1. Investigators must e-mail a Letter of intent (LOI) to empowr@emory.edu for Oversight Committee (OC) review.
- The goal of this LOI is to ensure that the proposed research is sufficiently independent of other approved research proposals.
- The LOI should document the objectives of the study, study design, variables to be requested, and a rational for why the EmPOWR registry & repository is needed.
- The LOI must be reviewed and approved by the OC prior to any IRB applications or completion of the full research application.
- For all applications, the Principal Investigator (PI) must include an attachment containing the data fields to be requested from the registry. The registry fields supplement will be provided at the time of LOI approval, however the EmPOWR Registry Codebook is currently available on the website for your reference.
- If you are requesting de-identified data and/or samples, you do not need to seek IRB approval and can submit your application after receiving LOI approval.
- If you are seeking Protected Health Information (PHI) from the EmPOWR registry and/or repository, you must apply for IRB approval after your LOI is approved. You must also attach your IRB Approval Letter and IRB Approved Research Protocol when you submit the application form.
Please refer to the decision tree below to determine whether you need to provide additional IRB information along with your application.
3. Once the application has been approved, requested registry data for your specified patient population will be delivered to the PI in a secure Emory Box folder. Data will be de-identified unless otherwise approved by the IRB and OC. Pick up or delivery of repository samples will be coordinated on a case-by-case basis with the EmPOWR coordinator.