Applicant and institution requirements

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), 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.

To apply for access to data in the Pediatric MRI Data Repository, applicants must be affiliated with an institution/organization that is covered by an FWA.

Those applicants and institutions that have an FWA can proceed to step 2.

1) For those who need to apply or to check their institution's FWA status or number:

Information on FWAs can be found at:
http://www.hhs.gov/ohrp/assurances/assurances_index.html

2) The applicant needs to fill out the Data Use Certification form. Once filled, the applicant will need to print the form and complete the remaining portions, which include adding his/her signature, as well as obtaining the countersignature by his/her institutional official who has signing authority.¹ The completed form must then be faxed to the NIH for approval using the fax number at the end of the form.

As part of the Data Use Certification, applicants and institutions certify that their institution is covered by an FWA and that they will 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 45CFR56.101.

3) Filling out the on-line Data Use Certification form will place the applicant on a list of pending applications at the DCC, where his/her name will remain until either approved or until an expiration date of one month later.

4) The completed and countersigned form must be faxed to an NIH representative for approval. This representative will act for the NIH Pediatric MRI Data Repository Access Committee, comprised of the four NIH program officers from the sponsoring institutes (NICHD, NIDA, NIMH, and NINDS). The approval process will not evaluate the scientific merit of requests, but will focus solely on protecting human subjects, e.g., verification that the institution has an FWA and appropriate signatures on the Data Use Certification.

5) To access and complete the Data Use Certification form, click here.

¹The signing official for small businesses may be the applicant himself/herself.