In addition to submission of a request using UWHC Help Desk Self Service, copies of UW-Madison IRB research protocol, approval and/or certification documents are required for all research requests. The requested forms are required by the University for research activities and should already be completed by any staff engaged in research.
Details regarding the UW-Madison rules can be found on the following Web sites:
- UW-Madison HIPAA Privacy Rule Research Guidance: http://hipaa.wisc.edu/guidance.htm
- Health Sciences Human Subjects Committee: http://info.gradsch.wisc.edu/research/hrpp/hsirbs/index.html
- Required Authorization - All research data requests must be submitted by an appropriate principal investigator or faculty sponsor.
- Consistency with Protocol - Once a protocol has been approved by the IRB, Information Technology Services may only provide the information defined in the protocol. Therefore, it is important to think ahead regarding what data requirements you will have prior to protocol submission. UWHC HelpDesk Self Service is available to researchers who want to determine whether a particular data acquisition methodology is feasible.
- Minimum Necessary For Preparatory to Research requests - Information Technology Services may provide only the minimum amount of data necessary to address the preparatory to research activity. Please be specific regarding the questions you wish to investigate so we can assure we provide you sufficient data to support an answer.
- Processing Time - Allow 2-4 weeks for processing of your data request once all forms and information have been provided to UWHC Information Technology Services. Every effort will be made to fulfill your request as soon as possible, but data delivery time will vary according to the number of requests we receive.
Exceptions - If you believe your research data request is not subject to these requirements, please include an explanation with your data request.
Additional Documentation Requirements for Research Requests
|If your request is for:||In addition to the Data Request Form, please submit:|
Preparatory Information for Research Activities:
Copy of your Preparatory to Research Certification of compliance, on file with the UW-Madison Privacy Officer.
Copy of your Database Registration Form and Preparatory to Research Certification for Database Custodian, on file with the UW-Madison Privacy Officer, if the data query results will be stored in a database.
Protocol-Specific Use and Disclosure
|Limited Data Set
The data you request will lack 15 of the 18 identifiers specified by the HIPAA Privacy Rule (see the full list under De-identified Data). It may include dates (e.g., date of birth, admission, and discharge dates) and some geographic information: city, state and zip code, but not street address.
|UWHC can provide limited data sets without additional IRB documentation. A data use agreement that contains the provisions required by the HIPAA Privacy Rule must be made between UWHC and the researcher.|
|UWHC can provide de-identified data without additional IRB documentation.|