Data Contract Condition Language for:
Mutli-Ethnic Study of Atherosclerosis

sorted by Category and Condition

July 30, 2014, 9:19 pm

Data Use

No re-identification

8. Non-Identification. Recipient and Recipient’s PI agree that Materials and/or Data will not be used, either alone or in conjunction with any other information, in any effort to determine the individual identities of any of the participants from whom Data and/or Materials were obtained or derived.

No redistribution of data

4. Non-transferability.
4.1 Recipient and Recipient’s PI agree that substantive changes made to the Research Project, and/or appointment by Recipient of another Principal Investigator and/or transfer of Recipient’s PI to another institution or other entity to complete the Research Project, require execution of a separate DMDA. Except as provided in section 4.2 below, Recipient may not distribute Data or Materials to any other individual or entity, regardless of the intended use of such Data or Materials. However, nothing in this section precludes Recipient from publishing results of the Research Project through the usual channels of scientific publication.

4.2 Recipient and Recipient’s PI may transfer or cause to be transferred Materials to an institution or institutions or other entities not affiliated with Recipient but with which Recipient has either a fee-for-service or subcontract agreement or specific authorization from the NHLBI for performance of assays and/or genetic analyses for the Research Project as identified in section 3.2. A separate DMDA is not required if the derived data are either returned to the Recipient and Recipient’s PI or are deposited for Recipient and Recipient’s PI in a publicly accessible database authorized by the NHLBI upon completion of the assays. No Data are to be provided to such institutions or other entities unless a separate DMDA has been approved by MESA and NHLBI.

12. No Distribution; Avoidance of Waste. Recipient and Recipient’s PI agree to retain control over Data, Materials and their progeny, and derivatives thereof. Recipient and Recipient’s PI further agree not to transfer Data, Materials and their progeny, and derivatives thereof, with or without charge, to any other entity or individual, except for Data and/or Materials as provided for in section 4.2 above. Recipient and Recipient’s PI agree to make reasonable efforts to avoid contamination or waste of Materials.

Stick to original research plan

3. Research Project.
3.1 These Materials and Data will be used by Recipient's PI solely in connection with the Research Project as named and described in the attached research application (insert Research Project name below):
3.3 This DMDA covers only the Research Project cited in section 3.1 of this DMDA. Recipient must submit a separate DMDA for each Research Project for which Data and/or Materials are requested.

9. Use Limited to Research Project. Recipient and Recipient’s PI agree that Materials, their progeny, or derivatives thereof, and Resultant Data will not be used in any experiments or procedures unless said experiments or procedures are disclosed and approved as part of the Research Project.

Inspections & Penalties

Penalty

22. Disqualification, Enforcement. Failure to comply with any of the terms of this DMDA may result in disqualification of Recipient from receiving additional Data and/or Materials. The United States Government and/or MESA may have the right to institute and prosecute appropriate proceedings at law or in equity against the Recipient for violating or threatening to violate the confidentiality requirements of this DMDA, the limitations on the use of the Data or Materials provided, or both. Proceedings may be initiated against the violating party, or legal representatives, and assigns, for a restraining injunction, compensatory and punitive damages, mandamus, and/or any other proceeding at law or in equity, including obtaining the proceeds from any intellectual property or other rights that are derived in whole or in part from the breach of the confidentiality requirements or use limitations of this agreement. In addition, Recipient and Recipient’s PI acknowledge and agree that a breach or threatened breach of the confidentiality requirements or use limitations of this DMDA may subject Recipient and Recipient’s PI to legal action on the part of MESA participants, their families, or both.

Publication

Cite/acknowledge data

7. Acknowledgments. Recipient and Recipient’s PI agree to acknowledge the contribution of MESA staff in any and all oral and written presentations, disclosures, and publications resulting from any and all analyses of Data or Materials.

7.1 Collaborations. If a manuscript resulting from the Research Project has Study Investigators as co-authors, then the manuscript will be reviewed by MESA.

7.1.a If the manuscript is approved by MESA, the Recipient and Recipient’s PI agree to include the following language in an acknowledgment.

"The Multi-Ethnic Study of Atherosclerosis (MESA) is supported by contracts N01-HC-95159 through N01-HC-95169 from the National Heart, Lung, and Blood Institute (NHLBI).”

“This manuscript has been reviewed by MESA for scientific content and consistency of data interpretation with previous MESA publications.”

7.1.b If the manuscript is not approved by MESA and the Recipient and Recipient’s PI wish to proceed to publish without inclusion of Study Investigators as co-authors, the Recipient and Recipient’s PI agree to include the following language in an acknowledgment.

“The Multi-Ethnic Study of Atherosclerosis is supported by contracts N01-HC-95159 through N01-HC-95169 from the National Heart, Lung, and Blood Institute (NHLBI).”

“This manuscript was not approved by MESA. The opinions and conclusions contained in this publication are solely those of the authors, and are not endorsed by MESA or the NHLBI and should not be assumed to reflect the opinions or conclusions of either.”

7.2 Other Studies. If the Research Project does not involve collaboration with Study Investigators, then the Recipient and Recipient’s PI agree to include the following language in an acknowledgment.

"The Multi-Ethnic Study of Atherosclerosis is supported by contracts N01-HC-95159 through N01-HC-95169 from the National Heart, Lung, and Blood Institute (NHLBI).”

“This manuscript was not prepared in collaboration with investigators of MESA and does not necessarily reflect the opinions or conclusions of MESA or the NHLBI.”

7.3 Ancillary Study Investigator Acknowledgments. If Data include data provided to MESA by ancillary study investigators, Recipient and Recipient’s PI also agree to acknowledge their contribution in any and all oral and written presentations, disclosures, and publications resulting from any and all analyses of such Data.

Make effort to publish

6. Publication. Prompt publication of the results of the Research Project is encouraged

PMCID

13. Resultant Data to be Provided to MESA and NHLBI. Recipient and Recipient's PI agree to provide MESA with a report every twelve (12) months during the term of this DMDA. The report shall include a description of the activities performed and Resultant Data obtained during the twelve (12) months before the reporting date. Recipient and Recipient's PI agree that MESA and NHLBI, in accordance with the NIH Data Sharing Policy, may distribute all such Resultant Data through established NHLBI procedures to all institutions requesting access for their identified qualified scientific investigators to such Resultant Data and that submit to NHLBI a signed DMDA comparable to this DMDA. Recipient and Recipient's PI will provide all Resultant Data in the precise electronic format specified by NHLBI or MESA.

Pre-review required

6. Publication. Prompt publication of the results of the Research Project is encouraged. MESA and NHLBI request that the Recipient’s PI provide to the authorized representative for the MESA Coordinating Center (named below) a copy of any abstract ten (10) days in advance of submission for publication and any manuscript or other disclosure document thirty (30) days in advance of submission for publication, in order to permit review and comment and ensure compliance with the confidentiality requirements of this DMDA.

Security

Security plan incorporated by reference

19. Recipient’s Responsibility to follow Data Security Best Practices. Recipient is aware of computer and data security best practices and will follow them for receipt, storage and use of Data and Resultant Data. An example of best practice guidelines can be found in http://www.ncbi.nlm.nih.gov/projects/gap/pdf/dbgap_2b_security_procedures.pdf.

Legal Details

Inadvertent Discovery

13. Resultant Data to be Provided to MESA and NHLBI
. . . . . If errors in family structure, especially paternity, are identified, Recipient and Recipient’s PI agree to contact the Coordinating Center Authorized Representative (named below), at the time such errors are identified, to receive detailed instructions as to how to provide such information and to whom. Recipient and Recipient’s PI further agree to refrain from any disclosure of such identified errors to anyone other than individual(s) specifically identified and authorized by MESA and NHLBI.

Extras Administration

Annual/progress report required

13. Resultant Data to be Provided to MESA and NHLBI. Recipient and Recipient’s PI agree to provide MESA with a report every twelve (12) months during the term of this DMDA. The report shall include a description of the activities performed and Resultant Data obtained during the twelve (12) months before the reporting date

IRB required

If errors in family structure, especially paternity, are identified, Recipient and Recipient’s PI agree to contact the Coordinating Center Authorized Representative (named below), at the time such errors are identified, to receive detailed instructions as to how to provide such information and to whom. Recipient and Recipient’s PI further agree to refrain from any disclosure of such identified errors to anyone other than individual(s) specifically identified and authorized by MESA and NHLBI.

Return/destroy media

21. Termination. This DMDA shall terminate at the earliest of: the completion of the Research Project; five (5) years after the effective date of this DMDA; abandonment of the Research Project; or violation by Recipient of any provisions of this DMDA not remedied within 30 days after the date of written notice by NHLBI and MESA of such violation. Upon termination of this DMDA:

(a) If Data provided to Recipient include Center for Medicare and Medicaid Services (CMS) data, Recipient agrees to destroy all copies of all Data received from MESA and consult with MESA and the NHLBI regarding the disposition of all remaining Materials. Recipient will verify that the MESA data have been destroyed in a written or electronic communication to the MESA Coordinating Center.

(b) If Data provided to Recipient do not include Center for Medicare and Medicaid Services (CMS) data, Recipient agrees to consult with MESA and the NHLBI regarding the disposition of all remaining Data and/or Materials.

Signer has authority to bind university

20. Amendments. Amendments to this DMDA must be made in writing and signed by authorized representatives of all parties