HIPAA
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The HIPAA (Health Insurance Portability and Accountability Act) Privacy Rule imposes requirements on certain investigators and research organizations who qualify as "covered entities" to obtain permission before using or disclosing individually identifiable health information (Protected Health Information, or PHI). Before an investigator who is also a covered entity can use PHI in the course of research, including certain recruitment activities and retrospective chart reviews, the investigator must obtain the participant’s written permission to use and disclose the participant’s PHI.
As a matter of policy, Quorum Review IRB prefers that the privacy section of all new consent forms includes language that satisfies the standards of the HIPAA Privacy Rule. Please note that even though Quorum Review IRB reviews HIPAA Authorization language contained within consent forms, it is the investigator’s responsibility to comply with the HIPAA Privacy Rule and any applicable state privacy laws. Investigators are encouraged to seek legal counsel to review any HIPAA Authorization language that is used to ensure that it is adequate for the investigator’s needs and satisfies state privacy laws.
HIPAA Waivers
In some circumstances, it may not be practical for an investigator to obtain a signed HIPAA Authorization prior to the use and disclosure of a participant’s PHI. For instance, for research recruitment purposes an investigator may wish to obtain PHI via telephone screens before the potential research participants visit the research site. Alternatively, an investigator may desire to access PHI contained in patient medical charts for a retrospective chart review study.
In such circumstances, an investigator can apply to Quorum Review IRB for a waiver of the HIPAA Privacy Rule requirements. The Privacy Rule permits investigators to use and disclose PHI for research without a valid HIPAA Authorization so long as an Ethics Review Board determines that specified regulatory waiver criteria are satisfied.
Quorum reviews waiver requests for recruitment activities, retrospective chart reviews, research databases, and other activities. Under the HIPAA Privacy Rule, an Ethics Review Board may approve a waiver or an alteration of the HIPAA Authorization requirement in whole or in part. An application form for a complete waiver or a partial waiver may be obtained by contacting Quorum Review IRB’s Initial Study Support Team or by visiting Quorum Review IRB’s website.
Please contact Quorum Review IRB’s Initial Study Support team with any questions regarding HIPAA waivers.
As Indicated
F-044 - HIPAA - Request for Complete Waiver of Authorization
This application should be used ONLY when a covered entity (research site/Principal Investigator) seeks to waive the requirement to obtain an Authorization before using or disclosing protected health information.
F-045 - HIPAA - Request for Partial Waiver of Authorization for Research Recruitment Purposes
This application should be used ONLY when a covered entity (research site/Principal Investigator) seeks to waiver or alter the requirement to obtain an Authorization before using or disclosing protected health information ("PHI") for the sole purpose of recruiting research participants for a specified clinical investigation.
Guidance
G-043 - Handbook for Quorum Review IRB (Requires an OnQ Portal Account)
The Handbook provides a guide for using Quorum Review IRB as an ethics review board. It contains policies, procedures, and guidelines to be used in preparing materials for Board review, as well as information on managing ongoing research activities, continuing and periodic review, and closing.
HIPAA Waivers
Quorum Review
Initial Study Support Team
1601 Fifth Ave., Ste. 1000
Seattle, WA 98101
Fax: 206-448-4193
InitialStudySupport@quorumreview.com
