NICHD Data and Specimen Hub (DASH) Data Use Agreement


Available for download as a PDF here: NICHD DASH Data Use Agreement [137 kB]



INTRODUCTION



The Eunice Kennedy Shriver National Institute of Child and Human Development (NICHD) established the NICHD Data and Specimen Hub (DASH) as a data sharing mechanism that enables investigators to organize, store, and mine de-identified data from NICHD funded research studies for the purpose of secondary research use. In order to take full advantage of the research data already collected by NICHD funded investigators and maximize its research value, the NICHD has established policies and processes designed to make such data available through NICHD DASH, under appropriate terms and conditions, to the largest possible number of qualified investigators in a timely manner.

Data deposited in the NICHD DASH by the Submitters (defined below) have been stripped of all individually identifying information according to both (a) the standards set forth in the Department of Health and Human Services (HHS) Regulations for the Protection of Human Subjects and related guidance (which covers individually identifiable private information), and (b) the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule (which covers protected health information), and have been assigned random, unique codes.

However, the potential for deducing the identity of an individual from data stripped of identifiers is constantly evolving, due to the large number of individual data points and the advancement of computational tools. Therefore, to protect and promote the confidentiality and privacy of the individuals whose data have been deposited into the NICHD DASH, the NICHD is requiring all requesters of such data to sign and agree to the terms of this Data Use Agreement (DUA) as a condition of access. A requester who is granted access to NICHD DASH data is expected to adhere to the specifications of this DUA, as executed in its final form. Failure to do so could result in denial of further access to NICHD DASH data.

Submitters have made a substantial long-term contribution to public health by submitting data to the NICHD DASH. The NICHD encourages investigators who request and receive access to the data in the DASH to adhere to appropriate and reasonable conditions for data use, collaborative relationships with the Submitters, and to ensure proper acknowledgement of the Submitters’ contribution.


NICHD DASH DATA USE AGREEMENT



This Data Use Agreement (the “DUA”) is by and between

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (“NICHD”),





(NICHD Division Director/Designee), and





(The “Recipient” and “Recipient Institution”),
and is effective as of the date of the last signature affixed hereto
(the “DUA Effective Date”).

I. DEFINITIONS

The following definitions apply for the purposes of this DUA:

  • “Approved Affiliates” are individuals within the same institution as the Recipient, for whom access to data is required to carry out the Research Plan.

  • “Collaborators” are individuals collaborating with the Recipient, requiring access to the Data, and who are employed by a different institution than the Recipient.

  • “Data” refers to data and information collected and recorded from participants in research studies that are available through the NICHD DASH. For the purposes of this DUA, any associated study documentation provided along with the Data are included in this definition of Data. This Data is subject to release to the Recipient, according to the criteria laid out in the NICHD DASH Policy, which includes the execution of a NICHD DASH DUA, approval by the NICHD DASH Data Access Committee, and, if applicable, by study-specific entities.

  • “Data Request Form” is the online form completed by the requester during the Data request process in the NICHD DASH

  • “NICHD DASH Administrator” is the individual who interfaces with DASH users and manages Data submissions and requests

  • “Recipient” is a lead individual who receives access to the Data on behalf of the Recipient Institution. The Recipient may share the Data only with individuals who are included under the “Approved Affiliates” list shown in Appendix A.

  • “Recipient Institution” is an institution, e.g., a non-profit or for-profit organization or corporation, which is the employer of a Recipient. The Recipient Institution must have an approved Assurance from the Department of Health and Human Services Office for Human Research Protections and the institution’s name should be stated in the face page of the executed DUA.

  • “Research Plan” is a description of the proposed research that serves as the basis for the Data access request. The Research Plan must include the title of the Research Project, description of the research need (study aims/goals, hypothesis that will be tested, methodology to be used, and the expected outcomes), and, if required by the Submitter, a design and analysis plan.

  • “Study” is the research study that collected the Data described in this DUA.

  • “Submitter” is an investigator who has submitted Data to the NICHD DASH, according to the criteria laid out in the NICHD DASH Policy.

Below is a list of general responsibilities based on the listed roles. Specific responsibilities pertaining to the terms and conditions of the DUA are incorporated directly into the DUA.

Roles Responsibilies
Approved Affiliates • Acknowledge and agree to abide by the terms of the executed DUA
Collaborators • Execute separate DUA(s) with the NICHD before receiving access to the Data that is the subject of the DUA based on which Data has been granted to the Recipient
NICHD DASH Administrator • Communicates with the Recipient regarding any applicable terms and conditions pertinent to the DUA
Recipient • Acknowledge and agree to abide by the terms of the executed DUA
• Share the Data only with individuals who are included as “Approved Affiliates”
• Oversee the Approved Affiliates who are provided access to the Data
• Assume responsibility for the compliance of all Approved Affiliates with the terms and conditions of this DUA
• Maintain compliance with the human subjects protection requirements, if applicable, under 45 CFR 46 and local rules
• Contribute to the analytic effort and public disclosure of study results
Recipient Institution • Execute the NICHD DASH DUA
• Acknowledge and agree to abide by the terms of the executed DUA


II. TERMS AND CONDITIONS


The Recipient requests approval to access Data listed in Appendix B from the NICHD DASH for purposes of the Research Plan, which is specified in the DASH online Data Request Form and incorporated herein by reference. The Recipient agrees to the following terms:

  1. Non-Transferability of Agreement
    This DUA is not transferable. There are no third party beneficiaries to this DUA. Any other individual, including any Collaborator that wishes to receive Data from the NICHD DASH is required to execute a separate DUA. The following situations are examples of when the execution and approval of a new DUA is required:
    1. Any substantive change to the scope of the Research Plan
    2. The appointment of another Recipient to complete the Research Plan
    3. Change to the Recipient Institution. *Note, if the Recipient wishes to retain access to the Data, but has changed the institution under which this DUA was executed, a new DUA in which the new institution acknowledges and agrees to the provisions of the DUA is necessary. The Recipient agrees to notify the NICHD DASH Administrator about a change of institution within 30 days of starting at the new institution.

  2. Approved Parties for Access to Data
    The NICHD authorizes the Recipient and the Approved Affiliates identified in Appendix A to access the Data. The Recipient, and each Approved Affiliate listed, agree to the terms of this DUA.

  3. Non-Distribution of Data
    The Recipient agrees to retain control over the Data, and further agrees not to sell the Data, in any form, to any entity or individual or to otherwise distribute the Data to anyone other than the Approved Affiliates. The Recipient shall not transfer any Data obtained or accessed under this DUA to individuals or organizations not specified in this DUA, except as required by law.

  4. Research Use of the Data
    Data obtained from the NICHD DASH listed in Appendix B will be used by the Recipient for studies and analysis specifically indicated and described in the Research Plan. The Recipient agrees that Data will not be used in any research that is not approved by the NICHD DASH Data Access Committee as part of the Research Plan.
    The Recipient will submit a separate and completed DUA for each Research Plan for which Data are requested. A separate and fully executed DUA is also required when requesting new versions of the Data deposited at a later time by the Submitter.

  5. Data Access for Research
    Data are eligible for access by qualified investigators pursuant to the terms set forth in this DUA. The Recipient acknowledges that other investigators also have access to the same Data in the NICHD DASH, and that downloading and utilization of the same Data that the Recipient received from the NICHD DASH as well as the duplication of research from such Data are distinct possibilities.

  6. Data Disclaimers
    The Recipient agrees that although all reasonable efforts have been taken to ensure the accuracy and reliability of the Data, the NICHD does not and cannot warrant the results that may be obtained by using any Data included therein. The NICHD disclaims all warranties as to the accuracy of the Data in the NICHD DASH, or the performance or fitness of the Data for any particular purpose.

    It is the specific intent of the NICHD and the Recipient that nothing contained in this DUA gives rise to any right or cause of action, contractual or otherwise, in or on behalf of the individuals whose Data are used or disclosed pursuant to this DUA.

    The Recipient understands and acknowledges that any request for access to the Data is undertaken at their sole risk and with no expense applied to any study or to the NICHD.

  7. Prohibition on Identification of Subjects
    The Recipient shall not use Data to establish (or attempt to establish) the individual identities of any of the individuals from whom Data were obtained. In the event the Recipient discovers, or is able to deduce, the identity of a specific individual, the Recipient shall immediately notify the NICHD and suspend the use of the Data until further approval can be obtained. The Recipient shall not reveal the individual’s identifying information, or any associated information (such as clinically significant information in the Data), to any person or attempt to contact the individual.

    If, upon the use of the Data, the Recipient discovers any identifying information or any associated information (such as clinically significant information), the Recipient shall immediately notify the NICHD DASH Administrator and the Principal Investigator of the study from which the Data was obtained.

  8. Non-Endorsement and Liability
    The Recipient agrees not to claim, infer, or imply endorsement by the United States Government, the Department of Health and Human Services (HHS), the National Institute of Health (NIH), or the NICHD of the Research Plan, the entity or personnel conducting the Research Plan, or any resulting commercial product(s). The United States Government assumes no liability except to the extent provided under the Federal Tort Claims Act (28 U.S.C. § 2671-2680).

  9. Compliance with the Recipient's Institutional Requirements
    The Recipient acknowledges that access to the Data, if provided, is for research that is approved by the Recipient’s Institution, which must be operating under an Office of Human Research Protections (OHRP)-approved Assurance, which may require Institutional Review Board (IRB) or equivalent institutional approval, if applicable. Furthermore, the Recipient agrees to comply with all applicable rules for the protection of human subjects, which may include Department of Health and Human Services (HHS) regulations at 45 C.F.R. Part 46, and other Federal and State laws for the use of this Data as well as local policy. The Recipient agrees to report any proposed change in the Research Plan promptly to the NICHD. This DUA is made in addition to, and does not supersede, any of the Recipient Institution’s policies or any applicable local, State, and/or Federal laws and regulations that provide additional protections for human subjects.

  10. Data Disclosure/Breach
    The Recipient shall notify the NICHD DASH Administrator immediately upon the receipt of any legal, investigatory, or other demand for disclosure of Data. The Recipient shall notify the NICHD DASH Administrator promptly upon discovering any breach, or suspected breach, of any unauthorized disclosure of Data. Such prompt notification of a breach or suspected breach is not necessarily, but may be, grounds for DUA termination. The NICHD may also seek injunctive relief against the Recipient to prevent any disclosure of Data by the Recipient to anyone other than the NICHD.

  11. Intellectual Property
    Data in the NICHD DASH is made available to the research community for their use to further the research and development of ideas that will benefit and improve public health. The NICHD encourages the development of new diagnostics, therapeutics, or other interventions building on basic discoveries enabled through Data obtained from the NICHD DASH. Recipients are free to pursue patent protection on any inventions or discoveries developed through their analysis and use of NICHD DASH Data.

  12. Security Requirements
    The Recipient shall follow the security requirements listed below:
    1. Maintenance of, and access to, Data
      1. The Recipient shall retain the original version of the Data and may make no copy or extraction of the Data available to anyone other than the Approved Affiliates, who will be required to create an account and register in the NICHD DASH.
      2. The Recipient shall keep the Data secure and confidential at all times and adhere to the Recipient Institution’s information security best practices in all aspects of data management to assure that only Approved Affiliates have access to the Data obtained through this DUA.
    2. Retention of Data: Upon research termination or the termination of this DUA, the Recipient and all Approved Affiliates shall destroy all copies of the Data, except as required by publication practices or law to retain them.


  13. Format of Data
    Data under this DUA may take many formats, depending upon the available technology.

  14. Return of New Datasets
    The Recipient agrees to submit to the NICHD DASH any new datasets generated from the Data by either the date of acceptance of publication of the main/primary findings or one year after the analysis of the Data for a particular Research Plan is completed, whichever is the first to occur.

  15. Acknowledgments
    The Recipient agrees to acknowledge the contribution of the Principal Investigator(s) who conducted the original study from which the Data were generated, the funding organization(s) that supported the work, and the NICHD DASH in all resulting oral or written presentations, disclosures, or publications of the analyses, whether or not the Recipient is collaborating with the Submitter(s). Any manuscript resulting from the Data should include an acknowledgement, as specified by the Submitter(s), which can be obtained from the NICHD DASH when processing the request online.

    If the Research Plan involves collaboration with a Submitter or NICHD staff, then the Recipient will acknowledge the Submitter or NICHD staff as co-authors, as appropriate, on any publication. In addition, the Recipient agrees to include a reference to the Data analyzed and to cite NICHD DASH and the federal funding sources in abstracts as space allows.

  16. Permission to post information publicly
    The Recipient agrees to permit the NICHD to post the Recipient’s research use of the NICHD DASH along with the Recipient’s name and the name of the Research Institution on the NICHD DASH website.

  17. Annual Report
    As a means to determine the effectiveness of the NICHD DASH, the Recipient will submit to the NICHD DASH an Annual Report with the following:
    1. Summary of research accomplishments, including a list of oral or written presentations, disclosures, abstracts, or publications resulting from the use of the Data
    2. Publication number (or a copy) of any published patent application for newly discovered or developed technologies
    3. Any updates to the list of Approved Affiliates


  18. Data Use Reporting
    When requested by the NICHD, the Recipient agrees to respond to requests for information on the effectiveness of the NICHD DASH Data, workflows, and procedures (e.g., ease of access and use, utility of Data, policy compliance, and suggestions for improving data access, or the program).

  19. Privacy Act Notification
    The Recipient agrees that information collected from the Recipient, such as name, contact, funding, and data use information may be used in part, or in whole, for tracking and reporting purposes. This Privacy Act Notification is provided pursuant to Public Law 93-579, Privacy Act of 1974, 5 U.S.C. Section 552a. The authority for the collection of the information requested from the Recipient comes from the authorities regarding the establishment of the National Institutes of Health (NIH), its general authority to conduct and fund research and to provide training assistance, and its general authority to maintain records in connection with these and its other functions (42 U.S.C. 203, 241, 289l-1 and 44 U.S.C. 3101), and Sections 301 and 493 of the Public Health Service Act. These records will be maintained in accordance with the Privacy Act System of Record Notice 09-25-0156 (http://oma.od.nih.gov/ms/privacy/pa-files/0156.htm) covering “Records of Participants in Programs and Respondents in Surveys Used to Evaluate Programs of the Public Health Service (PHS), HHS/PHS/NIH/OD.”

    The primary uses of this information are to document, track, monitor, and evaluate the use of NICHD DASH Data, as well as to notify interested parties of updates, corrections, or other changes to the Data.

  20. Penalties for Violation of the DUA
    The Recipient agrees that in the event that the NICHD determines, or has a reasonable belief, that the Recipient has violated any terms of this DUA, the NICHD will provide the Recipient with a 30 day notice to remedy the violation. If the Recipient does not rectify the violation, the NICHD, at its sole discretion, will terminate the DUA and close the Recipient’s NICHD DASH account. Accounts that have been closed due to a violation of this DUA may be reactivated upon the submission of evidence of remediation that is acceptable to the NICHD, a revised online data request, and a new DUA. If the Recipient commits a material breach of this DUA, the NICHD may, in its sole discretion, terminate this DUA with 10 days written notice and require that the Recipient destroy the Data as instructed by NICHD. The following situations are examples of material breaches:
    1. Unauthorized distribution of Data (see Clause 3)
    2. Identification of subjects in the Data obtained from the NICHD DASH (see Clause 7)
    3. Unauthorized Data disclosure (see Clause 10)
    4. Retention of Data after the DUA expiration date (see Clause 12.b.)

    The Recipient understands that as a result of this determination, or reasonable belief that a material breach of this DUA has occurred, the NICHD may also refuse to release new data to the Recipient.
    The Recipient also agrees to immediately report violations of the NICHD DASH Policy by the Approved Affiliates who are subject to this DUA to the NICHD DASH Administrator.

  21. Termination of the DUA
    Either the NICHD or the Recipient may terminate this DUA without cause by providing 30 days written notice to the other party. This DUA may also be terminated by mutual written agreement between the NICHD and the Recipient. In addition to the specific circumstances whereby the NICHD may terminate this DUA (as indicated under various terms and conditions of this DUA), the NICHD reserves the right to terminate the DUA when the Submitter has withdrawn the Data from the NICHD DASH – either permanently or to submit a redacted or revised dataset. In both cases, the NICHD will terminate the DUA and instruct the Recipient to destroy the Data. If and when a redacted or revised dataset is deposited by the Submitter in the NICHD DASH, the Recipient may choose to execute a new DUA to obtain this new dataset.

  22. Term of the DUA
    This DUA will remain in effect for a period of three years from the DUA Effective Date and will automatically expire at the end of this period unless terminated earlier or renewed. The Recipient may request that the DUA be renewed three months prior to the expiration date by submitting an application to the NICHD DASH Administrator for renewal of the DUA.

  23. Amendments
    Amendments to this DUA must be made in writing and signed by the Recipient Institution and the NICHD. Any amendment must be submitted and approved; the DUA becomes effective only following the date of approval.