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Informed Consent: Does Anyone Really Understand What Is Contained In The Medical Record?

S H Fenton1, F Manion2, K Hsieh1

  • 1UT School of Biomedical Informatics , Houston, Texas, United States.

Applied Clinical Informatics
|October 9, 2015
PubMed
Summary
This summary is machine-generated.

Research consent documents often use ambiguous terms like "medical record" to describe patient data. This can lead to misunderstandings about data scope in research, impacting data governance and compliance with regulations like HIPAA.

Keywords:
Medical recordsinformation managementinformed consent

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Area of Science:

  • Health Informatics
  • Clinical Research
  • Data Governance

Background:

  • Standard definitions for health data terms (e.g., electronic health record) are inconsistently applied.
  • Ambiguous terminology in research consent forms hinders data availability and reuse for initiatives like biorepositories and learning health systems.
  • Lack of clear definitions raises concerns about participant understanding of data scope in research.

Purpose of the Study:

  • To explore the terminology used in research informed consent documents for describing patient data.
  • To assess if the term "medical record" accurately reflects the scope of data involved in research contexts.

Main Methods:

  • Reviewed informed consent document templates from 17 Institutional Review Board (IRB) websites.
  • Searched for terms describing data resources within consent documents.
  • Utilized the National Library of Medicine's Terminology Services for definitions from standards groups.

Main Results:

  • Research consent documents frequently employ outdated and ambiguous terms, such as "medical record".
  • Existing healthcare terminology systems may not adequately address the specific use cases within research.
  • There is a need to ensure contemporary activities like biorepositories align with regulations such as the HIPAA Omnibus Rule.

Conclusions:

  • The term "medical record" is insufficient for contemporary information management and governance in research.
  • Healthcare terminology requires context-specific definitions for research applications.
  • Updating consent documents and terminology is crucial for effective data governance and regulatory compliance.