Grants Bulletin

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February 29, 2008

"What Is Conflict of Interest?" - March 20

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

Carole Cole, M.S., Conflict of Interest Administrator, UK Office of Sponsored Projects Administration

Thursday, March 20, 2008
HG611 (Hospital Auditorium)
Lunch 11:30 a.m., Presentation Noon to 1 p.m.
Please call or e-mail the UK CRO office by Monday, March 17 to reserve your place (323-8545 or ukcro@email.uky.edu).

Attendees will:

1. Have an increased and enhanced awareness of UK’s administrative regulation about the Conflict of Interest/Financial Disclosure Policy for Research
2. Be able to describe disclosure procedures
3. Outline different strategies for managing COI, depending on particular situations

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February 14, 2008

"Research Ethics Issues in Trial Design: Uncertainty and Equipoise" - Feb. 25

Department of Behavioral Science Lecture Series:

Dr. M. Sara Rosenthal
Monday, February 25, 2008
3 p.m.
MN 363 (Medical Center)

Light refreshments will be served.

For further information, please contact Thomas F. Garrity, Ph.D. at tgarrit@pop.uky.edu or William W. Stoops, Ph.D. at william.stoops@uky.edu.

"Acute Spinal Cord Injury: A Devastating but Treatable Disorder" - March 6

The Dean’s Distinguished Lecture Series

Edward D. Hall, Ph.D.
Director, UK Spinal Cord & Brain Injury Research Center and SCoBIRC Endowed Professor of Anatomy & Neurobiology, Neurology and Neurosurgery

Noon to 1 p.m.
Thursday, March 6, 2008
Hospital Auditorium, HG611

Objectives:

1. Outline the pathophysiology of spinal cord injury (SCI) including promising targets for therapeutic intervention.
2. Briefly review the discovery and development of high dose methylprednisone therapy for acute SCI.
3. Discuss promising single and multi-drug therapeutic approaches for improving neurological outcome beyond the limits of the current methylprednisone therapy.

Lunch available at 11:30 a.m.
Presentation begins at noon.

Please RSVP by 3/3/08 to Jessica Wehle, gcrc@email.uky.edu.
If you require special physical arrangements to attend this meeting, please call 323-8150.

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

"Effective Proposal Development" - March 11

National Council of University Research Administrators Satellite Teleconference
Sponsored by the Office of Sponsored Projects Administration

Tuesday, March 11, 2008
11:30 a.m. – 3:30 p.m.
Student Center Theater

This program will provide a number of best practices in proposal development functions. Continual pressure to connect faculty with funding, to facilitate collaborations and manage limited submissions are among the few of the challenging tasks before you. Some institutions have a separate office to handle this function, others have a person within and still others are responsible for this area along with a host of other pre award functions. Our seasoned faculty represent both large and small institutions, representing different successful approaches. 

Topics include:

• Identifying funding sources (internal /external)
• Coordinating limited submissions
• Facilitating research collaboration (inter- and intra-institutional /international)
• NIH Roadmap
• Bridge funding
• Center development

Moderator:  Ed Herran, Director, Office of Sponsored Projects, Memorial Sloan-Kettering Cancer Center

Faculty:

• Robert Lowman, Associate Vice Chancellor for Research, University of North Carolina at Chapel Hill
• Jerry Pogatshnik, Dean of the Graduate School & Associate Vice President for Research, Eastern Kentucky University
• Samantha Westcott, Grant Manager, Division of Biology, California Institute of Technology

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.

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February 1, 2008

NIH revises the PHS 398 and 2590 forms and instructions

The National Institutes of Health (NIH) has revised the PHS 398 and 2590 forms and instructions which are used for the paper submission of proposals and progress reports. These changes were made mostly to bring these forms closer in format and language to the SF424 form which federal agencies are transitioning to for electronic submissions. The full text of the announcements can be found at http://grants1.nih.gov/grants/guide/notice-files/not-od-08-028.html and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-030.html.

PHS 398

The newly revised PHS 398 (rev. 11/07) instructions and forms are now available and will be accepted for due dates on or after January 25, 2008. All applications received for May 25, 2008, and subsequent due dates must use the new instructions and forms. During the transition period the previous version (interim revision 04/2006) will continue to be available, and applications using the previous version will be accepted. However, applications submitted using instructions and forms other than the PHS 398 (rev 11/07) for May 25, 2008, and subsequent due dates will be returned to the applicant.

The changes to the PHS 398 forms and instructions are mainly to bring the language and format into line with the SF 424. Most of the changes are in the instructions with very few changes being made to the forms themselves.

As part of the ongoing effort to keep the PHS 398 and the SF424 (R&R) synchronized, new terminology is implemented in the PHS 398:

OLD TERM	NEW TERM
Competing continuation application	Renewal application
Revision or amendment [to application]	Resubmission application
Competing supplement	Revision application

Highlights of changes to the instructions include:

Suggested Cover Letter Format - A suggested cover letter format is provided for greater consistency and to facilitate the use of requests for specific Institutes or Centers (ICs) or Scientific Review Groups.

Indefinite Plans for Involvement of Human Subjects or Use of Vertebrate Animals - Instructions for the Research Plan sections addressing human subjects and vertebrate animals are modified to provide guidance to applicants when plans are indefinite at the time of application.

Appendix Format - Appendix material is to be submitted on CDs in PDF format, and will no longer be accepted on paper (see NIH Guide Notice OD-08-031). All paper PHS 398 applications submitted for May 25, 2008, and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application. Paper applications submitted for due dates prior to May 25, 2008, may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix. Files on CDs must be in PDF format.

Part II, Instructions for Preparing the Protection of Human Subjects Section of the Research Plan - All exemptions appear in one scenario (Scenario C). A scenario for "Delayed Onset of Human Subjects Research" is incorporated.

Highlights of changes made to the PHS 398 form and format pages include:

398 Face Page - IACUC approval date (formerly item 5a) deleted since information is collected only as Just-in-Time; Item 5b renumbered 5a.

398 Form Page 2 and Project/Performance Site Format Page - Form page 2 is revised, and the Project/Performance Site Format Page created to collect information for each project/performance site as required by the Federal Financial Accountability and Transparency Act.

Modular Budget Form Page - Form page is no longer included since mechanisms using modular budgets have transitioned to SF424 (R&R) and do not use the PHS 398 paper application. Modular budget form pages still exist as part of electronic submission.

Checklist Form Page - A Disclosure Permission Statement checkbox is added to allow disclosure of certain information to organizations that may be interested in possible collaboration, investment, etc.

PHS 2590

The newly revised PHS 2590 (rev. 11/07) instructions and forms are now available and will be accepted immediately. All progress reports received on or after March 1, 2008, must use the new instructions and forms. During the transition period the previous version (interim revision 04/2006) will continue to be available, and progress reports using the previous version will be accepted through February 29, 2008.

One significant change to the PHS 2590 is the business process for submission of the continuation progress report. As of March 1, 2008, only the signed original continuation progress report is required to be submitted to the centralized mailing address (No additional copies required).

Notable Changes to the PHS 2590 Instructions (rev. 11/07):

Implementation of Grants.Gov Terminology - As part of the ongoing effort to keep the PHS 2590, 398 and the SF424 (R&R) synchronized, new terminology is implemented in the PHS2590:

OLD TERM	NEW TERM
Non-Competing Continuation Progress Report	Continuation Progress Report
Competing/Administrative Supplement	Revision application

Instructions for Career Development Award Applications - The term mentor is used in place of sponsor. Also, there is specific guidance for programs that include a requirement to become a mentor.

Progress Report Narrative for Ts and Ks - Maximum Length of progress report narrative expanded from 2 pages to 4 pages for Training and Career Development Awards.

Changes of note to specific form and format pages:

Face Page - Redesigned to include FFATA data. Removed boxes for “Full IRB or Expedited Review.” Item 11a. PI/PD name, telephone and fax number information has been incorporated into item 2a and 2e.

Project/Performance Site Format Page - The Project/Performance Site Format Page (Form Page 1-Continued) created to collect information for each project/performance site as required by the Federal Financial Accountability and Transparency Act.

Checklist Page (Form Page 6) - Assurances/Certifications itemized list removed from form and refers grantees to the list in the instructions and to the URL to Part III of the 398 for definitions.

If you have questions please contact your College Grants Officer or Research Administrator.

NIH Fiscal Policy for Grant Awards – FY 2008

This notice provides guidance about the NIH Fiscal Operations Plan for FY2008 and it implements the FY 2008 Congressional action that provided NIH with $29.2 billion or 1 percent more than FY 2007 funding. The NIH will continue to manage its portfolio of investments in biomedical research as described in the FY 2007 Fiscal Policy Notice (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-030.html and http://grants.nih.gov/grants/guide/notice-files/not-od-07-049.html). This includes continuing to address the need for a highly productive pool of researchers by providing support for new investigators and sustaining established investigators, who have little or no additional research support.

The following NIH fiscal policies are instituted in FY 2008:

Non-Competing Research Awards: The FY 2008 appropriation as specified in P.L. 110-161 provides NIH a 1 percent inflation allowance to NIH investments in research supported by research grants. Implementation requires a reduction to previously established commitments, based on a 3 percent inflation allowance. Accordingly, each Institute and Center (IC) will use its own discretion to allocate the adjustment among its non-competing research grants (modular and non-modular) to ensure compliance with the 1 percent inflation allowance provided in its FY 2008 committed level. Future year commitments will be adjusted accordingly, as consistent with the FY 2007 fiscal policy. This policy does not apply to Career Awards, SBIR/STTRs, and Ruth L. Kirschstein-National Research Service Award (NRSA) Individual Fellowships & Institutional Training Grants.

Non-competing awards previously issued in FY 2008 at reduced levels will be revised to restore funds to the level indicated above. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-001.html).

Competing Research Awards: Each NIH Institute and Center (IC) will manage its competing portfolio using funds that have not been committed for non-competing awards. Consistent with the FY 2008 Congressional action, the FY 2008 average cost of competing grants is allowed to increase by 1 percent over FY 2007 when compared to similar policies. It is estimated this will allow ICs to support the NIH investigator pool with approximately 9,700 new and competing RPGs. The following guidelines will apply to competing research awards in FY 2008:

1. Maintain the number of new investigators comparable to the average of the most recent five years.
2. Continue to use The NIH Director's Innovator Awards within the Common Fund (http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-08-014.html) and NIH Pathway to Independence Awards (http://grants.nih.gov/grants/guide/pa-files/PA-07-297.html) as previously described.
3. Continue to use the NIH Directors Bridge Award Program (http://grants.nih.gov/grants/guide/notice-files/not-od-07-056.html), which provides continued but limited bridge funding to meritorious investigators whose applications were close to the funding range of the relevant IC and have minimal other support. This program provides NIH with a flexible NIH-wide tool to help balance the grant cycling variation challenges and support other approaches to sustain established grantees and first time competing renewals. As in FY 2007, this program is designed to provide only one-year of continued but limited funding.

Each IC will establish fiscal policies consistent with these NIH-wide policies according to its specific scientific and programmatic imperatives. Additional information on FY 2008 Fiscal Operations, including specific funding strategies for ICs will be posted on February 6 at http://grants.nih.gov/grants/financial/index.htm.

Ruth L. Kirschstein National Research Service Awards (NRSA): Funds for stipends, tuition and training-related expenses are held at FY 2007 levels (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-057.html).