Here is the last of the new model CRADAs being published this week, the model Basic Science CRADA, along with applicable SOPs and annotations. This CRADA should be used for PI-initiated studies that do not involve human subjects or human materials.

Please take the time to become familiar with the three documents embedded below in Renée’s email.

Also, please take careful note of Renée’s comments below and the SOPs. TTP – not Regional Counsel – review and approval of all Basic Science CRADAs are required. PIs and NPCs are encouraged to enlist TTP involvement early in the development of a Basic Science CRADA.

In addition to Kris Burton who was introduced in the previous email, a second new staff member will be joining TTP in September to assist in CRADA and tech transfer processes.

Barbara F. West
Executive Director
National Association of Veterans' Research and
   Education Foundations (NAVREF)
5480 Wisconsin Avenue, Suite 214
Chevy Chase, MD 20815
T: 301-656-5005
F: 301-656-5008
Email: bwest@navref.org
Web Site: www.navref.org

From: Szybala, Renee (OGC)
Sent: Wednesday, August 22, 2007 4:33 PM
To: OGC Nonprofit Corporation Panel
Cc: Hall, Walter A., OGC
Subject: Basic Science CT CRADA Model - Aug 07

Installment number 3 – the penultimate installment. Here are the –

Basic Science CRADA Model, Basic Science CRADA Annotations and Basic Science CRADA SOP.

The Basic Science CRADA Model is for use in studies involving basic bench research. Usually, the VA researcher will have a lead or substantial role in the development of the protocol for the study. No human subjects or materials are contemplated in the research covered by this model. All Basic Science CRADAs must be provided directly to TTP for review and approval at the end of negotiations. The major change in the attached Basic Science CRADA SOP for VHA and NPCs, therefore, is the lack of a formal role for Regional Counsel. TTP anticipates that it will work closely with the VHA and NPC fields on these from an early stage, due to the science and policy issues likely to arise. This lack of a formal, mandated role in the process for RCs does not mean that you will not be asked by your clients for, and should not provide, advice and assistance on Basic Science CRADAS on an ad hoc basis.

Thanks.

Renée

Renée L. Szybala
Associate General Counsel (023C)
Alternate DAEO
tel. - 202-273-6334
fax - 202-273-6403
renee.szybala@va.gov