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Reg-ent within the Learning Health System.

Kayte Spector-Bagdady1,2, Andrew G Shuman1,3

  • 11 Center for Bioethics and Social Sciences in Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.

Otolaryngology--Head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery
|March 2, 2018
PubMed
Summary

Clinical data registries, like the American Academy of Otolaryngology-Head and Neck Surgery Foundation

Keywords:
data registryelectronic medical recordinformed consentlearning health systemresearch ethics

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Area of Science:

  • Health Informatics
  • Medical Ethics
  • Patient Engagement

Background:

  • Electronic medical records facilitate powerful clinical data registries.
  • The Reg-ent system by the American Academy of Otolaryngology-Head and Neck Surgery Foundation aligns with learning health system principles.
  • Deidentified data in registries generally do not require research informed consent.

Purpose of the Study:

  • To explore ethical considerations surrounding patient notification and consent for deidentified data in clinical registries.
  • To address patient perspectives on consent for deidentified research data.
  • To ensure responsible development of the Reg-ent clinical data registry.

Main Methods:

  • Analysis of ethical implications of deidentified data use in clinical registries.
  • Consideration of patient survey data regarding consent preferences.
  • Review of best practices for patient engagement in health data systems.

Main Results:

  • While legally exempt, ethical concerns persist regarding patient notification and consent for deidentified data.
  • A significant minority of patients believe consent is necessary for all research protocols, even with deidentified data.
  • Data breaches pose a serious risk, highlighting the need for robust data security and patient trust.

Conclusions:

  • The American Academy of Otolaryngology-Head and Neck Surgery Foundation should prioritize patient engagement best practices for the Reg-ent registry.
  • Ethical frameworks must evolve to address patient perspectives on data use, even when deidentified.
  • Balancing research utility with patient rights is crucial for the sustainable growth of clinical data registries.