Terms of Access Agreement

I request access to data housed at the biorepositories supported by the Foundation for Peripheral Neuropathy at Indiana University, the Peripheral Neuropathy Research Registry (PNRR), for the purpose of scientific investigation, teaching, or the planning of clinical research studies and agree to the following terms:

Section I: Access, Use, and Safeguards
  1. Recipient understands that any data the recipient receives pursuant to this agreement is for the purpose(s) of determining study feasibility, budget, methods, or protocol development.

  2. Recipient understands the data the recipient receives pursuant to this agreement are de-identified in accordance with the HIPAA Privacy Rule.

  3. Recipient understands the recipient will be required to complete a Material Transfer Agreement (MTA) to receive samples and a Data Use Agreement (DUA) to receive sample unblinded data for the purpose of analysis or publication.

  4. Recipient will not attempt to establish the identity of, or attempt to contact any of the subjects with data in PNRR.

  5. Recipient will not attempt to identify any specific study sites, unless PNRR has approved such identification as part of the recipient's project's protocol.

  6. Recipient understands that distributing these data to a third party is prohibited, and therefore the recipient will not distribute these data beyond the uses outlined in this agreement. A third party is defined as anyone who is not a collaborator or co-author on the analyses defined in the recipient's proposal.

  7. Recipient agrees that any use of artificial intelligence (AI) tools, including generative, analytical, or large language models, in connection with the Data must be conducted in a manner that guarantees the security and confidentiality of data inputs and outputs. Recipient will not use AI tools or platforms that transmit or process data through public-facing, cloud-hosted, or third-party systems unless those platforms:

    • Provide contractual assurances of confidentiality,

    • Do not use inputs or outputs for model training, product development or commercial purposes, and

    • The platform meets established standards for secure data handling of sensitive research data, including, at a minimum, data encryption, appropriate and reasonable access controls, and audit logging.

    Recipient understands that utilizing AI tools, including generative and analytical models, carries a potential risk of unintentional data disclosure. Recipient understands that due to how these tools store and process information, data may be sent, saved, viewed, or used in unforeseen ways. Recipient understands that it is the recipient's responsibility to prevent the misuse of data received under this agreement by conducting appropriate due diligence and only using secure systems. Recipient further understands that recipient will be held responsible for data breaches or other misuse of data resulting from recipient's decision to use AI to analyze the Data.

  8. Recipient will require anyone on the recipient's team who uses the data, or anyone with whom the recipient shares these data, to comply with this Terms of Access Agreement.

  9. Recipient will accurately provide the requested information about persons who will use the data and analyses that are planned using these data.

  10. Recipient will comply with any rules and regulations imposed by recipient's institution and its institutional review board in requesting and using these data.

  11. Recipient understands the Data delivered pursuant to this Agreement is understood to be provided "AS IS." DATA PROVIDER MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED, PERTAINING TO THE DATA.

  12. Recipient understands that any data the recipient downloads may change as new quality assurance measures are implemented and data records are updated.

  13. Recipient will ensure that Investigators who utilize data obtained from PNRR use appropriate administrative, physical, and technical safeguards to prevent use or disclosure of the data other than as provided for by this Agreement.

  14. Recipient will report any use or disclosure of the data not provided for by this Agreement of which the recipient becomes aware within 15 days of becoming aware of such use or disclosure.

Section II: Project Updates
  1. Recipient will respond promptly and accurately to PNRR's requests for updates on the status of the recipient's project for which the recipient requested access to the PNRR catalogs.

  2. Recipient will review the data documentation provided by PNRR and consult with PNRR research coordinators in order to ensure the accurate use and description of study data in the recipient's grant application, budget, proposed analysis methods, or protocol development.

  3. Recipient understands that the recipient's access to this data will expire in 1 year, and if the recipient wishes to retain access for an additional year, the recipient will be required to provide an update on the project or projects for which the recipient is using the PNRR catalogs.

  4. Recipient understands that failure to abide by the requirements found in this Agreement will result in termination of the recipient's privileges to access PNRR data.