HIPAA Privacy Rule Policy

The HIPAA privacy rule states that a covered entity must obtain written authorization from a patient to use or disclose his/her identifiable health information for research purposes, and also must employ certain safeguards to protect this information from unauthorized disclosure. The covered entity is responsible for ensuring compliance with the privacy rule and this responsibility cannot be transferred to a third party.

These privacy protections supplement the existing federal human research policies, including IRB oversight. The purpose of IRB oversight is to ensure that appropriate measures are in place to minimize risks and maximize protection of human subjects and to protect the subjects' rights and welfare during participation in a research study. Right to privacy and risks to confidentiality are among the many aspects evaluated by an IRB and the privacy rule prescriptions will support and guide Goodwyn IRB evaluations.

Impact on Goodwyn IRB Procedures

HIPAA Privacy Rule, Research and the IRB

HIPAA and Research - Quick Reference Guide

Application for Waiver of HIPAA Authorization