1. Requests that are preparatory for research – This is sometimes described as “cohort identification” and is the process by which an investigator assesses the number of subjects in the CRDW meeting given criteria to determine whether the planned research is feasible.
     
  2. Requests for de-identified data – An investigator may request de-identified data for a cohort, which may not include any protected health information (see Table 1 of this protocol for a complete list). Since the data set is de-identified, it will not be possible to re-identify the data, and therefore, it will not be possible to receive data updates or supplement the data set with additional data elements at a later date.
     
  3. Requests for coded data – This is similar to number 2, but in this case, the investigator may request the data for a cohort in a coded, rather than a de-identified, manner. The data request will not include any protected health information and will remain with the Honest Broker Staff. The investigator may not request and will not ever receive re-identification of the data set. Because the data are coded with an anonymous ID, updated data could be provided on an ongoing basis.
     
  4. Requests for a limited data set – This is similar to number 3, but may include specific dates, date ranges and zip codes as defined by HIPAA regulations (see definitions).The data request could be a snapshot of what is available at the time of request or updated data could be provided on an ongoing basis. The investigator may not request and will not ever receive additional subject identifiers.
     
  5. Subject identification for possible participation in a specific research project – In this purpose, individual patient contact information is provided to the investigator, such that subjects can be approached for their interest in participating in a clinical or translational research project.
     
  6. Data requests for an investigator defined identified cohort – The investigator defines a group of identified human subjects for which a specific set of data is requested. The identified cohort could be individuals that have provided consent in the context of an approved IRB protocol, individuals identified through one of the above processes or individuals identified through the investigator’s clinical activities. The data request could be a snapshot of what is available at the time of request or updated data could be provided on an ongoing basis.