Research News - April 2008

Essential Policy and Procedure Updates

DHS Chemical Standard Compliance Inventory

Thanks to the stalwart and generous efforts of hundreds of people across campus, the inventory has been completed.  EH&S indicated that 2100 different chemicals were reported (18,000 lbs. of material) of which 2 need to be reported. Thank you for your immensely valuable participation. 

For more information, please contact Kim Auletta 632-3032 or on email at  kim.auletta@stonybrook.edu.

RESEARCH COMPLIANCE UPDATE

Research Involving Human Subjects:

IRBNet:

• The ORC staff has been inundated with "new packages" that are created by investigators who just seek to add a document to a study or otherwise 'tweak' a package that was previously submitted and is awaiting review. If you submit a study package and realize you forgot to include a document, call up our office, 2-9036, and we will be able to 'unlock' the study for you so that you can easily add what is missing. This will result in less study packages to manage, and less time spent trying to figure out why we are receiving so many incomplete packages!
• All investigators listed in sections I.C and I.D of the IRB applications must be current in their IRB training. They also need to review the certification language provided at the end of the application, and then must electronically sign the study. Missing signatures will hold up final approval. Note that signatures may be provided on locked and submitted studies.
• In order to reply to decision letters from the IRB using IRBNet, please follow section XI in the IRBNet Instructions for SBU and BNL Investigators,  available at  http://www.stonybrook.edu/research/irbnet/                  

Commencement of Accreditation Process:

• In our continuing efforts to keep our clinical research program as strong as possible, and our research volunteers as safe as possible, SBU has begun to prepare for accreditation by AAHRPP, the Association for the Accreditation of Human Research Protection Programs. This is a time- and person-intensive process, involving detailed assessment, evaluation, and fine-tuning of our entire program. It requires input from the IRB, the researchers and Institutional officials across campus. We will keep you informed as the process moves forward. If you would like more information, please visit AAHRPP's website at  www.aarhpp.org.

Increase in Rates for IRB/Institutional Review of Pharmaceutical/Industry-sponsored studies:

• Effective April 1, 2008, The IRB/Institutional fee for full committee review by CORIHS of industry-initiated/ sponsored studies will now be $2750.00. This fee covers initial review, 4 continuing reviews, plus all associated reviews of amendments and unanticipated problems (e.g., serious adverse events etc). Charges for expedited review by CORIHS of such studies will remain at $950.   The Institutional fee for such studies reviewed by Chesapeake Research Review, Inc. will now be $900.  

Chesapeake Research Review IRB has gone Electronic!

• Effective immediately:
Submissions to CRRI IRB (for pharma/industry-sponsored studies) must be done via their new web-based system, CIRBI (“Center for IRB Intelligence”). We are in the process of updating our website to contain FAQ’s and other information pertaining to this new process. In the meantime, you are encouraged to go onto www.cirbi.net and sign up (left-hand column).  

Research Involving Recombinant DNA Molecules:

• Effective 4/1/08, any IBC-approved or IBC-exempted activity that has been active for three years or longer must be submitted as a new activity, using the full IBC application, available here:   http://www.stonybrook.edu/research/forms/campus/ibcapp.doc .
The submission can be done at the time of continuing review. You will receive e-mail notices if and when full application is required for your IBC activity.  

• Any research activity involving use of recombinant DNA molecules must be reviewed by the IBC. If you have any questions, please contact the Office of Research Compliance, 2-9036.

NIH ANNOUNCES NEW CENTRALIZED PROCESSING CENTER FOR RECEIPT OF GRANT CLOSEOUT DOCUMENTS AND REMINDS GRANTEES OF REQUIRED CLOSEOUT REPORTS FOR NIH ASSISTANCE AWARDS

Notice Number: NOT-OD-08-061
Release Date: April 2, 2008
Issued by: National Institutes of Health (NIH), (http://www.nih.gov/)

This Guide Notice announces a new business process and the creation of a centralized processing center for receiving closeout documents submitted for all NIH grants and cooperative agreements.  This centralized office currently receives and processes reports submitted by regular U.S. mail, courier and overnight services, as well as by e-mail and fax. They also process information submitted electronically through the Closeout feature in the eRA Commons. NIH expects that this new centralized business process will improve efficiency and service to the grantee community.

Effective immediately, all non-financial closeout documents (such as the final progress report and HHS 568 Final Invention Statement and Certification) not submitted through the eRA Commons will be required to be submitted to the following address:
 
NIH Centralized Processing Center
6705 Rockledge Drive
RM 2207, MSC 7987
Bethesda, MD 20892 (for regular or US Postal Service Express mail)
Bethesda, MD 20817 (for other courier/express deliveries only)
E-mail: DeasCentralized@od.nih.gov
Fax: (301) 480-2304

Note that this does not include submission of the SF269 Financial Status Report which will continue to require electronic, online submission through the eRA Commons.  See NIH Guide Notice NOT-OD-07-078 for more information on this requirement. 

NIH continues to strongly encourage use of the eRA Commons for online, electronic submission of all closeout documents and is committed to improving the eRA Commons Closeout feature with the ultimate plan to move towards eliminating paper submissions.   When NIH is ready to take that step, it will be announced to the community through a separate Guide Notice.  In the meantime, if grantees attempt to use the Commons Closeout feature and find the record has not been entered into a Closeout status yet by NIH, the centralized office noted above should be contacted.   See NIH Guide Notice NOT-OD-05-051 for more information on electronic submission of required closeout documents.

For more information, read the notice at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-061.html

NIH PUBLIC ACCESS MANDATE

For several years, the National Institutes of Health (NIH) has requested that you voluntarily make publications resulting from NIH-funded research available to the public by posting them electronically to the National Library of Medicine’s PubMed Central at http://www.pubmedcentral.nih.gov/.

Effective April 7th, the NIH is making the dissemination of NIH-funded research results mandatory (NIH Public Access Policy, PL 110-161). Any peer-reviewed article or manuscript accepted for publication that results in whole or in part from research funded by an NIH grant or cooperative agreement active in FY ’08 (October 1, 2007-September 30, 2008) or funded by a contract signed on or after April 7, 2008 must be submitted to PubMed central within twelve months of the publication date. 
 
The following scenarios provide guidance on meeting this NIH compliance requirement:

1. When publishing in a journal that automatically posts the final published version of the article to PubMed Central, no further action is necessary. The following link (http://publicaccess.nih.gov/submit_process_journals.htm) provides you with a list of the journals that submit articles directly to PubMed Central on behalf of authors.
   
2. For those journals that do not submit published manuscripts to PubMed Central automatically, you can request that the journal deposit a copy to PubMed Central on your behalf.  Note, that in the case of publishers that post only the accepted manuscript rather than the final published version of the article, you will receive a notice and will have to log on to the NIH Manuscript Submission System (http://www.nihms.nih.gov) to review the final version and approve release of the article to PubMed Central.
   
3. In those instances where the journal does nothing, you or your designee must submit the final, peer-reviewed manuscript that has been accepted for publication via the NIH Manuscript Submission System (http://www.nihms.nih.gov).

Regarding copyright, with the exception of the journals that automatically submit publications to PubMed Central (see #1 above), you need to ensure that you retain the right to post publications to PubMed Central in accordance with the NIH Public Access Policy. This can be accomplished by amending agreements with publishers to including the following language (best set forth as a separate addendum to the publisher’s copyright agreement):

"Journal acknowledges that Author retains the right to provide a copy of the final manuscript to the NIH upon acceptance for Journal publication, for public archiving in PubMed Central as soon as possible but no later than 12 months after publication by Journal.”

NIH APPLICATION ANNOUNCEMENTS

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

NOTE:  The New forms will be REQUIRED starting in May (applications not using the new forms will be returned without review!). For more information see: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-028.html

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

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.

Related Link: 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

NIMH ENCOURAGES COLLECTION OF BIO-SPECIMENS FROM NIMH-SUPPORTED CLINICAL RESEARCH STUDIES

Notice Number: NOT-MH-08-007
 
Release Date: March 27, 2008
 
Issued by: National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
 
The National Institute of Mental Health (NIMH) issues this notice to announce its support of and encouragement to grantees of NIMH-supported clinical research studies to collect and bank bio-specimens (e.g., DNA, RNA, whole blood, and/or serum) and phenotypic information from all consenting subjects.  An example of a current banking resource that might be utilized, may be found at the Center for Collaborative Genetic Studies on Mental Disorders, http://nimhgenetics.org.
 
NIH considers the sharing of unique research resources that are developed through NIH-sponsored research to be an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community.  (For example: see http://grants.nih.gov/grants/gwas/)
 
The collection and banking of bio-specimens from consenting subjects will provide a cost effective approach to building the infrastructure for genetic and other molecular analyses of mental illnesses and will provide a significant opportunity for scientific discovery, paving the way to more effective treatments and ultimately personalized cures for mental disorders.
 
For the NIH definition of clinical research see: NIMH Notice
 
Inquiries may be directed to:
 
Thomas Lehner, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7190, MSC 9643
Bethesda, MD 20892-9643
Telephone: (301) 443-9869
FAX: (301) 402-4740
Email:  tlehner@mail.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 session to be held on Friday, April 18th, 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

ADMINISTRATIVE HELP FOR MULTI-MILLION DOLLAR GRANT PROPOSALS

Strengthening multidisciplinary and interdisciplinary research at Stony Brook University is the primary responsibility of the Office of the Associate Vice President for Research. Specifically, the main objective of this office is to encourage, orchestrate and support the creative research activities of our faculty, especially in the context of facilitating greater collaboration across different disciplines and to help those teams develop and successfully submit large multidisciplinary proposals. 

Multidisciplinary proposals are often more complex and difficult to compile.  If you are contemplating writing a multi-million dollar (at least $1M per year) multidisciplinary grant proposal but lack the administrative support to pull it together, our office can provide administrative staff assistance. We can help you coordinate proposal meetings, enlist collaborators, manage and prepare proposal documents and applications, etc. 

Please review our website at http://www.stonybrook.edu/research/workgroups.html and contact Michael Hadjiargyrou, Associate VP for Research (Michael.Hadjiargyrou@stonybrook.edu), or Stefanie Massucci, Multidisciplinary Project Associate (smassucci@notes.cc.sunysb.edu) for more details.

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