Welcome to RAIN! Presented by: the folks in RDA with today’s emcee, Andrew Watson Date: November 21, 2013 Research Administration Information Network

RAIN Agenda Introduction Updates & timely information: Special Guest: OHSU Library RGC SPA New Group: International Affairs RATE ORIO Special Topic: CRII Project RFDS TTBD CTO/OCTRI Research HR USR Q & A RAIN: Dana Director

Special Guest OHSU Library - NIH Public Access Policy 3 RAIN:

OHSU Library: NIH Public Access Policy Policy Overview Peer reviewed papers NIH funding or support Submitted to PubMed Central upon acceptance for publication Citations in NIH applications, proposals and reports must include PMCID. Robin Champieux 4 RAIN:

OHSU Library: NIH Public Access Policy Publications in the Grant Life Cycle Inform new ideas & projects. Demonstrate expertise in applications and proposals. Show productivity in reports and renewals. Robin Champieux 5 RAIN:

OHSU Library: NIH Public Access Policy Compliance begins when a paper is submitted for publication. It’s the authors’ job. It’s the PI’s problem. Need to know the submission method.submission method Complete all necessary tasks. Robin Champieux 6 RAIN:

OHSU Library: NIH Public Access Policy Demonstrating Compliance PMCID or valid in process notation. On all NIH applications, proposals, and reports. Cannot use a PMID. “In process” and NIHMS ID are valid for papers in press or within 3 months of publication. Robin Champieux 7 RAIN:

OHSU Library: NIH Public Access Policy “Dear Grantee, The progress report for the above-reference award includes citation(s) that are out of compliance with the NIH Public Access Policy. Compliance with the NIH Public Access Policy is a legal requirement and a term and condition of all NIH awards. This award will not be processed until all publications arising from it are in compliance with the policy.” Robin Champieux 8 RAIN:

OHSU Library: NIH Public Access Policy Fixing Non-Compliant Papers 1.Make sure it falls under the policy. 2.Verify that it doesn’t have a PMCID. 3.In most cases, submit the paper to PMC via the NIH Manuscript Submission System. Robin Champieux 9 RAIN:

OHSU Library: NIH Public Access Policy Important Resources & Trouble-Shooting OHSU Library NIH PA Guide NIH Public Access Policy Home PageHome Page My NCBI PMID ConverterPMID Converter Robin Champieux 10 RAIN:

OHSU Library: NIH Public Access Policy My NCBI Bibliography Awards View Organize citations View compliance status Address issues Must be used for paper & electronic progress reports Robin Champieux 11 RAIN:

OHSU Library: NIH Public Access Policy The Library Can Help! Robin Champieux, MLIS Scholarly Communication Librarian Robin Champieux 12 RAIN:

RGC – Research Grants & Contracts 13 RAIN:

RGC: Research Grants & Contracts Holiday Closures Friday, November 29 th Tuesday, December 24 th Deborah Golden-Eppelein 14 RAIN:

RGC: Research Grants & Contracts InfoEd Downtime Monday, December 16 th Kellie Guentert 15 RAIN:

SPA – Sponsored Projects Administration 16 RAIN:

SPA: Sponsored Projects Administration Department Assessment Industry sponsored clinical trials 5% Assessed by OGA SPA will be contacting you if you are not currently utilizing this feature Nancy Duncan 17 RAIN:

SPA: Sponsored Projects Administration AHRQ Individual Draw NOT-HS Parallels NIH’s updated transition plan New awards will transition to individual draw FY14 Noncompeting continuations will transition FY15 Nancy Duncan 18 RAIN:

SPA: Sponsored Projects Administration FY13 Pocket Card Available Pocket Card FY13 If you’d like one/several pocket cards, please contact Nancy Duncan. Nancy Duncan 19 RAIN:

SPA: Sponsored Projects Administration Holiday Closure Friday, November 29 th Nancy Duncan 20 RAIN:

21 Questions? Contact SPA SPA: Sponsored Projects Administration Nancy Duncan RAIN:

New Group OIA - Office of International Affairs 22 RAIN:

OIA: Office of International Affairs Jennifer Crosby Newly Formed Office of International Affairs Three components join after a two year study with focus groups, survey and IRB study – we heard our Internationals and their departments! Accessible to all needing support with international activities: Faculty, Postdocs, Students, Unclassified and Classified staff members. Cohesive unit where our international members can access assistance with visas, understand export controls, and tap into knowledge and resources. RAIN:

Three departments, one office! -Export Controls -Immigration Services -Learning and Resources RAIN: OIA: Office of International Affairs Jennifer Crosby

International Travel –Are your electronics secure? –Pre travel information at Export Controls website. International Purchasing –Buying equipment from overseas? You will need help getting it to OHSU - contact Export Controls. International Shipping –Online form to clear shipment - plan ahead! 25 RAIN: OIA: Department of Export Controls Jennifer Crosby on behalf of Mark Peters

We provide immigration advice & services to all International OHSU members. Services Preparation of Immigration paperwork to obtain visas and maintain appropriate immigration status while at OHSU. Act as liaison between international OHSU member and Dept. of Homeland Security, Dept. of State, Dept. of Motor Vehicles & Social Security Administration. Advise academic departments and hiring managers on employment and education related immigration regulations and procedures. 26 RAIN: OIA: Department of Immigration Services Alison Roache Jones, J.D., Director, Lisa Dahme, Immigration Specialist

27 RAIN: Great Beginnings: Onboarding & Orientations Mapping Support: Connecting Employees to OHSU & Community Resources Outreach: Supporting the whole employee Education: Cultural competency classes for both employees & managers New International Orientation dates & locations Monday, February 3, 2014 in CHH Monday, April 28, 2014 in CHH 3070 (Conf. Rm. 4) OIA: Department of Learning & Resources Iaen Nylund, M.Ed.

28 RAIN: Questions? Contact any of today’s presenters or: OIA: Office of International Affairs

RATE –Research Administration Training & Education 29 RAIN:

Upcoming Classes Effort Certification DHHS Salary Cap Oracle Grants Accounting (OGA) RDA 101: Intro to Research Administration Schedule of RATE Courses RATE: Research Administration Training & Education Margaret Gardner 30 RAIN:

Questions? Contact Margaret Gardner at: Research Administration Training & Education RATE: Research Administration Training & Education Margaret Gardner 31 RAIN:

ORIO –OHSU Research Integrity Office RAIN:

Cloud Computing John Rasmussen 33 What is Cloud Computing? Applications and Infrastructure that may allow the user extensive and mobile access to their information resources. RAIN ORIO: Information Privacy & Security

Is Cloud Computing Allowed? John Rasmussen 34 Exceptions Signed Valid Contract Integrity office has granted exception Cloud computing is not allowed for any OHSU business. RAIN ORIO: Information Privacy & Security

John Rasmussen 35 University Business Use can be defined as a department representing themselves as OHSU and making a business arrangement on behalf of OHSU using OHSU data or resources. RAIN ORIO: Information Privacy & Security

John Rasmussen 36 Any protected health information Employee/Student information Financial information Proprietary Information Classified or restricted research data Information OHSU is required by law or bound by contract to keep confidential Examples of Confidential & Restricted Information RAIN ORIO: Information Privacy & Security

John Rasmussen 37 Constraints on Use of Cloud for Data Storage, Sharing and/or Analysis  Chart Chart HIPAA Regulatory Limits Export Controls FERPA FISMA Other Legal Constraints Business Issues RAIN ORIO: Information Privacy & Security

John Rasmussen 38 RAIN Increase presence of encryption on devices Changes to smart phones, enforced encryption Data Protection Project ORIO: Information Privacy & Security

John Rasmussen 39 RAIN Questions? John Rasmussen Chief Information Security Officer

ORIO: Institutional Review Board IRB Billing Process Dave Holmgren 40 RAIN Improved for greater efficiency. IRB Fees – Industry Sponsored Research

Introduction to IRB Review Getting Started in the eIRB Submitting a Study Maintaining Approval and Reporting Requirements Dave Holmgren 41 IRB Education RAIN ORIO: Institutional Review Board

IRB Classroom Training 11:30 to12:30 p.m. in CHH 3178 Getting Started in the eIRB Thursday, November 21st (today) Maintaining Approval & Reporting Requirements Thursday, December 5th Introduction to the IRB Thursday, January 16th 42 Dave Holmgren RAIN ORIO: Institutional Review Board

IRB Analyst Brown Bag Sessions IRB Chair’s Forum: Towards a Better IRB Presented by: IRB Chair, Kathryn Schuff, M.D., MCR Come hear about proposed changes! Thursday December 12 th 10 to 11 a.m. in UHS 8B60 Dave Holmgren 43 RAIN ORIO: Institutional Review Board

44 Questions? David Holmgren RAIN ORIO: OHSU Research Integrity Office

Special Topic CRII Project –Clinical Research Improvement & Integration Project 45 RAIN:

CRII: Clinical Research Improvement & Integration Project The CRII Project Goal Improve OHSU’s ability to start up human subjects research in a timely, efficient, and cost-effective manner. Simone Waddell 46 RAIN:

Success Looks Like… Increased protocols with successful enrollment. Decreased protocols with no enrollment. Reduced cycle time from project inception to successful enrollment. Removed barriers to launching clinical research projects. Removed barriers to integrating research into the clinical environment. 47 RAIN: CRII: Clinical Research Improvement & Integration Project Simone Waddell

48 Co-Chairs Dana Director, VP RDA & Student Affairs Eric Orwoll, Director, OCTRI Steering Committee Jennifer Ruocco, Chief Integrity Officer, OIO/ORIO Kathryn Schuff, Professor, Dept. of Endocrinology; IRB Chair Kristin Bialobok, Associate Director of Administration, Knight Susan Hayflick, Professor & Chair, MMG; Chair, Task Force 3 Darlene Kitterman, Director, ISIS (OCTRI) Deborah Golden-Eppelein, Director, RGC RAIN: CRII: Clinical Research Improvement & Integration Project Simone Waddell

49 Next Steps Development Approval Launch Stay tuned to RAIN for updates as we make progress! RAIN: CRII: Clinical Research Improvement & Integration Project Simone Waddell

50 RAIN: Questions? For more information: CRII Bridge siteCRII Bridge site Simone Waddell Hai Molinaro CRII: Clinical Research Improvement & Integration Project Simone Waddell

Wrap Up Q & A Next RAIN Meeting: January 16, 2014, 9:30 – 11:00am RAIN takes a break in December! Send agenda item requests to: Or use the RAIN Feedback FormRAIN Feedback Form Everyone RAIN: