Description | A registry contains health data and PROs approved for research purposes, and each record has been approved under different conditions. |
Primary actor/participant | Researcher (end-user) using registry |
Support actor/participant | Registry-affiliated entities who submit clinical data, patients who submit PRO data |
Preconditions | - Registry has been created with all necessary approvals
- Approval of research protocols by IRB
- Payment to cover costs of data extraction has been obtained
- The registry manages the data submitted by participating data sites, and manages that store relevant information for a given protocol/study.
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Post conditions | - The researcher accesses registry data electronically by the researcher (clinical data, and PROs).
- Researcher has access to data set and is able to analyze/combine them for a specific research study.
- Researcher contacts patients and collects additional PRO data.
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Alternatives | - Max is a member of the public interested in analyzing registry data.
- Max’s study does not involve contacting patients, but analysis of a limited data set with some risk of re-identification.
- No fees are charged.
- PROs contain measures of substance misuse/substance use disorders relevant to pain treatment that may have implications beyond screening for depression.
- PROs include measures of depression as well as functional status.
- Do other concerns apply if data submission to the registry is mandated by state law?
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Considerations | - Tracking conditions for the registry data that is obtained under a mixture of informed consent, waivers, and business associate agreements
- Researcher’s obligation, if any, to obtain explicit patient consent for the data patients may or may not have consented for research use
- Whether the PROs include instruments intended to measure post-surgical depression
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Data Elements Considered | Electronic data from multiple sites and patient reported outcomes, |
Purpose of the Data Collection | Improved clinical care and patient outcomes |
Purpose of Data Use | Analysis under a specific research protocol |
Terms of Transfer to the Data Holders | DUA between organizations, informed consent |
Terms of Transfer to Researchers | IRB approval and terms of consent or other agreements |