NHLBI ARIC Study
Data and Materials Distribution Agreement
For Principal Investigators of the NHLBI ARIC Study
The undersigned parties hereby enter into this Distribution Agreement as of the date specified on the final page hereof.
PRELIMINARY STATEMENT
To enhance scientific productivity and increase the use of its valuable data base, the ARIC Study has implemented a system of data analysis for publication that relies on the distribution of analysis files by the ARIC Coordinating Center to the Principal Investigators of the ARIC agencies. Biologic materials may also be distributed by the ARIC laboratories to the Principal Investigators of ARIC. The data distributed by the Coordinating Center of the ARIC Study have been stripped of all personal identifiers, but because of the nature of the data and the geographic specificity of the sites at which the study subjects were drawn, vigilant efforts are necessary to avoid the inadvertent or deliberate individual identification of some subjects. To protect the confidentiality and privacy of participants, investigators granted access to these data and materials must adhere to the requirements of this Distribution Agreement. Failure to comply with this Agreement can result in denial of further access to data and samples from the ARIC Study. Violation of the confidentiality requirements of this agreement may leave requesting investigators liable to legal action on the part of ARIC Study participants and their families, or the universities collaborating in the ARIC Study.
RECIPIENT
The recipient is a principal investigator of the NHLBI ARIC Study.
AGREED TERMS AND CONDITIONS
The Clinical Data, Biological Material, and/or Genetic Analysis Data from the ARIC Study will be used by Recipient solely for the purposes authorized by the Steering Committee of the ARIC Study, and its Publications Committee.
Supervision. Under supervision by the Recipient, co-investigators at the Recipient's Institution may use these Clinical Data and Biologic Materials for the purposes of statistical analysis and publication according to the policies established by the Steering Committee of the ARIC Study. All investigators who use these data and/or materials must review the guidelines and sign this agreement to abide by them.
Nontransferability. This Agreement is not transferable. Recipient agrees that substantive changes made to the Research Project described above, and/or appointment by Recipient of another Principal Investigator require execution of a new Agreement in which the new Principal Investigator and/or new Research Project are designated.
Publication. The purpose for the distribution of these data is the prompt publication of the results, through the channels established for this purpose by the Steering Committee of the ARIC Study.
Pre-Publication Review. The Recipient agrees to provide to the ARIC Study, through the channels provided, a copy of any abstract and any manuscript in advance of submission for publication, in order to permit review and comment, and ensure compliance with the terms of this Agreement.
Acknowledgments. Recipient agrees to acknowledge the National Heart, Lung, and Blood Institute and the ARIC Study in any and all oral and written presentations, disclosures, and publications resulting from any and all analyses of the Data and/or Materials received under this agreement.
NonIdentification. Recipient agrees that Biological Material and Clinical 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 subjects from whom Clinical Data or Biological Materials were obtained.
Use Limited to Research Project. Recipient agrees that neither Clinical Data nor Biological Materials, their progeny, or unmodified or modified derivatives thereof will be used in any experiments or procedures that are not disclosed and approved as part of the Research Project.
Use in Human Experimentation Prohibited. Recipient agrees that Biological Material, its progeny, and unmodified or modified derivatives thereof will not be used in human experimentation of any kind.
Compliance with Subjects' Informed Consent. Recipient agrees that the Clinical Data, Biological Materials, their progeny, or unmodified or modified derivatives thereof will not be used for any purpose contrary to a subject's applicable signed informed consent document(s). It is the responsibility of the Recipient's Principal Investigator to consult with the Institutional Review Board (IRB) at the Recipient's institution to ascertain, specifically and in detail, the terms and conditions of applicable ARIC Study informed consent documents.
No Distribution, Avoidance of Waste, Return of Materials. Recipient agrees not to transfer Biological Material, its progeny, or unmodified or modified derivatives thereof, with or without charge, to any other entity or any individual without specific approval by the ARIC Steering Committee or without receipt of the ARIC Blood Sample Specification form from the Coordinating Center for the approved transfer. Recipient agrees, in handling the Biological Materials, to make reasonable efforts to avoid contamination or waste of the samples. Recipient also agrees to further transfer data only to other ARIC co-investigators for approved ARIC manuscript proposals and to execute a transfer agreement with the recipients that the data would be used only for the specific approved manuscript proposal, that the resulting manuscript would not be submitted to a journal or an abstract to a meeting without specific ARIC approval for the purpose, under existing ARIC Publications procedures, and that the data would be destroyed after such use. Further, recipient agrees to notify the ARIC Coordinating Center when transferring manuscript analysis data to an ARIC co-investigator, with name of co-investigator, date, and manuscript number.
Recipient's Resulting Genetic Analysis Data to be Provided to Coordinating Center of the ARIC Study. Upon request from the Coordinating Center of the ARIC Study the Recipient agrees to provide Archival copies of all Clinical data and Genetic Analysis Data previously distributed by the ARIC Study, or developed based on data or biologic material distributed by the ARIC Study.
Recipient's Responsibility for Handling Biological Materials. Recipient acknowledges that Biological Material may carry viruses, latent viral genomes, and other infectious agents in an unapparent state. The Recipient agrees to treat Biological Materials as if they are not free of contamination, and agrees that Biological Materials will be handled only by trained persons under laboratory conditions that afford adequate biohazard containment. By accepting Biological Materials, Recipient assumes full responsibility for its safe and appropriate handling.
Recipient's Compliance with IRB Requirements. Recipient acknowledges that the conditions for use of these Clinical Data and Biological Material have been approved by the Recipient's IRB in accordance with Department of Health and Human Services regulations (45 CFR Part 46). Recipient agrees to comply fully with all such conditions and with the subjects' informed consent documents, on record with the ARIC Study. Recipient agrees to report promptly to the ARIC Study any proposed change in the research project and any unanticipated problems involving risks to subjects or others. Recipient remains subject to applicable State and local laws and regulations and institutional policies that provide additional protections for human subjects.
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Conflict of Interest.The Recipient agrees to disclose promptly any direct or indirect conflicts of interest, such as affiliation(s) with any organization with any financial interest, whether direct or indirect, in the subject matter of the proposed research employing Clinical Data or Biologic Materials from the ARIC Study, to the ARIC Study investigators, and to review and monitor or manage conflicts of interest and commitment as required by 42 CFR Part 50, Subpart F. Examples of such affiliations are employment consultancies, expert testimony, honoraria, stock, or retainers that may affect the work being considered.
Amendments. Amendments to this Distribution Agreement must be made in writing and signed by authorized representatives of both parties.
Termination. The ARIC Study may terminate this Distribution Agreement if Recipient is in default of any of its conditions and such default has not been remedied within 30 days after the date of written notice by the ARIC Study of such default. Upon termination of this Distribution Agreement, Recipient agrees to return all Clinical Data and all unused Biological Materials to the ARIC Study.
Disqualification, Enforcement. Failure to comply with any of the terms specified herein may result in disqualification of Recipient from receiving additional data and/or materials from the ARIC Study. The ARIC Study shall 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 agreement, the limitations on the use of the data or materials provided, or both. Proceedings may be initiated against the violating party, legal representatives, and assigns, for a restraining injunction, compensatory and punitive damages, mandamus, and/or any other appropriate proceeding in law or 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 acknowledges that a breach or threatened breach of the confidentiality requirements or use limitations of this agreement may subject Recipient to legal action on the part of ARIC Study participants and their families, or the universities participating in the ARIC Study.
Accurate Representations. Recipient expressly certifies that to the best of his/her knowledge and belief the contents of any statements made or reflected in this document are truthful and accurate.
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This Distribution Agreement is entered into as of:
RECIPIENT:
Name of the Principal Investigator at the Recipient Entity:
Principal Investigator's Surface Mail Address:
Principal Investigator's E-Mail Address:
Principal Investigator's Telephone Number:
Principal Investigator's Fax Number:
Signature and Date: Principal Investigator:
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