COVID-19 (Novel Coronavirus): Please click here for FAQs: Impact of COVID-19 on Human Subjects Research

Clinical Research Times

September 22, 2020

Dear Colleague:

Effective October 1, 2020, a significant change in our policy goes into effect:  Studies involving the use of publicly-available information must now be submitted to the IRB even if the study meets the criteria for Not Human Subjects Research.  Many study teams already routinely submit such studies.  The change is that a submission will now be required.    Examples of such projects include observation of public behavior and analysis of public data sets or social media postings.   The IRB’s review will assess whether the information being used does qualify as publicly available and whether any additional safeguards are needed.  Find out more about this new requirement in this month’s Feature Article.

Also check out:

  • “Dear IRB” on resuming in-person interactions, and establishing a research repository
  • “Things to Know” on new HRPP staff, and alternatives to IRB Office Drop-in Hours

Learn more at

John Ennever, MD, PhD, CIP, CR TIMES Editor
Director, Human Research Protection Program
Office of Human Research Affairs