Frequently Asked Questions (FAQ) Regarding IRB Approval for Rheum-Covid Registry Participation

  •  Is individual patient consent required for providers to enter data into the registry?
    • The short answer is “no.”
    • The 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.
    • At least one entity, Partners Healthcare, has determined that the registry was exempt. This category covers secondary research for which consent is not required.
  • Can I view the IRB materials? Applications and determination letters from academic entities can be requested from the Alliance by emailing
  • Do 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 hours.
  • 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.