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Max Researcher is a pain researcher with an NIH-approved study of post-surgical pain after knee replacement. Max would like to access and analyze data from a Joint Replacement registry containing functional status PROs that were created in a bya State-Funded contract (see PRO registry Creation Scenario). Max is conducting a study on the variability of outcomes after knee joint replacement.
The registry includes records of surgery details and patient reported outcomes PROs that were collected under a variety of agreements. Records included in the registry are subject to different terms governing research use:
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The registry has its own accredited IRB, which all organizations have agreed will approve research activities that involve using the data. Max Researcher receives approval by the registry IRB and her own IRB for an NIH-funded research protocol that involves selecting all knee replacement patients and contacting them for an interview about post-surgical pain. The researcher pays a small fee to the registry to cover the costs of data management and registry overhead costs.
Questions:
- Given that the data in the registry is obtained under a mixture of informed consent, waivers, and business associate agreements, how should these conditions be tracked?
- Given that the registry contains PRO data, which in some cases patients have consented for research use (and in other cases not), what, if any, are the researcher’s obligations for the use of data without explicit patient consent? How should the entity managing the registry deal with consent and data use?
- Does the fee affect real or perceived ethical concerns?
- Would concerns be different if the research obtained IRB approval had been obtained for use of deidentified data, with some concerns for re-identification?
- Do concerns differ if the PROs included include instruments intended to measure post-surgical depression?
- What additional protections must be in place given the availability of the limited data set?
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Title | Response |
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 |
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Post conditions |
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Alternatives |
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Considerations |
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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
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Purpose of Data Use | Analysis under a specific research protocol |
Terms of Transfer to the Data Holders | DUA between organizations, informed consent |
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Terms of Transfer to Researchers | IRB approval and terms of consent or other agreements |
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