ARIC Data User Registration

Data Use Agreement Terms and Conditions

For the purposes of this agreement, "Data" refers to data and associated records collected and recorded from ARIC Study subjects through periodic examinations conducted pursuant to the ARIC Investigators' Contract with the NHLBI, affiliated ancillary studies, and derivative data from linkages or laboratory studies of stored specimens.  ARIC data are provided to investigators in either the de-identified (NP, i.e., non-PHI) format where dates are converted to follow-up days (governed by DUA and local IRB which can be exempt or non-human subjects research) or the original format with dates (governed by DUA and the ARIC single IRB at Johns Hopkins University).  Data are provided to you for approved research purposes under the following stipulations:

1. I understand that the data is owned by the NHLBI, who is allowing me to use it for research purposes only. I will not use the data for any other project or investigation unless I receive written permission from the data's owner. I will abide by project guidelines, where they are specified, in the preparation and presentation of manuscripts and abstracts.
2. I will cite the data's source (as specified by the owner) in all of my publications and academic work based on this data. I will submit all abstracts, articles, manuscripts and other publications for review according to the terms established by the ARIC study policy.
3. I will not allow any access to the data to anyone other than myself (or ARIC approved individuals).
4. I will guard these data as carefully as I guard my personal information (such as social security number, credit card numbers and bank statements), because I understand that I am responsible for preventing others from accessing study participants' personal health information without my permission. Therefore, I will ensure that the computers, data files, laboratory logs and notebooks, archival files, and other materials containing the data will be secure at all times. I realize that this data use agreement may authorize the ARIC principal investigator or their designees to verify that the information is secure, and I agree to allow such verification of the data's security when the principal investigator/owner is acting in accordance with the aforesaid agreement.
5. I realize the information may be disclosed under special circumstances (i.e. a governmental authority lawfully requests access to this information). However, I will not disclose any of the data and instead ask the principal investigator/owner to address any requests for disclosure of this information.
6. I will comply with the study participants' informed consent and agree to the following:

• • I will not use the data for any purposes other than those explicitly authorized by the study participants in their informed consent.
  • Data linkage or analyses that require personal identifiers are not covered by the terms of this data use agreement. If personal identifiers are provided as part of this agreement, their use and safekeeping are governed by the provisions of the IRB of Johns Hopkins Medical Institutions (ARIC's single IRB), the University of North Carolina (Data Coordinating Center and its procedures) and that of the recipient institution.
  • I will not publish, share, disclose or release any identifiable information (also known as identifiers) of the study participants. This implies that only summary statistics will be used in reports and publications.
  • I will not attempt to link records included in the data to any other identifiable information without written authorization from the principal investigator and the data's owner.
  • I will not attempt to determine the study participants' individual identities.

7. I will comply with the IRB requirements of my local institution.

8. Within five years of receiving the data I will either: a) return all data to the owner specified above (this is satisfied by limiting the data storage to repositories at ARIC participating sites which allow for long term storage and archiving of datasets and research results in a secure manner which is preferable to long term storage by individual users); b) request an extension for use of the data; or c) destroy all data in accordance with the principal investigator's instructions. In the latter case, I will notify the owner in writing that the data have been destroyed. This document will be governed under the law of the US state that has jurisdiction over the forms authorizing the principal investigator and this study to use the data. In the event that the governing state is not specified, this document shall fall under Maryland law.