Recent Policy Developments

• NIH Public Access Policy (PL 110-161)

  April 1, 2008

  To all NIH-funded Principal Investigators:

  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 7^th, 2008 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.”

  Please note that you must meet the NIH’s compliance requirement.  If you do not meet this requirement, NIH may withhold funding increments. 

  Finally, please note that as of May 25, 2008, all applications, proposals and progress reports submitted to NIH must include the PubMed Central or NIH Manuscript Submission reference number in the citation of articles that arise from NIH-funded research.

  This new requirement will ensure that all NIH-funded research publications are catalogued in a digital repository and accessible by the public. Complete information regarding the NIH’s Public Access Policy, as well as frequently asked questions and an online submission tutorial can be found at http://publicaccess.nih.gov/index.htm or at the OVPR website at http://sunysb.edu/research/newsrsch.html.

  If you have any questions or concerns regarding this new policy, please contact Ivar Strand, Assistant Vice President for Sponsored Programs at Ivar.Strand@stonybrook.edu or Christian Filstrup, Dean of Libraries at christian.filstrup@stonybrook.edu.  

  Thank you for your compliance with the NIH Public Access Policy.

• Working with industry: Five basic rules in industrial contracts [Posted 12/13/05]
  
  The objectives of the Patents and inventions policy include: securing research support, identifying inventions, securing appropriate patents, marketing inventions through licensing and other arrangements, and managing royalties and other invention-related income.

  1. All inventions made utilizing State University of New York (SUNY) or The Research Foundation of State University of New York (RF) facilities shall belong to the State SUNY or the RF.  The SUNY patents and inventions policy has been codified at Title 8, Chapter V, Subchapter B, Section 335.28 of Codes, Rules and Regulations of the State of New York.
  2. The RF holds sole title to and ownership of all inventions developed using RF or SUNY facilities resulting from sponsored research or related sponsored research activities.
  3. The Inventor(s) and the inventor's heirs or legatees are entitled to a non-assignable 40 percent of the gross royalties paid by licensee.  All net proceeds after payment of the inventor's share, and other appropriate costs associated with the Research Foundation technology transfer program, are to be used to support SUNY research.
  4. If the RF elects not to patent and license an invention, it may be assigned back to the inventor, unless the sponsor requires assignment to the sponsor.  If an invention reassigned to the inventor and the technology is licensed, the Research Foundation may claim 10% of “net” proceeds received by inventor.
  5. In a research agreement, the RF may agree to give the sponsor an option to negotiate an exclusive license, the RF cannot grant a sponsor an exclusive license in the research agreement pursuant to the Tax Exempt Bond Act of the Tax Reform Act of 1986.  The Sponsor may request, as part of a sponsored research agreement, the option to negotiate an exclusive license to RF inventions made as a result of the agreement.  If the Sponsor exercises its option with the RF, the good faith negotiations to reach a license begin during the option period. 

  Some guiding principles include:

  1. The Bayh-Dole Act of 1980, found at Title 35, United States Code, Section 200, provides for the transfer of ownership regarding federally funded research.  Where inventions are made at universities pursuant to federally funded research projects, the federal government permits inventions to be owned by universities or their research corporations (the federal government does retain some rights however).  The universities are permitted to nonexclusively or exclusively license the “Bayh-Dole” inventions to other parties.  Although the federal government rarely uses the right, it does by this law retain "March-in” rights to license the invention to a third party, without the consent of the patent holder or licensee, where it determines the invention is not being made available to the public on a reasonable basis.
  2. U.S. patent law provides that ownership of a patent initially resides with the inventors listed on the patent.  The law further states that inventorship only includes individuals who have contributed an inventive concept – either an idea or reduction to practice – to a claim of the patent.  Funding a research project at the university does not qualify as inventorship (merely a request or payment for services), and furthermore, any sponsored research agreement cannot call for the assignment of inventions in a manner contrary to New York State law.
  3. Ownership of Software is governed by a separate policy, the Software Copyright Policy.  The use of SUNY or RF computers may result in the creation of computer software.  Computer software can be either copyrighted or patented, depending on the particular circumstances, and can often be licensed for commercial use.  Computer software and software support materials must be disclosed promptly to the RF Technology Transfer Office, which functions by formal agreement as the agent of State University of New York for the administration of such materials.

   

  4. Under the Software Copyright Policy, such title will belong to the creator if all of the following conditions exist:

  • The work was not created within the scope of employment of the creator;
  • The work created was not the result of a work for hire situation;
  • The work created was not a product or byproduct of sponsor funded or contracted activity; and
  • The work was not developed through the use of facilities, funds or personnel of the SUNY or the RF or under the control of SUNY or the RF.

  For the protection of patents and inventions, including software items, please contact the following RF Technology Transfer Office:
  The Office of Technology Licensing and Industry Relations (OTLIR)
  N5002 Frank Melville Jr. Memorial Library
  Stony Brook, NY 11794-3369
  Chester Bisbee, JD, Ph.D., Director
  Tel: (631) 632-9009 Fax: (631) 632-1505

   

• Revised Version of the NSF Grant Policy Manual Available
  
  NSF has announced a revised version of the NSF Grant Policy Manual  (GPM) (NSF 05-131) effective July 1, 2005. The new manual supersedes all previous versions. Important changes to NSF's policies and procedures and enhancements to Fastlane have been implemented. NSF strongly encourages NSF grantees to review the document before the implementation date. The updated version of the GPM is available at:
  http://www.nsf.gov/publications/pub_summ.jsp?ods_key=gpm

  Please contact NSF's Policy Office, Division of Institution and Award Support at (703) 292-8243 or policy@nsf.gov for any comments, questions or concerns.

• NIH Policy on Enhancing Public Access to Archived Publications Resulting from NIH Funded Research (link to pdf)

• Export Controls

  The devastating events that occurred on September 11th, 2001, coupled with this country's continuing war on terrorism have brought with them myriad new federal regulations and stronger enforcement of existing regulations for conducting research, most notably export controls, which may affect collaborations with researchers outside the United States. The regulations are subdivided into three categories – International Traffic in Arms Regulations, Export Administration Regulations and Office of Foreign Asset Control Regulations – administered by three separate entities – the State Department, the Commerce Department and the Treasury Department, respectively. Violations of these rules carry both personal (Investigator) and Institutional (The Research Foundation and SUNY) penalties of jail time and monetary fines. The level of university compliance is being scrutinized closely these days due to the intersection of cutting edge science, technology and engineering research with national security, foreign policy and homeland security in university laboratories.

  Generally stated, export controls regulate the disclosure, shipment, use, transfer or transmission of any commodity, material, technology, information or software appearing on the U.S. government's controlled technologies lists for the benefit of a foreign person or foreign entity anywhere. Additionally, export controls regulate transactions or the provision of services involving prohibited countries, persons or entities based on trade sanctions, embargoes and travel restrictions imposed by the US Treasury Department (see Foreign Travel Information below). Specifically:

  International Traffic in Arms Regulations (ITAR) control the export and temporary import of ITAR controlled military items like defense articles and defense services covered by the U.S. Munitions List (http://pmdtc.org/reference.htm), inclusive of space and satellite technologies.

  Export Administration Regulations (EAR) control the export and re-export of dual use (commercial and military/security applications) items appearing on the Commodities Control List (CCL) (www.bxa.doc.gov/licensing/exportingbasics.htm). EAR also covers encrypted software.

  Office of Foreign Asset Control Regulations (OFAC) enforces economic and trade sanctions based on U.S. foreign policy and national security goals against foreign targeted countries or entities, terrorists, international narcotics traffickers and those engaged in activities related to the proliferation of weapons of mass destruction. (www.access.gpo.gov/nara/cfr/waisidx_03/31cfr500_03.html)

  The targeted countries include those appearing on the T-7 list of terrorism-supporting countries (www.ustreas.gov/offices/eotffc/ofac/sanctions/index.html) and to a lesser extent India, Pakistan, China, Russia and Israel. Please note that individual faculty and staff members should consult with the Office of Sponsored Programs or Grants Management if they intend to have foreign visitors in their labs from any of these countries or are anticipating traveling to or providing services to these countries. Regulatory interpretation is not necessarily transparent: for example, the Treasury Department has recently ruled that if a U.S. faculty member is editing a publication for a collaborator in one of these countries this could constitute an OFAC violation.

  There is some good news in all of these burdensome and scary regulations. Even if the research you are conducting appears on the list, export may still be permissible if the "fundamental research exemption" pertains. Fundamental research is defined as basic and applied research in science and engineering conducted at a university located in the U.S. where the resulting information is ordinarily published (EAR) or is published (ITAR) and shared broadly within the scientific community (excluding encrypted software and research conducted outside the U.S.). Please note that for the exemption to be in force, the institution cannot agree to any publication restrictions on an award.

  A test scenario: If Prof. A is a faculty member at Stony Brook and he/she is conducting research that appears on the CCL and the research is covered under the fundamental research exemption, he or she should ask a three-pronged question. 1) Is the item on the controlled list? Yes. 2) What country am I exporting to? If it’s not one of the countries referenced/listed above you are in good shape. 3) Who is the intended recipient? If the individual is not a known terrorist or drug trafficker you again are in good shape. Under this scenario, the faculty member would be permitted to export and would be deemed to be a recipient of an EAR99 unilateral license from the Commerce Department. If the responses aren't as clear cut as those above, the faculty member should consult with his/her sponsored programs office for guidance, and that office might have to initiate a license application to the Commerce Department to export. This three-pronged test can be used for ITAR controlled technologies as well.

  The Office of Sponsored Programs and the Research Foundation's Central Office have put together quite a bit of documentation to steer faculty in the right direction for compliance with these complex regulations. On the Office of Sponsored Program's website (www.stonybrook.edu/research/spo/export-controls.pdf) you can view a presentation from a prominent D.C.-based law firm that specializes in export control issues. The Research Foundation's Central office has dedicated an entire webpage (www2.rfsuny.org/comply/controls/) to export controls (menu list down left side), which include an Advisory Memo from Executive Vice-President Tim Murphy (see Communications), Frequently Asked Questions, and Decision Trees to test applicability (see Research Guidance). The Chancellor has also sent a notice to University Presidents on the applicability of export controls to SUNY researchers which will be posted on this website in a few days. Should you have any questions concerning this issue please contact Ivar Strand, Director of Sponsored Programs, at 632-4402 or via e-mail at IStrand@notes.cc.sunysb.edu.

--Posted Aug. 9, 2004