Announcements

Oct 17, 2018 by COMIRB

We have updated the COMIRB template consent forms to remove lines for subjects' initials from each page and remove lines for an investigator signature.

Jul 20, 2018 by COMIRB

COMIRB is piloting a new application form for research involving only the collection and analysis of data collected for another purpose, where a waiver of informed consent is requested.

Jul 20, 2018 by COMIRB

As of July 19, 2018, IRBs are allowed to remove the requirement for continuing review for research eligible for expedited review.

Apr 20, 2018 by COMIRB

The Notice of Proposed Rulemaking (NPRM) to delay for an additional 6 months ((July 19, 2018 until January 21, 2019)).

Jan 17, 2018 by COMIRB

The U.S. Department of Health and Human Services and 15 other federal departments and agencies have announced an Interim Final Rule (IFR) that delays by six months the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149). Most provisions in the revised Common Rule were scheduled to go into effect on January 19, 2018.

Jan 16, 2018 by COMIRB

Bring your lunch and drop in for this open forum discussion!!

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.