Internal Submission Form for the Review of Data Use Agreements (Dua)

UNIVERSITY OF PITTSBURGH OFFICE OF RESEARCH (OR) INTERNAL SUBMISSION FORM FOR THE REVIEW OF DATA USE AGREEMENTS (DUA)

FOR UNIVERSITY REVIEW AND SIGNATURE, SUBMIT THE FOLLOWING MATERIALS BY EMAIL TO ( [email protected] ) **COMPLETED SUBMISSION FORM AND ANY COMPLIANCE DOCUMENTATION AS REQUESTED BELOW Basic Information 1. Principal Investigator: 2. Department Administratively Department Name: Responsible for this Agreement: Department ID: 3. Should Pitt Generate the first draft of Yes the agreement? No (if no, please attach a draft agreement for review)

4. Title of Submission: 5. Department Administrative Contact: Name: E-Mail:

Contracting Party Information1 1 Contracting Party Name: 2. Legal Contact Name: 3. Legal Contact E-Mail Address: 4. Legal Contact Phone Number: 5. Scientific Contact Name: 6. Scientific Contact E-mail: 7. Does the Principal Investigator have a Yes financial relationship with any of the Contracting Parties listed above that No is or should be disclosed on your University of Pittsburgh Conflict of Interest disclosure form? If Yes, please explain:

Pitt Principal Investigator will be SENDING data (complete sections labeled “Sending” below)

Pitt Principal Investigator will be RECEIVING data (complete sections labeled “Receiving” below):

If Pitt Principal Investigator will be both SENDING and RECEIVING data please complete both sections.

1 If there are multiple contracting parties for this agreement, please attach a list (including legal contact information) to your submission package.

Form Revision Date: 9/2014 Page 1 INTERNAL SUBMISSION FORM FOR THE REVIEW OF DATA USE AGREEMENTS (DUA) Data Information (Sending) 1. Description of data: 2. Purpose of sending the data: Compliance Information (Sending) 1. What is the origin of this data? Animal

Student (or Educational)

Human Subject Research, attach IRB approval letter

Other. If other, explain:

Human Subject Research Information (Sending) 1. Attach IRB Approval Letter 2. Was the data collected under Yes, if yes attach informed consent document. Informed Consent? No

3. If data was NOT collected under Yes, if yes attach the waiver of informed consent document. informed consent, did the IRB approve a waiver of Informed No Consent? 4. If data was NOT collected under Is the data identifiable? Yes informed consent AND the IRB did NOT approve a waiver of informed No consent, then: Is the data a Limited Data Set (LDS)? Yes

If yes, check the applicable fields that will be provided: Dates

Zip Codes

Funding Information (Sending) 1. Is the source of funding: Internal (e.g. departmental or start-up funding)

External (e.g. sponsored research)

2. Indicate the funding source used to Funding Source: collect the data: Grant Identifier/Award #: PI of Grant Funds: Are Funds Housed a Pitt? Yes No

If no, where are funds housed? 3. Are there any other Yes agreements/funding/materials applicable to your research No (consider all that apply, i.e., Form Revision Date: 9/2014 Page 2 INTERNAL SUBMISSION FORM FOR THE REVIEW OF DATA USE AGREEMENTS (DUA) Sponsored Research Agreement, Government or Other Grant, CDA, If yes - License, MTA, Subcontract, Other Please list the agreements: Agreement)? Institution Number: Project Details:

Does this agreement address data sharing with this recipient? Yes. If yes, please explain:

Recipient Information (Sending) 1. Do you require reimbursement for Yes. If yes, please explain: the cost to provide the data? No

2. Do you require the recipient to Yes. If yes, please explain: collaborate, share results or anticipate that they will jointly No publish with you?

Restrictions Information (Sending) 1. Are you aware of any restrictions Yes. If yes, please explain: or confidentiality obligations that would impact sharing of this data? No

2. Is the data under disclosure to or Yes patented by Pitt Office of Technology Management (OTM)? No

If yes: OTM Staff: OTM Case Number:

Form Revision Date: 9/2014 Page 3 INTERNAL SUBMISSION FORM FOR THE REVIEW OF DATA USE AGREEMENTS (DUA) Data Information (Receiving) 1. Description of data: 2. Purpose of sending the data: Compliance Information (Receiving) 1. What is the origin of this data? Animal

Student (or Educational)

Human Subject Research, attach IRB approval letter

Other. If other, explain:

Human Origin Information (Receiving) 1. Is the data considered Confidential Yes under HIPAA? No

2. Is the data a Limited Data Set Yes (LDS)? No

Funding Information (Receiving) 1. Is the source of funding: Internal (e.g. departmental or start-up funding)

External (e.g. sponsored research)

2. Indicate the funding source used to Funding Source: collect the data: Grant Identifier/Award #: PI of Grant Funds: Are Funds Housed a Pitt? Yes No

If no, where are funds housed? 3. Are there any other Yes agreements/funding/materials applicable to your research No (consider all that apply, i.e., Sponsored Research Agreement, Government or Other Grant, CDA, If yes - License, MTA, Subcontract, Other Please list the agreements: Agreement)? Institution Number: Project Details:

Does this agreement address data sharing with this recipient? Yes. If yes, please explain:

Data Use Information (Receiving)

Form Revision Date: 9/2014 Page 4 INTERNAL SUBMISSION FORM FOR THE REVIEW OF DATA USE AGREEMENTS (DUA) 1. Will you make a derivative or Yes. If yes, please explain: modification of the received data? No

2. Do you intend to collaborate, Yes. If yes, please explain: share results or anticipate that you will jointly publish with the sender? No

3. Do you intend to share this data Yes. If yes, please explain: with non-Pitt persons? No

If yes, What data will you share? Received Data

Modified Data

Restrictions Information (Receiving)

1. Are you aware of any restrictions Yes. If yes, please explain: or confidentiality obligations that relate to hardware, software or No office security?

2. Does the data need to be stored Yes and managed per any cited electronic security standards? No

If yes, provide - Department IT staff name: Department IT staff e-mail:

Additional Information

1. Additional information relevant to the review of this request, including any time constraints:

SUBMIT THE REQUESTED MATERIALS BY EMAIL TO [email protected]

ALL FIELDS ON THIS FORM ARE REQUIRED. Form Revision Date: 9/2014 Page 5 INTERNAL SUBMISSION FORM FOR THE REVIEW OF DATA USE AGREEMENTS (DUA)

FORMS MISSING INFORMATION OR SUBMISSION PACKAGES THAT DO NOT INCLUDE REQUESTED DOCUMENTATION WILL BE RETURNED TO THE SUBMITTER.

Form Revision Date: 9/2014 Page 6