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I. Introduction and Definitions
- The Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study ( the “STUDY”) Public Use Data Set (the “Data Set”) has been prepared by staff at the Data Coordinating Center, University of Utah School of Medicine (“UTAH”), on behalf of the Pediatric Emergency Care Applied Research Network (PECARN). In exchange for the ability to use the Data Set, the RECIPIENT agrees to comply with this Research Data Use Agreement (“Agreement”). The purpose of this availability is to provide the Data Set to investigators who wish to analyze the data in a secondary study designed to enhance the public health benefit of the original work.
- The RECIPIENT acknowledges its responsibility for ensuring adherence to the terms of this Agreement, subject to applicable Federal and State laws and regulations, including the privacy and security provisions of HIPAA and HITECH.
- The Data Set meets the definition of a De-identified Data Set as defined in 45 CFR Section 164.514(b).
II. Data Set Description and Support
- The Data Set will be provided as SAS datasets or CSV text files suitable for importation in statistical software. Electronic copies of the data worksheets, the final STUDY protocol, and a data dictionary will also be provided. No further support whatsoever will be provided by UTAH, STUDY investigators, PECARN or Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) to the RECIPIENT.
III. Approved Research Uses
- The RECIPIENT agrees that it will use the Data Set solely in connection with a research project which will be completed in compliance with the terms of this Agreement.
IV. Non-Identification of Subjects
- The RECIPIENT agrees that it will not attempt to identify or contact the subjects or institutions that are included in the Data Set.
V. Non-Transferability of Data/Security of Data
- The RECIPIENT agrees to maintain control over the Data Set and further agrees not to release or distribute the Data Set in any form to any entity or individual for any purpose except as may be required by law or as permitted by this Agreement. If multiple individuals are collaborating and it is necessary to share the Data Set, each individual who will have a copy of the Data Set must execute a separate Agreement with UTAH.
- RECIPIENT agrees to use appropriate safeguards to ensure that Data Set is not used or disclosed in a manner inconsistent with this Agreement. RECIPIENT agrees to immediately report to UTAH any use or disclosure of the Data Set not in compliance with this Agreement and to provide all reasonable information requested by UTAH related to such use or disclosure.
- With respect to the Data Set, RECIPIENT agrees to comply with the security and privacy standards for Electronic Protected Health Information as defined in 45 CFR parts 160 and 164, Subpart C, as may be amended thereafter; RECIPIENT also agrees to comply with the Health Information Technology for Economic and Clinical Health (HITECH) Act effective February 17, 2009, and its implementing regulations.
VI. Duration of Agreement
- This RDUA will be in effect for a period of three (3) years from its effective date for the requested Data Set. The RDUA may be extended upon execution of a new RDUA document. At the end of the three (3) year period or extension, if another new extension is not in place, the RECIPIENT agrees to destroy all copies of the Data Set, including derivative datasets that contain individual-level information.
VII. Acknowledgment of Data Resource
- The RECIPIENT agrees to acknowledge the contribution of the STUDY in all oral and written presentations, disclosures, or publications resulting from any analyses conducted on the Data Set.
- The source of the Data Set will be acknowledged by including language similar to the following either in the acknowledgement or in the text of the manuscript: “This manuscript was prepared using the Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study (STUDY) Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the STUDY investigators or the Health Resources Services Administration (HRSA) Maternal Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC). The PECARN was funded by the HRSA/MCHB/EMSC.” Manuscripts and meeting abstracts may not use the name of the STUDY in the title, nor may the name of the STUDY or PECARN be included in the byline of the publication.
- The RECIPIENT agrees to provide to UTAH a copy of any manuscript thirty (30) days in advance of submission for publication, in order to ensure compliance with the terms of this Agreement. In addition, UTAH may in its discretion forward the manuscript to STUDY investigators for comment. If STUDY investigators choose to offer additional comments, these are provided only as courtesy. The RECIPIENT is not obligated to incorporate additional comments from STUDY investigators; however, these comments may provide the RECIPIENT with additional insights towards improving the manuscript.
IX. Duplication of Research
- The RECIPIENT acknowledges that other researchers are entitled to access to the Data Set on the same terms as RECIPIENT, and duplication of the RECIPIENT’s research may occur.
- The RECIPIENT acknowledges that although reasonable efforts have been taken to ensure the accuracy and reliability of the Data Set, UTAH and the STUDY investigators do not and cannot warrant the research results or conclusions that may be obtained by using any data included therein. All contributors to the Data Set disclaim all warranties as to performance or fitness of the Data Set for any particular purpose.
XI. Termination and Violations
- UTAH may terminate this Agreement if RECIPIENT is in default of any terms and conditions of this Agreement and such default has not been remedied within 10 days after the date of written notice of such default. UTAH may unilaterally terminate this Agreement for any reason within 90 days written notice to RECIPIENT.
- Upon termination of this Agreement for any reason, RECIPIENT shall destroy any copies of Data Set in its possession, including derivative datasets that contain individual-level information, and shall document and report such destruction to UTAH.
- Amendments to this Agreement must be made in writing and signed by authorized representatives of all parties.