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 | - All parties obtain all legally required authorizations for health data linkage and transfer (consent only, no DUA/BAA).
- The IRB approved research protocol specifies terms of consent and data release.
- Data requests use unique identifiers to protect the identities of patients so they cannot be re-identified.
- A child/adolescent’s parent or legal guardian will provide proxy consent for enrollment in the Study.
- When the patient reaches the legal age of consent, the Covered Entity or the researcher contacts the patient to update their consent to release their records and use their data as outlined in the research protocol.
- The Covered Entity and the researcher transmit the updated consent documents to the CC.
- The Covered Entity or the researcher suspends data collection if a patient reaches the legal age of consent and does not update their consent.
|
Postconditions | - The CC receives the consent information.
- The Covered Entity continues to transmit the participant’s healthcare records to the CC in a standardized format consistent with policy and protocol.
- The Covered Entity or the researcher sends any data that was not pulled in the interim period between the patient’s shift in age and reconsent to the CC.
|
Alternative | - The patient who has come of age has sensitive information that was collected while they were a child in the Study Cohort. The patient would like this information removed from records once they reach the legal age of consent.
- In a Continuing Review conducted annually by the IRB, the research team reports information considered to be sensitive, and this changes the risk level of the study. Data management protocols are changed accordingly.
- The patient who is not yet of age disagrees with parent on terms of consented data use.
|
Considerations | - Both assent from the child and permission from a parent is required
- If a child does not assent, that takes precedence over a parent’s permission
|
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 |
Terms of Transfer to Researchers | IRB approval |
