UNIVERSITY OF PITTSBURGH OFFICE OF RESEARCH (OR) SUBMISSION FORM FOR THE EVALUATION OF

DATA USE AGREEMENTS (DUA)

Submit this completed form and supporting documents for University review and signature to:

NOTE: A DUA should not be used if a funding agreement (i.e., a subcontract) is in place between Pitt and the other entity for the same project as the funding agreement should address data sharing. Please consult with your Grants Management Officer to ensure that the appropriate language has been included in the applicable funding agreement.

University Principal Investigator (PI) Contact Information:
Name:
Title:
Email: / Name of Company/Institution: /
PI’s Departmental Administrative Contact (not Office of Research Staff):
Name:
Phone/E-mail:
PI’s Department: PI’s Dept. ID: / Company/Institution Contact for Contracts/Legal Issues:
Name:
Phone:
E-Mail: /
Describe Data being transferred under this DUA: / Company/Institution PI Name: /
SECTION A: IS PITT RECEIVING DATA? Yes - Complete this column
Describe purpose of the Exchange: / SECTION B: IS PITT PROVIDING DATA? Yes -
Complete this column
Describe purpose of the Exchange:
1. Is the Data human data? Yes No
If Yes, provide your IRB approval letter, exemption letter or determination of no human subject involvement.
2. Is the Data confidential under HIPAA? Yes No
http://www.hhs.gov/ocr/privacy/
3. Is the Data a Limited Data Set (LDS)? Yes No
http://www.irb.pitt.edu/HIPAA/HippaFaq.aspx
(see last FAQ)
4. Will you make a derivative or modification of the Data you receive? Yes No
5. Do you intend to share the results of your research/project back with the provider? Yes No
6. If there are physical storage requirements, please provide details re: locking procedure, workstation to be used, or office security measures:
7. If there are electronic security standards, please identify your Dept. IT Representative responsible for University computer systems:
Name:
Phone/Email:
8. What is the source of funds you are using to do the research with this Data? (Response cannot be “none”)
a. Source:
b. Federal funds? Yes No
c. Are funds housed at Pitt? Yes No
d. PI Name on funding acct:
9. List all other agreements related to this DUA, i.e., Sponsored Research Agreement, Government or Other Grant, CDA, License, MTA, Other Agreement and provide Institution Number/Project Number or specific details for each:
10. Do you intend to share this Data with any non-Pitt employees? Yes-Specify: No
10 a. If yes, Data shared is:
Original Data Modified Data / 1. Is the Data human data? Yes No
If Yes, provide IRB approval letter or exemption letter?
2. Was the Data collected under informed consent/HIPAA authorization? If yes, Questions 3, 3a, and 3b are no.
Yes No If yes, please attach the informed consent
and IRB approval letter.
3. Is the Data confidential under HIPAA? Yes No
http://www.hhs.gov/ocr/privacy/
a.  Is the Data de-identified (HIPAA safe harbor)?
Yes No
b. Is the Data a Limited Data Set (LDS)? Yes No
http://www.dshs.wa.gov/pdf/ms/rda/hrrs/HIPAALimitedDataSets.pdf
Data Set includes: dates zip codes
4. Do you require the recipient PI to share results back with you? Yes No
5. What is the source of funding you used to collect the Data? (Response cannot be “none”)
a. Source:
b. Federal funds? Yes No
c. Are funds housed at Pitt? Yes No
d. PI Name on funding acct:
6. Do you have any other requirements for the exchange?
Yes-Specify: No
7. Are you aware of any restrictions or confidentiality obligations that would impact sharing this Data?
Yes-Specify: No
8. Is the Data related to an invention disclosure submitted to OTM?
Yes No If yes, with whom are you working?
9. Is there a cost for you to provide Data? Costs charged must total exact costs spent to provide Data.
Yes; please explain: No
To the best of my knowledge, the answers to the questions are true, complete and accurate. I am a University of Pittsburgh faculty member authorized to oversee the transfer of the data named above.
Principal Investigator: Date:

OR DUA form (09/2009, Rev 5/2012, Rev 11/2013)