UI has retained Cayuse through June 30, 2010 with

March 31, 2009 Grants Updates - Jennifer Lassner o Stimulus Updates o Changes in NIH Peer Review o Cayuse updates o Mini-survey Grant Bulletin Oliva Smith NIH Public Access Oliva Smith Contracts Updates Wendy Beaver o DSP Contracts Team Staffing o DSP Contract Review Process o Contracts with State of Iowa Agencies o FFATA Reporting Requirements Outgoing Subawards Erin Brothers Conflict of Interest in Research Charlotte Talman STAR Daniel Gerwin Updates from Grant Accounting Audra Haddy UI FY08 A-133 audit Audra Haddy Compliance Issues (in relation to recent federal audits) Audra Haddy o Budgeting and Charging Costs to Federally Sponsored Projects o Cost Transfer Policy o Effort

Cayuse Updates UI has retained Cayuse through June 30, 2010 with support of ICTS and OVPR 123 applications submitted since January 1, 212 total CAYUSE424 supports ARRA (stimulus) funding opportunity announcements Be aware of Grants.gov overload for upcoming deadlines Friends don t let friends use Adobe forms! 1

Cayuse Updates DSP will no longer reject applications that have been submitted and accepted by the NIH era Commons Please encourage your faculty to review applications BEFORE routing to DSP 2

CAYUSE424 Training http://research.uiowa.edu/dsp/main/index.php?get=nihggtraining General Hospital SE 301 April 2, 2009 10:00am 11:30am This session will emphasize Challenge Grants via Cayuse 2117 MERF April 1, 2009, 10:00am noon April 7, 2009, 2pm 4pm S401 PBB April il9, 2009, 10:00am 00 noon 3

American Recovery and Reinvestment Act (ARRA) $10 Billion for National Institutes of Health $8.2 Billion for Research Priorities $7.4 Billion for Institutes and Centers $800 Million for NIH OD Challenge Grants $1B NCRR Extramural funds for construction, alterations and repairs $300 Million for shared instrumentation $500 Million for NIH building and facilities projects $400 Million Comparative Effectiveness Research 4

ARRA NIH Implementation R01s new and recently peer reviewed, highly meritorious applications capable of making significant progress within two years of funding Targeted Supplements to expand scope or add infrastructure to current awards New NIH Challenge Grant program Shared Instrumentation and Construction Grants ARRA funds will not have SBIR/STTR set asides 5

ARRA NIH Implementation Most R01 already peer reviewed and deemed meritorious, but not awarded due to funding constraints PIs may be asked to adjust scope and budget to what can be accomplished in two years Expect to be able to do no cost extensions, but don t exaggerate what can be done in 2 years Competing supplements to increase tempo of the research rather than expand aims Supplements will be awarded and tracked separately according to ARRA guidelines 6

ARRA NSF Implementation $2B for grant applications peer reviewed and deemed meritorious, but not awarded due to lack of funds $300M for Major Research Instrumentation program and capital equipment $200M Academic Research Infrastructure (laboratory construction grants) $400MMajorResearch Major Equipment andconstruction 7

ARRA NSF Implementation Majority are proposals already in house and that will be reviewed and/or awarded prior to September 30, 2009 Funding of new Principal Investigators and high risk, highreturn research will be top priorities Will fund previously declined dproposals Will not solicit additional applications, except in target areas Will not use ARRA funds to supplement existing awards Grants will be standard grants with durations of up to 5 years. 8

ARRA Other Federal Agencies See OVPR website for information http://research.uiowa.edu/vpr/?get=stimulus Department of Energy Department of Education NASA National Institute of Standards and Technology (NIST) National Oceanic and Atmospheric Administration (NOAA) Office on Violence Against Women 9

ARRA Reporting Requirements Summaries of expenditures required within 10 days of close of each quarter Will include funds awarded, funds spent and funds obligated but not spent Number of jobs created and retained (definition to come) Note: Objective is to stimulate the economy by spending money quickly on good projects. If the money is not spent within time period, agency may tk take back award. Common dl delays in hiring and start up may jeopardize award. Spend wisely, but spend! 10

Recovery Act Limited Competition: Core Facility Renovation, Repair, and Improvement (G20) 2 distinct applications per institution $1M $10M each Purpose: renovate, repair, or improve core facilities to support the conduct of PHS supported biomedicaland/or and/or behavioral research. May also improve the general equipment in the core facility or to purchase general equipment (less than $100,000) 11

Recovery Act Limited Competition: Extramural Research Facilities Improvement Program (C06) 3 distinct applications per institution $2M $15M each (no F&A) Purpose: construct, expand, remodel, renovate, or alter existing non federal biomedical or behavioral research facilities. UI submissions include projects for Medicine, Dentistry and Liberal Arts and Sciences 12

Recovery Act Limited Competition: High End Instrumentation Grant Program (S10) PAR 09 118 Applications due May 6, 2009 ; submitted electronically $600K $10M Purpose: purchase a single major item of equipment to be used for biomedical research that costs at least $600,000 000 3 or more NIH funded Principal investigators must be identified as users of the equipment $160 M dedicated to fund approximately 40 awards No limit on applications for unique pieces of equipment 13

Previously announced, Recovery funds added Shared Instrumentation Grant Program (S10) No limit on application for different types of equipment $100K $ 500K Purpose: to purchase or upgrade commercially available instruments that cost at least $100,000 000 for NIH funded investigators Application deadline, March 23, 2009 14

Recovery Act Limited Competition: NIH Challenge Grants in Health and Science Research (RC1) RFA OD 09 003 No limit on scientifically distinct applications $500K /yr total costs for two years F&A included in max Purpose: propose novel research in areas that address specific knowledge gaps, scientific opportunities, new technologies, dt data generation, or research methods Challenge areas defined by NIH Institutes and Centers Applications due April 27, submitted electronically 15

Research andresearch Infrastructure Grand Opportunities (RC2) RFA OD 09 004 500K /yr total costs for two years F&A included in maximum Letter of intent due April 27; full application submitted electronically by May 27 Scope: Groundbreaking, innovative, highimpactimpact andcross cutting cutting research projects that can be readily deployed and that will improve and accelerate biomedical research. Creation of large scale unique resources, accelerated application of high throughput, and other novel technologies. Creative approaches to overcome barriers to basic, translational, or clinical research using novel tools, technologies, and services. 16

NIH Announces the Availability of Recovery Act Funds for Competitive Revision Applications NOT OD 09 058 Receipt Date April 21, 2009 No limit on $; $500K pre approval ceiling applies Support length two years Eligible grants include R, P, T, K and U mechanisms Parent grantmust beactive, no cost extensions must bein place before submission Equipment (100K or less), employment opportunities, comparative effectiveness research, expandscope orenhance energyeffectiveness effectiveness Applications submitted electronically using FOA announcement of parent grant 17

NIH Announces the Availability of Recovery Act Funds for Administrative Supplements NOT OD 09 056 Up to two years in length No limit on $, but no more than 50% of parent budget Eligible grants include R, P, T, K and U mechanisms Parent grant must be active, no cost extensions allowed Increase tempo or project, without changing scope Equipment (100K or less), increased enrollment, employment opportunities, comparative effectiveness research Use PHS 398 forms for request PLEASE ROUTE 18

Recovery Act Funds for Administrative Supplements Providing Summer Research Experiences for Students and Science Educators NOT OD 09 060 Up to two years in length No limit on $, but no more than 50% of parent budget Eligible grants include R, P, and U mechanisms Parent grant must be active, no cost extensions allowable Summer research experience for high school students, undergrads and science educators Salary and fringe, up to $100oK per person for travel and research support Use PHS 398 forms for request PLEASE ROUTE 19

Enhancing Peer Review for NIH Grants Four Priority Areas: Engage the Best Reviewers Improve the Quality and Transparency of Review Ensure Balanced and Fair Reviews Across Scientific Fields and Career Stages, and Reduce Administrative Burden Continuous Review of Peer Review 20

Enhancing Peer Review: Implementation Timeline January 2009 Due Dates Early stage and New Investigator policy NIH Policy on Resubmissions May 2009 Review Meetings 9 point scoring system Enhanced review criteria Formatted reviewer critiques Clustering of New Investigator applications during review January 2010 Due Dates Shorter Applications (research plan) for R01s and other mechanisms Restructured Application to Align with Review Criteria 21

Enhancing Peer Review: New Investigators and Early Stage Investigators Beginning with applications submitted for February 5 deadlines and beyond: NIH will support applications from New Investigators at success rate comparable to established investigators ESIs expected to comprise a majority of funded NI s Applications from ESIs will be given special consideration during peer review and at the timeof funding. Peer reviewers will be instructed to focus more on the proposed approach than on the track record, and to expect less preliminary data than would be provided by an established 22

Enhancing Peer Review: Early Stage Investigators (ESIs) ESIs are New Investigators who are within ten years of completing their terminal research degree or medical residency All NIs should update NIH era Commons profiles and should see eligibility displayed in Commons NIs who wish to request an extension of ESI eligibility due to Illness, military duty, family responsibility or extended period of research training can submit a webform found at http://grants.nih.gov/grants/new_investigators/index.htm. 23

Enhancing Peer Review: New Investigators (NIs) PD/PI is identified as a New Investigator (NI) if he/she has not previously competed successfully for an NIH supported research project other than the following small or early stage research awards: Small Grant (R03) Exploratory/Developmental p Grant (R21) Fellowships and Career Awards (Fs and Ks) SBIR/STTR (R41/R43) Pathway to Independence (K99/R00) Dissertation Award (R36) Clinical Trial Planning Grant (R34) Other Shannon, AREA, LoanRepayment Program, etc. 24

Enhancing Peer Review New NIH Policy on Resubmissions Effective January 2009, all original new (never submitted) and competing renewal applications will be allowed a single amendment (A1) Original new and competing renewal application submitted prior to January 25 will be allowed two amendments (A1 and A2) For grandfathered applications allowed two amendments, the A2 application must be submitted no later than January 7, 2011 25

Enhancing Peer Review: Scoring and Review Criteria 9 point scoring system enhanced review criteria formatted reviewer critiques scoring of individual review criteria clustering of New Investigator applications during review Changes to the scoring and review criteria are described in detail in the NIH Guide, NOT OD 09 024 and NOT OD 09 025. 26

Enhancing Peer Review Additional Review Criteria Reviewers will consider the scientific and technical merit of the following, but will not assign a score for these items: Protections for Human Subjects Inclusion of Women, Minorities i i and Children Vertebrate Animals Resubmission Applications Renewal Applications Revision Applications Biohazards 27

Enhancing Peer Review: New Scoring Procedures 9 point rating scale (1 = exceptional; 9 = poor) Each assigned reviewer and discussant will give a separate ate score for each of the core criteria Each assigned reviewer and discussant will assign preliminary impact/priority score Preliminary impact/priority score will determine which applications will be discussed at study section meeting Eligible committee members will assign final impact/priority score Overall impact/priority score will be average of all final I/p scores multiplied by 10 (range 10 90 with 10 being the best possible score) 28

Enhancing Peer Review: New Scoring Procedures Each assigned reviewer and discussant will give a separate score for each of the five core criteria Scores for individual criteria will be reported on summary statement, even if application is not discussed in committee Impact Scores will reflect reviewers evaluation of overall impact tthat t the project tis likely l to have on the research field (not weighted average of criteria scores) An application does not need to be strong in all five core review criteria to be judged likely to have major scientific impact Reviewers will be given templates for scoring and written critiques, specific to each type of application 29

Enhancing Peer Review Restructured Applications Coming soon Shorter Applications Content to align with new peer review criteria Scheduled for implementation for January 2010 due dates Watch NIH Guide for announcements outlining changes 30

Questions? Jennifer Lassner 335 2123 Jennifer lassner@uiowa.edu Or DSP Helpdesk dsp@uiowa.edu 31

The UI Grant Bulletin http://research.uiowa.edu/grantbulletin/index.php The UI Grant Bulletin is one of the ways DSP communicates with campus Use the Category buttons to see announcements in your discipline Use the Search Box to look for active announcements as well as for archived announcements Sign up for the list serv to receive the newest announcements via email once a week Have announcements posted in the Grant Bulletin by contacting oliva smith@uiowa.edu

The UI Grant Bulletin http://research.uiowa.edu/grantbulletin is an online publication of funding opportunities and related news for faculty, staff, and students. To access all titles within a specific UI Grant Bulletin category, please see: Announcements http://research.uiowa.edu/grantbulletin/announcements Arts & Humanities http://research.uiowa.edu/grantbulletin/artshumanities Biological Sciences http://research.uiowa.edu/grantbulletin/biological International http://research.uiowa.edu/grantbulletin/international Interdisciplinary http://research.uiowa.edu/grantbulletin/multidisciplinary NIH Funding Opportunities and Notices http://research.uiowa.edu/grantbulletin/nih Physical & Mathematical Sciences http://research.uiowa.edu/grantbulletin/physicalmathematical Student Grant Opportunities http://research.uiowa.edu/grantbulletin/student Social Sciences http://research.uiowa.edu/grantbulletin/socialsciences UI Winning Institutional Nominations UI/WINS http://research.uiowa.edu/grantbulletin/uiwins ================================== Selected New Titles for March 13 27, 2009 ================================== *Recovery Act ARRA Applications of Nuclear Science and Technology http://www07.grants.gov/search/search.do?&mode=view&flag2006=false&oppid=45878 *Recovery Act ARRA R and D on Alternative Isotope Production Techniques http://www07.grants.gov/search/search.do?&mode=view&flag2006=false&oppid=45884 *International Research and Studies Program http://edocket.access.gpo.gov/2009/pdf/e9 6449.pdf * NASA's 21st Annual Planetary Science Summer School https://pscischool.jpl.nasa.gov/index.cfm *United States Israel Science Collaborations, Start up Grants, Travel http://www.bsf.org.il/bsfpublic/default.aspx

*Teacher Quality Partnership Grants Program Recovery Act ARRA http://www07.grants.gov/search/search.do?&mode=view&flag2006=false&oppid=46359 *Iowa Conservation Innovation Grants http://www.ia.nrcs.usda.gov/programs/cig.html * Public Health Law Research Brief Proposals http://www.rwjf.org/publichealth/product.jsp?id=40589 *NSF: Industry/University Cooperative Research Centers Program http://research.uiowa.edu/granttrack/preselection.php?view=yes&grantid=17270&type=2 *Public Education Programs Concerning the Anti discrimination Provision of the Immigration and Nationality Act http://www07.grants.gov/search/search.do?&mode=view&flag2006=false&oppid=46312 *NSF Funding Opportunities in Physics http://www.nsf.gov/div/index.jsp?div=phy *Integrative Organism Systems IOS http://www.nsf.gov/funding/pgm_list.jsp?org=ios *NSF Mathematical Sciences Funding Opportunities http://www.nsf.gov/funding/pgm_list.jsp?org=dms *NSF Chemical, Bioengineering, Environmental, and Transport Systems Funding Opportunities http://www.nsf.gov/funding/pgm_list.jsp?org=cbet *NSF Civil, Mechanical and Manufacturing Innovation Funding Opportunities http://www.nsf.gov/funding/pgm_list.jsp?org=cmmi *Wound Stasis System Abstracts http://www.darpa.mil/dso/solicitations/solicit.htm *Prevention of Biofouling Abstract http://www.darpa.mil/dso/solicitations/solicit.htm *Preservation Education and Training Grants http://www.neh.gov/grants/guidelines/pet.html *NIH Announces the Availability of Recovery Act Funds for Administrative Supplements http://grants.nih.gov/grants/guide/notice files/not OD 09 056.html *NIH Announces the Availability of Recovery Act Funds for Competitive Revision Applications http://grants.nih.gov/grants/guide/notice files/not OD 09 058.html *NIH Announces the Availability of Recovery Act Funds for Administrative Supplements Providing Summer Research Experiences for Students and Science Educators http://grants.nih.gov/grants/guide/notice files/not OD 09 060.html *NEH: Challenge Grants http://research.uiowa.edu/dsp/main/index.php?get=uiwins&grantid=17269&type=2&get=uiwins *Graduate Student International Travel Awards htt //i t ti l i d / t / t d t /f di / d t /i t ti l t l

Thank you! Grant Bulletin Contact: Oliva Smith oliva smith@uiowa.edu UIGrant Bulletin http://research.uiowa.edu/grantbulletin/all edu/grantbulletin/all

NIH Public Access Policy The law states: The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine s PubMed Central an electronic version of their final, peer reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law. http://grants.nih.gov/grants/guide/notice files/not OD 08 033.html 1

NIH Public Access Policy Specifics: The NIH Public Access Policy applies to all peer reviewed articles that arise, in whole or in part, from direct costs 1 funded by NIH that are accepted for publication on or after April 7, 2008. Institutions and investigators are responsible for ensuring that any publishing or copyright agreements concerning submitted articles fully comply with this Policy. PubMed Central* (PMC) is the NIH digital archive of full text, peerreviewed journal articles http://www.pubmedcentral.nih.gov/ The final, peer reviewed manuscript includes all graphics and supplemental materials that are associated with the article. Beginning May 25, 2008, anyone submitting an application, proposal or progress report to the NIH must include the PMC (PMCID)** or NIH Manuscript tsubmission i (NIHMSID)*** ID)*** reference number when citing applicable articles that arise from their NIH funded research. 2

*PubMed Central PMC vs.pubmed PubMed is a free search engine from the NLM that includes over 18 million citations and abstracts from MEDLINE, Old Medline (pre 1966) and other life science/biomedical databases. Some PubMed citations include links to full text articles in PMC. http://www.ncbi.nlm.nih.gov/pubmed/ nlm nih PubMed Central PMC is a free electronic digital library of full text, peer reviewed articles in biomedical and life sciences. http://www.pubmedcentral.nih.gov/ 3

**The PMCID is not the same as the PMID 4

***If no PMCID available, use NIHMS ID From: nihms help@ncbi.nlm.nih.gov To: sh@uiowa.edu Sent: Wednesday, March 25, 2009 1:48 PM Subject: [nihms] NIHMS48019: Approve Submission of Manuscript "Recent Developments in the Dorfman Berbaum Metz Procedure for Multireader ROC Study Analysis." (NIHMS48019) Dear SH, Author support, Elsevier has submitted the following manuscript for publication in PubMed Central in compliance with the NIH Public Access Policy <http://publicaccess.nih.gov/policy.htm>: Journal name: Academic radiology Manuscript title: Recent Developments in the Dorfman Berbaum Metz Procedure for Multireader ROC Study Analysis. The manuscript ID for this article is NIHMS48019. Please approve the submitted materials and confirm that it was supported by NIH and/or HHMI funding so the full text of this manuscript can be processed and made available to the public in PubMed Central. Please note that this must be done in the NIHMS System even though NIH or HHMI support may be acknowledged in the manuscript text. 5

Complying with NIH Public Access Policy by Washington University of St. Louis School of Medicine Becker Medical Library http://becker.wustl.edu/pdf/nihcomplianceflowchart.pdf 6

Copyright http://publicaccess.nih.gov/ Copyright Before you sign a publication agreement or similar copyright transfer agreement, make sure the agreement allows the paper to be submitted to NIH in accordance with the Public Access Policy. See Whose approval do I need to submit my final peer reviewed manuscript to PubMed Central at http://publicaccess.nih.gov/faq.htm#c2 htm#c2 Standard letter to Publisher which may be included with manuscript submission http://research.uiowa.edu/dsp/main/index.php?get=nihpubpolicypublisherltr Standard paragraph for publication agreements http://research.uiowa.edu/dsp/main/index.php?get=nihpubpolicypublisherprgrph 7

Journals that Submit to PMC without ih Author Involvement Check the NIH list of PMC Journals that will submit without author involvement. http://publicaccess.nih.gov/submit_process_journals.htm Cite the PMCID reference number OR PMCID is not yet available: IF and ONLY if the journal is on the PMC Journal list from above link, you may designate: PMC Journal In Process http://publicaccess.nih.gov/citation_methods.htm 8

Publisher Submits on Behalf of Author Does the publisher submit to PubMed Central PMC on behalf of the author? Consult the publisher s website author information to find out publisher s s policy relative to the NIH. Do not submit manuscript to PMC without knowing publisher s policy; this may violate the copyright agreement. If you cannot find publisher s policy, please contact me oliva smith@uiowa.edu or Janna Lawrence janna lawrence@uiowa.edu of the Hardin Library. Cite the PMCID or if PMCID not yet available Do not use the in process designation. Use the NIHMS ID 9

NIHMS ID Almost immediately after a manuscript is submitted to the NIHMS (whether by the publisher or by the author), the author/pi will receive an email with the NIHMS ID requesting approval of the manuscript. Use the NIHMS ID until the PMCID is assigned. Once PMCID is assigned (may take several weeks) use the PMCID. Example: From: nihms help@ncbi.nlm.nih.gov To: sh@uiowa.edu Sent: Wednesday, March 25, 2009 1:48 PM Subject: [nihms] NIHMS48019: Approve Submission of Manuscript 10

Publisher Submits on Behalf of Author The law states:... an electronic version of their final, peer reviewed manuscripts upon acceptance for publication, to be made publicly available [in PMC] no later than 12 months after the official date of publication. This delay or embargo period is set when the manuscript is sent to the NIHMS. (see set delay on p18 of pdf How do I submit... http://www.nihms.nih.gov/help/pi NPMC/PI NPMC 1.shtml ) 11

Publisher Submits on Behalf of Author Publishers are supposed to deposit the manuscript into PubMed Central as soon as accepted. which means the author/pi should receive a NIHMS ID number soon after the article is accepted for publication. The author needs to follow up with the publisher to be sure the manuscript is deposited into PubMed Central in a reasonable amount of time in order to receive NIHMS ID. 12

Public Access Policy Resources DSP Information on NIH Public Access http://research.uiowa.edu/dsp/main/index.php?get=pub accrequirements&viewreview=1 Hardin Library Guide on NIH Public Access http://guides.lib.uiowa.edu/content.php?pid=6167&sid=38601 NIH Public Access http://publicaccess.nih.gov/policy.htm NIH Manuscript Submission System http://www.nihms.nih.gov/ How to Locate and Cite the PMCID from the Becker Medical Library, Washington University in St. Louis, MO. http://www.becker.wustl.edu/pdf/pmcid.pdf 13

Thank You If you have questions regarding compliance to the NIH Public Access Policy, please contact: Oliva Smith Division of Sponsored Programs 100 Gilmore Hall oliva smith@uiowa.edu 335 3708 14

DSP Contracts Team Staffing Monica Moen, Contracts Administrator College of Engineering NADS (National Advanced Driving Simulator) Office of State Archaeologist Physics

DSP Contracts Team Staffing Virginia (Gini) Sipes, Contracts Administrator College of Liberal Arts & Sciences except Physics Broadcasting Services CBB (Center for Biocatalysis and Bioprocessing) CGRER (Center for Global and Environmental Research) Graduate College Hygienic Lab Iowa Consortium for Substance Abuse Public Policy Center Student Services UIHC Departments that are not collegiate departments (e.g., Hospital Pharmacy)

DSP Contracts Team Staffing Jessica Stroud DSP outgoing subaward coordinator for projects with more than five subawards Leslie Weatherhead h Budget review DSP Contact t List: http://research.uiowa.edu/dsp/main/?get=s taffdirectory1

DSP Contract Review Process Contract review begins after receipt of completed routing form Electronic copy of contract assists in negotiations Submit RFPs (Requests for Proposals) to DSP prior to proposal submission to allow time for review and comment on proposed terms

Contracts with State of Iowa Agencies Termination for lack of funding IDPH 10 days IDNR 30 days IDHS 60 days Intellectual property terms in RFPs

FFATA Reporting Federal Funding Accountability and Transparency Act (FFATA) Applies to Subawards > $25,000 Reporting requirements include Location including congressional district DUNS number CCR (Central Contractor Registration)

DSP Contracts Update Wendy Beaver Sr. Associate Director Sponsored Programs 335-2122 wendy-beaver@uiowa.edu d

Outgoing Subawards Amendment Request Form Zero Dollar Subawards & Request Form Change in Preqs

Amendment Request Form

Zero Dollar Subawards Zero Dollar Subawards & Request Form

Change in Preqs $3,001 $5,000 Enter true subaward amount in the description

Office of the Vice President for Research

James Walker, Conflict of Interest in Research Officer Office of the VP Research Charlotte Talman, Director Martha Hedberg, Coordinator Office of the VP Research

June 8, 2008, NY Times: Top Psychiatrist Failed to Report Drug Income (Dr. Joseph Biederman; Harvard; Peds Psychiatry) Oct 3, 2008, Wall Street Journal: Senator Says Emory Psychiatrist Didn t Disclose $500,000 in Payments (Dr. Charles Nemeroff; Adult Psychiatry) Legislative scrutiny Senator Grassley Office of the VP Research

UI policy has been in place since 1995; based on federal regulation (PHS); Operations Manual, Division II, Chapter 18.6 University-wide (all colleges and departments) Applicable only to individuals id involved in research Driven by events - triggered by a new study orbychangesinanexistingstudy existing study Office of the VP Research

Conflict of interest in research involves situations in which an investigator has a significant financial interes that may compromise, or have the appearance of compromising, professional judgment in the design, conduct, or reporting of research (UI Operations Manual) Office of the VP Research

Significant Financial Interest = anything of monetary value when such interest involves: Payments Equity (stock, stock options) Company position with fiduciary duty (partner, owner, employee, manager, director) Patents, copyrights Office of the VP Research

In excess of $10,000 000 within past year or expected in upcoming year Includes consulting fees, honoraria, gifts, and income from inventions (such as licensing fees, royalties) Applies to salary from a company; not salary support from UI under a grant or contract Office of the VP Research

Publicly-traded company: stock or stock options > $10,000 or > 5% of the business entity Pi Privately-held ld company (start-up company): ANY stock or stock options Office of the VP Research

Investigator = anyone involved in the design, conduct, or reporting of research, including: Principal investigator and any other faculty, staff, or student Spouses and dependent children of the above Collaborators at other institutions (subrecipients on grants and subcontractors) Office of the VP Research

Prior to launching the research Within 30 days if a new financial interest is created or a researcher with a financial i interest joins the study team Office of the VP Research

Question #19 on UI Routing Form COIR Disclosure Form: On UI Website, Conflict of Interest in Research VP Research; Disclosure Form (login with Hawk ID & password) IRB application Office of the VP Research

Conflict of Interest in Research Committee 15 faculty members from 12 colleges Chair Dr. Michael Cohen Proposes management plan to VP Research Office of the VP Research

Management plan signed by investigator Copy to Dean, DEO, DSP/CTO, IRB IRB process can proceed Contract can be signed Study awarded Office of the VP Research

Financial relationships with industry are not necessarily bad Transparency is always good Familiarize i yourself with UI Policy Do not assume that a study team member does not have a significant financial interest Office of the VP Research

STAR Human Subject Volunteer Registry A program of the University of Iowa Center On Aging STAR (Seniors Together in Aging Research) is a registry of research volunteers age 50 and over, living predominantly within a two-hour drive of the University of Iowa. STAR is maintained by the Center On Aging, which established the registry to address the under-representation of elders in clinical research. STAR seeks to facilitate aging-related research, and to promote the inclusion of older adults in studies at the University of Iowa. The registry is confidential and secure, with database access restricted to IRB-approved staff at the Center On Aging. In order to maintain confidentiality, STAR makes the initial contacts with all potential volunteers for a clinical study. The recruitment effort for STAR is continuous, as is the periodic updating of individual records. Over 1100 people are registered as of March 30, 2009. Particular attention is now directed toward recruiting volunteers from medically underserved communities, ethnic minorities, and people over age 65. The database includes searchable fields of self-reported medical, demographic, and behavioral information designed to identify volunteers who are potentially qualified for specific study requirements. Investigators may order queries from the STAR registry on a fee-for-service basis, and STAR has been designated a University of Iowa Recharge Center for this purpose. Query requests are expeditiously reviewed by a panel of three University of Iowa clinical faculty. STAR fees: $50 flat query fee, plus $2/per mailed piece. Example: A recruitment mailing to 100 people would cost $250 ($50 query plus $200 mailing). Additional information and request for registration is available on the STAR page of the Center On Aging website: http://www.centeronaging.uiowa.edu/star.shtml. The registry is directed by Dr. Robert Wallace. FOR MORE INFORMATION: Daniel Gerwin, Research Coordinator: daniel-gerwin@uiowa.edu, 319-384-4566 Linsey Abbott, STAR Coordinator: linsey-abbott@uiowa.edu, 319-384-4221

Research Administrator Meeting March 31, 2009 10:00-12:00 12:00 Illinois Room, IMU

Agenda Updates from Grant Accounting Audra Haddy UI FY08 A 133 audit Audra Haddy Compliance Issues Audra Haddy

Updates from Grant Accounting

FY08 A 133 Audit

Compliance Issues Related to Recent Federal Investigations & Audits

Compliance Issues Related to Recent Federal Investigations & Audits December 2008, Yale University Agreed to pay govt. $7.6M ($3.8 false claims and $3.8 penalties) US Attorney s Office alleged two types of mischarges to federal grants: Transferred charges to federal grants to which those charges were not allocable; done near end of award with intention of spending down remaining funds Researchers wrongfully charged 100 % of their summer effort to federal grants when in fact the researchers expended dsignificant ifi effort on unrelated work January 2009, Duke University HHS-OIG found $1.7M in unallowable charges University inappropriately claimed reimbursement for administrative & clerical expenses as direct costs

Compliance Issues Related to Recent Federal Investigations & Audits Budgeting and Charging Costs to Federally Sponsored Projects Cost Transfer Policy Effort

Budgeting and Charging Costs to Federally Sponsored Projects Salaries and benefits of admin/clerical staff, office supplies, local telephone costs, memberships and postage should not normally be charged as direct costs to federal grants, contracts or other agreements Feds expect we are covering these types of costs with F&A Exhibit C, examples of major project

Budgeting and Charging Costs to Fd Federally Sponsored dprojects At UI: PIs/Depts are responsible for ensuring that costs assigned to federal projects are appropriate as direct costs Appropriate admin/clerical costs should be included in the budget & approved by the sponsoring agency Depts must have documentation to support why the costs are an appropriate Based on definition of major project in OMB A-21 Based on definition of major project in OMB A 21, Exhibit C

Budgeting and Charging Costs to Fd Federally Sponsored dprojects Examples of costs that would not normally be included din the budget or charged to federally sponsored projects: Salaries of clerical/admin staff who perform routine services Office supplies that are used for general administrative support of a project including paper, pens, tape Tl Telephone rentals tl used dto conduct routine business Routine office equipment including chairs, desks, computers, printers, copiers, telephones Membership in professional and scientific organizations

Budgeting and Charging Costs to Fd Federally Sponsored dprojects Examples of costs that may be appropriate to include in the budget or charge to federally sponsored projects (with add l justification): Office supplies used exclusively for project-specific activities Telephone lines, data lines, and telephones used to conduct surveys or maintain contact with project activities conducted at remote locations Postage that is directly related to the conduct of the study, including correspondence with project participants or dissemination of surveys or materials produced as a result of the project activities Long distance calls that are directly related to the project-specific activities

Budgeting and Charging Costs to Fd Federally Sponsored dprojects Other considerations: Several sponsoring agencies have also made it clear that inclusion in the budget and subsequent award by the agency does not make a cost allowable Audit findings resulting in disallowances must be reimbursed to the federal government from departmental funds

Cost Transfer Policy When determining if a cost transfer is appropriate for a sponsored agreement, what should be considered? Is the cost allowable? Has the cost transfer policy been followed?

Cost Transfer Policy Is the cost allowable? Based on OMB A21, the cost must be reasonable, allocable, consistently treated, and not specifically prohibited

Cost Transfer Policy Reasonable? Cost is of a type generally recognized as necessary for the performance of the sponsored agreement Consistent with university policies

Allocable? Cost Transfer Policy Goods or services are chargeable or assignable in accordance with the relevant benefits received Any costs allocable to a particular sponsored agreement may not be shifted to other sponsored agreements in order to meet deficiencies i i caused by overruns or other fund considerations, to avoid restrictions imposed by law or by terms of the sponsored agreement, or for other reasons of convenience

Cost Transfer Policy Consistently treated? Admin/clerical costs are normally part of F&A costs Specifically prohibited by the agreement?

Cost Transfer Policy Has the cost transfer policy been followed? When the need for a cost transfer to a sponsored project account (fund 500 or 510) arises, the Cost Transfer Explanation and Justification Request form must be completed The explanation for the cost transfer must be clearly stated and must be sufficient for an independent reviewer (i.e. an auditor) to understand the transfer and conclude that it is appropriate.

Reminder: Cost Transfer Policy Cost transfers that are made only for the intention of spending down sponsored project funds or covering a deficit are not appropriate Any shared costs should be pro-rated among the applicable accounts at tthe time the costs are incurred dto the maximum extent tpossible Charging costs to one sponsored project with the intention of repaying the sponsored project when an award is received is not appropriate An explanation which merely states that the transfer was made to correct an error or to transfer to correct project is not sufficient

Effort Salary charges must be supported by actual effort Charges to federal grant accounts for researcher time and effort must reflect actual time and effort spent on a particular grant