Here is another document to add to your CRADA library. This one describes the legal review process for all CRADAs. In addition to the SOPs for each model CRADA, it is important for NPC personnel to be familiar with the legal review process so they understand the NPC role and can ensure preparation and submission of the appropriate documents.

Please discard the legal review procedure published previously and make note of the significant changes described in Renée’s email below.

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 8:48 PM
To: OGC Nonprofit Corporation Panel
Cc: Hall, Walter A., OGC
Subject: OGC CRADA Legal Review Procedure

Attached is the last of today’s documents –
The revised OGC Legal Review Procedure.

It contains only two substantive revisions: 1) its scope has been expanded so that it is applicable to all CRADA reviews, not just clinical trial CRADAs, and 2) it requires a review and approval of the proposed HIPAA Authorization by the RC. The Guidance Section has also been revised to cover the Authorization legal review. See Guidance 5.

The HIPAA Authorization to be signed by the subject may be a stand-alone document or combined with the patient’s Informed Consent. Where the Informed Consent gives notice of medical complications that may arise, the Authorization gives notice of the uses that may be made of the personal health information and data that will be collected. Both documents must fully inform the potential subjects of what participation in the research may mean to them, so that they can make fully informed choices as to whether to participate.

While the Informed Consent is a medical document, the HIPAA Authorization is a legal one. (It is not reviewed by the IRB at all, unless it is combined with the Informed Consent.) Legal review of the HIPPA authorization is required in all cases to protect VA’s vital interests – the privacy and legal rights of our veterans. There is additional information on review of the Authorization in the Device CT CRADA Annotation.

Thanks again for all your support. It has been a real pleasure to work with so many of you over the past few months.

Renée

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