In a field full of acronyms, here are two more. GDPR refers to the European Union’s General Data Protection Regulation and SPIND refers to Single Patient Investigational New Drug application, which is a type of expanded access program for investigational drugs.
We now have available some good resources about the GDPR and SPINDs. The GDPR resource is an article that gives a nice recap about the regulation and its applicability. The SPIND guidance is from the Food and Drug Administration and provides background about the submission and review of these applications. We at the IRB find this FDA resource particularly helpful, since there are at least two types of SPINDs and we have to look up the correct review path every single time one crosses our desk, it seems.
The GDPR is relevant to researchers working in, or with collaborators in, the European Union. SPINDs come into play when our providers want to make an investigational drug available to a patient outside of a clinical trial. Please keep these references in mind when you need to look up these topics in a hurry.