The data in the Pediatric MRI Data Repository is being made available to biomedical and biobehavioral researchers whose institutions are covered by a federalwide assurance (FWA), who are studying normal brain development, disorders, or diseases and/or developing image processing tools, and who agree to the terms of the Data Use Certification.

The principal investigator who is requesting access to the data agrees to comply with all applicable federal and state laws for the use of the data and to review the need for human subjects review (e.g., IRB review or exemption) with their appropriate institutional officials.

A Human Subjects Committee or IRB at the institution of each requester is responsible for determining whether the project for which the applicant is seeking access satisfies the requirements for the protection of human subjects. The institutional committee should determine whether the data contained in the repository should be considered human subjects data and whether it requires or is exempt from a full IRB review.

IRBs, whether within or outside of the U.S., are expected to operate under the Office of Human Research Protections (OHRP) approved assurance. The website for OHRP provides information regarding the process to obtain project assurances (http://ohrp.osophs.dhhs.gov/).

Prior to the release of these data, the NIH requires that the recipient and the recipient’s authorized institutional business official sign a Data Use Certification in which the recipient and his/her institution agree to protect the privacy of the parties, not to contact any party in the study, and other terms.

All obvious and inadvertent identifiers, including those specified by HIPAA regulations, have been removed from the data sets. However, because of the comprehensiveness of the data that is provided, there is a potential, though small, for identification of participants in these studies. Furthermore, because this is an ongoing longitudinal study, links to personally identifiable data exist. However, these will not be made available to recipients of data.

To obtain access to data, the applicant and his/her institutional official will need to execute a Data Use Certification by which they agree to:

  • Use the study dataset(s) only in accordance with the parameters described on the Pediatric MRI website for appropriate uses and in accordance with federal, state and local laws, and any relevant institutional policies;
  • Obtain an IRB review and approval or a determination that no human subjects are involved or that use of this dataset qualifies for an exemption under the Code of Federal Regulations Title 45 Public Welfare, Part 46 Protection of Human Subjects (45CFR46.101; http//www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm);
    Retain control over the data and agree not to distribute the raw data in any form to any entity or individual other than their research staff who agree to the terms within this Data Use Certification. The application and his/her institution acknowledge responsibility for ensuring appropriate use of these data by research staff subject to applicable law;
  • Agree that if the applicant changes institutions, a new Data Use Certification in which the new institution acknowledges and agrees to NIH policies and procedures and the terms of access will be required;
  • Agree not to use the study dataset(s) or any other information to identify or contact any individual study participant;
  • Agree not to claim, infer, or imply Governmental endorsement of any proposed research project, the entity, or personnel conducting the research project or any resulting commercial product(s);
  • Acknowledge that although reasonable efforts have been taken to ensure the accuracy and reliability of the data in the Pediatric MRI Data Repository, NIH does not and cannot warrant the results that may be obtained by using any data included therein. NIH disclaims all warranties as to the accuracy of the data in the study database or the performance or fitness of the data for any particular purpose.
  • Acknowledge that other researchers have access to the study datasets(s) and that duplication of research is a distinct possibility.

If the applicant publishes abstracts using data from the NIH Pediatric MRI Data Repository, he/she agrees to:

  • Cite the NIH MRI Study of Normal Brain Development and the NIH funding sources in the abstract as space allows and include a reference to the specific version of the study dataset analyzed.

If the applicant publishes manuscripts using data from the NIH Pediatric MRI Data Repository, he/she agrees to:

  • Include the specific version number of the dataset used and acknowledge the source of the data and the funding agencies by including a statement, such as the following:

    "Data used in the preparation of this article were obtained from the Pediatric MRI Data Repository created by the NIH MRI Study of Normal Brain Development. This is a multi-site, longitudinal study of typically developing children, from ages newborn through young adulthood, conducted by the Brain Development Cooperative Group and supported by the National Institute of Child Health and Human Development, the National Institute on Drug Abuse, the National Institute of Mental Health, and the National Institute of Neurological Disorders and Stroke (Contract #s N01-HD02-3343, N01-MH9-0002, and N01-NS-9-2314, -2315, -2316, -2317, -2319 and -2320). A listing of the participating sites and a complete listing of the study investigators can be found at http://www.bic.mni.mcgill.ca/nihpd/info/participating_centers.html."
  • and include the following statement:

    "This manuscript reflects the views of the authors and may not reflect the opinions or views of all the Study Investigators or the NIH."

  • Upon acceptance for publication, notify the NIH as to when and where a publication of a report from any research using the Pediatric MRI Data Repository dataset(s) will appear using the notification mechanism provided through the website.

Privacy Act notification:

The applicant further agrees that information collected from him/her as part of the Data Use Certification may be made public in part or in whole for tracking and reporting purposes. The Privacy Act Notification is provided pursuant to Public Law 93-579, Privacy Act of 1974, 5 U.S.C. Section 552a. Collection of the information requested (name of applicant, email address, degree, academic position, institution, FAX, department, address, name and title of authorized institutional business official) and FWA number is authorized under the Public Health Service Act, 42 U.S.C. 285p. The primary uses of this information are to document, track, monitor and evaluate use of the database, as well as to notify interested recipients of updates, corrections or other changes to the database.

The Federal Privacy Act protects the confidentiality of your NIH records. The NIH and any sites they designate to distribute the data will use the data collected from recipients for the purposes described above. In addition, the Act allows for the release of some information in your records without your permission; for example, if it is required by members of Congress or other authorized people. The information requested is voluntary, but necessary for obtaining access to data. In order for us to facilitate your access to data, you should complete all fields.

By signing and dating the Data Use Certification, the Recipient and his/her Institutional Officials certify their agreement to the NIH principles, policies and procedures for the use of the Pediatric MRI Data Repository dataset(s). By signing and dating the Data Use Certification, recipients further acknowledge that they will share the document with any research staff who will participate in the use of the Pediatric MRI Data Repository dataset(s). Institutional Business Officials also acknowledge that they have shared the document and the relevant NIH policies and procedures with appropriate institutional organizations.