The National Institute of Mental Health (NIMH) is requesting approval of the revised Data Submission Agreement (DSA) and Data Use Certification (DUC) information collection documents, which collect information about researchers submitting data and requesting access to shared data in the NIMH Data Archive (NDA). The NDA is an infrastructure for sharing human subjects research data and tools to further collaboration and scientific discovery.
US Code:
42 USC 203
Name of Law: Public Health Service Act
To provide a segmentation of the research domains supported, we added a hyperlink leading to the current list of permission groups and their data access requirements on the DUC. Because the NDA requires one DUC for each request for access to a permission group, the DUC now includes fillable fields for the description, data use limitations, IRB approval, and institutional sponsorship for the chosen permission group.
Additionally, the Data Use Terms and Conditions on the DUC have been updated. Specifically: new details have been added to the section titled âNo Distribution of Dataâ; the section titled âAnnual Update/Research Use Reportingâ has been deleted; the section âData Access for Researchâ has been deleted; and a new section, âDeletion of Dataâ has been added. Some sections have also been reordered or renamed, but the content of these sections has not been changed.
Another change to the DUC concerns applications for renewal of an expiring DUC. The DUC section titled â4. Renewal Applicants Onlyâ has been reordered and renamed to â2. Progress Updates (For Renewal Requests Only).â A new fillable field titled âProgress Report Statementâ has been added to this section for renewal requestors to describe progress on research they have conducted using data from the NDA.
Another overarching change relates to the requirements for accessing data. In the past all data access requests have required sponsorship by an Institution with an active FWA, which includes the signature of an institutional signing official. New research domains have been incorporated into the NDA that do not carry this level of requirement. A newly added Individual sponsorship does not require an active FWA or institutional business official signature but does still require the requestor to agree to the terms of data access. In both cases, new groups from which data are requested have been added to the DUC. The DSA has added the collection of additional grant related information that is targeted toward researchers not funded by the NIH who are requesting permission to submit data. Because the funding information is not accessible by NDA staff, the information is requested on the form.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Form 2 NDA Data Use Certification (DUC)
pub 30-day FRN2020-22932.pdf
D_NDA Consult List_09082020.docx
NDA Data Use Certification (DUC)