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Related Experiment Video

Updated: Jan 20, 2026

FDA Approved Drugs: Changes to Approved Drugs

FDA Approved Drugs: Changes to Approved Drugs

Published on: October 2, 2025

Content Among Locally Approved HIPAA Authorization forms for Research.

Peter Breese¹, Cornelis Rietmeijer, William Burman

¹Denver Public Health and University of Colorado Health Sciences Center.

Journal of Empirical Research on Human Research Ethics : JERHRE

|April 24, 2009

Summary

HIPAA authorization forms for clinical research met core requirements but often used complex language. Confusion over personal identifiers and data use may concern participants.

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Milgram's Experiment on Obedience to Authority

Milgram's Experiment on Obedience to Authority

Area of Science:

Health Law
Clinical Research Compliance
Informed Consent

Background:

The Health Insurance Portability and Accountability Act (HIPAA) mandates specific authorization forms for clinical research.
Ensuring participant understanding of data usage is crucial for ethical research conduct.

Purpose of the Study:

To evaluate the content and clarity of HIPAA authorization forms used in clinical research across various institutions.
To identify variations in form content and potential areas of participant confusion.

Main Methods:

Collected and analyzed 111 HIPAA authorization forms from academic medical centers and commercial Institutional Review Boards.
Assessed forms for specific required elements, including data use descriptions and distinctions between personal and aggregate data handling.

Main Results:

All forms described data to be collected (100%) and addressed information use (95%).
Only 19% of forms differentiated between entities accessing personal identifiers versus aggregate data.
Significant variations were found in disclosure agreement durations, and complex legalistic language was prevalent.

Conclusions:

While HIPAA authorization forms meet technical requirements, complex language and ambiguity regarding personal identifiers may hinder informed consent.
Further refinement of authorization forms is needed to enhance participant comprehension and trust in clinical research.