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[LT-05] Reversible De-Identification in Clinical...

[LT-05] When a study finds unexpected biomarker risk in 47 of 5,000 participants, researchers need to contact real patients.

April 20, 20269 min skaityti
reversible de-identificationclinical research pseudonymizationpatient re-contact protocolIRB data managementHIPAA reversible encryption

[LT-05]

The Longitudinal Research Problem

Longitudinal clinical research operates on a fundamental tension: participants' identities must be protected throughout the study period to satisfy IRB requirements and maintain participant trust, but the same participants may need to be contacted for clinical follow-up if the research reveals unexpected findings.

An oncology research center conducting a 5,000-patient biomarker study discovers mid-study that 47 participants show markers suggesting elevated...

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