For program and hotel reservation details, and to register for the conference, please go to: http://www.regonline.com/2011NAVREFAC.  Please see below for a list of registrants as of 4:30 p.m. East Coast time on July 26, 2011.  If the name of someone you believe to be registered is not listed, please contact the NAVREF office.

Extend your stay in Seattle to attend our workshop on “The Essentials of Federal Funds Management.” The workshop will focus on preparing a winning grant proposal and cost estimating; understanding management of federal funds; excellence in grant compliance and internal controls, and much more. For details, go to: http://www.regonline.com/2011NAVREFAC and click on the “Agenda” tab near the top of the screen.

While there is no requirement to amend already executed CRADAs, please be sure that any CRADAs currently under negotiation and those initiated in the future include the human subject protection clause among those listed in the survivability provision.  The applicable human subject protection clauses are listed below:

Model:  CT CRADA phase I or II
Human Subject Protection Clause:  3.4.1

Model:  CT CRADA phase III or IV
Human Subject Protection Clause: 3.4.1

Model: Principal Investigator Initiated CRADA
Human Subject Protection Clause: 3.3

Model:  Investigational Device CRADA
Human Subject Protection Clause: 3.4.1

It is important to always download the latest model CRADA appropriate for a particular study when initiating negotiations with a potential sponsor.  This ensures that all TTP/OGC modifications to model CRADAs are reflected in executed agreements.  VA model CRADAs can be downloaded from http://vaww.research.va.gov/programs/tech_transfer/model_agreements/default.cfm  Note that this is a VA intranet URL that may be accessed only from a VA computer.

If you have questions about this or any other matter related to CRADAs, please contact your local Regional Counsel or Jeffrey Moore, PhD, (Jeffrey.Moore@va.gov) in TTP.

• Many thanks to all who responded to the NAVREF survey on the NPC Annual Report to VA template and questionnaires being used by the Nonprofit Program Office (NPPO) for oversight purposes.  Your responses and comments were extremely helpful in framing NAVREF’s comments on the four documents proposed for OMB approval under the requirements of the Paperwork Reduction Act.  To view the NAVREF comments, which were submitted on July 21, please go to:  http://navref.org/newsletter/pdf/FR_2900-New_(VA_Form_10-0510)-NAVREF_Comments_Complete.pdf

NPCS are welcome to submit their own brief (or extensive) comments on the documents before the comment period ends at 5:00 p.m. on August 8.  Alternatively, you may simply endorse the NAVREF comments.  To submit comments, go to http://www.regulations.gov.  Under “Select Document Type” choose “Agency Documents.”  Under “Keyword,” enter VA-2011-VACO-0001-0142.  Up to 2000 characters may be entered (or pasted) into the comment box and/or PDFs may be uploaded using the “Browse” feature.

• The Office of Government Ethics (OGE) has proposed a rule that would relax the long-standing prohibition on government employees serving on association and nonprofit boards in their official capacity unless there is a statutory or agency waiver.  If adopted, the new OGE rule would give each agency the ability to write its own rules for allowing employees to serve in their official capacity on nonprofit boards and committees.  Since 1996, government employees have been prohibited from serving in their official capacity on a nonprofit board or any committee with a fiduciary responsibility due to perceived conflicts of interest; the original regulation noted that because nonprofits have fiduciary obligations under state law, this would conflict with federal employees’ obligations to federal law.
  
  OGE notes in the advance notice of proposed rulemaking (ANPRM) that the new exemptions are driven by the need for federal employees to interact more closely with the private sector as well as allow them the ability to grow professionally through membership on the board of a nonprofit organization.  The regulation notice cites a letter from the director of the Office of Personnel Management (OPM) advocating the change, saying “Restrictions act as a barrier to employees achieving professional stature in their respective fields, which may discourage scientists and professionals from considering Federal employment.”  Because OGE and OPM are in favor of the proposed amendment, it is highly likely that it will be approved.

Implications for NPCs:  If approved, statutory VA directors on NPC boards would be unaffected by the new rule.  However, many NPCs have appointed other VA personnel, including PIs, to their boards to ensure broad representation of perspectives.  Currently, such non-statutory VA personnel may serve on NPC boards only in their personal capacity.  This means that they cannot use VA resources, including their VA-paid time, to fulfill their board obligations, and board meetings including such individuals must be held outside of normal duty hours unless the affected individuals take annual leave or have an approved irregular tour of duty. However, as noted above, federal agencies will write their own rules for implementing the amended regulation.  At this writing, the stance VA will take on their employees serving on outside boards in their official capacity is not known. 

Regardless of whether the new rule will have implications for NPCs, it clearly is in the best interests of VA personnel interested in serving on the boards of medical, scientific and academic societies so NAVREF sent a letter in support of the amendment. 

• The Federal Register notice regarding the new rule is posted at http://navref.org/newsletter/pdf/FR_Proposed_Rule-Gov_Emp_Serving_on_Nonprofit_Boards.pdf.
• The NAVREF letter is available at http://navref.org/newsletter/pdf/FR_NAVREF_Comments_on_OGE-RIN_3209-AA09-Gov_Empl_Serv_in_Of_Cap_in_NP_Orgs.pdf

• On July 25, the federal government proposed what the Washington Post described as “sweeping revisions” to the rules that govern research involving human subjects.  The intent of the changes is to extend “protections to a larger number of people while simultaneously streamlining the oversight and paperwork required of scientists.” 

The proposed regulations include efforts to address aspects of research that have become more common during the 20 years since the “Common Rule” was adopted for federally funded research in the US.  These include conducting the same clinical trial at multiple sites, the expansion of research by pharmaceutical companies and collecting/storing biomedical specimens.  Additionally, the new rules would extend the Common Rule to cover all research involving human subjects conducted at institutions that get money from a federal agency, even if the study is paid for by non-federal sources such as drug companies or nonprofits.

The deadline for public comments is 5:00 p.m. on September 26, 2011.

For more details, go to http://www.hhs.gov/news/press/2011pres/07/20110722a.html.
The ANPRM) is posted at http://navref.org/newsletter/pdf/FR_ANPRM_re_Human_Subject_Protections.pdf

To submit a comment, follow the instructions in the notice.