Announcements

Dec 18, 2017 by COMIRB

InfoEd now offers the submission type "Study Closure." Please select "Study Closure" when closing out an expedited or full board study.

Nov 13, 2017 by COMIRB

The FDA updated Form 3629 (Individual Patient Expanded Access Investigational New Drug Application) and related guidance documents (e.g., Guidance on Expanded Access to Investigational Drugs for Treatment Use, June 2016) in October, 2017.

Aug 28, 2017 by COMIRB

The U.S. Food & Drug Administration has released a new guidance document titled “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects.”

Aug 25, 2017 by COMIRB

Effective Monday, September 5, 2017, COMIRB will only review and approve updates or changes to individuals in the roles of: Principal Investigator, Co-investigator, Primary Contact, or Faculty Mentor.

Jun 1, 2017 by COMIRB

COMIRB no longer requires a signature line from the Principal Investigator or designated co-investigator on consent and assent forms. The regulations do not require that these lines be present

May 31, 2017 by COMIRB

COMIRB welcomes its new Assistant Director, Catherine Sutherland.