The new Model Device CRADA and relevant SOPs and annotations are attached to this email. Please take the time to become familiar with these documents.

Please note:

1. The CT CRADA SOPs have been updated and modified to apply to the Device CRADAs as well as Clinical Trial (CT) CRADAs. Please discard and disregard previous versions of the CT CRADA SOPs.

2. As noted in Amy’s email below, for CRADAs involving human subjects, there is a significant new requirement regarding the HIPAA authorization. That is, a copy of the proposed HIPAA authorization form must be provided to the Regional Counsel for review along with the proposed CRADA and the memo that justifies significant changes (“Justification Memo”).

The reason for this requirement is explained in the annotations as follows:

Regional Counsel attorneys reviewing/negotiating a CRADA must review the proposed HIPAA authorization to ensure that it is consistent with the CRADA and 45 C.F.R. § 164.508, which lists what a valid authorization must contain. This is a critical legal document. It makes the research possible by allowing the sharing of protected health information. It is what protects the patient’s right to privacy. It must fully disclose who the information may be shared with and what it will be used for. Make sure that the authorization allows sharing the health information with the NPC, the Collaborator’s monitors, the IRB and representatives of governmental and regulatory agencies (i.e. FDA). In research, the law allows the HIPAA authorization to be as narrow as allowing use of protected health information for one particular study or as broad as allowing use of protected health information for research including inclusion in a data repository or database. You must ensure that the HIPAA authorization goes as far as required by the CRADA, but no further. It must inform the subject that the disclosure to the Collaborator, an entity that is not subject to privacy laws, means the information is potentially subject to re-disclosure, and no longer protected by those laws. See 45 CFR 164.508(c)(2)(v). VA must ensure that the HIPAA authorization provides full disclosure to the veteran subject on the extent to which the information could be used, so that the veteran can make an informed decision on whether to sign.

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: Centanni, Amy [mailto:amy.centanni@va.gov]
Sent: Wednesday, August 22, 2007 12:09 PM
To: VHA CO 12 ACOS; VHA CO 12 AO
Cc: Kupersmith, Joel; Francis, Joe; Moore, Jeffrey Ph.D.; West, Barbara F. (NAVREF)
Subject: Device CT CRADA model

Hi, again:

Here’s the second installment of today’s publication of new CRADA Models which includes the Device CT CRADA Model, Device CT CRADA Annotations and a new CT CRADA SOP.

The Device CT CRADA Model is a tweaking of the CT CRADA model to cover clinical trials of Investigational Devices, rather than drugs. The attached CRADA SOP for VHA and NPCs is a revision of the previously published SOP for CT CRADAs. There are two substantive changes in the CT CRADA SOP:

1) a clarification of the scope to cover clinical trials of Investigational Devices, as well as drugs, and

2) a requirement that, along with the proposed CRADA and Justification memo, Regional Counsels be provided with the proposed HIPAA Authorization for the CT. This is explained to a large extent in the Annotation attached, and will be further explained when the revised CRADA Legal Review Procedure is distributed later today.

Questions and comments are greatly appreciated. Thanks.

Amy Centanni
Director, Technology Transfer (12TT)
Department of Veterans Affairs
810 Vermont Ave, NW
Washington, DC 20420
(202) 254-0199
(202) 254-0460 (fax)