Data Broker Corner: Data Requests for Reviews Preparatory to Research
The Data Broker Group is here to provide a variety of data services for the University community at large. A main function of the Data Broker Group is to provide both a centralized and standardized review of clinical data requests to ensure approved, authorized releases of such data. For research related requests typically require an IRB approved protocol. Alternatively, if the data is needed more to determine feasibility for a potential study, then such a request is described as “Reviews Preparatory to Research.”
Under HIPAA regulation (45 CFR 164.512(i)(1)(ii)), covered entities may permit researchers to use protected health information (PHI) for preparatory to research purposes if the covered entity obtains assurances from the research that –
- Use or disclosure of PHI is solely to review PHI that is necessary to prepare a research protocol or other similar purposes for research preparation (i.e., determining feasibility, identifying potential research subjects, etc.).
- No PHI will be removed from the covered entity by the researcher during the review.
- The PHI requested is necessary for the research purposes.
The University’s Human Subject Research Office (HSRO) permits the use of PHI for reviews preparatory to research. Per the UM HSRO HRP-103 Investigator Manual (Revised 12-03-2019); investigators may use the exception to the requirement for a HIPAA Authorization for purposes preparatory to research by completing and submitting the Certification for Reviews Preparatory to Research (Form E) (p 28) to the IRB via email. Receipt and acknowledge of this certification permits access to PHI for subject identification, assessing feasibility and other activities in preparation for research (p 55).
To request data for research preparations, e-mail a data request to firstname.lastname@example.org, cc’ing the data broker group (email@example.com). To reduce processing time, please include the following information in the e-mail:
- The reason for the request (Review Preparatory to Research);
- A copy of the IRB-approved Form E
- What inclusion/exclusion criteria should be used to create the data extract (i.e., patient demographics, date of service range, CPT Procedure Codes, ICD Diagnosis Codes, provider name, service location, etc.). The inclusion criteria must be clear and explicit so that an accurate data extract can be created; and
- What columns/fields should be included in the data extract (i.e., MRN, date of service, ICD Diagnosis Codes, CPT Procedure Codes, patient demographics, service location, etc.).
As always, such data needs to be adequately safeguarded at all times – See Best Data Practices for more information.
For further information on the Data Broker program please contact the UHealth Privacy Office at 305-243-5000 or at firstname.lastname@example.org. For questions regarding IRB submissions, contact the Human Subject Research Office at 305-243-3195.