Information for Human Subjects Committees and Institutional Review Boards
To: Human Subjects Committees and Institutional Review Boards
Re: Considerations for Approval of Studies Involving the Pediatric MRI Data Repository from the NIH MRI Study of Normal Brain Development
Welcome to the Pediatric MRI Data Repository website. This site provides information about the NIH MRI Study of Normal Brain Development and resulting Pediatric MRI Data Repository.
The overarching goal of the NIH MRI Study of Normal Brain Development is to foster a better understanding of normal brain maturation as a basis for understanding atypical brain development associated with a variety of disorders and diseases affecting children and adults. This ongoing longitudinal, multi-site study is producing a rich database of MR images and correlated clinical/behavioral data on over 500 children, newborn to young adult.
A Human Subjects Committee or IRB at the institution of each requester is responsible for determining whether the project 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.
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.
Prior to 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 agrees to protect the privacy of the parties, not to contact any party in the study, and other terms.