I. Introduction

The Human Health Exposure Analysis Resource (HHEAR) was established by the National Institute of Environmental Health Sciences (NIEHS) to provide analytical and laboratory services to support researchers who want to include environmental exposure assessment in their studies. The HHEAR Data Center at the Icahn School of Medicine at Mount Sinai will provide a data repository for storing epidemiologic and biomarker data that were previously collected in an approved HHEAR research study and for all new biomarker data generated by the HHEAR National Exposure Assessment Laboratory Network ("Lab Hubs").

This Data Users Guide covers the download of de-identified data of the HHEAR Data Repository.

II. Instructions

The Data User must read and agree to the terms and conditions of this HHEAR Data Use Guide and Publication policy.

III. Terms and Conditions

The Data User requests approval to download data of the HHEAR Data Repository for research purposes by agreeing to the following terms:

• 1
  Non-Identification of Subjects: Data User agrees that data will not be used to establish the individual identities of any of the study participants from whom data were obtained and/or contact the individual study participant.
• 2
  Restrictions on Sharing and Redistribution: Data User understands and agrees that data downloaded from the HHEAR Data Repository are provided solely for the Data User's research purposes and may not be shared with, distributed to, or accessed by any unauthorized individual. HHEAR data may not be posted to public websites, uploaded to external repositories, distributed through file-sharing platforms, or otherwise made publicly available without prior written authorization from the HHEAR Data Center and any other required approvals.
• 3
  Compliance and Access Privileges: Failure to comply with the terms and conditions of this Data Use Guide or the HHEAR Publication Policy, including unauthorized sharing, redistribution, or public posting of HHEAR data, may result in suspension or revocation of access privileges to the HHEAR Data Repository. The HHEAR Data Center may also notify the user's institution or take other appropriate actions as warranted.
• 4
  Data Disclaimers: Data User acknowledges that the HHEAR Data Center does not and cannot warrant the results that may be obtained by using any data included in the HHEAR Data Repository. The HHEAR Data Center disclaims all warranties as to the accuracy of the data in the HHEAR Data Repository or the performance or fitness of the data or data analysis tools for any particular purpose.
• 5
  Publication Policy: Data User agrees to read the HHEAR publication policy available through the following link: HHEAR Publication Policy
• 6
  Acknowledgments: In any and all oral and written presentations, disclosures, and publications (including abstracts, as space allows) based upon dataset(s) downloaded from the HHEAR Data Repository, the Data User agrees to cite the appropriate HHEAR components as described in the HHEAR publication policy: HHEAR Publication Policy
• 7
  Notification to HHEAR of Publication: Data User agrees to notify the HHEAR Data Center via email (HHEARsupport@mssm.edu) providing information on when and where a publication (or other public disclosure) from the Research Project will appear.
• 8
  Non-Endorsement; Liability: Data User agrees not to claim, infer, or imply endorsement by the United States Government, the Department of Health & Human Services, the National Institutes of Health, or the National Institute of Environmental Health Sciences of the Research Project, the entity, or personnel conducting the Research Project 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
  Security: Data User agrees to abide by the following Security Best Practices and Security Standards for the use and security of data. The HHEAR Data Repository conforms to HIPAA and NYS Privacy regulations. Keeping HHEAR Data Repository information secure through these best practices is of the utmost importance.

IV. Security Best Practices

• 1
  Do not attempt to override technical or management controls to access data for which you have not been expressly authorized.
• 2
  Do not use your trusted position and access rights to exploit system controls or access data for any reason other than in the performance of the proposed research.
• 3
  Do not allow others to use your account or access data that you have downloaded from the HHEAR Repository. Each user must obtain and use their own account to access HHEAR data. Downloaded data may not be shared with individuals who have not independently obtained authorization to access the data.
• 4
  Ensure that anyone directed to use the system has access to, and is aware of, HHEAR Data Repository Information Security Best Practices and Security Standards as well as all existing policies and procedures relevant to the use of the HHEAR Data Repository, including but not limited to 45 CFR Part 46.
• 5
  Follow the HHEAR Data Repository password policy which includes:
• • Create a password at least seven characters long that includes a combination of uppercase letters, lowercase letters, and numbers.
• • Change your passwords every six months.
• • Protect your HHEAR Data Repository password from access by other individuals - for example, store it electronically in a secure location.

V. Security Standards

• 1
  Store HHEAR data only on secure systems under the control of the authorized researcher and institution. HHEAR data must not be hosted on publicly accessible servers, websites, repositories, or cloud-based platforms that allow access by unauthorized users.
• 2
  Protect the data, providing access solely to authorized researchers who have obtained appropriate approvals. Downloaded HHEAR data may not be shared with unauthorized individuals, transmitted through unsecured methods, uploaded to external data repositories, or posted on publicly accessible websites or platforms.
• 3
  When you download HHEAR Data Repository data, download the data to a secured computer, with strong password protection, and encrypted storage.
• 4
  For the computers hosting HHEAR Data Repository data, ensure that they have the latest security patches and are running virus protection software.
• 5
  Make sure the data are protected from anonymous access from users both inside and outside of the organization.
• 6
  If you leave your office, close out of data files or lock your computer. Consider the installation of a timed screen saver with password protection.
• 7
  When finished using the data, destroy the data or otherwise dispose of it properly.