Welcome to RAIN! Research Administration Information Network Presented by: the folks in RDA with today’s emcee, Rachel Dresbeck Date: February 21, 2013 RAIN Agenda Rachel Dresbeck • 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 ORIO – OHSU Research Integrity Office RAIN: 2-21-2013 3 ORIO IBC: Institutional Biosafety Committee Kara Drolet, PhD 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. RAIN: 2-21-2013 4 ORIO IBC: Institutional Biosafety Committee Kara Drolet, PhD New Synthetic Nucleic Acids NIH Regulations (continued) Revised policies, guidance documents and forms will be posted on the 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. RAIN: 2-21-2013 5 ORIO IBC: Institutional Biosafety Committee Kara Drolet, PhD 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. RAIN: 2-21-2013 6 ORIO IBC: Institutional Biosafety Committee Kara Drolet, PhD 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?” RAIN: 2-21-2013 7 ORIO IBC: Institutional Biosafety Committee Kara Drolet, PhD DRAFT New PPQ Question (continued) If Yes to Any, complete IBC Initial Classification Form and submit with this PPQ. 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. RAIN: 2-21-2013 8 ORIO IBC: Institutional Biosafety Committee Kara Drolet, PhD Contact Information: ibc@ohsu.edu 503-494-7887, option 1 Institutional Biosafety Committee Online RAIN: 2-21-2013 9 ORIO CoI: Conflict of Interest Kara Drolet, PhD 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. RAIN: 2-21-2013 10 ORIO CoI: Conflict of Interest Kara Drolet, PhD 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. RAIN: 2-21-2013 11 ORIO CoI: Conflict of Interest Kara Drolet, PhD 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 RAIN: 2-21-2013 12 ORIO CoI: Conflict of Interest Kara Drolet, PhD 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. RAIN: 2-21-2013 13 ORIO CoI: Conflict of Interest Kara Drolet, PhD Outside Activity/Outside Compensation Once this policy is in effect, any scheduled events may be completed, however, no new engagements should be initiated. RAIN: 2-21-2013 14 ORIO CoI: Conflict of Interest Kara Drolet, PhD Contact Information: coir@ohsu.edu 503-494-7887, option 1 OHSU Conflict of Interest Online RAIN: 2-21-2013 15 USR - University Shared Resources RAIN: 2-21-2013 16 USR: University Shared Resources Andrew Chitty 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 RAIN: 2-21-2013 17 USR: University Shared Resources Andrew Chitty 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 RAIN: 2-21-2013 18 USR FCSR: Flow Cytometry Shared Resource Philip Streeter 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 RAIN: 2-21-2013 19 USR FCSR: Flow Cytometry Shared Resource Philip Streeter Enables Simultaneous Study of Many Cells RAIN: 2-21-2013 20 USR FCSR: Flow Cytometry Shared Resource Philip Streeter Enables Simultaneous Study of Many Cells RAIN: 2-21-2013 21 USR FCSR: Flow Cytometry Shared Resource Philip Streeter Flow Cytometers Fluidics Optics Lasers Electronics RAIN: 2-21-2013 22 USR FCSR: Flow Cytometry Shared Resource Philip Streeter Flow Cytometry: Fluidics and Lasers RAIN: 2-21-2013 23 USR FCSR: Flow Cytometry Shared Resource Philip Streeter Flow Cytometry: Cell Sorting RAIN: 2-21-2013 24 USR FCSR: Flow Cytometry Shared Resource Philip Streeter Type I Diabetes: Loss of Pancreatic b Cells RAIN: 2-21-2013 25 C Dorrell M Grompe USR FCSR: Flow Cytometry Shared Resource Philip Streeter 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 RAIN: 2-21-2013 26 USR FCSR: Flow Cytometry Shared Resource Philip Streeter RAIN: 2-21-2013 27 USR FCSR: Flow Cytometry Shared Resource Philip Streeter RAIN: 2-21-2013 28 USR: University Shared Resources Andrew Chitty SmartPhone App with Expandable Listings • Description of service • Contact info • Link to full site RAIN: 2-21-2013 29 USR: University Shared Resources Andrew Chitty http://www.ohsu.edu/cores-mobile/ chitty@ohsu.edu 503-494-5887 University Shared Resources Online RAIN: 2-21-2013 30 Guest Speaker - Office of Internal Services RAIN: 2-21-2013 31 OIS: Office of International Services Alison Roache Jones, Director Sponsorship of Foreign Nationals New OHSU Policy No: 03-10-020 • 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 OHSUsponsored immigration status and OHSU-sponsored permanent residency. RAIN: 2-21-2013 32 OIS: Office of International Services Alison Roache Jones, Director Procedures Upon notification from hiring/hosting department, OIS determines if foreign national needs OHSUsponsored immigration status and prepares necessary paperwork. Prior to expiration of foreign national’s OHSUsponsored 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. RAIN: 2-21-2013 33 OIS: Office of International Services Alison Roache Jones, Director Contact Information: OIS@ohsu.edu 503-748-7636 Office of International Services Online RAIN: 2-21-2013 34 RFDS – Research Funding & Development Services RAIN: 2-21-2013 35 RFDS: Research Funding & Development Services Katie Wilkes & Rachel Dresbeck Research Week Call for Abstracts! • Abstract submissions due March 22, 2013 • Visit http://www.ohsu.edu/researchweek • New: Scholarships available to students RAIN: 2-21-2013 36 RFDS: Research Funding & Development Services Katie Wilkes & Rachel Dresbeck 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. • 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. RAIN: 2-21-2013 37 RFDS: Research Funding & Development Services Katie Wilkes & Rachel Dresbeck New: Research Career Development webpage • 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). RAIN: 2-21-2013 38 RFDS: Research Funding & Development Services Katie Wilkes & Rachel Dresbeck 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. RAIN: 2-21-2013 39 RFDS: Research Funding & Development Services Katie Wilkes & Rachel Dresbeck Questions? funding@ohsu.edu http://www.ohsu.edu/funding http://www.ohsu.edu/researchnews RAIN: 2-21-2013 40 RGC – Research Grants & Contracts RAIN: 2-21-2013 41 RGC: Research Grants & Contracts Deborah Golden-Eppelein New: Facilities & Administrative Cost Reduction/Waiver Form Guidance is posted at RDA Forms. RAIN: 2-21-2013 42 RGC: Research Grants & Contracts Deborah Golden-Eppelein 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. RAIN: 2-21-2013 43 RGC: Research Grants & Contracts Deborah Golden-Eppelein 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. RAIN: 2-21-2013 44 RGC: Research Grants & Contracts Deborah Golden-Eppelein 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. RAIN: 2-21-2013 45 RGC: Research Grants & Contracts Deborah Golden-Eppelein 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). RAIN: 2-21-2013 46 RGC: Research Grants & Contracts Kellie Guentert 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 RAIN: 2-21-2013 47 RGC: Research Grants & Contracts Kellie Guentert 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 RAIN: 2-21-2013 48 RGC: Research Grants & Contracts Kellie Guentert 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 RAIN: 2-21-2013 49 RGC: Research Grants & Contracts Kellie Guentert 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. RAIN: 2-21-2013 50 RGC: Research Grants & Contracts Kellie Guentert 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. RAIN: 2-21-2013 51 RGC: Research Grants & Contracts Kellie Guentert 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) • Grants.gov submission requirements are needed, including ePPQ and routing. RAIN: 2-21-2013 52 RGC: Research Grants & Contracts Kellie Guentert ePPQ User Guides Currently in two locations: • RATE Bridge • RGC Website Eventually, all will be housed on the RATE Bridge Site InfoEd & ePPQ page. RAIN: 2-21-2013 53 RGC: Research Grants & Contracts Kellie Guentert InfoEd Support RGC Questions: rgcfaq@ohsu.edu InfoEd & ePPQ training classes are posted on the RATE Course Calendar. RAIN: 2-21-2013 54 SPA – Sponsored Projects Administration RAIN: 2-21-2013 55 SPA: OHSU Sponsored Projects Administration James Trotter Combined OMB Circulars! Link to Proposed Changes Send your comments to James Trotter. Deadline for comments to James is April 19th. RAIN: 2-21-2013 56 SPA: OHSU Sponsored Projects Administration James Trotter Reminder: Changes to Account Set-up Process • New process to begin this Friday, February 22nd • 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 RAIN: 2-21-2013 57 SPA: OHSU Sponsored Projects Administration James Trotter 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. RAIN: 2-21-2013 58 SPA: OHSU Sponsored Projects Administration James Trotter Addition to End Date Notifications • If NIH, ensure all relevant publications are in compliance with 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 RAIN: 2-21-2013 59 SPA: OHSU Sponsored Projects Administration James Trotter 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 RAIN: 2-21-2013 60 SPA: OHSU Sponsored Projects Administration James Trotter Staffing Changes Nancy Duncan Policy & Financial Compliance Manager Laura Dolan LD, Effort, & Billing Accounting Technician RAIN: 2-21-2013 61 SPA: OHSU Sponsored Projects Administration James Trotter Need to contact SPA? 503-494-0355 spaacctg@ohsu.edu Sponsored Projects Administration RAIN: 2-21-2013 62 RATE – Research Administration Training & Education RAIN: 2-21-2013 63 RATE: Research Administration Training & Education Margaret Gardner 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 RAIN: 2-21-2013 64 RATE: Research Administration Training & Education Margaret Gardner 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 RAIN: 2-21-2013 65 RATE: Research Administration Training & Education Margaret Gardner 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 RAIN: 2-21-2013 66 RATE: Research Administration Training & Education Margaret Gardner Questions? Contact Margaret Gardner at: gardnerm@ohsu.edu 503-494-8990 Also, join discussions, get announcements, find course information and more via RATE Bridge. RAIN: 2-21-2013 67 ORIO – OHSU Research Integrity Office RAIN: 2-21-2013 68 ORIO IRB: Institutional Review Board Kathryn Schuff 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 RAIN: 2-21-2013 69 ORIO IRB: Institutional Review Board Kathryn Schuff 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. RAIN: 2-21-2013 70 ORIO IRB: Institutional Review Board Kathryn Schuff Change to HIPAA • Revision to law allows streamlined and consolidated consent forms. • Revised HIPAA and Consent Templates will be available in April. RAIN: 2-21-2013 71 ORIO: OHSU Research Integrity Office Kathryn Schuff Analyst Brown Bag Session Repository Refresher Thursday, February 28th 11:30 a.m. -12:30 p.m. in UHS 8B60 RAIN: 2-21-2013 72 Wrap Up Everyone Q&A Next RAIN Meeting: March 21, 2013, 9:30 – 11:00am Send agenda item requests to: rain@ohsu.edu Or use the RAIN Feedback Form RAIN: 2-21-2013 73