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Table of Contents

Introduction

What is HIPAA?

What is PHI?

What is a covered entity?

What research activities are covred by HIPAA?

Impact on Research Protocols

Requirements for Research Use of PHI

Research Using or Creating PHI of Living Individuals

Consent Obtained Prior to April 14, 2003

Research Under a Participant's Authorization

Waiver of Authorization

Activities Preparatory to Research

Research on Decedents

Recruitment

De-identified Data

Limited Data Sets

Studies Exempted from IRB Review

Databanks and Repositories

International Research

Resignations of Investigators or Research Staff

Patient's Rights Provisions in Research Studies
Privacy and Security Measurers
Resources and links
Researcher Certification




Human
Investigation Committee
Yale University
School of Medicine
47 College Street,
Suite 204
New Haven, CT
06520-8010 USA


Phone:
(203) 785-4688


Fax:
(203) 785-2847





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YSM - HUMAN INVESTIGATION COMMITTEE.

HIPAA In Research Contacts and Links


Human Investigation Committees ( School of Medicine)
47 College Street, Suite 204
P.O. Box 208010
New Haven, CT 06520-8010
Phone: (203) 785-4688
Fax: (203) 785-2847
http://info.med.yale.edu/hic

 

Human Subjects Committee (Faculty of the Arts & Sciences)
155 Whitney Ave., Room 210
New Haven, CT 06520-8337
Phone: (203) 436-3650
Fax: (203) 432-4033
email: human.subjects@yale.edu

http:/www.yale.edu/hsc

 

Human Subjects Research Review Committee (Yale School of Nursing)
100 Church Street South, Suite 200
P. O. Box 9740
New Haven, CT 06536-0740
Phone: (203) 737-2371
Fax: (203) 737-4480
email: sarah.zaino@yale.edu

 

Yale University HIPAA Privacy Office
155 Whitney Ave., Room 210
New Haven, CT 06520-8337
Phone: (203) 436-3650
Fax: (203) 432-4033
email: hipaa@yale.edu

 

Yale University HIPAA Web Site
http://hipaa.yale.edu/

 

U.S. Department of Health & Human Services, Office of Civil Rights, (OCR)
http://www.hhs.gov/ocr/hipaa/privacy.html

 

U.S. Department of Health & Human Services, Office for Human Research Protections (OHRP)
http://ohrp.osophs.dhhs.gov/

 

Researcher Certification for HIPAA Privacy Rule Training Compliance with HIPAA in Research Projects

 

This guidebook will be regularly updated. Please be sure to check the HIC and HIPAA websites at the URL listed above for the most recent copy.

 

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