HIPAA


Home › Additional Services › HIPAA


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


Q.    How do I submit a HIPAA Waiver to Quorum? >>
Quorum accepts HIPAA Waivers via the OnQ Portal, email to our Initial Study Support team, fax, or mail.

Quorum Review
Initial Study Support Team
1601 Fifth Ave., Ste. 1000
Seattle, WA 98101
Fax: 206-448-4193
InitialStudySupport@quorumreview.com
Q.    What is the difference between a complete waiver and a partial waiver? >>
A complete HIPAA waiver allows the investigator to use and disclose Personal Health Information (PHI) for a particular research trial without obtaining either a verbal or written authorization from the participants. A partial HIPAA waiver allows an investigator to obtain and use PHI in the course of recruitment without first obtaining a written authorization.
Q.    Which form should I complete if I want to submit a HIPAA Waiver? >>
For a complete waiver, the Request for Complete Waiver of Authorization should be completed. For a partial waiver, the Request for Partial Waiver of Authorization for Research Recruitment Purposes should be completed.
Q.    Who should I contact if I have questions about completing the HIPAA waiver request? >>
Our Initial Study Support team should be contacted with any questions regarding a HIPAA waiver requests. They can be reached by phone at (206) 448-4082 or by email at InitialStudySupport@quorumreview.com.

HIPAA and Recruitment


Q.    When might I need a partial waiver for recruitment purposes? >>
An investigator may need to obtain and use PHI in the course of recruitment without first obtaining a written authorization (e.g., when an investigator wants to conduct telephone screens of potential study participants who are responding to an advertising campaign). Quorum Review IRB encourages investigators to seek partial waivers in conjunction with such recruitment activities.
Q.    What is Quorum’s policy on cold calls for recruitment? >>
Quorum Review IRB discourages investigators from recruiting participants with "cold calls" based on information derived from the medical records of another practitioner when the investigator has no prior relationship with the recruits. Instead, Quorum Review IRB recognizes the ability of a practitioner to discuss with his or her own patient the possibility of participating in clinical research studies. When an investigator seeks a HIPAA waiver/partial waiver for recruitment activities that include "cold calls" to potential recruits, Quorum Review IRB prefers that potential recruits be contacted only by individuals who have been actively involved in providing health care to the potential recruits.
Q.    Are there any state law considerations in regard to HIPAA and recruitment? >>
An investigator must proceed with recruiting carefully in light of the HIPAA Privacy Rule as well as state laws that prohibit the release of PHI. Most states do not allow an exception to confidentiality laws for purposes of recruitment into a research study. This is true even though the federal HIPAA Privacy Rule technically allows partial waivers for recruitment purposes.

HIPAA and Consenting


Q.    Does Quorum review standalone HIPAA documents? >>
No. Aside from HIPAA Authorizations incorporated into consent forms (i.e. compound authorizations) and HIPAA waiver requests, Quorum Review IRB will not review HIPAA compliance documents developed by the investigator. This includes stand-alone HIPAA authorizations.
Q.    My Quorum consent form does not have a section on HIPAA. Do I need to have participants sign a separate HIPAA document? >>
If the model consent does not contain a HIPAA section, your site needs to present HIPAA according to your site’s requirements. The Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) requires investigators who are "covered entities" to obtain a HIPAA Authorization from each participant in a research trial. Obtaining a HIPAA Authorization from a research participant allows the investigator to use and disclose the participant’s protected health information (PHI) for research purposes.