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), 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.

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. The applicant must have an NIH Commons user account or an NIH login. Institutions who are registered in the NIH electronic Research Administration (eRA) Commons can provide their investigators with a Commons user account.

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 complete a data access request using a standard form (SF) 424 available through the website and fill out the Data Use Certification form. Once filled, the applicant will need to print both the forms and complete the remaining portion of the Data Use Certification form, by adding his/her signature, and obtaining the countersignature of his/her institutional official who has signing authority This would normally be the individual who countersigns grant applications and who has been specified as a "signing official" in the NIH Commons. The signing official for small businesses may be the applicant himself/herself. Both completed forms must then be faxed to the NIH for approval using the fax number at the end of the Data Use Certification 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 data access request and countersigned Data Use Certification 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 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 insure that the application is complete and focus on protecting human subjects, e.g., verify that the institution has an FWA and that the Data Use Certification is appropriately signed and countersigned.

Forms

5) Non-NIH Staff: To complete the data access request:

a) Download and complete the form, (SF 424)

b) Fill out the Data Use Certification form by clicking here.

c) FAX both forms to NIH using the FAX number at the end of the Data Use Certification.

6) NIH staff: To complete data access request:

a) Download and complete the form, (SF 424)

b) Fill out the Data Use Certification form for NIH staff, by clicking here.

c) FAX both forms to NIH using the FAX number at the end of the Data Use Certification.