You may want to include language that requires the sponsors "not to use, without the specific written consent of the patient, the patient data, results or samples for any purpose other than the specific project for which it was acquired."  In this way, the patient has to be informed in the consent form if the sponsor plans to use data or samples obtained for this project in other projects.  One sponsor added HIPAA language and then tried to slip the use in further research by as a limited data set.

----------------------------------------
Alexander Schoen
Director, Office of Sponsored Programs
Winthrop-University Hospital
259 First Street
Mineola, NY  11501
Phone: (516) 663-8997
Fax:     (516) 663-9718
xxxxxx@winthrop.org

-----Original Message-----
From: Debbie Smith [mailto:xxxxxx@UTMEM.EDU]
Sent: Tuesday, April 08, 2003 5:13 PM
To: xxxxxx@HRINET.ORG
Subject: Re: [RESADM-L] HIPAA Language in Subcontracts

Our attorney's office sent us HIPAA language to put in all contracts; however, we're having trouble getting it approved especially by industry sponsors who--apparently--are NOT covered entities and also not required to do business associate agreements.  So, we're having to do a lot of compromise language.

Debbie Smith

Deborah (Debbie) L. Smith, Ed.D.
Director, Research Administration
UT Health Science Center
8 So. Dunlap, Suite C-109
Memphis, TN  38163
901 448-4823
901 448-7600 fax

----- Original Message -----
From: Wendy  <mailto:xxxxxx@UIOWA.EDU> Beaver
To: xxxxxx@HRINET.ORG
Sent: Tuesday, April 08, 2003 3:27 PM
Subject: [RESADM-L] HIPAA Language in Subcontracts

1.    Are you routinely adding business associate agreements or other HIPAA language to your outgoing subcontracts without regard to applicability for a particular subcontract?

2.    Have you seen business associate agreements or other HIPAA language in the subcontracts or privately funded contracts you receive?  If so, has the language been included only in those agreements where applicable or without regard to relevance?

I realize that business associate agreements are not required for disclosures from a covered entity to a researcher for research purposes, however, we've started receiving some of these agreements.  The senders have indicated they want all of their subcontractors to enter into such agreements regardless of applicability.

Thanks in advance for any responses.

****************************************************************
Wendy Beaver
Associate Director
Sponsored Programs          Ph:  319-335-2122
2 Gilmore Hall
The University of Iowa          Fax:  319-335-2130
Iowa City, IA 52242
xxxxxx@uiowa.edu
****************************************************************

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