Grant Admin News: New Regulations for Research with Human Subjects

[Research Services <Research_Services@orsa.uoregon.edu>]

February 13, 2003

 

 

New Regulations for Research with Human Subjects under HIPAA

 

HIPAA, or the Health Insurance Portability & Accountability Act of 1996,
is now applicable to research involving human subjects in specific
circumstances.  The Act includes a Privacy Rule that restricts
disclosure of protected health information (PHI) for individuals, and
the Rule is effective for research projects on April 14, 2003.  

 

Researchers must comply with the new rules if they are currently
accessing or may want to access protected health information on
individual research subjects from "covered entities" (includes doctors,
hospitals, mental health providers, billing services, and insurance
carriers), whether obtaining PHI directly from those covered entities or
through a collaborator on the project who accesses PHI for the project.
The Privacy Rule under HIPAA requires legal descriptions in the consent
form and in the "authorization for release of records form" for each
research subject.  The UO Compliance Office for Human Subjects is
working on acceptable language and will have it available in the near
future.  

 

Improper disclosure or use of PHI without a signed release for that
purpose can result in very large fines and up to 10 years imprisonment
of the individual researcher.  For additional information on HIPAA, the
Privacy Rule or PHI, contact Juliana Kyrk at 6-3106 or email
<mailto:Juliana_Kyrk@orsa.uoregon.edu> Juliana_Kyrk@orsa.uoregon.edu.

 

-------------------------------------------------------------------

To be removed from this list, forward this message

to: Research_Services@orsa.uoregon.edu

subject: unsubscribe grant-admin-news

text: Please add your name and telephone number to the beginning of the
message