Essential Policy and Procedure Updates

Updates to SBU's Human Subject Protection Program (HSPP)

Our Human Subject Protection Program (HSPP) has many active participants, including Principal Investigators and their study teams, staff of the Office of Research Compliance (ORC), and the membership of our Institutional Review Boards (IRBs). Our combined efforts continue to help ensure that our HSPP is solid and effective in keeping safe those individuals who volunteer to participate in our research activities at SBU.

The ORC and the IRBs are constantly evaluating the program to assess the need for clarifications of current SBU policies and procedures, promulgation of new policies and procedures, and dissemination of new federal guidance and regulations. The following is a summary of such actions that have been taken or proposed over the past year, including some clarifications of unchanged policies and procedures, since our last update in December 2006.

June 2007 Important Updates to SBU's Human Subject Protections Program (HSPP):
http://www.sunysb.edu/research/humans/2007humsub.html

As always, it is extremely important that you review this information with all members of your study team.

--Contributed by Judy Matuk, Assistant Vice President for Research Compliance

NOA Replaces NOGA – NIH Revises Notice of Award (NoA) Letter

NIH announces the revision of the Notice of Grant Award Letter, now known as the Notice of Award Letter (NoA). The revised NoA has several enhancements and a new look and feel. This NoA gives NIH the flexibility to make changes as needed and issue the NoA in PDF format resulting in a more user / reader friendly document. Listed below are the most notable enhancements. NIH started to issue the revised NoA effective April 13, 2007.

  • The revised NoA will be attached to an email in PDF format instead of being part of the text of the email; moving to the PDF format eliminates the excessive “white space” within the NoA. This helps to reduce the number of pages of the NoA.

  • New - First Page: In accordance with the NIH Public Access Policy, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html, a paragraph has been included to encourage award recipients to submit published publications to PubMed Central (PMC).

  • Updated - Section I – Award Data: This section has been revised to include a new data table and to reflect existing data in structured tables.  Specifically:

    New feature - Summary Total Federal Award Amount Year table – When more than one award action is issued in a budget period (e.g., administrative supplement through a separate award), a table will appear when the parent award is revised.  This table will list each award transaction separately (parent and supplement) and provide the total cumulative amount of federal funds awarded in the current budget period as shown in the example below.

    SUMMARY TOTAL FEDERAL AWARD AMOUNT YEAR (11)

    GRANT NUMBER

    TOTAL FEDERAL AWARD AMOUNT

    3P01HL052490-11A1W1

    $142,754

    2P01HL052490-11A1

    $23,596

    TOTAL

    $166,350



    Revised - Summary Total For All Years – Previously this section provided total costs commitments for the future years, but only for the award being issued.  This section is now revised to provide a table reflecting the recommended total costs for the award being issued as well as the cumulative total costs.  The cumulative costs figures will include all supplement award actions issued for a particular budget year as reflected in the example below.

    SUMMARY TOTALS FOR ALL YEARS

    YR

    THIS AWARD

    CUMULATIVE TOTALS

    11

    $142,754

    $166,350

    12

    $22,920

    $91,900

    13

    $568,650

    $695,910

    14

    $15,380

    $860,760

  • (Updated) Section IV – Spreadsheet Summary: The categorical budget data is now reflected in table format.

NSF Announces New Proposal and Award Policies and Procedures Guide

The Guide consolidates two previous standalone NSF policy documents: the NSF Grant Proposal Guide (GPG) and the Grant Policy Manual (GPM) and combines them into a single electronic policy framework.   The Proposal & Award Policies & Procedures Guide will be effective for proposals submitted on or after June 1, 2007.  This document supersedes all prior versions of the GPG and GPM and can be accessed at: http://www.nsf.gov/publications/pub_summ.jsp?ods_key=nsf07140. 

The new guide increases ease of access to the policies and procedures that govern the entire grant lifecycle and eliminates duplicative and sometimes truncated coverage between the GPG and GPM.   

The Guide has two parts:

  • Part I - NSF’s proposal preparation and submission guidelines – the NSF Grant Proposal Guide and the NSF Grants.gov Application Guide (to be incorporated at a later date).

  • Part II - Documents to guide, manage and monitor the administration of awards The Grant Policy Manual has been renamed the Award & Administration Guide (AAG).

Each Part contains a by-Chapter summary of significant changes to assist the user in navigating through the changes.   

The Guide will be available in HTML format, as originally described, by the end of this month.  The document currently is available as a fully Web-linked and searchable PDF version which gives users the ability to print either Parts of the Guide or the document in its entirety. If you have any questions regarding the new NSF Proposal & Award Policies & Procedures Guide, please contact the Policy Office on 703-292-8243 or by e-mail to policy@nsf.gov .    

Updated NSF Grants.gov Application Guide

NSF has announced publication of an updated Grants.gov Application Guide (June 1, 2007). The Guide has been updated for consistency with the re-issuance of the NSF Grant Proposal Guide (GPG). NSF application packages posted to Grants.gov will continue to utilize PureEdge forms as the transition by Grants.gov from PureEdge to Adobe forms remains in progress. Upon completion of the transition process, the NSF Grants.gov Application Guide will be updated and reissued with instructions for Adobe forms. The updated Guide can be accessed at:
http://www.nsf.gov/pubs/policydocs/grantsgovguide607.pdf

Grants.gov News - PureEdge for Mac Users

Grants.gov has posted a new version of the IBM Workplace Forms (PureEdge) Viewer for Macintosh users on their download software page (note the release notes have not changed). The new version addresses the issues associated with using the viewer in conjunction with the recent Mac security upgrade (2007-004 v1.0 and v1.1). 

"How NIH Works" Presentation Available on AAU Web Site

A primer on the National Institutes of Health (NIH) presented at the AAU-sponsored briefing at NIH on April 10 is now available on the AAU Web site. The presentation by Walter T. Schaffer, Senior Scientific Advisor for Extramural Research, includes such information as the organizational structure of the agency, a summary of the NIH budget, grant statistics, types of awards, grant application procedures, and the role of the agency’s PubMed Central in making research results available to the general public.
The presentation can be accessed on the AAU Web site at: http://www.aau.edu/research/How_NIH_Works.pdf.

New OSP Proposal Submission Website

Due to the growing number of electronic proposal submissions and the need for faculty to transmit extremely large proposal files to the Office of Sponsored Programs, a website is now up and running to facilitate this transmission. The website is: http://www.stonybrook.edu/proposalsosp

The process is simple. Submitters access this website, provide pertinent information (so that OSP can identify the proposal and have contact information), attach their full proposal files where indicated and hit the “submit” button. Office of Sponsored Programs staff can access the proposal information and all attachments quickly and easily. 

***Reminder: full proposals and all required completed campus forms should be submitted five business days before the sponsor deadline. Questions regarding the use of this website can be addressed to your Sponsored Programs Coordinator or Contracts Administrator.

Pandemic Flu Planning

Influenza viruses cause yearly epidemics and, much less frequently, worldwide epidemics (pandemics). The tremendous impact of influenza may be seen from the following figures: approximately 36,000 people die each year in the U.S. from seasonal influenza and its complications and ~500,000 people died in the U.S. died in each of the influenza pandemics of 1957 and 1968. The virus that caused the 1918 pandemic was especially lethal and was responsible for the deaths of as many as 50 million people worldwide. Although we live under the constant thread of an influenza pandemic , the circulation of a highly deadly avian influenza virus (referred to as H5N1) among birds in Asia, Europe and Africa and its spread, albeit limited, to humans has greatly heightened concern. If the H5N1 virus were to mutate and become a pandemic strain, infectious disease experts predict that as many as 90 million persons in the U.S. alone would become ill, 9.9 million people would require hospitalization and 1.9 million deaths would result. These dire predictions, and the widespread social disruption that would accompany a severe influenza pandemic, have prompted the Federal, state and local governments to formulate response plans with the overall goal of mitigating the effects of an influenza pandemic.

The Director of Environmental Health and Safety, Gary Kaczmarcyzk, is leading Stony Brook University's pandemic influenza preparedness planning efforts. The University's response plan, frequently asked questions, and pandemic flu planning information have been posted on the EH&S web site (http://www.stonybrook.edu/ehs/) and researchers are encouraged to consult this site as they prepare for the possibility of an influenza pandemic. The University's response plans will need to address the need to provide continuity in animal care and other essential services for the research community. Principal investigators and core facility directors should review their laboratory's critical needs and develop individual plans to lessen the impact of an influenza pandemic. These plans should prepare for potential interruption in some services, e.g. tanked gas deliveries and delivery of other essential consumable supplies, and anticipate that employees may be unable to work due to illness or inability to use public transportation to reach the campus. Plans may include the cross-training of employees to carry out essential duties.

Investigators whose research involves travel to areas of the world in which the H5N1 virus is circulating, or involves contact with avian species, should consult in advance the Centers for Disease Control and Prevention Traveler's Health website at http://www.cdc.gov/travel for recommendations regarding international travel and http://www.oie.int/downld/AVIAN%INFLUENZA/A_AI-Asia.htm for information about influenza in domestic and wild birds.

To learn more about seasonal and pandemic influenza and the governmental response plans visit:
Department of Health and Human Services web site for Pandemic Flu
http://www.pandemicflu.gov
NY State Department of Health web site for Pandemic Flu
http://www.nyhealth.gov/diseases/communicable/influenza/pandemic/index.htm

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Funding Opportunities

DoD FY 2008 Defense University Research Instrumentation Program (DURIP)

The Department of Defense (DoD) announces the Fiscal Year 2008 Defense University Research Instrumentation Program (DURIP), a part of the University Research Initiative (URI). DURIP is designed to improve the capabilities of U.S. institutions of higher education to conduct research and to educate scientists and engineers in areas important to national defense, by providing funds for the acquisition of research equipment.

The DoD is interested primarily in the research and related science and engineering education that the equipment would facilitate. For this reason, the proposal must adequately describe the goals of the research and research-related education, so that judgments can be made on relevance to DoD goals. In some cases, proposed instrumentation and associated research may be relevant to more than one of the participating agencies.

Through this DURIP competition, the DoD intends to award approximately $40 million for FY 2008, subject to the availability of funds. These funds will be awarded via grants made by ARO, ONR, and AFOSR. Grants will be for the purchase of research equipment costing $50,000 or more, for items that typically cannot be purchased within the budgets of single-investigator awards. An individual award may not exceed $1,000,000 in DoD funding. In FY 2007, 201 awards totaling $41.2 million were made. Awards ranged from approximately $50,000 to $950,000 averaging $205,000; very few awards exceeded $500,000.

Proposals are due 4:00PM Eastern Daylight Time, 21 August 2007. Program details and application can be found at: http://www.afosr.af.mil/pdfs/afosr_baa_2007_9_2.pdf

Upcoming Funding Opportunities

For a complete list of upcoming deadlines, please go to -
http://www.stonybrook.edu/research/fndopp/deadlcal.html

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News

GCRC's 'Outstanding' Evaluation

The General Clinical Research Center received its highest score yet in an evaluation by the National Center for Research Resources (NCRR), a component of NIH. 100 is a perfect score in the NCRR evaluation with a range from 100-500 (lower scores are better) and the University Medical Center's GCRC scored 148, 100-150 being considered 'outstanding'. According to Program Director, Marie Gelato, Medicine, the evaluative report highlighted the GCRC's collaboration with BNL, outstanding patient protocols and exceptional plans for future research and described the biostatistical and informational components of the center as "a model of what bioinformatics should be.

Supercomputing Chemist Wins Top Humanitarian Award

Professor Carlos Simmerling was awarded the top honor in the Humanitarian Impact Innovation category of the Itanium Solutions Alliance Innovation Contest. The Alliance is a computing industry organization that includes Intel, HP, Fujitsu, Hitachi, NEC, SGI, Microsoft, Redhat and Oracle. The contest is meant to recognize the most important applications of Itanium® 2 processor-based computer systems in three categories: Humanitarian Impact Innovation, Enterprise Business Application and Entrepreneurial Innovation. Professor Simmerling's work using high-end computing to create advanced simulations showing how transient structural changes in HIV protease allow drugs to bind to its interior and inhibit its ability to make new HIV viral particles was honored with the top Humanitarian Impact Innovation prize. Simmerling's simulations were performed on an SGI Altix system located at the National Center for Supercomputing Applications (NCSA), where his program has been awarded over $10 million in allocation time.

Pat Cruso, Research Advocate, to Retire

After 17 years of service to the University Pat Cruso will be retiring at the end of June. Pat has worked most recently as the University Outreach Coordinator and as the recruitment chair for SB Day in Albany. From 1997 to 2006 Pat was Government Liaison Office in the Office of Governmental Relations, where, among other duties, she worked with the OVPR to advance the University's research mission through monthly 'Hot Topics' presentations by researchers, by serving as a liaison to the Science Coalition and helping Stony Brook's contributions to twice yearly web pages devoted to SBU research on the Science Coalition's web site, and by bringing specific research programs and their faculty leaders to the attention of officials in Albany and Washington. Pat's role in federal and state government relations helped get direct visibility with decision-making elected officials for our research enterprise.

Pat was a fount of ideas and a pleasure to work with. She will be sorely missed and we at the OVPR wish her a fulfilling and joyous retirement.

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For More Information

Gail S. Habicht is Vice President for Research. She can be reached at (631) 632-7932. An abundance of specific information for the research community is available on our Website, where past issues of this bulletin can also be found.

Office of the Vice President for Research -
http://www.stonybrook.edu/research/

Research News and Monday Memo archive - http://www.stonybrook.edu/research/monmemo/mmarchive.html

All Past issue of Research News and Monday Memo are keyword searchable. The index can be accessed at - http://www.stonybrook.edu/research/sitemap.html.

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