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
Return to HIPAA Research Guide main page
Questions or comments?
Contact us
.
Last updated: September 19, 2003
HIPAA
Privacy Rule
