Expiration Date: XX/XX/XXXX
Public reporting burden for this collection of information is estimated to average 60 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering, and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-NEW). Do not return the completed form to this address.
This Data Use Certification (DUC) Agreement outlines the terms of use for working with data from participants who identify as American Indian/Alaska Native (AI/AN) in NIH Brain Development Cohorts, including but not limited to the Adolescent Brain Cognitive DevelopmentSM (ABCD) Study. Recipients who intend to disseminate findings from descriptive and/or inferential analyses of AI/AN data (e.g., via presentations, pre-prints, publications, website posts, etc.) must submit this DUC after receiving approval of a general NIH Brain Development Cohorts DUC.
The ABCD Study® is a longitudinal study of nearly 12,000 youth beginning at ages 9-10 and continuing for 10 years into early adulthood to assess factors that influence individual brain development trajectories and functional outcomes. The ABCD Study has adopted an open science model, making data available to researchers around the world, including fast-track raw neuroimaging data that are released on an ongoing basis, as well as curated data released annually. The data are available to authorized users affiliated with an NIH-recognized institution with Federal Wide Assurance (see https://ohrp.cit.nih.gov/efile/FwaStart.aspx for more information). Authorization requires users to submit a signed DUC that includes signature by the user’s institution business official.
The NIH encourages the use of these resources to facilitate rapid scientific progress. To take full advantage of such resources and maximize their research value, it is important that data are made broadly available, with appropriate terms and conditions, to the largest number of qualified investigators in a timely manner.
Researchers accessing human subjects’ data and their research institution are responsible for maintaining the privacy of those subjects and the confidentiality of their data. By signing and submitting this DUC, you and your institution are accepting terms for responsibly using human subjects’ data. Read the entire DUC carefully before signing and submitting this agreement. Ensure that all listed Recipients have also read the DUC and have agreed to abide by the terms of the DUC. You and your institution are responsible for the way that all listed Recipients use the data.
The NIH Brain Development Cohorts Data Repository
I request approval to conduct scientific investigation, scholarship or teaching, or other forms of research and research development using data from AI/AN participants in NIH Brain Development Cohorts, and I agree to adhere to the following additional terms and conditions regarding specific use of AI/AN data.
Failure to adhere to these terms and conditions will result in a report to your institution business official. It could also result in denial of access to NIH Brain Development Cohorts data and will be elevated to NIH leadership for further action.
I, and any Other Recipients listed in this DUC, have an approved general DUC for NIH Brain Development Cohorts data use and agree to the following additional terms for using data from AI/AN participants, specifically:
Non-transferability of Agreement
Ethical Use of Data from American Indian/Alaska Native (AI/AN) Participants
Inclusion of participants in research who self-identify as AI/AN is essential for developing solutions to health challenges facing AI/AN communities. Recipients agree to NOT use the data for research that is discriminatory or stigmatizing of individuals, groups, families, or communities. This DUC will be reviewed to protect against potential harm to AI/AN individuals and communities. Recipients agree to follow the code of conduct for the analysis and interpretation of AI/AN data found at [insert link] to ensure data are handled in a way that is respectful of and meaningful to AI/AN communities and is consistent with Tribal sovereignty.
Recipients agree to register pending publications with an online registration platform, such as Open Science Framework (https://help.osf.io/article/330-welcome-to-registrations) upon submission of manuscript for publication, at the latest.
5. Submit Manuscripts Analyzing AI/AN Data for Pre-Publication Review
Recipients analyzing AI/AN data must submit manuscripts for pre-publication review. Please refer to this document (insert link) for instructions on submitting manuscripts for pre-publication review.
6. Term, Access Period, and Renewal
Recipients are granted permission to access requested and approved data from the NIH Brain Development Cohorts for a period of one year and this DUC will automatically terminate at that time. Data access may be renewed upon receipt of a new DUC. Renewal applications will be reviewed to ensure that all terms and conditions of the previous access period have been met.
7. Accurate Representations
Recipients certify that the contents of any statements made or reflected in this document are truthful and accurate.
Request Type: New ___ ___ Renewal: ______
First Name: ______________________ Last Name: _____________________________ Degree: ______
Institution: ___________________________________________________________________________
City: ____________________________ State/Province: _______________________ Country: _______
Describe the purpose of the scientific investigation, scholarship or teaching, or other form of research and research development for which you are requesting access to data from NIH Brain Development Cohorts. Include detailed information about study aims pertaining to use of data from AI/AN participants, including plans for mitigating risk of harm to individuals and communities (See Term #3). ___________________________________________________________________________________
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Researchers who conduct a secondary analysis on shared data, are expected as part of the Terms of Use (above) to report their results (See #12 in the general DUC).
Has a publication, computational pipeline, or other public disclosure of results from the analysis of data accessed from NIH Brain Development Cohorts resulted from a Recipient’s previous access period? Note that publication includes preprint services (e.g., PsyArXiv, BioRxiv). Yes: ___ No: ___
If Yes, have the derived data used in disclosure of results been identified? Yes: ___ No: ___
List the DOI(s):
List the PubMed ID(s) or citation(s): _______________________________________________________
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First Name: ______________________ Last Name: _____________________________ Degree: ______
Phone: _____________________ Email Address: ____________________________________________
First Name: ______________________ Last Name: _____________________________ Degree: ______
Phone: _____________________ Email Address: ____________________________________________
First Name: ______________________ Last Name: _____________________________ Degree: ______
Phone: _____________________ Email Address: ____________________________________________
First Name: ______________________ Last Name: _____________________________ Degree: ______
Phone: _____________________ Email Address: ____________________________________________
First Name: ______________________ Last Name: _____________________________ Degree: ______
Phone: _____________________ Email Address: ____________________________________________
Requests to access data requiring an Institutional sponsorship must list an individual with a signing official role as defined in the NIH eRA Commons - https://commons.era.nih.gov/commons
Name: _____________________ Email Address: ____________________________________________
By signing and dating this DUC to request access to data in the NIH Brain Development Cohorts Data Sharing Platform. I and my Institution Signing Official certify that we will abide by the Data Use Terms and Conditions defined in this DUC. I further acknowledge that I have shared this document with any Other Recipients who will participate in the use of data from NIH Brain Development Cohorts, and that they have read and agreed to the terms of this document. My Institution Official (if required) also acknowledges that they have shared this document with appropriate institutional organizations.
Lead Recipient Signature: ____________________________________ Date: _____________________
Authorized Institution Signing Official Signature (if required): ________________________________
Date: _____________________
File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
Author | Rosen, Rebecca (NIH/NIMH) [E] |
File Modified | 0000-00-00 |
File Created | 2023-09-20 |