicator in patient header Kristin Hackney 14 RAIN: 07.21.2011

15. CRBCO: OHSU Clinical Research Billing Compliance To view inactive research trials for a patient -Click on Research Indicator in patient header Kristin Hackney 15 RAIN: 07.21.2011

16. CRBCO: OHSU Clinical Research Billing Compliance Identifying Research Subjects – In effect now CRBO flagging research patients in Epic Coordinator to notify CRBO via email on the Research Subject Study Status Change Form within 3 days of a patient signing consent and when no longer receiving clinical services for the study CRBO will update Epic within 2 business days Study staff no longer has access to place research FYIs Kristin Hackney 16 RAIN: 07.21.2011

17. CRBCO: OHSU Clinical Research Billing Compliance Contact the CRBCO at crbo@ohsu.edu with questions or to schedule a department specific training on the Epic research upgrade.crbo@ohsu.edu Find the Research Subject Status Change Form on the CRBCO website http://www.ohsu.edu/xd/research/about/integrity/irb/clinical- research-billing.cfm http://www.ohsu.edu/xd/research/about/integrity/irb/clinical- research-billing.cfm Kristin Hackney 17 RAIN: 07.21.2011

18. Office of the VPR –Office of the Vice President for Research 18 RAIN: 07.21.2011

19. Where in the world is the VP’s Office?? (during the road closure) RAIN: 07.21.2011 19 VPR: Office of the Vice President for Research Dana Director Pssst..

20. OHSU/PSU Collaboration Efforts RAIN: 07.21.2011 20 VPR: Office of the Vice President for Research Dana Director Portland State University, Vanguard Archives

21. ORIO –OHSU Research Integrity Office 21 RAIN: 07.21.2011

22. ORIO: OHSU Research Integrity Office Don’t forget to schedule your visit with Bill and Phil! Drs. Dale and Streeter want to talk to your department about developing a program that: –assures the highest standards of animal care and use; – is sensitive and responsive to the needs of OHSU’s scientific community; – and encourages feedback from scientists. Contact us to schedule Bill Dale: 4-9644; daleb@ohsu.edudaleb@ohsu.edu Phil Streeter: 4-1762; streetep@ohsu.edustreetep@ohsu.edu Amy Cline: 4-7842; clineam@ohsu.educlineam@ohsu.edu Bill Dale 22 RAIN: 07.21.2011

23. ORIO: OHSU Research Integrity Office Institutional Gift accounting due August 1st all schools, departments, divisions, and units that receive gifts from industry –totaling greater than $100,000 in a fiscal year from any individual Vendor –excluding industry funds provided for research or other sponsored projects annual accounting of those funds on a form approved by the OIOform –http://www.ohsu.edu/xd/about/services/integrity/coi/gifts/index.cfm Amy Cline 23 RAIN: 07.21.2011

24. ORIO: OHSU Research Integrity Office Not sure where to go for your biosafety and other research safety needs? The Research Safety Program is now incorporated into the Research Integrity Office. Amy Cline 24 RAIN: 07.21.2011

25. ORIO: OHSU Research Integrity Office Meet the new team Institutional Biosafety Committee (IBC) questions or any other questions about the Research Safety Program –Kara Drolet, PhD, Associate Director, ORIO Central Campus Any biosafety or research chemical safety questions on the central or waterfront campuses –Debra Brickey, PhD, Central Campus Research Safety Manager Biosafety level 2 lab practices and containment questions –Ben Smith, MS, Biosafety Specialist For other central campus safety needs such as Radiation safety and hazardous waste, please contact EHRSEHRS Amy Cline 25 RAIN: 07.21.2011

26. ORIO: OHSU Research Integrity Office West Campus Any of your biosafety or other research safety questions on the west campus. –Gwynn Daniels, PhD, West Campus Research Safety Manager Compliance with the Select Agent program –Sarah Byers, PhD, Biosafety Specialist Animal biosafety containment and practices at the primate center. –Susan Clary, MS, Biosafety Specialist General research safety –Daniel Toyooka, West Campus Safety Specialist Radiation safety –Vacant, Health & Safety Specialist Amy Cline 26 RAIN: 07.21.2011

27. ORIO: OHSU Research Integrity Office IBC IBC questions related to central campus IACUC protocols –Leta Guptill, IBC/IACUC analyst All other IBC questions –Hilde Wette, PhD, IBC/CoIR senior analyst Amy Cline 27 RAIN: 07.21.2011

28. ORIO: OHSU Research Integrity Office IRB reminder Informed consent requirements for studies involving human subjects: –Legally effective informed consent must be obtained before a subject undergoes any research interventions –Legally effective informed consent requires that the basic elements of informed consent 45 CFR 116, and additional elements when appropriate, are included in the consent form –The consent document must be signed by the subject (or LAR) unless the IRB has approved a waiver of documentation of informed consent Informed consent is not required when: –The study is determined to be exempt by the IRB –The IRB approves a waiver of consent –Research is conducted in emergency settings Mindy Roberts 28 RAIN: 07.21.2011

29. ORIO: OHSU Research Integrity Office IRB updates We have a new IRB Co-Chair –Kathryn Schuff, MD, MCR Associate Professor of Medicine Division of Endocrinonlogy, Diabetes and Clinical Nutrition Clinical Research Compliance Manager, Clinical Research Center Mindy Roberts 29 RAIN: 07.21.2011

30. ORIO: OHSU Research Integrity Office IRB updates Our repository Policy Deadline is August 31 st Next Repository Brown Bag –Thursday August 11 th –11:00 am to 12:30 pm –UHS 8B60 Mindy Roberts 30 RAIN: 07.21.2011

31. ORIO: OHSU Research Integrity Office IRB updates IRB Drop-in Sessions scheduled: –Every Friday from now until August 26 th –1130am to 130pm –BRB 381 Final session on Tuesday August 30 th from 9am to noon. Mindy Roberts 31 RAIN: 07.21.2011

32. ORIO: OHSU Research Integrity Office IRB updates Changes to Repository forms Check our website and Research News blog for updates on policies Mindy Roberts 32 RAIN: 07.21.2011

33. ORIO: OHSU Research Integrity Office IRB updates Regular Brown Bag sessions beginning in the fall We’d love to hear about your ideas for topics Send all suggestions to Amy Cline Mindy Roberts 33 RAIN: 07.21.2011

34. Research HR –Research Human Resources 34 RAIN: 07.21.2011

35. New Research and Academic Staff Members of note:  Mark Peters, Export Compliance Officer  Andrew Chitty, MBA, Program Manager, OHSU Shared Resources  Kirsten Wall, MA, Senior Learning and OD Consultant for Diversity and Inclusion RAIN: 07.21.2011 35 Research HR: Research Human Resources Jennifer Crosby

36. Volunteer Services Update  500 active volunteers plus 100 more who are about to join our program.  Volunteer Services Office hours are Tuesday and Thursday (1-5pm). Tuesdays are walk-ins; Thursdays are appointment only.  We will be hosting an invitation-only Program Manager and Department Volunteer Coordinator Luncheon this September (details forthcoming). Research Outreach Project Update  Communication plan  NEO and Rewards and Recognition Program exploration RAIN: 07.21.2011 36 Research HR: Research Human Resources Jennifer Crosby

37. RATE –Research Administration Training & Education 37 RAIN: 07.21.2011

38. RATE: Research Administration Training & Education Margaret Gardner RAIN Feedback Form http://www.ohsu.edu/xd/research/administration/rain.cfm#Feedback NEW 38 RAIN: 07.21.2011

39. RDA 101 for Research Administrators Learn about Research Development and Administration (RDA) departments as they apply to, and support, your role as an administrative staff member in a research unit.  introduction to RDA departments and representatives  discussion of Roles & Responsibilities  online tour of relevant resources, and more.  Save the date: First course scheduled for 9:30 a.m. Thursday, September 29, 2011 at Bancroft.  Registration opens late August.  Grant Administration training (including pre- and post-award topics) slated for October. Stay tuned! RATE: Research Administration Training & Education Margaret Gardner 39 RAIN: 07.21.2011

40. Early terminations: Only the PI can modify end date and change stipend amount. TN amount must match amount paid from grant. When prorating, list methodology in comment section. OHSU recommends: (number of days worked) x 30 xTrain calculations need to be checked. If a change is needed, this must be completed by PI. Click ‘save’ button, and then click ‘save and route to BO’ button. If Delegates face challenges coordinating with program managers (PIs), contact Margaret Gardner at gardnerm@ohsu.edu or 4-8990.gardnerm@ohsu.edu RAIN: 07.21.2011 40 RATE: Research Administration Training & Education Margaret Gardner xTrain Update

41. Wrap Up Q & A Next Meeting: September 22, 2011 9:30 AM Send agenda item requests to: rain@ohsu.edurain@ohsu.edu Or use the feedback form at: http://www.ohsu.edu/xd/research/administration/rain.cfm Everyone 41 RAIN: 05.19.2011