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Human Subjects Division (HSD)

Announcements

HIPAA Authorization forms and the UW Clinical Research Center

Apr 23, 2010 at 10:51am

The Issue

The UW Clinical Research Center (CRC) is a unit in the UW Medical Center.  This means that a medical record is created for every subject who comes to the CRC, if the subject does not already have a UW Medicine medical record.  When the CRC staff interact with the subject to obtain research information or conduct any research procedures other than single blood draws, the information from or about those activities goes into the subject's medical record.  When the CRC staff subsequently give the information to the researcher, it is considered to be an access to (and disclosure from) the subject's medical record.   

Also, the occurrence and treatment of any adverse event that happens on the CRC is entered into the subject's medical record and then disclosed to the researcher.  Examples:  fainting during a blood draw, nausea in response to a study drug, or stumbling while stepping off the weight scale.  When the CRC provides the researcher with information about the event and its treatment, this is again considered to be an access to (and disclosure from) the subject's medical record.

This means that the CRC needs a signed HIPAA Authorization from each subject.  

The Process
The following process will be used to address this compliance and subject confidentiality concern.

1      IRB application

A new question has been added to the IRB application.  It asks researchers about their use of the CRC.  If they answer "yes", they are instructed to complete and attach a research HIPAA Authorization form using the template on the HSD Forms webpage. 

2      HIPAA Authorization template

Language about the CRC has been added to the end of section B in the UW HIPAA Authorization template.  Researchers who are using the CRC can chose one of two short paragraphs.  One is for studies where CRC staff are collecting research information or conducting research procedures.  The other paragraph option is for studies where the only possible medical records access & disclosure is for information about adverse events that may occur on the CRC.

3      Institute of Translational Health Sciences (ITHS) Scientific Review Committee (SRC) review  

The SRC review is the process by which a researcher applies for the use of the CRC and associated core ITHS resources.  It typically occurs several months before a study starts.  The researcher is required to provide a copy of the submitted IRB application, resource utilization forms, and other documents specific to the ITHS.  The CRC staff will compare the answer on the IRB question about the CRC with the information in the resource utilization forms.  This will verify the researcher's assessment about what information the CRC staff are disclosing from subjects' medical records to the researcher.  If necessary, the researcher will be directed to submit a Modification to the IRB, for a revised HIPAA Authorization form.

4      Protocol Implementation Meeting (PIM) with CRC Nursing Staff

The PIM meeting occurs just before a study starts.  In this meeting, the researcher and assigned primary CRC Nurse define the roles, responsibilities, and activities of the CRC staff.  This provides yet another opportunity to determine what medical records information is being accessed and disclosed by CRC staff to the researcher.  If necessary, the researcher will be directed to submit a Modification to the IRB, for a revised HIPAA Authorization form.

This process has been approved by the ITHS Clinical Compliance Officer, Research Subject Advocate and staff of the CRC; the Director of the UW Medicine Privacy Office; and the Director of the Human Subjects Division.