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- How often does the Covered Entity or the researcher need to obtain consent? Quarterly? Yearly? Is it legal and/or ethical to ask for perpetual consent?
- At what age should a child’s assent factor into the consent process, in addition to the parent or legal guardian’s consent? At what age is there a dual responsibility?
- What are the obligations of the Covered Entity and/or the researcher to end the data flow once consent has expired when a participant reaches the legal age of consent?
- What procedures should there be for the data itself and how it is preserved, protected or destroyed when reconsent is not obtained. Are there laws that address retention that we need to account for here?
- Are there additional state law restrictions beyond the legal age of consent that would preclude a researcher from tracking down a participant for reconsent?
- Acknowledging that information systems that the Covered Entity and the researcher have access to are imperfect and resources are limited, how should they parse out the shared responsibilities of managing consent for (a) data release and (b) data use for minors as their consent status changes with age?
- What technical specifications are necessary to carry out the provisions in the research protocol for the Covered Entity’s or the researcher’s Information Systems?
Title | Response |
Description | The Covered Entity must obtain authorization from the patient or the patient’s parent/legal guardian to release their records. The researcher must obtain consent from the patient or the patient’s parent or legal guardian to use their data for the study, in a manner consistent with the terms of consent included in the IRB approved research protocol. |
Primary actor/participant | Covered Entity, Researcher |
Support actor/participant | Information System(s), Coordinating Center |
Preconditions |
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Postconditions |
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Alternative |
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Considerations |
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Data Elements Considered | Healthcare records, Study Data |
Purpose of the Data Collection | Clinical care, administrative purposes, research |
Purpose of Data Use | Data registry |
Terms of Transfer to the Data Holders | Patient authorization
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Terms of Transfer to Researchers | IRB approval |
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