Quarterly Research Administration Meeting

Quarterly Research Administration Meeting
April 3, 2019

Spring QRAM 2019 Agenda General Announcements
Research Administrators United Kick-Off What are sIRBs? C&G Accounting Updates Research Development Fundopps Website Launch of State of California Guidance Webpage EH&S Overview - Field and Dive Safety ERA Updates and Tips

Spring QRAM 2019 QRAM Q = “quarterly” More topics
Covering more areas of Research Administration What do you want to hear about? us at

Spring QRAM 2019 Research Support Fair Tuesday, April 9 12:45-2:30
Gross Hall, 4th Floor, Thorp Conference Center Target audience: UCI faculty, staff, etc. involved in research Highlights: Q&A Session with OR Senior Leadership Opportunities to meet with representatives from the many resources available at UCI related to research Win raffle prizes – like lunch with leadership! Research Support Fairs monthly starting in January – the next one is on Tuesday, April 9. We’ll also be holding a fair at he Med Center on May 9.

Spring QRAM 2019 Research Support Fair

Spring QRAM 2019 Staffing Updates Electronic Research Administration
Sponsored Projects Administration Barbara: ERA – Alison is back working on KR Award, Kim and Jonathan helping with KR Subaward, Martin working on KR Protocols, RMS support, and introduce Jessica

Research Administrators United!
Next Meeting May 1, 2019 11:30 am - 1:30 pm Humanities Gateway Room 1030 Contact us: Shelley Scallan: or x42644 Jasmin Ramirez: or x42460

Valerie Sanchez, MA, CCRP IRB Administrator April 3, 2019
Spring QRAM 2019 Reliances Valerie Sanchez, MA, CCRP IRB Administrator April 3, 2019 Hi My name is Valerie Sanchez, IRB Administrator – IRB stands for Institutional Review Board, we are the entity that oversees the conduct of human subjects research at main campus and at the medical center. Today I’ going to talk to you about obtaining IRB Approval in order to have permission to conduct research involving people.

Spring QRAM 2019 Agenda Intro to Reliance Master Agreements NIH Budget
Basics of Reliances – terminology Types of Reliance Agreements – to familiarize some key names

Spring QRAM 2019 What is a Reliance?
Institutional Review Board (IRB) What is a Reliance? Reliance = Single IRB (sIRB) = Trust & Rely = MOU Agreement between IRBs Institutional Authorization Agreement (IAA) Project Principal Investigator (PPI) Relying Investigator (RI) Reviewing IRB = IRB of Record Relying IRB MOU = Memorandum of Understanding Agreement bt IRBs – called IAA if I want to collaborate with Dr. Triton at UCSD, I am the recipient of the grant, it is my study conducted here, I am the PPI. Dr. Triton at UCSD is the Relying Investigator. The agreement isn’t between me and Dr. Triton, the agreement is between UCI IRB and UCSD IRB. UCI is the Reviewing IRB. We are conducting the review for both UCI and UCSD PPI – responsible for the overall conduct of the study, responsible for disseminating information to Relying site RI – lead investigator at a Relying site

Spring QRAM 2019 Agreements Alpha Stem Cell Consortium (ASCC)
CMU Reliance: CHOC / MHS / UCI Fountain Valley Regional Hospital Independent / Commercial / Private IRB IREx (IRB Reliance Exchange) NeuroNEXT National Cancer Institute Central IRB (NCI CIRB) National Institutes of Health (NIH sIRB) NEALs (Northeast ALS Consortium) UC BRAID (Biomedical, Research, Acceleration, Integration & Development) UC Reliance Single MOU: Chapman University SMART IRB Reliance (Participating Institution) StrokeNet TINs: Trial Innovation Network CMU Reliance Indep IRBs – aka Commercial IRB, Private IRB Advarra (Quorum, Chesapeake, Schulman Associates), Western IRB clinical trial studies, sponsor funded, sponsor written, contracted with Advarra (Chesapeake & Schulman Associates), Quorum, Western IRB instead of conducting the review in house by UCI IRB, they are sent to one of these companies SMART IRB – over 550 institutions across US signed up UC Reliance – with another sister campus Single MOU – one offs NIH – sIRB (exact same research procedures) Shift gears and talk about NIH and budgets

Spring QRAM 2019 NIH Rates Negotiation of IAA: $1600
Initial Review of Site: $1200 Modification / Amendment: $500 Renewal (per site): $700 Reportable Event (UP, NC): $1200 Rates as of November 2017 UP – unanticipated problem NC – non compliance

Spring QRAM 2019 Example Dr. Peter Anteater wants to collaborate with colleagues at UC Davis, University of Minnesota, and Notre Dame 5-year grant to NIH Minimal Risk study requiring IRB Review/Approval Dr. Anteater will be the PPI UCI will act as the IRB of Record UCD/UMN/ND IRBs will Rely on UCI IRB

Spring QRAM 2019 Budget Negotiation of IAA: $1600
UCD: no charge (UC Reliance & SMART IRB) UMN: no charge (SMART IRB) ND: $1600 Initial Review of (Relying) Site = $3600 UCD: $1200 UMN: $1200 ND: $1200 Rates are not published on our website Must go thru Reliance Team for sign off as part of submission to SPA Ensure number of sites, which institutions to Rely on UCI, up to 3 sites (exceptions may be made?)

Spring QRAM 2019 Budget Modifications = $2500 ($500/mod, 1/yr over 5 yrs) Renewals = $8400 UCD: $700/renewal x 4 renewals over 5 year period UMN: $700/renewal x 4 renewals over 5 year period ND: $700/renewal x 4 renewals over 5 year period Reportable Event = $1200 (anticipate 1 over life of study) Total = $17,300

Spring QRAM 2019 Contact Information Reliance Staff Valerie Sanchez Administrator Kirsten Nau Sr. Analyst Muzhgan Afzal RP Assistant Beverley Alberola Interim Director, IRB Operations Laverne Estanol Assistant Director, HRP

C&G Accounting Updates – Beata Najman
Spring QRAM 2019 C&G Accounting Updates – Beata Najman

Spring QRAM 2019 CGA Staffing and Current Projects
C&G Training Sessions Dates: April 23, 25, 30 and May1, from 10:00 am to 12:00 pm Award Expiration Notification - Notifications for all awards to be sent 60 days before the award end date - Clinical trials balances (CT Expense Accounts) don’t include expected funding in the Budget figures, but Fixed Price awards (PC Expense Accounts) include expected funding listed in the holding account , 8525 CONTROL – CONTRACTS & GRANTS Example: This is a notification that the referenced award has an end date listed as of: 05/13/2019 As of Mar 14, 2019, Fiscal Period FEB. 2019 , the general ledger activity for the award shows: Mobile ABO Report - available via the With U For U Mobile App

Spring QRAM 2019 KFS Decision Support – New Report for Contracts and Grants

Spring QRAM 2019 Questions?

The Research Development Function at UCI
Spring QRAM 2019 The Research Development Function at UCI Dr. Michael Gallo Jr. Director of Research Development Office of Research

The Goal: Increase research expenditures to over $500 million annually
Spring QRAM 2019 The Goal: Increase research expenditures to over $500 million annually Pillar 1 of Strategic Plan Building on various disciplinary models of research, substantially increase the number of grant proposals submitted by UCI faculty

Why the Need to Increase?
Spring QRAM 2019 Why the Need to Increase?

The Rise of the Research Development Professional
Spring QRAM 2019 The Rise of the Research Development Professional What do we do? Assist researchers in finding funding opportunities Project manage the development and submittal of research proposals Grant writing and editing support Conduct grant writing workshops Coordinate and manage the limited submission process Facilitate collaborations among researchers from UCI and other institutions Coordinate cross-disciplinary research initiatives Facilitate interactions between federal agencies and UCI researchers

Who are the Research Development Professionals at UCI?
Spring QRAM 2019 Who are the Research Development Professionals at UCI?

Spring QRAM 2019 Michael Gallo Director of Research Development Office of Research Located at 160C Aldrich Hall

Spring QRAM 2019 Beth Riley, Editorial Director Office of Research Located at 4421 CALIT2

Lori Greene Director of Research Development School of Physical Sciences Located in 162 Rowland Hall

Spring QRAM 2019 Tara Massimino Director of Research Development School of Medicine Located in 240 Irvine Hall

Spring QRAM 2019 Amanda Swain Executive Director, Humanities Commons School of Humanities Located in 1112 Humanities Gateway

Spring QRAM 2019 Melinda Gormley Research Development Officer School of Biological Sciences Located at 5103 Natural Sciences II

Spring QRAM 2019 Holly Hapke Research Development Director Schools of Social Sciences & Social Ecology Located at 5404 Social & Behavioral Sciences Gateway

Spring QRAM 2019 Proposal Development is a Team Effort and it cannot happen without the efforts of departmental administrators Meet with your Research Development Officer (RDO) Discuss which opportunities your faculty are pursuing What are the upcoming deadlines Ask to participate in kickoff and status update meetings with the research team Manage up Become part of the team! Areas of collaboration for RDOs and Department Administrators expertise: Budgets Salary information (Summer salary) Budgeting for Postdocs and Graduate Students Supporting Documentation Biosketches Current and Pending grant support Facilitating communication among research and administrative team members

Spring QRAM 2019 Questions?

Manager, Communications
fundopp.uci.edu Contact: Greg Ruth Manager, Communications Office of Research (949)

STATE OF CALIFORNIA GUIDANCE WEBPAGE
Spring QRAM 2019 STATE OF CALIFORNIA GUIDANCE WEBPAGE Coming Soon! Proposal templates and instructions Basic contact information to use in all proposals and awards Resources for UCOP Guidance, F&A rates, template terms and conditions will be sent when the page is live Give example

Spring QRAM 2019 QUESTIONS?

Environmental Health & Safety Blaise Bautsch Senior Safety Specialist
Spring QRAM 2019 FIELD & DIVE SAFETY Environmental Health & Safety Blaise Bautsch Senior Safety Specialist

What can we do for you? Safety Policy Fieldwork Reviews
Field Safety Plans Safety Supplies Additional Information and Communications Wilderness First Aid Training Drones

Field incidents are serious
Head Injury What happened: I was launching the boat from the pier one day when a diver was dropped off by another boat. She had hit her head with a dive slate while doing a giant stride entry. She had a pretty solid bump on her head which required some bandaging to stop the bleeding. I walked with her to the base of the pier and talked to her in an attempt to asses her mental state. She was totally coherent and lucid, just a little flustered. I had another staff member take her to urgent care as a precaution. It turns out she was fully concussed and didn't remember a single thing from the time she hit her head until she woke up the next day, including walking and talking with me. Lesson learned: Never mess around with head trauma, even when it seems like the patient is totally fine and just had a superficial wound. Getting them checked out by a doctor is always necessary in my book.

Field incidents can turn dangerous
UC Berkeley Research area-Certified AMA Field with Registered Pilots UC Students go to Afghanistan to Climb mountains for Women Empowerment

Field incidents can turn deadly
UC Santa Barbara marine ecologist dies off the Cambria coast Don Canestro passed away on November 9, 2018, shortly after he’d been diving off the Kenneth S. Norris Rancho Marino Reserve in Cambria where he was the Resident Manager. Don was a key figure in the scientific diving and NRS communities; his work and impact were captured nicely in this 2016 profile "Stewards of Nature."

Questions? Blaise Bautsch (949) 824-9940 bbautsch@uci.edu
Thank you for your time!

Spring QRAM 2019 ERA Tips and Updates Alison and Jonathan

Existing CITI Users: Your profile must:
For individuals engaged in human subjects research (i.e. interact with participants or access identifiable data), the IRB requires the completion of the Collaborative Institutional Training Initiative (CITI) Human Research Protections Training Course Non-UCI CITI Users: Register or update your profile to affiliate with UCI. You must provide a copy of the tutorial completion report with the IRB application. New CITI Users: “Log in through my Institution” to sign-on using your UCInetID. Existing CITI Users: Your profile must: 1) Reflect your UCI as the primary AND 2) Affiliate with UCI. Nightly Data Transfer: CITI data is transferred each night and credit is available the next morning.

Spring QRAM 2019 Questions for IRB Webapp support

Animal & Human Protocol Search
Spring QRAM 2019 Animal & Human Protocol Search From Zot!Portal > Research > Research Tools & Support Replaces old AR & HP Search websites Look up status of IACUC & IRB protocols Look up active personnel on protocols

Spring QRAM 2019 RMS http://rms.research.uci.edu/
New Purchased Numbers report Look up animal numbers and info for previous orders Users that are on a protocol can look up purchased numbers

Spring QRAM 2019 Questions? RMS Support:

Add a Note on the Attachments Tab!
Kuali Research – Tips Use Notes to insert notes in a KR proposal Add a Note on the Attachments Tab! This is a place where you can identify the post award contact if it’s not you…

Do not enter sponsor code twice!
Kuali Research – Tips Prime Sponsor ONLY entered for true flow-through proposal. Do not enter sponsor code twice! We noticed this when running reports for “Federal” during the government shut down.

Check status of award setup!
Kuali Research - Tips Access the Negotiations module “fancybox” For awards processed by the Federal and non-Federal teams, use the “in progress negotiations search”, from your results screen, click “view activities”. You’ll see the new “fancybox” that shows the basic activities and status of award set up. Check status of award setup!

ERA Service Level Agreement (SLA)
Effective today Posted on the ERA Webpage > Support Time Frames: Major/Critical: within 4 hours Moderate: 1 business day Routine: 2 business days Definitions: Service Unavailable The ERA system or tool is not functioning at all; unable to proceed with work Service Degraded The ERA system or tool is still available & functional, but performance is slower and/or inconsistent Interferes with Work The ERA system or tool performance is inconsistent; requires user to retry or reload before system works again Tasks More Difficult The ERA system or tool is hindering efficient workflow; user still is able to proceed with work Dear Colleagues, The Electronic Research Administration (ERA) Team is pleased to announce the implementation of a Service Level Agreement (SLA) effective today The goal of the SLA is to ensure that proper resources are in place to provide consistent and effective functional helpdesk service support. The full text of the SLA, including priority classifications, can be referenced on the ERA web page . ERA will respond to service related incidents and/or requests submitted by the customer within the following time frames: To ensure that proper attention is given to each and every issue reported, the SLA provides definitions that will help users determine the level of severity of their reported issue, and response times that can be expected.

Final Questions?

June 19, 2019 Emerald Bay B 1:30-3:30 Spring QRAM 2019
See you next time… June 19, 2019 Emerald Bay B 1:30-3:30 Also ask for topics

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