- Is individual patient consent required for
providers to enter data into the registry?
short answer is “no.”
registry has been determined “not human subjects research” under US Federal
Guidelines by at least two entities, UCSF and UT Southwestern. This category covers activities such as
quality improvement and surveillance.
least one entity, Partners Healthcare, has determined that the registry was
exempt. This category covers secondary research for which consent is not
I view the IRB materials? Applications and determination letters from
academic entities can be requested from the Alliance by emailing email@example.com.
I need to get approval from my local IRB in the USA? U.S. entities
generally recognize our existing IRB approvals, and you should not need additional
approvals. However, some academic institutions may have special requirements. Most
local IRB reviews and determinations have been made quickly, often within a few
- I am in private practice, do I need to request separate IRB approval to enter cases? There is no need for seeking an additional IRB, as the UCSF IRB should cover those in private practice.