NIA Multi-site COVID-19 Related Clinical Trial Implementation Grant on Aging-Related Topics in at-risk Older Adult Populations (R01 Clinical Trial Required)

This Funding Opportunity Announcement (FOA) invites applications for implementation of investigator-initiated multi-site clinical trials (all phases or stages) of interventions focused on specific aging-related issues to reducing transmission, risk, morbidity, mortality, severity, or complications of Coronavirus Disease 2019 (COVID-19). Applications on the following priority topics are invited:

Community Interventions to Address the Consequences of the COVID-19 Pandemic among Health Disparity and Vulnerable Populations (R01- Clinical Trial Optional)

This Funding Opportunity Announcement (FOA) encourages applications to implement and evaluate community interventions testing 1) the impacts of mitigation strategies to prevent COVID-19 transmission in NIH-designated health disparity populations and other vulnerable groups; and 2) already implemented, new, or adapted interventions to address the adverse psychosocial, behavioral, and socioeconomic consequences of the pandemic on the health of these groups.

Who is responsible for obtaining a Data Use Agreement (DUA)?

UA must enter into a Data Use Agreement (DUA) whenever it is transmitting or receiving a Limited Data Set, a type of Protected Health Information (PHI), for research, public health activities or health care operations. 

UA Contract Offices and Principal Investigators (PIs)/Business Owners are responsible for:

1. Determining if a Limited Data Set is involved for a specific purpose (research, public health activities, health care operations), and if so;

What is a Data Use Agreement?

A Data Use Agreement (DUA) is a specific type of agreement that is required under the HIPAA Privacy Rule and must be entered into before there is any use or disclosure of a Limited Data Set (defined below) from a medical record to an outside institution or party for one of the three purposes: (1) research, (2) public health, or (3) health care operations purposes.  A Limited Data Set is still Protected Health Information (PHI), and for that reaso

What is a Limited Data Set?

A Limited Data Set is a data set that is stripped of certain direct identifiers specified in the HIPAA Privacy Rule.  A Limited Data Set may be disclosed to an outside party without a patient’s authorization only if the purpose of the disclosure is for research, public health, or health care operations purposes and the person or entity receiving the information signs a data use agreement (DUA) with the covered entity or its business associate.

How are Limited Data Sets created?

A HIPAA Covered Entity, or a Hybrid Covered Entity like UA, may use a member of its own workforce to create the "Limited Data Set."  Alternatively, the recipient may create the "Limited Data Set," so long as the recipient is acting as a Business Associate or Subcontractor (pursuant to a Business Associate Agreement) of the Covered Entity or Hybrid Covered Entity.  

Where do I obtain a DUA?

1.    When UA is disclosing or transmitting a Limited Data Set to another institution, organization or entity, UA requires that a DUA must be signed to ensure that the appropriate provisions are in place to protect the Limited Data Set as required under the HIPAA Privacy Rule.  Contracting Services maintains a template DUA.  When UA is disclosing or transmitting a Limited Da

If the intended recipient of a limited data set is also creating the limited data set as my business associate, do I need both a Data Use Agreement and Business Associate Agreement?

Yes, you will need both a Data Use Agreement (DUA) and Business Associate Agreement (BAA) because the Covered Entity or Hybrid Covered Entity (UA) is providing the recipient with PHI that includes direct identifiers.  For that reason, a BAA would be required to disclose the direct identifiers to the recipient.

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