Research News - December 2007

Essential Policy and Procedure Updates

Urgent Memorandum Regarding DHS Chemical Standard Compliance Inventory

The US Department of Homeland Security has implemented a new requirement for all chemical users to inventory and report quantities of designated high risk chemicals.  Stony Brook University is subject to this standard and is required to submit an inventory or risk civil penalties.

In order to gather this information, each department (academic and administrative) must perform a chemical assessment to inventory the designated high risk chemicals in each of their laboratories and other locations housing chemicals.  EH&S has developed a web-based inventory system that each department must utilize to record inventories for each of their locations, or document that they do not have any of the designated chemicals.  The inventory must be as accurate as possible and completed by January 31, 2008.

The web-based inventory can be accessed via a quick link on the EH&S homepage at:   http://www.stonybrook.edu/ehs. Information and instructions for completing the inventory to comply with the new regulation can also be found on the EH&S homepage.   A fact sheet is also attached below.

Additionally, EH&S is offering two voluntary 30 minute information sessions with an opportunity to ask questions as follows:

• - Wednesday January 9, 2008, 2:00PM, Chemistry Seminar Room 412 
• - Tuesday, January 15, 2008, 11:30 am, HSC Lecture Hall 5

Kim Auletta, will review the chemical assessment requirement and the new web-based inventory system for recording the designated high risk chemicals.  All faculty with chemical-containing laboratories are encouraged to attend along with a designated person who will actually be posting the information.

Download Chemical Facility Anti-Terrorism Standards Fact Sheet here.

Who do I contact with questions?

• Your Department – Lab Security Coordinator (see the EH&S Website for a list of coordinators.)
• Department of Environmental Health and Safety – Kim Auletta 632-3032 or 632-6410 or kim.auletta@stonybrook.edu

FDP - 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

Guidance On New Law (Public Law 110-85) Enacted To Expand The Scope Of Clinicaltrials.Gov

As you are aware, the CORIHS application (Section I.H) has long had a series of questions regarding required registration of clinical trials with clinicaltrials.gov.

The requirement to register has recently been expanded and the deadline in some instances is 12/26/07 (per the section below 'When must I register my trial').

Usually, the registration requirement is handled by the sponsor, but sometimes, a local PI is the sponsor (e.g., holder of the IND or IDE etc) and therefore it is that individual who must register the trial.

If you read the guidance below and determine that you are responsible for the required registration of your clinical trial, proceed to http://prsinfo.clinicaltrials.gov/fdaaa.html for further information, and then onto http://prsinfo.clinicaltrials.gov/gettingIndivAccount.html to commence with registration (i.e., this will set up an individual account for your trial. We do not currently have an organizational account for SBU, although it is in process. When Stony Brook’s organizational account is successfully completed, all individual registrations associated with SBU will be automatically transferred to the organizational account and no further action from you will be required).

Note that Multi-institutional and/or multi-sponsor clinical trials need  only be registered once.
--------------------------------------------------------------------------------------

Guidance on New Law (Public Law 110-85, 'FDA Amendments Act') Enacted to Expand the Scope of ClinicalTrials.gov Registration

Which Trials Must be Registered? The trials that must be registered are called “applicable clinical trials.”  Under the statute, these trials generally include:

1. Trials of Drugs and Biologics:  Controlled, clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation; and
2. Trials of Devices:  Controlled trials with health outcomes, other than small feasibility studies, and pediatric postmarket surveillance. You should review the statutory definition of applicable clinical trial to identify if any of your trials must be registered to comply with the law.  See PL 110-85, Section 801(a), (adding new 42 U.S.C. 282(j)(1)(A)). 

This is in addition to the long-standing clinicaltrials.gov registration requirement from the International Committee of Medical Journal Editors (ICMJE) of "any research study that prospectively assigns human participants or groups of humans to one or more health- related interventions to evaluate the effects on health outcomes"

Who is responsible? The entity responsible for registering is the “responsible party.”  The statute defines the responsible party as:

1. The sponsor of the clinical trial (as defined: 21 C.F.R. 50.3)
   
2. The principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee (provided that “the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements” for submitting information under the law.) See PL 110-85, Section 801(a), (adding new 42 U.S.C. 282(j)(1)(A)(ix)).

How do you determine if you are a responsible party? It is your responsibility to determine if you are obligated to register any of your clinical trials.

1. If you are the holder of an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE), you may be the “sponsor” as that term is defined in the FDA regulations found at 21 C.F.R. 50.3.  For studies that are conducted under an IND or IDE, the “sponsor” is identified in the course of filing the IND (commonly called the “IND holder” or the “part 812 sponsor”) or
2. You may not be the sponsor, but if you are the Principal Investigator you may have been delegated registration duties by the sponsor provided the other conditions for access and control over information are met.  or
3. For extramural trials, where there is no IND or IDE holder, NIH would not be the responsible party.  The funding recipient may be a “responsible party” as that term is defined in the Act, depending on the unique circumstances of the trial.

When Must I Register My Trial?

1. Trials initiated after 9/27/2007, or trials that are ongoing as of 12/26/2007 must be registered in full by:  The later of 12/26/2007 or 21 days after the first patient is enrolled.
2. Trials that were “ongoing” as of as of 9/27/2007 and do not involve a “serious or life threatening disease or condition,” must be registered by 9/27/2008. 
3. Trials that were “ongoing” as of as of 9/27/2007, do involve a “serious or life threatening disease or condition,” and are completed (meaning, not “ongoing”) by 12/26/2007 are not subject to these requirements, though they may be subject to pre-existing registering requirements. 

(“Ongoing” in this context means a trial had one or more patients enrolled, but had not examined the final subject or provided the final subject an intervention for the purposes of final collection of data for the primary outcome as of 9/27/2007.)

What are the penalties for failing to register an “applicable clinical trial?”

Penalties for responsible parties who fail to register, or provide false or misleading information in connection with, applicable clinical trials are significant  and may include civil monetary penalties and, for federally-funded trials, the withholding or recovery of grant funds.  See PL 110-85, Sections 801(a), (b), (adding new 42 U.S.C. 282(j), and new 21 U.S.C. 331(jj)).

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.

New F&A (Indirect Cost) Rates

The Department of Health and Human Services (DHHS) has approved Facilities and Administrative Cost (Indirect Cost) rates for the University, for the next four years, covering the period 7/1/07-6/30/11. The revised rate structure is described below. Effective for all proposals due 11/12/07 and thereafter, these are the appropriate rates to use when submitting new proposals through The Research Foundation of SUNY. If the beginning of the budget period falls outside of the Research Foundation's fiscal year (7/1/-6/30), the F&A rate that is in effect at the onset of the budget period should be utilized, increasing annually in accordance with the rates below.

Effective 7/1/08, the Office of Sponsored Programs will be incorporating the new rate structure into all funded proposals submitted prior to 11/12/07. This will affect the pace at which budgeted F&A costs are drawn down, but will not increase the amount of the Facilities and Administrative Costs charged against these awards nor affect Direct Cost budgets associated with these projects. These budgets are limited by the amounts approved at the time of the sponsored award.

Click Here to access the new F&A Rates.

Please note that the Office of Sponsored Programs will continue to honor special rates that are dictated by sponsor regulations and/or Stony Brook University/Research Foundation policies.  To view a copy of the current rate agreement please access the link at  http://www.stonybrook.edu/research/spo/IDCRateAgreement.pdf

Should you have any questions, please contact Ivar Strand, Assistant Vice-President of Sponsored Programs at 2-4402 or via e-mail at istrand@notes.cc.sunysb.edu.

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.

{Top}