Research News - February 2008

Essential Policy and Procedure Updates

Urgent Memorandum Regarding DHS Chemical Standard Compliance Inventory

The deadline to submit your inventory list was January 31, 2008. 

For more information, please contact Kim Auletta 632-3032 or 632-6410 or kim.auletta@stonybrook.edu in the Department of Environmental Health and Safety

NIH Application Announcements

NIH has made several announcements in the NIH Guide regarding PHS application kits. Please see the items below for more details.

Modified Application Submission, Referral and Review for Appointed NIH Study Section Members (NOT-OD-08-026)
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-026.html

NIH Policy on Late Submission of Grant Applications (NOT-OD-08-027)
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-027.html

Revised PHS 398 (DHHS Public Health Service Grant Application) Now Available (NOT-OD-08-028)
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-028.html

Revised PHS 2271, PHS 3734, and HHS 568 Forms Now Available (NOT-OD-08-029)
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-029.html

Revised PHS 2590 (DHHS Public Health Service Noncompeting Continuation Progress Report) Now Available (NOT-OD-08-030)
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-030.html

Appendices to Paper PHS 398 (DHHS Public Health Service Grant Application) to be Submitted on CD (NOT-OD-08-031)
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html

NIH REVISES PUBLIC ACCESS POLICY

NIH has changed its policy concerning the posting of publications resulting from NIH funding in the NIH Pub Med Central system. Until now participation has been voluntary. It is now mandatory. Please see the NIH Guide notice for more information, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html

The changes in policy correspond to recently enacted legislation, which reads "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." 

Under the policy notice:
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 the 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: http://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.
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html >

Research Compliance Reminder: Use of recombinant DNA and/or gene transfer technology requires prior Institutional Biosafety Committee Review/Approval!

You must apply to, and receive, approval (or confirmation of exemption) from SBU’s Institutional Biosafety Committee (IBC) prior to commencing with the following types of research:

Recombinant DNA research involves molecules that:
(a) are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or
(b) result from the replication of those described in (1).

Human gene transfer research involves the deliberate transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA into the somatic cells of human subjects.

All the information you need regarding this requirement (including policies, procedures and applications) is provided here.

The federal Office of Biotechnology Activities (OBA), within the National Institutes of Health has jurisdiction over recombinant DNA and gene transfer activities conducted at SBU. Their guidelines and IBC requirements are applicable to all faculty, staff, students, and users of the facilities of this University who propose and conduct research involving recombinant DNA, regardless of source of funding. See IBC policy for approval requirements for activities conducted off-site at collaborating Institutions.

Recently, NIH issued a notice reminding the grantee community of the principles and requirements of the NIH Guidelines for Research Involving Recombinant DNA Molecules.
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-096.html

Please review this notice for confirmation of the need for compliance in this area. If you have any questions, please contact Judy Matuk at Judy.Matuk@stonybrook.edu, or 632-9036.

THE SCIENTIFIC COUNCIL OF THE EUROPEAN RESEARCH COUNCIL GUIDELINES FOR OPEN ACCESS

The guidelines require that all peer-reviewed publications from ERC-funded research projects be deposited when published into an appropriate research repository where available, such as PubMed Central, ArXiv or an institutional repository, and subsequently made Open Access within 6 months of publication.

RelatedLink: http://tinyurl.com/35o6ch

NOTICE REGARDING THE APPLICABILITY OF THE FEDERAL INFORMATION SECURITY MANAGEMENT ACT TO NIH GRANTEES

Notice Number: NOT-OD-08-032             Release Date: January 9, 2008

Issued by National Institutes of Health (NIH), (http://www.nih.gov)

NIH is providing this notice to inform its grantee organizations of the recent Department of Health and Human Services (HHS) announced policy regarding applicability of the Federal Information Security Management Act (FISMA) to grantees.

All information systems, electronic or hard copy which contain federal data need to be protected from unauthorized access. This also applies to information associated with NIH grants and contracts.

Congress and the Office of Management and Budget (OMB) have instituted laws, policies and directives that govern the creation and implementation of federal information security practices that pertain specifically to grants and contracts. The current regulations are pursuant to the Federal Information Security Management Act (FISMA), Title III of the E-Government Act of 2002 Pub. L. No. 107-347 (beginning on page 48).

Given the nature of the relationship between the NIH and its grantees (which differs from a contractual relationship), the question arose as to whether data collected in the course of NIH-funded research through grants and cooperative agreements fall under the FISMA regulations.  The applicability of FISMA to grantees funded by the Department of Health and Human Services (including the NIH) has been addressed by the HHS Chief Information Security Officer in an October 29 memo clarifying federal regulations governing the management and protection of the data the federal government collects for grants.

The memo states that:

“FISMA (Federal Information Security Management Act) applies to grantees only when they collect, store, process, transmit or use information on behalf of HHS or any of its component organizations.

In all other cases, FISMA is not applicable to recipients of grants, including cooperative agreements with grantees. The grantee retains the original data and intellectual property, and is responsible for the security of this data, subject to all applicable laws protecting security, privacy and research. If and when information collected by a grantee is provided to HHS, responsibility for the protection of the HHS copy of the information is transferred to HHS and it becomes the agency’s responsibility to protect that information and any derivative copies as required by FISMA.”

Inquiries

If you have any questions about whether the data collected in the course of your NIH-funded research fall under FISMA please contact Sally Rockey at 301-496-1096 or srockey@od.nih.gov

NIH NOTICE REGARDING AUTHENTICATION OF CULTURED CELL LINES

Notice Number: NOT-OD-08-017
Release Date: November 28, 2007

Issued by National Institutes of Health (NIH), (http://www.nih.gov)

A recent open letter to Secretary Leavitt from Dr. Roland Nardone and several experts in cell biology highlighted an important methodological issue associated with research involving cultured cells.  The letter identifies a number of instances in which research has been based on misidentified or contaminated cultures.  In some cases, proper characterization would have altered the experimental outcome significantly.  Improper characterization can impede efforts to replicate published findings and therefore the advancement of science. 

The letter goes on to indicate that there are relatively inexpensive ways to authenticate lines and characterize these experimental systems. Dr. Nardone recommends that granting agencies restrict funding to institutions that do not use available authentication procedures. 

We are convinced by the body of evidence developed by Dr. Nardone and his colleagues that misidentification of cell cultures is a serious problem.  Because authentication methods can be quite specific and are continuously evolving, it would be impractical for the NIH to require application of particular methods in all grant applications.  The peer review process has been designed to carefully examine the experimental approach and assure that the investigators propose appropriate methods and resources for the described study.  A similar process is used to screen manuscripts for publication.  Both review processes can accommodate improvements in methodologies and experimental systems in ways that would be difficult for the segments of a granting agency involved in making awards.

We believe that professional societies, researchers, and reviewers are continually working to establish a range of acceptable experimental practices.  Grant applications that fail to employ such practices would not be considered of the highest quality and such manuscripts would not fare well in the journal review process.  We encourage all reviewers to consider these issues carefully in order to protect and promote the validity of the science we support. 

Norka Ruiz Bravo, Ph.D.
NIH Deputy Director for Extramural Research

Michael Gottesman, M.D.
NIH Deputy Director for Intramural Research

For further information contact Walter T. Schaffer, Ph.D., Senior Scientific Advisor for Extramural Research, Building One, Room 144, Bethesda, Maryland 20892  Phone 301-402-2725, Email: ws11q@nih.gov

PRINCIPAL INVESTIGATOR AWARD INTERFACE (PIAI) TRAINING SESSIONS

For Projector Directors who are new to The Research Foundation’s Business System, or staff  who’d like a better understanding of the Principal Investigator Award Interface (PIAI), the Office of Grants Management is offering 90-minute training sessions.  The PIAI application is considered to be a superior and more user friendly information interface for inquiry only access, while Oracle is viewed primarily as a transaction processing system for the administrative departments that handle your financial transactions. 

The sessions will be held on Monday, February 25th , Thursday, March 27th, and Friday, April 18th.  All will take place in the OVPR Conference Room, W5510 Frank Melville Library from 9:00-10:30 a.m.

To register for one of these sessions, please send an email to Marie Bilbao in the Office of Grants Management at marie.bilbao@stonybrook.edu

NSF Cracks Down on Delinquent Progress Reports

In an unprecedented action for Stony Brook, the National Science Foundation recently de-obligated the final increment of a multi-year NSF award due to the failure of the principal investigator to submit his annual progress report in a timely manner.

In this particular case, the report was due just prior to the beginning of the federal government's new fiscal year and NSF was in the midst of trying to make funding decisions for the coming year. Ultimately, NSF decided to allocate the money (approximately 41K) to an NSF grant recipient at another institution. As you can well imagine, such an action can be disastrous for a research project and can harm the reputation of the institution and the principal investigator.

The Office of Sponsored Programs urges faculty to take all progress report deadlines regardless of sponsor very seriously, and make every effort to comply with them. If there are extenuating circumstances preventing a submission, please let us know so that we can intercede with the sponsor. Should anyone have any questions, please contact Ivar Strand, Assistant Vice-President of Sponsored Programs at Ivar.Strand@Stonybrook.edu, or via phone at 2-4402.

NIH Reduces Temporary “Error Correction Window” for Electronic Grant Applications from Five Business Days to Two

NIH will reduce the “error correction window” (i.e. the time allowed after the submission deadline to address NIH system identified errors/warnings) from five (5) business days to two (2) business days for all electronically submitted grant applications with submission deadlines on or after January 8, 2008.

For more information click here.

IRBNet is Live!

The Office of Research Compliance is pleased to announce that SBU's IRB processes are now fully electronic.

Effective immediately, you may proceed to the IRBNet website at www.irbnet.org, register, and begin using the system for submission of your new and continuing review studies. After December 21, 2007, paper submissions of these materials will no longer be accepted.

Please take a moment to review the resource information developed for you at http://www.stonybrook.edu/research/irbnet/.

• If you are a researcher, you will find information on how to use IRBNet for creating, sharing, submitting, and obtaining appropriate signatures for your application packets.

• If you are a department chair, or chair of a departmental review commitee, you will find out how to review and provide your electronic signature on IRB submissions from your faculty. This is important, because submissions for new and continuing review studies will not be accepted without your e-signature.

Please forward this information to your study teams (if you are a PI) and members of your department (if you are a Department Chair) as soon as possible.

Note that study coordinators and other representatives from the east, west, and south campuses have received in-person training from the Office of Research Compliance (ORC). Ask your study coordinator if s/he has undergone such training so that s/he can assist you and others in your department with IRBNet.

If you are planning on submitting a study (new or continuing) in the near future, and would like personalized training on the electronic submission process, appointments may be scheduled by calling ORC at 632-9036.

Faculty Research Interest Database NOW available

The Office of the Vice President for Research and Division of Information Technology has created a web-based database system that is available to all of the University community. The purpose of this system is to identify and record faculty research interests and expertise, and for delivery of available funding opportunities. Specifically, this shared resource is available to everyone at SBU, with easy navigation and one-stop access to the research interests, job history, publications and grants of all faculty and/or researchers.

We are asking that every researcher on campus please complete or update their records.

The second important feature of this system is the new Funding Opportunities web site. As our office collects funding opportunities each week from a variety of sources, we add them into the database, assigning to each a selection of disciplines and keywords. If the assigned keywords match those you've indicated in your profile, you will receive an automated weekly email providing you with the critical elements of the opportunity (sponsor, opportunity title, funding amounts, deadlines, synopsis, etc.) that you can click on and explore. Also, as a way of encouraging multidisciplinary collaboration, you'll see the names, email addresses and phone numbers of all other faculty who also matched the specific funding opportunity, and you'll be able to click on their profiles to learn more about them.

Links will take you to the database:
http://www.stonybrook.edu/researchinterests
http://www.stonybrook.edu/fundingopportunities.

To access, you simply need your SBU NET ID and password (this can be found in SOLAR [click here for instructions]).

Please feel free to explore the features of this database. Remember, it is important that each faculty member and/or researcher complete his/her profile in order to fully benefit from this service.

Finally, we are very interested in visiting your department during a faculty meeting to demonstrate the database and show you some of its features. Please contact Stefanie Massucci at smassucci@notes.cc.sunysb.edu or 632-8589 to schedule a demo.

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