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Welcome to…RAIN

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. Agenda. Dana Director. Intros Updates & timely information from the units:. TTBD RGC SPA Office of the VPR CRBCO. RFDS ORIO Research HR

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Welcome to…RAIN

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

  3. RGC • Research Grants & Contracts RAIN: 07.21.2011

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

  5. RGC: OHSU Research Grants & Contracts Deborah Golden-Eppelein 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

  6. RGC: OHSU Research Grants & Contracts Deborah Golden-Eppelein 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

  7. SPA • Sponsored Projects Administration RAIN: 07.21.2011

  8. SPA: OHSU Sponsored Projects Administration Amber Roberts • 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 18th deadline • 51% of statements were received during the week before the deadline. • 4% of statements required LD adjustments. RAIN: 07.21.2011

  9. SPA: OHSU Sponsored Projects Administration Amber Roberts • 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 15th • LCTA forms are due in August 12th • Statements will be in the mail to campus by August 30th. • *Deadline to return statements is October 19th *Individuals pulled for FY11 A-133 Audit will need to be returned significantly sooner! RAIN: 07.21.2011

  10. SPA: OHSU Sponsored Projects Administration Laura Smith • 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 RAIN: 07.21.2011

  11. SPA: OHSU Sponsored Projects Administration Charlie Resare • 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 RAIN: 07.21.2011

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

  13. CRBCO: OHSU Clinical Research Billing Compliance Kristin Hackney 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 RAIN: 07.21.2011

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

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

  16. CRBCO: OHSU Clinical Research Billing Compliance Kristin Hackney 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 RAIN: 07.21.2011

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

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

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

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

  21. ORIO • OHSU Research Integrity Office RAIN: 07.21.2011

  22. ORIO: OHSU Research Integrity Office Bill Dale 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.edu Phil Streeter: 4-1762; streetep@ohsu.edu Amy Cline: 4-7842; clineam@ohsu.edu RAIN: 07.21.2011

  23. ORIO: OHSU Research Integrity Office Amy Cline 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 OIO • http://www.ohsu.edu/xd/about/services/integrity/coi/gifts/index.cfm RAIN: 07.21.2011

  24. ORIO: OHSU Research Integrity Office Amy Cline 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.  RAIN: 07.21.2011

  25. ORIO: OHSU Research Integrity Office Amy Cline 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 EHRS RAIN: 07.21.2011

  26. ORIO: OHSU Research Integrity Office Amy Cline 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 RAIN: 07.21.2011

  27. ORIO: OHSU Research Integrity Office Amy Cline 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 RAIN: 07.21.2011

  28. ORIO: OHSU Research Integrity Office Mindy Roberts 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 RAIN: 07.21.2011

  29. ORIO: OHSU Research Integrity Office Mindy Roberts 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 RAIN: 07.21.2011

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

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

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

  33. ORIO: OHSU Research Integrity Office Mindy Roberts 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 RAIN: 07.21.2011

  34. Research HR • Research Human Resources RAIN: 07.21.2011

  35. Research HR: Research Human Resources Jennifer Crosby 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

  36. Research HR: Research Human Resources Jennifer Crosby 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

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

  39. RATE: Research Administration Training & Education Margaret Gardner 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! RAIN: 07.21.2011

  40. RATE: Research Administration Training & Education Margaret Gardner • xTrain Update 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. RAIN: 07.21.2011

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

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