Grants Bulletin

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January 25, 2008

“Medicare Coverage Analysis for Clinical Research Trials” - Feb. 21

University of Kentucky Clinical Research Development and Operations Center (CR-DOC) presents

Rebecca Scott, Clinical Research Compliance Manager, UK Office of Corporate Compliance

Thursday, February 21, 2008
HG611 (Hospital Auditorium)
Lunch 11:30 a.m., Presentation Noon to 1 p.m. (Come early at 11:40 a.m. for a special presentation from Linda Rice regarding flagging clinical research participants in sunrise clinical manager.)

Registration: Please call or e-mail the UKCRO office by February 18 to reserve your place 323-8545 or ukcro@email.uky.edu.

Attendees will be able to understand:

• What Medicare will and won’t cover in a clinical research trial
• How to conduct a Medicare Coverage Analysis
• Coding and documentation requirements
• Their role in conducting a fiscally compliant clinical research trial

NIH Administrative Revisions for Human Pluripotent Stem Cell (hPSC) Research Using Non-Embryonic Sources

Notice Number: NOT-NS-08-013

The National Institute of Health (NIH) announces the availability of one-year administrative revisions (previously referred to as supplements) for NIH-funded grantees to encourage research into the derivation and/or characterization of human pluripotent stem cells (hPSCs) from non-embryonic sources.

Eligibility
This program will support administrative revisions to any grant mechanism that is normally eligible for an administrative revision at the NIH institute or center (IC) that awarded the parent grant. Principal investigators (PIs) are strongly encouraged to contact the NIH Program Director who administers the parent grant to inquire as to whether their grant is eligible to receive an administrative revision. Parent awards must be actively funded through August 3, 2009 in order to be eligible. Grants that are in a no-cost extension period will not be considered for support under this program. Only one revision request may be submitted per PI.

How to Apply
Before submitting a formal request for an administrative revision, it is highly advisable to first discuss your request with the NIH Program Director who manages your grant or the IC Program contact listed below under “Inquiries.” Once it has been determined that the supplement request is within the scope of the parent award, a formal request can be made. Formal requests must be received on or before April 1, 2008.

This is a one-time announcement. Do not send applications to the Center for Scientific Review.

Revised Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research

Notice Number: NOT-OD-08-033

In accordance with Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008 ), the NIH voluntary Public Access Policy (NOT-OD-05-022) is now mandatory. 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.

Specifics

1. The NIH Public Access Policy applies to all peer-reviewed articles that arise, in whole or in part, from direct costs funded by NIH, or from NIH staff, that are accepted for publication on or after April 7, 2008.
2. Institutions and investigators are responsible for ensuring that any publishing or copyright agreements concerning submitted articles fully comply with this Policy.
3. PubMed Central (PMC) is the NIH digital archive of full-text, peer-reviewed journal articles. Its content is publicly accessible and integrated with other databases (see www.pubmedcentral.nih.gov).
4. The final, peer-reviewed manuscript includes all graphics and supplemental materials that are associated with the article.
5. Beginning May 25, 2008, anyone submitting an application, proposal or progress report to the NIH must include the PMC or NIH Manuscript Submission reference number when citing applicable articles that arise from their NIH funded research. This policy includes applications submitted to the NIH for the May 25, 2008, due date and subsequent due dates.

Compliance

Compliance with this Policy is a statutory requirement and a term and condition of the grant award and cooperative agreement, in accordance with the NIH Grants Policy Statement For contracts, NIH includes this requirement in all R&D solicitations and awards under Section H, Special Contract Requirements, in accordance with the Uniform Contract Format.

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January 18, 2008

Pharmaceutical Center Director Candidate Seminar - Jan. 23

DIRECTOR CANDIDATE SEMINAR
Center for Pharmaceutical Research and Innovation

Joel Linden, Ph.D.
Vice Chair for Research
Cardiovascular Research Center
University of Virginia

“A2A Adenosine Receptors in Tissue Protection from Reperfusion Injury”

Wednesday, Jan. 23, 2008
9 – 10 a.m.
(COP 223)

Hosted by the Office of the Vice President for Research and the College of Pharmacy

Currently Open Limited Submission Competitions

Because an increasing number of extramural programs limit the number of applications an institution may submit, the University of Kentucky has established an internal selection procedure for the programs listed on the following Proposal Development Office website: http://www.research.uky.edu/pdo/FundingOpportunities/LimitedSubmission/CurrentlyOpenLimitedSubmissionCompetitions.htm. Click the links for the most recent information on each program. (Limited Submission programs that are targeted toward a specific department or college are also included in this list but are coordinated at the departmental or college level.) If you have questions about a particular program, or if you identify a program not listed that limits submissions, please contact PDO to ensure that your application is appropriately considered (257-2861 or proposal@email.uky.edu).

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January 11, 2008

Modified Application Submission, Referral and Review for Appointed NIH Study Section Members

The National Institutes of Health is implementing an alternate plan for submission and review of research grant applications from appointed members of chartered NIH study sections in order to recognize their outstanding service and to minimize disincentives to study section service. The timing of Study Section meetings and most standard due dates for grant applications overlap (http://grants1.nih.gov/grants/funding/submissionschedule.htm).
Thus, reviewers are under pressure to review applications and prepare their own applications simultaneously.

Beginning February 5, 2008, the alternate submission and review procedures, described below, will be available for appointed members of NIH Study Sections. This alternate process is limited to 1) appointed members of chartered standing Study Sections and 2) applications that would normally be received on standard submission dates (but not special receipt dates). Depending on the timing of the submission and the number of other similar applications received during the pre-meeting time window, NIH staff will decide if the application will be reviewed in a different standing Study Section or in a Special Emphasis Panel (SEP). These applications will be processed and assigned to NIH Institute Review Offices or CSR Integrated Review Groups (IRGs) using the standard referral guidelines (http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescription).

This continuous submission process will enable appointed members of chartered NIH Study Sections to submit their applications as soon as they are fully developed. The applications will be reviewed no later than 120 days after receipt.

NIH plans to analyze this opportunity on an ongoing basis in order to assess feasibility and satisfaction.

Eligibility

• Only appointed regular (not temporary or ad hoc) members of chartered CSR and other NIH study sections may take advantage of the continuous submission process. Appointed members are those who are approved for service on the Study Section by the Director of NIH, typically for a four-year term. Multi-PI applications are eligible if one or more of the Program Directors/Principal Investigators (PD/PIs) is an appointed member of a Study Section.
• Appointed regular members of NIH Study Sections may participate up to one and a half months after the date of retirement from regular service on the committee typically on June 30. Continuous submission is thus permissible until August 16 of that year.
• This applies only to R01, R21 and R34 applications submitted for the standard due dates (http://grants1.nih.gov/grants/funding/submissionschedule.htm).
• Continuous submission is not available for applications submitted for special dates (RFAs, some PARs) or other activity codes. Continuous submission is limited to R01, R21 and R34 (including AIDS-related) applications. While most of these applications will be reviewed at the Center for Scientific Review (CSR), some R01, R21 and R34 applications will be reviewed in chartered study sections at other Institutes and Centers (ICs) of the NIH.
• This does not apply to applications for which appointed members have a role other than PD/PI, including appointed members serving as sponsors for fellowship applications or mentors for career award applications. Such applications are expected to be submitted on the normal due dates. Any requests for late acceptance must relate to the fellow or PD/PI of the fellowship or career award (not a member or sponsor).
• This does not apply to individuals who serve as reviewers for Federal agencies other than the NIH or private organizations.
• Temporary or ad hoc members of CSR study sections will still be eligible for the late submission window. Members of NIH Boards of Scientific Counselors or NIH Advisory Boards or Councils are also eligible for that window. A companion Notice updates the NIH policy on Late Applications (http://grants1.nih.gov/grants/guide/notice-files/not-od-08-027.html).
• If desired, appointed members of chartered study sections may request review by a standing study section (different from the one they are serving on), but those applications must conform to regular submission deadlines. As such, the late window of consideration for members will apply (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-026.html).

Processing and Review Schedule

All applications submitted in response to this opportunity will be reviewed no later than 120 days after receipt. Because of the need to assign an Advisory Council date, the following schedule will be followed. However, applications may be moved to earlier councils following review as timing permits.

Schedule for Assignment to Advisory Council Rounds

Council Round	Non-AIDS applications	AIDS applications
May	August 17 - December 16	October 8 - February 7
October	December 17 - April 16	February 8 - June 7
January	April 17 -  August 16	June 8 - October 7

Inquiries

A series of Frequently Asked Questions has been prepared (see http://cms.csr.nih.gov/ResourcesforApplicants/ContinuousSubmissionFAQ.htm).

Inquiries may also be addressed to:
Division of Receipt and Referral
Center for Scientific Review
6701 Rockledge Drive MSC 7720
Bethesda, MD 20892-7720
Voice: (301) 435-0715
Fax: (301) 480-1987

National Council of University Research Administrators Satellite Teleconference: "Managing Cost Issues" - Jan. 22

Sponsored by the Office of Sponsored Projects Administration

January 22, 2008
11:30 a.m. – 3:30 p.m.
Student Center Theater

Regardless of your role, almost all research administrators in all type of universities need to know how to advise and/or manage cost issues. These are before you in proposal budgets, when negotiating terms and conditions and, maybe the most challenging of all, while managing the day-to-day accounts for sponsored projects. Representing the pre and post award central office as well as the departmental business office, our faculty will cover topics including:

• personnel and payroll issues
• cost transfers
• cost-sharing management and companion accounts
• costing and billing service centers
  
• allow-ability of certain troublesome costs (such as food)
• procurement cards

Case studies used to provide participants with useful applications of some best practices and systems used to manage costs.

Moderator: Jerry Fife, Assistant Vice Chancellor for Research Finance, Vanderbilt University

Faculty:

• Rob Barbret, Associate Director of Financial Operations, University of Michigan
• Tracey Fraser, Associate Controller, Post Award Administration, California Institute of Technology
• Brian Squilla, Administrative & Financial Officer, Pathology Research Administration, University of Pennsylvania

To sign up, please call or e-mail Jessica Craft at 257-9424 or jessica.craft@uky.edu.

Lunch will be provided for participants who register prior to the conference.

"The Pathogenicity of Pandemic Influenza Viruses" - Feb. 7

Noon to 1 p.m.
Thursday, February 7, 2008
Location: Hospital Auditorium, HG611

Speaker: Peter Palese, Ph.D., Professor and Chairman, Department of Microbiology, Mount Sinai School of Medicine

Objectives:

• To reconstruct the extinct 1918 pandemic influenza virus by reverse genetics.
• To demonstrate high virulence of the genetically engineered 1918 influenza virus in cell culture and animal models.
  
• To better understand molecular basis of virulence and the mechanisms by which pandemic influenza viruses are transmitted.

Lunch available at 11:30 a.m. Presentation begins at noon.
RSVP By 2.4.08 to Jessica Wehle, gcrc@email.uky.edu.
If you require special physical arrangements to attend this meeting, please call 323-8150

Sponsors: Dr. Jay A. Perman, M.D., Dean, College of Medicine, C. William Balke, M.D., Associate Provost for Clinical and Translational Science

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January 4, 2008

NIH Issues Further Information about Registration of Clinical Trials

The December 21 NIH Guide contains a notice with further information concerning the new law requiring registration of clinical trials on ClinicalTrials.gov. It also outlines information needed in proposals and progress reports applicable to NIH funded clinical trials. The complete notice is here http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-023.html.

Visit the NIH Frequently Asked Questions site at http://grants.nih.gov/grants/policy/hs/faqs_aps_clinical_trials.htm. You may want to review the December 16 NIH Guide Notice on this topic as well as the December 24 Research Grants Bulletin.

The UK Clinical Research Development & Operations Center offers assistance with registering clinical trials. To obtain an access code to the UK Organizational Account on ClinicalTrials.gov, send a request with name, department and e-mail to:
Belinda Smith, MS, CCRC, Sr. Research Administrative Coordinator/ Education
UK Clinical Research Development & Operations Center (CR-DOC)
859-323-8150
belinda.smith@uky.edu

"Practice-Based Research and the Community" - Jan. 17

Presented by the University of Kentucky Clinical Research Development and Operations Center (CR-DOC)

Speakers:

• Kevin A. Pearce, MD, MPH, Professor and Vice Chair, Academic Affairs, Department of Family and Community Medicine
• Mary A. Barron, RN, CCRC, Sr. Research Nurse Coordinator, Department of Family and Community Medicine, KY Ambulatory Network

Date: Thursday, January 17, 2008
Location: HG611 (Hospital Auditorium)
Time: Lunch 11:30 a.m., presentation noon to 1 p.m.
Registration: Please call or e-mail the UK CRO office to reserve your place 323-8545 or ukcro@uky.edu.

Attendees will be able to:
1. Define practice-based research
2. Describe processes for developing collaborations with community healthcare professionals in practice-based research
3. Describe current activities taking place at the UK to further encourage/enhance practice-based research
4. Describe the process for coordinating practice-based research studies