Accessing Patient Information
If you will be accessing patient information, before you embark on any research activities, including
- review of EMR to see if your project is feasible within our system
- collection of data that you may later tap to support a research project
you must file a HIPAA privacy representation form and/or obtain prior IRB approval.
Collection of data for research purposes may be performed in several ways:
1. Collection of data only to establish feasibility of a project with no retention of the data beyond feasibility phase of proposal development.
EXAMPLE 1: You wish to determine whether there are enough patients diagnosed with a specific condition to support that there is a sufficient number of subjects that will need to be included in the research project you are planning. In this case, an electronic search may be requested.
EXAMPLE 2: You wish to determine how reliable specific information you are planning to abstract from the EMR is captured and you want to do a trial abstraction on a representative number of charts with no intention of keeping the data.
If you are planning on performing research feasibility without retention of identifiable patient data, a HIPAA Representation Form must be filed. If you are accessing protected health information through the Data Warehouse on-line data request form, the HIPAA Representation Form is built into the electronic request. If you are accessing protected health information in any other way, please contact the Office of Research Integrity and Protections for a HIPAA Researcher Representation Form.
This short form alerts the Institute Offices of your research activities with no further IRB review required and ensures compliance with the HIPAA Privacy Rule.
2. Collection of data with the intention to retain the data for future research use
EXAMPLE: The information you are seeking to access is labor intensive and time consuming to retrieve and you therefore wish to retain your initial feasibility data set and add to it to accomplish your full study. If you wish to retain data, you must file the following IRB form and gain IRB approval prior to collecting the data: IRB Application - Observational, Data or Specimens
3. Collection of data over time which you may wish to store and access for one or more projects.
EXAMPLE: This might include collection of patient data associated with establishment of a cohort of patients with a common condition. Information that you may wish to store for future use should be collected into an IRB-approved research database. To establish such a database, the following IRB form must be completed prior to collection of the data: IRB Application - Databases_Specimen Repositories
For additional information regarding accessing patient information or other issues related to human subjects in research, please click here to access the website of the Office of Research Integrity and Protections.