Welcome to…RAIN

Welcome to…RAIN(the meeting formerly known as SPIN)

Presented by: the folks in RDA, with today’s emcee, James Trotter

Date: February 16, 2012

Agenda

• Intros

• Updates & timely information from the units:

James Trotter

Export Controls CTO SPA RATE ORIO OHSU Foundation

Office of the VPR

RGC

TTBD

CRBO

Research HR

• Q & A

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• Office of the Provost– Export Controls

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Transfer of technology, information, equipment, software or services to a foreign person in the U.S. or abroad by any means. For example:actual shipment outside the USvisual inspection in or outside the USwritten or oral disclosureOverseas Travel- Discussions & Technology

OHSU Exports to every Foreign National who works or studies on campus

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What is an Export? Does OHSU Export?

Office of the Provost: Export ControlsMark Peters

• Any shipment if select agents, equipment, and/or technology may be subject to export controls

• THIS INCLUDES DNA OR COMPONENTS OF SELECT AGENTS

http://www.ohsu.edu/xd/education/office-of-export-controls/controlled-agents-list.cfm

DO NOT SHIP WITHOUT APPROVAL FROM EXPORT CONTROLS!

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International Shipments


• Frequent references to “FRE” or “fundamental research exemption” in export control compliance

• Regulations actually contains three separate, distinct exemptions applicable to universities and their work:

– “Published information and software”

– “Fundamental research”

– “Educational information”

• Many situations in university settings may blend or combine aspects of more than one exemption

• Activity may be exempt even if not “fundamental research”

EXEMPTIONS DO NOT APPLY

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University Exemptions from Export Controls


• The penalties for non-compliance are severe. Fines can reach up to $1 million (for Universities and Individuals) for each civil violation of an EAR, ITAR, or OFAC regulation.

• Criminal penalties for willful misconduct can also result in up to 10 years of imprisonment or $1 million fine for each violation of an EAR, ITAR, or OFAC regulation for researchers and administrators.

• Violations are for the individual and the institution!

(No Universities have been fined)

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What are the penalties for ignoring export controls?


• If the materials are either being received from, or shipped to a foreign country, an export control license may be necessary. If in violation, the signatory may be personally responsible and subject to fines, and both civil and criminal penalties.

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International Shipping & Export Control


Equipment, software, chemical, bio-agent, or technology is on the US Munitions List (ITAR)

Equipment, software, chemical, bio-agent, or technology is designed or modified for military use, use in outer space or there is reason to know it will be for or in weapons of mass destruction

Equipment, software, chemical, bio-agent or technology is on the Commodity Control List (EAR)

Contract contains a restriction on export or foreign national access

Equipment or encrypted software is involved

Technology is not in the public domain

No

No

No

No

No

Yes

Yes

MOST LIKELY SUBJECT TO EXPORT CONTROL Contact Office of Export Controls. www.ohsu.edu/export

Contract or grant restrict publication or the presentation of research results

No

Contract or grant prohibit results or deliverables from being disclosed to any foreign country or foreign person

No

Yes

Yes

Technology may be exposed to foreign nationals (even on campus) or foreign travel is involved

Yes Equipment, software and technology (or information or instruction of same) is on the Commodity Control List

Yes Yes

Foreign nationals are from or travel to an embargoed country

No

Yes

No

No

No

Yes

MOST LIKELY NOT SUBJECT TO EXPORT CONTROL

Yes

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Mark PetersExport Compliance Officerwww.ohsu.edu/[email protected](503) 494-0137

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Thank you!


• CTO

– Clinical Trials Office• Oregon Clinical & Translational Research Institute

(OCTRI)

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OCTRI: Oregon Clinical & Translational Research Institute

CRMS New Name!

• eCRIS (electronic Clinical Research Information System)

• Submitted by Jeffrey Jensen, MD

Darlene Kitterman

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Project Status

• Completed Work– Study Startup– Study Management– Subject Tracking

• Remaining Work– Invoicing/Payment Terms– Interfaces– Reports– User Testing

Darlene Kitterman

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Roll-Out Schedule

• June 4, 2012 (Go-Live)– Big Brain training available to all users– Knight Cancer Institution begins migrating ongoing studies

• July 1, 2012: Knight begins mandatory use of eCRIS • October 1, 2012: Open eCRIS for optional use to remaining

Research Community• January 1, 2013: All new studies prospectively consenting subjects

submitted to IRB as of January 1, 2013 require eCRIS• June 1, 2013: Target deadline for all existing studies involving

prospectively consented subjects to be migrated to eCRIS

Darlene Kitterman

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Studies Required to Use eCRIS

• All studies prospectively consenting subjects• Excludes studies that involve a single sample collection• Other studies may use the eCRIS, but are not required• All funding sources (and unfunded)

– Industry: • All: Budget, visit schedule, contract, department approval (aka, PPQ),

invoicing, subject tracking• If clinical services: research billing review/approval, clinical services

approval (aka, research rate request)– Non industry: No budget or department approval (done in

InfoEd at grant submission), or contract (N/A)

Darlene Kitterman

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• SPA– Sponsored Projects Administration

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SPA: OHSU Sponsored Projects Administration

New NIH Policy on Efficient Spending Related to Grants Supporting Conferences and Meetings

• Direct charges for meals/food and beverages are unallowable

• Applies to R13s and U13s for FY 2012 effective the date of this notice (Jan 27, 2012)

• Other conference grant mechanisms will be considered on case by case basis

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-041.html

James Trotter

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Stipend & tuition levels have been announced for FY 12

• FY 2012 awards issued at FY 2011 levels will be revised to increase the stipend category

• For trainees already appointed to FY 2012 budget period, stipends must be adjusted to reflect the new level when revised award notice is received

• Amended appointments must be submitted through xTrain

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-033.html

James Trotter

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OHSU/AFSCME Merit Based Pay Pilot Project-SPA Participation

• A brief survey was sent to all ADFM, PDFM, CRCs and post award contacts asking for feedback on all of the SPA analysts.

• Final day to submit survey is tomorrow (Friday, Feb 17th)

• Thanks to all who participated!

James Trotter

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• RATE

– Research Administration Training & Education

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Upcoming Courses!

DHHS (Dept of Health and Human Services) Salary CapTuesday, February 28, 2012 – Marquam Hill

Clinical Trials – Pre-Award and Post-AwardThursday, March 22, 2012 – Marquam Hill

Registration & Details on the RATE webpage:http://www.ohsu.edu/xd/research/administration/rate_courses.cfm

RATE: Research Administration Training & EducationMargaret Gardner

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• ORIO– OHSU Research Integrity Office

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ORIO: OHSU Research Integrity Office

The VA IRB Agreement has been finalized!

• Under this agreement, the OHSU IRB will serve as the single IRB for all studies that would have previously been reviewed by both the VA and OHSU IRBs.

• We are planning for a May 1st launch date.

Ames Elliot

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IRB Brown Bags:

2/23 – Minimal Risk Research

3/22 – PI Eligibility and Research Collaborations

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Ames Elliot

http://www.ohsu.edu/xd/research/about/integrity/irb/index.cfm


2/16 – Intro to IRB Review

3/1 – eIRB 101

3/15 – eIRB 201

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Ames Elliot

http://www.ohsu.edu/xd/research/about/integrity/irb/eirb_info.cfm


Integrity Week 2012

April 30th to May 4th

Last year…

Ames Elliot

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• OHSU Foundation

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1. OHSU Foundation

2. Fundraising at OHSU

3. Corporate & Foundation Relations

4. Future RAIN OHSUF topics

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OHSU Foundation: Sarah Panetta, VP Development

An Overview

• Exists solely to support OHSU• Reports to OHSU Foundation Board, which includes

university president as a member• Serves as receiving entity for philanthropic gifts made

to OHSU• Provides staffing resources to Doernbecher Children’s

Hospital Foundation through a shared services agreement

• Has received clean audits for 17 years in a row

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Fast Facts


• OHSU has charged the combined foundations with raising $100 million/year sustainably, starting with fiscal 2013-14– From fiscal 2006-7 through 2009-10, we raised an

average of $68 million/year (subtracting one $40 million gift and one $100 million gift)

• In fiscal 2010-11, we achieved $100.5 million– This included one gift of $10 million and two gifts of

$5 million

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Looking Ahead


OHSU Foundation has access to range of fundraising tools used in multiple combinations– Working with individual donors on personalized

proposals– Direct marketing techniques (phone, letters, email,

web)– Fundraising events– Gifts & grants from corporations and private

foundations

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Fundraising Mechanisms


• Outcome: $18M identified in 8 weeks• Leading up to that:

– Decades of relationship building– 2 failed attempts to move project forward– Opportunity created to leverage other gifts

Vision + Urgency + Donors = Campaign– New goal – raise $16M in three years

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Case in Point: School of Dentistry Building


• Outcome: $25M gift ($5M over 5 years, $20M later)• Leading up to that:

– Referral from M/M Moore’s advisors– Campus tours and discussions to craft vision– Internal and external negotiations

Vision + Urgency + Donors = Campaign

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Case in Point: Bob & Charlee Moore Institute


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Basic Sciences (lead)

Neurosciences

Basic Sciences (lead)

Neurosciences

Clinical Programs (lead)

School of Medicine - Alumni Fundraising

School of Medicine Dean’s Priorities

Clinical Programs (lead)

School of Medicine - Alumni Fundraising

School of Medicine Dean’s Priorities

Basic and Translational SciencesBasic and Translational Sciences

Casey Eye Institute

Diabetes & Metabolism

Global Health

Nutrition

Women's Health

Casey Eye Institute

Diabetes & Metabolism

Global Health

Nutrition

Women's Health

BME

Knight

OCSSB

BME

Knight

OCSSB

Provost’s Funding Priorities (TBD)

Center for Ethics

Diversity

School of Dentistry

School of Nursing

Provost’s Funding Priorities (TBD)

Center for Ethics

Diversity

School of Dentistry

School of Nursing

34

Structure


OHSU Foundation Corporate & Foundation Relations:

Updates

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OHSU Foundation: Bonnie Schade, Director, Corporate & Foundation Relations

• OHSU Foundation central development team• In FY11, raised more than $22 million from companies

and foundations• In FY12, focusing on:

– Stewarding previous corporate donors– Building relationships with untapped (inter/national)

corporations and foundations, particularly $1M+ giving capacity

– Continual process improvementRAIN: 02.16.2012 36

Corporate & Foundation Relations


• Robust, growing foundation relations program• Historical corporate funding, but no formal program to

manage and grow corporate relationships• September 2010, hired Director of Corporate Relations• January 2011, combined corporate and foundation

relations into one unit at OHSUF

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Corporate & Foundation Relations


Partnerships that drive innovation• August 2011, launched Corporate Catalyst Program• Recognizing recent and significant giving $50K+

cumulative in past 5 years• 4,500 corporate donors: less than 5% (125

companies) are recognized as Corporate Catalysts; 80% of giving from this group

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Corporate Catalyst Program


• FY13 and beyond: annual recognition program for $25K+ corporate donors

• Goal is to steward and cultivate companies for future solicitations

• Corporate donors receive additional and consistent levels of recognition and benefits to further engage them with OHSU

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Corporate Catalyst Program


• 6 employees• Assist development directors, faculty, and staff in

working with and applying to companies and foundations for research and program funding

• Identify, cultivate, solicit, and steward corporate and foundation prospects to promote and advance university goals and priorities

• Primary focus on OHSU President’s List

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Corporate & Foundation Relations Office


• Includes just over 100 companies & foundations

OHSUF staff is actively working with • Requires special attention and internal coordination• Reserved for top institutional priorities• Require relationship building & management• Increase likelihood and success of proposal

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OHSU President’s List


• Prior to 2012: Clearance & Tracking form• Beginning 2012: Notice of Intent form• What does this mean for you?

– OHSU Foundation will continue to process “Notice of Intent” forms and communicate the outcome of that review to the applicant and RGC.

– Require that Notice of Intent forms be submitted prior to submission for those companies and foundations on the President’s List, but not for all other organizations.

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OHSUF Notice of Intent


• Purpose of Notice of Intent remains the same• Coordinated submission/limited submission• Background info on OHSU’s relationship and info not

found on website• Establish relationship with board or staff• Strategize approach & contact organization• Arrange meetings & site visits• Help write & edit some proposals

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OHSUF Notice of Intent


Questions?RFDS Website: Funding Portal

Bonnie Schade

503-552-0699

[email protected]

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Stay tuned…

Future RAIN topics:

• OHSU/F Fundraising Priorities• OHSUF gift administration

(agreements, funds, transfers, admin fees)

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Wrap Up

Q & A

Next Meeting:

March 15, 2012 9:30 AMSend agenda item requests to: [email protected]

Or use the feedback form at:

http://www.ohsu.edu/xd/research/administration/rain.cfm

Everyone

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