HIPAA Privacy Rule
Research Guidance

WHAT'S NEW? Recent changes and revisions to the HIPAA Research Guide

FREQUENTLY ASKED QUESTIONS

WHY? Overview of the Privacy Rule

WHEN?  April 14, 2003
  Actions needed before April 14, 2003
  Actions needed after April 14, 2003

WHO? Researchers associated with certain parts of the University (including investigators, research staff, postdoctoral fellows, residents, graduate students, undergraduate students, and anyone who uses protected health information (PHI) for research purposes).

HOW?
  Forms:
    Research Authorization
    Combined HIPAA Research Authorization and Common Rule Informed Consent Form
    Application for Waiver of Authorization
    Application for Altered Authorization
    Preparatory to Research Certification
    Database Registration Form
    Data Use Agreement
    Disclosures Log
    Certification for Research on the Protected Health Information of Decedents
    Additional forms available here...
  Other Resources:
    Instructions for Research Authorization
    Database decision tool
    Human Subjects Regulation Chart
WHAT DO I DO?
  Take online training (REQUIRED)
  Read the General Instructions
  Consult the definitions
  Understand key concepts:
    Protected health information (PHI)
    Health care component (HCC)
    Affiliated covered entity (ACE)
    Uses of PHI as distinguished from disclosure of PHI
    Preparatory to research activities as distinguished from research
    Individual rights of subjects and participants
  Seek guidance:
    Planning a project (preparatory to research activities)
    Conducting research
    De-identification of information
    Limited data sets
    Databases
    Accounting for disclosure of PHI
    Re-analyzing data
    Exempt research
    Chart review
    Waiver or Altered Authorization
    PHI of Decedents

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Last updated: September 19, 2003