march 31, 2009...april 2, 2009 10:00am ‐11:30am thissession will emphasize challenge grants via...

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 OVPRsupport of ICTS and OVPR

123 applications submitted since January 1, 212 total CAYUSE424 supports ARRA (stimulus) funding CAYUSE424 supports ARRA (stimulus) funding opportunity announcements

Be aware of Grants.gov overload for upcoming g p gdeadlines

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 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 301pApril 2, 2009 10:00am ‐ 11:30amThis session will emphasize Challenge Grants via Cayuse

2117 MERF

April 1, 2009, 10:00am – noon

April 7 2009 2pm – 4pmApril 7, 2009, 2pm 4pm

S401 PBB

A il 9 2009 10 00

3

April 9, 2009, 10:00am – noon

American Recovery and Reinvestment ActAmerican 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 $7.4 Billion for Institutes and Centers $800 Million for NIH OD Challenge Grants

$1B NCRR Extramural funds for construction, alterations and repairs$ f $300 Million for shared instrumentation

$500 Million for NIH building and facilities projects $400 Million Comparative Effectiveness Research $400 Million Comparative Effectiveness Research

4

ARRA

NIH Implementation

R01s ‐ new and recently peer‐reviewed, highly meritorious applications capable of making significant progress within

f f ditwo years of funding

Targeted Supplements to expand scope or add infrastructure to current awardsto 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 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 p ,exaggerate what can be done in 2 years

Competing supplements to increase “tempo of the research” th th d irather than expand aims

Supplements will be awarded and tracked separately according to ARRA guidelinesg g

6

ARRA

NSF Implementation

$2B for grant applications peer‐reviewed and deemed meritorious but not awarded due to lack of fundsmeritorious, but not awarded due to lack of funds

$300M for Major Research Instrumentation program and capital equipment

$200M Academic Research Infrastructure (laboratory construction grants)

$400MMajor Research Equipment and Construction $400M Major Research Equipment and Construction

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, high‐return research will be top priorities

Will f d i l d li d l Will fund previously declined proposals

Will not solicit additional applications, except in target areas

Will not use ARRA funds to supplement existing awards Will not use ARRA funds to supplement existing awards

Grants will be standard grants with durations of up to 5 years.

8

ARRAARRA

Other Federal Agencies

See OVPR website for information http://research.uiowa.edu/vpr/?get=stimulus

D f E Department of Energy

Department of Education

NASA NASA

National Institute of Standards and Technology (NIST)

National Oceanic and Atmospheric Administration (NOAA)p ( )

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 Will include funds awarded, funds spent and funds obligated but not spent

Number of jobs created and retained (definition to come)j ( )

Note: Objective is to stimulate the economy by spending money quickly on good projects. If the money is not spent within ti i d t k b k d C d l itime period, agency may take back award. Common 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 biomedical and/or behavioralthe conduct of PHS supported biomedical 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)$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 SciencesLiberal 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 000used for biomedical research that costs at least $600,000

3 or more NIH funded Principal investigators must be identified as users of the equipmentq p

$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) g ( )

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 for NIH funded instruments that cost at least $100,000 for NIH funded investigators

Application deadline, March 23, 2009pp , 3, 9

14

Recovery Act Limited Competition: NIH Challenge Grants in HealthRecovery Act Limited Competition: NIH Challenge Grants in Health and Science Research (RC1)RFA‐OD‐09‐003

No limit on scientifically distinct applications

$500K /yr total costs for two years ‐ F&A included in max$ /y y

Purpose: propose novel research in areas that address specific knowledge gaps, scientific opportunities, new technologies, d t ti h th ddata generation, or research methods

Challenge areas defined by NIH Institutes and Centers

Applications due April 27 submitted electronically Applications due April 27, submitted electronically

15

Research and Research Infrastructure “Grand Opportunities” (RC2)Research and Research 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 high impact and cross‐cutting researchGroundbreaking, innovative, high impact and cross 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 highCreation 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 servicesresearch 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 grant must be active no‐cost extensions must be in place beforeParent grant must be active, no cost extensions must be in place before submission

Equipment (100K or less), employment opportunities, comparative effectiveness research expand scope or enhance energy effectivenesseffectiveness research, expand scope or enhance energy 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 budgetNo 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 ff hopportunities, comparative effectiveness research

Use PHS 398 forms for request – PLEASE ROUTE

18

Recovery Act Funds for Administrative Supplements ProvidingRecovery 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 p g , g

science educators Salary and fringe, up to $100oK per person for travel and research

supportpp 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 Burdenand Career Stages, and Reduce Administrative Burden

Continuous Review of Peer Review

20

E h i P R iEnhancing 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 reviewg g pp g

January 2010 Due Dates Shorter Applications (research plan) for R01s and other mechanismspp ( p ) Restructured Application to Align with Review Criteria

21

Enhancing Peer Review:Enhancing Peer Review:

New Investigators and Early Stage InvestigatorsInvestigators

Beginning with applications submitted for February 5 deadlines and beyond: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 time of funding Peer reviewersduring peer review and at the time of 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 residencyresidency

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 web-extended period of research training can submit a web-form found at http://grants.nih.gov/grants/new_investigators/index.htm.

23


New Investigators (NIs)

PD/PI is identified as a New Investigator (NI) if he/she has notpreviously competed successfully for an NIH‐supported research project other than the following small or early stage p j g y gresearch awards:

Small Grant (R03) Exploratory/Developmental Grant (R21)p y/ p ( ) Fellowships and Career Awards (Fs and Ks) SBIR/STTR (R41/R43) Pathway to Independence (K99/R00)Pathway to Independence (K99/R00) Dissertation Award (R36) Clinical Trial Planning Grant (R34)

Other Shannon AREA Loan Repayment Program etc Other – Shannon, AREA, Loan Repayment 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 b itt d i t J 25 ill b ll d tsubmitted prior to January 25 will be allowed two

amendments (A1 and A2)

For grandfathered applications allowed two amendmentsFor grandfathered applications allowed two amendments, the A2 application must be submitted no later than January 7, 2011

25

Enhancing Peer Review:Enhancing Peer Review:

Scoring and Review Criteria

9‐point scoring system

enhanced review criteriaenhanced 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 d l h d ddetail in the NIH Guide, NOT‐OD‐09‐024 and NOT‐OD‐09‐025.

26

Enhancing Peer ReviewEnhancing Peer Review

Additional Review CriteriaReviewers will consider the scientific and technical merit of the following, but will not assign a score for these items:

Protections for Human SubjectsI l i f W Mi i i d Child Inclusion of Women, Minorities and Children

Vertebrate Animals Resubmission Applications Resubmission Applications Renewal Applications Revision Applicationspp Biohazards

27


New Scoring Procedures 9 point rating scale (1 = exceptional; 9 = poor) Each assigned reviewer and discussant will give a

separate score for each of the core criteriasepa ate sco e o eac o t e co e c te a Each assigned reviewer and discussant will assign

preliminary impact/priority score Preliminary impact/priority score will determine which Preliminary impact/priority score will determine which

applications will be discussed at study section meeting Eligible committee members will assign final impact/priority

scorescore 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)best possible score)

28

hEnhancing 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 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 i t th t th j t i lik l t h th h fi ldimpact that the project is likely 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 g p gcritiques, 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 Lassner335‐2123

Jennifer‐[email protected]

DSP [email protected]

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 disciplinep

•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‐[email protected]

• 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/biologicalhttp://research.uiowa.edu/grantbulletin/biological•• International• http://research.uiowa.edu/grantbulletin/international•• Interdisciplinary• http://research.uiowa.edu/grantbulletin/multidisciplinary•• NIH Funding Opportunities and NoticesNIH 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

h kThank you!

• Grant Bulletin Contact: Oliva Smith oliva‐[email protected]

• UI Grant Bulletin http://research uiowa edu/grantbulletin/allUI Grant Bulletin http://research.uiowa.edu/grantbulletin/all

NIH Public Access PolicyNIH 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 l t i i f th i fi l i d i telectronic 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 lawconsistent 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 2008accepted 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.fully comply with this Policy.

PubMed Central* (PMC) is the NIH digital archive of full‐text, peer‐reviewed journal articles http://www.pubmedcentral.nih.gov/

The final, peer‐reviewed manuscript includes all graphics and , p p g psupplemental 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 M i t S b i i (NIHMS ID)*** f b hNIH Manuscript Submission (NIHMS ID)*** reference number when citing applicable articles that arise from their NIH funded research.

2

*PubMed Central PMC vs.PubMedPubMed Central PMC vs.PubMed

• PubMed is a free search engine from the NLM thatPubMed 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 PubMedcitations include links to full text articles in PMC. http://www ncbi nlm nih gov/pubmed/http://www.ncbi.nlm.nih.gov/pubmed/

• PubMed Central PMC is a free electronic digital glibrary 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 PMIDThe PMCID is not the same as the PMID

4

***If no PMCID available, use NIHMS IDFrom: nihms‐[email protected]: [email protected]: [email protected]:Wednesday, March 25, 2009 1:48 PMSubject: [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 radiologygyManuscript 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 Policyby Washington University of St. Louis School of Medicine‐Becker Medical Libraryy g y y

http://becker.wustl.edu/pdf/NIHComplianceFlowchart.pdf

6

CopyrightCopyright

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 tothe 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#c2PubMed Central at http://publicaccess.nih.gov/FAQ.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 PMCi h h lwithout Author Involvement

• Check the NIH list of “PMC Journals” that will submitCheck 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

OROR

• PMCID is not yet available: IF and ONLY if the journal is on the “PMC Journal” list from above link you mayis 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 AuthorPublisher Submits on Behalf of Author

• Does the publisher submit to PubMed Central pPMC on behalf of the author?– Consult the publisher’s website “author information” to find out publisher’s policy relative to the NIHto find out publisher s policy relative to the NIH.

– Do not submit manuscript to PMC without knowing publisher’s policy; this may violate the copyright agreementagreement.

• If you cannot find publisher’s policy, please contact me oliva‐[email protected] Janna Lawrence janna‐[email protected] of the Hardin Library.

– Cite the PMCID – or if PMCID not yet available • Do not use the “in process” designation.• Use the NIHMS ID• Use the NIHMS ID

9

NIHMS IDNIHMS ID

• Almost immediately after a manuscript is submitted to the NIHMS ( h th b th bli h b th th ) th th /PI ill(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 isUse the NIHMS ID until the PMCID is assigned. Once PMCID is assigned (may take several weeks) use the PMCID.

Example:Example: From: nihms‐[email protected]: [email protected]:Wednesday, March 25, 2009 1:48 PMy, ,Subject: [nihms] NIHMS48019: Approve Submission of Manuscript

10


• The law states: . . . an electronic version of their final,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” onmanuscript 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


• Publishers are “supposed to” deposit the manuscriptPublishers 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.

Th th d t f ll ith th bli h t• The author needs to follow up with the publisher to be sure the manuscript is deposited into PubMedCentral in a reasonable amount of time in order toCentral in a reasonable amount of time in order to receive NIHMS ID.

12

Public Access Policy ResourcesPublic Access Policy Resources

• DSP Information on NIH Public AccessDSP Information on NIH Public Access http://research.uiowa.edu/dsp/main/index.php?get=pub‐acc‐requirements&viewReview=1

• Hardin Library Guide on NIH Public Access• 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/

d i h• 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 YouThank You

• If you have questions regarding compliance to theIf you have questions regarding compliance to the NIH Public Access Policy, please contact:

Oliva Smith

Division of Sponsored Programs

100 Gilmore Hall

oliva‐[email protected]@

335‐3708

14

DSP Contracts Team Staffing

Monica Moen, Contracts Administrator– College of Engineering– NADS (National Advanced

Driving Simulator)– Office of State Archaeologist– Physics


Virginia (Gini) Sipes, Contracts Administrator

– College of Liberal Arts & Sciences except PhysicsCollege of Liberal Arts & Sciences except Physics– Broadcasting Services– CBB (Center for Biocatalysis and Bioprocessing)– CGRER (Center for Global and Environmental Research)

Graduate College– Graduate College– Hygienic Lab– Iowa Consortium for Substance Abuse– Public Policy Center

S d S i– Student Services– UIHC Departments that are not collegiate departments (e.g.,

Hospital Pharmacy)


Jessica Stroud– DSP outgoing subaward

coordinator for projects with more than five subawards

L li W th h dLeslie Weatherhead– Budget review

DSP C t t Li tDSP Contact List:http://research.uiowa.edu/dsp/main/?get=s

taffdirectory1taffdirectory1

DSP Contract Review Process

Contract review begins after receipt of completed routing form

Electronic copy of contract assists in negotiationsnegotiations

Submit RFPs (Requests for Proposals) to DSP prior to proposal submission to allow time for review and comment on proposed termsproposed terms

Contracts with State of IowaContracts with State of Iowa Agencies

Termination for lack of funding– IDPH 10 daysy– IDNR 30 days– IDHS 60 daysIDHS 60 days

Intellectual property terms in RFPs

FFATA Reporting

Federal Funding Accountability and Transparency Act (FFATA)

A li S b d– Applies to Subawards >$25,000R ti i t i l d– Reporting requirements include

• Location including congressional districtdistrict

• DUNS number• CCR (Central Contractor (

Registration)

DSP Contracts Update

Wendy BeaverSr. Associate DirectorSponsored Programs

335-2122d b @ i [email protected]

Outgoing SubawardsOutgoing Subawards

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

Amendment Request Form

Zero Dollar SubawardsZero Dollar Subawards & Request Form

Change in Preqs

• $3,001 $5,000• Enter true subaward amount in the

d i tidescription

Office of the Vice President for Research

James Walker, Conflict of Interest in Research OfficerOfficer

Charlotte Talman DirectorOffice of the VP ResearchOffice of the VP Research

Charlotte Talman, Director

Martha Hedberg, Coordinatorg,

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 DiscloseSays Emory Psychiatrist Didn t Disclose $500,000 in Payments”

(Dr. Charles Nemeroff; Adult Psychiatry)

Legislative scrutiny – Senator Grassley


UI policy has been in place since 1995; based on federal regulation (PHS); Operations Manual, g pDivision II, Chapter 18.6

University-wide (all colleges and departments)

A li bl l i di id l i l d i Applicable only to individuals involved in research

Driven by events - triggered by a new study or by changes in an existing studyor by changes in an existing study


“Conflict of interest in research involves situations in which an investigator has asituations in which an investigator has a

significant financial interest that may compromise, or have the appearance of p pp

compromising, professional judgment in the design, conduct, or reporting of research”

(UI Operations Manual)


“Significant Financial Interest” = anything of g y gmonetary value when such interest involves:

Payments Equity (stock, stock options) Company position with fiduciary duty

(partner, owner, employee, manager, director)Patents copyrights Patents, copyrights


I f $10 000 ithi t In excess of $10,000 within past year or expected in upcoming year

Includes consulting fees, honoraria, gifts, and income from inventions (such as licensing co e o e t o s (suc as ce s gfees, royalties)

Applies to salary from a company; not salary support from UI under a grant or contract


Publicly-traded company: stock or stock options > $10,000 or > 5% of the business entity

P i l h ld ( ) Privately-held company (start-up company): ANY stock or stock options


“Investigator” = anyone involved in the designInvestigator = 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 (sub-

recipients on grants and subcontractors)


Prior to launching the research

Within 30 days if a new financial interest is t d h ith fi i lcreated or a researcher with a financial

interest joins the study team


Question #19 on UI Routing Form

COIR Di l F COIR Disclosure Form: On UI Website, Conflict of Interest in Research – VP Research; Disclosure Form (login with Hawk ID & password)

IRB application


Conflict of Interest in Research Committee

15 faculty members – from 12 colleges

Ch h l C h Chair Dr. Michael Cohen

P t l t VP R h Proposes management plan to VP Research


Management plan signed by investigator Management plan signed by investigator

Copy to Dean DEO DSP/CTO IRB Copy to Dean, DEO, DSP/CTO, IRB

IRB process can proceed IRB process can proceed

Contract can be signedg

Study awarded


Financial relationships with industry are not necessarily “bad”

l d Transparency is always good

F ili i lf ith UI P li Familiarize yourself with UI Policy

Do not assume that a study team member Do not assume that a study team member does not have a significant financial interest


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: [email protected], 319-384-4566

Linsey Abbott, STAR Coordinator: [email protected], 319-384-4221

Research Administrator MeetingResearch Administrator Meeting

March 31, 200910:00-12:0010:00 12:00

Illinois Room, IMU

Agendag• Updates from Grant Accounting – Audra Haddy• UI FY08 A‐133 audit – Audra Haddyy• Compliance Issues – Audra Haddy

Updates from Grant AccountingUpdates from Grant Accounting

FY08 A‐133 AuditFY08 A‐133 Audit

Compliance Issues Related to Recent Federal Investigations &Recent Federal Investigations &

Audits

Compliance Issues Related to Recent Federal Investigations & Audits

• December 2008, Yale UniversityDecember 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 h i f h h d d i ifi ffgrants when in fact the researchers expended significant effort on

unrelated work

• January 2009, Duke UniversityHHS OIG found $1 7M in unallowable charges– 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 B d i d Ch i C• Budgeting and Charging Costs to Federally Sponsored ProjectsC T f P li• Cost Transfer Policy

• Effort

Budgeting and Charging Costs to Federally Sponsored Projects

• Salaries and benefits of admin/clerical staff• Salaries and benefits of admin/clerical staff, office supplies, local telephone costs, memberships and postage should not normally p p g ybe charged as direct costs to federal grants, contracts or other agreements– Feds expect we are covering these types of costs

with F&AExhibit C examples of “major project”– Exhibit C, examples of “major project”

Budgeting and Charging Costs to F d ll S d P j tFederally Sponsored Projects

• At UI:– PIs/Depts are responsible for ensuring that costs

assigned to federal projects are appropriate as direct costscosts

– 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-21Based on definition of major project in OMB A 21, Exhibit C


• Examples of costs that would not normally be i l d d i h b d h d f d llincluded in the budget or charged to federally sponsored projects:

Salaries of clerical/admin staff who perform routine services– Salaries of clerical/admin staff who perform routine services – Office supplies that are used for general administrative support

of a project including paper, pens, tapeT l h t l d t d t ti b i– Telephone rentals used to conduct routine business

– Routine office equipment including chairs, desks, computers, printers, copiers, telephones

– Membership in professional and scientific organizations


• Examples of costs that may be appropriate to i l d i h b d h f d llinclude in the budget or charge to federally sponsored projects (with add’l justification):– Office supplies used exclusively for project-specific activitiesOffice 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 g y y, g

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


• 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 fundsfunds

Cost Transfer Policyy

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?


Is the cost allowable? – Based on OMB A21, the cost must be

reasonable, allocable, consistently treated, and not specifically prohibited


Reasonable?– Cost is of a type generally recognized as

necessary for the performance of the sponsored agreement

– Consistent with university policies


Allocable?– 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

hift d t th d t i d t t d fi i ishifted to other sponsored agreements in order to meet deficiencies 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


• Consistently treated? – Admin/clerical costs are normally part of

F&A costs• Specifically prohibited by the agreement?


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 Transferaccount (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)must be sufficient for an independent reviewer (i.e. an auditor) to understand the transfer and conclude that it is appropriate.


• Reminder:– 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

t th ti th t i d t th i t t iblat the time the costs are incurred to the maximum extent possible– 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– 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

march 31, 2009...april 2, 2009 10:00am ‐11:30am thissession will emphasize challenge grants via...

Documents