Before you begin the Data Use Certification (DUC) process, please do the following:

1. Make sure that you meet the following access eligibility requirements: 
   • You must have a research-related need to access the data. 
   • You must be associated with an NIH-recognized research institution and have the approval of an authorized signing official (SO) from your institution. Visit Signing Official (SO) on eRA Commons to learn about institutional signing officials. 
   • Your institution must have an active Federalwide Assurance (FWA). 
2. Identify an authorized SO at your institution.
   If you are unsure of who at your institution is an authorized SO, do not know whether your institution has an FWA, or have any other questions, please contact your institution’s grants office. ‍
3. Decide whether to submit an individual or group-level DUC.
   Users may submit either an individual or Investigator-led group DUC. Users may submit a DUC either as an individual recipient or as a PI with others from your institution listed on the same DUC. Trainees must be on a group-level DUC. For group-level DUCs, the lead PI must ensure that all listed recipients on the DUC comply with its terms and conditions. Note: Recipients may only be listed on one DUC.‍
4. Check whether you will need to submit a second DUC.
   Recipients who intend to disseminate findings from analyses of American Indian/Alaska Native (AI/AN) data separated out from other groups in presentations, pre-prints, publications, website posts, etc. must submit a second DUC governing use of AI/AN data (A-DUC) after obtaining approval on the general DUC.
5. ‍Before you begin the DUC process, please review the new NIH security requirements for controlled access data.
   NIH expects that users comply with NIH Security Best Practices for Users of Controlled-Access Data and maintain such data on institutional IT systems, cloud service providers, and/or third-party IT systems with security standards that meet or exceed NIST SP 800-171 or the equivalent standards. Please see this summary for detailed information.

Once you have an account and have logged into the Lasso Informatics platform, please follow these steps to request access to the data. 

Select Data Access from the left-hand menu followed by Request access in the lower right-hand corner of the page. You can then either choose an Individual DUC or an Investigator-led group DUC. For an Investigator-led group DUC, there will be an extra step where you will need to enter names and emails of your team members who need access to the NBDC data.  

This will bring you to the first of four forms of the Data Use Certification (DUC) to fill out before review and submission. Fill out the information as follows: 

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Form 1: Lead Recipient 

Provide information for all required fields, marked with an asterisk ( * ), including Name, Degree, Institution, and Address. Once complete, select Continue (lower right-hand corner of the page). 

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Form 2: Research Data Use Statement 

This form asks you to describe (within a limit of 250 words) why you need access to the dataset. Once complete, select Continue (lower right-hand corner of the page). 

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Form 3: NIST 800-171 Compliance  

This form requires you comply with the NIST SP 800-171 or the equivalent ISO/IEC 27001/27002 Security Standards as required by NIH Security Best Practices for Users of Controlled-Access Data.  

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Form 4: Authorized Institutional Business Official 

Provide the (1) name and (2) email address of the Institutional Signing Official for your institution who will be authorizing your access and has signing authority (both fields are mandatory). Once complete, select Submit in the lower right-hand corner of the page and the following screen will appear: 

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This section of the DUC process asks you to agree to electronically signing the DUC. If you wish to proceed with signing, follow these steps. 

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1. You will see the form that requires your signature. Read through the DUC and select START once you are ready to apply your electronic signature:

2. Input your full name and initials in the fields of the following Adopt Your Signature dialogue box that appears:

3. Select ADOPT AND SIGN to apply the signature to the document signature page.

4. Select FINISH in the upper right-hand corner of the page to submit the signed document.

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After submitting the DUC, DocuSign automatically notifies the SO at your institution to add their signature, after which it is automatically routed to the NBDC Data Access Committee (DAC) for final review. You will receive an email notification once approved and will be prompted to undergo mandatory training on responsible data use after signing into the platform. Once this training is complete, you will have access to the requested data.

After obtaining DUC approval, users must complete mandatory training on responsible data use to gain access to the data.

Access is valid for one year. To maintain access, recipients must submit a renewal request before the DUC expires. If the DUC expires prior to a renewal request being submitted, a New Request submission will be required.

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The submitted DUC is required to be signed by a SO in order to be routed to the Data Access Committee (DAC) for final review. SOs receive an automated email from DocuSign asking for their review and signature each time a new DUC is submitted. If you are an SO, please follow the steps below to complete the DUC: 

1. Open the email received from Lasso Informatics via DocuSign. 
2. Select REVIEW DOCUMENT.
3. Select the Electronic Record and Signature Disclosure checkbox. REMINDER: The checkbox must be selected in order to enable the CONTINUE button.
4. Select CONTINUE.
5. Select START.
6. Review the document.
7. Sign the document to approve or, if you choose to decline to sign, select Decline to Sign from OTHER ACTIONS drop-down list in the upper right-hand corner of page. In the same document, the SO will also need to confirm that the user will comply with the NIST Security Standards.
8. Select FINISH.
9. Wait for the NBDC Data Access Committee (DAC) to approve the request.

You will receive an email from us with instructions and a link to the training. 

Even if your DUC has been approved by NIDA, you will not gain access to the data until you: 

1. Complete the required “NBDC Responsible Data and Biospecimen Use  Training.”
2. Score at least 90% on the Responsible Data Use quiz included in the course. 

Users will have unlimited attempts to pass the Responsible Data Use quiz. Access is only granted once both the DUC is approved and the training is successfully completed. 

If you've completed training but still don't have access, double-check that you met the 90% quiz score requirement. 

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NOTE: Subapplicants will not receive a training email unless they have first signed into the NBDC Datasharing Platform. They must authenticate via RAS before they can be notified. PIs should ensure their subapplicants sign in so they can receive timely notifications regarding their Data Use Certification (DUC) status.

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